cyrilzakka/clinical-trials huggingface dataset:
Noninvasive Positive Pressure Ventilation in Overlap Syndrome

Chronic obstructive pulmonary diseases (COPD) coexisting with obstructive sleep apnea is called overlap syndrome (OS). Patients with OS seem to have worse prognosis than patients with only one disorder. Noninvasive positive pressure ventilation is an efficient treatment in obstructive sleep apnea, but the effectiveness in improving outcomes of OS patients is still not fully investigated. The aim of this non-randomized concurrent control trial is to evaluate noninvasive positive pressure ventilation's effectiveness in OS patients.


Eligibility Criteria:
Inclusion Criteria:

* patients with COPD and sleep apnea dyspnea syndrome

Exclusion Criteria:

* patients with non-stable hemodynamics;
* patients with limited life expectancy;
* patients with other severe respiratory diseases;
* patients with motor neuron diseases;
* patients with contraindications for NIPPV
Cerebral and Peripheral Near Infrared Spectroscopy Monitoring in Low and High Flow Anaesthesia in Pediatric

To investigate the effects of non-invasive cerebral and peripheral NIRS monitoring and low and high flow sevoflurane anaesthesia on cerebral and peripheral NIRS in paediatric patients. To determine the effects of two different flows on these monitoring techniques and thus to facilitate intraoperative patient monitoring and to predict complications (hypoxia) that may occur.

The study will involve American Society of Anesthesiologists Physical Status Classification (ASA) I-III risk group patients, aged between 2 and 12 years, who will under go general anesthesia with a surgical procedure time of 1 hour or more, and who will undergo pediatric surgery, orthopedic and urological surgery, will be included in the study. Preoperative patients' age, gender, height, weight, ASA score and operation type information will be recorded. Patients will be randomized by the sealed envelope method and divided into 2 groups: Low-Flow Anesthesia (LFA) and High-Flow Anesthesia (HFA) groups.

Two groups will undergo NIRS monitoring alongside routine ASA monitoring. Cerebral NIRS probe will be attached to the right and left frontotemporal region, and a peripheral NIRS probe will be attached to the inner surface of the forearm and the basal values will be noted.

Eligibility Criteria:
Inclusion Criteria:

* Between 2-12 years of age, those who are planned to undergo pediatric surgery, orthopedic and urological surgery, and whose procedure time is 1 hour or more
* ASA I-III risk group
* Patients who agreed to be included in the study
* Patients whose informed consent form is approved by their parents will be included in the study.

Exclusion Criteria:

* Patients who do not want to participate in the study
* Patients with ASA score above III
* ASA III patients with decompensated cardiac and pulmonary disease
* Patients with neurological sequelae
* Cases with an operation duration of less than 1 hour
* Patients with contraindications to the use of any anesthetic drugs
* Patients for whom low-flow anesthesia is contraindicated

  * Smoke and gas poisoning
  * Malignant Hyperthermia
  * Septic Shock
  * CO2 absorbent depletion
  * Insufficient oxygen monitoring
* Laparoscopic surgeries
* Patients who develop unexpected intra-operative surgical complications
* Patients whose parents do not approve the informed consent form will not be included in the study.
Diagnosing Minimal Hepatic Encephalopathy

Our purpose is to

1. Examine the correlation between MDF in a resting EEG, recorded just before the CRT test, and the variance in reaction times indicated by the CRT index
2. At simultaneous CRT and EEG recording, examine whether a change in EEG is seen immediately before an extended reaction time occurs (defined by the 75th percentile). This will shed light on a direct pathophysiological association between what is measured with EEG and CRT.
3. Investigate whether cyclicity can be detected in the continuous reaction times and if so, whether amplitude and wavelength in this cyclic activity are correlated to EEG parameters.
4. Examine whether a response to standard HE treatment can be detected with EEG in patients who are thought to suffer from it. As well as if baseline outcome predict future hepatic encephalopathy.
5. With a view to further validating our findings, investigators want to correlate results from EEG and CRT with the most internationally widespread psychometric test, the Portosystemic Encephalopathy test (PSE), which necessitates the establishment of Danish normal values. A secondary purpose of this study is therefore
6. To establish Danish normal values for the PSE test and the Animal Naming test in Danes


Eligibility Criteria:
Inclusion criteria for patients with liver cirrhosis:

1. Age\> 18
2. Liver cirrhosis verified by biopsy or appropriate clinic and biochemistry as well as imaging.
3. Written informed consent
4. Speaks and understands Danish

For the subgroup with liver cirrhosis and normal cognition:

1. Normal result in PSE and CRT testing and clinical examination without evidence of HE

   For the subgroup with liver cirrhosis and minimal hepatic encephalopathy:
2. Abnormal result in PSE and / or CRT test, but oriented in time, place and own data.

   For the subgroup with liver cirrhosis and HE grade 2, the following applies:
3. Abnormal PSE and CRT result and / or disoriented in time, place or own data and / or asterixis or other clinical symptoms of HE
4. Ability to collaborate on the performance of CRT test, PSE test and EEG

Inclusion criteria healthy:

1. Liver healthy
2. Age over 18 years
3. Formal education ≤ 14 years
4. Written informed consent
5. Speaks and understands Danish

Inclusion criteria for pre-cirrhosis liver disease:

As for healthy controls plus:

1. In our local outpatient clinic
2. Proven pre-cirrhosis liver disease

Exclusion Criteria:

1. Organic brain disease (eg previous epilepsy, apoplexy, dementia)
2. Hyponatraemia (Na \<124 mmol / L)
3. Sepsis one week prior to tests.
4. Heart failure (EC less than 30% or NYHA class III and IV)
5. Severe chronic obstructive pulmonary disease (GOLD stage 3 and 4 ie FEV1 / FVC below 0.7 and FEV1 \<50% of expected value)
6. Highly controllable diabetes (HbA1C\> 60 mmol / mol)
7. Renal failure (eGFR below 60)
8. Known neurological diseases (epilepsy, stroke, dementia)
9. Intake of coffee or alcohol 6 hours before tests and change of dose in psychoactive drugs within 6 days of the test (morphine, antipsychotics, antidepressants) -
One-year Results After Single-center Water Vapor Thermal Therapy for Symptomatic Benign Prostatic Hyperplasia.

Objective: Rezūm vapor ablation is a minimally invasive treatment for benign prostatic hyperplasia (BPH) that uses injections of sterile water vapor directly into the prostate for tissue ablation. Although Rezūm is currently indicated for use in men with prostate sizes ≥30 and ≤80 ml, it is unclear how effective Rezūm is for men in urinary retention. The investigators sought to determine whether Rezūm is effective in the treatment of catheter-dependent urinary retention secondary to BPH.

The data of participants who underwent Rezūm operation with the diagnosis of BPH between 2021 and 2023 were evaluated retrospectively. The investigators evaluated procedure details and evaluated pre- and post-Rezūm (including International Prostate Symptom Score (IPSS), IPSS quality of life (IPSS-QOL), prostate volumes, maximum flow (Qmax), post-void residual urine volume, IEEF-5, ejaculation dysfunction). The investigators examined variables at 6 and 12 months).

Eligibility Criteria:
Inclusion Criteria:

-Benign prostatic hyperplasia

Exclusion Criteria:

* Prostate cancer
* Parkinson's disease,
* Neurogenic bladder
* Overactive bladder
* Bladder calculus,
* Bladder Tumor
* Urinary infection
* Alzheimer's disease
The Long Term Impact of Initiating Pramipexole Versus Levodopa in Early Parkinson's Disease (CALM-PD Cohort Study)

To determine the long-term consequences (8 years) of initiating patients with Parkinson's disease on either pramipexole or levodopa. We hypothesize that patients initiating therapy with pramipexole compared with levodopa will demonstrate less self-reported disability as measured by the Modified Schwab and England (S/E) scale 8 years after randomization.


Eligibility Criteria:
Inclusion Criteria:

* Available 301 subjects enrolled in the CALM-PD study.

Exclusion Criteria:

* Those not enrolled in the CALM-PD study.
Paricalcitol Injection Phase II Trial

The PK and tolerability of paricalcitol after repeated intravenous administration for 2 weeks (total 6 doses at every HD session) are studied in subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal failure.

The purpose of this study is pharmacokinetic \& tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal failure

Exclusion Criteria:

* Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study
Biomechanical Properties and Their Association With Balance and Functional Mobility in Children With Cerebral Palsy

This study aimed to investigate the differences in the biomechanical properties of the dorsal trunk and lower extremity muscles of children with unilateral spastic cerebral palsy compared with their typically developing peers, and the effect of these biomechanical properties on balance and functional mobility performance.


Eligibility Criteria:
Inclusion criteria for unilateral spastic cerebral palsy were:

* aged between 4 and 12 years,
* spasticity level MAS≤2,
* mental level sufficient to understand commands given,
* and ambulation without the use of an orthosis or other device. In addition, children had to be GMFCS level I or II.

Exclusion criteria were:

* a history of spinal surgery or spinal orthosis use,
* uncorrected vision or hearing problems,
* severe epileptic seizures,
* lower extremity contractures,
* botulinum toxin A injection in the previous six months,
* lower extremity surgery in less than one year,
* use of pharmacological agents that affect muscle tone,
* and poor cooperation.

Inclusion criteria for controls were:

* aged between 4 and 12 years,
* no neurological or orthopaedic diagnosis,
* no known systemic problems,
* normal vision and hearing,
* and a mental level sufficient to understand the commands given.
First in Man Study of the JenaValve TAVI Plus System Transfemoral

The objective of this study is to evaluate feasibility, safety and effectiveness of the first generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus System- Transfemoral) in an elderly patient population with severe aortic stenosis who are at high risk for surgical aortic valve replacement.

The study is designed as a prospective, multi-center trial conducted at 2 centers in Germany enrolling up to 12 subjects. Each patient will be followed for 2 years. The last patient's follow-up will end in February 2016. It is planned that the study will end in June 2016. Study endpoints are defined in accordance with the "Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium (VARC-2)". These endpoint definitions combine the expertise of surgeons, interventionalists, medical cardiologists, clinical trial and other specialists and allow for comparison of different trials concerning effectiveness and safety in TAVI.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with severe native aortic valve stenosis
* NYHA functional class II or higher
* Increased risk for surgical aortic valve replacement
* Comply with post-operative follow-up visits and requirements

Exclusion Criteria:

* Combined aortic valve disease with severe aortic insufficiency
* Presence of moderate mitral insufficiency or previous mitral prosthesis
* Severe pulmonary hypertension
* Congenital uni- or bicuspid aortic valve
* Endocarditis or active infection
* Life expectancy \< 12 months
* Need for emergency surgery for any reason
Effect of 4 Weeks Treatment With Acipimox in Patients With Chronic Heart Failure

The primary objective of this study is to evaluate whether metabolic modulation improves left ventricular function, work capacity, insulin sensitivity and modifies substrate metabolism in chronic heart failure


Eligibility Criteria:
Inclusion Criteria:

* EF\<40 %
* IHD
* NYHA-class II-III.

Exclusion Criteria:

* pregnancy
* severe renal failure
* new brady- or tachyArrhythmia
* Severe stenotic valvular disease
* myocardial infarction within last 6 weeks
* insulin treated diabetes mellitus
* peptic ulcer
* pregnancy or lactating women
* allergy towards tested medicine
Retrospective Follow-up of Synvisc® in Active Patients With Knee Osteoarthritis

Retrospective collection of data, aimed at a better knowledge of the context of use of Synvisc® among the patients practising a regular activity (professional/leisure), and at evaluating the different practices and their results.


Eligibility Criteria:
Inclusion Criteria:

* use of Synvisc®
* patients practising a regular activity (professional/leisure)

Exclusion Criteria:

* none
Nutrition and Physical Activity Intervention in Preventing Excess Weight Gain in Pediatric Patients With Leukemia or Lymphoma Treated With Prednisone and/or Dexamethasone

This trial studies how well a nutrition and physical activity intervention works in preventing excess weight gain in pediatric patients with leukemia or lymphoma treated with Treated with prednisone and/or dexamethasone. A nutrition and physical activity intervention may help develop healthier eating habits and prevent rapid excess weight gain in pediatric patients with leukemia or lymphoma who are receiving prednisone and/or dexamethasone.

PRIMARY OBJECTIVES:

I. To evaluate if a nutrition counseling intervention will prevent an increase in waist circumference from baseline measurements for children/adolescents diagnosed with leukemia or lymphoma and being treated with prednisone and/or dexamethasone.

SECONDARY OBJECTIVES:

I. To conduct qualitative research on diet habits, likeability of low-fat and-low sucrose foods.

II. To conduct qualitative research on exercise habits and willingness to engage in moderate walking.

III. To assess receptivity to electronic dietary and physical activity (PA) interventions in pediatric cancer patients and survivors (PCPSs) and their parents.

IV. To determine if nutrition interventions will prevent an increase in body mass index (BMI) from baseline measurements for children/adolescents diagnosed with leukemia or lymphoma and being treated with prednisone and/or dexamethasone.

V. To determine if a nutrition counseling intervention will help maintain or decrease triglyceride and cholesterol levels, prevent abnormal values of hemoglobin A1C and improve absolute lymphocyte counts (ALC) from baseline measurements for pediatric leukemia or lymphoma patients, receiving prednisone and/or dexamethasone therapy.

VI. To evaluate caloric intake, nutritional parameters and oxidative stress in pediatric leukemia or lymphoma patients receiving prednisone and/or dexamethasone therapy.

VII. To evaluate responses to various energy balance interventions.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients attend 13 nutrition counseling sessions over 45 minutes each for 1 year. Patients may receive nutrition handouts.

ARM II: Patients attend 2 tasting sessions for low-fat and low-sugar recipes and complete 2 PA sessions over 1 hour for each session.

Eligibility Criteria:
Inclusion Criteria:

* Leukemia or lymphoma patient at MD Anderson Children's Cancer Hospital
* Patients receiving prednisone and/or dexamethasone therapy at MD Anderson Children's Cancer Hospital at time of enrollment
* Karnofsky performance status greater than or equal to 70
* Must be cleared by treating oncologist to participate in study
* Must live close enough to attend measurement sessions at one of the clinical centers

Exclusion Criteria:

* Patients receiving nutrition counseling or weight management counseling elsewhere
* Pediatric patients who are already receiving steroids that are not part of treatment
* History of psychological disorders as indicated in the medical record (eg: eating disorders, depression)
PICSO in Patients With STEMI Treated by Primary Percutaneous Coronary Intervention

A prospective multi-center study in which patients with an acute heart attack (in the left anterior descending artery) with ECG changes (ST segment elevation) receive angioplasty followed by stent placement and 90 minutes of PICSO treatment. This is a proof of concept study designed to document the safety and feasibility of the Pressure Controlled Intermittent Coronary Sinus Occlusion (PICSO) Impulse system.


Eligibility Criteria:
Inclusion Criteria:

* First time anterior STEMI defined by the following:

  * Symptoms of myocardial ischemia \> 30 minutes and \< 12 hours
  * ST-segment elevation \> 1mm (\> 0.1 mV) in two contiguous precordial leads in the anterior territory on a 12-lead ECG
* Uncomplicated PCI of a LAD culprit lesion (defined as angioplasty followed by stent placement or direct stenting without the occurrence of an adverse event(s) that would preclude further study participation, such as major bleeding, perforation, hypotension, pulmonary edema or instability that in the judgement of the investigator preclude participation in the trial)

Exclusion Criteria:

* Younger than 18 years of age
* Hospitalization with a primary diagnosis of acute myocardial infarction (AMI) previously or has evidence of previous Q-wave infarct
* Left main coronary artery culprit lesion
* Additional stenosis in the LAD for which PCI or CABG is likely to be needed in the next 6 months and which is not treated during the index procedure
* Cardiogenic shock (systolic blood pressure ≤90 mmHg in spite of conservative measures) or pulmonary edema (O2 saturation \<90% by pulse oximetry and the presence of rales or crackles)
* Cardiac arrest requiring chest compression or resuscitation
* Anatomical complications limit capacity to place PICSO Impulse device or achieve stable catheter placement or occlude coronary sinus
* Known renal disease (GFR \< 30 mL/min/1.73m2) or dialysis
* History of stroke, TIA or reversible ischemic neurological disease within last 6 months
* Left bundle branch block
* Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.)
* Presence of any lead in the coronary sinus
* Active or treated malignancies in the last 12 months
* Previous coronary artery bypass graft surgery
* Known severe anemia (Hgb \< 10 g/dL or \< 6.2 mmol/L)
* Known platelet count \< 100,000, known coagulopathy or bleeding diathesis, or unwilling to accept transfusions
* Participation in another ongoing clinical study
* Women of child-bearing age
* Non-cardiac comorbidities and life expectancy \< 1 year
* Legal incompetence
* A condition that, in the opinion of the Investigator, precludes participation, including compliance with all follow-up procedures
* No dependents neither to the sponsor nor to the investigator
Performance of an Investigational Blood Glucose Monitoring System in a Clinical Trial

Subjects with diabetes and study staff used an investigational blood glucose monitoring system.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years of age and above
* Diagnosed as having type 1 or type 2 diabetes
* Currently self-testing blood glucose at home for at least three months
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Gestational Diabetes
* Hemophilia or any other bleeding disorder
* Employee of competitive medical device company
Exercise in Peripheral Artery Disease

This research project aims to investigate the gender-based difference in patients with peripheral artery disease. To attend this, this study has two specific objectives:

Objective 1: To identify gender-specific barriers towards exercise and physical activity in patients with peripheral artery disease (PAD).

Objective 2: To evaluate gender-specific differences in functional capacity and cardiovascular function and regulation in patients with PAD at rest, during and following a single session of maximal exercise.


Eligibility Criteria:
Inclusion Criteria:

* Ankle-brachial index (ABI) ≤ 0.9 in one or two legs
* Fontaine stage II of PAD
* Body mass index \<35 kg/m2
* Resting systolic blood pressure (BP) \<160 mmHg and diastolic BP \<105 mmHg
* Ability to walk at least 2min at 3.2 km/h
* Ability to undertake an incremental treadmill test
* Decrease of at least 15% in ABI after a maximal treadmill test
* Not currently engaging in any regular exercise program

Exclusion Criteria:

* Exercise induced signs of myocardial ischemia or complex ventricular arrhythmias
* Cardiovascular autonomic neuropathy
* Use of beta-blocker
* Nondihydropyridine calcium antagonists or insulin and hormone replacement therapy
The Effect of Leptin A-200, Caffeine/Ephedrine and Their Combination Upon Weight Loss and Body Composition in Man

The purpose of this study is to compare three treatments to see which causes the most weight loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol.

Three treatments are compared to see which causes the most weight loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol.

1) Leptin A-200 injections daily with 2 inactive pills taken three times a day, 2) Caffeine with ephedrine pills taken 3 times a day with an inactive injection daily and 3) Both Leptin A-200 injections daily and caffeine with ephedrine pills taken three times a day.

Eligibility Criteria:
Inclusion Criteria:

* You are healthy.
* You are not pregnant or nursing.
* You are between 18 and 60 years of age.
* You have a body mass index, calculated from your height and weight, of 30 to 40 kg/m2.

Exclusion Criteria:

* You take chronic medications except hormone replacement or contraception.
* You are a woman and are unwilling to use effective contraception during the trial.
* You have blood pressure higher than 150/90.
* You have heart disease.
* You have urinary symptoms from an enlarged prostate.
* You have gained or lost more than 10 pounds in the last 6 months.
* You have used a monoamine oxidase inhibitor medication in the last month.
* You have high or low thyroid function that has not been controlled in the normal range for at least 2 months.
* You have heart disease or a history of stroke.
* You have a known sensitivity to E. coli or E. coli derived products.
Electric Toothbrush Efficacy in Preventing Dental Plaque Development

The present study will be the first to compared dental plaque quantitation between an oscillating-rotating electric toothbrush and a manual toothbrush with a new QLF technology.

This is a randomized controlled trial of 12-weeks duration designed to assess whether a new commercially available oscillating-rotating electric toothbrush can objectively improve dental plaque parameters obtained via light induced fluorescence (QLF) technology. The study will be conducted in a dental clinic in Italy

Eligibility Criteria:
Inclusion Criteria:

* healthy adult (aged 18-50 years)
* non-smokers
* without clinical signs of periodontitis with at least 10 natural anterior teeth in total (cuspid to cuspid and lower and upper jaw).

Exclusion Criteria:

* significant oral soft tissue pathology or any type of gingival overgrowth other than plaque-induced gingivitis,
* with fixed and removable orthodontic appliances or removable dentures,
* with any other medical condition that, in the opinion of the principal investigator, would jeopardize the participant's safety or diminish the validity of study results