cyrilzakka/clinical-trials huggingface dataset:
Delayed Umbilical Cord Clamping - C-section Pilot

This is a pilot study of delayed cord clamping (DCC) at progressively longer intervals (90 to 120 seconds) during elective cesarean deliveries of term infants. The investigators hypothesize that the pilot trial of DCC in cesarean sections will demonstrate safety of this procedure for mothers and babies.

Despite expert recommendations to delay clamping the cord for at least 2 minutes, early cord clamping remains a common obstetrical practice. The World Health Organization has noted that data on cesarean deliveries are more limited, particularly with respect to long-term effects in infants. Recently, the American College of Obstetrics and Gynecology also noted in a committee statement that " the ideal time for clamping of the umbilical cord in cesarean section vs. vaginal birth is a particularly important area for future research".

The objective of this study is to conduct a pilot trial of delayed cord clamping during cesarean deliveries to determine if progressively longer intervals of cord clamping are feasible and not related to poorer maternal and neonatal outcomes as compared to outcomes from historical controls. We will offer study entry for women planning elective cesarean delivery to collect prospective data on progressively longer intervals, analyzing outcomes for each time interval to ensure they are clinically acceptable, prior to extending the interval another 30 s. We anticipate approximately 20 women at each interval (90 and 120 sec) and will perform hemoglobin analysis on the infants specifically for this study. If intraoperative blood loss is clinically deemed excessive, or mother or baby are unstable, the cord will be clamped.

Eligibility Criteria:
Inclusion Criteria:Subjects that are pregnant (women 18 years of age and older) and scheduled for an elective C-section at ≥ 37 weeks gestation will be eligible for the study.

Exclusion Criteria:

Pregnant women that do not plan on having a C-section and individuals that are not pregnant. Pregnant women that are medically unstable, have poorly controlled diabetes mellitus, multiple gestations, anomalous fetuses and/or severe intrauterine growth retardation will be excluded. Adults unable to consent will not be included
Progressive Goal Attainment Program for Veterans

The purpose of this study is to test the effectiveness of the Progressive Goal Attainment Program (PGAP) in improving employment outcomes and community engagement among U.S. veterans with disabilities.

Veterans with disabilities often have low self-esteem and motivation, significant depression and a belief that their disability precludes them from gainful employment. The Progressive Goal Attainment Program (PGAP) is specifically designed to target these psycho-social risk factors of disability. PGAP is a structured, 10-week intervention that focuses on helping clients develop a planned activity schedule to assist them in resuming desirable life activities, including employment. The PGAP for Veterans Project will test the feasibility of delivering PGAP to U.S. military veterans. The research will focus on the best means of service delivery, staffing needs and how to coordinate PGAP in a larger veteran service system. MDRC will also gather information on the target population, recruitment methods, the feasibility of scaling and replication, and employment outcomes among the sample. Two hundred veterans will be enrolled and randomly assigned into the study across two sites: Errera Community Care Center within (part of the VA Connecticut Health Care System) and the Michael DeBakey VA Medical Center in Houston, Texas.

Eligibility Criteria:
Inclusion Criteria:

* Self-reporting a disability.
* Unemployed or under-employed.
* Likely to benefit from PGAP (i.e. unengaged in social and community activities, difficulty attaining work due to motivational factors).

Exclusion Criteria:

* Does not consent to be in the study.
* Significant barriers: serious substance abuse, significant psychotic disorders and cognitive disabilities that would preclude them from active participation in PGAP.
Evaluation of Prognosis and Prognostic Scores in Geriatric Patients With Acute Pancreatitis

* To compare the prognosis of acute pancreatitis between geriatric and other adult patients
* To evaluate the efficacy of various prognostic scores in geriatric patients with acute pancreatitis


Eligibility Criteria:
Inclusion Criteria:

Acute pancreatitis Hospitalisation Adult patients

Exclusion Criteria:

* Recurrent pancreatitis
* Chronic pancreatitis
* Outpatient follow up
* Loss of follow up within 3 months of discharge
Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246

The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral dose for 14 days to healthy, fed volunteers. The results of this trial determine which dose will be used in expanded pivotal safety trials.

This study is a Phase II, double-blind, randomized, placebo-controlled, multi-center (3 sites) trial to assess the safety, tolerability, and pharmacokinetics of 400 mg and 600 mg Form I ST-246 when administered as a single daily oral dose for 14 days to 107 healthy, fed volunteers between 18 and 74 years of age. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms.

Eligibility Criteria:
Inclusion Criteria:

1. 18 - 75 yrs
2. Healthy volunteer
3. Ability to consent
4. Available for clinical follow-up for study
5. Not taking other medications
6. Adequate venous access
7. Using adequate birth control; negative pregnancy test
8. Able and willing to avoid alcohol for screening and study duration

Exclusion Criteria:

1. Inability to swallow study medication
2. Pregnant or breast-feeding
3. Medical condition, e.g., asthma, hypertension, angioedema, traumatic brain injury other than concussion, bleeding disorder, blood dyscrasia, idiopathic seizures, cardiac disease that limits activity, diabetes, active malignancy, Hepatitis B or C, HIV or AIDS, chronic microbial infection,
4. History of drug allergy that contraindicates study participation
5. Medical, psychiatric, social, occupational or other reason that jeopardizes the safety/rights of participant or renders he/she unable to comply with the protocol (including drug or alcohol abuse, or homelessness)
6. Clinically abnormal ECG
7. Has or will participate in a clinical trial or experimental treatment within 30 days of, or during, the study
8. Cannot or will not do physical exercise 24 hrs before and after PK days
9. Will not consume grapefruit/grapefruit juice during study
10. Vaccination within 2 wks of screening, or planned before Day 42 of study
11. Treatment with prednisone or equivalent immunosuppressant/modulatory drug \<3 mths before screening
12. Clinically significant physical exam and lab results \<2weeks from 1st study drug dose
Diabetes Nutrition Algorithm - Prediabetes

Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies to prevent progression from prediabetes to diabetes have been widely studied, however, without striking long-term effects of any kind of intervention (pharmacological, behavioral...). The investigators therefore investigate certain nutritional approaches concerning nutrient content and favorable food components, targeting metabolic improvement.

Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies to prevent progression from prediabetes to diabetes have been widely studied, however, without striking long-term effects of any kind of intervention (pharmacological, behavioral...). The investigators therefore investigate certain nutritional approaches concerning nutrient content and favorable food components, targeting metabolic improvement.

The main comparison will assess differences in metabolic outcome due to low-carb or low-fat dietary intervention in short- and long-term design.

Additionally, the role of PUFA will be assessed during long-term intervention to achieve better maintenance of metabolic improvements from the first study phase.

Eligibility Criteria:
Inclusion Criteria:

* impaired fasting glucose (IFG) fasting blood glucose 100-126 mg/dl

and/or

* impaired glucose tolerance (IGT) 75 g OGTT 120 minutes: 140-200 mg/dl

Exclusion Criteria:

* current pregnancy or breastfeeding
* BMI \> 45 kg/m²
* Diabetes mellitus Typ 1 or 2
* serious disease e.g symptomatic coronary heart disease
* serious symptomatic malignant disease (weight loss \> 10% within the last 6 month)
* severe liver or kidney disease ( an increase in transaminases \> 3 times than the upper limit of the standardized range, GFR \< 50 ml/min/1,73m²)
* systemic infection (CRP \> 1 mg/dl)
* severe mental illness
* drug abuse
* treatment with steroids
* potentially incompliant subjects
* exclusion criteria for magnetic resonance tomography
* any kind of metal in or on the body: cardiac pacemakers prosthetic heart valves metal prosthesis magnetic implanted metallic parts contraceptive coil metal fragments/ grenade shrapnel fixed braces acupuncture needles insulin pump intraport etc. Field strength \> 3 Tesla further tattoos, permanent make-up
* persons with limited thermosensory or heightened sensitivity to heating
* persons where cardiovascular disease cannot be ruled out by examination
* persons with heightened sensitivity to loud noise or diseases of the ear
* used closed whole body scanner: claustrophobia
A Comparison of Dorsal Branch of the Digital Nerve Versus Dorsal Digital Nerve for Finger Pulp Reconstruction

As the donor nerve attached with the flap, the dorsal branch of the digital nerve and the dorsal digital nerve is commonly used for finger pulp reconstruction.This study compares two donor nerves: the dorsal branch of the digital nerve and the dorsal digital nerve.

The investigators compares two donor nerves attached with the flap for sensory reconstruction of finger pulp: the dorsal branch of the digital nerve and the dorsal digital nerve. The main outcomes were static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, and pain and cold intorlence of the reconstructed finger.

Eligibility Criteria:
Inclusion Criteria:

* The pulp or fingertip defect in only one finger
* A defect greater than or equal to 1.5 cm in length
* Necessity to preserve finger length
* A patient between 18 and 60 years of age

Exclusion Criteria:

* Injuries to the dorsum of the middle phalanx
* Injuries to the course of the vascular pedicle or donor nerve
* A defect less than 1.5 cm in length
* Multiple finger pulp defect
* Extremely contaminated wounds
Repeated-dose Brief Intervention to Reduce Overdose and Risk Behaviors Among Naloxone Recipients

REBOOT is a pilot randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients (REBOOT). It includes an established overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will test the feasibility of an efficacy trial of REBOOT vs treatment as usual (information and referrals) that will evaluate overdose events (non-fatal or death), drug use cessation, and overdose and HIV risk behaviors, among opioid-dependent persons who have previously overdosed and already received take-home naloxone (the opioid antagonist used to reverse overdose).


Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years;
* current opioid dependence by SCID
* urine positive for opioids during screening, excluding prescribed agonist maintenance therapy
* history of prior opioid overdose
* previously received take-home naloxone
* no serious illnesses likely to progress clinically during trial
* able and willing to provide informed consent, provide locator information, communicate in English, adhere to visit schedule

Exclusion Criteria:

* suicidal ideation by concise health risk tracking (CHRT)
* currently participating in another interventional research study that could possible impact the study's outcomes of interest
* any condition that, in the Principal Investigator's judgment, interferes with safe study participation or adherence to study procedures
Strategies to Continue Gynae-oncology Services in the Era of COVID-19 Outbreak: Concerns and Challenges in a Referral Centre in Malaysia

A short survey involving 100 participants was conducted online to explore the understanding of Covid 19 pandemic impact and importance of vaccination among cancer survivors.


Eligibility Criteria:
Inclusion Criteria: Female cancer survivors or care-taker undergoing national covid 19 vaccine -

Exclusion Criteria: Male, not cancer survivors

-
Far Infrared Radiation Treatment for Osteoarthritis

A study to evaluate the possibility of using far infrared radiation to manage pain due to osteoarthritis.

Arthritis consists of more than 100 different conditions. These conditions range from relatively mild forms such as tendonitis and bursitis to crippling forms as rheumatoid arthritis. Pain syndromes include fibromyalgia and arthritis-related disorders as lupus erythematosus that involve every part of the body. There are forms of the disease, such as gout that almost nobody connects with arthritis. Osteoarthritis is the most common form of arthritis.

The objective for the study is to access the possibility of using far infrared radiation for pain management.

Eligibility Criteria:
Inclusion Criteria:

* 1 year old and above

Exclusion Criteria:

* None
A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma

The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.


Eligibility Criteria:
Select Inclusion Criteria:

1. Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component.
2. Measurable disease as determined by the investigator.
3. Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib).
4. Recovery from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
5. Adequate organ and marrow function.
6. Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment.
7. Female subjects of childbearing potential must not be pregnant at screening.

Select Exclusion Criteria:

1. Prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (eg, temsirolimus), or cabozantinib.
2. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization.
3. Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before randomization.
4. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Systemic treatment with radionuclides within 6 weeks before randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
5. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.
6. Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors.
7. Chronic treatment with corticosteroids or other immunosuppressive agents.
8. Serious illness other than cancer.
9. Major surgery within 3 months before randomization. Complete wound healing from major surgery must have occurred 1 month before randomization and from minor surgery at least 10 days before randomization.
10. Pregnant or lactating females.
11. Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low grade tumors.
Bioequivalence Study of 2 Sizes of SHR4640 Tablets Orally in Healthy Subjects

The study is being conducted to evaluate the pharmacokinetic, and safety of two sizes of SHR4640 tablets in healthy adults, to explore the bioequivalence between two sizes of SHR4640 tablets.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent.
2. 18 years to 45 years (inclusive).
3. Body weight should above 45 kg, and body mass index should be between 19 and 28 kg/m2 (inclusive).
4. The physical examination, vital signs, laboratory examination and electrocardiogram are not abnormal or abnormal but with no clinical significance.

Exclusion Criteria:

1. Pregnant or nursing women.
2. No birth control 1 weeks before screening or until one week after SHR4640 administration.
3. Average daily alcohol consume more than 14g for female or more than 28g for male within 1 month before screening, or baseline alcohol screening is positive.
4. Smokers (average daily smoking of 5 cigarettes or more in the 3 months before screening).
5. Subject with a history of substance abuse and drug abuse.
6. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
7. sUA level ≥480 μmol/L.
8. eGFR \< 90 mL/min/1.73 m2.
9. Positive result for human immunodeficiency virus (HIV), hepatitis C virus antibody, or syphilis antibody, or hepatitis B surface antigen.
10. 12-lead electrocardiogram (ECG) showed abnormal and clinically significant.
11. Cardiovascular, neuropsychiatric, respiratory, digestive tract, endocrine and other systemic diseases within 1 year before screening, which were judged to be serious by the investigators.
12. History of hypersensitivity to SHR4640 or its analogues.
13. History or suspected crystals or stones in the urinary system during the screening period of B-ultrasound.
14. History of been diagnosed with acute kidney injury in the past or screening period.
15. Had undergone major surgery within 3 months prior to screening, or have not recovered from surgery, or plan major surgery during the study.
16. Blood donation within 1 month before screening; Or patients with trauma or major surgical procedures who donated blood or lost blood \> 400 mL in the 3 months prior to screening.
17. Has unsuitable venous for blood sampling.
18. Received the last dose of a study drug (or treatment with a medical device) within 3 months or 5 T1/2 (whichever is longer) of the screening or are currently participating in another study of a study drug (or medical device).
19. Have received or been exposed to other live vaccines or live attenuated vaccines within 3 months prior to Day 1, or who plan to receive live vaccines or live attenuated vaccines during the study.
20. Consumes grapefruit and/or poppy seed within 48 hours before SHR4640 administration.
21. Taken any prescription drugs, over-the-counter drugs, herbal medicines or food supplements within 2 weeks before screening.
CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis

The goal of this clinical trial is to evaluate the effectiveness of CXCR4 targeted PET imaging in preoperative localization diagnosis of primary aldosteronism (PA). Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET, and then underwent adrenal venous sampling (AVS). Then, the responsible adrenal adenoma will be resected by adrenalectomy, and examined with pathological section and staining. Researchers will compare the sensitivity and specificity between 68Ga-PentixaFor PET imaging and AVS in preoperative localization diagnosis of PA.


Eligibility Criteria:
Inclusion Criteria:

* Patients with PA, confirmed by an elevated aldosterone/renin ratio (ARR) and an intravenous salt loading test.
* The patient has provided written informed consent authorisation before participating in the study.
* The patient is 18 to 70 years of age at the time of consent.

Exclusion Criteria:

* Refusal by the patients to undergo 68Ga-PentixaFor PET/CT, AVS, CT, or adrenalectomy.
* Suspicion of familial hyperaldosteronism type 1 (FH-1) or type 3 (FH-3).
* Suspicion of adrenocortical carcinoma.
* Severe comorbidity potentially interfering with treatment or health-related quality of life.
* Patients need to take drugs that interfere with clinical research.
* Any medical condition present that in the opinion of the investigator will affect patients clinical status.
* Pregnancy or lactation.
* Estimated glomerular filtration rate \<40mL/min/1.73m2.
* Interfering treatment in between 68Ga-PentixaFor PET/CT and AVS.
Magnesium Sulfate Versus Indomethacin for Preterm Labor

The purpose of this study is to investigate the efficacy of Indomethacin compared to Magnesium Sulfate (MgSO4) in reducing neonatal morbidity through a prospective double blind randomized clinical trial. The specific aim of the project is to test the hypothesis that Indomethacin, compared to MgSO4, will decrease the proportion of neonates diagnosed with major complications or death.


Eligibility Criteria:
Inclusion Criteria:

* Initial episode of preterm labor for enrollment
* The diagnosis of preterm labor
* Gestational age between 24 and 32 weeks
* Singleton or twin gestation
* The ability to understand the requirements of the study

Exclusion Criteria:

* Cervical dilation \>5 cms
* Suspected chorioamnionitis
* Fetal distress
* Vaginal bleeding
* Severe pre-eclampsia
* History of gastrointestinal bleeding
* Abnormal renal function
* Suspicion of fetal malformation by ultrasound
* Known allergy to, or intolerance of, Magnesium sulfate and/or Indomethacin
* Documented rupture of amniotic membranes
* Multiple gestations of triplets or more.