cyrilzakka/clinical-trials huggingface dataset:
Low Molecular Weight Heparin in Prevention of Recurrent Arteriovenous Graft Thrombosis in Chronic Hemodialysis Patients.

The aim of the study is to evaluate the effect of Enoxaparin (LMWH) on the incidence of AV graft thromboses in patients on chronic hemodialysis.

Primary efficacy end point of the study: to compare the time of onset of a new thrombotic event after successful angiography of the AV graft.

Pprimary safety outcome of the study: frequency of hemorrhage. Design and methods: Following a first AV graft thrombosis and successful thrombolysis with angioplasty, patients on chronic hemodialysis will be randomized to s.c Enoxaparin (Clexane) 0.5 mg/1kg of body weight per day or control group (not on Clexane). Patients will be followed for a year or till next AV graft thrombotic occlusion, if it occurs before. In both groups we will compare time periods in months between first and recurrent thrombotic events of AVG by evaluation the difference between two sample means. Also interim analysis of AV grafts patency between the two groups will be evaluated at different time points: three, six and twelve months after randomization. Patients in both groups will receive unfractionated heparin during dialysis session to prevent thrombosis of extracorporeal circulation. Patients from Enoxaparin group will receive a half dose (500 units/hour) to prevent possible risk of bleeding during the session. Before randomization all patients will be evaluated for hypercoagulability state which will include: Factor V Laden deficiency, Anti phospholipid antibodies (APLA), Antithrombin III deficiency and Protein C/S deficiency.


Eligibility Criteria:
Inclusion Criteria:

* hemodialysis patients ≥ 18 years of age after occurrence of AVG thrombosis and successful thrombolysis/thrombectomy with angioplasty.

Exclusion Criteria:

1. Known allergy to enoxaparin
2. Persistent systolic blood pressure 180 or more and/or persistent diastolic blood pressure 100 or more
3. Chronic Warfarin treatment
4. Double antiagregant treatment (aspirin plus clopidogrel)
5. Platelets count below 80000/µl
6. Known HIT (Heparin Induced Thrombocytopenia)
7. Recent bleeding (\<2 weeks)
8. Recent stroke (\<4 weeks)
9. Reduced mental status and inability to give informed consent
Investigation of Psycho-Physiological Parameters in Adolescent Inpatients With Anorexia Nervosa

A study to assess changes in mental and physical symptoms in adolescent inpatients with anorexia nervosa, a severe eating disorder.

This is a prospective controlled trial to assess changes in psycho-physiological parameters, including eating disorder features (drive for thinness, body dissatisfaction) and comorbid symptoms such as anxiety, depression and quality of life as well as heart rate variability, body warmth and BMI in adolescent inpatients with anorexia nervosa. Parameters were assessed at admission, six weeks after admission and three months thereafter and compared to reference values of healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Age 11-18 years
* Restrictive subtype of adolescent AN
* Fulfilling the AN diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV and V)
* Admitted to the Filderklinik for inpatient treatment

Exclusion Criteria:

* Patients diagnosed with the binge-purge subtype of adolescent AN or with other eating disorders
* Healthy controls: BMI beyond the defined norm for their age group
* Healthy controls: acute or chronic disorders including psychiatric disorders, heart defects, cardiac arrhythmia, other disorders requiring medication
Prospective Study of Colon Serrated Polyps

With this study, the investigators plan to review the clinical, epidemiology, pathology, and endoscopic features of colon serrated lesions as well as outcome of endoscopic resection of these lesions. The findings will help us define the natural history of colon serrated lesions, develop techniques for endoscopic management of patients with serrated lesions, and identity areas for improvement. The data will be used for continuing quality improvement and presenting our outcomes at academic meetings and publishing our results in peer reviewed journals.

Our goal is to collect data from our endoscopy reports and electronic medical record system to complete a descriptive analysis of the demographics, colonoscopy resection procedure, and outcome of resection - immediate and delayed complications, tumor recurrence, and cancer during follow-up 010/01/2014 - 12/31/2025.

Specific variable to be reviewed:

1. Patient Demographics: Age, Sex, Race, Height, Weight, BMI (patient privacy will be acknowledged).
2. Indications for Colonoscopy (screening, surveillance, symptoms or tertiary referral \[EMR\]).
3. Comorbid conditions: cancer and surgical history, medical conditions.
4. Colonoscopy procedure: Quality of colon preparation (using the Boston Bowel Preparation Scale) 0 - 3 for each section of the colon (Ascending, Transverse, Descending and Total Colon), cecal intubation rate, cecal intubation and total procedure time, type of colonoscope (if CO2 was used in the procedure and techniques for colonoscope insertion, including position changes.
5. Examination findings: Number of polyps and nature of polyps removed (site, size, surface, vascular pattern); type of polyp removed (serrated and sessile (flat); optical features and histology of polyps.
6. Resection techniques: Biopsy, snare resection, endoscopic mucosal resection, endoscopic submucosal dissection etc.
7. Including Pathology report findings so that a comparison can be made of the optical features and actual pathology report.
8. Outcomes of colonoscopy: Complete or incomplete resection, local recurrence, need for surgery, etc.
9. Outcome of colonoscopy: Complications (Bleeding and perforation).

Eligibility Criteria:
Inclusion Criteria:

1. All Patients with a serrated polyp (Hyperplastic polyps above sigmoid colon, sessile serrated adenoma, traditional serrated adenoma)

Exclusion Criteria:

N/A
Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma

The purpose of this study is to determine the efficacy of indacaterol 55µg once daily (and 27.5 µg twice) in QVA149 compared to 75 µg indacaterol monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Asthma for at least 6 months, using inhaled corticosteroid for at least one month, foreced breath test less than below the normal value of the general population, -show an immediate improvement in breathing when given albuterol

Exclusion Criteria:

* patients who have smoked in the past 6 months or are currently smoking, including those who smoked more than a pack of cigarettes a day for at least 10 years, -patients who have a history of life-threatening asthma, -patients who have had an astham attack, in the last 6 weeks, requiring use of systemic steroids, hospitalization, or ER visit, -patients who have had a respiratory tract infection or worsening asthma between screening or run-in periods, patients requring use of other asthma-related drugs during the trial, other protocol-defined inclusion/exclusion may apply
Heart Failure Caregiver Study

Family caregivers are vulnerable to health problems because of the stress and demands of their role as a caregiver. With the growing incidence of heart failure (HF) and the anticipated growth in the aging population, the number of HF caregivers is expected to rise. This study will pilot test a cognitive behavioral intervention designed to reduce stress among HF caregivers, which will ultimately contribute to promoting health and quality of life among HF caregivers and their loved ones with HF.


Eligibility Criteria:
Patient Inclusion Criteria:

* 21 years or older
* Having primary or secondary diagnosis of HF (NYHA class II-IV)
* Having a family member or friend providing care for them at home
* Being able to communicate in English

Patient Exclusion Criteria:

* Being on the transplant list
* Having terminal illness (e.g., terminal cancer)

Caregiver Inclusion Criteria:

* 21 years or older
* Having the primary responsibility for the care of the patient for at least 6 months
* Living in the greater Los Angeles area
* Being able to communicate in English

Caregiver Exclusion Criteria:

* Being a paid caregiver (an individual who is hired to provide care for the patient)
* Having terminal illness (e.g., terminal cancer) or a serious medical condition that requires ongoing medical care (e.g., cancer requiring ongoing chemotherapy or radiation therapy)
* Having a history of major psychiatric illness (i.e., schizophrenia, bipolar disorder, and/or any personality disorder)
* Diagnosed with Cushing's or Addison's disease
* Taking medication that could influence cortisol levels (e.g., steroid based anti-inflammatory drugs)
Breath Analysis for the Detection of Invasive Fungal Infections

Patients with leukemia and concomitant neutropenia are at high risk of developing invasive fungal infections (IFI) that are associated with high morbidity and mortality. As these patients typically have severe thrombocytopenia, direct diagnostic sampling with invasive procedures is often not possible due to the high peri-interventional risk. Therefore, the presumptive diagnosis of IFI is primarily based on compatible lung findings on computed tomography and serologic detection of fungal cell wall components, which, however, have limited sensitivity and specificity.

With the present study, the investigators aim to determine a set of specific volatile biomarkers in leukemia patients with proven or probable IFI using secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute leukemia
* Planned chemotherapy with a duration of hospitalisation of 2 weeks or longer
* Neutropenia (\<500/µl) present at inclusion or planned chemotherapy with expected neutropenia (\<500/µl) for more than 7 days

Exclusion Criteria:

* Unable to follow instructions for breath analysis
* Anatomic abnormalities precluding the use of a mouthpiece for breath analysis
Evaluation of the Performance of an e-Health System

Prospective, non-randomized, open-label, pilot study conducted in a single group of 30 evaluable patients, i.e. patients completing an approximate 3 month follow-up.

The eHealth system developed in the present study is dedicated to multimorbid patients' follow-up. The medical device consists in Telemonitoring, Telenotification and Telecoaching. It aims to both increase patient autonomy, with regard to management of his/her pathologies, and facilitate coordination between health professionals.

By providing patients with tools enabling early detection of clinical worsening combined with an appropriate management, the medium and long-term objectives are to reduce hospitalizations and improve health status and quality of life of these patients at home.

In the first instance, the only objective of the present study is to evaluate the performance and feasibility of implementation of the device. This evaluation is based on a comparison between the telenotifications generated by the software and those calculated from the raw data captured by the software.

Eligibility Criteria:
Inclusion Criteria:

Patients presenting all the following characteristics are eligible for inclusion:

1. Adult (\>18 yrs), male or female
2. Presenting at least two chronic diseases among the following three: chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), diabetes
3. Having been hospitalized in the CHANGE or in any other medical care center (hospital or private clinic) for acute decompensation of CHF or exacerbation of COPD at least once during the 12 months prior to inclusion
4. Able to speak and understand French to a satisfactory standard
5. Having a phone land line
6. Capable of understanding and accepting the study constraints
7. Having signed a written informed consent after a full explanation of the study by the investigator prior to inclusion

Exclusion Criteria:

Patients presenting any one of the following characteristics are not eligible for inclusion:

1. Pregnant or breast-feeding woman
2. Institutionalized
3. Having a life expectancy of less than 3 months
4. Receiving or having received chemotherapy or radiotherapy for cancer within the past 6 months
5. Undergoing dialysis for chronic renal insufficiency
6. Presenting a condition likely to hamper accomplishment of the study procedures, such as chronic alcoholism, drug or solvent addiction, uncontrolled psychiatric disease or severe cognitive deficiency
7. Not covered by French Social Security
8. Participating or having participated in another interventional trial within the past 30 days
Clinical Outcome of Liver Transplant Patients With Tacrolimus-based Immunosuppression

Genetic polymorphism and numerous clinical factors could influence tacrolimus pharmacokinetics, which led to large inter-and intra-individual variability.Since its narrow therapeutic range,predicting therapeutic outcome and individualized dosage remains to be a challenge. The study's objective is to identify the genetic and clinical factors that can influence clinical outcome in liver transplant.

A great number of studies had found significant correlation between tacrolimus pharmacokinetics and gene polymorphism. However, previous studies on the correlation between genetic factors and clinical outcome were controversial. Furthermore, most studies focused on single genetic polymorphism and clinical outcome, and very limited studies took multiple genetic factors and clinical factors into account.

This is a retrospective study. Eligible patients were those who had signed informed consent for genetic study in previous research projects ( IRB approval number：201512005RINC and 201612023RIND ). The present study will collect laboratory data, concurrent medications, and therapeutic drug monitoring (TDM) data. Patient survival, graft survival, acute rejection and tacrolimus-associated adverse events will be assessed.

Eligibility Criteria:
Eligible patients were those who had signed informed consent for genetic study in our previous research projects.

Inclusion Criteria of the Previous Study:

* patients who underwent living-donor liver transplantation during January 2008 to December 2017
* at the age of 20-65
* with tacrolimus-based immunosuppression after liver transplant for at least 6 months.

Exclusion Criteria of the Previous Study :

* retransplantation
* multi-organ transplantation
* human immunodeficiency virus (HIV) positive.
Strength Training to Improve Gait in People With Multiple Sclerosis

This study will pilot a strengthening intervention targeted to muscles found to be important to gait in people with multiple sclerosis (MS). Previous studies that have tried to strengthen leg and trunk muscles in people with MS have failed to improve walking ability consistently. The investigators think that is because strengthening exercises were not targeted to the correct muscle groups. For this study the investigators propose targeting muscle groups that they have found to be strong contributors to walking in a prior study. This is the first study to target these muscles, so the investigators propose doing a small trial to first evaluate the feasibility of the strength program and the outcomes. The investigators will measure strength and walking measures twice before and once after an 8-week strengthening intervention in a single group of 10 people with MS who are able to walk independently. The results of this study will help inform future, larger trials that could change the way strength training is conducted in people with MS.


Eligibility Criteria:
Inclusion Criteria:

1. People with MS,
2. Age 18-65,
3. A confirmed diagnosis of MS, and
4. Are ambulatory for 100m without an assistive device (EDDS 0-5.5), and
5. Have a gait speed measured by time to walk the 25-foot walk test of at least five seconds.

Exclusion Criteria:

1. Subjects are not ambulatory,
2. Subjects rely on a wheelchair,
3. Subjects cannot ambulate 100m (EDDS 6 or greater) without use of assistive devices, braces, or orthotics,
4. Walk the T25FW in less than five seconds,
5. Have lower extremity spasticity of 2 or greater on the Modified Ashworth Scale (MAS),
6. Have pain or other conditions that limit ambulation or ability to test muscle strength,
7. Cannot give consent,
8. Cannot follow simple directions,
9. Have had an exacerbation in the past month,
10. Have had changes to their drug therapy in the last month,
11. Have other neurologic diagnoses, or
12. Are currently undergoing physical therapy for strength training.
Efficacy of LCQ908 on Cardiovascular Risk

This is a study designed to evaluate the potential for the pradigastat (LCQ908) to impact cardiovascular risk.

This study had 2 parts. Part A was a multicenter, double-blind, randomized, placebo-controlled, non-confirmatory crossover study assessing response to a high-fat meal challenge in the setting of pradigastat versus placebo. Part A had 2 cohorts i.e. Cohort 1 patients with stable coronary artery disease and hypertriglyceridemia and Cohort 2 patients with asymptomatic non-obstructive coronary artery disease or elevated coronary heart disease risk and hypertriglyceridemia.

Part B was a double blinded phase designed to assess response to three months of chronic treatment with pradigastat versus placebo on a normal diet.

The trial was terminated after the interim analysis of Part A, Cohort 1. The interim analysis results indicated that the high-fat meal challenge did not induce any impairment on either myocardial perfusion reserve index (MPRi) or exercise treadmill performance. Part B was never started.

Eligibility Criteria:
Inclusion Criteria:

* History of coronary artery disease
* Elevated triglycerides
* On medication to help lower cholesterol

Exclusion Criteria:

* Poorly controlled diabetic patients and/or change in diabetic medication within 12 weeks of screening
* History of myocardial infarction (heart attack) within 6 months of screening
* History of a procedure to open a blocked coronary artery within 12 months of enrollment
* History of Coronary Artery Bypass Graft (CABG) surgery
* History of congestive heart failure
* History of significant heart valve disease
Pharmacokinetic (PK)/Pharmacodynamic (PD), Study of Single-dose Subcutaneous CDP6038 in Healthy Japanese Male Subjects

To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc) administration of CDP6038 to Japanese subjects.

To evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of CDP6038 to Japanese subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese volunteers

Exclusion Criteria:

* Subject has participated in any other clinical drug study (including a biologic product or a medical device) within 5 PK half-lives or 3 months (whichever is longer) prior to Screening, or the subject is currently participating in another clinical study.
* Subject is not healthy (eg, taking any drug treatments, any psychological or emotional problems, a drug/alcohol abuse or a having a history of drug/alcohol abuse, having abnormal safety parameters)
Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial

The aim of the present study is to evaluate the (cost) effectiveness of a new health care system in which an individualised multidisciplinary assessment is given to patients with Parkinson's Disease(PD)in combination with treatment by a dedicated team of specifically trained health professionals, compared to usual care. Overall, we anticipate to gain more insight in the clinical effectiveness and health care costs of multidisciplinary treatment in PD.

PD is a complex disorder, with motor as well as non-motor symptoms. Despite the complexity of PD, management of the disease is often 'monodisciplinary' since most patients are only treated by a neurologist. Stimulating compensatory strategies by allied health professionals might offer additional therapeutic relief, but this assumption is mainly based on theoretical arguments and expert opinion. Even less is known about the claim that a multidisciplinary team of multiple professionals active in complementary domains (e.g. physiotherapy, occupational therapy and speech therapy) is superior to management by each of these professionals alone.

This study anticipates to provide more insight in the clinical effectiveness and health care costs of multidisciplinary treatment in PD. Therefore, our multidisciplinary care concept (a comprehensive assessment by a dedicated multidisciplinary team and subsequent treatment by specifically trained health professionals) that is tailored to the patients' individual needs will be compared to usual care in terms of effectiveness and costs.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Idiopathic PD, diagnosed according to the Brain Bank Criteria of the UK Parkinson's Disease Society
* Regular control by the neurologist
* Living independently in the community
* Able to complete the trial questionnaires

Exclusion Criteria:

* Atypical parkinsonian syndromes
* Hoehn and Yahr stage 5
* Severe cognitive impairment (MMSE\<24)
* Presence of other neurological disorders
* Severe co-morbidity (e.g. cancer)
* Planned surgical procedure for PD within the intervention period
* Patients who have already visited the Multidisciplinary Assessment Center
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture

This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one finger, other than the thumb, that was at least 20° as measured by finger goniometry and was suitable for injection were randomized 2:1 to receive AA4500 0.58 mg or placebo.

This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7 non-pivotal studies were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of Dupuytren's contracture, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100°, for MP (80° for PIP) joints, caused by a palpable cord that had never been treated with AA4500.
* Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
* Judged to be in good health.

Exclusion Criteria:

* Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
* Had received a treatment for Dupuytren's contracture, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug.
* Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.