cyrilzakka/clinical-trials huggingface dataset:
Ferritin Screening And IRon Treatment for Maternal Anemia and FGR Prevention Trial

Prevalence of anemia in Asia is more than 50%. All woman who book for antenatal care with non-anaemic iron deficiency (NAID) can be offered therapeutic doses of parentral iron, as a directly observed complete therapy, to prevent of maternal anaemia and fetal growth restriction. The investigators will compare this intervention with usual care in a multicentre randomised trial.

Prevalence of anemia (haemoglobin less than 11 gm/dl) in Asia is more than 50% and non-anaemic iron deficiency (ferritin less than 30 microgm/l) or NAID is likely to be more prevalent than this figure. It has been hypothesised that NAID in pregnancy can be linked to maternal fatigue and anaemia, and infant birth weight and growth restriction. The investigators will compare, in NAID, active intervention (therapeutic doses of parentral iron, as a directly observed complete therapy, to replenish iron stores) vs usual care (prophylactic oral iron supplementation) to prevent of maternal anaemia and fetal growth restriction in a multicentre randomised trial.

Eligibility Criteria:
Inclusion Criteria:

* Non-anaemic iron deficiency

Exclusion Criteria:

* Anaemia or normal iron stores
Study of SGR-3515 In Participants With Advanced Solid Tumors.

The purpose of this study is to learn about the effects of a new study drug, called SGR-3515 that may be a treatment for advanced solid tumors.

SGR-3515-101 is a phase 1, first-in-human, single agent, dose-escalation study designed to evaluate the safety, tolerability, dose limiting toxicities, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of SGR-3515 and to identify the maximum tolerated dose, recommended phase 2 dose and schedule of SGR-3515, in participants with advanced solid tumors hypothesized to be sensitive to Wee1/Myt1 inhibition and any solid tumors with designated molecular perturbation relevant to DNA damage repair pathway, including but not limited to CCNE1 amplification.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced/metastatic solid tumor
* Measurable disease per RECIST version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Participant must understand and sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures
* Adequate bone marrow and organ function
* Women of child-bearing potential (WOCBP) or males must agree to use highly effective contraception for the duration of study and for 90 days after the last dose of study drug

Exclusion Criteria

* Participants with primary Central Nervous System (CNS tumors).
* Participant has received prior systemic anti-cancer treatments or other investigational agents ≤ 21 days of first dose of study drug, or 5 half-lives, whichever is shorter
* Participant who has received definitive local control radiation (any dose greater than 50 Gy) \< 42 days prior to the first dose of study drug.
* Participant who has received major surgeries ≤ 21 days prior to first dose of study drug
* Participants who have not recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade 2 alopecia, peripheral neuropathy and ototoxicity.
* Participant who has another clinically significant invasive malignancy, as determined by the investigator, ≤ 2 years prior to the first dose
Biomarkers for Prediction of Hand Function After Stroke - The ProHand Study

The overall aim is to identify key determinants for recovery of hand function after stroke by applying newly developed hand function measures together with MRI measurements of the lesioned cerebral structures.

Almost half of surviving stroke patients are left with impaired function of the hand but individual profiles of weakness, spasticity, sensory and bimanual function vary widely. Improved prediction of recovery after stroke has broad implications for clinical decisions on the type, duration and goals of rehabilitation.

100 consecutive patients with 1st ever stroke and upper limb hemi-paresis will be subject to imaging, at 4 weeks and 6 months, and behavioral assessments at 4 weeks, 3 months and 6 months after stroke. The imaging protocol includes anatomical sequences for lesion mapping, diffusion tensor imaging and resting-state functional MRI for structural and functional connectivity analyses, respectively. Clinical hand function measures will be combined with novel validated methods to quantify spasticity,grip force control, sensory and bimanual function.

ProHand will provide insights into neural mechanisms related to recovery of hand function after stroke and enable enhanced prediction and development of targeted treatment trials.

Eligibility Criteria:
Inclusion Criteria:

* first ever stroke and clinically diagnosed arm paresis

Exclusion Criteria:

* incapability to give informed concent and/or understand and comply with instructions, other disorders that may affect hand function (e.g. other neurological conditions, arthritis), cerebellar lesions.
Angiotensinogen Variants and Adverse Pregnancy Outcomes

To examine angiotensinogen genetic variants and adverse pregnancy outcomes.

BACKGROUND:

Early in gestation maternal blood volume normally expands by an unknown mechanism; failure of this normal adaptation to pregnancy has been associated with common adverse pregnancy outcomes including preeclampsia, intrauterine growth retardation, and premature labor. The renin-angiotensin system has a critical role in controlling maternal fluid volume and probably in the pathophysiology of these serious complications of pregnancy. Kenneth Ward and his group have recently discovered DNA variants which cause amino acid substitutions in angiotensinogen (renin substrate), one of which (T235) is strongly associated with preeclampsia. They hypothesize that functionally different angiotensinogen proteins may underlie the pathophysiology of preeclampsia and other related disorders (such as intrauterine growth retardation and premature labor) by not allowing normal volume expansion to occur.

The four interrelated approaches in the study should lead to a better understanding of the role of angiotensinogen in pregnancy and of the pathophysiology of preeclampsia. Unlike any previous finding in preeclamptic patients, the genetic alteration in angiotensinogen described is an intrinsic defect which, although it may be modified by other factors, cannot be 'secondary' to other pathophysiologic variables. This molecular hypothesis demands a reinterpretation of many prior findings in preeclampsia, fetal growth retardation, and premature labor based on angiotensinogen genotypes. The DNA and plasma collected for this study will be invaluable resources for future molecular investigations of abnormal pregnancies.

DESIGN NARRATIVE:

Four different strategies were used. First, a prospective, epidemiologic survey of 24,000 pregnancies was conducted to determine the role of the T235 variant in common disorders of pregnancy. From this population, nulligravida volunteers, 150 who were homozygous for T235 variant and 150 who were homozygous for the alternative M235 allele, were selected for a longitudinal study of maternal-fetal physiology and biochemistry in order to determine how and when the T235 variant exerted its adverse effect. Taking advantage of the large average family size in Utah, the female relatives of women with preeclampsia were also studied in order to define the genetics of important angiotensinogen variants. Finally, DNA from preeclamptic patients was examined for additional mutations in the angiotensinogen gene which may offer unique pathophysiologic insight.

The study was renewed in 1999 for another four years to investigate the hypothesis that disease-associated angiotensinogen alleles promote abnormal spiral artery remodeling and inhibit maternal plasma volume expansion.

Eligibility Criteria:
No eligibility criteria
Computerized Cognitive Skills Training for Adolescents With Velocardiofacial Syndrome

This study will test a computer-based treatment for youth with the genetic disorder velocardiofacial syndrome (VCFS) to help them improve skills in memory, attention, and executive functioning.

Velocardiofacial syndrome (VCFS) is a genetic condition caused by deletion of a segment of the 22nd chromosome at the location 22q11.2. VCFS is characterized by a combination of medical problems related to the palate (velo) and the heart (cardio) and by a distinct facial appearance. Also common in people with VCFS, among other problems, are learning and speech difficulties. These difficulties are specifically categorized as deficits in attention, working memory, and executive functioning. This study will develop and test a computer-based intervention for adolescents with VCFS that will teach them cognitive skills to lessen these deficits.

This study will have three phases. In the first phase, the intervention will be pilot tested with an in-person coach. In the second phase, the intervention will be pilot tested remotely with a video-conferencing coach. In the third phase, the intervention will be delivered remotely, and testing will be expanded to include more participants and a longer assessment period. Information on participant drop-out and level of difficulty will be gathered and used to refine the treatment between phases.

Participation in Phase 1 will last 6 months. At study entry, participants will complete baseline measures that involve a structured diagnostic interview to assess behavioral or emotional difficulties and cognitive testing to assess intellectual functioning. Then they will meet with a study training coach three times a week at their homes. During these sessions, participants will complete exercises in the Challenging our Minds program, a computer-based system designed to improve learning. Exercises will develop skills in seven domains: attention, decision making, memory, understanding relationships between objects, problem solving, communication, and social perception.

Participation in Phase 2 will last 6 to 9 months. Participants in this phase will complete the same baseline measures that occurred at study entry and then complete exercises in Challenging our Minds three times a week. Instead of having a training coach come to their homes, participants in Phase 2 will work with a training coach via video-conferencing software.

Participation in Phase 3 will last 2 years. Participants will undergo assessments at four points: at baseline, after 9 months, after 18 months, and after 27 months. These assessments will include the baseline measures from the previous phases as well as a virtual reality computer task. Between their visits at 9 and 18 months, participants will work with a training coach via video conferencing three times a week to complete the Challenging our Minds exercises.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of velocardiofacial syndrome (VCFS)
* IQ score between 70 and 90

Exclusion Criteria:

* Presence of psychotic symptoms
A Study of PLX3397 in Patients With Unresectable or Metastatic KIT-mutated Melanoma

The purpose of this Phase I/II study is to evaluate safety, pharmacokinetics, and preliminary efficacy of the investigational drug PLX3397 in subjects with unresectable or metastatic KIT-mutated melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Unresectable stage III or stage IV melanoma which is histologically confirmed at the treating institution with KIT mutation(s) not known to be resistant to PLX3397
* Presence of measurable lesions by Response Evaluation Criteria in Solid Tumors
* Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0-2
* Life expectancy ≥ 3 months
* Adequate organ and bone marrow function
* Women of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 3 months after the last dose of study drug. Women of non-child-bearing potential must have been postmenopausal for ≥ 1 year or surgically sterile.
* Fertile men must agree to use an effective method of birth control during the study and for up to 3 months after the last dose of study drug.
* Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements

Exclusion Criteria:

* Prior treatment with a KIT inhibitor for melanoma
* Presence of NRAS or BRAF mutation
* Exposure to any investigational drug within 28 days or unresolved adverse effects from previous therapy
* Symptomatic brain metastases.
* Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Sponsor
* Concomitant treatment with other anti-neoplastic agents (hormonal therapy acceptable)
* Uncontrolled intercurrent or infectious illness
* Major surgical procedure or significant traumatic injury within 14 days of initiating study drug or anticipation of the need for major surgery during the study
* Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy within 28 days prior to study entry
* Inability to swallow capsules, or refractory nausea and vomiting, malabsorption, an external biliary shunt, or significant bowel resection that would preclude adequate absorption
* Congestive heart failure (CHF) New York (NY) Heart Association class III or IV; unstable coronary artery disease \[myocardial infarction (MI) more than 6 months prior to study entry is permitted\] or serious cardiac arrhythmia
* Baseline QT interval corrected using Fridericia equation (QTcF) ≥ 450 msec (for males) or ≥ 470 msec (for females) at Screening
* Active or chronic infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
* Known chronic liver disease
* Women who are breast-feeding or pregnant
Comparison Between Modified Bass and Horizontal Brushing Techniques

The goal of this observational study is to determine mean plaque scores to compare the effectiveness after using modified bass and horizontal brushing technique in undergraduate dental students. The main question\[s\] it aims to answer are:

* Modified bass method is less effective than the horizontal brushing technique for plaque removal in undergraduate dental students
* Modified bass method is more effective than the horizontal brushing technique for plaque in undergraduate dental students.

Participants will check plaque scores with the help of probe and disclosing agents after applying both techniques in a separate quadrant on the same subject. Researchers will compare modified bass and a horizontal brushing technique to see which one is reliable and more effective.


Eligibility Criteria:
Inclusion Criteria:

* Dental students between the ages of 19-24; irrespective of gender
* Informed consent

Exclusion Criteria:

* Students undergoing orthodontic treatment
* Students having periodontal pocket
* Students who underwent scaling less or equal to 3 months ago
Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing a Procedure

Phase 4 observational cohort study to characterize the treatment patterns and effects of avatrombopag use in patients with thrombocytopenia associated with chronic liver disease who are either undergoing, or have already undergone, a procedure.

Data (e.g. type of procedure, platelet count, etc.) will be collected retrospectively or prospectively from patient visits occurring within approximately 7 calendar days prior to the first dose of avatrombopag, on Procedure Day, on Discharge Day, and from any clinic visit performed up to 30 days post-procedure. All treatment decisions and clinical assessments will be at the discretion of the treating physician per routine medical care and are not mandated by study design or protocol.

Eligibility Criteria:
Inclusion Criteria:

* Patient has thrombocytopenia associated with chronic liver disease and is planned for or underwent treatment with avatrombopag prior to a procedure
* Patient provides written informed consent

Minimum Data for Retrospective Enrollment

* Platelet count from approximately 7 days prior to starting avatrombopag
* Platelet count on Procedure Day
Bio-enhanced Curcumin as an Add-on Treatment in Maintaining Remission of Ulcerative Colitis

Inflammatory Bowel Disease, including ulcerative colitis, is thought to result from an imbalance of pro-inflammatory and anti-inflammatory factors. As such, the majority of treatment options are directed at attempting to control the chronic inflammation and prolonging remission of clinical symptoms. Several studies have proven that curcumin has well-established anti-inflammatory properties. However, curcumin has poor bioavailability and prior studies have needed to use high concentrations in order to study the efficacy of the product. The investigators propose that a bio-enhanced preparation of curcumin will require a lower dosage to reach and affect its target tissue and will subsequently produce less adverse side effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been in symptomatic remission from Ulcerative Colitis for at least 3 months. This is defined as a Partial Mayo Index Score of 0 or 1
* Age 18 years and above
* Male or female
* Patients who are able and willing to follow the treatment given and record responses in survey form

Exclusion Criteria:

* Patients who are currently experiencing symptomatic flares of mild or moderate ulcerative colitis, or have a partial mayo index score of 2 or greater
* Patients who have been taking azathioprine or mercaptopurine for \<12 weeks for the treatment of their ulcerative colitis
* Patients who are taking steroids, immunosuppressants, or biologic agents for the treatment of their ulcerative colitis
* Patients who have severe ulcerative colitis
* Patients who are noncompliant with medication or regular follow up visits
* Patients who are unable or unwilling to record their responses in survey form
* Patients with comorbid illnesses, including: Diabetes Mellitus, Stage III or above Congestive Heart Failure, chronic pancreatitis, severe liver or renal disease
* Patients who have current gallstones or biliary dysfunction
* Patients with anemia (Hemoglobin \<10), thrombocytopenia, abnormal lymphocyte counts, or coagulation abnormalities
* Patients with current sepsis or current ongoing infection, including C. difficile colitis or enteritis
* Patients with a history of malignancy
* Patients who are currently pregnant or nursing
* Patients who are current smokers
Migrant Health Promotion Program for University Students

The aim of the study is to determine effect of program about developing nursing students' attitudes towards refugees based on contact hypothesis on Xenophobia, Attitude towards Refugees and Intercultural Sensitivity.

This Randomized Controlled Trials has been conducted with Bachelor's degree in nursing. Ninety students selected and randomly assigned to the intervention and control group as 45 students. Intervention group received a program about developing refugees health for 12 weeks. The content of this program consists of education and practices for refugees health.

Primary Outcome Measure: Xenophobia, Attitude towards Refugees and Intercultural Sensitivity Scale.

Eligibility Criteria:
Inclusion Criteria:

* The university students in the fourth year of nursing education

Exclusion Criteria:

* Refugees or immigrants students
Effect of a Glucagon Like Peptide 1 (GLP1) Booster in Healthy Humans

BACKGROUND GLP1 booster (GB) was designed to stimulate the endogenous production of GLP1, which in turn releases insulin, controls blood glucose level, suppresses appetite and thus helps people lose weight.

PURPOSE The purpose of this study is to assess several clinical endpoints and questionnaires in healthy volunteers taking the new GB formula.

SCOPE The scope of this protocol covers the non-clinical portion as well as the assessment of several clinical endpoints and questionnaires. In brief, the non-clinical design will be an open-label study involving volunteers taking GB everyday for 12 weeks. Data analysis will involve measuring the clinical endpoints across the group at different timepoints.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers must be over the age of 18.
* Volunteers cannot be smokers.
* Volunteers cannot be currently taking a dietary supplement or prescription for weight loss.
* Exercising volunteers must maintain their regimen consistently throughout the course of the 12-week study.
* Caffeine drinking volunteers must maintain their caffeine intake consistently throughout the course of the 12-week study.
* Volunteers need to be overweight but not obese, as defined by having a BMI between 25.0 and 29.9

Exclusion Criteria:

* Female volunteers who are pregnant or planning to become pregnant within the next three months.
* Volunteers who are taking any stimulant medications (e.g. Adderall, Adzenys, Dexedrine, Ritalin, Methylphenidate, etc).
Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS)

This is an open label study with 30-day run in phase to establish baseline parameters, 90-day treatment phase, and a 90-day withdrawal phase to determine long-term effects, duration of treatment response, and potential effects of EPI-589 therapy on known trajectory.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of possible, probable, laboratory supported probable, or definite ALS by E1 Escorial Criteria
* Forced vital capacity (FVC) ≥ 70% of predicted
* Weakness onset within 3 years
* Agreement to use contraception if within reproductive years
* Willingness and ability to comply with study procedures
* Stable regimen of dietary supplements and /or riluzole for at least 30 days prior to enrollment
* Abstention from use of other investigative or non-approved drugs
* Participants must be able to swallow 0.375 \* 0.700 inch tablets

Exclusion Criteria:

* Allergy to EPI-589
* Use of ventilation
* Participation in other intervention studies
* Diagnosis of any other neurologic disease
* Malignancy within the past 2 years
* History of stroke
* History of brain surgery
* Hepatic insufficiency with liver function tests (LFTs) greater than 3 times upper limit of normal (ULN)
* Renal insufficiency requiring dialysis
* End stage cardiac failure
* Participation in a trial of a device, drug, or other therapy for ALS within 3 months of screening or during the trial