cyrilzakka/clinical-trials huggingface dataset:
Effect of a Hybrid Rehabilitation Program on Walking, Quality of Life & Cardiovascular Risk in People With PAD

Peripheral arterial disease (PAD), a disabling condition, affects 800,000 Canadians. People with PAD suffer from poor quality of life due to leg pain, which makes walking difficult. They also have a high risk of heart disease. In November of 2017, the University of Ottawa Heart Institute (UOHI) launched Canada's first specific walking rehabilitation and cardiovascular risk reduction program dedicated to patients with PAD.

An on-site, supervised exercise program to improve walking endurance and quality of life in PAD has been shown to be successful. However many patients are not able to participate in the on-site program due to barriers such as transportation, parking, or other commitments. Recently, a home-based walking program has also been shown to significantly improve walking endurance and quality of life among people with PAD. It was decided that a hybrid program, that has a short on-site program followed by a home-based program may allow more patients to participate and have the highest chance of success.

The goal is to develop a new hybrid program for medical care in PAD patients in order to: (a) improve their walking distance, (b) improve their quality of life and (c) improve their cardiovascular risk.

As part of this study the investigators will enrol 25 participants with PAD. Participants will be studied at baseline (before their first on-site class) and at 3 month follow up (after their last home program phone call).


Eligibility Criteria:
Inclusion Criteria:

* Intermittent claudication with PAD documented by:

  * ABI ≤0.90 or \>1.40;(14) or
  * Anatomic evidence of lower extremity arterial stenosis ≥50% (by lower extremity angiography, CT angiography, MR angiography or ultrasound)
* Ability to participate in the study (ability to walk)
* Willingness to provide informed consent

Exclusion Criteria:

* They have had previous lower extremity amputation
* They are unable to walk
* They have critical limb ischemia or open lower extremity wounds.
* Patient is unable to read and understand English or French
* Patient is unable, in the opinion of the qualified investigator or referring physician, to comprehend and participate in the exercise intervention.
Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis

The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Rheumatoid Arthritis.

Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into chondrocyte and osteocyte, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Rheumatoid Arthritis.

To investigate the effects of hUC-MSC treatment for Rheumatoid Arthritis, 20 patients with Rheumatoid Arthritis will be enrolled and receive 4 times of hUC-MSC transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-80 Rheumatoid Arthritis patient;
* Patients must consent in writing to participate in the study by signing and dating an informed consent document;
* Patients must have a diagnosis of Rheumatoid Arthritis according to the 2010 ACR/EULAR criteria for at least 12 weeks duration;
* Stage I and II according to X-ray.

Exclusion Criteria:

* History of neurological disease, head injury or psychiatric disorder;
* Pregnant women;
* Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition;
* Progressive apoplexy;
* With malignant tumors;
* Patients who had participated in other clinical trials within three months prior to this study.
Different Lung Ultrasound Imaging Protocols in COVID-19 Pneumonia

Lung ultrasonography (LUS) is also used in COVID 19 pneumonia for diagnostic and follow-up purposes.It has been demonstrated in different studies that it can be used for pathologies in pleural and lung tissue. LUS was applied by different researchers by dividing the lungs into 12 and 14 regions and the results were shared.

In our study, we aimed to determine the correlation between lung findings of COVID 19 pneumonia and thoracic tomography with the results of LUS applied to different numbers (12 versus 14) of areas.

Eligibility Criteria:
Inclusion Criteria:

* 18 and 85 years old
* Hospitalized in intensive care unit
* PCR (polymerase chain reaction) tested
* Thoracic CT applied

Exclusion Criteria:

* Previous lung operation
* Thoracic wall disorder
* Interstitial lung disease
* Patients who did not consent to participate in the study
CBT-based and Motivational Interviewing Supported Psychoeducation in Obese Individuals

The aim of this study is to examine the effects of cognitive-behavioral and motivational interview-supported psychoeducation on emotional eating and psychological resilience in obese individuals. The study will be conducted with a randomized controlled experimental design. The sample of the study will consist of 102 obese individuals in total, 51 in the experimental group and 51 in the control group, who meet the inclusion criteria. A cognitive-behavioral and motivational interview-supported psychoeducation program will be applied to the experimental group. All patients will be evaluated at three time points: pre-test (baseline), post-test (8 weeks), and follow-up test (3 months after the post-test). No intervention will be applied to the control group. The Emotional Eating Scale and Psychological Resilience Scale will be used as data collection tools in the study. As a result of the study, the hypothesis that the cognitive-behavioral and motivational interview-supported psychoeducation program is effective in reducing the emotional eating levels of obese individuals and increasing their psychological resilience levels will be tested. The findings of the study will contribute to the importance and effectiveness of psychological approaches in the treatment of obesity.


Eligibility Criteria:
Inclusion Criteria:

* Obese individuals (body mass index 30 kg/m2 or more)
* Between the ages of 18-65
* Not having any psychiatric disorder or not using psychiatric medication
* Volunteering to participate in psychoeducation
* Being in a physical and mental condition that will allow them to adapt to treatment
* Signing the informed consent form

Exclusion Criteria:

* Having communication problems
* Having a medical condition (e.g. Cushing syndrome, hypothyroidism) or taking medication that causes obesity
* Having a psychiatric diagnosis (e.g. depression, anxiety disorder, eating disorder) or taking psychotropic medication
* Being pregnant or breastfeeding
* Participating in another diet or exercise program
Program to Promote Engagement in Care for the Prevention of Recidivism

In France, the number of emergency visits for suicide attempts is estimated at 220,000 per year. Suicide management aims to reduce suicide risk factors in order to improve the mental health of patients and prevent recurrences.

To day, no study has compared the approaches to health surveillance and case management in a clinical trial, nor established the benefit of each on commitment to care and beyond the prevention of suicidal recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18.
* Male and female.
* Admission to CH St Denis for a suicide attempt.
* Referral for outpatient follow-up.
* Patient with no psychiatric follow-up or who has been out of follow-up for at least three months.
* Patient having given their written informed consent.

Exclusion Criteria:

* Patients not affiliated with social security or state medical aid.
* Patients who do not have the required faculties to be evaluated (cognitive and delusional disorders).
* Patients treated for more than 72 hours after their procedure (maximum length of stay in the UAS and/or in medical intensive care.
* Patient currently under psychiatric care.
* Patients who cannot be called back by telephone (no telephone, homeless, incarceration).
* Patients who do not master the French language.
Ridge Preservation Comparing a PTFE Nonresorbable Membrane to a Collagen Membrane

A non-resorbable PTFE (teflon) membrane will be compared to a resorbable collagen membrane when used for a post-extraction ridge preservation procedure to prevent the bone loss that typically occurs. The hypothesis is that there will be no difference in the clinical and histologic results between the two membranes.

Patient Selection 30 patients will be selected that meet the following criteria:

Inclusion Criteria

1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
2. Healthy male or female who is at least 18 years old.
3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria

1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
2. Presence or history of osteonecrosis of jaws.
3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
4. Patients who have been treated with oral bisphosphonates for more than three years.
5. Patients with an allergy to any material or medication used in the study.
6. Patients who need prophylactic antibiotics.
7. Previous head and neck radiation therapy.
8. Chemotherapy in the previous 12 months.
9. Patients on long term NSAID or steroid therapy.
10. Pregnant patients.

Eligibility Criteria:
Inclusion Criteria:

1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
2. Healthy male or female who is at least 18 years old.
3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

   -

Exclusion Criteria:

1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
2. Presence or history of osteonecrosis of jaws.
3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
4. Patients who have been treated with oral bisphosphonates for more than three years.
5. Patients with an allergy to any material or medication used in the study.
6. Patients who need prophylactic antibiotics.
7. Previous head and neck radiation therapy.
8. Chemotherapy in the previous 12 months.
9. Patients on long term NSAID (nonsteroidal anti-inflammatory drug) or steroid therapy.
10. Pregnant patients. -
A Study to Evaluate Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation

To evaluate the efficacy of ivacaftor treatment, as measured by lung clearance index (LCI), in subjects with cystic fibrosis (CF) who have a specified CF transmembrane conductance regulator (CFTR) gating mutation


Eligibility Criteria:
Inclusion Criteria:

* Male or female with confirmed diagnosis of CF.
* Must have 1 of the following CFTR gating mutations on at least 1 allele: G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, or G1349D.
* Hematology, serum chemistry, and coagulation at Screening with no clinically significant abnormalities or concomitant diagnosis that would interfere with the LCI and CT scan study assessments, as judged by the investigator.

Exclusion Criteria:

* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before Day 1
* Any clinically significant laboratory abnormalities at the Screening Visit that would interfere with the study assessments or pose an undue risk for the subject (in the opinion of the investigator)
* Abnormal liver function, at Screening, defined as ≥3 × upper limit of normal (ULN), of any 3 or more of the following: serum aspartate transaminase (AST), serum alanine transaminase (ALT), gamma-glutamyl transpeptidase (GGT), serum alkaline phosphatase (ALP), and total bilirubin
* History of solid organ or hematological transplantation
* Any clinically significant "non-CF-related" illness within 2 weeks before Day 1
* Use of any moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A within 2 weeks before Day 1
* Participation in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 terminal half-lives (whichever is longer or as determined by the local requirements) before Screening
MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation on PD Patients

Deep Brain Stimulation represents the golden standard for surgical treatment of Parkinson's disease (PD), but it is not optimally effective for controlling every motor sign and adverse events are not so infrequent. Therefore,other approaches should be considered. New Approaches in MRI at 3T and long-term local field potential (LFP) recording are very important to target subthalamic nucleus (STN) and understand mechanisms of DBS on Parkinson Patients. This study aims at evaluating the safety and effectiveness of 3T MRI Compatible and LFP recordable deep brain stimulation on PD patients. The Chronically LFP recording using G106R is for two goals: 1) Evaluate the performance of long-term recordable neural simulation. 2) Study long-term clinical and electrophysiology effects of deep brain stimulation on STN.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18，≤75，idiopathic Parkinson's disease，both male and female
2. MMSE score ≥24
3. H-Y score ≥2.0 on the medicine off situation
4. UPDRS-III score≥30 on the medicine off situation
5. The duration of this disease ≥5 years
6. Ability to provide informed consent as determined by preoperative neuropsychological assessment
7. History of appropriate response to dopaminergic medication, with at least a 30% improvement in motor UPDRS with L-DOPA by history or in-clinic testing, for the PD patients
8. Excellent responsiveness to levodopa
9. ≥6h in medicine off state

Exclusion Criteria:

1. Lack of ability to provide informed consent as determined by preoperative neuropsychological assessment
2. Otherwise not eligible for DBS surgery, for example known inability to undergo anesthesia
3. Hydrocephalus，brain atrophy，cerebral infarction ，cerebralvascular diseases
4. Patients who are unable to follow verbal instructions
5. Other severe pathological chronic condition that might confound treatment effects or interpretation of the data
Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation (MUCO-IRC)

Chronic renal failure is a serious complication of lung transplantation especially in patients with cystic fibrosis. Their medical history prior to the Lung Transplantation has already exposed to kidney damage. Post-lung transplantation, these patients are subjected to renal toxicity anticalcineurins they receive large doses.

The measurement of renal function of patients by formula to estimate GFR in routine use is unreliable and other markers seem indispensable.

The purpose of this study is to evaluate two markers, PIIINP (Procollagen III aminoterminal peptide N), whose urinary levels was correlated to the intensity of fibrosis in different types of kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Bearer of lung transplantation (single or double lung, with or without associated cardiac transplantation)
* Suffering from cystic fibrosis
* Aged 18 and over
* With at least 6 months of transplantation
* Having a glomerular filtration rate measured by technical radionuclide \> 30 ml / min
* Having given written consent to the study Patients meeting these criteria will enter in the "organic" in the study (determination of PIIINP urinary)

Exclusion Criteria:

* Lung transplantation for a condition other than cystic fibrosis
* Patient refused follow-up
* Patients with advanced liver disease (conditions that interfere with the assay of PIIINP)
* Minor
* Pregnant women,
* Major Trust, benefiting from a regime of legal protection (guardianship, trusteeship, safeguarding justice.
* Patient unable to grant informed consent.
Telerehabilitation in Patients With Pulmonary Hypertension

Patients with pulmonary hypertension will be randomized into two groups. One group will receive telerehabilitation sessions including upper and lower extremity strengthening exercises and breathing exercises. The other will me monitored routinely. Patients will be assessed by 6 minute walk test, emphasis-10 questionnaire for quality of life and muscle strength with hand-held dynamometer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pulmonary hypertension

Exclusion Criteria:

* Patients with severe exercise intolerance
* Patients with musculoskeletal problems that hinder exercise
* Patients who refuse to join the study
Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication

Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) \<35% and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is associated with a significant reduction in the risk of subsequent life-threatening ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for defibrillator back-up after an event-free first CRT-D service-life for patients with improved LVEF is a controversy question.

80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary prevention do not experience VTA during the life-time of their first device.

So, regarding patients implanted with a CRT-D for primary prevention at the time of first implantation, the question is will they experience VTA after their device replacement by another CRT-D.

The objective of this study is to describe, in a population of patients who had a primary prevention ICD indication at first implantation of a CRT-D, the relevance defibrillator back-up after the replacement of the first CRT-D. For that, the rate of patients with at least one sustained VTA detected by the CRT-D or a conventional surface ECG will be assessed after the device replacement.

Furthermore, the association between the baseline characteristics of the CRT-D population after replacement and the risk of subsequent VTA will be explored after a minimum of two years FU.

Eligibility Criteria:
Inclusion Criteria:

* Patient with primary prevention indication for defibrillation at the time of the first CRT-D implantation
* Patient implanted as first replacement by a CRT-D device (CRT-D by CRT-D)
* Lifetime of the previous CRT-D \> 3 years
* Patient willing and able to comply with the protocol and who has provided written informed consent
* Patient whose medical situation is stable.

Exclusion Criteria:

* Patient with an ICD lead under advisory (e.g. Fidelis lead)
* Right or left ventricular leads exchange during CRT-D replacement
* Non functional atrial (except for patient with chronic AF) or right/left ventricular leads
* Life expectancy \< 1 year
* Age \< 18 years
* Pregnant woman or woman who plan to become pregnant during the trial
* Participation in another interventional clinical study
Applications for Methotrexate Optimization in Rheumatoid Arthritis

The goal of this study is to enable the study sponsor to assess the impact of a marketed or validated blood test has on physicians' clinical treatment decision making when treating RA patients who have been taking methotrexate.

Ultimately, the blood test will allow treating physicians to modify current methotrexate therapy in partially responding Rheumatoid Arthritis (RA) patients' therapy, on an individualized basis, as a means of improving clinical outcomes.

The study requires a blood sample from RA patients who have been on methotrexate therapy for a minimum of 3 months and are having an inadequate response to therapy. Physicians will then be provided with the results of the test indicating the methotrexate polyglutamate (active metabolites of methotrexate) levels in the patient's red blood cells as a means to help determine whether a patient's exposure to methotrexate has been optimized.

This study is currently enrolling individuals who have an established diagnosis of RA and are receiving methotrexate as part of their therapy. Patients are required to submit a blood sample. There is no cost to volunteers who participate.

Eligibility Criteria:
Inclusion Criteria:

* Able to read, understand, and sign the informed consent form
* Able to read, write, and speak English
* ≥18 years of age
* Diagnosed with RA within past 24 months (waiver)
* Taking oral methotrexate therapy for a minimum of 3 months
* Considered to have an insufficient response to methotrexate and therefore a candidate for change to therapy, including changing MTX dose or changing route of delivery, or adding or switching DMARDs (including but not limited to biologic DMARDs)

Exclusion Criteria:

* Prior exposure of the study center, study physician or study patient to the Avise PG laboratory test
* Patients with known abnormal hepatic and or hematological parameters
* Use of prednisone \>10mg/day (or its equivalent)
* Rheumatologic diagnosis other than primary RA
An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis

The purpose of this study is to determine whether early use of a bland emollient in newborns, prior to the clinical signs of skin disease, will delay the onset or prevent the development of atopic dermatitis.

All neonates will be treated with Cetaphil cream starting within 1 week of birth. All neonates enrolled will have an increased risk of developing atopic dermatitis because they have a family history of either asthma, hay fever, or atopic dermatitis. These neonates will then be followed for 2 years for the signs and symptoms of atopic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* at least one parent diagnosed with Atopic Dermatitis
* one parent or sibling with hayfever or asthma

Exclusion Criteria:

* newborns with dermatitis at birth
* newborns born greater than four weeks prematurely
* newborns with medical problems necessitating prolonged hospitalization
* newborns diagnosed with any immune deficiency syndrome
Trends Over Time (1990-2010) of Diarrhoea-related Hospitalizations and Deaths in Children < 5 Years of Age in Brazil

This study aims at collecting data to obtain baseline incidence and monitor trends over time in hospitalizations and deaths from all cause gastroenteritis in children \<5 years of age, before and after implementation of Rotarix™ universal mass vaccination in Brazil.

In this study baseline gastroenteritis related hospital discharges and mortality data from the Ministry of Health databases (DATASUS) will be compared to the current data after introduction of Rotarix™.

Eligibility Criteria:
Inclusion Criteria:

* Gastroenteritis associated hospital discharges and gastroenteritis related deaths occurring in children \<5 years of age during the period analyzed and registered in the DATASUS databases will be collected for the study

Exclusion Criteria:

* Not applicable