cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With COVID-19 Lung Injury

The primary objective of the study is to evaluate the days until reaching clinical stability after starting randomization in hospitalized patients with elevated inflammatory parameters and severe COVID-19 lung injury.

Unfortunately, the treatment of COVID-19 disease is still based on life support therapies. Nowadays, there is no scientific evidence from clinical trials regarding the efficacy or safety of different drugs to treat COVID-19 patients, despite some of them evolving to fatal severe lung injury due to important inflammatory process secondary to pro-inflammatory cytokines. Interestingly, Tacrolimus has been shown to inhibit both pro-inflammatory cytokines and, also, human coronavirus SARS-Cov replication, but it has not specifically been tested in COVID-19 patients.

Our working hypothesis is that severe SARS-CoV-2 (COVID-19) pneumonia is secondary to a deleterious inflammatory process; so, the use of Methylprednisolone pulses and Tacrolimus in hospitalized severe COVID-19 lung injury patients might have a positive clinical effect.

Given the COVID-19 current health emergency, this study could provide useful evidence to treat some COVID-19 patients with Methylprednisolona and Tacrolimus, which might represent a new therapeutic option for them. Tacrolimus is a drug with more than 20 years of experience, and therefore, its side effects are well known and usually reversible. In addition, since tacrolimus is a low-cost and easy to produce at large-scale drug, it could be used to treat a large number of patients. The administration of this drugs could not only decrease mortality secondary to lung involvement by COVID-19, but also decrease the excessive burden of care that intensive care units are bearing.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 infection confirmed by PCR
* New onset radiological infiltrates
* Respiratory failure (PaO2 / FiO2 \<300 or satO2 / FiO2 \<220)
* PCR\>100 mg/L and/or D-Dimer\>1000 µg/L and/or Ferritin\>1000 ug/L
* Informed consent.

Exclusion Criteria:

* Life expectancy ≤ 24h
* Glomerular filtration ≤ 30 ml / min / 1.73 m2
* Leukopenia ≤ 4000 cells / µL
* Concomitant potentially serious infections.
* Contraindication for the use of tacrolimus according to the specifications of the product
* Known adverse reactions to treatment
* Have participated in a clinical trial in the last 3 months
Hippocampus-sparing WBRT and Simultaneous Integrated Boost for Multiple Brain Metastases From NSCLC

This study evaluates hippocampus-sparing whole-brain radiotherapy with simultaneous integrated boost for patients with multiple brain metastases from non-small cell lung cancer. The primary endpoint is intracranial progression free survival, and secondary endpoints are verbal neurocognitive function, overall survival, adverse events according to CTCAE v4.03, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven diagnosis of primary non-small cell lung cancer
* 3 or more measurable brain metastasis ≥3 mm outside a 5-mm margin around either hippocampus on gadolinium contrast enhanced MRI within 14 days prior to registration
* KPS ≥70
* Age ≥55 years
* Informed consent prior to study entry

Exclusion Criteria:

* Patients with leptomeningeal metastases
* ≥3 organ sites of extracranial metastases (including lung-to-lung metastases) within 3 months
* Contraindication to MRI such as implanted metal devices or foreign bodies
* Prior radiation therapy (including SRS) to the brain
Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid

This study is being done to find out how much of the drug raltegravir (RGV) gets into cerebrospinal fluid (CSF), compared to how much get into the blood and to find out if normal changes in a certain gene in your body affects how much RGV gets into the CSF.

The multidrug efflux transporter P-glycoprotein (P-gp) is expressed in the blood-brain barrier where it limits entry of substrate drugs into the central nervous system. Raltegravir (MK-0158), a new HIV-1 integrase inhibitor and potentially major addition to the therapeutic armamentarium against HIV, is a substrate for P-gp. Studies are warranted to elucidate the relevance of P-gp transport for raltegravir in the central nervous system.

Eligibility Criteria:
Inclusion criteria:

1. Able to give informed consent.
2. Negative HIV-1 serology.
3. At least 18 but no more than 55 years of age.
4. Body mass index \<30.
5. Estimated creatinine clearance ≥ 50 mL/minute within 30 days prior to study entry.
6. Within 30 days prior to study entry:

   * Absolute neutrophil count ≥ 1,000/mm3.
   * Hemoglobin ≥ 12.5 g/dL for males and ≥ 11.5 g/dL for females.
   * Platelet count ≥ 100,000/mm3.
   * AST, ALT, and total bilirubin within normal range.
   * Alkaline phosphatase \< or = 1.5 x upper limit of normal.
7. Female study volunteers of reproductive potential must have a negative serum or urine pregnancy test performed within 30 days before study entry.
8. Must agree not to participate in a conception process.
9. Drug transporter gene ABCB1 position 3435 genotype C/C or T/T.

Exclusion criteria:

1. Use of any medication that is metabolized by CYP3A or UGT1A1.
2. Anticipated need to take any medication that is metabolized by CYP3A or UGT1A1 during the study.
3. Active drug use or dependence.
4. Inability to abstain from alcohol-containing beverages, grapefruit, and grapefruit juice.
5. Serious illness that would interfere with study participation.
6. Hospitalization for any reason or therapy for serious illness within 14 days prior to study entry.
7. History of hypersensitivity to study drug or its formulation.
8. As determined by the investigator, a significant active or previous history of cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, or immunologic disease(s). This is inclusive of chronic illnesses such as hypertension, coronary artery disease, arthritis, diabetes, any chronic gastrointestinal conditions that may affect drug absorption, etc.
9. Breast-feeding.
10. Evidence of CNS infection or space occupying lesion by history or physical examination.
11. History of significant CNS disorder.
12. Prisoners or subjects who are compulsorily detained.
13. ABCB1 position 3435 C/T heterozygosity.
Serum Biomarkers for Portal Hypertension in Cirrhosis (Pan-CHESS1802)

This is a prospective, multi-center diagnostic trial conducted at 6 liver centers in China designed to study the correlation between serum biomarkers associated with endothelial dysfunction and immune inflammation and hepatic venous pressure gradient in cirrhosis.

Hepatic venous pressure gradient (HVPG) is the gold standard for assessing portal pressure, of which the measurement is invasive and therefore not suitable for routine clinical practice. The detection of serum biomarkers is potential for noninvasive diagnosis of portal hypertension in cirrhosis. However, many are still in the exploratory phases of testing and are not yet ready to enter clinical practice. This study prospectively enrolled participants in 6 liver centers (Beijing YouAn Hospital, Shandong Provincial Hospital, Beijing Shijitan Hospital, Beijing Friendship Hospital, Xingtai People's Hospital, and 302 Hospital of PLA) in China designed to study the correlation between serum biomarkers associated with endothelial dysfunction and immune inflammation and HVPG in cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* age 18-75 years;
* confirmed cirrhosis based on histologic examination of liver or combined physical, laboratory, and radiologic findings, including a nodular surface, a coarse texture, and an enlarged caudate lobe of the liver.

Exclusion Criteria:

* prior drug therapy (e.g. β-blocker, vasopressin) within two weeks
* prior surgeries (e.g. TIPS, partial splenic embolization/ devascularization, splenectomy, liver transplantation)
* non-sinusoidal portal hypertension \& HCC inability to adhere to study procedures
* pregnancy or unknown pregnancy status
* no informed consent
Alcohol Induced de Novo Lipogenesis in Women

The study is cross-sectional is design. In the first Aim of this study, 5 women and 5 men will be asked to consume 2g/kg of \[2H\]water (a.k.a. deuterium oxide or heavy water) which incorporates 2H tracers into newly synthesized fatty acids and triglycerides. Deuterated water is not radioactive and has a long history of application in human studies. Researchers will collect blood samples 2 hours before and 5 hours after the participants consume 20 grams of alcohol as vodka to measure alcohol induced hepatic de novo lipogenesis (DNL) in both men in women. In addition, for Aim 2 researchers will recruit an additional 10 women who will be randomized into one of two groups who will consume a beverage containing vodka and sucrose, or sucrose alone. Aim 2 will be identical to the experimental scheme in Aim 2 in order to determine if sucrose enhances the effects of vodka on hepatic DNL.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Ages 21 - 45
* Healthy
* Light to moderate alcohol consumption (≤1 drink a day (\~14g) in women and ≤2 drinks a day (\~28 g) in men)
* BMI between 18.5-29.9
* Normal Nutritional Status
* Ability to speak and understand English

Exclusion Criteria:

* BMI \>29.9
* Comorbid conditions
* Any regular medications, except Oral Contraceptives
* Pregnant or Breastfeeding
* Regular exercise above activities of daily living
Grocery Assistance Program Study for Families

An experimental trial will be conducted whereby a Supplemental Nutrition Assistance Program (SNAP)-like food benefit program will be implemented in 240 SNAP eligible households. Baseline and follow up measures will include three 24-hour dietary recalls; household food purchase receipt collection; and household food security questions. The individual level measures will be collected from the adult most responsible for food shopping and a child in the household. After baseline measures are completed households will be randomized to one of three conditions: 1) restriction (not allowed to buy sugar sweetened beverages, sweet baked goods, or candies with food benefits); 2) restriction paired with an incentive (30% financial incentive on fruits and vegetables and restriction of purchase of sugar sweetened beverages, sweet baked goods, or candy with food benefits); or 3) control (no incentive or restrictions). Households in all conditions will be given a debit card that will have funds added monthly for a five month period. The dollar amount placed on the card monthly will be similar to the amount the household would receive if enrolled in SNAP. All participants will be instructed to use the debit card for food purchases only, and they'll be told they shouldn't use the card to purchase items currently non-eligible for purchase with SNAP benefits (e.g. alcohol, food from restaurants). Those in the restriction condition will also be told they cannot use the card to buy sugar sweetened beverages, sweet baked goods, or candies. They may purchase these foods using their own money, but not the debit card. Those in the restriction plus incentive condition will receive the instructions provided to the restriction group plus they will be told that they'll receive a 30% bonus for fruits and vegetables purchased using their debit card. Analyses will determine whether the nutritional quality of the diet at follow-up differs between experimental groups.


Eligibility Criteria:
Inclusion Criteria:

* SNAP-eligible household
* at least one child between the ages of 3-11
* Less than or equal to 6 people in the household
* Primary food shopper
* Ability and willingness to collect and submit household food purchase receipts for 22 weeks
* Willingness to attend two study visits
* willingness to complete three dietary recalls at both baseline and follow-up
* not planning to apply for SNAP in the next 5 months
* ability to speak and understand either Spanish or English

Exclusion Criteria:

* households that are not SNAP-eligible
* no children in household between the ages of 3-11
* not primary food shopper
* 7 or more people in household
* inability to collect and submit household food purchase receipts for 22 weeks
* unwillingness to comply with study measures
* inability to speak or understand Spanish or English
* planning on applying for SNAP within the next 5 months.
Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

The purposes of this study are to assess the efficacy of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis (IPF)and to assess the safety of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis.

This is a Phase 3, randomized, double-blind, placebo-controlled, safety and efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF). Approximately 320 patients at approximately 50 centers will be randomly assigned (1:1) to receive pirfenidone 2403 milligrams or placebo equivalent administered in divided doses three times per day (TID) with food. The primary outcome variable will be the absolute change in percent predicted Forced Vital Capacity from Baseline to Week 72. Patients will be randomized by geographic region.

Patients will receive blinded study treatment from the time of randomization until the last patient randomized has been treated for 72 weeks. A Data Monitoring Committee (DMC) will periodically review safety and efficacy data to ensure patient safety.

After week 72, patients who meet the Progression of Disease (POD) definition, which is a ≥ 10% absolute decrease in percent predicted Forced Vital Capacity or a ≥ 15% absolute decrease in percent predicted carbon monoxide diffusing capacity (DLco), will be eligible to receive permitted idiopathic pulmonary fibrosis therapies in addition to their blinded study drug. Permitted idiopathic pulmonary therapies include corticosteroids, azathioprine, cyclophosphamide and N-acetyl-cysteine (with restrictions).

Eligibility Criteria:
Primary Inclusion criteria:

* diagnosis of idiopathic pulmonary fibrosis
* 40 to 80 years of age
* Forced Vital Capacity ≥ 50% predicted value
* carbon monoxide diffusing capacity (DLco) ≥ 35% predicted value
* either Forced Vital Capacity or carbon monoxide diffusing capacity (DLco) ≤ 90% predicted value
* no improvement in past year
* able to walk 150 meters in 6 minutes and maintain saturation ≥ 83% while on no more than 6 liters per minute supplemental oxygen

Primary Exclusion criteria:

* unable to undergo pulmonary function testing
* evidence of significant obstructive lung disease or airway hyper-responsiveness
* in the clinical opinion of the investigator, the patient is expected to need and be eligible for a lung transplant within 72 weeks of randomization
* active infection
* liver disease
* cancer or other medical condition likely to result in death within 2 years
* diabetes
* pregnancy or lactation
* substance abuse
* personal or family history of long QT syndrome
* other IPF treatment
* unable to take study medication
* withdrawal from other IPF trials
Taxi STEP (Social Networks, Technology, and Exercise Through Pedometers)

This study is divided into four groups. Group 1 includes Health Fairs implemented at NYC taxi garage bases and airport taxi holding lots and pedometers. Group 2 includes Health Fairs, pedometers and text messaging to facilitate walking and living a healthier lifestyle. Group 3 includes Health Fairs, pedometers and social network support. Group 4 includes Health Fairs, pedometers, text messaging and social network support.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Over 21 years of age
* Planning on remaining in NYC for at least 7 months
* Licensed taxi driver for at least three months
* Speaks English, Bengali, Hindi, Spanish or French
* Currently owns a cell phone, uses text messaging services and is willing to accept text messages for this study

Exclusion Criteria:

* Part-time driver (fewer than 5 shifts/week, totaling less than 35 hours per week)
* History of any CVD or any other medical conditions (e.g. severe osteoarthritis) that will prevent him from walking

  * Please note: All inclusion/exclusion criteria are based upon self reported information captured during study screening procedures.
Efficacy of Education Versus Education Plus Prescribed Fluid Intake on Hydration Status in High School Athletes

Sports science testing by investigators at Gatorade Sports Science Institute has revealed that many athletes arrive at practice with a high urine specific gravity indicating they are hypohydrated. Though the data showed that most athletes don't lose more than 2% of their body weight in sweat during a training session, it is not known what the cumulative effects of living and training in a hot environment are over the course of a week. Previous research has indicated that prescribing fluid intake is more effective than education in improving drinking behavior during exercise. No studies to date have compared the impact of fluid intake prescription versus education in adolescent boys and girls playing outdoor and indoor sports.

Comparing sexes and training environment may provide more clarity around potential barriers and challenges to proper hydration for each environment.

This study will implement a parallel design with 4 sports team groups: 1) Indoor girls, 2) Indoor boys, 3) Outdoor girls, and 4) Outdoor boys. Each group of 36 per groups will be randomized into 1 of 3 conditions: 1) control (no intervention), 2) hydration education intervention, 3) prescribed hydration and education intervention. Athletes will be observed for three practices per week for 2 weeks. Practices are separated by at least 48 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Females and males between the ages of 13-19 years old
2. Non-smoker
3. Currently enrolled in the IMG sports program
4. Able to give verbal and written informed consent for participation as well as obtain parental consent if \<18 years of age
5. Must be fluent in English reading, writing, and speaking
6. Parental permission

Exclusion Criteria:

1. Expulsion from school for any reason
2. Leaving the IMG sports program
3. Pregnant or planning to become pregnant
4. Illness or injury that impacts sport participation or fluid balance
5. Taking any medication that impacts fluid balance
6. Participation in a clinical trial within past 30 days
7. Participation in any PepsiCo trial within past 6 months
8. Any condition the study investigator believes would interfere with eligibility following the study protocol, effect the study results, or put the subject at undue risk
A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia

Multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of KLH-2109 to Leuprorelin acetate in uterine fibroids patient with menorrhagia


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal Japanese woman diagnosed with uterine fibroids
* Patients confirmed by transvaginal ultrasonography to have at least 1 myoma that meet all of the following conditions:
* Larger than a certain standard
* No calcification
* Not receiving surgical treatment
* Patients with a normal menstrual cycle
* Patients diagnosed with menorrhagia

Exclusion Criteria:

* Patients with complication or history of blood system diseases (salasemia, sickle erythrocyte anemia, folic acid deficiency, coagulation disorder, etc.) (excluding iron deficiency anemia and latent iron deficiency anemia)
* Patients with lower abdominal pain due to irritable bowel syndrome or lower abdominal pain due to severe interstitial cystitis
* Patients with undiagnosed abnormal genital bleeding
Use Therapeutic Chinese Massage to Treat Peripheral Neuropathy in People With HIV

Background: Peripheral neuropathy (PN) occurs in half of the people with human immunodeficiency virus (PHIV). Currently, there is no Food and Drug Administration-approved treatment for HIV-related PN. Only half of PHIV who take medications report a significant reduction in pain. Therapeutic Chinese Massage, structured palpations or movements of soft tissues of the body, is a promising non-harmful, and non-costly intervention that can potentially alleviate or even treat PN but relevant research is limited.

Method: Investigators conducted a single centered, two-arm, single-blinded randomized controlled trial pilot study to examine if a series of three weekly 25-minute therapeutic Chinese massage sessions by a therapist of therapeutic Chinese massage, compared with placebo massage, could reduce PN-related pain and improve lower extremity functioning in PHIV. Twenty PHIV were recruited from the AIDS Foundation Houston, Inc in Texas. Pain, lower extremity functioning, and health-related quality of life were assessed for both groups prior to and post-massage.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of HIV and peripheral neuropathy have self-reported PN-related pain in lower extremity are not taking any kind of medications to alleviate PN symptoms age at least 18 years old not pregnant or lactating

Exclusion Criteria:

have received any kind of massage in the past three months Can not give informed consent
SMV + SOF With/Without RBV for IFN-II Patients With CHC

Prior trials have shown that many G1 CHC patients are ineligible or intolerant to pegylated (PEG)-based regimens due to prior severe side effects, worsening of cytopenias, exacerbation of underlying psychiatric disorders, or autoimmune disorders. These patients will not be candidates for treatment with the approvals of SMV and SOF in early 2014 due to the combination with PEG-regimens. Results of the COSMOS study suggest that these patients are likely to have excellent responses to SMV+SOF with or without RBV with 12 weeks of therapy, and that 24 weeks are unnecessary. This trial is designed to rapidly enroll and be completed in order to confirm this hypothesis.


Eligibility Criteria:
Inclusion Criteria:

1. Targeted at least 20% enrollment of patients with cirrhosis
2. Adults \>/= age 18 years.
3. Active infection with hepatitis C virus (HCV) genotype 1
4. Must have health insurance that covers therapy with SOF+RBV
5. Female patients of childbearing age must have a negative pregnancy test prior to initiating therapy, use at least two effective methods of contraception during treatment, and undergo monthly pregnancy tests.
6. Patients must be either IFN-ineligible due to psychiatric, autoimmune, neurological, or other causes that are confirmed appropriate by the PI; OR,
7. IFN-intolerant due to flu-like symptoms, psychiatric problems, cytopenia or other causes deemed appropriate by the PI.

Exclusion Criteria:

1. Presence of HIV co-infection
2. Presence of hepatocellular carcinoma (HCC)
3. Prior organ transplantation
4. Any history of hepatic decompensation
5. Patients taking any of the following medications:

   * Anticonvulsants- Carbamazepine, Oxcarbazepine, Phenobarbital, or Phenytoin.
   * Anti-infectives-erythromycin, clarithromycin, or telithromycin.
   * Antifungals- systemic itraconazole, ketoconazole, posaconazole, fluconazole, or voriconazole.
   * Antimycobacterials- rifampin, rifabutin or rifapentine.
   * Corticosteroids- systemic dexamethasone.
   * Propulsives- Cisapride.
   * Herbals- Milk thistle or St. John's Wart.
6. Patients that have been exposed to direct acting anti-viral agents
7. Patients with severe renal impairment (estimated Glomerular Filtration Rate (eGFR) \<50 mL/min/1.73m2) or with end stage renal disease (ESRD).
8. Patients with platelet count \<50 x109/L, Hemoglobin \<10 g/dL, or Neutrophils \<0.5 x109/L.
9. Women who are pregnant.
10. Men whose partners are pregnant or plan on becoming pregnant.