cyrilzakka/clinical-trials huggingface dataset:
Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use)

Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx)

Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx) and living donor kidney transplant.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure
* Patient is receiving first renal transplant
* Patient is receiving a renal transplant only
* The crossmatch is negative between donor and recipient
* Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours of initiating total body irradiation (TBI) and agree to use reliable contraception for 1 year following transplant
* Potential donors who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving Granulocyte colony-stimulating factor (G-CSF)
* No evidence of donor-specific antibody presently or historically

Exclusion Criteria:

* Clinically active bacterial, fungal, viral or parasitic infection
* Pregnancy
* Clinical or serologic evidence of viral infection which would preclude the recipient from receiving a kidney transplant
* Previous radiation therapy at a dose which would preclude TBI
* Positive crossmatch between donor and recipient
* Evidence for immunologic memory against donor
* BMI \>35 or \<18
* Re-transplant
* Positive serologies for hepatitis B virus (HBV), hepatitis C virus (HCV), HIV
Nasogastric Tube in Pancreatic Surgery

Introduction: The value of routine nasogastric tube (NGT) decompression after pancreatic surgeries is not yet established. Previous studies in the setting of abdominal surgery suggested that the use of NGT does not accomplish any of its intended goals.

Methods/design: This is a prospective, randomized, controlled multicenter trial with two treatment arms. One group underwent pancreatic surgeries with routine NGT and was left in place after surgery until the patient passed flatus or stool. The other group underwent pancreatic surgeries without receiving NGT decompression, in which the NGT was removed at the end of surgery.

Discussion: Routine NGT decompression after pancreatic surgeries does or does not appear to have its anticipated advantages would be discovered in this RCT.


Eligibility Criteria:
Inclusion Criteria:

* Patients with age between 18 - 80 years.
* Patients underwent any kind of pancreatic surgeries, including but not limited to PD, distal pancreatectomy, central pancreatectomy, pancreatic enucleation, etc.
* Patients accepted the trial and could completed a written consent.

Exclusion Criteria:

* Combined with digestive tract obstruction before the surgery.
* History of upper abdominal surgery.
* Serious heart, brain, lung, metabolic diseases history.
* Pregnant women.
* Unwillingness or inability to consent for the study.
A Study to Characterize Puff Topography With Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers

A Study to Characterize Puff Topography with Use of a JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers

This will be an open label study to evaluate puff topography in adult smokers using a JUUL 5% ENDS. Up to 30 subjects will be enrolled and evaluated on Day 1 and Day 15. The duration of the study is 15 days with up to a 28 days screening window.

Eligibility Criteria:
Key Inclusion Criteria:

1. Healthy, adult, male or female smoker, 21 to 65 years of age
2. Has been a smoker for at least 12 months prior to Screening.
3. Currently smokes an average of 5 to 40 manufactured combustible (menthol or non menthol) cigarettes per day.
4. A female subject of childbearing potential must have been using 1 of the following forms of contraception and agree to continue using it through completion of the study
5. Provides voluntary consent to participate in this study documented on the signed informed consent form.

Key Exclusion Criteria:

1. Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, or clinical laboratory results, in the opinion of the PI.
2. Has a body mass index (BMI) \> 40 kg/m2 or \< 18 kg/m2 at Screening.
3. Has a history of drug or alcohol abuse within 24 months of Day 1.
4. If female, the subject is pregnant, lactating, or intends to become pregnant during the time period from Screening through the end of study.
Changes in FeNO Value During Pulmonary Rehabilitation in Patients with Asthma

This study investigates the use of fractional exhaled nitric oxide (FeNO) measurement to monitor non-pharmacological therapy during a three-week inpatient rehabilitation programme for asthma patients. It compares FeNO levels (measured three times a day) with clinical parameters and quality of life to analyse daily fluctuations and the acute effect of exercise training on FeNO levels. As FeNO is a non-invasive biomarker of airway inflammation, this study aims to expand its role in therapy monitoring and explore its application in a rehabilitation setting.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of bronchial asthma (all disease severities)
* Chronic Obstructive Pulmonary Disease (COPD) with an asthma component, where the asthma component plays a clinically relevant role
* written informed consent

Exclusion Criteria:

* Chronic Obstructive Pulmonary Disease (COPD) as the primary disease
* unability to perform FeNO measurement independently
CMR Exercise Stress Testing in HFpEF

Patients of the University Hospital Göttingen with echocardiographic signs for diastolic heart failure and indication for right heart catheterisation will undergo additional diagnostic testing with CMR including exercise stress for detailed evaluation of diastolic dysfunction and tissue characterisation correlating the results with well-established clinical standards.


Eligibility Criteria:
Inclusion Criteria:

* adult patients with dyspnoea under stress, echocardiographic criteria for diastolic dysfunction (E/E'\>8) and clinical indication for right heart catheterisation

Exclusion Criteria:

* arrhythmia (brady- or tachycardic)
* bronchial asthma (allergic)
* incompliant patient
* pacemaker, ICD, non MRI-capable devices
* inability to use the ergometer in the MRI
* haemodynamic relevant valvular heart disease
* pulmonary disease (vital capacity or forced expiratory flow \<80% of healthy control)
* angina pectoris
* post cardiac infarction
* anaemia (Hb \<12 g/dl)
* uncontrollable hypertension (\>150 mmHg systolic or \>100 mmHg diastolic)
* age \<18 years
* pregnancy
* claustrophobia
* renal insufficiency
* allergic to gadolinium based contrast agents
Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy

This is a prospective, observational study to collect stool and blood from acute myeloid leukemia patients undergoing intensive chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Adults (ages 18 - 99 years) undergoing inpatient intensive chemotherapy for newly diagnosed, refractory, or relapsed AML. Patients may or may not have been exposed to any type of therapy before.
* Any intensive chemotherapy regimen defined as a planned \~4 week inpatient stay. Chemotherapy may be delivered for any number of days and on any schedule. Patients may be discharged from the hospital sooner than 4 weeks if the treating physician choose so, but the expectation at the initiation of chemotherapy must be \~4 weeks of inpatient stay, as is typical.
* Able to provide written voluntary consent before performance of any study related procedure.
Exercise Training in Coronary Artery Disease Patients After Stenting

To determine the effect of exercise training on cardiac outcomes in coronary artery disease patients after Stenting. There is a need to develop strategies, not only to prevent restenosis but also to improve patients' functional status and perception of well-being. In particular, it is not well defined whether exercise training can reduce the restenosis rate and improve the outcome after PCI.

Based on an analysis of literature reviews, psychological symptoms (such as depression and anxiety), angina, vital exhaustion, and dyspnea have been observed to have the most significant influence on the quality of life in people with CAD. Almost half of the patients, after an initial encouraging improvement in functional capacity and quality of life (QOL) after the PCI, deal with recurrent chest pain that requires medical attention, reduces functional capacity, and creates a status of psychological distress.

Eligibility Criteria:
Inclusion Criteria:

* GCS = 15
* Disease chronicity: 1-3 years
* Elective / stenting procedure
* Single or Double vessel stunting
* EF: 35 above

Exclusion Criteria:

* Unwilling to participate in research
* Known cases of Uncontrolled DM or HTN
* Known cases of Cognitive/memory/neurological disorders
* Known cases of any Systemic disease
Phase Ⅱ Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Venous Leg

This project adopts a prospective clinical trial study to compare and evaluate the efficacy of local transplantation of human umbilical cord mesenchymal stem cells combined with silver ion dressing and simple silver ion dressing in the treatment of venous lower extremity ulcer wounds. To improve the healing rate and quality of life of patients.

Chronic wounds refer to the pathological changes such as cell senescence, imbalance of synthesis and degradation of extracellular matrix, and decreased activity of growth factors caused by different reasons when the wound is prolonged and does not heal after conventional treatment for more than 1 month without healing tendency. Chronic wound can be caused by a variety of diseases, including arterial disease, diabetes, vasculitis, venous disease and skin malignant tumor, chronic venous insufficiency (CVI) is a disease leading to chronic wound, Venous ulcer (VLU) of lower limbs is the advanced manifestation of CVI, and the incidence of this disease ranges from 0.4% to 1.3% in China. 60% of VLU patients' ulcer wounds heal in 3-6 months, 33% in 12 months, and 7% May be permanently unhealed. The probability of recurrence is as high as 70% in patients 3-5 months after wound healing, which not only seriously affects the health and quality of life of patients, but also causes a very heavy social medical burden. At present, the conventional treatment for VLU mainly includes drug therapy, stress therapy, wound treatment and surgical treatment, but the therapeutic effect is not ideal.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 70, no gender limitation;
2. It met the diagnostic criteria of venous ulcer of lower limbs in Clinical Vascular Surgery (5th edition), and the following conditions were met: the ulcer lasted for more than 1 month; The wound area was between 10cm2 and 40cm2. Wound depth: All wounds were deep tissue ulcers below the epidermis.
3. Participate in the clinical study voluntarily, observe the study procedure, and observe the curative effect cooperatively.

Exclusion Criteria:

1. Pregnant or lactation women; Women who have planned to have children recently (within 6 months);
2. Patients with peripheral artery disease with ankle-brachial index (ABI) \< 0.8;
3. Patients with active clinical systemic infection;
4. Serious skin wound infection is not under control;
5. low immune function and systemic failure; Severe heart, liver, lung, kidney and other important organ lesions (ALT, AST, Cr \& GT; Normal 1.5 times, congestive heart failure ejection fraction \&lt; Normal 30%) and severely impaired hematopoietic function;
6. Abnormal coagulation function or current anticoagulant treatment;
7. Systemic autoimmune diseases in the active stage;
8. With systemic organ or hematological malignancy;
9. PERSONS infected with HIV or addicted to drugs, tobacco and alcohol;
10. Have a clear history of mental illness;
11. Participation in clinical studies of any drug within 1 month prior to treatment (or the 5 half-life of the investigational drug, whichever is longer).
Safety Study About the mRNA Vaccines Against COVID-19 in Children (PEDIVACOV-HCSC)

Drugs side effects in children need to be evaluated in a different way because of their constant growth and body changes.

The use of COVID-19 vaccines (mRNA vaccines) is worldwide spread as a safety measure against the pandemic.

Although clinical trials have shown that vaccines are safe in the general population, specific real-life monitoring is needed to address the special situation that applies to children.

Drug-related side effects are an important health problem causing an increase in health costs. Most of the related research is focused on the adult population, therefore evidence in pediatric patients is scarse. This situation remains true in the clinical trials of the mRNA vaccines against COVID-19, with most studies suggesting the need of a greater follow up and specific research that address the pediatric population. Even though vaccines seem to be a safe and effective ways to protect the population against the COVID-19 pandemic, more information is needed regarding the safety profile for pediatrics in the short and long term.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes between 5 and 12 years old.
* Pediatric patients with data included in the Clinico San Carlos' Hospital available for consultation.
* Acceptance by the parents/legal guardians for the participation and follow up.

Exclusion Criteria:

* None
Influence of Corticosteroids on Heart Function

This study will examine the effect of corticosteroid treatment on heart function.


Eligibility Criteria:
Inclusion Criteria:

* Patients with good echogenic body structure
* Patients with sinus rhythm with no conduction disorder

Exclusion Criteria:

* Patients with major medical condition
* Patients who are not hemodynamical stable
* Patients receiving long-term corticosteroid therapy
Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System

PILOT:

The study is pilot trial to evaluate the safety and performance of the Twelve TMVR System in very high risk mitral regurgitation patients.

EFS:

The study is an EFS trial to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Severe, Symptomatic Mitral Regurgitation

PILOT:

The study is a prospective, multi-center, non-randomized trial to evaluate the safety and performance of the Twelve TMVR System in very high-risk patients with severe, symptomatic mitral regurgitation, who are deemed ineligible for standard surgery.

EFS:

The study is a multi-center, prospective, non-randomized, trial to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Moderate-Severe or Severe, Symptomatic Mitral Regurgitation

Eligibility Criteria:
Key Inclusion Criteria:

* Severe mitral regurgitation (MR Grade 3-4+)
* Symptomatic mitral regurgitation (NYHA Class II-IV)
* Trans-apical access deemed feasible by the treating physician (PILOT only)
* Subjects anatomically suitable for the Intrepid TMVR delivery system including transfemoral and transseptal access (EFS only)
* Native mitral valve geometry and size compatible with the Twelve TMVR/Intrepid

Key Exclusion Criteria:

* Left ventricular ejection fraction (LVEF) \< 20 (PILOT) or \<25% (EFS)
* Evidence of intracardiac mass, thrombus, or vegetation
* Prior valve surgery or need for other valve surgery
* Prior stroke within 4 weeks (PILOT) or 90 days (EFS)
* Prior myocardial infarction within 6 months (PILOT) or 90 days (EFS)
* Need for coronary revascularization
* History of, or active, endocarditis
* Renal insufficiency (Creatinine \> 2.5 mg/dL)
Coronary Artery Stent Evaluation With 320-slice Computed Tomography - The CArS 320 Study

The investigators aim at analyzing the diagnostic accuracy of 320-row CT for coronary stents.


Eligibility Criteria:
Inclusion Criteria:

* Suspected coronary artery in-stent restenoses based on clinical findings or findings on other noninvasive imaging tests and planned coronary angiography within the next 14 days.
* Able to understand and willing to sign the Informed CF.

Exclusion Criteria:

* Creatinine of above 2.0 mg/dl
* Age below 40 years
* Women of child bearing potential (no hysterectomy, no menopause, or menopause since less than 12 months) must demonstrate a negative pregnancy test performed within 24 hours before CT.
* Resting heart rate above 70 beats per minute and contraindications to beta blockers (e.g. moderate to severe bronchospastic disease, asthma)
* Atrial fibrillation, uncontrolled tachycardia, A-V block II or III degree or other non-sinus rhythms
* Inability to hold the breath for 10 seconds
* Hypotension \< 80 mmHg systolic
* Unstable angina pectoris, acute myocardial infarction \< 48h
* Continuous therapy with Dipyridamol
* Severe aortic stenosis
Renal Function Assessment in the Elderly Using Plasma Creatinine Assay and Lean Body Mass Measurement

Glomerular filtration rate (GFR) is the recommended parameter to assess renal function. The reference technique to measure GFR (clearance of a glomerular agent) is not commonly used. Instead, estimations (eGFR) are routinely taken from serum creatinine (SCr) with several published formulae: Cockcroft and Gault, MDRD, CKD-EPI. Basically, all these formulae aim at predicting the endogenous creatinine production by morphological parameters (age, body weight...) However, in the elderly, muscular mass is extremely variable and sarcopenia is quite commonly encountered (frequently linked to Alzheimer disease). This is probably the main reason why the aforementioned formulae are not valid in this population: for a given renal function, a lower muscular mass induces a lower creatinine production and, henceforth, a lower SCr value, which gives an overestimation of eGFR.

Muscular mass is closely linked to lean body mass (LBM), which can be properly assessed by whole-body dual X-ray absorptiometry (DXA). Alternatively, Bioelectric Impedance Spectroscopy (BIS) can also be used.

Investigators postulate that it is possible to estimate GFR in the elderly from both SCr and LBM estimation from DXA. Proof of concept has already been made by others but until now, no specific formula for the elderly has been devised and properly validated.

Investigators'aim is thus to propose a new formula to predict GFR from both SCr and LBM (estimated from DXA) in the elderly. This formula will be elaborated from a first series of 100 patients and validated on a second series of 100 other patients.


Eligibility Criteria:
Inclusion criteria :

* age of 75 years of more
* origin from Western Europe or North Africa
* covered by social health insurance
* general health condition allowing transportation and ambulatory procedures during one day

Exclusion criteria :

* ascitis, oedema or third compartment
* fast change in body weight (more than 5% in less than one week)
* eGFR \< 30 mL/min/1.73 m² (using MDRD formula)
* legal concerns: prisoners, guardianship, lack of health insurance, failure to consent
* intake of drugs that interfere with creatinine tubular secretion

  * cimetidine
  * trimethoprim
* intake of drugs that interfere with creatinine assay

  * calcium dobesilate
  * hydroxocobalamin
  * N-ethylglycine
  * phenindione
  * lidocaine
* inability to lie during 10 minutes without moving
* patients who are bedridden, hemiplegic or highly dependent on others
* any health condition that, in the investigator's opinion, could rapidly (\< 1 week) vary the extracellular volume or GFR (these is voluntarily left open to the investigator because it is hardly possible to make an exhaustive list here)
A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate

Exclusion Criteria:

* Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.
Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent

This study is an investigator initiated placebo controlled double blinded trial. The hypothesis is that treatment with modafinil positively will affect behavioural and cognitive rehabilitation after stroke, causing the treatment group to experience decreased fatigue, increased endurance, improved skills of sustaining attention and faster reaction times. The cognitive rehabilitation will show in increased muscle mass, decreased osteoporosis and better physical performances due to a higher level of physical activity.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and stroke within 14 days
* Modified Rankin Scale 3 or under and Barthel 85 or over before stroke
* Person that can understand instruction and do tests and questionnaires on their own or with support
* has given informed consent
* MFI-20 score of 12 or more
* Infertile person or fertile women tested negative of pregnancy and using safe anticonception

Exclusion Criteria:

* Dementia or other neuropsychiatric disease making the person incapable of understanding instructions
* Other disease with fatigue as a known symptom
* stroke induced by trauma, infection or surgical procedure
* former drug abuse
* known contraindication to treatment with modafinil
* known active malignancy, benign intracranial tumor, subdural or epidural bleeding
* kidneydysfunction with creatinin more than 265 micromol/L or liver disease with ASAT (aspartate aminotransferase) elevated to more than 70 U/L for women or 100 U/L for men.
* allergy to project treatment
* use of benzodiazepin or antiepileptic drugs in a fixed dose. Sleeping pills not included.
* Patients threaded with ciclosporin or anti HIV medication