cyrilzakka/clinical-trials huggingface dataset:
Analgesic Efficacy of a Multiport Versus Uniport Flexible Catheter for Labor Epidural Analgesia

The purpose of this study is to determine whether multiple ports improve the analgesic efficacy of flexible catheters used for the provision of epidural analgesia during the entire continuum of labor and delivery

Multiport catheters, when compared to uniport catheters, have been associated with better analgesic quality during labor epidural analgesia because the presence of more than one port may enhance the distribution of epidural medication

Flexible catheters, when compared to rigid catheters, have been associated with better analgesic quality during labor epidural analgesia because greater flexibility may minimize catheter deviation in the epidural space, facilitate more optimal catheter placement in the epidural space, and result in better distribution of epidural medication

It is unknown whether multiple ports, which promote better distribution of epidural medication, provide added analgesic benefit to flexible catheters, which also facilitate better distribution of epidural medication, when used for the provision of epidural analgesia during labor and delivery

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Classification I-III parturients
* Mixed parity
* Estimated gestational age of at least 37 weeks
* Singleton gestation
* Cephalic presentation
* Spontaneous or induced labor

Exclusion Criteria:

* Body mass index (BMI) \> 45 kg/m2
* Prior cesarean section
* Multiple gestation
* Fetal abnormality
* Use of chronic analgesic medication
* Local anesthetic allergy
* Coagulopathy or anticoagulation
* Infection at epidural insertion site
* Spinal deformity other than mild scoliosis
* Uncontrolled/uncompensated/uncorrected cerebral, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, endocrinologic, metabolic, or hematologic condition
Blood Brain Barrier Penetration and Pharmacokinetics of the Elemene in Malignant Patients.

The purpose of this study is to elucidate the pharmacokinetics and the blood-brain barrier penetration of the elemene.


Eligibility Criteria:
Inclusion Criteria:

* histopathological or cytopathology diagnosis of malignancy
* heart, liver and renal function is normal
* Expected survival time is more than 3 months
* Signed informed consent

exclusion Criteria:

* non cancer patient
* accepted elemene administration in 1 month
* Expected survival time is less than 3 months
* no Signed informed consent
* heart, liver and renal function is abnormal
A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma (COBALT-RCC)

This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory renal cell carcinoma.

The study may enroll approximately 107subjects in total.

Eligibility Criteria:
Abbreviated Inclusion Criteria:

1. Age ≥18 years and body weight ≥42 kg.
2. Unresectable or metastatic RCC that has exploited standard of care treatment.
3. Karnofsky performance status (KPS) ≥80%.
4. Adequate renal, liver, cardiac, and pulmonary organ function.
5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX130 infusion.

Abbreviated Exclusion Criteria:

1. Prior treatment with any anti-CD70 targeting agents.
2. Prior treatment with any CAR T cells or any other modified T or natural killer (NK) cells.
3. History of certain central nervous system (CNS), cardiac or pulmonary conditions.
4. Active HIV, hepatitis B virus or hepatitis C virus infection.
5. Previous or concurrent malignancy, except treated with curative approach not requiring systemic therapy and in remission for \>12 months, or any other localized malignancy with low risk of developing into metastatic disease.
6. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
7. Prior solid organ transplantation or bone marrow transplant.
8. Pregnant or breastfeeding females.
A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome

This phase I study is a single arm, multi-dose study that will evaluate steady-state apixaban pharmacokinetics (PK) and pharmacodynamics (PD) in subjects with Nephrotic Syndrome (NS) vs healthy control subjects. This study will enroll 20 subjects diagnosed with NS and 10 healthy control subjects. Comparing differences in steady-state apixaban PK/PD parameters between subjects with NS and healthy volunteers will be essential to identifying a safe and effective apixaban dose and dose administration schedule for future randomized controlled trials (RCTs).


Eligibility Criteria:
Inclusion Criteria:

Study Subjects

* 18-79 years of age
* Confirmed diagnosis of NS, with at least one of the following (confirmed within 1 month prior to scheduled Day 1 Study Visit):
* Nephrotic-range proteinuria, defined as \>3.0 g/24 hours
* UPC (ratio of protein to creatinine in random spot urine sample), defined as \>3.0
* Hypoalbuminemia, defined as \<3.0 g/dL

Control Subjects

* 18-79 years of age
* Normal albumin levels (\>3.0 mg/dL)
* No history of chronic kidney disease

Exclusion Criteria:

* Age \<18 or ≥80 years old
* Serum Creatinine (SCr) ≥1.5 AND weight ≤60kg (these subjects would receive a reduced apixaban dose, per drug labeling)
* Weight \>120 kg OR body mass index (BMI) ≥40 kg/m\^2
* Estimated Glomerular Filtration Rate (eGFR) \<15 mL/min or on dialysis
* Signs and symptoms of increased risk of bleeding, including but not limited to: frequent nosebleeds, unexplained or worsening bruising, blood in urine or stool
* Unwilling to avoid engaging in activities that may increase the risk of bleeding through body injury or bruising, during the study period (e.g., contact sports)
* Baseline prolonged INR, defined as INR \>1.4

  * If INR is elevated, but PT and aPTT are below the upper limit of normal (13.3 sec and 37.7 sec, respectively), then the subject may be cleared to receive the study drug at the discretion of one of the study physicians.
* Platelets \<100 x 109/L
* History of stroke, or a history of gastrointestinal or intracranial bleeds
* Use of any prescription medications, over-the-counter (OTC) medications, or herbal products that are strong inhibitors or inducers of CYP3A4 and/or P-gp within 14 days prior to Study Day 1 or anticipated need for such drugs during the study. Examples included:

  * Strong inducers of CYP3A4 (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort, etc.)
  * Strong inhibitors of CYP3A4 (e.g., ketoconazole, ritonavir, clarithromycin, etc.)
  * Antiplatelet and/or anticoagulant agents: heparin, aspirin\*\* (see below), clopidogrel, prasugrel, non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, rivaroxaban, dabigatran, edoxaban
* Pregnancy or breastfeeding
* Liver disease with impaired synthetic function (INR \>1.4, total bilirubin \>1.2)
* Evidence of acute kidney disease by the KDIGO criteria (\>1.5 x baseline SCr, or \>0.3 mg/dL increase in SCr, over past 48 hours
* Unwillingness to forgo drinking alcohol during the study period due to heightened bleeding risk.
Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer

To evaluate progression of metastatic renal cell carcinoma from the initiation of PULSAR radiotherapy in combination with IMSA101 injectable onward.

The study expects to accrue the 20 patients over a 3-4 year period.

Patients with oligoprogressive disease (1-3 lesions) after treatment with Anti-PD1 / Anti-CTLA-4 will continue Anti-PD1 (nivolumab). All patients will have a mandatory PD-L1 PET (Pre-treatment and Week 12). All patients will undergo baseline biopsy (just before the administration of IMSA101 of the same lesion to be injected). SAbR will be delivered in 3 fractions at 12 Gy every 4 weeks (PULSAR regimen) to all progressing lesions. One lesion will also receive 5 intratumoral injections of IMSA101 (C1D1, C1D8, C1D15, C2D1, C3D1) immediately after radiation either on the same day or within 72 hours after the PULSE.

Selected Phase 2 dosing of IMSA101 (1200mcg) will be utilized.

At disease progression, patients have the option to undergo additional imaging and tissue/blood collections.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have metastatic ccRCC.
* Patients must have oligoprogression defined as progression in ≤3 lesions.
* All oligoprogression lesions must be suitable for radiation.
* Patients must have at least one site of disease that can be safely injected with IMSA101. Lung metastases are excluded.
* ECOG performance status 0-2.
* Age ≥ 18 years.
* Patients must have adequate organ and marrow function within 14 days prior to study entry.
* All IMDC risk categories are allowed.

Exclusion Criteria:

* Patients with progressive ultracentral/central chest lesions will be excluded
Effects of Chronic Dietary Grape Seed Extract Supplementation on Aortic Stiffness and Hemodynamic Responses to Exercise in Obese Males

It was demonstrated that acute dietary supplementation with GSE reduced arterial blood pressure via reduction in Q in obese individuals. However, no studies have investigated the chronic effects of dietary GSE supplementation on hemodynamic responses during exercise. Given the fact that obesity is associated with an impaired function of eNOS, the effect of chronic dietary GSE supplementation on abnormal blood pressure response to exercise and aortic stiffness (AoS) needs be elucidated. Thus, it is hypothesized that GSE decreases systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), Q, and aortic stiffness at rest and during exercise. This study would determine that this supplementation may be used as a non-pharmacological intervention to prevent incident hypertension and cardiovascular events during exercise via enhanced endothelial function.

We investigated whether elevated blood pressure and aortic stiffness (AoS) characterized in obese and overweight males (N=10) are reduced following chronic GSE supplementation during exercise. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (Q), total vascular conductance (TVC), and AoS to two submaximal cycling exercises (40% and 60% VO2peak) were compared 7 days after ingestion of GSE or placebo (PL) within an one week washout period. Compared with PL, GSE supplementation significantly decreased MAP at rest, 40%, and 60% workloads. AoS was significantly reduced at rest. Q tended to be decreased, but there was no significant difference. GSE had no effect on HR, TVC, and SV. Our study indicates that chronic supplementation with GSE reduces arterial pressure at rest and during exercise primarily via the combined reduction of AoS and Q. Thus, GSE can be a dietary supplement to treat augmented blood pressure responses in obese and overweight males at rest and during exercise.

Eligibility Criteria:
Inclusion Criteria:

* Overweight: 25-29.9 kg/m2
* Obese: \> 30 kg/m2
* Waist circumference: \> 90 cm

Exclusion Criteria:

* Antihypertensive medication
* Major systemic disease (cancer)
* Musculoskeletal diseases
* Cardiovascular diseases or symptoms including chest pain
* Myocardial infarction
* Arrhythmias
* Heart failure
Clinical and Radiographic Evaluation of Zirconomer Restorative

Is zirconomer restorative material more effective than a glass ionomer cement in restoration of primary molars

This trial seeks to evaluate the clinical and radiographic performance of two materials zirconomer restorative material and glass ionomer cement to achieve better treatment for primary molars.

Eligibility Criteria:
* Inclusion criteria:

  1. Children having carious primary molars(class1) without pulp exposure and normal radiograph.
  2. Children between age 5 and 7 years.
  3. Both male and female are included.
  4. Cooperative Children.

     Exclusion criteria:

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  1. Patients with systemic diseases.
  2. Parent refuse to participate.
Remote Ischemic Preconditioning in Aortic Valve Surgery

RIP-VALVE is a randomized, single blinded study that will test the hypothesis that remote ischemic preconditioning initiated before surgery reduces post-operative myocardial damage in aortic valve surgery. Infarct size will be determined by 72 hours area under curve of troponin-I.

The hypothesis tested in this research proposal is that remote ischemic preconditioning initiated immediately before aortic valve surgery reduces myocardial damage related to surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Aortic valve surgery for aortic stenosis
* Written informed consent

Exclusion Criteria:

* Aortic valve surgery combined with CABG or an other valve surgery
* Previous Q-wave myocardial infarction or previous coronary artery bypass graft
* Coronary artery stenosis \>70%
* Ejection fraction \<35%
* Surgery performed in emergency
* Nicorandil ou metformin treatment within 8 days before surgery
* Patient refusal / patient not having provided written informed consent.
A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men

This study consists of a randomized controlled trial (RCT) of a multi-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP use among Latinx sexual minority men (SMM).

This study consists of a randomized controlled trial (RCT) of a multi-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP use among Latinx sexual minority men (SMM). We will test intervention effects on regular HIV testing and use of prevention strategies. The intervention was developed in partnership with community stakeholders at Bienestar Human Services, Inc., a Latinx-focused organization in Los Angeles County (LAC), CA. The intervention is flexible for use in community-based organizations, such as in ongoing support groups.

The Specific Aims are:

Aim 1. To conduct a randomized controlled trial of a culturally congruent cognitive behavior therapy group intervention for immigrant Latinx sexual minority men, to test intervention effects on regular HIV testing and PrEP uptake.

Aim 2. To examine mechanisms of intervention effects on regular HIV testing and PrEP uptake, including more effective coping (e.g., reduced internalized stigma).

Aim 3. To conduct a cost-effectiveness analysis of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years-old
* biologically male at birth
* identify as male
* identify as Latino
* is an immigrant
* report having sex with men in the past 12 months
* report HIV-negative or unknown serostatus
* anticipate being available for the next 12 months to attend study visits
* able to interact and communicate in spoken Spanish or English.

Exclusion Criteria:

* HIV-positive
* cisgender women
* transgender women
Evaluation of the JUICE HA® as an Anti-sarcopenia

This study plans to recruit 60 participants aged 65 years and older who have been diagnosed with sarcopenia by a physician. Participants will be randomly assigned into JUICE HA® supplement and placebo group. All of the participants will be asked to take 15 mL/day of JUICE HA® supplement or placebo group for 12 weeks. The aim of this trial is to evaluate the potential of JUICE HA® to enhance physiological status (muscle mass and functional fitness) and to improve the quality of life in patients with sarcopenia.

JUICE HA® is a nutritional supplement formulated with hyaluronic acid (HA), branched-chain amino acids (BCAA), and chondroitin. Hyaluronic acid contributes to enhancing hydration levels in the skin and connective tissues; BCAA promotes muscle protein synthesis and repair; and chondroitin is believed to support the structural integrity and functionality of joints. The synergistic combination of these components is anticipated to provide comprehensive, multidimensional support for individuals with sarcopenia, potentially alleviating symptoms and improving overall quality of life. Therefore, this study will explore 15 mL/day of JUICE HA® supplement to improve the muscle mass and functional fitness in the elderly with sarcopenia.

This study aims to recruit 60 participants aged 65 years and older who have been diagnosed with sarcopenia by a physician and meet the Asian Working Group for Sarcopenia (AWGS) 2019 diagnostic criteria. Participants will be enrolled in a randomized control-group pretest-posttest design and randomly assigned to receive either the JUICE HA® supplement or a placebo (Lin et al., 2021). Functional fitness assessments, the Sarcopenia Quality of Life questionnaire (SarQoL), and blood sample collections will be conducted at baseline, at the 6th and 12th weeks of the supplementation period, and at the 6th and 12th weeks of the follow-up period. Blood samples will be analyzed for oxidative stress markers (SOD, MDA), inflammatory markers (TNF-α, IL-10), and muscle synthesis and degradation indicators (mTOR, MuRF1, atrogin-1). Body composition assessments will be performed at baseline, at the 12th week of the supplementation period, and at the 12th week of the follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Participants that have been diagnosed with sarcopenia by a physician and meet the AWGS 2019 criteria for sarcopenia.

Exclusion Criteria:

* Participants with a history of severe lower extremity musculoskeletal injuries within the past six months or those who have a fear of blood sampling will be excluded.
Efficacy of a Brief Intervention to Improve Sexual and Gender Minorities' Mental Health: Randomized Controlled Trial.

Experiences of violence, from micro to physical aggressions, have a deleterious impact on mental health. According to the Minority Stress Theory, unfavorable social conditions (such as anticipated and experienced discrimination and internalized homophobia), mediated by resilience strategies, can lead to mental health or illness. Sexual and gender minorities (SGM) face stigma and discrimination aggravating multiple aspects of their lives: from school drop-out to halting health care access. SGM reveal avoiding medical assistance for fear of discrimination while health professionals disclose feeling unprepared to handle SGM health needs. There are two main challenges: 1) developing specific psychological interventions to reduce the impact of stigma and discrimination on SGM' mental health; and 2) training public health professionals to properly address SGM needs. Therefore, the present trial aims to assess the efficacy of a brief, self-guided, on-line, asynchronous and unsupervised psychological intervention in improving SGM' mental health.


Eligibility Criteria:
Inclusion Criteria:

* Self-identity as sexual and gender minority.
* Being older than 16 years old.
* Have a stable on-line connection for, at least, 20 minutes in a place where won't be disturbed.
* Reports, in the baseline survey, previous experiences of discrimination, having depression or anxiety symptoms.
* Currently living in Rio Grande do Sul.

Exclusion Criteria:

* Disagrees with the consent form.
Nplate® Pregnancy Exposure Registry

US study to estimate the prevalence at birth of major birth defects (ie, those that cause significant functional or cosmetic impairment, require surgery, or are life-limiting) in children born to mothers who have received Nplate® therapy at any time during the pregnancy.

The purpose of the NPER is to monitor pregnancies exposed to Nplate® and to detect and record serious adverse events in infants up to one year after birth. The lack of adequate human fetal safety data for Nplate® makes the NPER an important component of the pharmacovigilance program on the safety of this drug. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects that are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects will be currently pregnant women residing in the US who: Have had any exposure to Nplate® at any time during the pregnancy, which is defined as the period between first day of the last menstrual period (LMP) (ie, within two weeks of conception) up to any date before the date of delivery or end of the pregnancy. The date of conception will be defined as fourteen days prior to the next expected menstrual period for women who report a regular menstrual cycle. If the date of the first day of the LMP is unclear, or if the estimated date of conception as determined by a first-trimester ultrasound differs by more than one week from the date as determined by the first day of LMP, the first-trimester ultrasound-derived date will be used to estimate the timing of exposure to Nplate®, as well as timing of enrollment. If neither a clear date of the first day of the LMP nor a first-trimester ultrasound is available, the estimated date of conception for purposes of enrollment will be determined by best estimate of the woman's prenatal care provider.
* Agree to enroll at any time from the estimated date of conception up to any date before the date of delivery or end of the pregnancy and who have not already had prenatal diagnosis of any major structural birth defect in the current pregnancy prior to enrollment.
* Agree to provide consent for participation in the registry including follow-up interviews.

Exclusion Criteria:

* Subjects will be ineligible for study participation if any of the following apply:
* Exposure to Nplate® did not occur during pregnancy.
* Prior knowledge of prenatal diagnosis of a birth defect. Patients who fall under this category will be encouraged to call the Amgen PSP toll free number for enrollment and follow-up.
* Cases reported to the NPER after completion of the exposed pregnancy. Patients who fall under this category will be encouraged to call the Amgen PSP toll free number for enrollment and follow-up.