cyrilzakka/clinical-trials huggingface dataset:
The Reproductive Microbiome & Perinatal Health Outcomes

Pregnant African American women between 18 and 45 years of age will be enrolled at 20 weeks of gestation or less. Biological specimens (vaginal swabs, rectal swab) will be collected at enrollment, 23-24 weeks, at 28-29 weeks, and at the onset of labor. A urine sample will be obtained at entry and at the time of delivery for metabolomic analysis. Participants will also collect a dietary survey at entry, 23-24 weeks, and 28-29 weeks. The biological specimens will then be analyzed for their microbiomial profile. This will then be correlated with the timing of their delivery as well as other comorbidities such as obesity, hypertension, and diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Able to read and understand English, full decision making capabilities, African American (self-identified), Pregnant, At 20 weeks or less of gestation, Singleton pregnancy, 18-45 years of age

Exclusion Criteria:

* Race other than African American, Advanced gestational age (\>20 weeks), Multiple gestations, Less than 18 years or greater than 45 years of age.
Improving Communication With Patients With Breast Cancer

RATIONALE: An education program based on patients' health communication needs may improve patients' overall healthcare experience and sense of control.

PURPOSE: This clinical trial is studying the health communication needs of patients with breast cancer to develop patient education programs.

OBJECTIVES:

* Determine patients' health communication needs during the first 6 months of care by interviewing patients with breast cancer (as well as their families, caregivers, and healthcare teams) and observing interactions between patients and oncologists throughout the trajectory of care from initial diagnosis through the initial treatment course.
* Determine patients' health communication needs at the point of bone metastases by interviewing patients with breast cancer (as well as their families, caregivers, and healthcare teams) and observing interactions between patients and oncologists in the Hematology-Oncology Clinic.
* Develop Patient Education Programs to help meet patients' health communication needs by conveying information about essential elements of cancer care in a clear and consistent manner, thus allowing clinicians to focus more attention on answering questions, engaging in counseling, and responding to emotional issues.
* Create a Patient Education Program that models effective strategies for asking questions and expressing concerns and needs for symptom control (i.e., pain, anxiety, depression).
* Develop Patient Narrative Videos, with women identified by their providers, to provide members of the healthcare team with a better understanding of the patient experience and issues that arise for patients outside the formal health care setting.
* Conduct a pilot test to determine whether the Patient Education Programs affect patients' experience of care, sense of control, and perceptions of caring communication, as well as knowledge, satisfaction, anxiety, depression, pain, and self-reported health.
* Determine patient and family response to Patient Narrative Videos and healthcare team response to Patient Narrative Videos and Patient Education Programs.

OUTLINE: This is a pilot, multicenter study.

A visit between the patient and his/her oncologist and healthcare team is videorecorded. Patients, family members, caregivers, and healthcare team members then undergo a 10-minute interview. Patients then undergo a 5-minute follow-up interview once every 2 weeks for 6 months. Some patients may participate in a one-time group discussion.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer

PATIENT CHARACTERISTICS:

* Patients: 30 to 80 years of age
* Family members: 20 to 80 years of age
* Healthcare team members: 20 to 80 years of age
* Must be conversant in English

PRIOR CONCURRENT THERAPY:

* Not specified
Mindful Positive Reappraisal: a Daily Diary Randomized Controlled Trial

Brief and cost-effective interventions teaching emotion regulation techniques can be feasibly applied to promote mental health in University students. The tools of mindfulness (i.e., objective awareness and acceptance) and positive reappraisal (i.e., positive re-evaluation of negative events) can mutually benefit one another to promote well-being. The current study explored the effects of a randomly-assigned Mindful-Reappraisal intervention (n=36) compared to Reappraisal-Only (n=34) and an active control (n=36) on university students' daily affect over five days. Time by condition interactions were analyzed with planned contrasts and multilevel growth modelling.

The University student lifestyle can lead to heightened stress, anxiety, and burnout. To promote mental health, brief and cost-effective interventions teaching beneficial emotion regulation techniques can not only counteract the negative but also foster positive functioning. The tools of mindfulness (i.e., objective awareness and acceptance) and positive reappraisal (i.e., positive re-evaluation of negative events) can mutually benefit one another to promote well-being. However, there is currently little research testing the viability of brief, self-administered interventions combining training of mindfulness and positive reappraisal. The current study explored the effects of a randomly-assigned Mindful-Reappraisal intervention (n=36) compared to Reappraisal-Only (n=34) and an active control (n=36) on university students' daily affect over five days. Time by condition interactions were analyzed with planned contrasts and multilevel growth modelling.

Eligibility Criteria:
Inclusion Criteria:

* Undergraduate students

Exclusion Criteria:

* Not undergraduate students
Effect of a DASH-Style Diet on Urinary Risk Factors for Kidney Stone Disease

The true capacity for a healthy diet to improve urinary stone risk factors is not well-defined. The objective of this study is to measure the effect of adopting a healthy dietary pattern on kidney stone disease (KSD) risk. The working hypothesis is that a Dietary Approaches to Stop Hypertension (DASH)-style diet will improve 24-hour urine stone risk parameters. The approach to testing this hypothesis will be to randomize participants with KSD to a standardized DASH-style vs. Western-style diet for one week. The Bionutrition Unit of the Center for Clinical and Translational Science will provide all meals to participants. The rationale for this study is that by measuring the effect of a DASH-style diet on urinary stone risk parameters, a benchmark for future real-world, implementation studies will be established. Based on available evidence, this will be the first controlled diet study to assess the DASH dietary pattern for improving urinary stone risk parameters.


Eligibility Criteria:
Inclusion Criteria:

* Birmingham, AL area participants of the Coronary Artery Risk Development in Young Adults (CARDIA) study OR patients of the University of Alabama at Birmingham/Kirklin Clinic
* Self-reported, documented, and/or prior imaging-based diagnosis of kidney stone disease
* Age 19-89
* Any sex
* Any race
* Able to provide informed consent
* Willing to perform 24-hour urine collections
* Willing to consume meals prepared by Bionutrition Unit
* No food allergies/intolerance to any of the foods in the study menus
* Willing to stop for 7 days before and during study: Multivitamins and/or Dietary supplements (including calcium and vitamin C)

Exclusion Criteria:

* Dialysis
* Kidney transplant recipient
* Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73m2 based on historical laboratory measurements
* Renal tubular acidosis
* Current use of acetazolamide, topiramate, or zonisamide
* Primary hyperparathyroidism or history of parathyroidectomy
* Hyperthyroidism
* Sarcoidosis
* Primary hyperoxaluria
* Cystinuria
* Nephrotic syndrome
* Malabsorptive conditions including inflammatory bowel disease or history of malabsorptive surgery (e.g., Roux-en-Y gastric bypass, small bowel resection)
* Urinary retention requiring catheterization
* Urinary diversion
* Pregnancy
* Breastfeeding
* Malignancy treated in the past 12 months other than non-melanoma skin cancer
Effects of Exercise on Physical Fitness Among Hemodialysis Patients With Chronic Kidney Disease

Regular physical exercise was adapted to the situation of the patient with hemodialysis to help improve the quality of life of the patient

It has been observed that programs that combine aerobic and resistance exercise can increase muscular strength and endurance, functional capacity and quality of life of patients in Hemodialysis. Aerobic exercise and muscular endurance during dialysis increase blood flow at the muscular level with an increase in capillary surface area, which dynamizes the flow of urea and toxins from the tissues to the vascular compartment, which could improve the effectiveness of dialysis In addition, moderate regular exercise can modulate the inflammatory response, which would be beneficial in patients with chronic kidney disease

Eligibility Criteria:
Inclusion Criteria:

* Famel and male between 55 - 85 year old. in hemodyalisis treatment

Exclusion Criteria:

* Younger than 55 years and older than 85 years.
* Presenting myocardial infarction in the previous 6 weeks.
* Unstable angina to exercise or at rest.
* Recent cerebral vascular disease or with risk of recurrence.
* Musculoskeletal, respiratory (COPD with frequent decompensation).
* Hypertensive disorders, patients with peripheral vascular disease,
* Active liver disease.
* Osteoporosis diagnosed, in which the medical criterion is contraindicated physical exercise.
* Solution of problems of the following circumstances:
* Fraction of cardiac ejection \<of 45%, Hb \<of 10gr / dl.
* Problematic vascular access, both immature fistulas or with risk of extravasation and catheter dysfunctions of postural characteristics.
A Study of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD

This study is a phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of HM15211 in obese subjects with NAFLD

This study will be single-blind and conducted in up to 6 cohorts comprising a total of up to 72 obese subjects with NAFLD. Each cohort will enroll subjects to ensure that at least 12 subjects per cohort will complete the study. Subjects will be randomized to investigational product (IP) or placebo in a 3:1 ratio via an Interactive Web Response System (IWRS). Per cohort (n=12 subjects), 9 subjects will be randomized to IP and 3 subjects to placebo. Cohorts may partially overlap after at least 9 subjects have completed 2-4 weeks of treatment (2 weeks of treatment is reached at Visit week 3) and a dose escalation decision has been made. Study drug will be administered weekly over a period of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index ≥ 30 kg/m2
* Waist circumference ≤ 57 inches
* Fasting Plasma Glucose \< 7 mmol/L (126 mg/dL)
* HbA1c \< 6.5%
* Controlled Attenuation Parameter ≥ 300 dB/m by FibroScan
* Liver fat by MRI-PDFF ≥ 10%.

Exclusion Criteria:

* A history of or active chronic liver disease due to alcohol, auto-immune, HIV, HBV or active HCV-infection or NASH disease
* Any history of clinically significant chronic liver disease including esophageal varices, ascites, encephalopathy or any hospitalization for treatment of chronic liver disease; or Model for End Stage Liver Disease (MELD) ≥ 10
* Previous surgical treatment for obesity
* Uncontrolled hypertension
* Any weight control treatment
* History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis
* History of major depression, anxiety, suicidal behavior or attempts, or other psychiatric disorder requiring medical treatment
* History or current diagnosis of heart disease
* Presence of clinically significant ECG findings
* History of renal disease or abnormal kidney function tests
* History of alcohol or illicit drug abuse
* Daily heavy use of cigarettes or any tobacco product
Citicoline Effects on Cortical Membrane Structure and Function

The goal of this project is to determine the effects of 6-week dietary supplementation with one of two doses of citicoline (250 mg/d, 500 mg/d) or placebo on prefrontal cortical membrane dynamics (31P-MRS) and event-related functional activation (fMRI) in healthy middle-aged adults.

To determine the effect of citicoline supplementation on cortical structure and function in healthy middle-aged adults. Test 1: The effect of citicoline (500 mg/d) compared with placebo on event-related anterior cingulate cortex (ACC) activation during sustained attention by fMRI. Test 2: The effect of citicoline (500 mg/d) compared with placebo on reaction time and increasing accuracy on the sustained attention task (CPT-IP). Test 3: The effect of citicoline compared with placebo on phosphodiester (PDE) and b-NTP levels in the ACC by 31P-MRS. Test 4: ACC activation and CPT-IP performance (fMRI) and ACC PDE levels (31P-MRS) following high-dose citicoline (500 mg/d) compared with placebo at Week 3. Test 5: The effect of low-dose citicoline (250 mg/d) compared with placebo on an ACC activation and CPT-IP performance (fMRI) and ACC PDE levels (31P-MRS). Test 6: Among all subjects (n=60), the relationship between baseline red blood cell (RBC) omega-3 fatty acid (EPA+DHA) levels and ACC activation, ACC PDE levels, or the effects of citicoline.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent;
* Ages 40-60 years old;
* Right handed.
* If female, not pregnant (as determined by a positive pregnancy test); and agrees to use one of the following methods of birth control: abstinence from sexual intercourse, barrier (diaphragm or condom), or oral/injectable contraceptive;

Exclusion Criteria:

* Contraindication to an MRI scan (i.e., braces, claustrophobia, pacemaker etc);
* A history of a major medical (e.g., diabetes) or neurological illness (e.g., epilepsy);
* Body mass index (BMI) ≥ 30;
* An IQ \<75 and \>130;
* A positive urine drug test (nicotine dependence is permitted);
* Personal history of a DSM-5 Axis I psychiatric disorder;
* Requiring treatment with a drug which might obscure the action of the study treatment.
Project THINK: Trajectories of Health, Ingestive Behaviors, and Neurocognition in Kids

Overweight/obesity and loss of control eating (characterized by the sense that one cannot control what or how much one is eating) are prevalent among children and adolescents, and both are associated with serious medical and psychosocial health complications. Although our recently published data suggest that youth with these conditions may have relative deficits in neurocognitive functioning, particularly working memory, understanding of how these processes and their neural correlates are related to change and stability in eating and weight-related outcomes over time is limited, thereby impeding development of targeted, optimally timed interventions. The present study aims to assess prospective associations between general and food-specific executive functioning and underlying neural substrates, and eating and weight outcomes among children at varying levels of risk overweight/obesity and eating disorders, which will help guide research efforts towards the development of effective prevention and intervention strategies.

The current study will examine prospective associations among general and food-specific EF and related neural substrates, and the developmental course of weight gain and LOC eating from middle childhood through early adolescence. Specific aims are to:

1. Investigate prospective associations between general and food-specific EF and z-BMI trajectories. We expect that across risk groups, a) poorer baseline performance on both general and food-specific behavioral EF measures will predict steeper z-BMI gain trajectories; and b) worsening general and food-specific EF will track with the steepest z-BMI gain trajectories.
2. Investigate associations between general and food-specific EF and LOC eating trajectories. We expect that across risk groups, a) poorer baseline performance on general and food-specific behavioral EF measures will predict worsening course of LOC eating; and b) worsening general and food-specific EF will track with worsening course of LOC eating.
3. Investigate prospective associations between EF neural substrates and trajectories of z-BMI and LOC eating. We expect that across risk groups, a) greater activation in prefrontal regions associated with EF (e.g., dorsolateral prefrontal cortex, dorsal cingulate, parietal cortex) during general and food-specific WM tasks, and b) smaller decreases in activation of these regions over 18 months, will predict steeper z-BMI gain trajectories and worsening course of LOC eating.

Eligibility Criteria:
Inclusion Criteria:

* Not currently taking any medications known to affect weight or appetite
* Free of any current or past medical or psychiatric conditions known to significantly affect eating or weight (e.g., diabetes, bulimia nervosa), with the exception of binge eating disorder
* In the low average range or higher on measures of general intellectual functioning
* Free of any conditions affecting executive functioning (e.g., recent concussion, history of traumatic brain injury)
* Fluent in English, and able to read and comprehend study materials
* Not currently pregnant
A Study Exploring the PK/PD Relationship of QRL-101 in Adults With ALS

This Phase 1 randomized, placebo-controlled, double-blind study will evaluate the PK/PD relationship of single doses of QRL-101 in 12 ALS participants. The study will also assess safety and tolerability in participants receiving either QRL-101 or placebo.

This is a randomized, placebo-controlled, double-blind, single-dose, single-site, Phase 1 study to explore the pharmacokinetics (PK) and pharmacodynamics (PD) of single doses of QRL-101 in participants with ALS. In addition, the safety and tolerability of QRL-101 will be evaluated. Single doses of QRL-101 or placebo will be administered as an oral liquid to approximately 12 participants with ALS. The study will explore the PK, PD, and PK/PD relationship among three dose levels of QRL-101 and placebo. The randomization will be 1:1:1:1 for the four study groups and will be conducted in 3 blocks (cohorts) of 4, where participants will be randomized 3:1 (QRL-101:placebo) for increasing dose levels of QRL-101.

Eligibility Criteria:
INCLUSION CRITERIA

1. Age 18 to 80 years of age inclusive at the time of signing the informed consent.
2. Diagnosis of ALS, by either Gold Coast Criteria or El Escorial Criteria (possible, probable laboratory supported, probable, or definite)
3. Clinical chemistry laboratory values within acceptable range for the population, as per investigator judgment.
4. Body mass index of 18 to 32 kg/m2 (inclusive).
5. Willing and able to practice effective contraception.

EXCLUSION CRITERIA

1. Currently enrolled in any other clinical trial involving a study drug, off-label drug or device use, or any other type of medical research judged not scientifically or medically compatible with this study.
2. History or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicate a medical problem that would preclude study participation.
3. Off-label use of drugs or devices that are being used or investigated as disease-modifying therapies in ALS
4. Participated in another clinical study within 30 days, or 5 half-lives of the previous investigational product, whichever is greater, prior to the planned randomization date.
5. Taking any prescription or nonprescription medicines that are cytochrome P450 3A4 inducers, inhibitors, or substrates within 30 days or 5 half-lives, whichever is greater, prior to the planned randomization date
VAP-PRO-C6. Effectiveness and Tolerability of Venoactive Drugs in Combination Therapy in Patients With CVD (CEAP C6)

The VAP-PRO-C6 is a Russian multicenter observational program to be implemented at the routine visits and assessments. The program will include patients with chronic venous disease of CEAP classes C6. This program is planned to be carried out in Russia in 2021-2022.

Aim of the program is to describe effectiveness and tolerability of systemic pharmacotherapy as a part of combination therapy and its effect on the overall treatment outcomes in patients with venous ulcers (CEAP classes C6) treated in real clinical settings.

The planned number of patients is 350.

The inclusion period lasts for 6 months. The treatment will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation. The following objective methods will be used to assess the changes in the skin condition:

* measurement of the area of reference ulcer (using LesionMeter\*) before and after the treatment;
* changes in status localis.
* The presence and location of venous reflux and/or occlusion. The study does not implicate any intervention to routine management of patients with chronic venous disease (CVD). In particular, in this study the parameters that are usually evaluated during the examination of patients with classes C6 CVD (CEAP) will be recorded. Special attention will be paid to evaluating changes of the area of referent VU using objective methods (measuring ulcer area using LesionMeter, time to ulcer healing).

  * LesionMeter is a generally available tool for measuring the venous ulcer area.

Eligibility Criteria:
Inclusion Criteria:

* CVD documented by venous DUS
* Age over 18 years
* Written informed consent is provided
* No treatment with venoactive drugs within 4 weeks prior to inclusion in the study
* Presence of a primary /active venous ulcer (class C6/ CEAP) that meets criteria for the referent ulcer
* No surgical intervention or procedure (including sclerotherapy) for CVD is planned

Exclusion Criteria:

* Withdrawal of the informed consent
* Pregnancy or willingness to become pregnant within at least 2 months after the end of the study
* Indications for surgery (including sclerotherapy)
* Serious violation or non adherence to the prescribed therapy/ regimen
* Use of prohibited drugs that can cause edema of lower extremities (calcium channel blockers, hormonal agents, NSAIDs, etc.)