cyrilzakka/clinical-trials huggingface dataset:
Perioperative Immunotherapy for NSCLC (ECTOP-1030)

This trial is a randomized, multicenter, open label phase II clinical study. The main objective is to evaluate the efficacy of three perioperative immunotherapy modalities (atezolizumab adjuvant therapy, nivolumab neoadjuvant therapy, pembrolizumab neoadjuvant+adjuvant therapy) in early-stage resectable NSCLC patients. The enrolled patients are randomly assigned in a 1:1:1 ratio to receive relevant treatment in the three perioperative immunotherapy groups mentioned above, and undergoing short-term pathological efficacy evaluation and long-term prognosis follow-up after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who sign the informed consent form and are willing to complete the study according to the plan;
2. Aged from 18 to 80 years old;
3. ECOG equals 0 or 1;
4. Not receiving lung cancer surgery before;
5. Resectable cIB-IIIA tumors;
6. Not receiving chemotherapy or radiotherapy before.

Exclusion Criteria:

1. Not cIB-IIIA tumors;
2. Nodules not suitable for resection;
3. Not lung adenocarcinoma diagnosed cytologically or pathologically;
4. Receiving lung cancer surgery before;
5. Receiving radiotherapy or chemotherapy.
A Study to Evaluate RAF265, an Oral Drug Administered to Subjects With Locally Advanced or Metastatic Melanoma

The purpose of this study is to determine the safety profile, pharmacokinetics, pharmacodynamics and maximum tolerated dose of RAF265 in patients with locally advanced and metastatic melanoma.

Phase II portion of study (dose expansion) has been cancelled with Amendment 7 as of Dec 2011.

The Ras/Raf/MEK/ERK pathway plays a prominent role in controlling several key cellular functions including growth, proliferation and survival. B-Raf is a member of the Ras/Raf/MEK/ERK pathway and is frequently mutated in melanoma resulting in activation of the MAPK pathway. RAF265 is a novel, orally active, small molecule with potent inhibitory activity against B-Raf kinase and additional antiangiogenic activity through inhibition of vascular endothelial growth factor receptor type 2 (VEGFR-2) in non-clinical studies.

The primary objectives of this study are to determine the maximum tolerated dose (MTD), dose limiting toxicities (DLTs), and the safety profile of RAF265 when administered orally to subjects with locally advanced or metastatic melanoma; to determine the plasma pharmacokinetics (PKs) of orally administered RAF265; and to evaluate potential pharmacodynamic effects of RAF265 using tumor biopsies, peripheral blood samples, and tumor imaging.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of melanoma, locally advanced AJCC Stage IIIB to metastatic Stage IV
2. Measurable disease - at least one lesion measured in at least one dimension as ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral computed tomography (CT) scan
3. ECOG performance status of 0 or 1
4. No concurrent anticancer or investigational therapy for at least 4 weeks prior to enrollment
5. No major surgery for at least 4 weeks prior to enrollment

Exclusion Criteria:

1. Significant cardiac disease or other significant medical/psychiatric disease
2. History of primary central nervous system tumor or brain metastases
3. History of melena, hematemesis, or hemoptysis within the last 3 months
4. Previous therapy with certain molecularly targeted agents
Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis

The project is designed to test new biomarkers that are more sensitive than the current standard in detecting injury to the proximal kidney tubule and will establish better criteria for when kidney safety concerns may halt further testing of a drug in humans.

The goal of this clinical study is to advance the acceptance of new biomarkers designed to detect drug-induced kidney injury in clinical trials.

The Kidney Safety Project is being conducted at four major medical centers:

* University of Southern California
* University of Minnesota
* MD Anderson Cancer Center
* Dana-Farber Cancer Institute.

Blood and urine samples will be collected from patients undergoing treatment with either cisplatin or aminoglycosides, which are two different drugs known to cause injuries to the proximal tubule of the kidney. Aminoglycosides are a common antibiotic drug taken by patients with cystic fibrosis. Cisplatin is a common chemotherapy drug taken by patients with head and neck cancer.

The Aminoglycoside Study of the Kidney Safety Project is being conducted at the University of Southern California and the University of Minnesota and aims to evaluate aminoglycoside induced acute kidney injury in patients with cystic fibrosis.

The companion study, the Cisplatin Study of the Kidney Safety Project, is being conducted at the MD Anderson Cancer Center and the Dana-Farber Cancer Institute and aims to evaluate cisplatin induced acute kidney injury in patients with head and neck cancer.

The data from the Kidney Safety Project, from both the Aminoglycoside Study and the Cisplatin Study, will be combined for determination of the best biomarkers for predicting drug-induced acute kidney injury.

Eligibility Criteria:
Inclusion criteria:

1. Males and females ≥ 18 years of age.
2. Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:

   * Sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test.
   * Two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; or
   * Abnormal nasal potential difference.
3. Hospitalized and initiated on systemic antibiotic therapy for treatment of an acute pulmonary exacerbation.
4. Willingness and ability to comply with study procedures and study restrictions.
5. Ability to provide written informed consent.

Exclusion criteria:

1. Chronic kidney disease defined by microalbuminuria (\> 30 mcg/mg creatinine) or eGFR \< 60 mL/min/1.73m2.
2. Receiving medications known to alter the tubular secretion of creatinine (e.g. trimethoprim, cimetidine).
3. Hospitalized for treatment of an acute pulmonary exacerbation or received intravenous aminoglycoside antibiotics within 3-months of study entry.
Pilot Compassionate Use Study of Thioctic Acid Treatment in Mitochondrial Myopathy

OBJECTIVES:

I. Assess the efficacy of thioctic acid in treating a single patient with mitochondrial myopathy.

PROTOCOL OUTLINE: The patient receives one thioctic acid tablet 3 times a day. If patient experiences no side effects after 1 week, 2 tablets are administered and given 3 times a day over 3 months for compassionate use.

The patient is followed at weeks 3, 8, and 12.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Long standing ophthalmoparesis and fatiguable weakness of the limbs
* Mild ataxia and no central nervous system involvement
* History of mitochondrial DNA deletion and a measurable biochemical defect of the respiratory chain
* Steady deterioration in skeletal muscle mass and power over 5 years

--Prior/Concurrent Therapy--

* Previous participation in studies of muscle disease natural history (CRC Protocol 183A)
Effect of Deep Propioceptive Stimulation in Prader-Willi Syndrome

The main objective is to study the effect of deep propioceptive stimulation with a heavy blanket for 2 weeks compared with a placebo blanket on sleep quality and behavior in patients with PWS

Prader-Willi syndrome (PWS) is a genetic disease associated with sleep disorders whose etiology is partly central due to the inherent hypothalamic deficit. It is associated with low cognitive performance and worsening behavior with more impulsivity, tantrums, scratches and obsession for food. Deep propioceptive stimulation with a heavy blanket (HB) stimulates the parasympathetic system and improves the state of anxiety in persons with autism or other causes of intellectual disability and/or psychopathology. To date, there are no studies evaluating the effect of HB on sleep quality or brain activity in persons with PWS. The main objective is to study the effect of HB for 2 weeks compared to a placebo blanket on sleep quality and behavior in patients with SPW.

Methodology: Actigraphy, questionnaires, crossover study in 60 patients with PWS, with HB/placebo blankets (15 days each). Effect of HB on brain connectivity with functional magnetic resonance imaging in 30 patients and 30 controls. Expected results: PWS group will show worse sleep quality and behavior that will improve after using HB. Brain connectivity will be different with/without HB. These favorable changes will help to justify the use of this ecological treatment and its inclusion in the NHS clinical practice guidelines for improving the quality of life of these patients and their caregivers.

Eligibility Criteria:
Inclusion Criteria:

* Patients with PWS genetically confirmed at least 16y old willing to participate and being able to be still in the MRI.

Exclusion Criteria:

1. Age \< 16 years old
2. Presence of uncontrolled Obstructive Sleep Apnea (Residual AHI ≥ 30).
3. Narcolepsy or other sleep disorders with daily somnolence
4. Intolerance to the heavy blanket in spite of previous adaptation sessions
5. Active psychopathological disorder that may interfere with sleep
6. Use of hypnotic or sleep regulator drugs (change of dose in the last 3 months)
7. Contraindications for MRI
8. Impossibility to stay still during MRI adquisition
Early Primary Prophylaxis of Esophageal Varices

Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal varices with or without red color signs and have not bled previously will be enrolled. After baseline evaluation, the participants will be randomized to receive either Placebo or Carvedilol 12.5 mg BD. After randomization they will be followed up for one year. The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) at 1 year in each group. The secondary endpoint are survival,reduction in HVPG,change in CTP and MELD score\& adverse events.


Eligibility Criteria:
Inclusion Criteria:

- Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal varices with or without red color signs and have not bled previously.

Exclusion Criteria:

* Any contra-indication to beta-blockers
* Any EVL or sclerotherapy within last 3 months
* Child Turcotte Pugh (CTP) score \> 12, refractory ascites, hepatorenal syndrome
* Any past history of surgery for portal hypertension
* Significant cardio or pulmonary co-morbidity
* Any malignancy that affects survival.
* Active alcohol abuse or last intake ≤ 4 weeks to avoid possibility of ongoing alcohol hepatitis.
* Past history of surgery for portal hypertension
* Uncontrolled diabetes
* Peripheral vascular disease
* Refusal to participate in the study
Observational Study in Participants With Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and Non-Hodgkin's Lymphoma (NHL) in Latin America

The primary purpose of the study is to quantify participants' demographic parameters, country standard therapies, treatment patterns and outcomes among participants with chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) in oncology concentration hospitals in Latin America.

This is a retrospective (take a look back at events that already have taken place), non-interventional, multicenter (when more than one hospital or medical school team work on a medical research study) study to review medical records of adult participants with a diagnosis of CLL, MM or NHL anytime since 01 January 2006. Only data available from clinical practice will be collected. All eligible participants at participating centers will be included regardless of participant's demographics, prior or current treatments for disease, or clinical outcome. The period of observation will span from 01 January 2006 through present, but all eligible participants must be followed for a minimum of 1 year, unless the participant died within that first year. Participant demographic parameters, standard therapies, treatment patterns and outcomes will be primarily quantified.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic lymphocytic leukemia (CLL), multiple myeloma (MM), or non-Hodgkin lymphoma (NHL) anytime since January 1, 2006
* At least one year of data following first observed diagnosis except in the case of the participant death within one year following first observed diagnosis
* Participant must sign a participation agreement/informed consent form (ICF)

Exclusion Criteria:

- Having one and only one consult in the center
The Study of Dachengqi Decoction Combined With Probiotic L92 to Improve the Prognosis of Patients With Severe Abdominal Hypertension

Patients with severe infections, wounds (burns), and severe pancreatitis often have abdominal hypertension (IAH), which is an important objective manifestation of acute gastrointestinal failure in severe patients. Timely diagnosis and effective intervention can improve the treatment rate of patients. In the early stage, we conducted clinical exploration and observational research on the treatment of IAH with Dachengqi Decoction and Lactobacillus in the treatment of critically ill patients including the above diseases, and achieved significant clinical effects. On this basis, it is planned to verify the protective effect of Lactobacillus acidophilus L92, Dachengqi Decoction and the combination of the two on the gastrointestinal mucosal barrier function of patients with IAH and the regulation of the intestinal flora, and analyze the intestinal mucosal barrier The relationship between intestinal flora and the prognosis of IAH patients.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion and exclusion criteria and critically ill patients (acute severe pancreatitis, cervical spinal cord injury) who are 60 years old or older than 18 years old, expected to be mechanically ventilated in the ICU, and hospitalized for more than 48 hours, replaced intra-abdominal pressure monitoring with bladder pressure measurement, and repeated on admission The results of the three measurements are ≥12 mmHg.

Exclusion Criteria:

* Patients who have not signed the informed consent; cannot tolerate intra-abdominal pressure monitoring; pregnant women; patients after bladder surgery; systemic diseases and recent use of related drugs; previous infections, such as history of tuberculosis or PPD positive; previous high History of blood pressure, poor blood pressure control (SBP/DBP\>=140mmHg); patients with severe mental illness; long-term use of traditional Chinese medicine, probiotics, gastric mucosal protectors, proton pump inhibitors, chemotherapy or immunosuppressive drugs, etc., such as admission The drug was not discontinued within the previous month.
Safety and Efficacy Study of IV Ganaxolone as Adjuvant Therapy for Established Status Epilepticus (ESE)

This study is designed to optimize the dosing regimen and evaluate the preliminary safety and efficacy of Intravenous (IV) ganaxolone as adjuvant therapy for participants with ESE receiving initial IV antiepileptic drug (AED) according to currently practiced standard of care (SOC). The study will be composed of 2 phases: an initial, open-label, dose optimization phase followed by IV ganaxolone versus placebo double-blind phase.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females at least 18 years of age at the time of the first IP bolus dose.
2. Has received benzodiazepines before or after arrival to the ED for generalized convulsive seizures lasting more than 5 minutes.
3. Has received the last dose of benzodiazepine more than 5 minutes prior to the first IP bolus initiation.
4. Ongoing or recurrent convulsions, or evidence of electrographic SE on rapid EEG immediately prior to the first IP bolus initiation.
5. The participant has not yet received a second-line IV AED for the treatment of the current episode of SE or the first IP bolus can be initiated within 15 minutes before or 10 minutes after the administration of such IV AED(s).

Exclusion Criteria:

1. The participant is intubated or the decision to proceed with intubation has been made.
2. The cause of SE is acute anoxic brain injury, cardiac arrest, acute trauma, hyper- or hypo-glycemia, or eclampsia.
3. The participant is known or suspected to be pregnant.
4. The participant is incarcerated at the time of SE occurrence.
5. Participants who pre-emptively opted out of the study.
6. A known allergy or sensitivity to progesterone or allopregnanolone medications/ supplements.
7. Receiving a concomitant IV product containing Captisol®.
8. Known estimated glomerular filtration rate (eGFR) \<30 milliliters per minute (mL/min) and not receiving dialysis (may initiate first IP bolus prior to acute labs).
9. Individual weighing or suspected to weigh \<40 kilograms (kg).
10. Hypotension requiring 2 or more vasopressors.
11. An individual who, in the opinion of the investigator has a life expectancy of less than 24 hours.
12. Use of an investigational product for which less than 30 days or 5 half-lives have elapsed from the final product administration. Participation in a non-interventional clinical study does not exclude eligibility.
13. Known or suspected history or evidence of a medical condition that, in the investigator's judgment, would expose participant to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the study.
Target Mitochondrial Fitness, Chronobiology and Metabolism

Exercise could be an element that affects the biochemical, metabolic and microbiome parameters of organisms. Thus, to identify and validate the effects of aerobic and anaerobic exercises at different times of the day (morning or afternoon) on mitochondrial fitness and whether this changes could have a relation with metabolism and cardiovascular parameters and microbiome is of great interest for its applicability in biomedicine.

As specific objectives of this project will study:

1. - To study the direct effect of aerobic and anaerobic exercise at different time points in the day on mitochondria fitness (short study: basal, at the end of the exercise and 2 h after exercise).
2. - To study mitochondria fitness under morning or afternoon aerobic and anaerobic exercise (prospective study: basal, 4, 8 and 12 weeks of the study).
3. - To identify and validate modulators and target proteins of mitochondria fitness affected by exercise (miRNA omic and proteomic analysis of mitochondria from the different groups of the study at basal and 12 weeks of the study).
4. - To study the relationship of the mitochondrial response (Objectives 1 and 2) to the different combination of exercises and chronobiology with anthropometric-clinical, carbohydrate and lipid metabolic and cardiovascular changes.
5. - To check the effect of morning or afternoon aerobic and anaerobic exercise on gut microbiota and its relation to mitochondria fitness, clinical and metabolic parameters (basal, 4, 8 and 12 weeks of the study).


Eligibility Criteria:
Inclusion Criteria:

* 20-
* IMC \<30 kg/m2
* Informed consent

Exclusion Criteria:

* Smoker
* Previous physical exercise of more than 20 minutes / 2 times a week
Ropivacaine Though Laterosternal Catheters After Cardiac Surgery

This is a prospective double-blinded and randomised study involving patients undergoing cardiac surgery with median sternotomy, the effects on postoperative analgesia of a 48-hr continuous infusion of ropivacaine 2 mg.mL-1, at the rate of 4 mL.hr-1 through two catheters inserted at the lateral edges of the sternum will be studied, versus a control group in which normal saline will be infused in the same conditions.

Diverse methods for infusion of local anaesthetics after cardiac surgery have been proposed, but none of them provided high-level evidence of efficacy. The catheters studied here are designed for a surgical insertion before closure of the sternotomy, with the aim of infusing the drug the closest possible of the terminations of intercostal nerves.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled cardiac surgery.

Exclusion Criteria:

* - surgery in emergency
* thoracotomy
* cardiac graft
* redo
* pregnancy
* patient's refusal
* minor or adult under legal protection
* psychiatric ongoing disease
* addiction to opiates
* ongoing opiate treatment
* inability to use a PCA device
* respiratory insuffiency (Vital capacity or maximal expired volume per sec. \< 50% of the expected value, or mean PAP \> 50 mmHg)
* intra-aortic balloon
* severe renal insuffiency
* history of allergy or intolerance to: morphine, acetaminophen, bupivacaine.
Evaluation of Apnea Tolerance in Bariatric Patients Following Rapid-sequence Induction of Anesthesia

The purpose of this study is to compare the effect of the 25° head-up position versus the 55° head-up position on tolerable apneic time (TAT) in bariatric patients scheduled for laparoscopic adjustable gastric band surgery following maximum preoxygenation and rapid-sequence induction (RSI) of anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status II-III patients
* Body Mass Index (BMI) of 40-60
* Scheduled for an elective laparoscopic adjustable gastric band surgery

Exclusion Criteria:

* Patients with abnormalities of the upper airway that require awake tracheal intubation
* Asthma
* Chronic obstructive pulmonary disease
* Pregnant patients
Study of the Spermatic Characteristics of Patients With Fabry Disease

The objective of this project is to estimate the prevalence of spermatic abnormalities in patients with Fabry disease.The main objective of this project is to estimate the prevalence of spermatic abnormalities in patients with Fabry disease.

Fabry disease is a lysosomal storage burden of X-linked genetic transmission due to alpha-galactosidase deficiency. This enzyme deficiency causes deposits of globotriaosylceramide in virtually all cell types of the body. The majority of hemizygous men develop a severe multisystemic disease dominated by renal failure, neurological and cardiac involvement. There is a specific treatment based on enzyme replacement therapy.

The incidence of Fabry disease is estimated between 1/60000 and 1/3500 in the general population.

Infertility in Fabry disease is poorly documented. Only a few cases have been reported, from alteration of spermogram to azoospermia. The identification of deposits suggestive of Gb3 in light microscopy and electron microscopy at the level of the genital tract argues in favor of the attack of this device. The low prevalence of Fabry disease requires a cross-sectional multicenter study to determine the frequency of alterations in sperm characteristics, their impact on fertility, and the possible effect of substitution therapy, in order to establish appropriate measures. adequate preventive measures.

The objective of this project is to estimate the prevalence of spermatic abnormalities in patients with Fabry disease.The main objective of this project is to estimate the prevalence of spermatic abnormalities in patients with Fabry disease.

Eligibility Criteria:
Inclusion Criteria:

* male patients with Fabry disease regardless of the clinical form of the disease; treated with enzyme replacement therapy or not (from the initial diagnosis). The definite diagnosis of Fabry disease will be established on the deficit of the activity of alpha galactosidase A (\<12%). A molecular genetic study is desirable but not mandatory,
* patients aged 18 to 65,
* giving their free and informed consent to participate, after information on the research.

Exclusion Criteria:

* persons placed under the protection of justice,
* unaffiliated or non-beneficiary subject of a social security scheme.