cyrilzakka/clinical-trials huggingface dataset:
The Exploration of the Regulatory Effect of Zinc on Intestinal Flora in Healthy Adults

In this A Single-center, Prospective, Self-controlled trial, subjects should avoid a high-Zinc diet for 2 weeks and then take Zinc supplements for 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 20-30 years from the general community were recruited to participate in the study voluntarily without underlying diseases.

Exclusion Criteria:

Patients who have taken antibiotics orally in the past 3 months or have acute or chronic inflammation; Those who have taken hormones within 3 months; Have taken any drugs that may interfere with glucose and lipid metabolism (such as insulin, glyburide, indomethacin, phentolamine, fuuside, phenytoin sodium, cortisone, etc.) and have had probiotic intervention within 1 month; smokers and drinkers; Uncontrollable mental disorders (including hospitalization history of mental illness); (6) Currently attending a weight loss or weight management course; prescribed diet for specific or other reasons (e.g. celiac disease); pregnant or lactating women; Patients with cardiac and renal insufficiency; Patients with other underlying diseases; Long-term constipation.
The Effect of Nutrition and BMI on on Lung Capacity, Functional Capacity and Mortality in End-Stage Lung Patients

The aim of this study was to investigate the effect of nutritional risk index, BMI and body fat, muscle ratio on functional capacity, lung capacity, exercise capacity index, all-cause mortality, post-transplant intensive care unit stay and survival time in end-stage lung patients on the lung transplant list.

This study aimed to determine the nutritional status of patients awaiting lung transplantation and examine the effects of nutritional status, immunonutrition use, and BMI on lung capacity, mortality, and health status after lung transplantation. The study was designed in two different periods. The first period was a retrospective descriptive study. During this study, we will examine the retrospective nutritional status of patients who are waiting for lung transplantation, those who exited while on the list, or those who have received lung transplantation. In the second phase, we will conduct face-to-face interviews with patients on the lung transplant list, take bioelectrical impedance analyses (BIA), and record 24-hour food consumption to examine their detailed nutritional status.

Eligibility Criteria:
Inclusion Criteria:

1. End-stage lung disease
2. To be on the Lung Transplant list.
3. Being between the ages of 19-65
4. Not having severe psychiatric illness
5. Being fed orally
6. Volunteering to participate in the study for Patients Waiting on the Transplant List

Exclusion Criteria:

1. To be removed from the Lung Transplant List
2. Being pregnant or lactating
3. Severe psychiatric illness
4. Peg or Jeg feeding (unable to feed orally)
5. Missing data in the file
Lenalidomide in Subjects With intermediate2 or High MDS Associated With a Deletion (DEL) 5q [31]

We are evaluating the incidence of significant hematological response, according to IWG criteria including CR, PR or, major HI, (HI-E, Hl-N,or Hl- P), and cytogenetic response of patients diagnosed with intermediate-2 or high-risk (International Prognostic Scoring System \[IPSS\]) MDS with a deletion (del) 5q\[31\]

Subjects meeting all inclusion and exclusion criteria will receive lenalidomide

lenalidomide will be administered at 10 mg (two 5 mg capsules) once daily on Days 1-21, every 4 weeks.

Bone marrow aspirate (baseline and during the course of the study at week 8, 16, 32, 52 and when clinically indicated/for assessment of disease progression) evaluations

Subjects may participate in the study for up to 52 weeks ( in patients still responding after 52 weeks, the drug wil continue to be supplied).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years at the time of signing the informed consent form
* MDS with IPSS scores Int-2 or high with deletion 5q(31)
* Prior thalidomide allowed
* Documented diagnosis of MDS (RA, RARS, RAEB, RAEB-T and CMML with WBC \< 13,000/mm3 according to FAB classification) that meets IPSS criteria for intermediate-2 or high-risk disease and has an associated del 5q\[31\] (the deleted chromosomal region must include 5q\[31\]), with or without additional cytogenetic abnormalities

Exclusion Criteria:

* Pregnant or lactating females
* Prior therapy with lenalidomide
* MDS with IPSS scores low or Int-1
* Clinical neuropathy of greater than grade 2
* Proliferative (WBC ≥ 13,000/mL) chronic myelomonocytic leukemia (CMML)
* Recombinant human erythropoietin (rHuEPO) therapy received within 28 days
* Use of androgens other than for treating hypogonadism
Study to Assess the Use of a Simple Lab Test to Screen for Rickets in Children

Some experts recommend that all breastfed babies receive supplemental vitamin D. The purpose of this study is to determine the rate of vitamin D use in breastfed babies, the recommendations of pediatricians regarding vitamin D, and the impact on these recommendations on parental choice of vitamin D. In addition, in preparation for a large study to see how many breastfed children who don't receive supplemental vitamin D have rickets, in this study we will determine if a simple blood test, an alkaline phosphatase level, could be used to screen for rickets. Parents of children 6-23 months old are eligible to complete feeding surveys and children 6-15 months old who were breastfed for at least the first six months of life and didn't routinely receive vitamin D are eligible for alkaline phosphatase levels. We postulate that most breastfed babies don't receive supplemental vitamin D, and that alkaline phosphatase levels will only be abnormal in a few babies who will have evidence on x-ray of rickets.

The Puget Sound Pediatric Research Network (PSPRN) is a practice-based research network of pediatricians in the Puget Sound area and at the University of Washington and Children's Hospital and Regional Medical Center. The network has extensive experience in conducting large studies on contentious issues that are pertinent to children, their parents, and primary care providers. In 2004, vitamin D supplementation was recommended for all exclusively breastfed infants. This recommendation was based on sporadic reports over the last 30 years of vitamin D deficient rickets in infants and toddlers who have been exclusively breastfed. The recommendation has been controversial because it might undermine efforts to promote breastfeeding, and because the prevalence of rickets in these patients is unknown. PSPRN proposes to conduct a preliminary study to determine the feasibility of a larger planned project by the network to determine the prevalence of rickets in breastfed infants and toddlers who do not receive supplemental vitamin D. Systematic surveys will be conducted in PSPRN practices to determine current levels and trends in vitamin D supplementation. Current practices of PSPRN pediatricians regarding supplementation, and their effect on parents, will also be assessed. The utility of a serum alkaline phosphatase level as a screening test for vitamin D deficient rickets will be determined in the proposed study by obtaining levels on approximately 300 patients, 6-15 months old, seen by PSPRN practitioners, who have been breastfed. In addition to assessing possible methodologies for the larger project, the preliminary study is designed to yield standalone results with important implications.

Eligibility Criteria:
Inclusion Criteria:

* Predominantly breastfed for first 6 months of life
* No routine use of vitamin D during first six months of life
* Singleton birth
* Birth at \> 35 weeks gestation

Exclusion Criteria:

* Formula fed
* Significant formula supplementation
Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)

This study \[contRAst 2 (201791: NCT03970837)\] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to csDMARD(s) or bDMARD(s). The study will consist of a screening phase of up to 6 weeks followed by a 52 week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with csDMARD(s). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165 may be included in the long-term extension study \[contRAst X (209564: NCT04333147)\]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.


Eligibility Criteria:
Key inclusion criteria

* \>=18 years of age
* Has had RA for \>=6 months and was not diagnosed before 16 years of age
* Has active disease, as defined by having both\*

  * \>=6/68 tender/painful joint count (TJC), and
  * \>=6/66 swollen joint count (SJC)
* Has at least 1 bone erosion present on hand/wrist or foot radiographs
* Has had an inadequate response to one or two of the csDMARDs:

  * methotrexate (MTX) 15-25 mg/week\*\* oral or injected
  * hydroxychloroquine up to 400 mg/day or chloroquine up to 250 mg/day
  * sulfasalazine up to 3000 mg/day
  * leflunomide up to 20 mg/day\*\*\*
  * bucillamine up to 100 mg/day (or up to 300 mg/day if permitted per local requirement)
  * iguratimod up to 50 mg/day

    * If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC.

      * A lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to MTX or per local requirement.

        * Concomitant use of leflunomide and methotrexate is not allowed, for safety reasons.

Key exclusion criteria

* History of other inflammatory rheumatologic or systemic autoimmune disorder, other than Sjögren's syndrome secondary to RA, that may confound the evaluation of the effect of the study intervention.
* Has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections.
* Has received prior treatment with an antagonist of GM-CSF or its receptor or Janus kinase (JAK) inhibitors (either experimental or approved).
Visual Restoration Using Focused Ultrasound Stimulation and Immersive Virtual Reality After Stroke

This research will explore if brain stimulation combined with virtual reality therapy improves visual impairment. The stimulation technique is called low-intensity focused ultrasound stimulation (LIFUS). The treatment uses ultrasound to stimulate vision specific parts of the brain. Before this therapy, the participants will get structural brain imaging. Functional brain imaging will be performed before and after the study's completion to measure brain activity response to therapy.

The purpose of this research study is to evaluate patients who have had a stroke between 6 and 24 months ago with a visual field impairment. The duration of active participation in the study is 1.5 months.

Randomization visit and 1st Intervention visit:

The randomization visit and 1st intervention vision will be on the same day. Participants will be "randomized" into one of the study groups described below.

* Group 1 (Sham Group): Inactive LIFU + VR
* Group 2 (Active Group): LIFU + VR Neither the subject nor the researcher conducting this study will know which group participants are in.

Sham LIFU: The setup is similar for the active stimulation group, except that a high acoustic impedance disk will be placed between the LIFU probe and the scalp that mimics the audible sensation of a slight buzzing but attenuates more than 95% of the energy into the brain. The audible sound is nearly identical for both the sham and active stimulation.

Intervention visits (9 sessions over 21 days, about 2.5 hours per visit):

At these visits, participants will undergo the investigational study interventions.

There will be 30 minutes of a VR session and 20 minutes of active LIFU or inactive LIFU treatments.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old of any gender and race
* Clinical ischemic stroke or hemorrhagic (confirmed by CT or MRI) that occurred \>= 6-24 months ago
* Partial or complete homonymous hemianopsia on clinical exam

Exclusion Criteria:

* Documented history of severe dementia with or without medication before stroke that affect subject's ability to participate in and be compliant to study protocol
* Significant upper motor deficits and the subject cannot do IVR sessions at the baseline
* History of seizures
* Inability to get a new MRI
* Presence of any ultrasonic stimulation risk factors: an electrically, magnetically, or mechanically activated metal or nonmetal implant including cardiac pacemaker, intracerebral vascular clips, or any other electrically sensitive support system; non-fixed metal in any part of the body; pregnancy (the effect of ultrasonic stimulation on the fetus is unknown); preexisting scalp lesion or wound or bone defect or hemicraniectomy.
* Patients will be excluded if they have a previous diagnosis of hemianopsia, a new diagnosis of central retinal ischemic injury, or visual blindness or a history of any other ocular disease.
* Concerns about the inability to complete study visits/procedures by the PI.
The Effects of Dark Chocolate (70% Cacao) on EEG Brain Waves in Vigorously Active Individuals

The purpose of this graduate student study is to determine if ingestion of dark chocolate (70% cacao) will change brain frequencies between visualization at a state of rest and a state of exercise performance via electroencephalography (EEG) in vigorously active individuals.

The procedures include: On day one, participants will fill out a dark chocolate Likert scale, physical activity assessment, and demographic questionnaire. Day two and three, on consecutive days will include, three EEG measurements will be recorded: 1) at baseline, 2) during visualization of rest for one minute, and 3) during visualization of usual vigorous exercise for one minute. The second day all three measurements will be recorded without dark chocolate (70% cacao). The third day all three measurements will be recorded again. Measurements 2 and 3 will be recorded savoring dark chocolate and after fully ingesting the dark chocolate respectively.

Eligibility Criteria:
Inclusion Criteria:

* 21-45 years of age
* vigorously active individuals, based on the General Physical Activities defined by Level of Intensity guidelines, greater than 75 minutes per week
* enjoy dark chocolate

Exclusion Criteria:

* Caffeine, sedatives, or tranquilizers within 12 hours of study
* Creatine or other performance enhancing steroid supplementation within 24 hours of study
* Ginseng supplementation within 24 hours of study
* Barbiturates within at least 36 hours of study
* Currently taking antiepileptic medications
* Any allergies, colds or sinus infections day of the study
Effects of Autogenic and Reciprocal Inhibition, Muscle Energy Techniques in the Management of Mechanical Neck Pain

Neck pain is among the most common musculoskeletal disorders worldwide and is an important public health issue in terms of personal wellbeing. Prevalence of neck pain show excessive variations, with a point prevalence varying between 6% and 22%, and one year prevalence ranging between 1.5-75%. Neck pain like all other mechanical disorders leads to pain, disability and decreased range of motion (ROM). Stretching is a very common exercise performed by sportsmen, elderly, in physical therapy and rehabilitation patients, thus practiced in all sorts of fitness programs. The major types of stretching included in the literature are static, dynamic and pre-contraction stretching; of which static stretching is the conventional type of stretching. The different types of pre-contraction stretching include Proprioceptive Neuromuscular Facilitation (PNF) stretching, Post Isometric Relaxation (PIR), Post Facilitation stretch (PFS) and Active Isolated Stretch (AIS). Pre-contraction stretching is also considered a part of Muscle Energy Technique (MET). Recently MET and pre-contraction stretching have been shown to have significant superiority over conventional stretching in management of mechanical neck pain, but the evidence is currently lacking regarding which of the two pre-contraction stretching protocols, namely autogenic and reciprocal inhibition is more effective than the other. A RCT will be conducted in order to find and compare the effectiveness of conventional stretching and pre-contraction stretching (autogenic inhibition and reciprocal inhibition). One Control group (conventional group) and two Experimental groups (Experimental Group A - Autogenic Inhibition \& Experimental Group B - Reciprocal Inhibition) will be formed. The participants will be recruited in the study if they meet the inclusion criteria using consecutive sampling from Fauji Foundation Hospital and randomized into the three respective groups. All the groups will receive the gold standard treatment for chronic neck pain including mobilization and modalities. In addition to the gold standard treatment the participants will receive specific stretching protocol based on their interventional group


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 70 years;
2. Neck pain on NPRS 4 to 8 (moderate cases);
3. Subacute or chronic cases (4 to 12 weeks).
4. Decreased or painful Cervical range of motion (CROM)

Exclusion Criteria:

1. Signs of serious pathology (e.g., malignancy, inflammatory disorder, infection);
2. History of cervical spine surgery in previous 12 months;
3. History of trauma or fractures in cervical spine;
4. Signs of cervical radiculopathy or myelopathy; and
5. Vascular syndromes such as VBI
Evaluation of A Mindfulness Resiliency Training Program for Refugees Living in Jordan

To estimate the efficacy of a structured, scalable and replicable psychosocial intervention targeting refugees living in Jordan, Amman who have been forced to flee their homes due to regional conflicts.

The study is designed to examine the effects of the Mindfulness Resiliency Training Program (MRTP) conducted at Collateral Repair Project (CRP) on the resilience of refugees. The study group and the control group will be recruited from refugees currently residing in Amman, Jordan who are participating in the MRTP at CRP, an ongoing program independent of our study.

In order to assess the effect of the MRTP on participant resiliency, the three survey tools described above will be used:

1. the Strength and Difficulties Questionnaire (SDQ) as a measure of the individual's degree of traumatization and
2. the Child and Youth Resiliency Measure (CYRM-12) (for adolescents) or the Adult Resiliency Measure (ARM-12) (for adults) as a measure of resiliency

Eligibility Criteria:
Inclusion Criteria:

* Participants who will be recruited in the study are adult and adolescent (13-19 years) refugees, Syrian and non-Syrians, who are currently residing in Amman, Jordan who will be participating in the MRTP at CRP.

Exclusion Criteria:

* Jordanian refugees residing in Amman, Jordan.
Metoclopramide for Post Traumatic Headache

Nearly 1.5 million patients present to US emergency departments annually following head trauma. Headache is a frequent symptom of victims of head trauma. The purpose of this study is to see if an intravenous medication called metoclopramide can improve the symptoms of patients with acute post-traumatic headache.


Eligibility Criteria:
Inclusion Criteria:

Included patients will be adults who meet International Classification of Headache Disorders criteria for acute post-traumatic headache. These are as follows:

* Traumatic injury to the head has occurred
* Headache has developed within 7 days of injury to the head
* Headache is not better accounted for by another diagnosis (eg, previous history of migraine or tension-type headache)

The headache must be rated as moderate or severe in intensity at the time of initial evaluation.

Exclusion Criteria:

Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.
A Single-Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Adults With Hepatic Insufficiency (MK-4618-013)

This study will investigate the pharmacokinetics of a single oral dose of vibegron (MK-4618) administered to participants with moderate hepatic insufficiency and healthy participants matched for age, gender, and body mass index (BMI). Participants may be enrolled with mild hepatic insufficiency.

This study is planned to be conducted in two parts. Part 1 of the study will include participants with moderate hepatic insufficiency and healthy participants. If Part 2 is conducted, Part 2 of the study will include participants with mild hepatic insufficiency.

Eligibility Criteria:
Inclusion Criteria

For both healthy participants and participants with hepatic insufficiency:

* Continuous non-smokers who haven't used nicotine-containing products for at least 3 months prior to study drug administration
* Body mass index (BMI) ≤39 kg/m\^2
* Good health based on medical history, physical examination, vital signs, laboratory safety tests, and electrocardiogram (ECG)
* Females of childbearing potential must be sexually inactive for 14 days prior to study drug administration and throughout study or use acceptable birth control method
* Females of non-childbearing potential must have undergone an acceptable sterilization procedure at least 6 months prior to Day 1 of study or be postmenopausal with amenorrhea for at least 1 year prior to Day 1
* Non-vasectomized males must agree to use a condom with spermicide or abstain from sexual intercourse during the trial and for 3 months after study drug administration

For participants with hepatic insufficiency only:

* Diagnosis of chronic, stable, hepatic insufficiency
* For Part 1 Participants: Child-Pugh scale range from 7 to 9
* For Part 2 Participants: Child-Pugh scale range from 5 to 6