cyrilzakka/clinical-trials huggingface dataset:
Early TIPS in Real Life for Patient Admitted to Intensive Care Unit

Acute esophageal variceal bleeding (AEVB) is a serious complication of cirrhosis, with high morbidity and mortality. The latest European recommendations(1) recommend the early implementation, within 72 hours following esophageal variceal bleeding, of a transhepatic porto-systemic shunt set up by transjugular route (TIPS) called "early TIPS" in patients at high risk of recurrence, i.e. Child C\<14 or Child B with active bleeding at the time of endoscopy. The implementation of early TIPS appears to improve survival without transplantation in these patients, although the benefit among Child B patients without active bleeding has yet to be demonstrated.

Renal failure is a determining factor in the prognosis of the cirrhotic patient. For patients with refractory ascites, or type 2 hepato-renal syndrome (i.e. chronic renal failure related to portal hypertension), the use of TIPS is recommended. Although a few studies with low levels of evidence have reported a benefit in the placement of TIPS in hepato-renal syndrome type 1 (i.e. acute renal failure related to portal hypertension), the European recommendations do not recommend the use of TIPS in this context due to lack of studies on the subject. Some studies have shown an improvement in renal function after performing TIPS in refractory ascites. To date, no studies have evaluated the impact of the implementation of early-TIPS on renal function in intensive care patients.

The investigators would like to evaluate the impact on survival without liver transplantation on D28 of the implementation of early-TIPS in cirrhotic patients with AEVB requiring ICU hospitalization, compared to standard treatment (medical and endoscopic).

Using electronic patient data monitoring systems, the investigators reviewed all patients with a diagnosis of cirrhosis admitted to ICUs at the Nantes University Hospital, and departmental Hospital of Vendée from January 1, 2012, to december 31, 2018. For enrolled patients, general clinical characteristics were collected. Patients were categorized into two groups according to the type of treatment performed: early TIPS or standard treatment.

Eligibility Criteria:
Inclusion Criteria:

Adult patients (age \>18 years) with cirrhosis Admitted in Intensive Care Unit Cirrhosis Child B or Child C With Acute esophageal variceal bleeding confirmed by endoscopy.

Exclusion Criteria:

Patients under guardianship Patients with a decision to limit care at the admission Patients with already a TIPS. Patients with a invasive multifocal hepatocellular carcinoma pregnancy
Pregabalin, Celecoxib, Total Knee Arthroplasty and Intrathecal Morphine

To evaluate whether pregabalin and/or celecoxib could improve analgesic efficacy of intrathecal morphine for patients after total knee arthroplasty.

A single-dose spinal anesthesia combining with morphine for total knee arthroplasty (TKA) is a simple, economical anesthetic technique commonly used in our hospital. Still some patients could not get effective postoperative pain control. Pregabalin, an anticonvulsant, has been shown to reduce acute pain after molar extraction, laparoscopic cholecystectomy, and reduce postoperative morphine requirement after total hip arthroplasty, and celecoxib, a selective cyclo-oxygenase (COX) - 2 inhibitor, with perioperative prescription is successfully reduces pain score and opioid consumption after TKA under spinal anesthesia alone. However, no clinical study has yet investigated whether preoperative single-dose of pregabalin, celecoxib or in combination compared to placebo can improve analgesic efficacy of intrathecal morphine after TKA. The primary objective of this study was to evaluate whether these medications could reduce pain scores at rest / when movement and morphine requirement after TKA under spinal anesthesia with intrathecal morphine. Secondary outcome assessed include adverse effects, anxiety score and patients' satisfaction score.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 50-75 years of age
* Patients with an American Society of Anesthesiologists physical status of I to III
* Patients scheduled for primary TKA with a diagnosis of osteoarthritis under spinal anesthesia

Exclusion Criteria:.

* Patients had a known allergy to any of the medications being used
* a history of drug or alcohol abuse
* a history of taking chronic pain medications (ie, show-release preparations of opioids, given that morphine consumption was the primary outcome)
* a history of taking pregabalin or gabapentin / non-steroidal anti-inflammatory drugs / COX-2 inhibitors
* a psychiatric disorder
* a history of impaired renal function (Cr \> 1.5 mg/dl), peptic ulcer, asthma, thrombotic cerebrocardiovascular diseases, uncontrolled hypertension
* a history of contraindication for spinal anesthesia
* a history of bleeding tendency
* pregnancy
* unable or unwilling to use patient - controlled analgesic (PCA)
Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

The objective of this study was to assess the bioequivalence of a potential generic 600 mg oxcarbazepine tablet formulation with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, folloiwng a single 600 mg dose administered with food.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or advers response to oxcarbazepine or any other comparable or similar product.
Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML

In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine. In the control arm, patients receive DA regimen with standard dose of cytarabine.The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.

In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine at at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/Q12h on day5-7. In the control arm, patients receive DA regimen with standard dose of cytarabine at a dose of 100mg/㎡/d on day 1-7. Patients receive consolidation therapy containing high-dose cytarabine after achieved complete remission. Stem-cell transplantation is permitted for patients with intermediate- or poor-risk disease. The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 14 to 55 years old;
2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).
3. ECOG score ≤ 2;
4. Patients with eligible laboratory examination including liver,renal and heart function.
5. Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.

Exclusion Criteria:

1. Patients who had received induction therapy.
2. Secondary leukemia.
3. Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor.
4. Patients with other blood diseases(for example, haemophiliacs) are excluded.However, patients with abnormal blood count, but with undiagnosed MDS or MPD patients are included.
5. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
6. With BCR-ABL fusion gene;
7. Pregnant or lactating women;
8. AML with ineligible renal or liver function;
9. AML with active cardiovascular disease;
10. Severe infection disease including uncured tuberculosis pulmonary aspergillosis;
11. AIDS;
12. Patients had central nervous system involvement when they were diagnosed as AML.
13. Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research.
14. Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results.
15. Patients with other factors which were considered unsuitable to participate in the study by the investigators.
A Study of Chimeric Antigen Receptor T Cells Combined With Interventional Therapy in Advanced Liver Malignancy

The purpose of this study is to collect the date on the safety and potential effectiveness of CART cells combined with interventional therapy in patients with advanced liver malignancy.

Designer T cells are prepared by PBMC which from patients or suitable donator by leukapheresis, and then activated and re-engineered to express chimeric antigen receptors (CARs). There are three options for CAR-targets: GPC3 for hepatocellular carcinoma; mesothelin for pancreatic cancer metastatic; CEA for colorectal cancer metastatic. Cells are expanded in culture and returned to the participant by vascular interventional therapy or by intra-tumor injection at the dose of （1.25\~4）×107 CAR positive T cells/cm3 tumor bulk. The volume of cell products and the time of cell perfusion process lasted would depend on the ways of cell perfused.

Eligibility Criteria:
Inclusion Criteria:

* tumor histological examination confirmed as GPC3/ mesothelin/CEA positive expression;
* persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients
* life expectancy greater than 6 months
* satisfactory organ and bone marrow function as defined by the following: (1) creatinine \<1.5mg/dl; (2) cardiac ejection fraction of \>55%; (3) hemoglobin\>9g/dl, bilirubin 2.0×the institution normal upper limit
* without bleeding disorder or coagulation disorders
* Don't allergy to Radiocontrast agent
* birth control
* Adequate venous access for apheresis, and no other contraindications for leukapheresis
* Voluntary informed consent is given

Exclusion Criteria:

* Pregnant or lactating women
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
* patients in the situation of: (1) 30 days before apheresis is still in the period of other antitumor drug observation; (2) patient dont recuperate from earlier acute adverse influence brought by any treatments accepted before
* Four weeks before recruit accepted radiation therapy
* Previously treatment with any gene therapy products
* Feasibility assessment during screening demonstrates\<30% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to CD3/CD28 costimulation
* Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, CNS diseases)
* Patient with severe acute hypersensitive reaction
* Taking part in other clinical trials
* Study leader considers not suitable for this tiral
The Influence of Qigong Wuqinxi on Health Status of the Community-Dwelling Older Adults

Pain and sleep disturbance are common symptoms of community-dwelling older adults observed in traditional Chinese medical(TCM) clinics. Acupuncture or other medical treatments have their side effects and usage limitations, so it is expected that other non-medical interventions can relieve the symptoms. The purpose of this study was to test the effect of Qigong Wuqinxi intervention on pain, sleep quality, TCM body constitution and tongue features of the community-dwelling older adults.

Methods: using cluster randomised clinical trial , two community care sites in Sanmin District, Kaohsiung City were selected. Community-dwelling older adults who are over 65 years old and have the ability to communicate in Mandarin and Taiwanese were recruited . Those who had severe mental illness, moderate to severe dementia (level 2 or above on the Clinical Dementia Assessment Scale) and Barthel Index score \<60 were excluded. There were 63 valid cases divided into experimental group(n=32) and control group(n=31). The experimental group practiced Qigong Wuqinxi 50 minutes three times a week for 12 weeks; meanwhile, the control group maintained routine daily activities. The two groups of participants were tested before and after the intervention period with the following research tools: 1) The Brief Pain Inventory, (BPI), 2) Pittsburgh Sleep Quality Index (PSQI), 3) Body Constitution Questionnaire (BCQ), 4) automatic tongue diagnosis system (ATDS). The research data were analyzed with SPSS 19 software package for descriptive statistics, chi-square test, independent t test and paired t test.

Eligibility Criteria:
Inclusion Criteria:

* 65-85 year olds
* have the ability to communicate in Mandarin and Taiwanese and can answer questions orally

Exclusion Criteria:

* severe mental illness,
* moderate to severe dementia (Clinical Dementia Assessment Scale Level 2 or above)
* almost unable to perform daily activity by self. (Barthes scale \<60)
Vitamin D Supplementation to Patients With Type 2 Diabetes

The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metabolic control in patients with type 2 diabetes.

The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metabolic control in patients with type 2 diabetes.

We will include 70 patients with type 2 diabetes. They will be treated with 40.000 IU cholecalciferol per week (or placebo) for 6 months. Metabolic control will be evaluated with measurements of glycated hemoglobin, home glucose measurements, and fasting blod glucose and serum insulin. Only subjects using insulin at bedtime combined with metformin during the day will be included.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 1 year
* age 21-75 years
* long-acting insulin at bedtime
* metformin during the day
* for women of child bearing age use of reliable method of birth control

Exclusion Criteria:

* serum creatinine above 130 umol/l for men and above 110 for women
* systolic blood pressure \> 175 or diastolic \> 104 mmHg
* heart disease
* serum calcium \> 2.54 mmol/l
* history of renal stones
Random-start Ovarian Stimulation in Egg-donors (ROSE)

The purpose of this prospective single-center study is to evaluate the laboratory outcome after random start ovarian stimulation in oocyte donors. The study will be performed in egg-donors but this type of treatment has the potential to be implemented in general infertility population.

The study group will start ovarian stimulation randomly in different moments throughout the menstrual cycle.

Randomization will take place on day 2-3 of the menstrual cycle, according to a list of random allocation of treatments and egg-donors will be assigned to random start ovarian stimulation: During follicular phase starting at day 5,7,9,11 or 13 of the menstrual cycle and during luteal phase starting at luteinizing hormone (LH) peak +3,+5,+7,+9 or +11.

Egg-donors will receive urinary follicle stimulating hormone (FSH) 150-225 IU/d in gonadotropin-releasing hormone (GnRH) antagonist protocol with cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation and a GnRH agonist trigger with triptorelin 0,2 mg to induce the final follicular maturation. Transvaginal ultrasound and serum analysis (estradiol, progesterone, LH and FSH) will be included for cycle monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women
* 18-35 years old
* FSH levels \< 10 IU/liter
* Antral follicle count (AFC) \> 10
* Regular cycles
* Body Mass Index (BMI) \< 28
* Signed informed consent

Exclusion Criteria:

* Polycystic ovary syndrome (PCOS) patients
* Allergy to gonadotrophins
* Concomitant participation in other trial
Behaviors of Children Ages 15 Months to Five Years Around Microwave Ovens

The purpose of this study is to assess the typical behavior of children ages 15 months to five years around a microwave oven. The UCH Burn and Complex Wound Center has observed scald burn injuries in young children operating and/or removing hot liquids from microwave ovens. The knowledge we hope to gain is the developmental age that a child is able to open and/or operate a microwave oven safely. This work may influence future microwave oven design to protect young children from microwave-related scald burn injuries. These injuries have resulted in visits to the emergency room, stays in the hospital and debridement and skin grafting procedures in the operating room.


Eligibility Criteria:
Inclusion Criteria:

* a microwave oven in the child's home environment,
* age appropriate development,
* intact visual acuity, and
* English speaking.

Exclusion Criteria:

* developmental delay,
* non-English speaking.
Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy

The primary objective is to assess whether 16 weeks of treatment with dupilumab as an adjunct to Timothy Grass Subcutaneous Immunotherapy (SCIT) improves upon the efficacy of Timothy Grass SCIT to reduce provoked allergic rhinitis symptoms, as measured by Total Nasal Symptom Score (TNSS) after nasal allergen challenge (NAC) with Timothy Grass extract at week 17.

The secondary objectives of the study are:

* To assess whether 16 weeks of treatment with dupilumab as compared to placebo reduces provoked allergic rhinitis symptoms, as measured by TNSS after nasal allergen challenge (NAC) with Timothy Grass extract
* To assess whether 16 weeks of treatment with dupilumab as compared to dupilumab + SCIT reduces provoked allergic rhinitis symptoms, as measured by TNSS after nasal allergen challenge (NAC) with Timothy Grass extract
* To assess changes in serum Timothy-grass-specific immunoglobulin G4 (IgG4), serum Timothy grass-specific immunoglobulin E (IgE), and ratio of serum Timothy Grass-specific IgG4 to IgE over 16 weeks of treatment with dupilumab + SCIT as compared to SCIT monotherapy
* To evaluate the safety and tolerability of 16 weeks of treatment with dupilumab as an adjunct to Timothy Grass SCIT


Eligibility Criteria:
Key Inclusion Criteria:

1. Male and female participants aged 18 to 55
2. History of grass pollen-induced seasonal allergic rhinitis
3. Grass pollen allergy confirmed by both:

   1. Positive skin prick test (SPT) with Timothy Grass extract (mean wheal diameter at least ≥5 mm greater than a negative control)
   2. Positive serum Timothy Grass-specific IgE (≥0.35KU/L)

Key Exclusion Criteria:

1. Significant rhinitis, sinusitis, outside of the grass pollen season
2. Any contraindications to SCIT (i.e, severe cardiovascular disease, malignancies, autoimmune disease, use of beta blocker, asthma severe enough to require chronic medication, acute infection)
3. Use of systemic corticosteroids within 4 weeks of screening visits or any NAC visits
4. Abnormal lung function as judged by the investigator
5. A clinical history of asthma requiring chronic medication such as regular inhaled corticosteroids for \>4 weeks per year
6. History of significant recurrent sinusitis, defined as 3 episodes per year for the last 2 years, all of which required antibiotic treatment
7. History of chronic sinusitis (with or without nasal polyps)
8. Tobacco smoking (ANY) within the last year

Note: Other protocol defined inclusion/ exclusion criteria apply
Induction Chemotherapy With Afatinib, Ribavirin, and Weekly Carboplatin/Paclitaxel for Stage IVA/IVB HPV Associated Oropharynx Squamous Cell Cancer (OPSCC)

This study seeks to develop a new induction chemotherapy regimen which is a combination of two pill drugs taken by mouth and two drugs given by vein. This is a phase I study, which means that the primary goal is to establish the recommended dose of an investigational drug when added to chemotherapy. The researchers wish to evaluate the effects, good and bad, of the investigational drug.


Eligibility Criteria:
Inclusion Criteria:

* Department of Pathology at MSKCC confirmation of diagnosis of oropharynx squamous cell cancer, stage IVA/IVB, that is HPV associated.

Evidence of HPV can be p16 immunohistochemistry and/or HPV in situ hybridization positive test result on tumor tissue, either at MSKCC or other CLIA-approved lab.

* Age ≥ 18 years of age
* Karnofsky Performance Status ≥ 80
* Adequate organ function, as follows:

Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 X 109/L, platelets ≥ 160 X 109/L, hemoglobin ≥ 12 g/dL Hepatic: total bilirubin within normal limits (≤ 1.0 mg/dL); alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 X ULN (upper limit of normal) Renal: Serum creatinine ≤ 1.3 mg/dL. Patients with serum creatinine \> 1.3 mg/dL may be eligible if creatinine clearance (CrCl) ≥ 55 mL/min based on the standard Cockroft and Gault formula.

* Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
* Ability to swallow oral medication.
* Expansion Cohort only: At least one unstained slide from pre-treatment diagnostic biopsy or fine needle aspirate must be available for correlative immunohistochemistry study.

Exclusion Criteria:

* Prior chemotherapy or radiation for tonsillar or base of tongue squamous cell cancer
* History of hemolytic anemia or thalassemia
* Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment.
* Current therapeutic anticoagulation with Coumadin (warfarin)
* Current or prior treatment with ribavirin
* Known active Hepatitis B or C
* Any prior documented history of transient ischemic attack (TIA) or cerebrovascular accident (CVA)
* New York Heart Association (NYHA) Grade II or greater congestive heart failure
* Clinically significant peripheral vascular disease
* Inability to discontinue any of the following potent P-gp inhibitors (cyclosporine, erythromycin, ketoconazole, itraconazole, quinidine, phenobarbital salt with quinidine, ritonavir, valspodar, verapamil) or inducers (St John's wort, rifampicin).
* Known pre-existing interstitial lung disease.
* Presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohn's disease, ulcerative colitis, malabsorption, or CTC grade ≥2 diarrhea of any etiology) based on treating physician assessment.
A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients

This is a Phase 3, randomised, active controlled, multicentre extension study to investigate the long-term safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. This is an extension study to PA-CL-05A (NCT01324128), subjects have already been enrolled and have been treated with study medication for at least 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed treatment in Protocol PA-CL-05A
* Written Informed Consent

Exclusion Criteria:

* Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)
* Other significant medical conditions
* Pregnancy