cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of PN-232 in Healthy Volunteers

This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of PN-232 in healthy volunteers. It is a first-in-human (FIH) study for PN-232 that will be conducted in three parts. Part 1 is a single ascending dose study, Part 2 is multiple ascending dose study, and Part 3 is crossover solid dose comparison and effect of food study.

Part 1: Approximately 32 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo as single doses.

Part 2: Up to 40 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo once daily for 10 days.

Part 3: Twelve subjects will receive single doses of PN-232 in a 3-way, randomized, crossover fashion.

In total, approximately 84 subjects will participate.

Eligibility Criteria:
Key Inclusion Criteria:

* Subjects must have BMI between 18 and 32 kg/m2
* Subjects must be non-smokers or social smokers
* Subjects must comply with contraception requirements
* Subjects must be willing to consume meals provided by the clinical center
* Subjects must be willing to attend required clinic visits
* Subjects must be suitable candidates for study procedures

Key Exclusion Criteria:

* Subject with a history of clinically significant endocrine, neurological, cardiovascular, hematological, hepatic, immunological, renal, respiratory, gastrointestinal or genitourinary abnormalities or diseases within previous 10 years
* Subjects with a history of surgical resection of the stomach, small or large intestine
* Subjects with a fever or symptomatic viral or bacterial infection within 2 weeks of screening or intestinal infection within 30 days prior to screening
* Subjects with clinically significant laboratory abnormalities
* Subjects with corrected QT greater than 450 msec in males and 470 msec in females
* Subjects who test positive for Hepatitis C or B, or HIV at Screening
* Subjects who cannot refrain from use of prescription and non-prescription drugs and herbal remedies prior to initial dose of study drug and throughout the study
* Subjects who test positive for drugs of abuse or alcohol at Screening
Real-world Study of CHina Ozempic cLinicAl pRactice in Patients With Type 2 Diabetes (SCHOLAR)

This study is to describe the real-world use and impact of semaglutide once-weekly (OW) among participants with type 2 diabetes mellitus (T2DM) in China. Participants diagnosed with T2DM who initiated semaglutide OW for the first time between 1 Jan 2022 (the date when semaglutide OW was listed in the National Reimbursement Drug List \[NRDL\] in China\] and 28 Feb 2023 (9 months prior to the data extraction cut-off date of 30 Nov 2023) will be included in this study. The study period will be 36 months prior to the first date of participants identification period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged greater than or equal to (≥) 18 years on index date
* Participants with diagnosis of T2DM prior to or on index date
* Participants with initiation of semaglutide OW for the first time within the identification period

Exclusion Criteria:

* Participants with diagnosis of type 1 diabetes prior to or on index date
* Participants who were pregnant within 36 months prior to or on index date
* Participants who participated in any clinical trials within 36 months prior to or on index date which could be identified from medical records
Project Health Intervention Among Latinx Adults in Primary Care

The proposed study will examine acceptability/feasibility and establish initial estimates of effect sizes of an existing intervention (Project Health) on a sample of young adult Latinx individuals in a primary health care setting. Project Health intervention involves making small, participant-identified, gradually increasing improvements to their dietary intake and exercise.

The primary goal of the research study is to investigate the acceptability/feasibility and establish initial estimates of effect sizes of Project Health that addresses dietary intake and exercise to reduce BMI, eating disorder symptoms, negative affect, and food cravings at post-intervention. To address this aim, the research will involve a randomized control trial that will employ a longitudinal experimental design that will involve: (a) phone-screener (pre-screener); (b) baseline appointment consisting of a pre-intervention assessment (eligibility); (c) 6-week intervention (randomized to Project Health or Video Control); (d) 3-month follow-up, (e) 1-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported Hispanic/Latino ethnicity
* Ability to read, write, and communicate in Spanish
* Report concern about their weight
* Affirming weight gain within the past year and/or belief that there is room for improvement in diet/exercise habits.

Exclusion Criteria:

* Limited mental competency
* Inability to provide, voluntary, written consent
* Endorsement of current or past psychotic-spectrum symptoms
* A reported BMI of \< 20 or \> 30
* Current diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder
* Active suicidality.
Clinical Trials for Single Oral Dose of 60mg Fimasartan and Single IV Infusion of 30mg Fimasartan to Evaluate the Absolute Bioavailability of Kanarb® Tablet (Fimasartan) in Healthy Subjects

Open-label, randomized, crossover clinical trials for single oral dose of 60mg fimasartan and single IV infusion of 30mg fimasartan to evaluate the absolute bioavailability of Kanarb® tablet (fimasartan) in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* age: 20 - 55 years
* body weight: standard weight(Broca's index, Possible range is plus or minus 20percent)
* written informed consent

Exclusion Criteria:

* known allergy to Fimasartan
* existing cardiac or hematological diseases
* existing hepatic and renal diseases
* existing gastrointestinal diseases
* acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder
* abnormal diet which could affect drug absorption or metabolism
* positive drug or alcohol screening
* smokers of 10 or more cigarettes per day
* participation in a clinical trial during the last 90 days prior to the start of the study
Effect Of Multiple Biofortified Food Crops On Micronutrient Status And Immune Function Among Indian Infants and Their Mothers

In this study, meals based on multiple food crops (containing either biofortified or commercially-available food crops) will be fed to young children in Madanapalle, Andhra Pradesh, India over a period of nine months to measure growth, cognitive changes, and immune function in comparison to children receiving non-biofortified crops. Mothers of the participating children will also be included in the study.

Iron, zinc, and vitamin A deficiency remain a major worldwide public health problem especially in developing countries such as India. In this randomized study, 200 children aged 6-12 months (and their lactating mothers) from Madanapalle, Andhra Pradesh, India will be fed meals based on (either biofortified or commercially-available) multiple food crops three times per day, six days per week, for nine months. We will recruit children from 6 - 24 months of age. The goal of this study is to examine the effects of the biofortified multiple food crops on immune function, growth, and cognitive function in this age group. The key outcome measures are biomarkers of vitamin A, iron and zinc status, growth (anthropometric z-scores), and immune and cognitive function. Nutrient biomarkers will be assessed at enrollment (baseline), at an intermediate time point (midline; random serial sampling) and after 9 months of follow-up (endline). Additionally, we will measure concentrations of C-reactive protein (CRP) and alpha 1-acid glycoprotein (AGP), as iron and zinc biomarkers can be influenced by inflammation. To assess cognitive function, multiple specific aspects of memory and attention will be assessed. Higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will also be assessed. In addition, the Development Assessment Scales for Indian Infants (DASII) test will be conducted at baseline, intermediate, and endline assessments to obtain a broad measure of attainment of developmental milestones that can be used to compare the characteristics of this cohort with those reported in the literature.

Eligibility Criteria:
Inclusion Criteria

Children: Age 6 to 24 months (at enrollment);

Mothers: Biological mothers of included children.

Exclusion Criteria

Children

* Age below 6 months or above 24 months (at time of screening);
* Hemoglobin \<9 g/dL (at time of screening);
* Presence of severe malnutrition according to Wellcome Classification (marasmus, marasmic kwashiorkor, kwashiorkor, weight-for-height z-score \< -3);
* Prior known or current diagnoses of HIV/AIDS, Malaria, Dengue fever, Tuberculosis;
* Children whose biological mother is unable to bring her/him to feeding center daily;
* Possibility of migrating out of the study catchment area for more than 4 consecutive weeks;
* Prior or current consumption of iron, zinc, and/or vitamin A supplements;
* Any known dietary allergies.

Mothers

- Severe anemia (Hemoglobin \<7g/ dL)
Early Trial of Allogeneic Hematopoietic Stem Cell Transplantation for Patients Who Will Receive a Kidney Transplant From the Same Donor

This is a single center, non-randomized, non-controlled open-label phase 1b/2a trial of performing sequential αβdepleted-HSCT and KT in patients requiring KT to prevent kidney rejection post-KT, in the absence of any post-KT immunosuppression, to abrogate the need for lifelong immunosuppression, the risk of chronic rejection and, ultimately, the need for repeated transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Anticipated need for kidney transplant due to:

  a. Underlying genetic/immunologic disease the following conditions i. SIOD ii. FSGS iii. Cystinosis iv. SLE v. Membranoproliferative glomerulonephritis vi. Renal vasculitis characterized by positivity of the presence of ANCA vii. Other genetic diseases leading to kidney disease requiring KT Or b. Patients who have rejected a previous KT regardless of the underlying disease
* Chronic kidney disease (CKD) stage 3 or greater
* Steroids \< 0.5 mg/Kg/day
* The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DQB1 and HLA-DRB1
* Lansky/Karnofsky score \> 50; the Karnofsky Scale will be used in subjects ≥ 16 years of age, and the Lansky Scale will be used for those \< 16 years of age.
* Able to give informed consent or have an LAR available to provide consent
* Male and female subjects of childbearing potential must agree to use an effective means of birth control to avoid pregnancy throughout the transplant procedure, while on immunosuppression, and if the subject experiences any cGvHD

Exclusion Criteria:

* Pregnant or lactating females.
* Greater than Grade II aGvHD or severe, unmanaged extensive cGvHD due to a previous allograft at the time of inclusion
* Dysfunction of liver (ALT/AST \> 10 times upper normal value, or direct bilirubin \> 3 times upper normal value), unmanageable dysfunction of renal function while undergoing dialysis
* Severe cardiovascular disease at the time of evaluation unresponsive to nutritional and dialytic support (left ventricular ejection fraction \< 40%), or clinical or echocardiographic evidence of severe diastolic dysfunction
* Current active infectious disease. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.
* Serious concurrent uncontrolled medical disorders except for primary disease leading to chronic kidney disease
* Lack of patient/parent/guardian informed consent
* Any severe concurrent disease which, in the judgement of the investigator would place the patient at increased risk during participation in the study
Triple Tourniquets With or Without Tranexamic Acid for Reducing Blood Loss at Open Myomectomy

In this study, the investigators will investigate the effectiveness of an intravenous tranexamic acid plus triple tourniquets compared with triple tourniquets alone for the reduction of blood loss at the time of myomectomy

An RCT investigated the efficacy of intravenous tranexamic acid (TA) during abdominal myomectomy. The study was unable to demonstrate any significant impact on blood loss, duration of surgery or need for blood transfusionHemostatic tourniquets to reduce intra-operative bleeding have long been available, but data on their efficacy from controlled trials are lacking. The investigators set out to evaluate the use of triple tourniquets plus tranexamic acid in controlled conditions and for the first time to investigate the hypothesis that adding tranexamic acid to tourniquet around the uterine artery reduces postoperative bleeding from the uterine incisions, a well-recognized sequel to surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for abdominal myomectomy with documented uterine fibroids on ----pelvic imaging
* Age ≥ 18 years and ≤ 50 years
* Pre-operative hemoglobin \>8 g/dl
* Ability to understand and the willingness to sign a written informed consent.
* Admissible medical/surgical history
* Five or less symptomatic uterine myomas
* All myomas are subserous or intramural.
* Uterine size less than 24 weeks of pregnancy

Exclusion Criteria:

* Patients who have had a prior abdominal myomectomy
* Post-menopausal women
* Patients with known bleeding/clotting disorders
* Patients with a history of gynecologic malignancy
* Hypertension.
* Cardiac and Pulmonary Diseases.
* Obesity (body mass index \> 30 kg/m2).
* History of allergic reactions attributed to misoprostol
* Cases that will require intraoperative conversion of myomectomy to hysterectomy
Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea

OBJECTIVES:

To evaluate the effect and cost-utility of a combination therapy of SPT+MAD compared with continuous positive airway pressure (CPAP) in patients with moderate positional obstructive sleep apnea (POSA).

HYPOTHESIS:

The SPT+MAD combination is more cost-effective and effective, in means of reduction of the apnea-hypopnea index (AHI), quality of life and compliance, compared with CPAP.

STUDY DESIGN:

A multicenter randomized clinical trial (RCT) will be performed with a follow-up of 12 months per patient. Patients will be randomized for CPAP or the combination SPT and MRA. All outcomes will be measured at baseline, month 3, 6 and 12.

STUDY POPULATION:

Patients diagnosed with moderate POSA according to polysomnography (PSG) results.

INTERVENTION / STANDARD INTERVENTION TO BE COMPARED TO:

The SPT trains POSA patients to sleep in non-supine positions, CPAP uses positive airway pressure to open the airway; MRA is an intra-oral prosthesis, which holds the mandible in a protrusive position, all to prevent effectively apneic events.

OUTCOME MEASURES:

AHI, compliance, quality-adjusted life year (QALY), direct and indirect costs, cardiovascular parameters, incremental cost-effectiveness ratio (ICER)

SAMPLE SIZE / DATA ANALYSIS:

100 subjects in each treatment group, total of 200 patients.

COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS:

The SPT is expected to improve the cost-effectiveness of overall treatment of POSA patients, and will save annually approximately 35-150 million euros.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Ability to speak, read and write Dutch
* Ability to follow up
* Diagnosis with symptomatic moderate OSA (15 \< AHI \< 30)
* Diagnosis of 10 to 90% supine position during the night
* AHI supine is 2 \> as high as AHI non-supine
* Own a Windows PC and ability to install SPT connection software and upload research data
* Expected to maintain current lifestyle (sports, medicine, diet etc.)

Exclusion Criteria:

* Many dental problems; insufficient teeth for wearing MRA
* Medication used/ related to sleeping disorders
* Central Sleep Apnea Syndrome
* Night or shifting work
* Severe chronic heart failure
* Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy)
* Seizure disorder
* Known medical history of mental retardation, memory disorders or psychiatric disorders
* Shoulder, neck and back complaints
* Reversible morphological upper airway abnormalities (e.g. enlarged tonsils)
* Inability to provide informed consent
* Simultaneous use of other treatment modalities to treat OSA
* Previous treatment for OSA with MRA, CPAP or SPT
* Pregnancy
Genome Analysis Across Populations in Inflammatory Bowel Disease

Objective:

To use clinical, genetic and genome analysis to better understand and define the genetic and environmental factors that contribute to IBD within affected populations.

Background:

Inflammatory bowel disease (IBD) is a chronic, and often disabling, disorder of the intestines characterized by dysregulation of mucosal immune response. Recent data suggests that the incidence and prevalence rates among all populations may be increasing due to constantly changing environmental exposures. The goal of the study is to identify susceptible genes that contribute to the pathogenesis of IBD in affected individuals.

Eligibility Criteria:
Inclusion Criteria:

* Subjects: diagnosed with Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis, IBD-undetermined)
* Available medical records to confirm IBD diagnosis (Crohn's disease, Ulcerative colitis, IBD undetermined (IBD-U))
* Healthy controls: no personal history of IBD, no family history of IBD, no history of unexplained chronic diarrhea/blood in stool/anemia/abdominal pain/weight loss
* Any age

Exclusion Criteria:

- Subjects with other gastrointestinal conditions not meeting the above IBD or Healthy Control criteria
Functional Evaluation of Kefir Drink on Antifatigue and Exercise Exercise Performance-2

Purpose: The aim of the present study was to evaluate potential beneficial effects of Kefir drink (Synbio Tech Inc., Kaohsiung City, Taiwan) on fatigue and ergogenic functions following physiological challenge. Methods: 16 male subjects, 8 in each group, were divided into two groups according to the principle of maximal oxygen uptake, which were (1) first-stage placebo and second-stage Kefir group (hereinafter referred to as group A). (2) The first phase of Kefeier, the second phase of the placebo group (hereinafter referred to as group B), after 4 weeks of supplementation, the performance and fatigue resistance tests were carried out in sequence, including: treadmill aerobic endurance exhaustion time, and fixation Exercise time and intensity challenge changes in blood lactate, blood urea nitrogen concentration and creatine kinase activity, as well as differences in body composition before and after supplementation. After the first phase of the test is completed, the four weeks of emptying are performed. And after adding the crossover sample, perform four weeks of supplementation and testing again.


Eligibility Criteria:
Inclusion Criteria:

* \>20 years old
* health

Exclusion Criteria:

* No smoking
* drinking habits
* no nutritional supplements or medications
* no food allergies
* normal liver and kidney function
* no diabetes and other chronic diseases
Detrusor Contraction During the Ice-water-test

In this randomized, double-blind clinical trial including patients with a neurogenic lower urinary tract dysfunction undergoing urodynamic investigation at the Spinal Cord Injury Center, Balgrist University Hospital, Zürich, we aim to investigate whether the detrusor contraction during the ice-water-test is provoked by the ice water or the rapid filling.

The ice-water-test (IWT) was first described 1957 by Bors and Blinn and it was thought to differentiate between lesions of the upper and lower motoneuron. In cat studies, it was shown that the IWT is a C-fiber mediated lower motoneuron segmental reflex and that these unmyelinated C fibers are associated with cold receptors. This explains the positive IWT in patients with upper motoneuron lesions. In healthy humans, the IWT is positive up to the age of 4 years and becomes negative thereafter since the reflex is centrally inhibited. However, this reflex might be unmasked by a neurological disease and/or injury.

Considering that C-fibers are involved in the pathogenesis of detrusor overactivity, the IWT seems to be a useful diagnostic tool in daily practice. However, although there are many studies published on the IWT, it is unclear whether the detrusor contraction during the IWT is provoked by the ice water or whether it might be caused by the rapid filling. Therefore, we designed this randomized, double-blind trial.

Eligibility Criteria:
Inclusion Criteria:

* neurogenic lower urinary tract dysfunction
* urodynamic investigation
* written informed consent
* ≥ 18 years old

Exclusion Criteria:

* symptomatic urinary tract infection
* \< 18 years old
* ≥ 90 years old
* no written informed consent
* pregnancy
Bright Ideas - CIN Feasibility Study

In this study investigators will determine the feasibility of a future trial comparing chemotherapy-induced nausea control in children with ALL receiving oral 6-mercaptopurine who do and do not receive problem-solving skill training. This is a novel approach to controlling an important and common treatment-related symptom.

This study will evaluate a novel approach to controlling a treatment-related symptom that detracts significantly from the quality of life of many patients. It will preserve and enhance the patient's and family's autonomy with respect to self-care. If found to be effective, this approach may be generalizable to pediatric patients receiving chemotherapy other than 6-mercaptopurine and thus has the potential to improve the quality of life of many children receiving cancer therapy.

This study will evaluate the efficacy of Bright IDEAS-CIN, adapted from the validated Bright IDEAS framework to improve CIN control in children with ALL who experience nausea while receiving 6-mercaptopurine. Bright IDEAS is an 8-session face-to-face intervention with a caregiver. In this first session, the caregiver is taught the problem-solving framework and begins working on their first self-selected problem. Sessions 2-7 involve working through relevant problems, with most caregivers working through 3-4 different problems. The final session summarizes the skills and discusses how to continue to use these new skills for new problems instead of lapsing into old ineffective strategies. Investigators adapted Bright IDEAS to meet the specific problem of CINV by adapting it to 3 sessions focused specifically on CINV, including the child in the conversation when developmentally appropriate and allowing the latter sessions to be conducted by phone or video-chat.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 4 years (PeNAT validated in patients 4 to 18 yrs)
* newly diagnosed or recurrent disease: first diagnosis of ALL (i.e. non-relapsed) in maintenance therapy
* English, French or Spanish-speaking with an English, French or Spanish-speaking guardian (PeNAT available in these languages)
* without physical or cognitive impairments that preclude use of the PeNAT
* planned to receive PO 6-mercaptopurine
* not planned to receive IV, IM, SC or IT chemotherapy or oral or IV corticosteroids during the 7-day study period