cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College

This study utilizes implementation science principles to culturally adapt a pre-existing web-based application (WebApp) for use with college students. The ADAPT-ITT process will be utilized to adapt the WebApp to a diverse (race, ethnicity, gender/sexual identity) college population with a focus on life skills and holistic self-care as reinforcement to currently available primary prevention programming available to incoming students. The study hypothesis is that the adapted WebApp will be usable, acceptable, and students will be willing to use it as a reinforcement to current university primary prevention programming. The study team will also monitor retention of participants over the academic year.


Eligibility Criteria:
Inclusion Criteria:

1. Currently enrolled as a student at the participating university (University of Michigan)
2. Age 18 or older
3. Willing to participate in the study
4. Able to speak and read English
5. Participated in Relationship Remix at Alice Lloyd Hall or Mosher-Jordan Hall during the Fall of 2017. These residence halls were selected due to their similar sizes and demographic populations to allow for "approximate matching" between the control and intervention group.

Exclusion Criteria:

1. Did not complete the Relationship Remix session
A Phase I Study of BMS-690514 in Combination With Paclitaxel and Carboplatin

The purpose of this clinical research is to assess the safety and tolerability of BMS-690514 when given in combination with paclitaxel and carboplatin. Paclitaxel and carboplatin will be administered on a standard regimen every 3 weeks at standard doses. BMS-690514 will be given in the interval at escalating doses until the maximum tolerated dose (MTD) is identified. An additional cohort of subjects will be treated with BMS-690514 at the MTD in combination with Paclitaxel and carboplatin


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced or metastatic solid tumors for whom paclitaxel/carboplatin is considered an appropriate therapy
* Centrally located squamous cell carcinoma of the lung is permitted
* ECOG performance status of 0-1
* Life expectancy of at least 3 months
* Men and women age 18 and above

Exclusion Criteria:

* Symptomatic brain metastases. Patients with signs for symptoms of brain metastases are ineligible unless brain metastases are ruled out by CT or MRI
* Peripheral neuropathy ≥Grade 1 for any reason
* History of thromboembolic disease or bleeding diatheses within the last 6 months
* Women of child bearing potential without adequate contraception, breastfeeding, or pregnant
* Serious, uncontrolled medical disorder or active infection
* Uncontrolled or significant cardiac disease
* Uncontrolled hypertension (150/100)
* Allergy to Cremophor EL®
Habituation to Food as a Risk Factor for Pediatric Obesity

The study is designed to assess habituation of behavioral responding for food as risk factors for increases in Standardized Body Mass Index (zBMI) over two years in non-overweight children.

Cross sectional data have shown slower habituation is related to greater energy intake, and habituation is slower for overweight/obese compared to leaner youth, but it is not known whether this is a result of being overweight, or whether slower habituation is a risk factor for weight gain. The goal of this application is to study individual differences in behavioral (responding for food) habituation as risk factors for alterations in zBMI and body fat over a two year period in 200, 8 to 12 year-old non-overweight children. This project will provide the first test of the hypothesis that slow habituation to food is a risk factor for increases in zBMI in non-overweight youth.

Eligibility Criteria:
Inclusion Criteria:

* 8-12 years of age
* Participants will include children who are at the 50th BMI percentile and less than the 85th BMI percentile (BMI = kg/m2) at baseline. We will also include children who are below the 50th percentile, but have at least one biological parent with a current BMI ≥ 25 kg/m2.

Exclusion Criteria:

* Food allergies or special diets: Youth should have no dietary restrictions that could interfere with these experiments, including food allergies or religious or ethnic practices that limit food choice or medical conditions which alter nutritional status or intestinal absorption (e.g. inflammatory bowel disease).
* Activity restrictions: Children who have activity restrictions due to medical or physical problems, such as uncontrolled exercise induced asthma or a disability requiring wheelchair use will not participate.
* Psychopathology, medications or sickness: Children should have no psychopathology (e.g. childhood schizophrenia) or developmental disabilities that would limit participation. Children will also be excluded if they are taking medications that could affect their level of activity or appetite (e.g. methylphenidate).
* Moderate or greater liking of study foods. Children must report at least a moderate liking ( 3 or greater on a 5-point Likert-type scale) of the foods used in these studies and be willing to consume them.
A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris

The objectives of this study are to evaluate the therapeutic equivalence and safety.

The objectives of this study are to evaluate the therapeutic equivalence and safety of the test product Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to the reference product Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of these test and reference products over the placebo control.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
* Must have a minimum ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
* Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Exclusion Criteria:

* Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
* A history or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis.
* A history of hypersensitivity or allergy to clindamycin, benzoyl peroxide and/or any of the study medication ingredients and its excipients.
Impact of Resident Participation in Post-ICU Follow Up Clinic

This study is being conducted to describe the impact of a meeting between patients that were admitted to the intensive care unit (ICU) and a provider that cared for the patients during the period of critical illness. The study team is aiming to describe the effect this meeting has on the physician that previously cared for the patient.

The study team hypothesizes that facilitating involvement in post-ICU clinic and creating longitudinal relationships between providers of critical care and survivors of critical illness will have positive effects on trainees, both in professional fulfillment and burnout scores and in perceptions of critical care.

Physicians and patients that had been cared for in the ICU will be enrolled in this project. Residents that are recruited will be randomized to the encounter group or the control group.

Eligibility Criteria:
Inclusion Criteria for Patients:

- Must be eligible for Post ICU Longitudinal Survivor Experience (PULSE) clinic follow up and/or have received referral to clinic

Inclusion criteria for Residents:

* Must have completed at least one 2-week rotation in the medical ICU at the University of Michigan
* Must have cared for an enrolled patient in the study

Exclusion Criteria for Patients:

- Died during ICU stay

Exclusion Criteria for Residents:

- Provided only "cross-cover" for the patient.
Drug Interaction With Envarsus XR and Grapefruit Juice

Transplant patients must take lifelong immunosuppression in order to prevent rejection of their organ. Tacrolimus is the most widely used immnosuppressive agent. Part of the routine education given to patients regarding tacrolimus is that they must avoid many drugs and substances that can interact with tacrolimus so that they don't experience side effects or lack of effect. Patients are told they must avoid readily available substances such as grapefruit juice and St. John's wort. A new once daily formulation of tacrolimus, Envarsus XR, may bypass the place in the gut in which many of these drug interactions occur. We will give kidney transplant patients Envarsus with and without grapefruit juice and measure the effect on blood levels throughout the day. Results from this study will also give us information about the likelihood of other drugs interacting with Envarsus XR.


Eligibility Criteria:
Inclusion Criteria:

* Primary Kidney Transplant Age \> 18 years At least 3 months post-transplantation Taking a stable dose of tacrolimus extended release with a target trough of 8-10 ng/mL BMI between 18-32

Exclusion Criteria:

* Multi-organ transplant Concomitant use of mTOR inhibitor Concomitant use of belatacept Concomitant use of medication affecting CYP3A or P-gp History of rejection Hypersensitivity to midazolam Hypersensitivity to Envarsus Active diarrhea or constipation BMI \< 18 or \> 32
Efficacy and Safety of the Anti- COVID-19 Vaccin in Clinical Hematology Patients

Coronavirus disease 2019 (COVID-19) is an emerging infectious disease that was first reported in December 2019 in Wuhan, China. Infection with this new coronavirus called SARS-CoV-2 can lead to fatal pneumonia associated with high rates of hospitalization in intensive care units (ICU).

Hospitalized patients with hematologic malignancies have a higher mortality rate than patients without hematologic malignancies (62% vs. 8%). The severity of Covid-19 may be related to their treatment, in particular anti-CD20 used in B lymphoid hemopathies. In fact, anti-CD20 antibodies induce rapid and prolonged depletion of B cells, but they are necessary for development. humoral immune responses.

But currently, no immunogenicity data are known for patients with hemopathy or in those on anti-lymphocyte immunochemotherapy.

The aim of this study is to evaluate the humoral response after vaccination against SARS-CoV-2 in a French multicenter cohort of patients with hemopathies. Analysis of hemopathies and immunochemotherapy subgroups will determine whether there is a need to strengthen immunization schedules. In addition, the study wish to assess the safety and clinical efficacy of mRNA vaccines in this cohort.

Eligibility Criteria:
Inclusion Criteria:

* Benign or malignant hemopathy
* With priority vaccination indication
* Having benefited from anti-covid-19 mRNA vaccination

Exclusion Criteria:

* Patients under legal protection
* Palliative care patients
* History of known Covid-19 disease (\<1 year)
Passive Limb Movement Study

Stroke survivors have compromised vascular function which may contribute to secondary stroke risk, cardiovascular disease, and may limit their exercise tolerance. No studies have examined how femoral blood flow responds to both passive leg movement, a measure of microvascular function, as well as active leg contractions, a measure of the hyperemic response to exercise. Leg muscles with a reduced blood flow response to movement could be associated with decreased neuromuscular function, such as leg strength and fatigue. Preliminary data showing a single bout of ischemic conditioning may improve vascular function and muscle activation in healthy adults and individuals post-stroke. Therefore, the investigators want to examine if ischemic conditioning will also improve the blood flow response to passive leg movements as well as during single leg active contractions.


Eligibility Criteria:
Inclusion Criteria:

* Individuals Post-Stroke

  * 18 - 85 years of age
  * Cortical or sub-cortical stroke ≥ 6 months ago with residual hemiparesis
  * Able to give informed consent and follow 2-step command.
  * English Speaking
* Age- and Sex-Matched Controls (CON)

  * Matched to age of individual post- stroke ± 5 years.
  * Matched to sex of individual post-stroke
  * Able to give informed consent and follow 2-step command.
  * English Speaking
* Young Healthy Adults (CONyoung)

  * Age 18-30 years old
  * Able to give informed consent and follow 2-step command.
  * English Speaking

Exclusion Criteria:

* All Groups

  * Unable to stand from chair and walk 10 meters without physical assistance from another person (able to use assistive device).
  * History of blood clots in the extremities or any condition in which compression of the thigh or transient ischemia is contraindicated (i.e., wounds in the leg).
  * Chronic lasting symptoms (\> 6 months) of severe COVID-19 (i.e., hospitalization)
  * Low back or hip pain that limits lower extremity motor testing.
  * History of head trauma or concussion within the past 6 months
  * Comorbid neurological disorder
  * Peripheral vascular disease
  * Myocardial infarction in the previous year
  * Condition where fatiguing contractions or resisted leg contractions are contraindicated
  * Resting SBP ≥180 mmHg or DBP ≥ 100 mmHg
  * Pregnancy or breastfeeding.
  * Other significant medical condition likely to influence study or jeopardize safety as assessed by the Primary Investigator
* CON and CONyoung

  * History of Stroke
Personalized HIV and STI Testing Tool

The PHASTT Study is focused on understanding of facilitators and barriers to mHealth use among young Black men who have sex with men (MSM), and testing a novel mobile app to increase HIV/STI testing and PrEP uptake.

The Sex Pro mobile application (app) being tested facilitates home HIV-testing, home sexually transmitted infection (STI) test self-collection, and pre-exposure prophylaxis (PrEP) uptake. The app integrates a personalized HIV risk assessment with home HIV and STI testing options for young, Black MSM.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Black.
* Self-report being HIV negative.
* Report anal sex with at two or more male sex partners in the prior 12 months.
* Own an iOS or Android mobile phone.
* Willing and able to give written informed consent to participate in all activities outlined by the protocol.

Exclusion Criteria:

* Inadequate contact information for follow-up
* In a mutually monogamous sexual relationship for the past 12 months
* Currently taking PrEP
* Does not have reliable access to the internet
* Does not live, work or play in the San Francisco Bay Area
* Currently enrolled in another HIV intervention study
* Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product
* Any medical, psychiatric, or social condition, or occupational, or other responsibility that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Rheumatoid Purpura in Children: a Multicenter Observational Study of Pediatric Emergency Department Management and Follow-up by Primary Care Physicians

The main objective of this study is to describe the management of children with rheumatoid purpura from admission to the pediatric emergency room to follow-up by primary care physicians after hospital discharge.

Secondary objectives The secondary objective is to assess general practitioners current knowledge and practice of the condition and potential barriers to monitoring and follow-up by general practitioners.

Conduct of research Children diagnosed with rheumatoid purpura within the past 2 years at the 3 participating sites will be included in the study if parental authority holders do not object.

Patients will be identified through the Medical Information Department of each hospital.

Parents will be contacted - first by mail, then by phone - to request permission to collect the child's medical data from medical records, and to retrieve information on the surveillance and follow-up of the disease by general practitioners up to two years after diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Underaged patient diagnosed with rheumatoid purpura during a visit to the pediatric emergencies of Mulhouse, Colmar and Strasbourg
* No objection to the study from the two holders of parental authority

Exclusion Criteria:

- Patient followed in the context of a genetic or malformative pathology, an immune deficiency, or a cancer
T-lymphocytes CD8+/HLA-DR+ and Acute Rejection After Lung Transplantation

The objectives of the study is to identify associations between acute rejection and the increase of T (CD4/CD8) and B circulating lymphocytes expressing specific markers of activation and differentiation (HLA-DR, CD25, CD38, CD45RO, CCR7).

110 adults over 18 years, on national waiting list for a first lung transplantation in the centers of Marseille and Strasbourg, whatever the lung disease, and who will be transplanted and benefit immunosuppressive induction therapy that specifically targets T lymphocytes will be included. Peripheral venous blood sampling just prior to pulmonary transplantation, at day 15 and one month post-transplant will be realized for lymphocyte phenotyping by flow cytometry (CD45, CD3, CD4, CD8, CD19, HLA-DR, CD25, CD38, CD45RO, CCR7). Acute rejection will be evaluated at 1 month and 1 year post-transplant by trans-bronchial biopsies.

The two main perspectives are to 1) find a specific, non-invasive, blood-based diagnostic marker of acute post-lung transplant rejection with diagnostic performance equivalent to trans-bronchial biopsy 2) demonstrate a specific blood marker, non-invasive, predictive of acute rejection in order to adapt immunosuppressive therapy early and reduce the occurrence of this risk.

The objectives of the study is to identify associations between acute rejection and the increase of T (CD4/CD8) and B circulating lymphocytes expressing specific markers of activation and differentiation (HLA-DR, CD25, CD38, CD45RO, CCR7).

110 adults over 18 years, on national waiting list for a first lung transplantation in the centers of Marseille and Strasbourg (France), whatever the lung disease, and who will be transplanted and benefit immunosuppressive induction therapy that specifically targets T lymphocytes will be included. Peripheral venous blood sampling just prior to pulmonary transplantation, at day 15 and one month post-transplant will be realized for lymphocyte phenotyping by flow cytometry (CD45, CD3, CD4, CD8, CD19, HLA-DR, CD25, CD38, CD45RO, CCR7). Acute rejection will be evaluated at 1 month and 1 year post-transplant by trans-bronchial biopsies.

The two main perspectives are to 1) find a specific, non-invasive, blood-based diagnostic marker of acute post-lung transplant rejection with diagnostic performance equivalent to trans-bronchial biopsy 2) demonstrate a specific blood marker, non-invasive, predictive of acute rejection in order to adapt immunosuppressive therapy early and reduce the occurrence of this risk.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* French national waiting list of lung transplantation
* Transplanted in Marseille or Strasbourg (France)

Exclusion Criteria:

* \<18 years old
* Refused to participate
* Redo lung transplantation
* Other organ transplanted
Audio Vestibular Assessment in Patients with Fibromyalgia

Fibromyalgia (FM) is a common rheumatic illness distinguished by chronic pain, fatigue, cognitive problems, and functional disability. However, the differences between men and women have not yet been comprehensively studied, especially after the development of the last 2016 American College of Rheumatology (ACR) criteria. The disease is more common and more severe in female patients according to a study on gender differences among Egyptian patients (A. Moshrif et al., 2023)

Fibromyalgia (FM) is a common rheumatic illness distinguished by chronic pain, fatigue, cognitive problems, and functional disability. However, the differences between men and women have not yet been comprehensively studied, especially after the development of the last 2016 American College of Rheumatology (ACR) criteria. The disease is more common and more severe in female patients according to a study on gender differences among Egyptian patients (A. Moshrif et al., 2023) (FM) is a non-inflammatory chronic disease, characterized by widespread musculoskeletal pain (Tuncer et al., 2021). The etiology is still unknown and (FM) is often misdiagnosed (Tuncer et al., 2021).The estimated prevalence in the general population is between 2 and 11% (Hulens et al., 2023). Although the underling Pathological mechanisms controlling the (FM) have not been determined, neuroendocrine, genetic or molecular factors can be involved (Zeigelboim \& Moreira, 2011).(FM) affects females between the ages of 25 to 65 years old, although it can be seen in all ages and in both sexes (Fitzcharles \& Yunus, 2012), It's more common in females than in males (Müller et al., 2007).

The main symptoms of (FM) include, muscle pain, muscle spasms, insomnia, fatigue, tension, abdominal pain, facial tenderness, sensitivity to noise and bright lights, and central nervous system abnormalities. Various neurological symptoms such as tinnitus, ear fullness, vertigo, and dizziness may also be associated, regardless of the disease severity (Koca et al., 2018) Many patients with FM were reported to have dizziness which may attributed to hypotension and autonomic nervous system (ANS) dysfunction, in this study we want to explore if dizziness and imbalance occur due to these factors only or due to a direct effect of (FM) on the vestibular system (Kanjwal et al., 2010) (Mohamed et al., 2021).

Eligibility Criteria:
1. Inclusion criteria: - Age: 15-50 years.

   * Sex: Male \& Female.
   * Patients with fulfilling the criteria for the diagnosis of FM
2. Exclusion criteria: Patients not fulfilling the criteria for the diagnosis of FM.

   * Other causes of SNHL as Meniere's disease.
   * Other causes of Conductive hearing loss (CHL) as chronic suppurative otitis media CSOM.
   * Other causes of collagen and connective tissue diseases.
   * Abnormal EMG.
   * Abnormal radiological studies of the brain.
   * Patients are receiving of ototoxic drugs.
Evaluation of the Long-term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension

The purpose of this study is to evaluate long-term safety,tolerability and blood pressure effects of metoprolol versus nebivolol in patients with hypertension. These drugs may be given alone or in combination with other drugs that are commonly used in the treatment of hypertension

Approximately 50 million Americans have hypertension defined as a systolic blood pressure (SBP) greater then or equal to 140 mmHg and/or a diastolic blood pressure (DBP) greater then or equal to 90 mmHg. To control blood pressure, more than 2 agents are required in many patients. The current study is a randomized, titration-to-effect, open-label, multi center study. Patients will be randomized to either nebivolol or metoprolol. The dose of the randomized treatment can be titrated as needed to achieve blood pressure control. If necessary, additional antihypertensive agents (calcium antagonist, diuretic, etc.) can be added to achieve control. Patients will be seen every 1-3 months for approximately 18 months to assess long-term safety, tolerability and effectiveness of nebivolol versus metoprolol.

Eligibility Criteria:
Inclusion Criteria:

* Completion of previous nebivolol study
* Stage 1-2 Hypertension (HTN) at baseline of first study

Exclusion Criteria:

* Recent myocardial infarction or stroke
* Contraindications to beta blocker therapy