cyrilzakka/clinical-trials huggingface dataset:
Effect of Yoga on Psychological Aspect and Quality of Life in Premenstrual Syndrome

This study will be carried out to evaluate the effect of yoga on psychological aspect and quality of life in premenstrual syndrome.

Premenstrual syndrome (PMS) is characterized by a collection of physical, emotional, psychological, and behavioral symptoms that appear in a cyclic and recurring pattern during the late luteal phase of the menstrual cycle and alleviate within two to four days of menstruation.

Premenstrual Syndrome has a negative impact on young girls' lives, which can lead to reduced work efficiency and quality of work, increased accidents and lack of school attendance. Therefore, there is a need to develop treatment protocols for coping with premenstrual symptoms.

Yoga denotes union and integration and improves biopsychosocial and spiritual wellness. In other words, yoga is a form of mind-body health that combines physical activity with inner-directed mindfulness to achieve self-consciousness through breathing and meditation.

So, this study will be conducted to contribute and add new information that may help the field of physical therapy. It will provide an evidence base for the efficacy of yoga on management of psychological aspect and quality of life in premenstrual syndrome, owing to its low cost, and ease use that may lead to improvement of symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Their ages will be ranged from 18 to 25 years old.
* Their body mass index (BMI) will be less than 30 kg/m².
* They will be virgin.
* They will have regular menstrual cycles.
* They will suffer from Premenstrual syndrome based on daily record of severity of problems.
* All women will be conscious and free from any medical disease.

Exclusion Criteria:

* Women with the following criteria should be excluded from this study:
* Women with endocrine disturbance.
* Endometriosis.
* Pelvic inflammatory disease.
* Any pelvic pathology conditions.
* Women had hysterectomy or ovariectomy.
* Women use medications as contraceptive pills, pain relief drugs and antidepressant drugs.
Epidemiology of IgA Selective Deficiency - Clinical Manifestations and Risk of Transmission

The management of patients with a selective IgA deficiency currently consists of symptomatic treatment with treatment of infections by occasional or prolonged antibiotic therapy, immunosuppressive treatments for autoimmune pathologies, symptomatic treatment of allergic manifestations.

IVIG supplements are sometimes proposed in the event of recurrent infections and the demonstration of deficiencies in IgG subclasses (IgG1, 2, 3) often not sought for diagnosis The factors associated with the severity of clinical manifestations are not well identified and patients with IgA deficiency must be monitored over the long term because of the risk of the appearance of autoimmune manifestations and neoplasia. The identification of such factors could lead to the proposal of close monitoring for these patients.

IgA deficiency, which is frequent, has not been identified as a risk factor for severe COVID-19 infection, probably due to a lack of studies with sufficient recruitment. The therapeutic attitude concerning patients with an IgA deficiency in the event of COVID-19 infection is therefore not consensual.

There is currently no action to be taken regarding the risk of transmission of IgA deficiency.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years old)
* Subject treated at the HUS, with a primary selective IgA deficiency, considered as definitive (IgA concentration \< 0.07g/L or total absence of IgA on immunofixation) or as probable (IgA concentration lower than two standard leads to standard for age) with no other humoral immunodeficiency and no other cause of decreased gammaglobulins 01/01/2005 to 01/31/2022.
* Subject having not expressed, after being informed, their opposition to the reuse of their data for the purposes of this research.

Exclusion criteria:

. Subject who expressed their opposition to participating in the study
Artificial Intelligence-assisted Colonoscopy on Detection of Missed Proximal Lesions

This is a prospective multi-center randomized study is to determine whether the use of artificial intelligence (AI)-assistance could reduce the miss rates of polyps and adenomas in the proximal colon during tandem examination

Centers

1. Queen Mary Hospital, Hong Kong, China (Co-ordinating Center)
2. Tan Tock Seng Hospital, Singapore, Singapore
3. Institute of Gastroenterology and Hepatology, Vietnam Union of Science and Technology Association, Hanoi, Vietnam

Study population

Inclusion:

All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the participating centers will be recruited.

Exclusion:

* history of inflammatory bowel disease
* history of colorectal cancer
* previous bowel resection (apart from appendectomy)
* Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes
* bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe.

Post-randomization exclusion:

* Cecum could not be intubated for various reasons
* Boston Bowel Preparation Scale (BBPS) score of the proximal colon is \<2

Study design This is a prospective randomized trial comparing the miss rates of proximal colonic lesions by AI assisted colonoscopy or conventional colonoscopy (Fig. 1). The study will be conducted in the Endoscopy Centre of the participating hospitals.

Randomization Eligible patients in each center will be randomly allocated in a 1:1 ratio to undergo tandem colonoscopy of the proximal colon first with AI-assistance and follow by conventional white light colonoscopy (Group 1) or conventional white light colonoscopy without AI assistance follow by conventional colonoscopy (Group 2). Proximal colon refers to colonic segment proximal to the splenic flexure. Randomization will be conducted in blocks of 4 by computer generated random sequences and stratified according to indications of colonoscopy (symptomatic vs screening/surveillance). Patients will be blinded to the group assignment.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the participating centers will be recruited

Exclusion Criteria:

* history of inflammatory bowel disease
* history of colorectal cancer
* previous bowel resection (apart from appendectomy)
* Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes
* bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe.
Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old

This study is an open-label nonrandomized exploratory proof of concept and descriptive 4-year immunogenicity study to assess immunogenicity after administration of a 2-dose regimen of 9-valent human papillomavirus vaccine (9vHPV) vaccine separated by 12 months (months 0, 12).

Study participants will include 150 boys and girls aged 4-8 years (total, 75 boys and 75 girls) to receive 2 doses of the 9vHPV vaccine at 0 and 12 months. Patients will be recruited by age-group to achieve balanced enrollment of 15 girls and 15 boys per year of age. The investigators will examine the immunogenicity profile in this cohort, for which titers will be analyzed one month after dose 2 (Month 13) and at Month 60.

Though clinical efficacy cannot be assessed in young children because of limited exposure to human papillomavirus (HPV), this descriptive study will allow the investigators to understand whether the 9vHPV vaccine in younger patients provides immunogenicity similar to that shown for the 9-14 and 16-26 age groups who have received the 9vHPV vaccine.13 This study will require an IND for the use of the HPV vaccine in children younger than 9 years.

Immunogenicity will be measured by examining serum antibodies of all participants using a competitive Luminex immunoassay (cLIA).15 Month 60 serology will be by cLIA and IgG LIA assays. The antibody response testing will be performed at Merck Research Laboratory.

The goal of this study is to explore whether a 2-dose 9vHPV vaccine regimen with dosage separated by 12 months is immunogenic among children aged 4-8 years. The primary outcome will be geometric mean titers (GMT) for HPV6, HPV11, HPV16, HPV18, HPV31, HPV33, HPV45, HPV52, and HPV58 antibodies at months 13 and 60. Results will allow the investigators to qualitatively compare immunogenicity in individuals vaccinated at age 4-8 years to known immunogenicity in 9vHPV recipients vaccinated at ages 9-14.13 Knowledge of whether vaccination in this age group is sufficient to induce high-level protective antibody titers through 4 years after the second dose will support further efficacy studies in a larger randomized trial of a 2-dose 9vHPV regimen for children aged 4-8 years.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 4-8 years old
2. Receives care at the Boston Medical Center or one of the affiliated Community heath centers
3. Naïve to HPV Vaccine

Exclusion Criteria:

1. A history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic reaction to yeast
2. Immunocompromised/previous immunosuppressive therapy
3. Thrombocytopenia or other coagulation disorder
LobularCard Trial: Searching for Novel Germline Mutations in Lobular Breast Cancer Patients

This is a cross-sectional and retrospective study of a cohort of patients with invasive lobular breast cancer (LBC) or in situ lobular neoplasia (LIN3).

The main endpoint is the relative frequency of patients with a germline mutation using a recent panel including 113 genes from the "Illumina" protocol.

In case of identification of a novel pathogenetic germline mutations, a personalized follow-up will be offered to each patient (in case of genes at moderate-, low-penetrance), or prophylactic mastectomy (in case of genes at high-penetrance).

Breast screening in moderate-, low-penetrance mutated patients should be performed periodically using digital mammography, ultrasound and MRI, and will be routinely observed.

Patients will be scheduled for follow-up at six-month intervals for 5 years at our outpatient clinic, and yearly thereafter

Pathogenic or likely pathogenic variants (commonly referred to as mutations) in high-penetrance breast cancer (BC) susceptibility genes increase the risk of BC more than fourfold. Germline mutations in BRCA1 or BRCA2 (BRCA1/2) are found in 3% to 4% of all women with BC, including 10% to 20% of those with triple-negative breast cancer (TNBC) and 10% to 15% of Jewish women with BC.

Recent international guidelines consider only a small group of gene as high-penetrance risk: BRCA1/2, CDH1, PTEN, and PALB2 \[2\], the remaining are classified as moderate-, low-penetrance risks.

There are no specific associations between these germline mutations and BC histotypes. In accord with recent genetic results reported in literature, lobular histotype seems associated with a specific germline pathway.

We hypothesize that other genes are associated with a susceptibility for lobular breast carcinoma (LBC) predisposition and that novel genetic factors should be described, especially in subjects with early onset of LBC.

In this context we selected a recent panel including 113 genes from the "Illumina" protocol.

The screening analysis will be performed by Next Generation Sequencing (NGS) technology using the TruSight Hereditary Cancer panel (Illumina) to analyze the entire coding regions of 113 genes selected genes and 125 SNPs, starting from 50 ng of gDNA extracted with MagCore HF16 Plus (Diatech Labline).

The proposed project is scheduled in three major tasks:

1) Data collection, including family history assessment and pedigree analysis for eligible subjects deserving genetic screening; 2) Genomic characterization of LBC in subjects with germline mutation; 3) Evaluation of disease-free survival and overall survival in subjects with germline mutation and establishment of a specific clinical follow-up for these patients.

Eligibility Criteria:
Inclusion criteria:

1. All LBC observed retrospectively at the European Institute of Oncology, with a proved diagnosis of LBC (biopsy or operated)
2. Patients with blood available in biobank Exclusion criteria

   * Patients with a previous cancer (except skin basal cell carcinoma)
   * Patients with ductal or mixed BC
Alcohol and Innate Immunity

Alcohol leads to a leaky gut and translocation of bacterial products. This may lead to inflammation and immune dysfunction as well as the typical hangover symptoms.

Alcohol binge drinking, defined as 5 or more drinks for men and 4 or more drinks for women at one time, is the most frequent form of alcohol consumption worldwide, especially in younger people. This drinking pattern is popular and leads to increased mortality and morbidity. Therefore binge drinking is a major public health issue. The behavioural and neurological consequences of binge drinking are well characterized.

Less is known about the systemic effects on the gut as the first organ in contact with alcohol. Chronic alcohol intake can lead to increased gut permeability, bacterial translocation and alterations in the gut microbiome in animal models. Recently bacterial translocation has been shown in healthy volunteers after a single alcohol binge. On immune cells, acute alcohol intake seems to have dichotomous effects. On the one hand immunosuppressive and anti-inflammatory effects have been described, however, alcohol induced liver injury is driven by pro-inflammatory reactions. These immune effects seem to be driven by endotoxin or other bacterial products via Toll-like receptors that are translocated to the circulation via a defective gut barrier. Immune effects of alcohol have also been linked to hangover symptoms after an alcohol binge.

Furthermore there is evidence that endotoxemia might also contributes to alcohol dependence by promoting prolonged and increased voluntary alcohol intake in mice. On the other hand mutant mice lacking important genes for immune responses exhibit decreased alcohol consumption. This indicates that immune signaling promotes alcohol consumption. Therefore it is tempting to speculate that increased gut permeability leading to increased bacterial translocation after an acute alcohol binge could promote the desire for further alcohol consumption.

The investigators aim to test in this pilot trial whether one alcohol binge damages gut barrier function, increases bacterial translocation and causes innate immune dysfunction. Furthermore the effect of glucose and fructose will be studied too.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Age above 18 years
* Willingness to abstain from alcohol 48h prior to the study visits

Exclusion Criteria:

* Alcohol abuse .Alcohol Use Disorders Identification Test ≥ 8 in men or ≥ 7 in women or CAGE test ≥ 2 (both men and women)
* Elevated liver function test
* Any disease or medication that does not allow concomitant consumption of alcohol
* Women: pregnancy and lactation
Gabapentin Treatment of Alcohol Dependence

Gabapentin treatment for alcohol dependence

This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with alcohol dependence. Subjects receive 900mg or 1800mg gabapentin or placebo daily for 12 weeks accompanied by weekly standardized counseling for alcohol-related behavior, with assessments of alcohol consumption, mood, sleep and alcohol-craving performed each week.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over age 18 with alcohol dependence

Exclusion Criteria:

* Currently meets Diagnostic and Statistical Manual 4 Text Revision (DSM-IV-TR) criteria for dependence on illicit substances
* Significant medical disorders that will increase potential risk or interfere with study participation
* Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
* Treatment with an investigational drug in the last month.
Unobtrusive Monitoring of Affective Symptoms and Cognition Using Keyboard Dynamics (UnMASCK)

Mood disorders are associated with significant financial and health costs for the United States, partially due to cognitive problems in these patients that can worsen disease course and impair treatment response. This study proposes to use smartphone-based technology to monitor cognitive problems in patients with mood disorders by linking brain network changes with predicted worsening of mood symptoms. The proposed study will provide evidence for using smartphone-based passive sensing as a cost-effective way to predict illness course and treatment response.


Eligibility Criteria:
Inclusion Criteria:

* 25-50 years, as age-related declines in brain connectivity occur starting around 40-45 years of age (49-51);
* Participants must meet criteria for one of the following disorders according to Diagnostic and Statistical Manual of Mental Disorders-5 criteria (52): major depressive disorder (MDD), persistent depressive disorder (PDD), bipolar disorder (BD) type I/type II, cyclothymia. To ensure adequate representation across diagnostic categories (including controls), the investigators will cap enrollment of major mood disorders (MDD, BD type I/II) to 50%, PDD and cyclothymia to 25% and recruit a healthy comparison group to comprise the remaining 25% of the sample.
* Own a BiAffect-compatible smartphone.

Exclusion Criteria:

* Active suicidal ideation as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)(50), suicide attempt in the last 3 months
* Severe cognitive impairment secondary to a neurological disorder (mild cognitive impairment, neurocognitive disorders, traumatic brain injury, developmental delay)
* Active moderate or severe alcohol and/or substance use disorders;
* Major medical or neurologic illness that would interfere with protocol adherence and/or interpretation of findings; and
* Presence of contraindications to MRI.
* Pregnancy (positive pregnancy test), trying to become pregnant, or lactation.
Hemodynamic Determinants of Urine Output During Spinal Anesthesia

This clinical trial investigates the relationship between urine output and mean arterial pressure (MAP) during spinal anesthesia. The study aims to validate observations from animal models in humans by concurrently measuring hemoglobin levels, MAP, and urine output, focusing on the effects of Ringer's solution, to provide crucial insights into optimal fluid management during anesthesia with minimal complexity.

The proposed clinical trial aims to explore the relationship between urine output and mean arterial pressure (MAP) during spinal anesthesia, a subject that has not been thoroughly studied in humans despite previous research under general anesthesia. Studies have demonstrated that the diuretic response to intravenous volume loading, using Ringer's solution or 20% albumin, varies with MAP levels. Specifically, Ringer's solution shows a greater diuretic effect when MAP exceeds 70 mmHg, whereas 20% albumin is more effective at lower pressures. This differential response highlights the importance of considering MAP in the choice of fluid for managing hypovolemia and oliguria.

The study's relevance is highlighted by the physiological dynamics at play, particularly how high levels of anesthesia, which influence the sympathetic nervous system from the mid-thoracic region, might reduce MAP and consequently decrease urine output. While this hypothesis has been examined in animal studies, its validity in humans remains unconfirmed.

To address this, the trial will measure hemoglobin levels, MAP, and urine output simultaneously, aiming to establish a clear correlation among these variables during spinal anesthesia. This methodical approach seeks to yield significant insights with minimal additional effort, contrasting with the complexities inherent in more elaborate study designs.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent provided by patients or their legally authorized representatives.
* Adults aged 18 years and older.

Exclusion Criteria:

* Contraindications to Spinal Anesthesia:

  * Patient refusal
  * Presence of coagulopathy.
  * Current use of anticoagulant or antiplatelet medications.
  * Critical or severe aortic stenosis or other fixed cardiac output states.
  * High risk of infection at the spinal needle insertion site.
  * Elevated intracranial pressure.
  * Allergy
  * Sepsis
* Procedures Not Amenable to Spinal Anesthesia:

  * Planned concurrent procedures that cannot be performed under spinal anesthesia.
Promoting Optimal Parenting (Bright Start)

The purpose of this study is to determine if providing parenting education materials delivered in different ways during the first 30 months of a child's life will increase child-parent attachment and promote mother-child interaction, if certain types of strategies improve cognitive, language, and emotional development in infants and toddlers, and if our way of delivering these materials is cost-effective.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* 18-23 year-old first-time mother of a healthy newborn

Exclusion Criteria:

* Anything other than above
Chronic Pain After Operation for Breast Cancer

The purpose of this study is to identify intraindividual as well as iatrogenic factors disposing for the development of chronic and acute pains after surgery for breast cancer in order to improve treatment and prevent the development of acute and chronic postoperative pains.

Surgery for breast cancer is followed by acute undesirable sequelae (pain, nausea, vomiting, psycho-social adaptation) and late sequelae with discomfort or more severe neuropathic pain problems in the surgical area due to nerve damage or adjuvant-/radiotherapy. The late sequelae occur in 30-50% of patients but the exact mechanisms (preoperative disposing factors, intraoperative nerve damage/inflammatory response), acute postoperative pain and psychosocial factors remain to be determined in large, detailed, well-described studies, including stratification to modern breast cancer treatment (sentinel node strategy/ radiotherapy/ chemotherapy). The present study will describe in detail preoperative psychosocial/genetic pain mechanisms, intraoperative technique, multi-modal anaesthesia and opioid-reduced analgesia with a detailed, early and late postoperative follow-up with neurophysiological assessment in the surgical area and randomised studies on preventive therapy.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women

Exclusion Criteria:

* Pregnancy
* Lactating
Physician Focused Intervention to Improve Adherence With HIV Antiretrovirals

We hypothesized that providing physicians treating with HIV disease, at the time of a routine outpatient visit, with a detailed report describing patients' adherence with HIV antiretroviral medications, would improve the quality of the physician-patient interaction, and also patients' subsequent adherence.


Eligibility Criteria:
Inclusion Criteria:

* on ART
* willing to use MEMS cap
* speaks and reads English
* detectable viral loads

Exclusion Criteria:

* uses a pill box