cyrilzakka/clinical-trials huggingface dataset:
Effect of HIV/STD Risk Reduction Program on South African Adolescents

This study will evaluate the effect of an HIV/STD risk-reduction program on the sexual behavior of South African adolescents.

HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. HIV is transmitted through the exchange of bodily fluids, primarily through sexual intercourse. South Africa has been one of the countries in which the AIDS pandemic has had an especially devastating effect. New cases of HIV infection in South Africa have been occurring at a high rate in people 15 to 24 years of age. There is no vaccine or cure for HIV yet, making disease prevention methods imperative. An important part of the prevention process is early education on HIV to reduce sexual-risk behavior and to promote safe sexual practices. This study will evaluate the effect of an HIV/STD risk-reduction program on the sexual behavior of South African adolescents.

In this single-blind study, participants will include sixth grade students from 18 South African schools that meet study criteria. The participants will be randomly divided into 2 structurally similar treatment groups. One group will take part in HIV/STD risk-reduction sessions, while the other group will take part in health promotion sessions. There will be 12 total sessions, each lasting 1 hour. The participants in the HIV/STD risk-reduction group will be taught to practice abstinence and condom use through interactive activities, comic workbooks, and take-home assignments. Through similar methods, the participants in the health promotion group will be taught about general health problems, such as heart disease, diabetes, alcohol and drug abuse, and certain cancers. Participants will also be taught healthful behaviors to help prevent these health problems. All participants will provide self-reports of sexual behavior and precautionary methods used in sexual intercourse immediately before the first and after the last treatment sessions. Follow-up evaluations will occur at Months 3, 6, 12, 42, and 54 months post-treatment. STDs will be assessed 42 and 54 months post-treatment

Eligibility Criteria:
Inclusion Criteria:

* Schools, with Grade 6 learners, that served the general population of learners, not just those with learning disabilities
* Grade 6 learners at participating schools with signed parent/guardian consent forms

Exclusion Criteria:

* Schools exclusively serving children with learning disabilities
A Study of Otezla® in Patients With Plaque Psoriasis Under Routine Conditions

The objective of this NIS is the collection of data on the utilization of Apremilast under routine conditions in Germany. Patients' quality-of-life and treatment satisfaction on treatment with Apremilast in daily practice will be documented. Moreover, physician's and patient's assessments of the effectiveness and safety of Apremilast will be recorded. FPI was 3rd August 2015, LPO was 14th of June 2018. A total of 391 patients have been enrolled.

The objective of this NIS (according to section 4(23) of the German Medicinal Products Act) is the documentation of data on the effectiveness and tolerability of an Apremilast treatment under routine clinical conditions in German patients with plaque psoriasis.

This NIS is intended to reflect the apremilast treatment of patients with plaque psoriasis who have received at least one prior conventional, systemic therapy or, if a contraindication is present, did not receive a systemic therapy so far, and who were diagnosed by their treating physicians to be eligible for an apremilast treatment. The treatment of Apremilast will be documented for a period of approximately 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* The decision for a therapy with Apremilast was made before enrolment and independent of this study.
* Patient ≥ 18 years of age
* Diagnosis of moderate to severe plaque psoriasis
* Inadequate response or intolerance to a previous systemic treatment, or contraindication for systemic therapies.
* Written informed consent by the patient for data recording, statistical analysis, filing and forwarding of the data

Exclusion Criteria:

* Pregnancy
* Hypersensitivity to apremilast or any of the excipients of the film-coated tablet
* Other criteria according to the Summary of product characteristics (SmPC).
Effects of Home-based or Center-based Aerobic Exercise in Patients With Chronic Kidney Disease

Patients will be randomly assigned to perform the training program in center or home-based . The training program will be conducted in accordance with the recommendations of the American College of Sports Medicine. All training sessions will be preceded by stretching of large muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes). The program will consist of 24 weeks with three sessions per week on alternate days. The aerobic training will be continuous, with an increment of 10 minutes in duration every 4 weeks. The intensity will be prescribed according to ventilatory threshold, characterized by the highest intensity of physical exertion fully maintained by aerobic energy pathways. The intensity control was done by means of the heart rate value obtained at ventilatory threshold.

Both groups receive the same intervention. However, a group exercise held in the center on a treadmill with the direct supervision of a physical education teacher. The other group will exercise at home with telephone follow-up weekly and once a month will be held at the training center under the supervision of a physical education teacher.

It will also constituted a control group remain without performing any activity during the study period. After 24 weeks patients receive the same advice the team conducting the training at home.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary individuals with chronic kidney disease stages 3 or 4 disease;
* Both genders;
* Age between 30 and 65 years;
* Overweight (BMI\> 25 kg/m2);
* With a negative stress test.

Exclusion Criteria:

* Patients with chronic obstructive pulmonary disease,
* class IV heart failure,
* myocardial infarction within the last 6 months,
* decompensated hypertension (systolic blood pressure\> 180 mmHg or diastolic\> 110 mmHg in the last 6 months),
* uncontrolled cardiac arrhythmia,
* decompensated diabetes mellitus (glycated hemoglobin\> 8.0%),
* unstable angina,
* infectious processes in the last 3 weeks;
* begin use of erythropoietin or with hemoglobin \<11g/L.
* use of beta-blocker medication
Personalized Nutrition for Type 2 Diabetes

This project will compare medical nutrition therapy personalized by continuous glucose monitor (CGM) feedback to control interventions in participants with type 2 diabetes mellitus (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* previous diagnosis of T2DM
* HbA1c of 6.8-8.5%

Exclusion Criteria:

* type 1 diabetes mellitus
* treatment with insulin, sulfonylurea, or meglitinide
* use of nondiabetic medications that affect blood glucose control (such as corticosteroids)
* BMI \<25 kg/m2 or \<23 kg/m2 for participants who self-identify as Asian
* weight change \>5 pounds in the 3 months prior to study enrollment
* estimated glomerular filtration rate \<60 ml/minute/1.73 m2
* pregnancy or immediate plans to become pregnant 8) breastfeeding 9) anemia (which would affect measurement of HbA1c) 10) changes to glucose lowering medications, including change in dose, in the 3 months prior to enrollment 11) presence of any disease that would make adherence to the protocol difficult."
The Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors

This study is an open-label, phase I clinical trial of SHR-A2009 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
2. Have at least one measurable tumor lesion per RECIST v1.1;
3. ECOG performance status of 0-1;
4. Life expectancy ≥ 12 weeks;
5. Adequate bone marrow and organ function.
6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Exclusion Criteria:

1. Patients with active central nervous system metastases or meningeal metastases;
2. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
3. Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;
4. History of serious cardiovascular and cerebrovascular diseases;
5. Severe infection within 4 weeks prior to the first dose;
6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
Evaluation of a Rwanda Hospital Feeding Program on Nutrition, Recovery, Costs of Care and Health Related Quality of Life

The purpose of this interventional study was to evaluate outcomes for Solid'Africa's Gemura feeding program in four selected public hospitals comparing results between patients receiving and patients not receiving the feeding program. The study measured the effects of the program on patients nutritional status, recovery during hospitalization, patient health related-quality of life, patient satisfaction, and patient costs of care. Participants were asked: (1) to eat meals provided three times a day if they were in the intervention group; (2) to participate in an intake and discharge survey; and (3) to participate in a daily food intake survey.

A multi-center, quasi-experimental study using difference-in-differences controlled comparison to test the outcomes of Solid'Africa's Gemura feeding intervention in four selected public hospitals (two in intervention group and other two in control group) from urban and peri-urban areas targeting socioeconomically vulnerable inpatients. This study has a primary outcome which is nutritional status as measured by body mass index (BMI), and secondary outcomes which include recovery during hospitalization, patient health-related quality of life (HRQOL), patient satisfaction, and patient costs of care.

Eligibility Criteria:
Inclusion Criteria:

* Hospital inpatients
* Vulnerable socioeconomic status according to social worker assessment
* Most inpatient categories
* Voluntary, self-feeding ability
* Able to stand on scale, with help if needed

Exclusion Criteria:

* Hospital outpatients
* Patients not determined socioeconomically vulnerable by social worker
* Pregnant women hospitalized for delivery
* Patients undergoing special treatment for malnutrition
* Patients receiving enteral or parenteral nutrition treatment
* Patients receiving any kind of artificial feeding support
* Patients unable to stand on scale to measure weight
Efficacy of Serratus Anterior Plane Block With Dexmedetomidine During Breast Surgery

This study aims to compare single level serratus block versus bilevel serratus block with and without dexmedetomidine in cancer patients undergoing modified radical mastectomy for breast cancer regarding pain control and possible side effects.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for modified radical mastectomy,
* Age 18-65 years,
* ASA I-II

Exclusion Criteria:

* patient refusal,
* coagulation defects,
* abnormal kidney or liver functions,
* local infection at site of injection.
Dialectical Behavior Therapy for Adults With Autism Spectrum Disorders

Dialectical Behavior Therapy (DBT; Linehan, 1993) effectively diminishes emotion dysregulation and self-harm behaviors in a number of disorders. However, to our knowledge, no studies have investigated the efficacy of DBT to treat emotional dysregulation associated with self-harm and suicidal behaviors in adults with ASD without intellectual disability. This randomized controlled study trial aims to assess the efficacy of a 5-month DBT intervention in adults with ASD without intellectual disability who present with self-harm and/or suicidal behaviors.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* ASD diagnosis according to the DSM-5
* IQ ≥ 70
* Suicidal ideas, suicidal attempts and/or self-harm behaviors 6 months prior to the inclusion
* Able to understand and consent to the research aims
* Membership in a health insurance fund

Exclusion Criteria:

* complete hospitalization
* ongoing CBT or DBT
* past DBT
* schizophrenia disorders
* under guardianship
Medtronic Terminate AF Study

The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal AF.

This is a multi-center, single-arm, prospective, non-randomized, interventional study. A maximum of 160 subjects will be treated at up to 25 centers in the US. The study will include male and female patients with a history of non-paroxysmal atrial fibrillation who are undergoing concomitant cardiac surgery. Subjects will be followed and assessed after procedure and for 12 months.

The purpose of this study is to evaluate the safety and effectiveness of the Cardioblate Surgical Ablation iRF and CryoFlex hand held devices to support an indication expansion to include treatment of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) to the product labeling.

Eligibility Criteria:
Inclusion Criteria:

* History of non-paroxysmal AF (persistent or longstanding persistent)
* Concomitant indication for non-emergent open-heart surgery, eg,

  1. Coronary artery bypass grafting
  2. Valve repair or replacement
* Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC)

Exclusion Criteria:

* Wolff-Parkinson-White syndrome
* NYHA Class = IV
* Left Ventricular Ejection Fraction ≤ 30%
* Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery
* Previous AF ablation, AV-nodal ablation, or surgical Maze procedure
* Contraindication for anticoagulation therapy
* Left atrial diameter \> 6.0 cm
* Preoperative need for an intra-aortic balloon pump or intravenous inotropes
* Renal failure requiring dialysis or hepatic failure
* Life expectancy of less than 1 year
* Predicted risk of operative mortality \>10% as assessed by STS Risk Calculator
* Pregnancy or desire to be pregnant within 12 months of the study treatment
* Current diagnosis of active systemic infection
* Active endocarditis
* Documented MI 30 days prior to study enrollment
* Current or planned participation in an investigational or observational drug or device trial related to the treatment of atrial arrhythmias
Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail

This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male and females 12 - 75 years of age
* Fungal toenail infection of one or both of the large (great) toenails
* The nail infection must be due to a dermatophyte, (mixed infections \[dermatophyte and non-dermatophyte\] are not allowed)

Exclusion Criteria:

* Target foot must not have severe plantar (moccasin) tinea pedis that would require systemic therapy. Mild to moderate tinea pedis (athlete's foot) infection should be treated with terbinifine prior to baseline or at any time during the trial. Other topical treatments for athlete's foot may be recommended at the discretion of the investigator.
* Subjects must not have abnormalities of the nail that could prevent a normal appearing nail if clearing of infection is achieved
* No administration of systemic antifungal medications within 6 months prior to screening visit
* No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
* No professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit
* Known pregnancy or lactation at time of enrollment

Other protocol-defined inclusion/exclusion criteria may apply
Periodontal Regeneration With Recombinant Human Platelet Derived Growth Factor (rH-PDGF-BB) and Allograft

Growth factors are defined as small proteins that trigger a cellular response after binding to cell receptors; Tissue engineering is now clinically applicable in a commercially available system involving the use of recombinant human platelet-derived growth factor.

The objective of this study is to evaluate clinical and radiographic parameters in bone defects treated with platelet-derived growth factor in combination with allograft.

Our hypothesis: Defects treated with DFDBA and rhPDGF-BB have better clinically and radiographic results that the defects treated with DFDBA and saline solution.

The study will be performed in 30 periodontal defects of 2 and 3 walls. The experimental group will consist of DFDBA placement with rhPDGF-BB and control DFDBA with saline solution. The clinical parameters recorded were Probing deep (PD), clinical attachment level (CAL), recession depth, Index of bleeding and plaque at baseline and at six months. Our universe is patients with periodontitis attending at the clinical in Periodontics at the Autonomous University of Nuevo Leon (UANL) School of Dentistry.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of periodontitis
* Infrabony defects of 2 walls, 3 walls and combined defects
* Patients ASA (American Society of Anesthesiologists) I and II
* Patients who smoke less than 10 cigarettes

Exclusion Criteria:

* Patients undergoing bisphosphonate therapy
* Furcation defects
* Patients with evidence of blood dyscrasias.
* Pregnant patient
Bonds Between Circulating Tumoral ADN (ctDNA) and the Development of Peritoneal Carcinomatosis for Patients Under PIPAC

PIPADN is a pilot monocentric, study with a total duration of 42 months. The purpose of this study is to describe the variation of plasma ctDNA concentration between the 1st and the 3rd PIPAC session in patients with peritoneal carcinomatosis.

The improvement of life quality with this type of treatment will also be evaluated though the EORTC QLQ-C30 survey.

Each patient will have three PIPAC sessions spaced 6 to 8 weeks apart. Two blood samples will be taken during the first 3 PIPAC sessions, one the day before each procedure and a second one 24 hours afterwards.

The EORTC QLQ 30 survey will be completed by patients during the pre-operative consultation and at each post-operative consultation (about 3 weeks after PIPAC sessions).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* WHO 0 to 2
* Patient with cancer in the form of peritoneal carcinosmatois not eligible for cytoreduction surgery
* A histological diagnosis of the primary tumor or peritoneal carcinomatosis is essential.
* Patient with an indication for PIPAC for any reason (whether as part of a clinical research protocol or not). Patients with prior treatment with PIPAC are eligible.
* Patients with abdominal metastases or a single metastasis regardless of location (oligometastasis).
* For patients of childbearing age need for an effective method of contraception
* Informing patients and obtaining informed consent, dated and signed.
* Patient affiliated with a social security scheme

Exclusion Criteria:

* Age \< 18 years old
* WHO \> 3
* Patient who may benefit from cytoreduction surgery
* Patient with a contraindication to PIPAC
* Extra peritoneal disease with the exception of oligometastatic disease
* Persons deprived of liberty or under guardianship (including curatorship)
* Impossibility to undergo the medical follow-up of the trial for social, geographical or psychological reasons.
* For patients of childbearing age without an effective method of contraception
* Woman who is pregnant, likely to be pregnant, or breastfeeding
The Effects of VEGF-B Signaling Pathway in Obesity and Metabolic Disease

The investigators will enroll about 120 subjects from the hospital's healthcare center. The investigators will collect the basic informations, blood pressure, body mass index, fasting blood glucose and fasting blood lipids of each subject. The investigators will collect the blood samples and then test them for fasting insulin levels, VEGF-B levels, the gene promoter region methylation status and the genomic protein methylation levels of the VEGF-B gene of the cells，and finally do the statistical analysis.

The investigators will enroll about 120 subjects from the hospital's healthcare center, and these 120 subjects will be divided into four groups: normal weight with or without metabolic diseases and obesity with or without metabolic diseases. Each group has 30 subjects. The investigators will collect the basic information(name, gender，age, medical history，family history, etc.), blood pressure, body mass index, fasting blood glucose and fasting blood lipids of each subject from the healthcare center. The investigators will collect the blood samples of each subject,separate the plasma and then test the fasting insulin, VEGF-B levels by ELISA. The investigators will separate the peripheral blood mononuclear cells from the blood, and then test the gene promoter region methylation status of the VEGF -B gene by PCR and the bisulfite-modified sequencing and test the genomic protein methylation level of the VEGF-B gene by chromatin immunoprecipitation assay(CHIP) and real-time quantitative PCR of the cells，and finally do the statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* NA

Exclusion Criteria:

* subjects with active history insulin treatment; and female participant pregnant at the time of recruitment.