cyrilzakka/clinical-trials huggingface dataset:
A Structural HIV Prevention Intervention Targeting High-risk Women

The purpose of this study is to assess the effectiveness of a community based combination HIV prevention package, including biomedical, behavioral, and structural services for female sex workers (FSW) in Baltimore, Maryland. This study is a prospective two-group trial comparing the efficacy of a community-based comprehensive HIV/STI prevention package compared to standard of care (HIV testing, counseling, and referrals) among FSWs. Outcomes will be assessed through self-reported illicit drug use and sexual risk behaviors (behavioral) as well as HIV/STI testing (biological).

This study aims:

1. To examine the effect of exposure to community intervention components on HIV/STI risk behaviors (e.g., drug use/unprotected sex), and HIV/STI cumulative incidence over time in FSWs in the intervention (n=275) compared to those in the comparison group (N=175);

   a. to explore the intervention's effects on the risk environment of exotic dance clubs (N=15) over time
2. To examine how socio-structural (e.g., social cohesion, stigma) and structural vulnerability (e.g., financial and housing stability) indicators change and are associated with the biological and behavioral outcomes over time in FSWs in the intervention (n=275) compared to those in the comparison (n=175) group

   a. examine the role of these indicators as mediators of the intervention effect on study outcomes;
3. To examine the intervention's implementation through qualitative (e.g., in-depth interviews) and quantitative (e.g., assessment of program fit, reach, facilitators, barriers, program costs) measures.

3.1 To examine participant knowledge of the COVID-19 crisis as well as the impact of the crisis on their mental, and physical well-being.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older;
* Assigned female at birth and identify with female gender
* Have exchanged sex in Baltimore City at least 3 times in the past 3 months;
* Willing to undergo testing for HIV, gonorrhea, and chlamydia
* Willing to provide locator information.

Exclusion Criteria:

* Inability to provide informed consent in English;
* Women who are determined as too high or drunk;
* Women who are cognitively impaired.
* Currently enrolled in the SAPPHIRE study
Forearm Immobilization, Metabolic Health, and Muscle Loss

The present study will investigate the impact of altered substrate availability on muscle atrophy, insulin sensitivity and muscle protein synthesis following short-term forearm immobilization

Thirty-six healthy young volunteers will undergo 2 days of forearm immobilization combined with ingestion of one of two drug or placebo. Before and after immobilization, they will receive a stable isotope tracer infusion (5.5 h) combined with repeated blood and muscle sampling under insulin clamp conditions, in order to measure insulin sensitivity and muscle protein synthesis in the fasted and fed state.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 18-40 years of age
* Body mass index between 18 and 27

Exclusion Criteria:

* Any diagnosed metabolic impairment (e.g. type 1 or 2 diabetes)
* Any diagnosed cardiovascular disease
* Hypertension (≥140 mmHg systolic and/or ≥90 mmHg diastolic)
* Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
* Regular use of nutritional supplements
* Metallic implants
* A personal or family history of thrombosis, epilepsy, seizures or schizophrenia
* Any previous motor disorders
* Any known disorders in lipid metabolism
* Any known disorders in muscle metabolism
* Known allergy for Acipimox, beta agonist, or other substances in the tablets
* Known sensitivity for sympathomimetic drugs
* Known hypokalaemia
* Presence of an ulcer in the stomach or gut and/or strong history of indigestion
* Known severe kidney problems
* Pregnancy
* Unable to give consent
Adipokines in Polycystic Ovary Syndrome

The aim of the study is to compare the concentrations of leptin, resistin, and omentin-1 in women across three research groups: those with polycystic ovary syndrome without insulin resistance, those with polycystic ovary syndrome with insulin resistance, and women without polycystic ovary syndrome.

Polycystic ovary syndrome (PCOS) is the most prevalent endocrinopathy among reproductive-age women, characterized primarily by insulin resistance (IR), which has a prevalence of 35% to 80%. Metabolic disturbances associated with PCOS contribute to a higher incidence of cardiovascular diseases and endometrial cancer prior to menopause. The hyperinsulinemic-euglycemic clamp study is regarded as the gold standard for assessing insulin sensitivity; however, its clinical application is limited. Alternative assessments, such as the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) and fasting insulin or glucose tolerance tests, provide limited clinical utility. Therefore, there is a pressing need for the identification of more precise and universal markers of insulin resistance. There is a need to elucidate the precise role of adipokines in the etiology of PCOS and their association with insulin resistance, which is responsible for the development of adverse health-related complications.

The aim of the study is to measure and compare the concentrations of selected adipokines: leptin, resistin, omentin-1 across three research groups: those with polycystic ovary syndrome without insulin resistance, those with polycystic ovary syndrome with insulin resistance, and women without polycystic ovary syndrome.

The tests will be performed using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer.

The concentrations of the investigated substances will be measured and compared within the three research groups.

Statistical analysis will be conducted using SPSS Statistics software.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-45

Exclusion Criteria:

* previous removal of at least one ovary
* treated diabetes of any type
* diagnosed and treated metabolic diseases
* diagnosed and treated autoimmune diseases
* diagnosed and treated autoinflammatory diseases(Edited)Restore original
Nicotine Patch as an Analgesic Adjuvant After Surgery

Effect of nicotine patch as an adjutant for acute pain after surgery.

This is a dose finding trial for nicotine patches as analgesics. Doses used are 5mg/ 10mg/ 15mg or placebo. Primary outcome variable is reported pain score (VAS), secondary is morphine PCA utilization, nausea, sedation, and hemodynamic changes.

Eligibility Criteria:
Inclusion Criteria:

* Adult ASA 1-2

Exclusion Criteria:

* Cardiovascular disease
* Former smoker
* Pregnant
* Nursing
* Asthma
Pilot Study to Evaluate Daily Protein's Intake Following Bariatric Surgery by Using the Software Protein Assistant

The aim of this study is to evaluate the effect of the use of Protein Assistant on the daily protein intake in obese patients who underwent a bariatric surgery (in the 3 months following surgery).

After a bariatric surgery, food intake is reduced. Patients should favor proteins to avoid loss of muscles. The guidelines recommend a minimal protein's intake of 60g per day. But this goal is achieved only for 55 to 60 % patients 4 months after surgery and 50 à 65 % patients at one year.

Protein assistant is a software which can calculate the amount of proteins eaten per day and can propose solutions if the intake is insufficient.

The main objective of this study is to evaluate the effect of the use of Protein Assistant on the daily protein intake in obese patients who underwent a bariatric surgery (in the 3 months following surgery).

Protein Assistant is suggested 1 month after bariatric surgery on a digital tablet. The patient is educated to use Protein Assistant. The patient has to complete a dietary record every 2 weeks during 2 months. The aim is to intake 60g per day. If the aim is not reached, Protein assistant suggests qualitative and/or quantitative solutions.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a bariatric surgery a month +/- one week ago
* Able to use a digital tablet
* With internet access at home
* Accepting modalities of formation and of digital tablet lending
* When the average of protein intake is under 60g/j on a 3 days dietary record, one month after bariatric surgery

Exclusion Criteria:

* Lack of understanding of the use of a digital tablet
* Under the protection of justice
* Person participating to another trial
* Pregnant or breast-feeding women
A Study to Assess the Safety and Efficacy of Prograf and MR4 in Kidney Transplantation Patients

To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf and MR4 in new kidney transplant recipients


Eligibility Criteria:
Inclusion Criteria:

* Patient must receive first oral dose of randomized study drug 2days(min 1day) prior to transplant procedure
* Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment

Exclusion Criteria:

* Patient has previously received an organ transplant other than a kidney
* Patient has received a Kidney transplant from non-heart beating donor or a cadaveric donor
* Patients has received an ABO incompatible donor kidney
* Recipient or donor is known to be seropositive for human immunodeficiency virus(HIV)
* Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
* Patient has significant liver, disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
* Patient has an uncontrolled concomitant infection(including Hepatitis B, Hepatitis C)or any other unstable medical condition that could interfere with the study objectives
* Patient is currently taking or has been taking an immunosuppressive agents in the 30 days prior to transplant(except from two days prior to transplant)
* Patient has a known hypersensitivity to tacrolimus
* Patient is pregnant or lactating
Predicting COVID-19 Patients' Clinical Outcomes Using ICU Mobility Scale and MRC Sum Score

The investigators hypothesize that early mobility condition and muscle power may be the predictive factors for Coronavirus disease 2019(COVID-19) patients' activity prognosis and hospitalization days. To prove our hypothesis, the investigators proposed a retrospective cohort study to see if ICU mobility scale(ICUMS) and Medical Research Council Sum Score(MRCSS) can predicted the patients' Barthel index after discharge and hospitalization days.

The investigators hypothesize that early mobility condition and muscle power may be the predictive factors for COVID-19 patients' activity prognosis and hospitalization days. To prove our hypothesis, the investigators checked the patient's baseline ICUMS and MRCSS upon admission. Also, blood test results were also obtained. Subsequently, the investigators measured their outcomes by Barthel index and hospitalization length, and divided them into two groups. The ICUMS, MRCSS and the blood test results differences between two groups were checked. For those factors that showed significant difference between two groups, the investigators recruited them into regression model. Last, receiver operating curve of those factors were plotted to find the appropriate cutoff points for identifying two groups of outcomes.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 patients diagnosed by positive polymerase chain reaction(PCR)

Exclusion Criteria:

* Impaired baseline activities, such as stroke, fracture, neurodegenerative disease
* Baseline Barthel index score less than 100
* Lost follow-up
Acute Congestive Heart Failure Urgent Care Evaluation

This prospective validation study evaluates the ability of a risk algorithm, which can simultaneously predict the risk of death at 7 days and 30 days for patients with acute heart failure presenting to the emergency department. The risk algorithms for prediction of 7-day (Emergency Heart failure Mortality Risk Grade \[EHMRG\]) and 30-day mortality (EHMRG30-ST) have been previously derived.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute heart failure diagnosed in the emergency department

Exclusion Criteria:

* Palliative or do-not-resuscitate (DNR) directive
* Dialysis dependent
Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes

The purpose of this 6-month randomized clinical trial is to examine the feasibility of recruitment, attendance, retention, program adherence, and satisfaction of a digital application designed, Centering Appetite to improve glucose scores (HbA1c) and binge eating in African American adults with type 2 diabetes. Intervention participants will receive type 2 diabetes education and web-based lessons on appetite self-regulation. Participants will also receive a Fitbit to monitor daily physical activity. The investigators will follow up with participants at six months.

Using a randomized clinical trial design examine the feasibility and acceptability of a 6-month digital diabetes self-management education program plus an appetite self-regulation intervention for (n=60) African Americans (AA) with type 2 diabetes who report uncontrolled eating in North Carolina. Sixty AAs will be randomized to the Centering Appetite intervention or the control group. Over the 6 months, Centering Appetite participants will have two intervention sessions supplemented by monthly booster sessions and weekly messages related to the program. The control group will also receive two intervention sessions and weekly nutrition tutorials. The study will examine the following: recruitment feasibility, attendance/retention, treatment adherence, intervention, HbA1c, and binge eating.

Eligibility Criteria:
Inclusion Criteria:

Individuals are eligible if they

* identify as a Non-Hispanic, AA
* are over 18 years of age
* have an A1c value \> 7.5
* have a working Smartphone
* complete binge eating screening

Exclusion Criteria:

Individuals will be excluded if they:

* have major end-organ type 2 diabetes mellitus complications
* have a history of weight loss surgery
* are currently pregnant
* in substance use treatment or are involved in another weight reduction program.
Usefulness of Smartphone Application for Improving Nutritional Status of Pancreatic Cancer Patients

Malnutrition of hospitalized patients is reported in the range of 20-60% according to the definition and assessment method of malnutrition.

In particular, the incidence of malnutrition in cancer patients is high up to 30-85%.

Gastrointestinal disease is related to the digestion and absorption of nutrition therefore malnutrition rate of those patients is relatively high. Careful management of nutrition support is needed.

Malnutrition causes dysfunction of the mesenteric membrane, immune function impairment, decreased function of major organs such as liver, kidney and heart and alteration in pharmacodynamics. It could also increase infection rate and complications of chemotherapy, delay recovery time, so that increase morbidity, mortality and length of hospital stay.

Proper nutrition management reduces malnutrition prevalence and medical costs of hospitalized patient, therefore nutrition screening and evaluation is necessary. The recent spread of smartphones has made it easier to record and evaluate meals, which are used in the diet market for weight loss through meal records and feedback based on smartphone applications. This approach is also expected to benefit patients with gastrointestinal cancer, where proper nutrition and feedback are important. In particular, pancreatic cancer, the worst intractable cancer of mankind, is digestive cancer with the most severe muscle mass reduction and nutritional deterioration after diagnosis.


Eligibility Criteria:
Inclusion Criteria:

1) Among patients with pancreatic cancer who visited Severance Hospital of Yonsei University

1. Patients who received the explanation from the investigator and agreed to the written consent of the subject
2. Men or Women aged 20 to 70

2) First diagnosed with pancreatic cancer within 3 months 3) Patients scheduled to undergo first-line chemotherapy after the diagnosis of pancreatic cancer

Exclusion Criteria:

1. Those who have or had a history of abdominal surgery within the past 1 year
2. Those who have an acute illness (pneumonia, sepsis, shock, etc.) and have an infection at the time of registration
3. chronic liver disease and chronic obstructive pulmonary disease
4. Patients with nutrient absorption disorder due to gastrointestinal mucosal diseases (ulcerative colitis, Crohn's disease, acute and chronic diarrhea, etc.)
5. Severe disease patients (heart failure, liver failure, kidney failure and hemodialysis, etc.)
6. Those who are pregnant or breastfeeding
7. Those who have used steroids within the last one month
8. Patients diagnosed of peritoneal seeding or suspected GI obstructive sign
9. Those who are already taking nutritional supplements
Efficacy of High Intensity Laser for Provoked Vestibulodynia

This is a multicenter randomized controlled trial (RCT) investigating the effects of laser treatments in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Following their enrollment in the study, participants will undergo a gynecological examination for confirmation of their diagnoses. Eligible participants will then be asked to complete a consent form and the baseline assessment. The baseline assessment consists of the completion of validated questionnaires (outcome measures). Participants will be randomized into the laser group or sham-laser group. The laser group will receive 12 sessions of active high intensity laser therapy (HILT) (30 minutes biweekly for 6 consecutive weeks). The sham-laser group will receive 12 sessions (30 minutes biweekly for 6 consecutive weeks) of laser therapy using a deactivated probe. Outcome measures (validated questionnaires) will also be assessed 2 weeks post-treatment as well as 6 months post-treatment (follow-up assessment).

Vulvodynia, a chronic vulvar pain condition, affects between 8 and 18% of reproductive-aged women. The main subtype of vulvodynia is provoked vestibulodynia (PVD), which is characterized by a sharp or burning pain at the vaginal opening while applying pressure to the vulvar vestibule or attempting vaginal penetration. Women suffering from PVD experience greater psychological distress, a worsened quality of life and overall well-being as well as sexual dysfunctions for both the women and their intimate partners. Women suffering from PVD have limited treatment options, and some women have persistent pain despite the available treatment options. Therefore, a new therapeutic avenue needs to be explored. High intensity laser therapy (HILT), a non-invasive and non-ablative laser technique, was found to be effective in several chronic pain conditions. Our randomized pilot study confirmed that HILT is feasible for treating PVD. The promising findings obtained provided support for conducting this large multicenter randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe pain (≥ 5/10) at least 90% of the time during sexual intercourse or attempted sexual intercourse for at least 3 months
* Provoked vestibulodynia of at least 3 months duration prior to the study and diagnosed by a standardized gynaecologic exam

Exclusion Criteria:

* Other causes of vulvovaginal pain (e.g., spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvovaginal atrophy)
* Post-menopausal state
* Current pregnancy or pregnancy in the last year
* Urogynecological condition (e.g., pelvic organ prolapse (POP) ≥ 3, urinary/vaginal infection active or in the last 3 months)
* Anterior vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, corrective pelvic organ prolapse surgery)
* Prior use of laser treatments for vulvar pain
* Expected changes of medication that could influence pain perception (e.g., analgesic, antidepressant)
* Other medical conditions that could interfere with the study
Womens's Experiences of Pregnancy Loss Aftercare in the Gynecological Emergency

Introduction: Scientific papers on the womens's experiences of pregnancy loss aftercare in the emergency department show that how announcement is made and how much caregivers show empathy to women, help women to face this difficult moment. However, in most studies, women say they did not have enough information nor support from the medical teams.

Diagnosis of miscarriage in the emergency department is the routine for the caregiver but is often experienced by the woman as the loss of a child.

This study has for goal to bring to light the discrepancy between the caregivers's experience and the women's experience :the given information, the time for consultation, the empathy.

Methods : 2 months after the diagnosis of miscarriage in the emergency room, patients receive a phone call with explanations about the project. If the patient gives her consent, she receives a computer questionnaire by email (questions about : reasons for coming to the emergency room, circumstances of announcement, information given in the emergency room, satisfaction with the care...) In parallel, caregivers have to complete a questionnaire about the same parameters.

The main objective of this study is to evaluate womens's experiences of pregnancy loss aftercare in the emergency department of Montpellier Hospital.

The second objective is to assess the discrepancy between the patient's experience and the caregivers' experience in this situation with the aim of suggesting improvement.


Eligibility Criteria:
Inclusion criteria :

An individual must fulfill all of the following criteria in order to be eligible for study enrollment:

* Women \> 18 years old
* French speaker
* Diagnosis and management of miscarriage / pregnancy loss in the emergency department
* Miscarriage / pregnancy loss \< 15 SA

Exclusion criteria:

* Subject unable to read or/and write
* Pregnancy loss \> 15 SA.