cyrilzakka/clinical-trials huggingface dataset:
A Study of JNJ-30979754 (Decitabine) in Patients With Myelodysplastic Syndrome

The purpose of this study is to to determine the recommended dose level of JNJ-30979754 (decitabine) as well as to assess the safety and effectiveness in patients with Myelodysplastic Syndrome (MDS).

This is an open-label (both physician and patient know the name and dosage of drug), multi-center study. This study consists of two parts, Phase I and Phase II. In Phase I, approximately 9 participants will be enrolled ie, 3 participants for dose level 1 (15 mg/m2 of JNJ-30979754) and 6 participants for dose level 2 (20 mg/m2 of JNJ-30979754). Once the tolerability of 20 mg/m2 is confirmed additional 30 participants will be included to receive 20 mg/m2 and approximate total participants in Phase II will be 36. This study will include screening period (within 14 days prior to the day of initial administration of Cycle 1) and dosing period (1 cycle consists of administration of study medication for first 5 consecutive days + rested for 23 days; ie, total 28 days). Cycles will be reapeated in participants in whom decitabine was expected to be effective. Safety evaluations will include assessment of adverse events, vital signs, body weight, clinical laboratory tests: hematology, blood biochemistry and urinalysis, cardiopulmonary function tests: ECG, chest X ray and oximeter analysis.

Eligibility Criteria:
Inclusion Criteria:

* Myelodysplastic syndrome (de novo or secondary) fitting any of the recognized French-American-British classifications: refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia with white blood cells less than 13,000 /mm3
* International Prognostic Scoring System (IPSS) greater than or equal to 0.5 (Intermediate-1, Intermediate-2 or high risk) by bone marrow assessment and bone marrow cytogenetics within 28 days before study registration
* 20 years or older
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Normal renal and hepatic function

Exclusion Criteria:

* Acute Myeloid Leukemia (AML) with bone marrow blasts greater than or equal to 30%
* Participants with a history of high-dose cytarabine (Ara-C) therapy (greater than 1,000 mg/m2/day)
* Participants administered adrenal cortex hormones or anabolic hormones within 7 days of study initiation
* Participants who have received a colony stimulating factor (CSF) formulation within 7 days of study initiation
* Active double cancer
* Uncontrolled cardiac disease or cognitive heart failure
* Uncontrolled restrictive or obstructive pulmonary disease
* Uncontrolled diabetes mellitus
* Active viral or bacterial infection
* Known positive serology for Human immunodeficiency virus
10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature

Hypothermia occurs frequently during general anesthesia. This study is to evaluate the efficacy of 10 minutes of prewarming and warmed fluid during urologic surgery.

During general anesthesia, vasodilation distributes body heat and leads to hypothermia. Especially during urologic operation (transurethral resection of bladder and prostate), bladder irrigation worsens hypothermia. Hence, various methods are used to maintain core temperature during operation.

Previous studies have demonstrated that prewarming of the patient is effective in maintaining core temperature perioperatively. However, more than 50% of patients who have applied prewarming for more than 30 minutes preoperatively are reported to fall in hypothermia. Hence, developing simple and effective method to prevent hypothermia is expected.

Hence, the investigators planned to examine the effect of active warming (10 minutes of prewarming preoperatively and prewarmed intravenous fluid intraoperatively) on hypothermia in patients undergoing urologic operation under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing urologic surgery(transurethral resection of bladder, prostate)

Exclusion Criteria:

* moderate to severe cardiopulmonary, renal impairment
* thyroid disease
* any infection sign
* abnormal temperature prior to induction of general anesthesia (\<36'C or \>37.5'C)
* refusal to participate in the study
* unable to understand the study
Elderly Independent Patients With Non Small Cell Lung Cancer (NSCLC)

The purpose of this study is to determine duration before progression of first-line treatment chemotherapy following erlotinib in second-line comparing erlotinib in first-line following chemotherapy in second-line in old patients with none small cell lung cancer.

A multicenter phase II trial , prospective, randomized, open, non comparative

Eligibility Criteria:
Inclusion Criteria:

* Age \> 65 years
* Comorbidities score,
* PS frailty score\*\*.according to(TABLE N°1)
* No dementia, repeated falls, faecal or urinary incontinence, ADL=0, IADL=0
* Life expectancy at least 12 weeks
* Créatinine clearance de la créatinine \> or =30cc/mn according to Cockrofts
* Gault formula
* Competency to give written informed consent
* Haematological function as follows: absolute neutrophil count \> 1.5 x 109/l and/or platelet\> 100 x 109/l, hémoglobine \> or = 9,5 g/dl
* Hepatic function as followed :bilirubin \<1,25 LNS SGOT/SGPT \<5 x N,PAL \<5N
* PS \< 3
* No symptomatic cerebral metastasis
* Histologically or cytologically confirmed NSCLC
* Stage IV/IIIB4 (T4with pleural effusion)
* No prior chemotherapy for NSCLC
* Relapses of previous NSCLC treated by surgery or radiotherapy are eligible if the target is measurable out of initial radiotherapy field and if histological or cytological proof
* At least one measurable target lesion by RECIST guidelines.

Exclusion Criteria:

* Symptomatic cerebral metastasis
* Any severe co-morbidity calculated by Charlson score (according to table 1), any kind of disorder that compromises the ability of the subject to give written informed and/or comply with the study procedure ADL \> or = 1 et IADL \> or =1 Dementia, repeated falls, faecal or urinary incontinence- Peripheral neuropathy grade 2 or more
* Performance Status \> 2 ( ECOG)- Contraindication to corticosteroids
* Unwilling or unable to comply with study requirements for personal , family, sociologic, geographic or any reasons
* Lack of liberty following administrative or judicial decision
* Hypersensitivity to polysorbate
* Hypersensitivity to erlotinib or any excipients of this product
* Unusual hereditary disorders as galactosemia, deficit in lactase and malabsorption in glucose or galactose
* Participation in concomitant clinical trial
* Contraindication to a product of this study disease
* Bronchioloalvéolar or neuroendocrine or composite carcinoma
* Superior vena cava syndrome
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Treatment of COVID-19 Acute Respiratory Distress

This is a Phase 2 study to assess COVI-MSC in the setting of current standard of care in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acute respiratory distress / acute respiratory distress syndrome.

This is a Phase 2 multicenter (United States and Mexico) study to assess the safety and preliminary efficacy of COVI-MSC in the setting of current standard of care in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 (COVID-19) infection and acute respiratory stress (ARD) / acute respiratory distress syndrome (ARDS).

Subjects will be randomized 1:1 COVI-MSC to placebo. COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4.

Eligibility Criteria:
Inclusion Criteria:

* Laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen (can be documented from inpatient medical record)
* Hospitalized with at least "severe" COVID-19-induced ARD or ARDS as defined per FDA Guidance; COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
* Requires oxygen supplementation at Screening
* Willing to follow contraception guidelines

Exclusion Criteria:

* Current standard of care treatments for COVID-19 appear to be working and the subject is clinically improving
* Has severe ARDS with a PaO2/FiO2 (PF ratio) ≤ 100 mmHg or SpO2/FiO2 ratio \< 150 mmHg with PEEP ≥ 5cm H2O
* A previous stem cell infusion unrelated to this trial
* Pregnant or breast feeding or planning for either during the study
* Suspected uncontrolled active bacterial, fungal, viral, or other infection (aside from infection with COVID-19)
* History of a splenectomy, lung transplant or lung lobectomy
* Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
* Expected survival or time to withdrawal of life-sustaining treatments expected to be \< 7 days
* Has an existing "Do Not Intubate" order
* Has undergone home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing (eg, obstructive sleep apnea)
* Has any significant medical condition, laboratory abnormality or psychiatric illness that in the investigator's opinion would interfere or prevent the subject from safely participating in the study
Semaglutide vs Dulaglutide on Epicardial Adipose Tissue

Epicardial Fat (EAT), the visceral fat depot of the heart, is a modifiable cardio-metabolic risk factor and therapeutic target. EAT expresses GLP-1 receptors (GLP-1R). GLP-1 receptor agonist liraglutide is known to significantly decrease EAT thickness. However, the effects of GLP-1 receptor agonists semaglutide and dulaglutide on EAT thickness are unknown

This is a retrospective, observational, case control study. Data were obtained from retrospective review of the electronic medical records.

Patients were treated with either semaglutide, dulaglutide or metformin as standard of care, during routine clinical practice, regardless of the study. Each patient underwent routine labs and an onsite ultrasound measurement of EAT thickness at baseline and at the routine 12-week follow up visit, as standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes,
* BMI ≥27 kg/m2,
* Age ≥ 18 years old

Exclusion Criteria:

* Type 1 diabetes
* Concurrent use of dipeptidyl peptidase 4 (DPP-4) inhibitors or other GLP-1 agonist receptors
* History of diabetic ketoacidosis
* Known contraindications to GLP-1 receptor agonists such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of multiple endocrine neoplasia type 2
* Acute infective diseases, cancer or chemotherapy
* Use of systemic corticosteroids within the 3 months prior this study
* Known or suspected allergy to semaglutide or dulaglutide excipients or related products
* Pregnancy, breastfeeding or the intention of becoming pregnant
Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance

Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C infection. Given the likelihood of co administration of filibuvir and methadone, this study will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, without evidence of infection with HIV,HBV or HCV, who are on chronic methadone maintenance for at least three months and at a stable dose for at least 1 week prior to study start.

Exclusion Criteria:

* Evidence of chronic diseases including HIV, HBV or HCV.
* Evidence of acute or chronic liver disease.
* Treatment with prescription or nonprescription drugs other than methadone within 7 days.
Exploring the Application of Narrative Medicine Combined With Case-Based Learning in the Standardized Training of General Practice Residents

This was a prospective, longitudinal, single-center nonrandomized controlled study. A total of 36 first- and second-year general practice residents of Zhejiang University School of Medicine were voluntarily enrolled in the experimental group. The remaining 9 residents served as a control group. The experimental group received narrative medicine training combined with CBL training. The control group received normal CBL training. None of the participants had previously had any training in narrative medicine. Teaching evaluation scores were measured for all subjects at baseline and 1 year after the training.


Eligibility Criteria:
Inclusion Criteria:

* first- and second-year general practice residents of Zhejiang University School of Medicine

Exclusion Criteria:

* third-year general practice residents of Zhejiang University School of Medicine
Saving and Empowering Young Lives in Europe (Israel)

SEYLE is a health promoting program for adolescents in European schools. Its main objectives are to lead adolescents to better health through decreased risk-taking and suicidal behaviors, to evaluate outcomes of different preventive programs and to recommend effective culturally adjusted models for promoting health of adolescents in different European countries. Because of the significance of the SEYLE program and the importance of suicide research, Israel is honored to take part in this program and be a collaborator in it's implementation and research.

In this health promotion program, a pilot intervention study will be implemented to assess the effects of three different health promoting / suicide prevention programs in 11,000 students across 11 European countries (Sweden, Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain): 1. A general health promotion program targeting students' awareness on healthy/unhealthy behaviours and students' self-efficacy in diminishing unhealthy behaviours; 2. ProfScreen - screening by professionals of at-risk students through a questionnaire. For adolescents identified as high risk (screen positives) the program includes referral to mental health treatment and ensuring compliance. 3. QPR (Question, Persuade \& Refer) - a gatekeepers' program, training all adult staff at schools (teachers, counselors, nurses etc.) and parents on how to recognize \& refer a student with risk-taking behaviours or suffering from mental illness to mental-health help resources.

Each of these prevention programs uses a different active component in order to be successful. The first prevention program empowers the students by increasing their self-efficacy. The second prevention program (ProfScreen) empowers mental health professional in identifying subjects at risk. The third program (QPR) empowers teachers and parents in at-risk case finding and referring to mental health facilities. The registration of the complete RCT is available on the German Clinical Trials Registry (DRKS00000214).

Eligibility Criteria:
Inclusion Criteria:

* Adolescents between 13-17

Exclusion Criteria:

* none
Hemodynamic Effects During Exercise in Patients With Pulmonary Hypertension Receiving Sildenafil

To study hemodynamic effects of Sildenafil during exercise in patients with pulmonary hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

* resting partial pressure of oxygen \<8 kilopascal at Zürich altitude on ambient air
* exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* patients who take nitrates
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
Effect of Tiotropium on Inflammation and Exacerbations in COPD

Patients with COPD experience exacerbations that are a major cause of morbidity. Exacerbations are associated with increased airway and systemic inflammation and those experiencing frequent exacerbations demonstrate increased inflammation in the stable state. Tiotropium has been shown to reduce exacerbation frequency and it might be postulated that this is due to a reduction in inflammation. The study will compare airway inflammation and exacerbation frequency in patients with COPD on tiotropium or placebo.

Patients with COPD will be randomised to tiotropium or placebo in addition to their usual medication. They will be followed prospectively over 1 year and provide sputum for quantification of IL-6 and IL-8 at baseline and at 3 monthly intervals.Serum IL-6 will also be quantified at baseline and over the year. Changes in inflammatory markers will be assessed by analysis of area under the curve of log transformed data. Exacerbation frequency will be calculated from patient diary cards using a previously validated symptom-based exacerbation definition.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of COPD,
* FEV1 \< 80% predicted,
* minimum 10 pack year smoking history

Exclusion Criteria:

* asthma,
* atopic disease,
* eosinophilia,
* history of malignancy,
* history of clinically significant pulmonary disease
Vascularised Sentinel Skin Flaps to Predict Rejection in Intestinal Transplantation

This pilot study aims to validate the use of vascularised donor-derived sentinel skin flaps for diagnosing and monitoring rejection in intestinal transplantation

Intestinal transplantation is the current treatment option for patients with irreversible intestinal failure that has not responded to other methods of treatment. Whilst the majority of patients that have an intestinal transplant will obtain good graft function over many years, some patients suffer from reduced function of their new intestine following transplantation that can progress to the transplant failing completely.

Acute rejection may be the most common cause of transplant failure. Currently, there is not an effective way of monitoring the intestine that can detect rejection before irreversible damage occurs. If there is a more sensitive way of continuously monitoring the intestine transplant for rejection then issues could be earlier detected and early treatment could prevent permanent damage to the transplant.

The reason for this study is to assess a new technique that has been developed to detect early rejection in intestinal transplantation. The name of this technique is called a 'sentinel skin flap' and involves transplanting a patch of forearm skin from the donor at the same time as the intestine

Eligibility Criteria:
Inclusion Criteria

* Recipient of an intestinal transplant.
* Participant is willing and able to give informed consent for participation in the study
* Male or Female, aged 18 years or above

Exclusion Criteria

* Patient does not have a patent ulnar artery in either forearm or a negative Allen's test.
* Patient is not willing to return to the Institution for all clinical follow-up for 12 months
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the trial, or the participant's ability to participate in the study.
Nano Drug Interventional Therapy Using Digital Subtraction Angiography（DSA） for Lung Carcinoma

The purpose of this study is to evaluate the safety and efficacy of nano drug interventional therapy using digital subtraction angiography（DSA） for lung cancer. The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection.

By enrolling patients with lung cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of nano drug interventional therapy using digital subtraction angiography（DSA）for lung cancer.

The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection. The nano drug's size is detected by laser diffraction particle size analyzer.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18-80
2. Karnofsky performance status \>60
3. Diagnosis of lung cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive interventional therapy
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except lung cancer
2. History of coagulation disorders or anemia
Endovascular Repair of Juxtarenal Aortic Aneurysm

The investigators compare different endovascular techniques as an alternative to surgical reconstruction to repair JAAS regarding ; success rates, 30-day mortality,endoleak events secondary intervention rates

Aortic disease is the direct cause of close to 10000 deaths annually in the United States. 1

Aneurysmal disease can affect any segment of the aorta, from the aortic root to the aortic bifurcation. Juxtarenal Aortic Aneurysms (JAA) (where a specialty designed custom -made device (endograft)which has holes, or fenestrations ,on the graft body to maintain the patency of the visceral arteries) account for approximately 15% of abdominal aortic aneurysms.2

Successful aortic aneurysm treatment depends on either open replacement or endovascular exclusion of the aneurysmal segment with healthy artery proximal and distal to the repair.

The decision to treat an AAA is based on the associated risk of treatment, the risk of aneurysm rupture, the patient's life expectancy, and patient preference.

The primary determinant of rupture risk is maximum aneurysm diameter, with negligible rupture risk in aneurysms \<4cm in diameter compared with aneurysms \>8 cm . 3, 4.

The Society for Vascular Surgery recommends repair for all patients of acceptable perioperative risk with an AAA ≥5.5 cm in diameter as well as all patients with saccular and symptomatic aneurysms.5 ,6

These guidelines also suggest repair for women at a diameter of 5.0 cm.

Fenestrated Endovascular Aneurysm Repair (FEVAR) and Chimney Endovascular Aneurysm Repair (CHEVAR)are both effective methods to treat JAAs

Eligibility Criteria:
Inclusion Criteria:

* • Subject is ≥18 years old

  * Subject is scheduled for treatment of the juxtarenal aortic aneurysm with a short infrarenal neck aortic neck length \<15 mm, neck angulation \>60%, conical neck) (i.e. denovo cases).
  * Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
  * Subject has provided written informed consent.

Exclusion Criteria:

* Subject is participating in a concurrent study which may confound study results

  * Subject has a life expectancy ≤1 year
  * Subject has an aneurysm that is:

    * Mycotic
    * Inflammatory
    * Pseudoaneurysm
  * Subject requires emergent aneurysm treatment, for example, trauma or rupture
  * Subject has previously undergone surgical treatment for abdominal aortic aneurysm
  * Subject is a female of childbearing potential in whom pregnancy cannot be excluded
  * Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment.
Statin and PAF in Patients With Pacemaker

Statin could decrease AF burden

Statin could decrease AF burden in patients with PAF.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pacemaker

Exclusion Criteria:

* Patients with hepatic dysfunction