Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

All Conditions

Neoplasms

Acquired Immunodeficiency Syndrome

HIV Infections

Carcinoma

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anti-Infective Agents

All Drugs and Chemicals

Cidofovir

Antiviral Agents

Enzyme Inhibitors

This procedure will be implemented following the Standard of Care (SoC) on weeks: 0, 8 and 16 calculated since the day the patient is included into the trial.

Topical ointment wich contains 2 grams of active principle (sinecatechins 10%) at each administration. It will be taken three times per week during 8 weeks of treatment.

Topical ointment wich contains 2 grams of active principle (cidofovir 1%) at each administration. It will be taken three times per week during 8 weeks of treatment.

HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and electrocoagulation will be performed in 2-3 sessions (session every 2 weeks)

electrocoagulation

HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with cidofovir 1% ointment (3 times per week during 8 weeks)

cidofovir 1% topical ointment

HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with sinecatechins 10% ointment (3 times per week during 8 weeks)

sinecatechins 10% topical ointment

Joaquin Burgos Cibrian, Dr.

This study wants to demonstrate the non-inferiority in terms of efficacy and safety of treatment with cidofovir (1%) in topical ointment or topical sinecatechins (10%) ointment versus electrocoagulation (control group) for the treatment of high-grade anal intraepithelial neoplasia (HGAIN).

The target patients are Human Immunodeficiency Virus (HIV)-infected homosexual males.

All these patients will be randomized by a proportion of 1:1:1 setting up 3 different parallel arms of the study: control group, cidofovir (1%) group and topical sinecatechins (10%) group.

This Trial addresses one of the emerging problems in patients with HIV infection, such as the high incidence of anal dysplasia and anal cancer. The study proposes to evaluate new therapeutic options in the treatment of anal dysplasia, thus trying to overcome the current limitations of electrocoagulation (moderate efficacy, high recurrence, significant patient discomfort, and significant health cost).

Topical cidofovir has shown (in a non-comparative study) efficacy and tolerance rates similar to those observed for electrocoagulation, although with the benefits of self-application by the patient. This makes it an attractive topical treatment option that requires a direct comparison with the currently chosen treatment, which is electrocoagulation.

On the other hand, the medical properties of the sinecatechins, together with the results obtained in the treatment studies of oral and cervical dysplasia, and the possibility of being self, make this drug an attractive option to be evaluated experimentally in the treatment of anal dysplasia. Finally, the identification of prognostic markers of the disease should continue to be explored, in terms of the response to treatment and the recurrence of the disease.

A phase III, randomized, one-site, pilot, open-label, parallel groups trial for evaluating the efficacy and safety of electrocoagulation vs topic sinecatechins vs topic cidofovir within the treatment to high-grade anal intraepithelial neoplasia in HIV homosexual males.

Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males

A Phase III, Randomized, One-site, Pilot, Open-label, Parallel Groups Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males

% of patients with complete or partial regression of high grade anal intraepithelial neoplasia (HGAIN) at 10 weeks after end of treatment (with a permitted deviation of 4 weeks).

sinecatechins 10% ointment treatment for high grade anal intraepithelial neoplasia (HGAIN) with respect to electrocoagulation treatment in HIV-positive men who have sex with men.

By monitoring activities related with pharmacovigilance duties during the patient participation of each patient.

To describe the proportion of clinic and laboratory adverse events, which imply treatment dropout, in research treatment arm especially (cidofovir and sinecatechins). By monitoring activities related with pharmacovigilance duties during the patient participation of each patient

HIVTSQ has been modified by replacing the references to "HIV treatment" with "anal dysplasia treatment", and eliminating question 2 of HIVTSQ.

The following questions are related to the treatment you are being given in the trial and your experience in recent weeks. Please answer each question by circling a number on each of the scales evaluating them from 6 (very satisfied) to 0 (not satisfied).

* To what extent are you satisfied with your current treatment?
* To what extent are you satisfied with the side effects you have had from your current treatment?
* To what extent are you satisfied with the requirements related to your current treatment?
* To what extent do you consider your treatment to be comfortable / practical?
* o what extent do you think your treatment is flexible?
* To what extent are you satisfied with the information / knowledge you have about anal dysplasia?
* To what extent are you satisfied with the degree to which the treatment adapts to your

To compare % of decreased extension of HGAIN patients, with absence of regression during the study period according to protocol schedule.

To compare % of Human Papilloma Virus clearance in patients during the study period according to protocol schedule.

During the study period according to protocol schedule.

Hospital Universitari Vall d'Hebron Research Institute

Symptoms and General Pathology

Gland and Hormone Related Diseases

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Laparoscopic ovarian cystectomy using bipolar

Laparoscopic ovarian cystectomy using ultrasonic scalpel

Laparotomic ovarian cystectomy using suture

Ovarian cystectomy

Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation

changzhong li, M.D.

The purpose of this study is to investigate the impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst and the possible mechanisms.

Laparoscopic cystectomy is currently considered the treatment of choice in women with benign ovarian cysts and has gained increasing acceptance among gynecological surgeons(1). However, the safety of this technique in terms of ovarian damage to the operated gonad has recently been questioned. In the present study, with the combined use of serum hormonal evaluation and ultrasound examination, we planned to prospectively investigate the ovarian reserve after the excision of benign ovarian cysts. The damage to ovarian reserve will be evaluated through a 12-months follow-up after the application of bipolar, ultrasonic scalpel electrocoagulation or suture during ovarian cystectomy

The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst

The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Exc

Shandong University

Shandong Provincial Hospital

Xiayong Wang Ph.D

Laparoscopic ovarian cystectomy using suture

Chang-Zhong Li,, M.D.Ph.D.

Laparoscopic ovarian cystectomy is widely used for the removal of benign ovarian cysts but damage to ovarian reserve caused by electrocoagulation has recently been questioned.

The purpose of this study is to investigate the impact of bipolar and ultrasonic scalpel electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst.

Laparoscopic ovarian cystectomy is currently considered the treatment of choice in women with benign ovarian cyst and has gained increasing acceptance among gynecological surgeons(1). However, the safety of this technique in terms of ovarian damage to the operated gonad caused by electrocoagulation has recently been questioned. Many evidences support that the removal of ovarian cysts is associated with an injury to ovarian reserve. On the contrary, some retrospective studies did not show adverse outcomes compared with the control group (tubal infertility) . There is a lack of good clinical and scientific evidence such as randomized controlled study to report definitively the impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males	NCT04055142	High-grade Anal...	electrocoagulat... cidofovir 1% to... sinecatechins 1...	18 Years -	Hospital Universitari Vall d'Hebron Research Institute
Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males	NCT04055142	High-grade Anal...	electrocoagulat... cidofovir 1% to... sinecatechins 1...	18 Years -	Hospital Universitari Vall d'Hebron Research Institute
The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst	NCT00713778	Ovarian Cysts	Ovarian cystect... Ovarian cystect... Ovarian cystect...	18 Years - 40 Years	Shandong Provincial Hospital
The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst	NCT00713778	Ovarian Cysts	Ovarian cystect... Ovarian cystect... Ovarian cystect...	18 Years - 40 Years	Shandong Provincial Hospital
A Random Clinical Trial (RCT) of the Impact of Electrocoagulation on Ovarian Reserve	NCT00746278	Ovarian Cyst	Laparoscopic ov... Laparoscopic ov... Laparoscopic ov...	18 Years - 40 Years	Shandong Provincial Hospital

Spots Global Cancer Trial Database for electrocoagulation