cyrilzakka/clinical-trials huggingface dataset:
Engendering Healthy Masculinities to Prevent Sexual Violence

Sexual violence (SV) and adolescent relationship abuse (ARA) are prevalent among adolescents and associated with poor health. Global health organizations highlight engaging men and boys in preventing violence against women as a potentially impactful public health strategy. This study aims to test, via a two arm cluster randomized controlled trial, a "gender transformative" SV/ARA perpetration prevention program among African American adolescent males ages 13-19 (target is high school age) implemented in a community-based setting. "Gender transformative" refers to a theory- and evidence-based approach to alter gender norms that foster SV/ARA while promoting bystander intervention (i.e., giving boys skills to interrupt abusive behaviors they witness among peers) to reduce SV/ARA perpetration. As the acceptance of SV and involvement in unhealthy sexual behaviors are associated with SV/ARA perpetration, this program integrates analysis of social norms that condone violence against women, sexual health promotion, and skills in bystander intervention -- an approach that has been implemented in multiple non-U.S. settings among young adult males with reductions in violence, development of more equitable gender attitudes, and less risky sexual behaviors. This will be the first test of such a gender transformative program among adolescent males in the U.S. Via a 2-arm cluster-randomized trial in youth-serving agencies (16 clusters, N=840 adolescent males ages 14-19), this study will assess the effectiveness of "Manhood 2.0" (proposed name for this gender transformative program) compared to a job skills curriculum. Three months after the end of the program (Time 2), compared to controls, youth will demonstrate increased positive bystander intervention behaviors (secondary outcome). Intermediate outcomes are: condom use self-efficacy; contraception use attitudes; recognition of abusive behaviors; gender-equitable attitudes; and intentions to intervene with peers. Nine months after intervention completion (Time 3), youth will report less perpetration of SV and ARA toward females (Primary Outcome) compared to controls. This study will provide urgently needed information about the effectiveness of a gender transformative program that combines healthy sexuality skills, gender norms change, and bystander skills to interrupt peers' disrespectful and harmful behaviors to reduce SV/ARA perpetration among adolescent males.


Eligibility Criteria:
Inclusion criteria:

* adolescent males ages 13-19
* recruited from youth-serving agencies in the Pittsburgh region
* able to provide their own assent
* English speaking

Exclusion criteria:

* adolescent males younger than 13 years old or older than 19 years old
* not able to provide their own assent
* non- English speaking
A Study of HRS9531 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabetes

The study is being conducted to evaluate the efficacy and safety of HRS9531 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Semaglutide QW for 36 weeks and 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with type 2 diabetes ≥ 90 days；
2. Stable daily dose(s) for ≥3months prior to screening of : 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily) with one type of SGLT-2 inhibitors;
3. Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%;
4. Female patients of childbearing potential and male patients must agree to use highly effective contraception during the trial and for at least 2 months after the last dose of the investigational medicinal drug. Female patients of childbearing potential must test negative for pregnancy at Visit 1 and not be breastfeeding.

Exclusion Criteria:

1. Known or suspected allergy or intolerance to the investigational medicinal products or related products；
2. Acute complications of diabetes occurred during the previous 6 months；
3. Serious chronic complications of diabetes in the past；
4. Use other antidiabetic drugs for ≥3months prior to screening ;
5. Before screening, have disease or treatment that may affect weight; or any previous condition that may affect gastric emptying； or gastrointestinal surgery;
6. Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 3 months or 5 half-lives, whichever is longer, prior to screening;
7. Any conditions that the Investigator judges might not be suitable to participate in the trial.
Acute Respiratory Distress Syndrome in Taiwan

The study enrolls ARDS patients in medical ICUs in 11 Hospitals in Taiwan. The epidemiology and long-term outcomes of the patients will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patients in medical intensive care unit in Sep., 2017 and Jan., 2018.

Exclusion Criteria:

* Age less than 18 years.
* Pregnancy.
Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia

Almost all antipsychotics can induce dyslipidemia, but no treatment has been established. Vildagliptin can improve lipid levels in obese patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of vildagliptin for antipsychotic-induced dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-Ⅳ) criteria for schizophrenia dyslipidemia after antipsycotic treatment the duration of illness was less than 12 months taking only one antipsychotic stable outpatient the total score of Positive and Negative Syndrome Scale (PANSS)≤60.

Exclusion Criteria:

* liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension or diabetes mellitus
The Efficacy of Chlorhexidine Gluconate Gel Dressing in Preventing Surgical Drain Site Infection

This study aims to evaluate if the application of chlorhexidine gluconate dressing on surgical drain sites can decrease drain site infection vs the standard of care (dry, sterile gauze).


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Receiving two surgical drains during one of the following types of operative procedures: breast reduction, breast augmentation, abdominoplasty, panniculectomy, brachioplasty, thigh lift, lower body lift, belt lipectomy, back latissimus dorsi reconstruction, bilateral breast reconstruction, or bilateral chest reconstruction. These drains may be in fairly close proximity to one another but they must emerge from different areas of the skin, that way they can be considered to be located in two different sites.

Exclusion Criteria:

1. Concurrent implantation of any foreign objects, such as a breast implant
2. Patients who receive postoperative antibiotics without a suspected or identified site of infection
3. Subjects allergic to or hypersensitive to chlorhexidine gluconate. Before enrolling in the study, patients will be asked about previous exposure to chlorhexidine products and about their allergies. Those with potential allergic or adverse reaction to chlorhexidine will be excluded from the study.
Evaluation of Patient and Physician Satisfaction With the Zift eLevatIon of Facial Tissue Clinical Study

The LIFT study will document the first clinical use of the ZiftLift Tissue Anchor in a browlift for patients with age-related brow ptosis. It is a single arm, open label multicenter study, to evaluate the safety and efficacy of the Zift Lift System. Up to 20 subjects in up to 3 sites will be enrolled in this study. Data from this trial will be used to confirm the device safety and efficacy and provide inputs to further refine the device design and procedure technique for future device iterations

The LIFT study will document the first clinical use of the ZiftLift Tissue Anchor in a browlift for patients with age-related brow ptosis. It is a single arm, open label multicenter study, to evaluate the safety and efficacy of the Zift Lift System. Up to 20 subjects in up to 3 sites will be enrolled in this study. Data from this trial will be used to confirm the device safety and efficacy and provide inputs to further refine the device design and procedure technique for future device iterations Subjects with signed informed consents and who meet all the inclusion and none of the exclusion criteria and are treated with the device will be considered enrolled in the study. An interim report will be created after the first 20 patients has completed their 90 follow up and the data monitored. The 20 patients, 90 day report may be submitted to FDA and other agencies for product clearance and registrations. After FDA clearance has been obtained, the study may be converted to a post-market study for the long term follow up.

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent to the treatment
2. Willing and able to participate in all the required follow-ups
3. Over 18 years of age
4. Under 75 years of age
5. Brow ptosis and/or functional limitations such as vision defects due to tissue laxity caused by aging

Exclusion Criteria:

1. Known allergies to local anesthesia
2. Currently undergoing chemotherapy or radiation therapy for cancer
3. Known advanced osteoporosis that may lead to skull thinning
4. Taking long-term immunosuppressant therapy
5. Taking chronic anticoagulation therapy (including ASA and NSAIDS) which can't be stopped for 10 days before treatment.
6. Unable or unwilling to participate in follow-up examinations
7. Evidence of brow soft tissue thickness less than 4mm by physical exam, ultrasound or direct probe (probe at the time of procedure)
8. Stroke or TIE (Transient Ischemic Event) within the past 6 months and currently on anti-platelet or other blood thinners
9. Chronic facial paralysis due to trauma, Bells Palsy, or similar etiology
10. Treatment with neurotoxin in the past 6 months and during the study period. Subjects may undergo a neurotoxin washout for 6 months prior to study participation
11. Planned surgical procedures, fillers or other facial procedures during the study period.
12. Planned modification of the eyebrows (to include plucking or shaving) during the study period
13. Planned MRI during the study period
14. Known nickel allergy
Breast Cancer Screening in Ghana

This study is designed to test the feasibility of two intervention on promoting early screening for breast cancer in rural Ghana. In one intervention, screening for breast cancer, diabetes and hypertension will be offered together. In another intervention, a series of sessions with men will be conducted with a goal to change gender attitudes and increase support to women. The investigators' long-term goal is to test these interventions in a large-scale randomized controlled trial. The specific aims of this feasibility study are to: 1) refine the study materials, including the curriculum for the sessions with men, by consulting with an expert advisory committee and a local committee, and 2) determine the feasibility of the two interventions in four clinic zones in Yilo-Krobo district in eastern Ghana (1 clinic in control, 1 clinic in the first intervention, and 2 in the second intervention). This trial registration is for the second specific aim.


Eligibility Criteria:
Inclusion Criteria:

* ≥20 years. The age cutoff reflects early onset of BC in Ghana and the government's guidelines on screening.

Exclusion Criteria:

* ever clinically diagnosed with a case of breast cancer, as the study's aim is to reach women who would normally not visit or have experience with the health system with regard to breast cancer.

NOTE: For men in the MEGH arm, Inclusion and Exclusion Criteria are:

Inclusion Criteria: aged ≥20 years who are identified as male partners or relatives by the women enrolled in the MEGH group.

Exclusion Criteria: none.
Root Canal Disinfection: a Comparison Between Techniques

Caries disease is still the leading cause of severe tooth decay. Since this can lead to tooth loss, it is important that appropriate treatment is advised to help prevent damage and maintain tooth health. Faced with major coronary destruction, several times it becomes necessary to perform the endodontic treatment, aiming to maintain the element in the buccal cavity for longer. It is known that an excellent restorative treatment with poor endodontic treatment and vice versa has a direct impact on the (in) success of the treatment. In this context, the proper cleaning of the root canals is highlighted, aiming the removal of bacteria and toxins. There are several cleaning methods described in the literature, but it is not yet known which would be the most effective in the removal of these contaminants. In this double-blind randomized clinical trial, patients who need and meet the inclusion criteria will undergo endodontic treatment in two different root canal cleansing techniques (passive ultrasonic cleaning and cleaning with the XP Endo device). Patients will be monitored annually after finish your endodontic treatment to evaluate the periradicular repair and the quality of endodontic treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more;
* good general healthy;
* molars or premolar requiring endodontic treatment;
* at least 20 teeth;

Exclusion Criteria:

* root fracture;
* injury involving the furcation region
* need to behave as a prosthetic abutment;
* mobility greater than degree I;
Different Doses of Naronapride Vs. Placebo in Gastroparesis

This is a double-blind, randomized, multicenter, placebo-controlled, comparative phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 10, 20, or 40 mg Naronapride vs. placebo for the treatment of patients with Gastroparesis.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between ≥18 and ≤75 years of age,
* Body Mass Index (BMI) ≥16 and \<35 kg/m2 ,
* History of idiopathic or diabetic gastroparesis cardinal symptoms (e.g., nausea, vomiting, early satiety, postprandial fullness, bloating or upper abdominal pain) for ≥3 months,
* Evidence of delayed gastric emptying by 13C-spirulina gastric emptying breath test (GEBT) for solids with gastric emptying T1/2 ≥ 85.33 minutes (≥ 90th percentile of normative data) during the screening phase,
* Average weekly total symptom score of the ANMS GCSI-DD ≥2.0 based on the daily symptom scores recorded for at least 5 of 7 consecutive days in the week prior to Baseline,
* Participants with a type I or type II diabetes mellitus diagnosis must have a controlled diabetes mellitus defined as HbA1c ≤11% under stable antidiabetic medication,
* Exclusion of any mechanical and/or anatomical obstructions, stenosis, structural diseases, or gastric ulcers by upper gastrointestinal endoscopy during screening phase (previous endoscopic results within 12 months are acceptable, if no relevant changes in patient's disease status occurred since that time),
* No evidence of intestinal stenosis as determined by an imaging technique (i.e., either abdominal sonography, Magnetic resonance imaging \[MRI\] or imaging by computed tomography \[CT\] during screening phase (previous MRI/CT imaging or sonography results within 12 months are acceptable, if no relevant changes occurred in patient's disease status since that time),

Exclusion Criteria:

* History of major gastrointestinal surgery such as gastric bypass, anti-reflux surgery, gastric per oral endoscopic myotomy (G-POEM), gastrointestinal malignancy, colectomy,
* Intrapyloric botulinum toxin injection within 12 months,
* Gastric stimulator implant,
* Known secondary causes of gastroparesis including but not limited to Parkinson's Disease, cancer, or connective tissue diseases,
SHCP in 4-H Using Teenagers as Teachers

In close collaboration with the Nevada County 4-H Youth Development Program, the Shaping Healthy Choices Program was implemented utilizing 4-H teenagers as cross-age teachers for younger youth. The 4-H Youth Development Program is an education program of the University of California Cooperative Extension that emphasizes learning citizenship, leadership, and life skills. The program creates positive opportunities for youth to learn, develop skills, and become engaged in their local communities. This is accomplished with combined efforts of youth, volunteer leaders, and University staff and faculty through a fun, hands-on learning approach to non-formal education. As a requirement to participate in the program, all youth had to enroll in 4-H for the 2016-2017 year. Teenagers were initially trained in inquiry-based and experiential learning techniques before facilitating the program. Teenage teachers collectively lead classroom education, garden activities, and cooking demonstrations. Additionally, teenage teachers, UC Cooperative Extension staff, and UC Davis students organized and implemented a community health fair for elementary-aged children.

Measurements were taken on nutrition knowledge, vegetables preferences, civic responsibility, program fidelity, and self-efficacy for teaching nutrition. A parent interview was also conducted to gauge parental engagement and perception of whether their child had behavior changes while participating in the program. Preliminary findings from the parent interview show that children were more likely to support and engage in healthy eating practices throughout their involvement than they had before the program. Children also have expressed interests in continuing their participation in subsequent years. All other data for this intervention are currently undergoing analyses.


Eligibility Criteria:
Inclusion Criteria:

* The research team will recruit and consent youth study participants and their parents from members of the Nevada County 4-H Youth Development Program. Youth study participants must be ages 14-18 for teenage teachers and 8-13 for younger youth participants. Study participants must be able to attend two-hour bimonthly meetings at the 4-H office and/or (depending on the activity) Food Bank garden in Grass Valley, California. Teenage teachers will also be required to complete ten hours of initial training before the start of SHCP implementation. All participants will be required to join the Nevada County 4-H Youth Development Program if they are not already a member. Teenage teachers' registration fees will be paid for by the research team. Comparison youth will be recruited from registered members of the Placer County 4-H Youth Development Program. Placer County 4-H club members will also be ages 14-18 for teenage comparisons and 8-13 for younger youth comparisons.

Exclusion Criteria:

* Foster children and wards of the state will not be enrolled in this study. Children younger than 8 or older than 18 are not eligible to participate.
Efficacy of Interferon-gamma in Combination With Anidulafungin for the Treatment of Candidemia

The purpose of this study is to assess the feasibility and preliminary efficacy of interferon-gamma in combination with anidulafungin for the treatment of candidemia


Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant females (who must agree to use barrier methods of contraception during the study therapy period, women of childbearing age must have a negative urine pregnancy or serum test at baseline).
* Subjects who are 18 years of age or older
* Subjects with at least one positive blood culture isolation of Candida species from a specimen drawn within 96 hours prior to study entry.
* Subjects who have clinical evidence of infection AT SOME TIME WITHIN 96 HOURS PRIOR TO ENROLLMENT, including AT LEAST ONE of the following:

  * Temperature \>37.8 ˚C on 2 occasions at least 4 hours apart or one measurement \> 38.2 ˚C
  * Systolic blood pressure \<90 or a \>30 mmHg decrease in systolic BP from the subject's normal baseline.
  * Signs of inflammation (swelling, heat, erythema, purulent drainage) from a site infected with Candida (eg, joint, skin, eye, bone, esophagus)
  * Radiologic findings of invasive candidiasis
* Subject or their legal representative must sign a written informed consent form.

Exclusion Criteria:

* Subjects with a history of allergy or intolerance to echinocandins or IFNgamma
* Subjects with a history of documented epileptic seizures
* Subjects with severe renal impairment (creatinine clearance less than 30/mL/min)
* Subjects with severe liver failure (impaired synthesis of proteins such as coagulation factors manifested by increased prothrombin time)
* Subjects with an absolute neutrophil count of less than 500/mm3 at study entry
* Women who are pregnant or lactating
* Subjects who are unlikely to survive more than 24 hours
* Subjects who have failed previous systemic antifungal therapy for the Candida spp. infection which is being studied.
* Subjects who have received more than 48 hours of systemic antifungal therapy for the current episode, within 96 hours prior to study entry
Prospective Cohort Study on the Safety and Efficacy of Endorobotics for Endoscopic Submucosal Dissection (Endorobotics ESD)

This trial is a prospective, single arm study of 30 patients recruited to undergo endoscopic submucosal dissection (ESD) with a novel robotic assisted technology. It will assess the safety and performance of robotic-assisted endoscopic submucosal dissection (ESD) of superficial gastric and colorectal lesions that otherwise cannot be optimally and radically removed by snare-based techniques. The primary outcome of the study is rate of complete (R0) resection of the neoplasia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with endoscopic diagnosis of early gastric or colorectal neoplasia
* Patients will be recruited according to ESGE and JGES guidelines for gastric \& colorectal ESD including: 1. Lesions for which en bloc resection with snare EMR is difficult to apply; 2. Mucosal tumors with submucosal fibrosis; 3. Sporadic tumors in conditions of chronic inflammation and 4. Local residual or recurrent early carcinomas after endoscopic resection.

Exclusion Criteria:

* Informed consent not available
* Carcinoma of colon or rectum or stomach with invasion to submucosa or beyond
* Evidence of distant metastasis
* Presence of another active malignancy
* Pregnancy
* Patients unfit for general anesthesia
* Endoscopic platform cannot reach target lesion
* Patients recruited into another clinical trial.
The Impact of COVID-19 Pandemic on the Smoking Behaviour of Young Smokers and the Youth Quitline Service in Hong Kong

The aims of the present study are:

1. To explore the impact of COVID-19 pandemic on the smoking behavior of youth smokers
2. To explore the impact of COVID-19 pandemic on the Youth Quitline service in Hong Kong

The coronavirus disease 2019 (COVID-19) pandemic has spread rapidly across the globe. According to World Health Organization (WHO), due to the harmful effects on the lungs and the possible viral transmission from fingers to mouth during smoking, tobacco use is considered a major risk factor for developing COVID-19. Both tobacco use and COVID-19 can cause damage to the cardiovascular and respiratory systems. Smokers infected with COVID-19 are at higher risk of developing severe COVID-19 symptoms or death than non-smokers.

The Hong Kong SAR (HKSAR) government has announced different regulations to combat the spread of COVID-19 since late January 2020, which significantly affect the working patterns and everyday lives of people. It remains unknown how smoking habits and smoking cessation services are being affected during the pandemic.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong resident aged 25 or below
* Able to communicate in Chinese (Cantonese)
* Smoked in the past 30 days

Exclusion Criteria:

* Have difficulty to communicate via telephone