cyrilzakka/clinical-trials huggingface dataset:
Whey Protein Supplementation in High School Athletes

The overall aim of this project is to compare protein supplementation on performance, recovery, and body composition changes in adolescent soccer players between the whey protein and the control group in response to the 10-12-week intervention.

Informed Consent, Parental Permission and Assent: These will be obtained over Zoom, prior to participation in any study procedures.

Randomization: Randomization will occur following baseline testing. Participants will be randomized via random number generator stratified by sex, into either the whey protein supplement group or the placebo (isocaloric) control group.

Baseline and Post-Intervention testing will occur over a single day for each participant.

Baseline:

All athletes will report to testing facilities for a single blood draw to measure inflammatory biomarkers and a body composition assessment (via BodPod) to measure fat mass and fat free mass. Participants will then be escorted to a track where they will run a 30-yard dash to assess their speed and a 1.5-mile run to assess their estimated maximal rate of oxygen consumption (VO2max). Participants will then be transferred back to the testing facility where they will undergo assessment of lower body muscle fatigue (via HumacNorm).

Questionnaires: Athletes will complete the Munich Chronotype Questionnaire and the Pittsburg Sleep Quality Index (PSQI). Participants will also complete 3-day, 24-hour dietary recalls (via ASA-24).

Sleep measures: Fitbit (Inspire 2) will be used measure sleep efficiency, duration, and staging. Fitabase will be utilized to receive Fitbit data. Participants will be instructed to wear their Fitbit for 1-week.

Intervention:

In-season soccer practices and competition will occur 6-days per week across a 10-12 week period, depending on how far teams advance in postseason play. During the 10-12-weeks, participants will consume their assigned supplement or placebo twice per day, every day, immediately after practice or competition (or midday on rest days), and \~1 hour before bedtime.

Sleep measures: Sleep measures will be evaluated as described above. Sleep measures will be collected at weeks 2, 4, 6, 8, and 10.

Questionnaires: Participants will complete 3-days of 24-hour dietary recalls (via ASA-24) at weeks 5 and 10. Pittsburg Sleep Quality Index (PSQI), a delayed-onset muscle soreness questionnaire and a GI symptom Questionnaire will be completed at weeks 2, 4, 6, 8 and 10.

Urine Samples: We will randomly assign participants to provide urine samples at weeks 4 and 7 as a sham measure of compliance to supplementation protocol.

Post-testing will be the same as pre-testing and will commence after the 10-12-week competitive season. All measures described above in baseline testing will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* 13-18 years old; male and female High school soccer players

Exclusion Criteria:

* non-adolescents; untreated or underlying metabolic or cardiovascular diseases; allergies to dairy, or any allergies ingredients in the study provided granola bar or bagels, such as soy, wheat, tree nuts, peanuts, milk, and sesame.
A Study of the Effect of Food on Selpercatinib (LY3527723) in Healthy Participants

The main purpose of this study is to learn about how food affects selpercatinib in healthy participants. The selpercatinib will be administered in fed and fasted states. Participation could last about 7 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs and clinical laboratory tests.

Exclusion Criteria:

* Have a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data.
The Effect of Transcranial Direct Current Stimulation on Decision Making and Cognitive Flexibility in Gambling Disorder

The investigators conducted a double-blind randomised sham-controlled study. Upon enrollment into the study, participants were randomly assigned to one of two conditions: (i) active group: anodal stimulation over the right dlPFC (n = 10) or (ii) sham stimulation group (n = 10). Participants and raters were blinded to the condition.

Subsequently, the participants were administered the IGT and the Wisconsin Card Sorting Test by a trained neuropsychologist in a quiet laboratory. A computerized version of standard IGT was used. The order of the tasks performed in a single session was randomised.

After the psychiatric and neurocognitive assessment, participants received three sessions of 20-minute active or sham anodal tDCS (once a day, every other day).

Wisconsin Card Sorting Test and a modified version of Iowa Gambling Test were readministered after the last application. The order of the tasks was randomized again. A brief questionnaire on study blinding was also administered. Safety was assessed through open-ended questions based on the tDCS adverse events questionnaire


Eligibility Criteria:
Inclusion Criteria:

* Participants meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for gambling disorder
* Being right-handed
* Being 18-65 years old
* Being drug-free

Exclusion Criteria:

* Current DSM-5 diagnosis of major depressive disorder
* Current or previous DSM-5 diagnosis of alcohol and substance use disorders, schizophrenia, bipolar disorder, or other psychotic disorder
* Drug Use in the past 4 weeks of any medication with known pro-convulsant action or current regular use of any psychotropic medications (benzodiazepines, antipsychotic medications, tricyclic antidepressants, anti-epileptics, mood stabilizers)
* Any history of any clinically significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness for \> 5 minutes and retrograde amnesia for \> 30 minutes,
* The presence of mental retardation diagnosis (previously identified)
* Any personal or family history (1st degree relatives) of seizures other than febrile childhood seizures
* Illiteracy, deficient language or refusal to participate.
Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules

The purpose of this study is to prospectively compare percutaneous radiofrequency ablation (RFA) versus percutaneous laser ablation (LA) for the treatment of solid thyroid nodules.

Nodular thyroid disease is a common clinical problem whose prevalence increases with age and with a more widespread use of thyroid ultrasonography. Although most thyroid nodules are benign and need only periodic monitoring, some may require treatment for associated pressure and/or cosmetic symptoms. Although thyroid surgery is the main therapeutic approach for compressive thyroid nodules, it may be associated with several drawbacks. Long-term levothyroxine suppression treatment in elderly patients with large nodular goiters is unsatisfactory because it is ineffective. Furthermore, it is associated with adverse effects on bones and the cardiovascular system. Nonsurgical, minimally invasive treatment modalities such as percutaneous laser ablation (LA) and radiofrequency ablation (RFA) have been used to treat thyroid nodules. However no studies comparing LA and RFA have been published so far.

Aims of the study

1. To evaluate whether LA and RFA cause a reduction ≥50% in the volume of thyroid nodules after 6 months and 1 year follow-up
2. To evaluate whether the features of thyroid nodules as evaluated by thyroid ultrasound, contrast-enhanced ultrasound, power-doppler and core-biopsy influence LA and RFA outcomes
3. To evaluate changes in thyroid function and thyroid autoimmunity after LA and RFA.
4. To evaluate differences between LA and RFA in terms of complications, side effects and tolerability.

Patients will be recruited, treated and followed at Santa Maria Goretti Hospital in Latina, Italy, by physicians with expertise in LA and RFA. The scientific coordinator of this study is dr. Silvia Manfrini.

Eligibility Criteria:
Inclusion Criteria:

* Solitary thyroid nodule or dominating nodule which is well-identifiable in multinodular goiter.
* Compressive and /or cosmetic symptoms caused by thyroid nodule or increase in nodule volume \>20% in 1 year even without symptoms
* A nodule volume ≥ 5 ml
* Solid nodule (uniformly compact or nearly completely solid, with a liquid component not exceeding 30%);
* Two thyroid biopsies resulted negative for malignancy
* Calcitonin levels within normal ranges

Exclusion Criteria:

* Hyperfunctioning lesion as evaluated biochemically and/or by 99mTc scintigraphy
* Pregnancy
The Effects of Sufentanil vs. Remifentanil in Total Intravenous Anesthesia With Remimazolam on Postoperative Pain

In this study, the investigators evaluate the effect of total intravenous anesthesia using sufentanil-remimazolam and remifentanil-remimazolam on postoperative pain in patients undergoing laparoscopic gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

1. 20years or older
2. Scheduled for laparoscopic-assisted gastrectomy
3. American Society of Anesthesiologists(ASA) physical status I and III

Exclusion Criteria:

1. Emergency operation
2. Patients with a history of severe hypersensitivity reaction to dextran 40
3. Patients who cannot use patient controlled analgesia(PCA)
4. Patients with morbid obesity \[body mass index (BMI) \>35 kg/m2\]
5. Patients with history of uncontrolled hypertension (diastolic BP \>110mmHg) or DM
6. Patients with history of heart failure (unstable angina, congestive heart failure)
7. Patients with history of liver failure, renal failure, allergic to medicine
8. Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia)
9. Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
10. Patients with obstructive sleep apnea
11. Patients who cannot read the consent form (examples: Illiterate, foreigner)
12. Patients who withdraw the consent
Aerosolized Surfactant in Neonatal RDS

Respiratory distress syndrome (RDS), caused by surfactant deficiency, is the leading cause of mortality and morbidity in preterm infants. Intratracheal instillation, the only approved means of surfactant delivery, requires endotracheal intubation and mechanical ventilation with their attendant risks. Interventions that decrease need for intubation and mechanical ventilation like noninvasive ventilation (NIV) including nasal continuous positive airway pressure, high flow nasal cannula or nasal intermittent mandatory ventilation are increasingly being used for initial respiratory support in preterm neonates with RDS to improve outcomes. Aerosolized surfactant delivered during NIV is an innovative and promising concept for the treatment of RDS - retaining the advantages of early surfactant with alveolar recruitment while obviating the risks of intubation and mechanical ventilation. The investigators overall hypothesis is that treatment of RDS with aerosolized surfactant in preterm infants undergoing NIV is safe and feasible and will result in short-term improvement in oxygenation and ventilation. The objective of this proposal is to perform a single-center unblinded Phase II randomized clinical trial of aerosolized surfactant for the treatment of RDS in preterm neonates undergoing NIV. Funding Source - FDA-OOPD.


Eligibility Criteria:
Inclusion Criteria:

1. Infants admitted to the NICU at Hutzel Women's Hospital (HWH)/Children's Hospital of Michigan (CHM)
2. Gestational age of 240/7-366/7 weeks
3. Postnatal age ≤ 24 hours
4. Clinical diagnosis of RDS based on (i) presence of at least two of the four classic symptoms (need of supplemental oxygen, tachypnea, intercostal retractions or grunting), and (ii) exclusion of other causes of respiratory failure and (iii) Clinician intent to administer surfactant if infant requires intubation
5. Respiratory support with NIV (CPAP or NIPPV or HFNC) with FiO2 ≥25% or PEEP ≥ 4 cmH20 or HFNC rate ≥ 2 LPM for ≤8 hours
6. Written informed consent from parent/guardian

Exclusion Criteria:

1. Previous receipt of surfactant
2. Infants with respiratory distress who are unstable and require immediate intubation
3. Active air leak syndrome (e.g. pneumothorax, pneumomediastinum)
4. Lethal congenital malformations; death anticipated within first 3 days of life; decision to withhold support
5. Serious abdominal, cardiac, airway or respiratory malformations including tracheal esophageal fistula, intestinal atresia, omphalocele, gastroschisis, pulmonary hypoplasia, or diaphragmatic hernia
6. Neuromuscular disorder resulting in respiratory compromise
Polycystic Ovary Syndrome Genetics and Treatment Response

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in reproductive age women. Women with PCOS have a high risk of prediabetes, type 2 diabetes and heart disease. The investigators have found a possible change in the DNA (genes of the body that encode all of our traits) that seems to be related to insulin resistance. In this study, the investigators will try to determine whether the change in the gene affects a woman's ability to respond to a common treatment for PCOS, metformin.

These studies will uncover the change in a gene that might be one of the causes of PCOS. Discovering this gene will help better understand the diabetes and insulin abnormalities that are common in PCOS and will help us to better diagnose and treat PCOS to prevent the diabetes in these women.

Polycystic ovary syndrome (PCOS), which affects 7-10% of reproductive aged women, has traditionally been classified as a reproductive and dermatologic syndrome because of its high rate of infertility and the cosmetic complications of hyperandrogenism. However, it has become increasingly clear that insulin resistance is important in the pathogenesis of the disorder.

There are a number of variants that have been determined to be associated with PCOS risk. The investigators will determine the effect of these variants on the phenotype and response to treatment in PCOS. Subjects with PCOS will undergo extensive phenotyping including adipose tissue biopsy, dual energy X-ray absorptiometry (DXA, bone density) scan to examine adipose stores, an intravenous glucose tolerance test to study insulin sensitivity and beta cell function, androgen stimulation and inflammatory markers. The phenotyping will be repeated after 3 months of treatment with metformin. The studies will determine whether the genotype at PCOS risk variants dictates phenotype and response to treatment with metformin. Discovering genes involved in the etiology of PCOS will help pull us out of the endless circle that has characterized our understanding of PCOS pathophysiology for many years. The proposal also has the potential to illuminate one etiology of insulin resistance, which is present even in lean women with PCOS, and the impaired glucose tolerance and diabetes found in over 40% of PCOS patients.

Eligibility Criteria:
Inclusion Criteria:

* Polycystic ovary syndrome
* No medications for 1 month
* Good general health

Exclusion Criteria:

* Smoker
* Acute infection or chronic disease
* Diabetes
* Trying to get pregnant
* Bleeding disorders
REACT-01: Reversing Autoimmunity Through Cell Therapy

This is a phase 1, open-label, non-randomized study enrolling pediatric and young adult research participants with treatment-refractory Systemic Lupus Erythematosus (SLE), to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to express CD19 specific chimeric antigen receptor (CAR)

A child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have their T cells collected. The T cells will then be bioengineered into a CAR T cell that targets circulating and tissue residing B cells.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged between 2-30 years old. The first 3 subjects will be aged ≥ 17. The FDA will review safety data to determine if the age can be lowered first to ≥ 12 then, following the treatment of 3 further subjects aged 12-17, to ≥ 2
* Serologically active Systemic Lupus Erythematosus that is refractory to treatment
* Able to tolerate apheresis or already has an apheresis product available for use in manufacturing.
* ≥ 24 weeks post last Rituximab or related B cell depleting therapy
* ≥ 12 weeks post last Belimumab / Anifrolumab therapy
* ≥ 4 weeks post last calcineurin inhibitor treatment
* For subjects receiving non-calcineurin immunosuppressive therapy, on a stable dose for ≥ 8 weeks before enrollment
* For subjects receiving corticosteroid therapy, on a stable dose for ≥ 2 weeks before enrollment
* Adequate organ function
* Adequate laboratory values
* Subjects of childbearing or child-fathering potential must agree to use highly effective contraception from consent through 12 months following infusion of investigational product on trial
* Subjects must be willing to remain within 1 hour's drive of Seattle Children's Hospital for 4 weeks following CAR T cell infusion.
* Subject and/or legally authorized representative has signed the informed consent form for this study

Exclusion Criteria:

* History or presence of active CNS lupus or other CNS disease
* Kidney dysfunction requiring renal replacement therapy
* Pregnant or breastfeeding
* Insufficient pulmonary reserve including history of COPD, \>10 pack year smoking history or SLE lung disease with hypoxia at rest with oxygen saturation ≤92% on room air
* Unable to tolerate repletion with any formulation of IgG.
* Active or prior malignancy, unless the malignancy was treated and there is no evidence of recurrent disease \<5 years from enrollment.
* Prior solid organ transplantation.
* Presence of an active severe infection
* Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol
Randomized Clinical Trial Evaluating the Efficacy of Topical Imiquimod in High Grade Cervical Intraepithelial Lesions

Cervical cancer is one of the leading malignancies affecting women, with 311,000 deaths in 2018, most of them seen in underdeveloped countries. This neoplasm has a pre-invasive state, such as cervical intraepithelial neoplasia (CIN), which is caused by HPV (Human Papillomavirus) infection. The female organism most often is able to eliminate the virus, especially in young patients. However, when the infection becomes persistent, especially for subtypes 16 and 18, the risk of CIN developing an increased. Cytological screening programs can efficiently and wirelessly do this. As high-grade intraepithelial lesions (CIN 2/3) are as demonstrated by worse regression rate, only 13.3% at one year, and higher risk for progression to invasive cancer. As CIN 2/3 need treatment, and as more therapies as they are excisional, which theoretically are better, however, they may compromise the reproductive future of women who are unthreatened, increasing the risk of preterm labor, premature rupture of amniotic membranes, low weight Birth and perinatal mortality. This relationship aroused interest in seeking alternative therapies. Decrease antiviral activity directed against HPV, associated with a higher rate of elimination of the infection. Immediate, an agent that stimulates like dendritic cells to producer cytokines and activates epithelial T cells. Imiquimode, when used in vulvar neoplasias, has been shown to be effective, presenting satisfactory results without treatment of CIN 2/3 of the uterine cervix, requiring a better scientific compilation. Based on these data, this study aims to evaluate the efficacy of topical immunomodulatory treatment for high-grade cervical intraepithelial lesions.


Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 25 and 50 with histological diagnosis of CIN 2/3;
* Living 300 km or less from the city of Barretos-São Paulo / Brazil.

Exclusion Criteria:

* Suspected adenocarcinoma (in situ or invasive) or invading squamous cell carcinoma by colposcopy and/or citology;
* Being pregnant or breastfeeding;
* Women with some immunodeficiency or transplanted;
* Previous treatment history for CIN 2/3.
Application of Real-time PCR Platform for Detection of Vittaforma Corneae Among Patients With Microsporidia Keratitis

Diagnosis of patients with microsporiosis relies on pathological findings as well as laboratory detection of the causative organism. The conventional laboratory diagnosis of microsporiosis relies on microscopic visualization of the characteristic V. Corneae organisms. We develop a fully automated molecular platform for detection of Vittaforma corneae among patients with microsporidia keratitis.

Clinical infections due to Microsporidium spp. are protean and can be found in humans, insects, and fishes. The most common type of infection is keratitis and mostly is caused by Vittaforma corneae. Diagnosis of patients with microsporiosis relies on pathological findings as well as laboratory detection of the causative organism. The conventional laboratory diagnosis of microsporiosis relies on microscopic visualization of the characteristic V. Corneae organisms. Laboratory tools of identification of V. corneae include Gram staining, Giemsa staining, and modified Ziehl-Neelsen staining of scratching or biopsied specimens of infected cornea. However, the sensitivity of these staining methods is not acceptable due to the variation of specimen quality and quantity, processing, and low load of organisms in the specimens. The BD MAX system (Beckon Dickinson, Diagnostic Systems, Sparks, MD, USA) was introduced in clinical microbiology laboratory of NTUH in 2014 for Pneumocystis jirovecii detection. Till now, no data are available in using this system on V. corneae detection. We develop a fully automated molecular platform for detection of Vittaforma corneae among patients with microsporidia keratitis.

Eligibility Criteria:
Inclusion Criteria:

Patients with suspected microsporidia infection in eye

Exclusion Criteria:
Subcutaneous Adipose Tissue in Cases With Polycystic Ovarian Syndrome

This study aimed to search whether whole body and subcutaneous adipose tissues increase in PCOS patients and whether these tissues are related to HOMA-IR and plasma adiponectin levels.

Fifty-two patients with PCOS and fifty-tree healthy controls who were matched for body mass index (BMI) and age (p=0.430, p=0.112, respectively) were enrolled in the study. Biceps, triceps, subscapular and suprailiac skinfold thicknesses (SFT) of all cases were measured via caliper device; mid-upper arm circumference (MUAC) via a tape; and body fat distributions via a bioelectrical impedance device. Insulin resistance was calculated via HOMA-IR while ELISA was used to measure plasma adiponectin.

Eligibility Criteria:
Inclusion Criteria:

* All of the women with PCOS had normal thyroid-stimulating hormone and prolactin (PRL) levels.

Exclusion Criteria:

* Subjects with possible ovarian tumors, congenital adrenal hyperplasia, BMI greater than 35 kg/m2, any chronic renal or liver disease, were excluded from the study.