cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain

This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study duration will be approximately 9 months. Patients will be required to record menstrual pain in a daily diary.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe menstrual-related pain
* Regular spontaneous menstrual cycles

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives
* Treatment with an oral contraceptive in the last 3 months
* Previous treatment failure with an extended oral contraceptive regimen
BONE: STAR (Switching to TAF Based Anti-Retroviral Therapy) Study

The primarily objective of this study is to assess the effect of switching from Tenofovir Disoproxil Fumurate (TDF) to TAF based ART on bone mass and turnover among women on DMPA for contraception. HIV virologically suppressed women on DMPA will be switched from their TDF based regimen to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®) in a randomized fashion. HIV infected women on TDF and non-hormonal contraception will be switched to Biktarvy®).


Eligibility Criteria:
Inclusion Criteria:

* Age 20 through 40 years (inclusive) at screening, verified per site SOPs
* Able and willing to provide written informed consent to be screened for and to take part in the study.
* Able and willing to provide adequate locator information, as defined in site SOPs
* Previously participated in the BONE: CARE study. Additional women will be recruited from the health centers where the BONE: CARE participants were receiving HIV care, and these will be matched to those from the BONE: CARE cohort based on age, duration on ART and contraception use.
* Per participant report, plans to stay in the study catchment area in the next 24 months
* Per participant report, willing to continue using similar contraceptive method as in the BONE: CARE study.

Exclusion Criteria:

* Currently pregnant/ breastfeeding or was pregnant/ breastfeeding in the last 6 months prior to screening
* Intentions to get pregnant in the next two years
* History of active tuberculosis
* Pathologic bone fracture not related to trauma (ever)
* Has pre-existing condition known to affect bone metabolism (e.g. thyrotoxicosis, tuberculosis, diabetes mellitus, liver or renal disease)
* Is taking the following medications known to interfere with bone metabolism (steroids, anti-convulsants, bisphosphonates, cancer drugs, etc.).
Preventing Alcohol Misuse and Consequences in Vulnerable Women

Heavy alcohol use is a pressing public health issue that results in more negative consequences for young adult women, despite them drinking at lower rates than their male peers. However, particular groups of women, such as women who identify as lesbian and bisexual (i.e., sexual minority women), evidence markedly higher rates of alcohol misuse as well as negative consequences from this use. Sexual minority women are more likely to use alcohol, do so at problematic levels, and to meet criteria for alcohol use disorders than heterosexual women and sexual minority men. Despite these disparities, as well as evidence that sexual minority women have unique mechanisms of risk (e.g., minority stress, social context), there are currently no interventions designed to reduce alcohol misuse among sexual minority women. This study represents the first attempt to design an in-person intervention specifically tailored to sexual minority women, which will be accomplished through an Intervention Mapping framework to identify behavioral determinants of their use (e.g., minority stress and distress; social context) and then map effective behavior change strategies onto these determinants.

This particular study aim is devoted to the piloting of a brief motivational intervention to reduce alcohol misuse and consequences among sexual minority women. The objective of this study aim is to examine the preliminary feasibility and acceptability of the intervention following treatment development and refinement. Participants will be randomized to a brief intervention or an attention-matched control arm. Participants in both conditions will complete: a baseline survey as well as a follow-up assessment at 1- and 4-months post-intervention. The investigators hypothesize that the developed intervention will be feasible (as indicated by the number of women eligible who consent, attend their intervention session, and return for follow up). The investigators also hypothesize that the intervention will be acceptable to sexual minority women. The investigators will also obtain preliminary evidence of intervention efficacy in terms of alcohol use outcomes. Specifically, the investigators hypothesize that participants in the intervention will report less frequent heavy episodic drinking and fewer alcohol consequences post-intervention compared with those in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Female;
* English speaking;
* Currently reporting heavy drinking;
* Identifies as a sexual minority woman.

Exclusion Criteria:

* Unwilling or unable to provide informed consent;
* Low literacy (i.e., reporting they "often" or "always" need someone to read instructions, pamphlets, or other written material from a doctor or pharmacy to them)
* Women who report intention to move away during study period.
* Active suicidality.
Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

The purpose of this study is to evaluate the effectiveness of meditation in preventing of atherosclerotic cardiovascular disease (CVD) in postmenopausal, older African American women.

Older African American women suffer from disproportionately high rates of cardiovascular (CVD) morbidity and mortality compared to white Americans. Numerous controlled studies suggest that this disparity is associated with chronic psychosocial and environmental stress. Research indicates that Transcendental Meditation (TM) may result in significant improvements in CVD risk factors in this high risk population.

Participants in this study will be randomly assigned to either active stress reduction with TM or health education control, both in addition to usual medical care, for 12 months. The primary outcome will be carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography. Secondary measures will include traditional CVD risk factors (blood pressure, serum glucose and insulin levels, obesity, and sedentary lifestyle), stress-related neurohormones (catecholamine metabolite and cortisol), psychosocial stress, and quality of life. The results of this trial will yield valuable new knowledge for the prevention of CVD through a CAM intervention in high risk older African American women.

Eligibility Criteria:
Inclusion Criteria:

* African American, self-identified
* Coronary artery disease (CAD/CHD) defined by laboratory examination or documented clinical history of: a)myocardial infarction; b) coronary revascularization procedure--CABG, PTCA; c) coronary angiography--at least one coronary artery with \>50% stenosis
* Informed consent
* Written Permission of participant's referring physician
Oral Nutritional Supplementation With HMB Enhance Muscle Quality in Sarcopenic Surgical Patients

Aims:

Clinical frailty severely impacts the physical, functional and physiological reserves necessary for the recovery after surgery. Sarcopenia, a multifactorial, multi-organ process which lead to loss of muscle mass over time, eventually resulting in clinical frailty. These 2 entities result in an increased morbidity and mortality from surgery. They also lead to a slower recovery from surgery with some patients never reaching baseline function after their surgery. It is, therefore, important to optimize patients with sarcopenia prior to surgery to reduce the incidence of morbidity and mortality.

Nutrition and resistance training have been shown to be able to curb the effects of sarcopenia. However, the type and regime of nutrition is still unknown.

Hypotheses:

The study team hypothesize that Ensure Plus Advance + HMB (beta-hydoxy-beta-methylbutyrate) would reduce the amount of IMAT (inter and intramuscular adipose tissue) in sarocpaenic patients after 2-4 weeks of prehabilitation. This effect would be sustained even after surgery and would continue to improve up to 3-months post-surgery whilst participating in rehabilitation. Taking Ensure Plus Advance + HMB would also improve functional parameters after prehabilitation, ensure a similar QoL 1-month post-surgery even if biochemical parameters may not show a significant improvement.

Methods:

The investigators would be conducting a pilot interventional cohort with an institution with an established prehabilitation programme (SKH) to evaluate the effect of the use a high protein, high calorie oral nutritional supplement (ONS) with HMB on muscle quality, using a device with Automated Intelligence (AI), in sarcopenic patients undergoing gastrointestinal surgery. Primary outcomes will be changes in Intermuscular Adipose Tissue (IMAT) while secondary outcomes include changes in functional parameters, quality-of-life (QoL), surgical outcomes and biochemical results.


Eligibility Criteria:
Inclusion Criteria:

1. between 40-90 years old
2. are sarcopenia (defined by the Asian Workgroup of Sarcopenia 2019 definition)
3. due to undergo elective major gastrointestinal surgery
4. able to satisfy at least 2 weeks of prehabilitation before surgery
5. ambulant
6. able to comply with physiotherapy and dietician advice

Exclusion Criteria:

1. Are pregnant
2. Are prisoners
3. Intellectually, mentally or emotionally deemed not able to provide an informed consent and/or are unable to fill up the post-procedure questionnaires
4. Have disease conditions requiring emergent/semi-emergent operation
5. Diabetes on oral hyperglycemic agents (OHGA)
6. Chronic Kidney Disease (CKD) or End-stage Renal Failure (ESRF)
7. Unable to or decline assessment for sarcopenia
AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment

During or after antibiotic treatment, antibiotic residues impair the intestinal microbiota (gut flora) and lead to adverse effects such as the emergence of bacterial resistance or the occurrence antibiotic-associated diarrhoea (AAD) including antibiotic-induced C. difficile infection (CDI). The spread of resistant Gram-negative bacteria and the increasing number and severity of CDI are considered as worldwide public health threats.

Da Volterra is a biotechnology company developing a novel product, DAV132 (a medical device in Europe), intended to prevent these antibiotic adverse effects. Da Volterra is planning to carry out a phase 2-3 randomized controlled trial (RCT) of DAV132 in the prevention of antibiotic-induced CDI. The RCT will involve hospitalized patients aged ≥50 years old and treated with predefined antibiotic classes known to increase the risk of CDI. The incidence of CDI in this population is unknown, yet, incidence is an important determinant for the required sample size.

Therefore, the main objective of the current study is to assess CDI incidence in patients ≥50 years of age treated with predefined antibiotic classes.

In addition, to optimise the target population of the DAV132 RCT, the effect of the predefined antibiotic agents on the intestinal microbiota will be assessed. Furthermore, biomarkers predictive of CDI occurrence might help identify patients at high risk for the disease, which could further optimise the RCT. No validated biomarkers have been described in the literature yet. Assessment of potential biomarkers is another aim of the present study.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female hospitalized patient.
2. Aged ≥ 50 years old.
3. Initiation of intravenous or oral treatment with intended duration ≥5 days (≥1 day for clindamycin) with at least one of the following antibiotic classes, or treatment scheduled within the next 72 hours:

   * Third or fourth generation cephalosporins
   * Fluoroquinolones
   * Penicillins +beta-lactamase inhibitors
   * Clindamycin
   * Carbapenems
4. Written informed consent provided prior to inclusion.

Exclusion Criteria:

1. Ongoing antibiotic treatment with one of the above classes initiated \>6 hours before inclusion into the study.
2. ICU admission at the time of inclusion or anticipated admission within 48h.
3. Suspected or diagnosed CDI, ongoing treatment for CDI, or diarrhoea at the time of inclusion.
4. Patient with stoma.
5. Subject has been included into this study previously.
6. Patient treated with probiotics to prevent CDI.
7. Patient with any social or logistical condition which in the opinion of the investigator may interfere with the conduct of the study, such as incapacity to well understand, not willing to collaborate, or cannot easily be contacted after discharge.
8. Subject is subject to legal protection.
9. Subject deprived of liberty by judicial or administrative decision.
Effects Of McKenzie Exercises With And Without Mulligan Mobilization In Text Neck Syndrome.

This study aims to determine the effect of McKenzie exercises with and without Sustained Natural Apophyseal glide on pain, disability, and craniocervical angle in adults with Text neck syndrome.

Text neck syndrome is a condition that results from the repetitive use of electronic devices, causing the neck to flex forward or down for extended periods. This can lead to symptoms such as neck pain, reduced range of motion, weakened muscles, altered joint position, and postural changes such as forward head posture and rounded shoulders.

In this randomized clinical trial, forty eight participants with text neck syndrome will be randomly assigned to one of the two intervention groups:

Group A :McKenzie Exercises without Mulligan mobilization and Group B:McKenzie Exercises with Mulligan mobilization . Randomization will be performed using a convenient random sampling method via sealed opaque envelopes. Each participant will receive a total of eight treatment sessions over a four-week period. The efficacy of the interventions will be assessed at the beginning (first session), conclusion (eight session). Outcome measures, including pain intensity, disability levels and craniocervical angle will be evaluated using the Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI) and Image J software, respectively. Data will be analyzed using SPSS software version 26. Normality of data will be assessed using the Kolmogorov Smirnov test. For within-group comparisons, either repeated measures ANOVA or the Friedman test will be used. To compare changes between the groups, the independent t-test or Mann-Whitney U test will be applied, depending on the data distribution. The analysis of these outcome measures will provide valuable insights into the impact of the interventions on participants' symptoms and postural alignment.

Eligibility Criteria:
Inclusion Criteria:

Age (18-35 years) Male and Female CVA \<49° Using smart phone for more than 5 hours a day Having history of more than 3 months Score more than 3 on NPRS and more than 10 on NDI Score of SAS\> 88

Exclusion Criteria:

Neck surgery Spinal infection or inflammatory disorder Diagnosed cases of disc prolapse, stenosis, herniation, spondylolisthesis and osteoporosis, torticollis, scoliosis.
Study of Peer Relationships at School

The goal of this study is to compare the effects of two separate, manualized group interventions designed to improve social outcomes for young children with autism. The first type of group intervention utilizes a social skill curriculum delivered to a small group of children with autism at their school. This type of group will be referred to as the Skills group (SKILLS intervention). The other intervention delivers a social engagement curriculum at the children's school site and includes children with autism and typically developing peers, from the same school. This type of group will be referred to as the School Engagement Group (ENGAGE intervention).

Once families have decided to join the study, and have completed the informed consent process using the "Social Skills Club - Parent Consent", and once we obtain letters of agreement from participating elementary schools, children with ASD will be randomly assigned to one of two intervention conditions, SKILLS or ENGAGE, led by two trained doctoral students. Since children will be randomized to either the SKILLS or the ENGAGE group, we are hoping to determine the active ingredients for successfully integrating children with autism. For both the SKILLS and the ENGAGE groups, all interventions and observations of children will take place in the target child's school. Thus, upon admission to the project, research personnel will attend the participant's classroom at school, and distribute consent forms titled "Peer Relationships at School - Classroom Parent Consent" to all children in the class. The consenting process should be no more than ten minutes. For those children that return informed consent from their parents, as well as offer assent on the "Children's Classroom Assent" to join to the project, social network measures (including brief demographic information), as well as friendship surveys (Friendships Qualities Scale; FQS), and an emotion measure (loneliness questionnaire) will be distributed at pre-intervention (baseline), post-intervention, and follow-up time points. These measures will take approximately 30-40 minutes per each time point. Graduate students will administer the measures and will make every effort to do so at a convenient time for the teacher and for the classroom to avoid utilizing instructional time. In addition, the efficacy of the treatment interventions will be assessed with ongoing direct behavioral observations at entry, twice during treatment, at exit, and at the 2-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Children are between the ages of 7 and 12 years in grades 2-5.
* Children have a clinical diagnosis of autism or PDD-NOS, and/or meet criteria on the ADOS for ASD or autism.
* Children have an IQ of 70 or above
* Children are fully included in a typical classroom for 80% or more of the school day
* Children are expected to stay in the school or the classroom for the duration of the study.
* Families with low SES and/or from racial/ethnic minority backgrounds

Exclusion Criteria:

* Children must not have additional diagnoses or sensory or motor impairments.
A Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate. In addition, safety, pharmacokinetics, immunogenicity of atezolizumab and tiragolumab will be evaluated.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically or cytologically confirmed recurrent/metastatic SCCHN involving the oropharynx, oral cavity, larynx, or hypopharynx, that is considered incurable by local therapies
* Known results from human papillomavirus (HPV) status test for oropharyngeal carcinoma
* No prior systemic therapy for metastatic and/or recurrent SCCHN
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Tumor PD-L1 expression as determined by PD-L1 immunohistochemistry assay
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy \>=12 weeks

Key Exclusion Criteria:

* Disease suitable for local therapy with curative intent
* Progressive or recurrent disease within 6 months of the last dose of curative intent systemic treatment for locally advanced SCCHN
* Rapidly progressing disease in the opinion of the treating investigator
* Grade \>=2 unresolved toxicity related to surgery or other prior therapies
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* History of leptomeningeal disease
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* History of additional malignancy other than SCCHN within 5 years prior to randomization
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-TIGIT, anti-PD-L1, and anti-PD-1 therapeutic antibodies
* Treatment with systemic immunostimulatory agents or systemic immunosuppressive medication
* Pregnancy or breastfeeding
A Study of Effect of Selpercatinib (LY3527723) in Participants With Normal and Impaired Renal Function

The main purpose of this study is to assess the amount of study drug that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to healthy participants. The study will last up to 9 days, excluding screening.


Eligibility Criteria:
Inclusion Criteria:

For all participants:

* Body mass index (BMI) ≥ 18.0 and ≤ 40.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study
* Female of non childbearing potential: must have undergone sterilization procedures at least 6 months prior to the Screening
* Males who are capable of fathering a child must agree to use contraception from the time of the dose administration through 6 months after the last dose

For renal participants:

* Participant has stable renal disease status and function at least 1 month prior to LOXO-292 administration.
* Participant is not currently or has not previously being on hemodialysis
* Baseline estimated glomerular filtration rate (eGFR) based on the Modification of Diet in Renal Disease (MDRD) equation at screening as follows:

  * Severe Renal Impairment (RI): \< 30 milliliter per minute (mL/min)/1.73m²
  * Moderate RI: ≥ 30 and \< 60 mL/min/1.73m²
  * Mild RI: ≥ 60 and \< 90 mL/min/1.73m²

The MDRD equation is as follows (for females multiply result by 0.742, if African American multiply result by 1.212):

eGFR = 175 x \[serum creatinine in milligrams per deciliter (mg/dL) measured with a standardized assay\]\^-1.154 x (Age)\^-0.203

Exclusion Criteria:

For renal participants:

* Has rapidly fluctuating renal function, as determined by historical measurements; or has demonstrated or suspected renal artery stenosis. Rapidly fluctuating renal function is defined as creatinine clearance or eGFR that differs by more than 20% within at least 3 months of the screening creatinine clearance or eGFR. If historical measurements are not available, then the 2 screening measurements will be used to demonstrate stability.
* Participants who have had a renal transplant, a nephrectomy, or participants with a known history of nephrotic syndrome.
* Participants who have required new medication for renal disease within 30 days prior to Check-in