cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza

Clinical trial with an active ingredient of a pharmaceutical specialty marketed in Spain vs. placebo.

Randomized, double-blind, multicenter phase III clinical trial that evaluates the efficacy and safety of dexamethasone compared to placebo in patients with severe influenza.


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 18 years.
2. Diagnosis of influenza A or B virus infection by antigen or RT-PCR (local laboratory) at the time of entry or at 48 hours prior to randomization in respiratory specimens (nasopharyngeal swab or bronchoalveolar lavage).
3. Hospitalized patients with an estimated hospital stay of more than 24 hours.
4. In previous treatment or concomitant start of treatment with oseltamivir.
5. For women of childbearing age, use of contraceptive methods until day 30 after completion of treatment.
6. Signed informed consent.

Exclusion Criteria:

* 1. Patients with bronchial hyperresponsiveness that requires systemic corticosteroids for more than 24 hours.

  2. Pre-inclusion treatment with corticosteroids for more than 24 hours at a dose equal to or higher than 1 mg/kg methyl-prednisolone (0.2 mg/kg dexamethasone or 1.25 mg/kg prednisone).

  3. Inability to administer oral oseltamivir. 4. Patients on ECMO (extracorporeal membrane oxygenation). 5. Pre-existing condition or use of medication that, in the opinion of the local investigator, may pose a risk for the administration of corticosteroids.

  6. Patients with severe comorbidity with life expectancy of less than six months in the opinion of the investigator.

  7. Patients co-infected with SARS-CoV-2 or RSV.
Passive Cervical Range of Motion in Infants

Infants with and without torticollis will be measured at different time points to assess their passive cervical spine range of motion (pCROM).

Infants at the age of 2 to 12 month will be measured at several time points to assess their passive cervical range of motion. One group will include healthy subjects, the other group infants with a diagnosed torticollis. Healthy subjects will be measured at the age of 3, 4, 6 and 9 months. Infants diagnosed with torticollis, at their visit at a Chiropractor and one week later.

Eligibility Criteria:
Inclusion Criteria:

* age 2-12 month
* signed informed consent
* diagnosed with torticollis

Exclusion Criteria:

* defense reaction e.g. crying, screaming
* other illnesses
* neck trauma
* neck surgery
* developmental delay
A Phase 3 Clinical Study of KHK 4827

This study is designed to evaluate the safety and efficacy of long-term exposure to KHK4827 in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic erythroderma) who have completed Study 4827-003 (Study 003)and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004).


Eligibility Criteria:
Inclusion Criteria:

* Subject has voluntarily signed the written informed consent form to participate in this study
* Subject has completed the week 52 evaluation either in Study 003 or 004

Exclusion Criteria:

* Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration)
* Subject has been judged to be ineligible for participation in the study by the investigators/sub investigators
Stress-physiology Coherence, Interoception, and Well-being Following Mindfulness Training or Tracking Time Spent on Mobile Device

Chronic stress has been shown to impact long-term emotional and physical health. When nearly three-quarters of Americans report stress at levels that exceed what they consider healthy, there is a desperate need to understand factors that contribute to effective stress regulation. This work seeks to develop a measure tied to awareness and acceptance of stress that has shown promise as a predictor of multiple markers of mental and physical well-being, understand how it relates to awareness of the body, and explore whether it can be trained to alleviate suffering and promote well-being. This study aims to 1) Conceptually replicate and extend previous findings linking greater stress-physiology coherence to higher well-being. 2) Assess whether awareness of physiology is associated with stress-physiology coherence. 3) Explore whether stress-physiology coherence can be trained through a brief mindfulness training intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 65;
2. Comfortable reading, writing, and conversing in English
3. U.S. Citizen or permanent resident (for payment purposes)
4. Have a smartphone compatible with our study app

Exclusion Criteria:

1. Significant past experience with meditation, yoga, tai chi, or qi gong;
2. Current or past psychotic disorder, Bipolar Disorder, PTSD, or social phobia;
3. Current, severe major depressive episode;
4. Current, severe generalized anxiety;
5. Active prescription stimulant use (current or in the past month);
6. Active prescription beta-blocker, beta-agonist, anti-high blood pressure, or anti-anxiety medication use (current or in the past month);
7. Currently pregnant (due to physiological changes);
8. History of neurological disorder;
9. Currently diagnosed with high blood pressure, or heart murmur;
10. Have a pacemaker
11. Have participated in the Trier Social Stress Test previously
Effect of Focused Ultrasound on Abdominal and Intrahepatic Fat in Patients With Non-alcoholic Fatty Liver Disease

In recent years, a number of modalities have become available for the noninvasive reduction of adipose tissue. One of those is high intensity focused ultra sound (HIFU). The study aimed to discover the effect of Focused Ultrasound on localized abdominal fat size in fatty liver patients.

Methods: In total, 40 participants with a body mass index (BMI) 30-40 kg/m2, whose age ranged between 30 and 45 years, mild to moderate fatty liver (Liver to Spleen ratio \< 1), and with waist-hip ratio (WHR) greater than 0.8 for females and greater than 0.95 for males were included. The participants were randomly assigned to two groups, one group received focused ultrasound, diet, and exercises (the study group) and the other group received exercises, and diet only (the control group), respectively. Measures were abdominal subcutaneous fat volume, abdominal visceral fat volume, and liver to spleen ratio (L/S ratio) were measured at the beginning of the study and 3 months later.


Eligibility Criteria:
Inclusion Criteria:

participants with a body mass index (BMI) 30-40 kg/m2, whose age ranged between 30 and 45 years, mild to moderate fatty liver (Liver to Spleen ratio \< 1), and with waist hip ratio (WHR) greater than 0.8 for females and greater than 0.95 for males were included

Exclusion Criteria:

abdominal hernias, severe diabetes or autoimmune diseases; patients with osteoporosis, phlebitis and thrombophlebitis; patients with metallic sections, articular prosthesis, intrauterine devices or a pacemaker; pregnant women; patients with a reduced nervous sensibility or with neurological pathologies; patients with obliterating arteriopathies and patients with important inflammatory processes or neoplastic diseases
Study of Small Bowel Tumor With Dual-phase Enhanced Computed Tomography (CTE) and Magnetic Resonance Enterography (MRE)

Purpose: To compare the accuracies of computed tomographic (CT) enterography and magnetic resonance (MR) enterography for the detection and radiomics characterization of small-bowel tumors (including gastrointestinal stromal tumors, adenomas and lymphomas, etc); Hypothesis: MR enterography was noninferior to CT enterography for the diagnosis and evaluation of small bowel tumors in generally well-distended small bowel.

The investigators will conduct a 36-month clinical trial, the specific process is as follows:

1. Incorporate patients with the above criteria, communicate with the participants to make informed consent and sign informed consent;
2. It is recommended that the attending physician issue the corresponding MRE checklist and the CTE checklist and make an appointment to check the same day to remind the patient to perform the corresponding bowel preparation work in advance, and perform renal function tests within 3 days before the examination;
3. The enrolled patients were measured for height and weight, and the BMI was calculated. CTE and MRE were performed according to the results of balanced randomization. The MRE was performed on a 3.0T MRI scanner; the CTE examination was performed on a 320-row CT scanner, and the iodine-containing contrast agent was administered according to the patient's height and weight and GFR;
4. Both examinations require an empty stomach preparation (more than 4 hours), and oral (1500ml) 2.5% mannitol aqueous solution before the examination to ensure intestinal filling, subcutaneous indwelling needle preparation, in order to save patient examination time, so the two examinations are completed within 6 hours, before the second inspection, you need to add 150-300ml of 2.5% mannitol aqueous solution;
5. The images obtained were evaluated by two imaging physicians for lesions, numbers, size changes, density/signal values, and peripheral tissue lesions obtained by the two methods;
6. After the patient has obtained a definitive diagnosis according to the routine medical procedure, the above imaging diagnosis results are compared with the confirmed diagnosis results.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical suspicion of small intestinal neoplasms and prescribed CTE and/or MRE examinations;
* Age/sex: unlimited;
* Patients with no severe heart, liver, kidney insufficiency;
* Patients who voluntarily participate in clinical trials and sign written informed consent.

Exclusion Criteria:

* patients with heart and liver insufficiency;
* patients with pacemakers installed and which materials are unknown, and patients with metal implants in the body, and nerve stimulators;
* patients who are allergic to iodine and intestinal contrast agents;
* pregnant women, patients with acute or chronic renal failure and hemodynamic instability;
* patients unable to tolerate adequate breath holding for complete CT or MR examination;
* patients who can not maintain compliance and cannot strictly implement the plan.
The Effect of Lactisole on the Responses to Glucose Solution

The purpose of the study is to determine whether the sweet taste receptors in the gut are involved in sensing sweet substances and controlling appetite and the amount we eat. Lactisole is a substance commonly used in food products to reduce the perceived sweetness of certain sugars and sweeteners. The aim of this study is to investigate whether the responses to a glucose solution, intragastrically administered to healthy male and female volunteers, is affected by the presence of lactisole in the gut. Understanding the mechanisms by which nutrients are initially detected in the gut and how they influence food intake is critical to the development of novel food products that could reduce food consumption.

Obesity is epidemically prevalent and a major risk factor for chronic diseases making it fundamental to understand the pathways controlling food intake. During the course of a meal and afterwards the gut and brain communicate to control how full the eater feels and thus control the amount of food eaten. The information relayed from the gut to the brain regarding ingested nutrients is of increasing importance and understanding the mechanisms by which nutrient molecules are initially detected in the gut and how they signal to the brain to influence food intake is critical to the development of novel food products that could induce fullness and reduce food consumption. Increasing our understanding of how nutrients are sensed in the gut and how this may influence subsequent food intake provides promising targets for obesity prevention and treatment. Recent discoveries have shown that sweet taste receptors similar to those located in the tongue are present in the gut. It is suggested that theses receptors are involved in the way nutrients are sensed and may play an important role in appetite control and food intake.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-45 years
* BMI between 18-25kg/m2
* General good health

Exclusion Criteria:

* Underweight or Overweight (Body Mass Index \<19 or \>25 kg.m-2)
* Females who are pregnant or breastfeeding
* Currently taking medication (except females taking oral contraceptive)
* Smokers
* Currently dieting or have experienced a weight change +/- 3kg in past 6 months
* Metabolic disorders (eg. Type 2 diabetes)
* History of gastrointestinal disorders
* Participation in other research in past 3 months
Reducing Binge Eating to Prevent Weight Gain in Black Women

The purpose of the proposed study is to pilot a 6-month, cognitive-behavioral binge eating intervention, Appetite Awareness Training (AAT) to reduce binge eating and prevent weight gain for Black women with a BMI \> 25 kg/m\^2 and with weekly binge eating episodes. Intervention participants will receive a 8-week group AAT intervention, and will also receive bluetooth-connected scales for daily weighing. Participants will also receive tailored feedback on self-weighing frequency and weight change. The investigators will follow-up with participants at six months.

Aim 1. Using an experimental design, examine the feasibility and acceptability of 6-month AAT (N=40) in North Carolina. Forty overweight and obese (BMI ≥ 25 kg/m\^2) community-based Black women will be randomized to the AAT intervention or wait-list control (who will eventually receive the intervention). AAT participants will meet weekly for 8 weeks, followed by a 4-month period of daily weighing and weekly tailored feedback only. The study will examine the following: recruitment feasibility, attendance/retention, adherence, satisfaction, and barriers to completion.

Aim 2: At 4 and 6 months, compare changes in (a) binge eating, eating self-efficacy, and depressive symptoms and (b) weight, blood pressure, and waist circumference for participants in the intervention vs. control group.

H_1: Participants in the AAT intervention will report less binge and overeating and gain less weight than those in the control group at 2 and 6 months.

Secondary aim: Examine characteristics (e.g., baseline BMI, severity of binge eating, frequency of self-weighing) related to change in binge eating and weight.

Eligibility Criteria:
Inclusion Criteria:

Individuals are eligible if they are:

* non-Latino Black women,
* over 18 years of age,
* have a BMI ≥ 25kg/m\^2,
* use a Bluetooth-enabled smartphone,
* report at least one binge eating episode weekly, and
* complete the screening.

Exclusion Criteria:

Individuals will be excluded if they:

* are currently pregnant,
* are in substance abuse treatment,
* are involved in another weight reduction program,
* have a history of anorexia,
* are purging,
* are currently in treatment for eating difficulties,
* are concurrent intravenous drug users or consume \>4 alcoholic beverages/day.
A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer

This is a Phase 1b, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-c5 administered orally in combination with abemaciclib (VERZENIO®) in participants with advanced estrogen-receptor positive, human epidermal growth factor receptor-2 negative (ER+/HER2-) breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age
* Women can be peri- or postmenopausal, as defined by at least one of the following:

  * Age ≥ 60 years;
  * Age \< 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle-stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females;
  * Documented bilateral oophorectomy;
  * Must receive a gonadotrophin-releasing hormone agonist beginning at least 4 weeks prior to the first dose of study medication
* Histologically or cytologically confirmed diagnosis of advanced adenocarcinoma of the breast
* Estrogen receptor positive disease
* Human Epidermal Growth Factor Receptor 2 negative disease
* Measurable disease per Response Evaluation Criteria in Solid Tumors v1.1

Exclusion Criteria:

* Prior therapy within the following windows:

  * Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy \< 14 days;
  * Any investigational drug therapy \< 28 days or 5 half-lives (whichever is shorter)
  * Any prior systemic chemotherapy regardless of the stop date, but the subject must have recovered to eligibility levels from prior toxicity
* Prior treatment with CDK4/6 inhibitors
* Unexplained symptomatic endometrial disorders (including, but not limited to, endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Autism Spectrum Disorder and Associated GI Symptoms (SPROUT)

Adolescent autism spectrum disorder subjects with associated GI symptoms will be randomized to receive oral dosing of CP101 capsules in Treatment Group I or matching placebo capsules in Treatment Group II. The purpose of this study is to demonstrate the safety and effectiveness of CP101 in subjects with ASD and associated GI symptoms.

This is a Randomized Double-Blind Placebo Controlled Study of CP101 (Full-Spectrum Microbiota®) in Children with Autism Spectrum Disorder and Associated Gastrointestinal Symptoms

Eligibility Criteria:
Inclusion Criteria:

* Male or Female ages 5 to 17
* Diagnosis of ASD by health care provider
* CARS-2 score ≥35 by the study evaluator
* 1 year history of chronic abnormal bowel function with/without GI symptoms
* GSRS/Constipation sub-score ≥3.0, or/and GSRS/diarrhea sub-score ≥3.0, during Screening

Exclusion Criteria:

* Inability to ingest intact capsules.
* Change or anticipated change of prescription medications and/or nutrition supplement and/or therapy to treat ASD symptoms
* Prior history, evidence, or diagnosis of inflammatory bowel disease or chronic autoimmune GI disease
* Below 5th percentile for weight on Centers for Disease Control and Prevention (CDC) growth chart based on age
* History of fecal microbiota transplantation (FMT) for any condition, regardless of route of administration within 12 months of Screening, or plan to undergo during the study
* History of epilepsy or any other seizure (except febrile seizure) disorder.
* Enrollment in any other investigational drug or device study within 8 weeks prior to investigational study medication (CP101/placebo) administration or within 5 half-lives of the last dose of the previous investigational compound, whichever is longer.
* Major intra-abdominal surgery within the past 60 days prior to Screening (excluding appendectomy or cholecystectomy) and/or planned invasive surgery/hospitalization during the study.
* Use of systemic antibiotics, systemic antiviral, or systemic antifungal (non-topical) for any condition during 8 weeks prior to Screening, or any anticipated use of above for any condition (e.g., frequent otitis media requiring antibiotics) before EOT (Week 24).
* Recent change or anticipated change of non-dietary probiotics.
* Any clinically significant condition that would jeopardize the safety or rights of the subject, or would confound the results of the study, in the opinion of the Principal Investigator.
* Clinically significant laboratory abnormalities at Screening at the discretion of the Principal Investigator.
* Pregnant, breast-feeding, or positive pregnancy test at Screening (for females of child-bearing potential) or for sexually active subjects (as determined by the Principal Investigator), who refuses to practice an acceptable form of birth control for the duration of the study.
Examining the Effects of Diet on Health With an Online Program

The study is a pilot, designed to provide data regarding the feasibility and acceptability of conducting such a study on a larger scale. The present study is a randomized controlled clinical trial comparing two programs to help people manage diabetes and lose weight, one using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA) and the other using on a low-carbohydrate diet (LC) and mindfulness and positive affect lifestyle modifications. Intervention content will include information about nutrition (American Diabetes Association recommended diet or carbohydrate restriction) and, in the LC group, emotion regulation, positive affect, and mindful eating strategies.

Approximately individuals with type 2 diabetes will be randomized in a 1:1 ratio to treatment groups. Classes will occur online. Participants will be evaluated at 0, 16, and 32 weeks. Our main outcome of interest is HbA1c (glycated hemoglobin, a measure indicative of blood glucose levels and tied to diabetes severity).

Eligibility Criteria:
Inclusion Criteria:

1. HbA1c 6.5%-9% at screening.
2. Aged 18 years old and older
3. BMI 25 and above.
4. Willing and able to participate in the interventions such as having sufficient control over their food intake. Must have the ability to make choices about the food they eat; cannot have a lifestyle in which they eat out most of their meals.)

Exclusion Criteria:

1. Unable to provide informed consent.
2. Non English speaker.
3. No current use of insulin, no immediate plans to start or increase diabetic mediations, and no use of diabetes medications besides metformin.
4. A substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate in the intervention. Such conditions may include: cancer, liver failure, unstable coronary artery disease, severe emphysema, binge eating disorder or history of binge eating disorder, bulimia or strong history of bulimia.
5. Previous use or recent changes in medications that can interfere with the measures used in the study: current use of insulin; use of systemic (oral or IV) corticosteroids in the 6 months prior to enrollment or severe autoimmune disorders or other conditions (e.g. rheumatoid arthritis, lupus), that are likely to require these medications; and initiation of new class of psychiatric medications in past 2 months.
6. Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less than 6 months post-partum.
7. Current use of weight loss medications or supplements such as Alli or amphetamine-based drugs that are believed to have some effect on weight.
8. History of or planned weight loss surgery.
9. Vegan or vegetarian. The intervention diets are more challenging for vegan and vegetarian participants.
10. No or very limited internet access at a computer. Must be able to complete the online assessments and access the online class materials.
A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 3831 in subjects with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Agrees to use an acceptable method of contraception for the duration of the study
* Subject has completed the 24-week treatment period in the antecedent study, ALK3831-A303, within 7 days
* Additional criteria may apply

Exclusion Criteria:

* Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine
* Subject has a positive test for drugs of abuse at study entry
* Subject is pregnant, planning to become pregnant, or breastfeeding during the study
* Additional criteria may apply