cyrilzakka/clinical-trials huggingface dataset:
A Study to Obtain Additional Information on the Use of CorMatrix® CanGaroo ECM® Envelope

Actively gather additional information on the use of CorMatrix CanGaroo ECM Envelope in a post market observational study.


Eligibility Criteria:
Inclusion Criteria:

1. Subject who has received the CorMatrix CanGaroo ECM Envelope for an implantable electronic device following battery change out or upgrade.
2. Signed Informed Consent

Exclusion Criteria:

1. Known sensitivities to porcine material.
Phase I Trial of CEA Specific AAV-DC-CTL Treatment in Stage IV Gastric Cancer

The purpose of this study is to evaluate the clinical safety and preliminary efficacy of CEA specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene in the treatment of stage IV gastric cancer patients.

Carcinoembryonic antigen (CEA) describes a set of highly related glycoproteins involved in cell adhesion.CEA is normally produced in gastrointestinal tissue during fetal development, but the production stops before birth. The serum levels are raised in some types of cancer,such as Gastric Cancer.The expression of CEA in these cancers and succedent unfavourable prognosis such as tumor hyperplasia, recurrence make CEA become the desirable therapeutic target.

Cancer immunotherapy is the use of the immune system to treat cancer. Immunotherapies fall into three main groups: cellular, antibody and cytokine.Cellular therapies involve the removal of immune cells from the blood or from a tumor. Immune cells specific for the tumor are activated, cultured and returned to the patient where the immune cells attack the cancer. Cytotoxic T cells and dendritic cells can be used in cell-based immunotherapy.

This study is for patients that have a stage Ⅳ gastric cancer with elevated serum CEA concentration. This research study uses special immune system cells called CEA-specific cytotoxic T lymphocytes , a new experimental therapy.

Blood will be collected from the patient and the CEA-specific CTLs will be made.The cells will be injected by IV into the patient.The investigators will follow the patient from their last infusion,monitor side effects of immunotherapy and learn more about the way the T cells are working in the patient's body.The investigators will use blood samples to see how long the T cells last and to look at the immune response to the patient's response to cancer.

Eligibility Criteria:
Inclusion Criteria:

* Any patient, at least 18 yrs old regardless of sex, with a diagnosis of Stage IV Gastric Cancer
* Patients with life expectancy greater than or equal to 6 weeks.
* Patients with a Karnofsky score of greater than or equal to 80.
* serum CEA ≥ 20ng/ml.
* Patient provides consent for all required biopsies.

Exclusion Criteria:

* Patients with severe active infection.
* Patients receiving systemic corticosteroid within 48 hours of CTL infusion.
* Patients with HBV,HCV,HIV infection.
Rehabilitation Robotics After a Stroke

Upper limb motor control after a stroke may be improved with rehabilitation robotics at a subacute stage. The aim of this multicenter controled randomized single blind study is to define the place of rehabilitation robotics at this phase of the rehabilitation process. Both groups will realize the same time of rehabilitation. The cost benefit ratio will be compared in each group through medical assessment of improvement and definition of the costs due to the rehabilitation process.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic or hemorrhagic stroke of the middle cerebral arteria territory
* 18 to 80 years old
* stroke onset between 3 weeks to 3 months,with or without aphasia, with or without lateral neglect and homonymous hemianopia, with or without visual neglect
* 10\<or= Fugl Meyer upper limb Score \<or= 40
* upper limbs pain less or equal than 3/10 (VAS)
* inpatient or outpatient rehabilitation
* signed inform consent

Exclusion Criteria:

* ischemic or hemorrhagic stroke of anterior or posterior cerebral artery
* ischemic or hemorrhagic stroke of the brainstem
* major aphasia evaluated by a Boston Diagnostic Aphasia Examination (BDAE) score less or equal to 3
* asthenia not allowing to work 60 minutes with the robot.
* serious visual deficiency not allowing to use the robot
* impossibility to install the arm on the robot because of a serious and uncontrolled spasticity or for any other reason
* pronounced and constant muscular contractures, or deformation affecting the use of the extremity
* upper limb's pain superior to 3/10 and/or being worse at the active and passive mobilization
* serious infection and/or instability of vital functions
* perfusion of the affected upper limb not removable
* incapacity to stay on a chair
* contraindicated sitting position
* permanent deviation of the head and\\or of the eyes
* perturbed or non-cooperative patient
* patients that must have to be isolated due to an infection process
* bone fracture of the paretic limb with an onset less than 3 months stabilized or not
PET Imaging in ALS Patients

This is a pilot study to evaluate a potential imaging biomarker for aiding diagnosis and monitoring progression of ALS, based on a well established basic science pathway, published human autopsy data, preliminary data in ALS mutant mice, and our recently published data using brain PET scans to image the metabotropic glutamate receptor type 5 (mGluR5) in healthy human volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ALS patients, ranging in age from 18-80.
* Must meet El Escorial Criteria for Probable or Definite ALS.
* Disease duration \>1 year, but \<3 years.
* Weakness in at least two extremities.
* Forced vital capacity less than 80% and greater than 50%.

Exclusion Criteria:

* Documented orthopnea or otherwise unable to lie flat in a PET scanner for 90 minutes.
* Presence of pacemakers, aneurysm clips, shrapnel, or other implanted metallic devices that would preclude an MRI scan.
* Absence of sufficient collateral arterial circulation for radial arterial line placement in both wrists.
* Significant abnormalities of hepatic or renal function, or illicit substance use.
* Positive drug screen. (Subjects currently taking prescribed narcotic medication who have a positive drug screen for this medication will not be excluded. Medication history will be obtained during screening).
* Weighs \> 350 lbs.
A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer

The purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab FDC, also referred to as BMS-986213) for the treatment of non-microsatellite instability high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.


Eligibility Criteria:
Inclusion Criteria

* Histological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry.
* Participants must have:.

  i) progressed during or within approximately 3 months following the last administration of approved standard therapies (at least 1, but not more than 4 prior lines of therapies in the metastatic setting), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if RAS wild-type), if available in the respective country, or;.

ii) been intolerant to prior systemic chemotherapy regimens if there is documented evidence of clinically significant intolerance despite adequate supportive measures.

* Must have sufficient tumor tissue \& evaluable PD-L1 expression to meet the study requirements.
* Must have measurable disease per RECIST v1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately.

Exclusion Criteria

* Prior treatment with either an immunotherapy or with regorafenib or with TAS-102.
* Untreated central nervous system (CNS) metastases, participants are eligible if CNS metastases have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).
* History of refractory hypertension not controlled with anti-hypertensive therapy, myocarditis (regardless of etiology), uncontrolled arrhythmias, acute coronary syndrome within 6 months prior to dosing, Class II congestive heart failure (as per the New York Heart Association Functional Classification), interstitial lung disease/pneumonitis or an active, known or suspected autoimmune disease.
* Confirmed tumor microsatellite instable high/deficient mismatch repair (MSI-H/dMMR) status as per local standard testing; MSI/MMR test results from initial diagnosis are acceptable.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Atorvastatin in Pulmonary Hypertension

Clinical effect and tolerability of atorvastatin versus placebo in patients with Pulmonary Hypertension: double-blinded, randomised, prospective phase II study for 6 months with adjusted doses of Atorvastatin

PAH is characterized by dyspnea, fatigue, and lower extremity edema as a result of heart failure. Several research have proved that inflammation may participate in the pathogenesis of PAH. As atorvastatin inhibits inflammation and has beneficial effects on blood vessels in other types of cardiovascular disease. Therefore, atorvastatin may similarly benefit patients with PAH. Experimental data suggest that statins attenuates pulmonary hypertension in animal experiments. In addition, non-controlled clinical studies suggest that atorvastatin is effective and safe in patients with pulmonary hypertension.

Participants in this study will be randomly assigned to receive 6 months of daily placebo tablets or daily atorvastatin in a double-blind fashion. The study will compare the safety and efficacy of placebo and atorvastatin.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and willing to sign the informed consent form
* \<=65 and \>=18years old
* Diagnosis of pulmonary arterial hypertension (Mean pulmonary artery pressure greater than 25 mm Hg at rest with a pulmonary capillary wedge pressure less than 15 mm Hg )that is a) idiopathic, b) familial, or c) associated with connective-tissue disease, d)congenital systemic-to-pulmonary shunt occurring after surgical/interventional repair that had been performed at least five years previously or in the absence of indications for surgery/intervention treatment e) chronic thromboembolism PAH in the absence of indications for surgery
* Patients in WHO functional class II to III
* Vasodilator Testing nonresponders
* Baseline six-minute walking distance between 100 and 460 m

Exclusion Criteria:

* PAH related to other etiologies (Groups 2, 3 and 5 pulmonary hypertension)
* A forced expiratory volume in one second/ forced vital capacity bellow 50% or a total lung capacity of less than 60 percent predicted value
* A 6-minute walk distance of less than 100 or more than 460 m
* A positive acute vasodilator response
* Current treatment with calcium-channel blockers or specific therapy (endothelin receptor antagonist, phosphodiesterase-5 inhibitor, or prostacyclin)
* Inability to perform 6-minute walk test
* Serum transaminase level three times above the upper limit of normal
* Creatine kinase level five times above the upper limit of normal
* Previously diagnosed heart disease such as serious cardiac arrhythmias, unstable angina pectoris, myocardial infarction
* History of transient ischemia attack or stroke within three months
* Bleeding disorder
* Positive pregnancy test or breastfeeding practice
* History or suspicion of inability to cooperate
Role of Curarization During Anesthesia for Gynecologic Surgical Laparotomy Procedures

The primary outcome of this study is to investigate whether deep NMB reversed with Sugammadex is superior to moderate NMB reversed with Neostigmine, in terms of overall pain in the first 48 hrs after laparoscopic gynecologic surgery, reversal time from NMB (TOF≥0.9) and direct and indirect costs. Additionally we will also assess: drugs consumption for pain and antiemetics (rescue dose), surgical conditions, hemodynamic and respiratory stability, operation time, anesthesia time, total amount and flow rate of CO2, insufflation time, resolution of post-operative ileus, dry mouth and PONV in the first 48 hours, patient satisfaction


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years BMI between 16 and 40 Kg/m2 ECOG Performance Status tra 0 e 1 American Society Anesthesiologist (ASA) class 1 or 3 Able to provide informed consent to trial procedures

Exclusion Criteria:

* Age \< 18 or \> 75 years
* BMI \<16 o \> 40 Kg/m2
* ECOG Performance Status \>1
* Pregnancy
* Active or recent pelvic inflammation
* Anticipated airway difficulty
* Patients with history of allergy to rocuronium, neostigmine or sugammadex
* Allergy to NSAIDs
* Previous opioids consumption for chronic pain
* Patients receiving drugs for different medical conditions, that may prolong or shorten the duration of rocuronium effect (e.g aminoglycosides, magnesium)
* Hepatic or renal failure
* Persistent coagulopathy
* Neurological or cognitive disorders
* Conversion from laparoscopic to open surgery Onset of intraoperative complications
Colloid Improves Organs Function in Resuscitation of Extensive Burn Patients

The present study was to evaluate the effectiveness of colloid compared with crystalloids for fluid resuscitation in critical burn patients with total burn surface area ≥50%.

Extensive burn patients are some of the most challenging critically ill patients who may have multiple-system organ failure with life-threatening complications.Over time, several resuscitation formulae have been proposed to guide burn resuscitation and the best known ones are Parkland and Evans formulae. The main controversy between the two formulae also focuses on whether to infuse the colloid in the first 24 h.Controversy continues and the conflicting results left many clinicians unsure about the effect of colloids on fluid resuscitation in extensive burn patients who suffer higher risk of hypovolaemia, abdominal compartment syndrome (ACS), multiple organs dysfunction and mortality. To address this uncertainty, we conducted a prospective, randomized, controlled clinical trial to compare fluid resuscitation in extensive burns guided by Parkland formulae with TMMU formulae as a modified Evans formula routinely used in China.

Eligibility Criteria:
Inclusion Criteria:

* burn patients with total burn surface area ≥50% and full thickness burn surface area ≥30%.

Exclusion Criteria:

* age \<18 yrs, time between burn injury and fluid infusion \> 4 h, time arriving at our burn centre \> 6 h, pre-existing medical illnesses compromising the cardiopulmonary reserve or those need for compassionate care only.
Liver MRI With Primovist/Eovist in Pediatric Subjects Who Are Suspected or Have Focal Liver Lesions.

Medical records are reviewed to obtain information about the use of a MRI diagnostic imaging agent (contrast agent) called Primovist/Eovist in children older than 2 months and less than 18 years. Data that has been recorded in the child's medical records relating to the injection of Primovist/Eovist will be collected. Information will be collected from up to 2 weeks before the child received Primovist/Eovist until 12 months after the child received Primovist/Eovist. Copy of the child's MR images that were taken right before and after the child received Primovist/Eovist and all other reports (laboratory reports, other imaging reports, etc) that are part of the child's medical records during that time period will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Age \>2 months and \<18 years of age at the time of the Primovist/Eovist enhanced MRI
* MRI with Primovist/Eovist due to suspected or known focal liver lesions
* Evaluable safety data
* Evaluable efficacy data: precontrast and postcontrast magnetic resonance (MR) images must be available for review
* If the above criteria are met, the principal investigator (PI) and/or designee will obtain a signed consent for medical records release including access to anonymized electronic copies of the pre- and post-Primovist/Eovist MRI scans, in accordance with local regulatory requirements in order for subjects to be enrolled in the study.

Exclusion Criteria:

* A subject will be excluded from this observational / retrospective study if the subject has previously been enrolled into this study. Subjects may only be entered once into this study, even if they have been imaged multiple times and for different indications.
A Phase 1b/2a Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C

This is an open-label, randomized, safety, tolerability, dose-finding, PK/PD, and preliminary efficacy study of subcutaneous Hanferon™ in combination with ribavirin(RBV) in treatment-naïve subjects with genotype 1 hepatitis C.

The primary objective of this study is to evaluate the safety and tolerability of ascending doses of Hanferon™ in combination with ribavirin (RBV).

The secondary objective of this study is to define the PK and PD of ascending doses of Hanferon™ in combination with ribavirin(RBV). The exploratory objective of this study is to make a preliminary assessment of Hanferon™ efficacy in combination with ribavirin(RBV).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic hepatitis C genotype 1a or 1b
* Male or female aged 18 to 65 years, inclusive
* Compensated liver disease without evidence of cirrhosis
* No evidence of type 1 or 2 diabetes mellitus, lipodystrophy or polycystic ovary syndrome
* No history or presence of autoimmune or lymphoproliferative disease or hemoglobinopathies
* Stable medication doses for 1 month for the chronic disease if subjects have chronic diseases, including but not limited to hypertension and dyslipidemia

Exclusion Criteria:

* History of previous treatment of hepatitis C
* Currently use medication for psychiatric illness including depression, suicidal ideation, and psychosis
* History or presence of chronic liver disease
* History of drug or alcohol abuse within the past year
* Evidence of active illicit drug use
* Clinically significant abnormal electrocardiogram (ECG) or rhythm strip
* Female subject who has a positive urine pregnancy test or who is lactating
Luminex-based Assay to Identify Major IgE-binding Episode Among IgE-mediated Wheat-allergic Patient

This study will be using Luminex-based peptide assay (LPA) to determine major IgE-binding epitope among wheat allergic children to differentiate clinical phenotype.

Luminex-based peptide assay (LPA) is a novel tool using machine learning techniques, developed to predict different degrees of food allergy has been successfully reported among cow's milk protein allergy. This technique provide a more precise and advanced adaptation from microarray-based immunoassay (MIA). Using this technique will aid us for the differentiation of clinical phenotypes of wheat-allergic patients. This study will be the first study to date using this technique aim to determine major IgE-binding epitope among immediated-reaction of wheat allergic children to differentiate clinical phenotypes, and may lead to further study to develop the new therapeutic approach to wheat-allergic patients.

Eligibility Criteria:
Inclusion criteria

1. Patients with IgE-mediated wheat allergy, with one of the following criteria; 1.1 a convincing clinical history of the reactions within 4 hours after wheat ingestion during the past 12 months combined with positive skin prick test (SPT) and/or the level of specific IgE (sIgE) to wheat or 1.2 a positive oral food challenge (OFC) result to wheat during the past 12 months OR
2. Patients with wheat tolerant confirmed by negative oral food challenge (OFC) result to wheat during the past 12 months OR
3. Patients with IgE-mediated wheat allergy and underwent wheat oral immunotherapy for at least 6 months or at the maintenance phase of the treatment

Exclusion criteria Patients with delayed allergic reactions after wheat ingestion greater than 4 hours
Early Arthroscopic Partial Meniscectomy(APM)

Arthroscopic partial meniscectomy(APM) surgery outcomes for Metabolic Syndrome(MetS) patients with degenerative meniscus tears(DMTs) was still not clear. The aim of the study was to investigate outcomes of early APM vs delayed APM for MetS patients with degenerate meniscus tears.

Degenerate meniscus tears(DMTs) were the most common knee disease in aged and obese people. The most common treatment for DMTs was arthroscopic partial meniscectomy(APM) surgery. However, the time window for performing APM surgery was unclear, especially in obese patients with Metabolic syndrome(MetS). Abdominal obesity, insulin resistance with or without glucose intolerance, dyslipidemia or elevated blood pressure are included in the principal components of MetS. Whether early APM within 3 to 6 months or delayed APM surgery within 6 to 12 months are benefical to MetS patients with DMTs. The knee function outcomes between early APM and delayed APM for MetS patients with DMTs were assessed and follow up to 12 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* • Must be age between 35 and 70 years old;

  * Clinical diagnosis of metabolic syndrome;
  * Clinical diagnosis of degnerate meniscus tears;

Exclusion Criteria:

* Must be able to have no acute knee injury such as car crash or acute sports injury;

  * Must be able to have no knee surgeries history;
  * Must be able to have no rheumatoid arthritis or serious knee osteoarthritis with deformity;
  * Must be able to have no contraindications to MRI;
  * Must be able to have no severe cardiopulmonary disease;
  * Must be able to have no musculoskeletal or neuromuscular impairments ;
  * Must be able to have good visual, hearing, or cognitive;
The Effectiveness of Autonomic Nervous System, Sleep Quality, and Immune Regulation for Shift Nurses Practicing Alternative Nostril Breathing

The purpose of this study is to evaluate the efficacy of shift nurses practicing alternative nostril breathing to improve life quality, autonomic nervous system and immune status.

Breathing is regulated by autonomic nervous system. It is well-known that breathing exercise can regulate autonomic nervous function and promote relaxation. However, the mechanism for better immunity and sleep quality is not clear. We postulate that alternative nostril breathing might benefit nurses after undergoing shift work. The benefits could be due to improvement of autonomic nervous function, sleep quality, and even immune function.

The study design will include a randomization of two groups, with a control group and one experimental groups for 3 months (12 weeks). The control group will do normal breathing. The experimental groups will do alternative nostril breathing twice a week (20 minutes/time) for 3 months.

The study primary endpoints are 1) to improve autonomic nervous function, 2) to improve sleep quality and 3) to enhance human immunity.

We anticipate to reach the primary endpoints and publish the primary results in one year.

Eligibility Criteria:
Inclusion Criteria:

* Shift nurses

Exclusion Criteria:

* Upper respiratory tract infection such as nasal congestion, runny nose, coughing, wheezing, nosebleeds, fever and other symptoms.