cyrilzakka/clinical-trials huggingface dataset:
Phase I Study of Retrovirally Mediated Transfer of the Human Glucocerebrosidase Gene Into Peripheral Blood Stem Cells for Autologous Transplantation in Patients With Type I Gaucher Disease

OBJECTIVES: I. Transfer the human glucocerebrosidase (GC) gene into peripheral blood stem cells (PBSC) obtained from patients with type I Gaucher disease using a retroviral vector.

II. Transplant the autologous transduced PBSC in these patients. III. Measure the carriage and expression of the transferred gene and its duration in peripheral blood leukocytes.

IV. Assess the clinical effects of transplanting genetically corrected PBSC.

PROTOCOL OUTLINE: Patients undergo autologous transplantation using peripheral blood stems cells (PBSC) stimulated with filgrastim (G-CSF) and transduced with a retroviral vector containing the human glucocerebrosidase gene (R-GC). Patients may receive up to 4 transplants if a deficient glucocerebrosidase level is found in peripheral leukocytes 1 month following transplantation.

The G-CSF-stimulated PBSC are enriched for CD34-positive stem cells and transduced with the R-GC vector. Stem cells with normal gene activity are selected for transplantation.

Patients are followed every month for 6 months, every 6 months for 18 months, and then annually thereafter.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Enzyme proven type I Gaucher disease Glucocerebrosidase (GC) activity less than 30% of normal GC mutation identified Significant signs and symptoms of disease prior to therapy initiation At least 1 of the following after 12 months of therapy: Liver at least 2 times normal size Spleen at least 5 times normal size Platelet count greater than 150,000/mm3 Clinical bone disease with pain, fractures, or infarctions Multiple sites of marrow involvement Angiotensin-converting enzyme at least 1.5 times normal No GC antibody At least 3 of the following responses to therapy: Hemoglobin increase of 2 g/dL Platelet count increase of 50% Spleen or liver size decrease at least 25% Improvement in MRI or x-ray of the bones Nontartrate inhibitable acid phosphatase decrease of 50% Angiotensin-converting enzyme decrease of 50% OR Previously untreated and immediate enzyme therapy would not be life saving Meets at least 2 of the following criteria: Spleen at least 5 times normal size or liver at least 2 times normal size by physical exam and MRI Hemoglobin less than 11 g/dL Platelet count less than 90,000/mm3 Disabling bone pain with degenerative changes on x-ray Multiple sites of bone marrow infiltration and evidence of bony changes Pulmonary compromise with clubbing and PaO2 less than 70 mm Hg Biopsy proven cirrhosis and elevated hepatic parenchymal enzymes Bleeding esophageal varices --Prior/Concurrent Therapy-- At least 3 months since any prior investigational therapy Concurrent enzyme replacement therapy may be tapered on study --Patient Characteristics-- HIV negative No malignant disease No known sensitivity to egg or murine products Not pregnant or nursing Fertile patients must use effective contraception
A Clinical Study Evaluating the Effects of Memantine on Brain Atrophy in Patients With Alzheimer's Disease

Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Previous studies have shown that memantine helps to treat the symptoms of Alzheimer's Disease (AD). In AD, the rate of brain tissue loss, or atrophy, is faster than in normal aging and this seems to go hand in hand with some of the symptoms of the disease. This suggests that memantine treatment in AD could provide both symptomatic improvement and neuro-protective effects. The purpose of this study was to show whether memantine, in addition to providing symptomatic benefits, can slow the rate of brain atrophy as assessed using magnetic resonance imaging (MRI) technology.

The primary objective of this study was to evaluate the effects of memantine on the rate of brain atrophy compared to placebo in patients with AD (moderate severity) over a 1-year period. This was a multinational, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study (20 mg memantine). The study also included secondary imaging, cognitive and behavioural measures.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients at least 50 years of age with a current diagnosis of probable AD of moderate severity (MMSE score between 12 and 20, inclusive) consistent with NINCDS-ADRDA criteria and MRI scans
* Patients must have had a knowledgeable and reliable caregiver to accompany them to all clinic visits during the study
* Patients were either on or off existing acetylcholinesterase inhibitor (AChEI) treatment provided that the treatment had been initiated \>6 months prior to screening, had stabilised with respect to dose for \>3 months, and remained fixed during the entire study. AChEI treatment could not be initiated or modified during the study

Exclusion Criteria:

* The patient had evidence of clinically significant active disease (including recent myocardial infarction and uncompensated congestive heart failure \[NYHA II-IV\])
* The patient had evidence of any clinically significant neurodegenerative disease or neurological disorder other than AD
* The patient was contraindicated for MRI

Other protocol-defined inclusion and exclusion criteria applied.
Porous and Non-porous Bone Grafts in Intra-bony Periodontal Defects

Till date, no study has been reported in the literature where porous bioactive glass was used for the management of periodontal osseous defects. In this context, the present study is designed to assess the efficacy of the porous variant of bioactive glass and compare with that of nonporous variant using cone beam computed tomography.

OBJECTIVES:

1. To evaluate clinically the periodontal healing with Porous variant of Bioactive Glass placed in the intra bony defects at an interval of 6 months.
2. To evaluate clinically the periodontal healing with Non Porous variant of Bioactive Glass placed in the intra bony defects at an interval of 6 months.
3. To evaluate the radiographic changes in the intra bony defect grafted with Porous variant of Bioactive Glass at baseline and an interval of 6 months.
4. To evaluate the radiographic changes in the intra bony defect grafted with Non Porous variant of Bioactive Glass at baseline and an interval of 6 months.
5. To compare clinically soft tissue healing for sites grafted with Porous variant of Bioactive Glass and sites grafted with Non Porous variant of Bioactive Glass in the treatment of periodontal intra bony defects at an interval of 6 months.
6. To compare the radiographic changes for sites grafted with Porous variant and sites grafted with Non Porous of Bioactive Glass in the treatment of periodontal intra bony defects at an interval of 6 months.

Eligibility Criteria:
Inclusion Criteria:

* INCLUSION CRITERIA

  1. Age: 18-55 years.
  2. Probing Depth \>5mm.

Exclusion Criteria:

* EXCLUSION CRITERIA

  1. History of periodontal treatment last six months.
  2. Bleeding disorders.
  3. Gross oral pathology.
Evaluation of Readability of Consent Forms on the Understanding of the Information Received by Volunteers

Prior to the completion of biomedical research, any person undergoing it must receive a readable and intelligible information about this research, in order to give free and informed consent. The willingness to inform patients of all risks and constraints related to research may be in contradiction with the need to write informative and concise documents that are understandable to research participants. As a result, consent forms are long, contain a lot of information and are complicated to understand.

The objective of this study is to evaluate the impact of the readability of the information and consent forms on the understanding of the information received by participants in clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Every volunteers included in a study in a french clinical research center
* Ability to read and write in French

Exclusion Criteria:

* Refusal of participation
Early Assessment of Respiratory Function, Inflammation and Bronchial Reshuffle Among Newborns Screened for Cystic Fibrosis

The main objective of this study is to show that there is a concordance between lung disease at 13 months and the existing 9 weeks in newborn babies with cystic fibrosis asymptomatically.

This will identify at the first examination at 8 weeks, newborns who have the most impaired lung function at 13 months. To meet this objective an assessment of their lung function at 9 weeks and 1 month will be performed in newborns diagnosed with cystic fibrosis.


Eligibility Criteria:
Inclusion criteria :

* Infant aged 11 weeks

Exclusion criteria :

* Gestational age lower than 35 weeks of gestation,
* Background invasive mechanical ventilation in positive pressure
* Documented -Obstructive Sleep Apnea, heart defect, neuromuscular disease
Study of Prognostic Factors in Interventional Rhythmology

Develop a prospective register assessing the short- and long-term complications of patients undergoing interventional rhythm

To assess the fate of patients who have undergone a technical procedure at the Cardiology Plate (implantation / extraction of a pacemaker, a defibrillator, radiofrequency ablation or cryo-ablation, left auricle closure, electro- Physiological exploration), and to determine prognostic factors / markers in this population.

Eligibility Criteria:
Inclusion Criteria:

Patient to undergo:

* Implantation of a cardiac pacemaker or cardiac defibrillator or
* Extraction of pacemaker / defibrillator housing or probes or
* Realization of a radiofrequency / cryo-ablation:
* Atrial fibrillation
* Focus of ventricular tachycardia
* An accessory or
* Any electrophysiological exploration or
* Installation of Holter implantable or
* Left auricular closure percutaneously Having formulated its non-opposition

Exclusion Criteria:

* Minor
* Patient's refusal
* Patients under legal protection
Early Cardioprotective Effect of Sevoflurane

In vitro studies and in vivo animal experiments have shown that halogenated volatile anesthetics have a protective effect on the ischemic myocardium. In clinical settings however, anesthetic preconditioning may be of more interest. The aim of our study was to evaluate the cardioprotective effect of sevoflurane in patients undergoing off-pump coronary artery bypass surgery. We proposed that a cardioprotective effect of sevoflurane would save myocardial function, which we measured acceleration by esophageal Doppler and cardiac index with bolus thermodilution methods, both during brief ischemia and reperfusion.

Studies have been performed on human patients undergoing CABG surgery with cardiopulmonary bypass (CPB). Only a few studies however have evaluated the effects of volatile anesthetics during coronary artery bypass grafting on a beating heart (OPCABG) with conflicting results as far as cardiac biomarker release is concerned.

Because CPB is known to have a profound impact on cardiac function, studies performed on patients scheduled for OPCABG could evaluate more specifically the effects of the anesthetic agents themselves. Patients undergoing OPCABG have a predictable and predefined ischemic zone during surgery and represent an extremely interesting and safe model for the study of ischemia and cardiac damage in humans.

Presently, there is still no consensus on the method of administration of volatile anesthetics, including the time to begin administration, its duration, the dosage and selection of volatile anesthetics.

Eligibility Criteria:
Inclusion Criteria:

* the degree I or II of Cardiac Anesthesia Risk Evaluation score
* angiographically verified coronary artery disease
* left ventricular ejection fraction higher than 40%

Exclusion Criteria:

* atrioventricular conduction disturbances
* previously ventricular arrhythmias requiring antiarrhythmic treatment
* atrial fibrillation with rapid ventricular response
* myocardial infarction or stroke within 6 months
* diabetes mellitus
* end-stage of obstructive or restrictive pulmonary disease
Exercise Duration Models, in Middle-aged Men

Duration of exercise is an important factor among the medical guides for weight loss. However, there is still little knowledge about other its models in middle-aged and older men. The present study aimed to determine the effects of the interval training on weight loss and lipid profile, and to compare its efficiency with the continuous training.

Participants included sedentary men (age 45-75 years) with overweight or obesity (n= 82). They were randomly divided into two groups including continuous exercise, and interval exercise. The weight assessment parameters including change in weight and body composition, blood sample tests were performed pre- and three month post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary lifestyle
* Good Health
* Weight stability

Exclusion Criteria:

Abnormality or history of Disease
Genetic Biomarkers of Executive Stress

The purpose of this study is to examine whether stress predicts telomere length in individuals who hold executive-level positions. Telomeres are the caps at the end of each strand of DNA that may affect how cells age. Subjects will complete an online survey/interview and provide one blood sample or saliva samples. The goal is to understand whether stress predicts genetic markers of longevity.

The primary aim of this study is to evaluate the relationship between overall levels of stress and telomere length. It is hypothesized that the high stress group (based on the Perceived Stress Scale)compared to low stress group will have shorter telomere length. A secondary aim is to evaluate whether different types of stress have differing degrees of association with telomere length. An exploratory aim is to assess for gender differences in the association between stress and telomere length. The investigators are collecting a number of other measures, including demographics, work sector, perceived social support, and medical history, in order to adjust for potential confounders in the analysis.

This study is an extension of earlier work Dr. Rasgon has done with Dr. Elizabeth Blackburn at UCSF on the relationship between telomere length and mood outcomes. The investigators hope this study will add to the growing body of literature on stress and genetic markers of longevity, specifically how stress level and type is associated with telomere length. The increased understanding gained through this study may provide leads for predicting age-related diseases and early mortality in adults, thus benefiting others in the future.

Eligibility Criteria:
Inclusion Criteria:

1. People of either gender \>18 years of age.
2. Subject hold executive-level position as defined as meeting the following criteria: having managerial responsibility over an organization or substantial part of an organization and/or having strategic influence over the direction of the organization
3. Subject or representative is willing to sign the consent for prior to enrollment into the study, and to participate in all aspects of the study. Prospective subject must give verbal assent if unable to sign written consent.
4. Adequate visual acuity to complete questionnaires.

Exclusion Criteria:

1. Subjects will be excluded if they have any of the following medical conditions:

   1. active heart disease
   2. acute psychiatric disorder (hospitalized in the past year)
   3. any medical condition deemed exclusionary by the Principal Investigator (PI)
2. Subject has a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within one year prior to screening.
3. Subject is currently taking any medication deemed exclusionary by PI.
4. Subject is pregnant, lactating, or planning to become pregnant during the study period.
5. Subject is participating or has participated in another research study within 30 days prior to the screening visit.
Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty

This is a prospective, randomized study from pre-surgery to 6 weeks post-surgery designed to detect changes in coagulability following elective total knee and hip arthroplasty. Patients will be randomized to one of the two standard prophylaxis treatments used at Sinai Hospital:

1. Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks, or
2. Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women age ≥ 18 years old
2. Total knee or total hip arthroplasty planned in the 60 days following study enrollment

Exclusion Criteria:

1. Pre-existing anti-coagulant therapy (Heparin, Lovenox, Arixtra, Warfarin, Xarelto, and all other non-mentioned anticoagulants) on admission
2. History of bleeding diathesis
3. Known active malignancy
4. Prothrombin time \>1.5 x control
5. Platelet count \< 100,000/mm3, hematocrit \< 30%, creatinine clearance \<30 mL/min
6. Immunosuppression, e.g., human immunodeficiency virus (HIV) infection, Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, Bacterial endocarditis
7. Major surgery within past 3 months of enrollment
8. Patients requiring bilateral arthroplasty
9. Body weight \<50 kg (venous thromboembolism prophylaxis only)
10. Unable to return to site for follow-up visit
The Wild Man Programme - a Nature-based Rehabilitation Enhancing Quality of Life for Men on Long-term Sick Leave

The aim of the present study is to examine whether the nature based 'Wild man Programme' can help to increase quality of life among men on sick leave compared to treatment as usual. Additionally, the study examines which natural environments best work as supportive environments in the rehabilitation.

Many men in Denmark have poor mental health and need help to recover. However, designing a rehabilitation intervention appealing to men is challenging. The 'Wild man Programme' is a rehabilitation programme for men on long-term sick leave and with clinical or self-reported stress due to prolonged health problems such as stress, anxiety, depression, cancer, chronic obstructive pulmonary disease (COPD), cardiovascular disease or diabetes. The programme is a nature-based rehabilitation (NBR) initiative combining nature experiences, attention training, body awareness training and supporting community spirit.

The aim of the present study is to examine whether the 'Wild man Programme' can help to increase quality of life among men on sick leave compared to treatment as usual. Additionally, the study examines which natural environments best work as supportive environments in the rehabilitation.

A matched control study comparing an intervention group (N=38) which receives a nine-week nature-based intervention to a control group (N=38) receiving case management as treatment as usual in the municipalities. Outcomes are measured at baseline (T1), post treatment (T2), and at follow-up 6 months post intervention (T3). The primary outcome is an improvement in quality of life and the secondary outcome is a decrease in stress level.

With the 'Wild man Programme' we investigate whether it is a model that can be implemented in the health system in Denmark to help men with different kinds of health problems improve their quality of life and stress levels. The programme can also deliver valuable information for future nature-based rehabilitation for women (Wild woman) and mixed gender groups. The project will also contribute with information on whether the method and the concept can be a valuable tool for health professionals in the health sector.

Eligibility Criteria:
The inclusion and exclusion criteria are similar for the two groups.

The inclusion criteria are:

* male gender
* 18 to 68 years of age
* clinical or self-reported symptoms of stress, anxiety, depression
* clinical diagnosis of cancer, cardiovascular disease, chronic obstructive pulmonary disease (COPD), diabetes or other kinds of chronic diseases
* ability to walk approximately three kilometers in nature
* ability to understand and speak Danish

The exclusion criteria are:

- psychosis or psychotic disorders, brain injuries or physical disabilities that prevent the participant from participating in the physical exercise programme or move about in nature
Validation of a Novel Frailty Index in Surgical Cohorts

This study will validate the utility of a novel frailty index that uses ICD diagnoses to call frailty severity in a surgical cohort of patients 65 and older


Eligibility Criteria:
Inclusion Criteria:

* Patients 65 years or older, undergoing any surgery at Landspitali University Hospital with an anesthesia team involved

Exclusion Criteria:

* No American Society of Anesthesiology classification provided
Caduet and TLC Intervention in Metabolic Syndrome

To evaluate the effectiveness of Caduet in addition to therapeutic life-style change (TLC) intervention in resolving metabolic syndrome fifty three individuals were randomized to TLC intervention study with or without Caduet therapy for 12 months. The participants underwent monthly visits with investigators to obtain vital signs, and to undergo TLC counseling. Metabolic parameters were measured before and after intervention.

Single center, investigator driven, double blinded, randomized with Caduet 5/10mg vs placebo. The participants visited with investigators on a monthly bases to evaluate the BP, weight, and obtain the waist measurements, and counseling. OGTT was performed at the beginning and the end of the study. Lipid and glucose parameters were measured 5 times in duration of the study period.

Exercise physiologists and dietitians completed the baseline evaluations and provided recommendations throughout the study period in person, via phone or e-mail: per subject preference. VO2 max was measured at the beginning and end of the study. Pedometers dispensed to encourage physical activity.

Eligibility Criteria:
Inclusion Criteria:

* BP ≥130/85
* Metabolic syndrome per NCEP-ATP III revised (3/5 criteria)
* Men and women age 40-65

Exclusion Criteria:

* Inability to sign a consent form.
* Unwillingness to complete the protocol for the duration of 15 months
* Unwillingness of primary care physician to participate in the program
* Patients already on hypercholesterolemia agent
* Fasting plasma glucose above 126 mg/dL or current treatment for diabetes.
* If the physician believes the patient should be started on antihypertensive regimen.
* Creatinine clearance \<50ml/min.
* Therapy with anticoagulants
* Pregnant/lactating women (pre-menopausal women should be on birth control pill)
* AST/ALT \> x3 upper limit of normal
* Evidence of cholelithiasis
* Use of oral anticoagulants
* Cancer
* Recent cardiovascular event (\<6months)
* Substance abuse
* Since there is no translator, non-English speaking subjects will not be enrolled in the study.
Neural Mechanism Underlying Social Cognition in Depressive Patients

In the project, investigators plan to test difference of social cognition between depressive patients and healthy individuals and the brain activation underlying the difference to further understand the neural mechanism of depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Age range between 18 and 60
* Education experience above high school
* Score for Hamilton's Depression Scale \>=17
* Diagnosis of depression through Scid

Exclusion Criteria:

* Undergoing electric shock treatment in 3 months
* Excluding those who with bipolar disorder
* Excluding those who with postpartum depression
* Excluding those who with hysteria