cyrilzakka/clinical-trials huggingface dataset:
Education Programme on Continuous Positive Airway Pressure Treatment

The purpose of this study is to examine whether an education programme would enhance continuous positive airway pressure (CPAP) adherence.

Obstructive sleep apnoea (OSA) is a common sleep disorders associated with excessive daytime sleepiness and cardiovascular disease. It is prevalent both in populations of western and eastern countries. Continuous positive airway pressure (CPAP) therapy is an effective standard treatment and is widely prescribed for patients with OSA. However, the use of CPAP for such patients is disappointingly low. Low patient CPAP adherence limits the effectiveness of treatment. To determine whether there is a need for an extended education programme for the OSA patient in order to improve CPAP usage.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or over.
2. Newly diagnosed of OSA and will be starting CPAP therapy

Exclusion Criteria:

1. Not suitable for CPAP therapy
2. Previously received CPAP therapy
3. Possesses restrictive and obstructive pulmonary diseases
4. Possesses hypoventilation
5. Under unstable health conditions
6. pregnant
7. History of psychiatric illness
Nitrogen Balance in Infants After Post Cardiothoracic Surgery

The objective is to the amount of protein infants require after cardiopulmonary bypass surgery.

Postoperative neonates are susceptible to the adverse effects of surgery that is characterized by a breakdown of body stores. Without appropriate nutritional consideration this process can lead to increased physiological instability. It has been extensively documented that critically ill patients are typically catabolic. This results in body nitrogen losses from the breakdown of somatic protein to fuel metabolic processes such as, gluconeogenesis. The evaluation of this catabolic response is particularly crucial in infants due to their limited fat and lean body mass reserves. Quantifying the amount of protein needed to maintain body composition and to meet the demands of surgical stress is of clinical importance when considering factors associated with postoperative morbidity, such as delayed wound healing, impaired growth and prolonged hospital stay.

The results obtained from this study will assist with determining an appropriate level of protein for the development of optimal nutrition prescriptions that are aimed at reducing catabolism of body stores.

Eligibility Criteria:
Inclusion Criteria:

* Clinical decision to initiate parenteral nutrition based on determination by medical team
* Gestational age ≥ 35 weeks
* Birth weight ≥ 2000 grams
* Indwelling urinary catheters for urine collection
* Central venous access for parenteral nutrition

Exclusion Criteria:

* Chromosomal abnormalities known to effect protein metabolism
* Hepatic failure defined as ALT and AST \> 500 UL with an INR \> 2.5, not accounted for by therapeutic anticoagulation
* Renal failure defined as creatinine 2x the upper limit of normal for age.
* Sepsis or suspected sepsis, defined as clinical suspicion or confirmation of a systemic infection treated with antibiotics
* Excessive blood loss from chest tubes (5 ml/kg/hr) that has not resolved within six hours following admission to the CCCU; as indicated by the need for frequent blood transfusion these subjects will be withdrawn from the study
* Requiring Extra Corporeal Membrane Oxygenation (ECMO) support
CPAP Reduces Hypoxemia After Cardiac Surgery

The aim of study is to evaluate whether the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.

We want to test the hypothesis that the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.

Primary end point: to reduce the rate of re-intubation.

Secondary end point: to reduce the incidence of atelectasis, pneumonia, sepsis, the mortality rate, the intensive care unit (ICU) and hospital length of stay.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing cardiac surgery on cardiopulmonary bypass
* PaO2 /FiO2 \< 200 after extubation
* extubation time \< 24 h.

Exclusion Criteria:

* patients \< 18 years old
* extracorporeal membrane oxygenation
* severe cardiac dysfunction (FE\<25%)
* mechanical ventilation before the intervention
* severe COPD (patients on oxygen therapy, with a FEV1\< 50%)
* heart or lung transplantation
* lack of consent.
Respiratory Muscle Contribution to Blood Pressure During Exercise

The investigators seek to understand how reflexes from the breathing muscles influence blood pressure during exercise. Furthermore, the investigators are determining if increasing breathing muscle strength (via inspiratory muscle training) influences the respiratory muscle contribution to blood pressure during exercise.


Eligibility Criteria:
Healthy participants with no history of cardiovascular, pulmonary, neurologic, orthopedic or other neuromuscular diseases.
VTEval Project - Prospective Cohort Studies to Evaluate and Improve Diagnostics, Management Strategies and Risk Stratification in VTE

Venous thromboembolism (VTE) with its two clinical manifestations deep vein thrombosis (DVT) and pulmonary embolism (PE) is a life-threatening disease that is associated with considerable morbidity and mortality. The incidence of VTE increases with age and it - as the third most common cardiovascular disease after ischemic heart disease and stroke - represents an important public health problem in industrialized countries with several aspects in need to be addressed.

VTEval Project includes three long-term prospective observational studies to evaluate and improve VTE diagnostics and management, treatment and outcome. The aims of the project include a systematic assessment of VTE, i.e. disease status (symptoms, clinical and subclinical aspects) and risk profiles (classic, psychosocial and environmental factors), using a system-oriented approach. VTEval collects three large prospective cohorts of patients with suspected and incident VTE consisting of individuals with a clinical suspicion of acute PE, individuals with a clinical suspicion of acute DVT, and individuals with incidental diagnosis of VTE).

The standardized and harmonized data acquisition of the study establishes a sustainable resource for comprehensive research on VTE, thus providing the basis for both short- and long-term analysis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and Informed written consent
* Clinical condition:

  * Cohort 1: Clinical suspicion of acute PE (with or without DVT)
  * Cohort 2: Clinical suspicion of acute DVT (without symptomatic PE)
  * Cohort 3: Incidentally diagnosed VTE
Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection

This study investigates the burden of disease among kidney transplant recipients that have developed Chronic Active Antibody Mediated Rejection (caAMR) compared with kidney transplant recipients that have not developed caAMR


Eligibility Criteria:
Inclusion Criteria:

Chronic Active AMR group:

* 18 Years and older
* Recipient of blood group system (ABO) compatible solitary kidney transplant between \[1Jan2013\] and \[1Jan2018\]
* Chronic active AMR diagnosed via kidney biopsy based upon Banff criteria. Patients who additionally have diagnoses such as TCMR, acute tubular necrosis, recurrence of primary kidney disease are also eligible if not the predominant pathology.
* DSA antibodies within prior 6 months of the biopsy which confirmed chronic active AMR
* Minimum of 3 years of follow up data following diagnosis of chronic active AMR (unless patient had died)
* eGFR at time of diagnosis of chronic active AMR of \>25ml/min/1.73m2

Non-Chronic active AMR group:

* Age 18 years or older
* Recipient of ABO compatible solitary kidney transplant between \[1 Jan 2013\] and \[1Jan2018\]
* No documented diagnosis of chronic active AMR during the data extraction period. Patients with other diagnoses such as TCMR, acute tubular necrosis, recurrence of primary kidney disease are also eligible. Patients may or may not have had biopsies.
* Minimum of 4 years of follow up data since transplant (unless patient has died)
* eGFR of \>25ml/min/1.73m2 at time of matching

Exclusion Criteria:

Chronic active AMR group:

* Recipient of a multi-organ transplant
* ABO-incompatible transplant
* Patient lost to follow up within the first 3 years post-diagnosis of chronic active AMR and whose allograft status (graft failure or patient death) is unknown.

Non-Chronic active AMR group:

* Recipient of a multi-organ transplant
* ABO-incompatible transplant
* Patient lost to follow up within the first 4 years of transplant and whose allograft status (graft failure or patient death) is unknown.
Therapeutic Metabolic Intervention in Patients With Spastic Paraplegia SPG5

The purpose of this project is to study the efficacy of three candidate molecules (Xenbilox, Tahor and Resveratrol) in order to decrease the production of oxysterols by reducing the synthesis of cholesterol and/or regulate the production of bile acids and/or enabling neuroprotective action within the motor neuron.

The primary objective of the study is:

- decrease the accumulation of metabolites which can have a negative impact on neurological and systemic function of patients with SPG5.

The secondary objectives of the study are:

* confirm the clinical and biological tolerance of the different candidate molecules under study
* improve the serum bile acid profile of patients with SPG5

Eligibility Criteria:
Inclusion Criteria:

* patients that have confirmed through genetic testing their status as carriers of 2 mutations in the CYP7B1 gene
* age ≥ 18 years
* patients that have signed the informed consent form
* presence of health care coverage

Exclusion Criteria:

* known hypersensitvity to chenodeoxycholic acid, atorvastatin, resveratrol or to any of their byproducts
* cholesterol lowering medications other than the study treatment
* hepatic failure with transaminases \>3 times the normal level
* progressive biliary pathology
* chronic diarrhea
* serious mental illness
* significant comorbid neurological disorder
* incapacity to understand information about the protocol
* unwilling or unable to participate in any part of the study
* participation in another clinical trial during the study period
* person deprived of liberty by judicial or administrative decision
* adult subject under legal protection or unable to consent
* pregnant or breastfeeding women
* lack of health care coverage
* absence of a signed informed consent form
Mobile and Digital Application in Heart Failure Networks Berlin/Brandenburg

The MobiDig trial is designed to evaluate an implementation of a mobile phone application with secondary preventive/rehabilitative modules for patients with heart failure in certified Heart Failure Unit centers in Berlin and Brandenburg.

The aim is to evaluate the effect on quality of life, symptoms and the course of the disease. In addition, the acceptance, adherence and user behavior as well as the implementation potential for a permanent introduction of the application in national heart failure networks will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of heart failure
* Treatment in a certified Heart Failure Unit center in Berlin or Brandenburg
* Written informed consent of the participants
* User of a mobile device with an iOS operating system

Exclusion Criteria:

* Addiction or other illnesses that do not allow the participants to assess the nature and scope as well as possible consequences of participation or its scientific evaluation
* insufficient knowledge of the German language, which is necessary to use the application
Live Well: A Practical and Effective Low-Intensity Dietary Counseling Intervention for Use in Primary Care Patients With Dyslipidemia

The purpose of this study was to evaluate the effects on lipids and diet of a low-intensity dietary counseling intervention provided by the primary care physician (PCP), in patients at risk for cardiovascular diseases

The objective of this study is to design and evaluate the feasibility and the effect on diet quality and blood lipids a new dietary counseling intervention that will be sustainable in the "real-world" settings of the current clinical practice. The intervention will be initiated by the primary care physician during the routine office visits and will use paper and web-based counseling materials. Internet based healthcare, or e-healthcare, is a consumer focused health care delivery paradigm that physicians and the healthcare system can no longer ignore. Lifestyle counseling and preventive medicine are potentially ideal areas of patient care that could be provided efficiently through this emerging venue of healthcare delivery. Internet access is near-universal for Americans under the age of 60: 90% of 18-29 year-olds, 85% of 30-49 year-olds, and 70% of 50-64 year-olds.

The aims of this study are: 1) - develop a patient self-administered, computerized version of the paper-based Rate-your-Plate dietary screening Questionnaire; 2) - create counseling materials on diet and cholesterol and build a secure, HIPAA compliant, interactive web-based counseling application that will allow patients to receive personalized counseling base on the results of the screening dietary questionnaire and the goals chosen by the patients; 3) - to test the feasibility of this intervention in the clinical settings of primary care, and evaluate its effect on lipids panel at 3 and 6 months .

Eligibility Criteria:
Inclusion Criteria:

* Eligibility required documentation of a LDL-cholesterol level of 130 mg/dL or higher within the 12 months prior to enrollment. Potential subjects were also required to have access to the Internet and an active email account. The use of lipid lowering drugs was not an exclusion, but patients taking these drugs had be on the same medication and dose for at least 3 months prior to enrollment, with no changes anticipated for the duration of the trial.

Exclusion Criteria:

* We excluded patients with poorly controlled diabetes mellitus (defined by HbA1c\>9%), serum creatinine above 1.5 mg/dL, malignancy, cirrhosis, eating disorders, acute coronary syndrome in the last three months, congestive heart failure NYHA class lll and lV, ongoing warfarin therapy, uncontrolled hypo- or hyperthyroidism, ongoing weight loss, history of bariatric surgery, pregnant women, and patients who scored more than 250 (on a scale of 100 to 300) on a food frequency questionnaire administered on the day of enrollment. Patients with a history of triglycerides \>400 mg/dl were also excluded, since we used the Friedewald formula \[LDL-C=Total cholesterol-(TGs/5+HDL-C)\] to calculate LDL-cholesterol levels.
The Effects of Anodal and Cathodal tDCS Combined With Conventional Physical Therapy in Patients With Acute Stroke

The objective of the study is thus to compare the effects 5 consecutive sessions of anodal and cathodal tDCS combined with conventional physical therapy on upper and lower limb motor performance in acute stroke at immediate, and 1-month followup.

Stroke is a major cause of long-term disability in stroke survivors that related with motor impairment. After stroke, the cortical excitability of ipsilesional hemisphere is decreased; in contrast, the cortical excitability of contralesional hemisphere is increased. Conventional physical therapy is beneficial to motor recovery, but early rehabilitation was not always help the patients get full recovery. tDCS is an adjuvant tools which deliver weak direct current through scalp to promote motor recovery in stroke rehabilitation. The anodal-tDCS increases cortical excitability, while the cathodal-tDCS decreases cortical excitability. Previous studies demonstrated that both monocephalic techniques of tDCS can improve motor function in chronic, subacute, and acute phase, but it is still inconclusive that which monocephalic montages had better effect, especially in acute phase. There are several studies supported the benefits of monocephalic tDCS combined with rehabilitation programs on upper and lower limbs motor function in acute stroke. However, there is no evidence that directly compared the effect of monocephalic tDCS in acute stroke patients. The objective of the study is to compare the effects of anodal and cathodal tDCS combined with conventional physical therapy for 5 sessions on motor performance in acute stroke at immediate, and 1-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Acute ischemic stroke patients who have aged between 18 and 75 years
2. Having a first ever-ischemic stroke that are confirmed by MRI/CT scan
3. Post stroke onset 2-10 days
4. Be able to follow command
5. Be able to walk with or without assistive device (Modified Ranking Scale ≤ 4)
6. Free of any neurological antecedent or unstable condition (such as epilepsy) or cancer.
7. Be able to initiate the upper limb movement

Exclusion Criteria:

1. Recurrent stroke
2. National Institute of Health Stroke Scale ≥ 20 points
3. Presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker
4. Having excessive pain in any joint of the lower limb (numerical pain rating score \> 4/10)
5. Having an open wound or wound infraction on scalp
6. Having neglect or psychological diseases (such as schizophrenia, major depression)
Interleukin-2 Plus Interferon Alfa in Treating Adults With Metastatic Cancer

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill metastatic cancer cells. Interferon alfa may interfere with the growth of the cancer cells. Combining interleukin-2 and interferon alfa may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of interleukin-2 plus interferon alfa in treating adults with metastatic cancer.

OBJECTIVES: I. Determine the response rate, failure-free survival, and overall survival of interleukin-2 and interferon alpha administered subcutaneously on an outpatient basis for 8 weeks to patients with metastatic cancer. II. Determine the toxicities associated with this therapy.

OUTLINE: Biological Response Modifier Therapy. Interleukin-2 (Cetus), IL-2, NSC-373364; Interferon alpha (Schering), IFN-A, NSC-377523.

PROJECTED ACCRUAL: Up to 30 patients with various malignancies will be entered.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed metastatic cancer of any type Measurable or evaluable disease required, i.e.: Bidimensionally measurable lesions on physical exam, x-ray, CT, MRI, or other radiologic procedure Any lesion apparent on radiologic exam that is not measurable in 2 perpendicular diameters Previously irradiated lesions acceptable provided subsequent progression is documented No active brain metastases Previously treated brain metastases allowed provided measurable/evaluable disease exists outside the CNS

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: (within 14 days prior to entry) WBC at least 3,000 Platelets at least 100,000 Hematocrit at least 30% (may be transfused) Hepatic: (within 14 days prior to entry) Bilirubin less than 2.0 mg/dl PT and PTT normal Renal: (within 14 days prior to entry) Creatinine less than 2.0 mg/dl Cardiovascular: No MI within 6 months No medication for arrhythmia No medication for CHF Hypertension that is stable off medication allowed Pulmonary: pO2 at least 60 mm Hg in patients with primary lung cancer or symptomatic pulmonary disease Reasonable respiratory reserve No dyspnea at rest No requirement for supplemental oxygen Other: No familial history of malignant hyperthermia No chronic underlying immunodeficiency disease No HIV seropositivity No active infection requiring antibiotic therapy No other serious intercurrent illness No concurrent malignancy No pregnant or nursing women Adequate contraception required of fertile women

PRIOR CONCURRENT THERAPY: No concurrent therapy with other anticancer agents No concurrent immunosuppressive agents (e.g., cyclosporin) Biologic therapy: Prior interferon alpha allowed Chemotherapy: At least 4 weeks since systemic chemotherapy with recovery required Endocrine therapy: No concurrent corticosteroids Radiotherapy: At least 4 weeks since radiotherapy Surgery: Adequate recovery required Other: No prior organ allograft
Treatment of Cortical Myoclonus With Repetitive Transcranial Magnetic Stimulation

Myoclonus is a condition related to epilepsy of involuntary twitching or jerking of the limbs.

The purpose of this study is to determine if stimulation of the brain with magnetic pulses can decrease myoclonus. Researchers believe that this may be possible because in studies on normal volunteers, magnetic stimulation made areas of the brain difficult to activate for several minutes. In addition, early studies on patients with myoclonus have shown magnetic stimulation to be effective at decreasing involuntary movements.

Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that can be used to stimulate brain activity and gather information about brain function. It is very useful when studying the areas of the brain and spinal cord related to motor activity (motor cortex and corticospinal tract). Repetitive transcranial magnetic stimulation (rTMS) involves the placement of coil of wire (electromagnet) on the patient's scalp and rapidly turning on and off the electrical current. The changing magnetic field produces weak electrical currents in the brain near the coil. This permits non-invasive, relatively localized stimulation of the surface of the brain (cerebral cortex). The effect of magnetic stimulation varies, depending upon the location, intensity and frequency of the magnetic pulses.

Researchers plan to use rTMS for 10 days on patients participating in the study. The 10 day period will be broken into 5 days of active repetitive magnetic stimulation and 5 days of placebo "ineffective" stimulation. At the end of the 10 day period, if the results show that rTMS was beneficial, patients may undergo an additional 5 days of active rTMS.

Repetitive transcranial magnetic stimulation (rTMS) at frequencies in the single Hz range causes a decrease in the excitability of the primary motor cortex and there is preliminary evidence that it can suppress abnormal excess cortical activity. We plan to test 1 Hz rTMS as treatment for cortical myoclonus.

Eligibility Criteria:
Age 5 to 90 with severe cortical myoclonus.

No intracranial metal hardware (excluding dental fillings), pacemakers, indwelling medication pumps, cochlear implants, intracardiac lines, significant intracranial masses or increased intracranial pressure.

Subject must not be pregnant.