Preparation of the polidocanol foam according to Tessari technique immediately before application (so that the "microbubbles" of the foam did not disintegrate);
Application according to the Blanchard technique (Fig. 2) through a disposable transparent anoscope, with the patient in jackknife position, using a 20mL disposable syringe of the mixture (polidocanol + air) and a reusable 10 cm syringe extender adapted to an intravenous needle;
Patients treated in a maximum of 3 sessions at 3 weeks intervals;
Maximum dose per treatment session of 20mL of mixture of 4mL of polidocanol 3% with 16mL of air;
In each session more than one hemorrhoid cushion could be treated.

Use of reusable metal ligation device connected to a vacuum system (McGown suction method) to apply the rubber bands above the dentated line through a disposable transparent anoscope with the patient in jackknife position;
A maximum of 3 sessions of ligation at 3-week intervals were performed;
More than 1 band per session could be applied.

Hemorrhoids, Internal

Two distinct periods were considered: intervention and follow-up. During the intervention period patients were observed at 3-week intervals (minimum of 3 weeks and maximum of 9 weeks depending on the number of instrumental treatments performed). The required number of sessions of any of the office-based treatments (maximum of 3 sessions) was determined by clinical and anoscopy response (if after the treatment the participant scored zero points in the Sodergren scale or the anoscopy did not reveal significant hemorrhoidal disease, there was no place for additional instrumental therapy and the patient started the follow-up period.
If there was therapeutic failure at the end of the third session or if there was a significant complication (moderate or severe) the patient's participation in the study ended and he was referred for treatment with other type of office-based procedure or surgery.

Polidocanol Injectable Foam

Rubber band ligation

Centro Hospitalar Universitário do Porto

Polidocanol Foam Versus Rubber Band Ligation in the Treatment of Hemorrhoidal Disease

Sclerotherapy With Polidocanol Foam Versus Rubber Band Ligation in the Treatment of First, Second and Third-Grade Hemorrhoidal Disease: a Randomized, Controlled Trial

Achievement of therapeutic success. Classified as:
Complete (Sodergren score = 0 and bleeding grade ≤ 1);
Partial (Sodergren score> 0 and bleeding grade > 1 but with improvement over initial score);
Therapeutic failure (participants that, at the end of three sessions of instrumental treatment, aggravated or maintained the initial Sodergren score and bleeding grade).

Recurrence of hemorrhoidal disease during the follow-up period (only for patients who have had some degree of therapeutic success). Classified as:
Mild (Sodergren score and bleeding grade higher than the evaluation at the beginning of the follow-up period but lower than the initial ones without the need for instrumental or surgical intervention);
Severe (Sodergren score and degree of hemorrhage ≥ the initial one requiring instrumental or surgical intervention).

Complications resulting from the office-based procedures are recorded and classified as:
Mild (e.g. pain/discomfort; pruritus; bright red blood on toilet paper/cleaning pad, hemorrhoidal thrombosis requiring only medical treatment);
Moderate (e.g. external hemorrhoidal thrombosis requiring surgical intervention; bright red blood that drips in the toilet or clot expulsion not requiring blood transfusion, urgent hemostasis or urgent surgery): obliges the participant to be withdrawn from the study but do not endanger the patient's life or leave long term sequelae;
Severe (e.g. sepsis; Fournier's gangrene; perineal abscess; bleeding with hemodynamic instability, transfusional need or urgent surgery; sexual impotence in man): obliges the participant to be withdrawn from the study and put the patient's life at risk or implies long-term sequelae.

Number of instrumental treatment sessions required to achieve therapeutic success.

Evolution of the grade of hemorrhoidal disease (Goligher's classification).

Paulo Sérgio Durão Salgueiro

Principal Investigator

Universidade do Porto

Participants will be randomly assigned to either rubber band ligation or sclerotherapy with polidocanol foam, stratified by grade of hemorrhoidal disease

Patients on the waiting list for liver transplant treated at ambulatory liver transplant of Hospital of Clinics of the Federal University of Minas Gerais

Patients undergoing liver transplantation treated at ambulatory liver transplant of Hospital of Clinics of the Federal University of Minas Gerais

Liver Disease

Nutrition Disorders

Hospital of Clinics of the University Federal of Minas Gerais

Evolution and Clinical Outcomes in Patients Undergoing Liver Transplantation

Evolution of Nutritional Status, Metabolic, Functional and Clinical Outcomes in Patients Undergoing Liver Transplantation

Dinamometry Heart rate variability Six minute walk test

Resting Energy Expenditure Energetic Balance

Diabetes mellitus Hypertension Overweight

Maria Isabel Toulson Davisson Correia

Federal University of Minas Gerais

Attention Deficit Hyperactivity Disorder (ADHD)

Binge-Eating Disorder Disorder

dasotraline

Clinical Pharmacology of Miami, Inc.

Orlando Clinical Research Center

Atlanta Center for Medical Research

DaVita Clinical Research

American Research Cororation (ARC), Texas Liver Instituete (TLI)

Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction

Pharmacokinetics of Orally Administered Dasotraline in Subjects With Mild, Moderate, and Severe Hepatic Dysfunction

Plasma PK parameters: Area under the plasma/serum concentration-time curve from time zero to infinity (AUC0 inf)

Plasma PK parameters: time of occurrence of Cmax

Urine PK parameters: amount excreted in urine from time zero to time t (AEx0 t)

Urine PK parameters: renal clearance (CLR)

Urine PK parameters: percent of dose excreted in urine (%fe)

Unbound fraction of dasotraline in plasma at 10, 12, and 24 hours postdose .

Incidence of adverse events (AEs), SAEs, and AEs resulting in study discontinuation.

Absolute values and changes from baseline in clinical laboratory tests (hematology, serum chemistry, urinalysis, prothrombin time), vital signs (respiratory rate, body temperature, supine blood pressure, and supine pulse rate), and 12 lead ECGs.

Frequency of subjects with suicidal ideation or suicidal behavior using the Columbia Suicide Severity Rating Scale (C SSRS).

Plasma PK parameters: AUC0-last, area under the blood concentration time curve from time zero to 24 hours postdose (AUC0-24)

Plasma PK parameters: time of occurrence of Cmax (tmax)

Plasma PK parameters: apparent clearance (CL/F)

Plasma PK parameters: apparent volume of distribution (Vz/F)

varicose veins/potassium

Polidocanol Foam Versus Rubber Band Ligation in the Treatment of Hemorrhoidal Disease

Evolution and Clinical Outcomes in Patients Undergoing Liver Transplantation

Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction

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