cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a Physical ACtivity Coaching Intervention Using E-Health for COPD Patients in Pulmonary Rehabilitation

The goal of this randomized controlled trial is to evaluate the efficacy of a physical activity coaching intervention - delivered through an eHealth platform both during and after pulmonary rehabilitation - to enhance physical activity levels and health-related outcomes in patients with Chronic Obstructive Pulmonary Disease (COPD). All participants will attend the pulmonary rehabilitation program for 2 months; the experimental group will receive a physical activity coaching intervention at the end of the 1st month of the rehabilitation program, which will continue for 6 months following the completion of the program. Assessments will be conducted at the beginning, midway, and at the end of the coaching program, as well as 3 months and 6 months after its conclusion.

This randomized controlled trial aims to evaluate the efficacy of a physical activity coaching intervention - delivered through an eHealth platform, both during and after pulmonary rehabilitation - to enhance physical activity levels and health-related outcomes in patients with Chronic Obstructive Pulmonary Disease (COPD).

All participants will attend the pulmonary rehabilitation program for 10 weeks. At week 5 of the rehabilitation program, the experimental group will receive a physical activity coaching intervention, which will continue for 6 months following its completion. This intervention will include an eHealth platform divided into two applications (a mobile app for patients and a web app for researchers/healthcare professionals).

Goal setting and progression according to patients' performance and willingness to increase will occur every week, through phone calls. Barriers to physical activity and strategies to overcome them will be identified between the patient and researcher, during the goal-setting moments. Notifications about PA goals achievement and incentives will be sent to patients during the intervention.

The assessment moments will be conducted at the beginning, midway, and end of the pulmonary rehabilitation program, as well as 3- and 6 months after its conclusion.

Eligibility Criteria:
Inclusion criteria:

* age \> 40 years old
* diagnosis of COPD according to GOLD criteria, clinically stable (i.e., with no exacerbations in the previous month)
* being enrolled in a pulmonary rehabilitation program
* having a smartphone with access to the internet
* being able to understand and provide informed consent.

Exclusion criteria:

* simultaneous participation in another behavioural modification program
* having any clinical condition that precludes participation in a PA intervention (e.g., severe musculoskeletal or neurological disorders and unstable cardiovascular disease)
* another primary respiratory disease
* history of recent neoplasia (including last treatment) in the previous year.
Regional Anaesthesia

Spinal anesthesia is an established technique used in obstetric surgeries, It provides adequate analgesia both intra and post-operative and also avoids complications associated with general anesthesia for mother and fetus. The quality of spinal anesthesia has been reported to be improved by using additives Dexmedetomidine is a highly selective α2-adrenoreceptor agonist that has been introduced to anesthesia. It produces dose-dependent sedation, anxiolysis, and analgesia without respiratory depression. Neostigmine is an anticholinesterase agent, which inhibits the hydrolysis of acetylcholine by competing with acetylcholine for attachment to acetyl cholinesterase; administration of Neostigmine through intrathecal route apparently activates the descending pain inhibitory system that relies on spinal cholinergic interneuron. Study conducted to evaluate whether neostigmine given by intrathecal route with 0.5% hyperbaric bupivacaine for spinal anesthesia can provide prolongation of sensory blockade duration as effective as dexmedetomidine given by the same route and in compination with same drug with lower cost, more stable hemodynamics and comparable side effects. After obtaining Institutional Ethics Committee approval and written informed consent,54 patients American Society of Anesthesiologist (ASA) physical status I and II were enrolled into the study and were randomlyassigned into 3 groups. Group 1were received 10 mg (2ml) hyperbaric bupivacaine and 0.1 ml (10 μg) DXM and 0.1 ml normal saline, Group 2 were received 10 mg (2ml) hyperbaric bupivacaine and 0.1 ml (50 μg) neostigmine and 0.1 ml normal saline and Group 3were received 10 mg (2ml) hyperbaric bupivacaine and 0.2 ml normal saline as control.

The investigators measured the time to reach T4 dermatome sensory block, peak sensory level, Time to reach Bromage 3 motor block, the regression time for sensory and motor block, also the investigators measured hemodynamic, sedation score, visual analogue score, any complications occurred and Apgar score for fetus during blockade and the investigators assessed the duration of pain relief .


Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status I and II patients
2. Age: 18 - 40 years
3. Height 150 - 170 cm
4. Weight 70 - 110 kg.

Exclusion Criteria:

1. Patient refusal
2. Cardiac diseases as ( ischemic heart disease, severe valvular stenosis, pulmonary hypertension, uncontrolled arrhythmias )
3. Severe labile hypertension BP more than 160 / 100 )
4. Raised intracranial pressure or pre-existing neurological disorders, such as multiple sclerosis.
5. Patients with coagulopathy: platelets \< 100,000 INR ≥ 1.3 or therapeutic use of anti-coagulants.
6. Inability to communicate and understand the aim of the project.
7. Patients with history of allergic reaction to LA, DXM or Neostigmine.
8. Skin infection at injection site or systemic bacteremia.
9. Failure of the block and need for general anesthesia.
Effect of Bariatric Surgery on Physical Activity, Gait, Flexibility and Quality of Life

This study aimed to analyze spatio-temporal characteristics of gait, physical activity level and changes in quality of life in patients by measuring conditions before bariatric surgery and third-month after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of obesity
* Body mass index \> 35
* Speak and understand Turkish
* Ability of read and write

Exclusion Criteria:

* History of lower extremity surgery
* Musculoskeletal/systemic/neurological/psychiatric problems
* Urinary syndromes
* Limited gait due to cardio-pulmonary insufficiency
* Unwillingness to participate
Monitoring Response to Neoadjuvant Chemotherapy in Breast Cancer Using Ultrafast DCE-MRI

The study will assess whether changes in kinetic parameters of tumor and peritumoral vasculature using ultrafast dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) during neoadjuvant chemotherapy (NAC) are predictive of pathologic complete response (pCR) in patients with breast cancer appropriate for NAC. pCR is defined as having no residual invasive breast cancer or ductal carcinoma in situ.


Eligibility Criteria:
Inclusion Criteria:

1. Female;
2. Age 18 years or older;
3. Diagnosis of invasive breast cancer by ultrasound guided biopsy;

3. Planed for receiving neoadjuvant chemotherapy (NAC) 4. Planned definitive breast surgery following completion of NAC.

Exclusion Criteria:

1. Stage IV breast cancer;
2. Previous ipsilateral breast cancer;
3. Previous treatment (chemotherapy or radiation) to involved breast;
4. Medically unstable;
5. Pregnant or nursing.
The Topical Niacin Skin Flush Test in First Episode Psychosis

The purpose of this study is to gather normative data from healthy adults and to determine a sensitive and specific cut-off value for responders and non-responders to the Niacin Skin Flush Test in a sample of first episode psychosis patients.


Eligibility Criteria:
Inclusion Criteria:

* caucasian
* within twelve months of initial DSM IV TR diagnosis of schizophreniform psychosis, schizophrenia, schizoaffective disorder or psychotic disorder NOS
* outpatient

Exclusion Criteria:

* known allergy to study compound (methyl nicotinate, vitamin B3, niacin)
* skin conditions (e.g., dermatitis, psoriasis, eczema)
* diagnosis or treatment for medical conditions that may affect normal vascular tone (e.g., diabetes, vasculitis, chronic hypertension, etc.)
* Use of anti-inflammatory, antibiotic, or antihistamine medications within one month prior to study entry
* Use of supplements like Omega 3 fatty acids within 3 months prior to study entry
* Use of vitamin or nutritional supplement containing a dose of niacin/nicotinic acid above 50 mg/day at study entry
A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP)

This is a Phase 2a study to assess the safety and tolerability of TPN-101 patients with PSP.

This is a Phase 2a multi-center, randomized, double-blind, placebo-controlled parallel-group, 4-arm study with an open-label treatment phase in patients with PSP. This study includes a 6-week Screening Period, a 24-week Double-blind Treatment Period, a 24-week Open label Treatment Period, and a Follow-up Visit 4 weeks post treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of probable progressive supranuclear palsy (PSP)
2. Presence of PSP symptoms for less than 5 years
3. Has a reliable caregiver/informant to accompany the patient to all study visits.
4. Score ≥ 18 on the Mini Mental State Exam (MMSE) at Screening
5. Patient must reside outside a skilled nursing facility or dementia care facility at the time of Screening, and admission to such a facility must not be planned. Residence in an assisted living facility is allowed

Exclusion Criteria:

Patients must not meet any of the following criteria:

1. Presence of other significant neurological or psychiatric disorders
2. History of clinically significant brain abnormality
3. Presence of cerebellar ataxia, choreoathetosis, early symptomatic autonomic dysfunction, or moderate to severe resting tremor, responsive to levodopa
4. Known history of serum or plasma progranulin level less than one standard deviation below the normal patient mean
5. Known presence of disease-associated mutation in TARDBP, GRN, CHMPB2, or VCP genes; or any other frontotemporal lobar degeneration causative genes not associated with underlying tau pathology
6. History of clinically significant hematological, endocrine, cardiovascular, renal, hepatic, or gastrointestinal disease
DXR Stent(Previous Cilotax) Implantation Registry

Registry of cilotax stent(Dual drug eluting stent) implantation for CAD patients


Eligibility Criteria:
Inclusion Criteria:

* Patients with significant coronary artery disease and receiving Cilotax (dual drug eluting stent)
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site

Exclusion Criteria:

* Patients with a mixture of other DESs
* Terminal illness with life expectancy \<1 year
* Patients presented with cardiogenic shock
Do Clinicians Want Recommendations?

The use of the best evidence available for decision-making is nowadays an undisputed goal in health care. However, this is not always achieved in the context of clinical practice. Two of the potential solutions to bridge the gap between evidence and the clinical practice are the "evidence summaries" and the "evidence based recommendations". However, it is not clear, and frequently controversial, to what extent clinicians consider helpful recommendations accompanying evidence summaries. The investigators will explore this question by conducting a study where clinicians will be randomized to receive a clinical scenario accompanied by an evidence summary plus a recommendation and a second clinical scenario accompanied by only for an evidence summary (group A) or vice versa (Group B). The outcome will be clinicians' preferences.


Eligibility Criteria:
Inclusion Criteria:

* Were trained as Medical Doctors
* Practice primary care or general internal medicine.

Exclusion Criteria: none
Comparative Study Between Dexmedetomidine & Neostigmine as an Adjuvant to Local Anesthetic Mixture in Peribulbar Block in Vitreoretinal Surgeries

The majority of patients undergoing ophthalmic surgeries are elderly, with multiple chronic diseases, with increased risk of morbidity and mortality under general anesthesia.

Peribulbar anesthesia is widely practiced now as a first-choice local block for ophthalmic surgeries.

Dexmedetomidine is a highly selective alpha-2 adrenoceptor. It increases central and peripheral nerve blockade and when added to local anesthetic as an adjuvant, it will provide better anesthetic quality as well as prolongation of postoperative analgesia .

Neostigmine is a parasympathomimetic drug that increase the level of acetylecholine at peripheral muscarinic receptors present in the peripheral nerve endings .

Many researches examined the analgesic effects of peripherally administered neostigmine as in intravenous regional anesthesia reporting that addition of neostigmine to the local anesthetic solution accelerated the onset of anesthesia

\& prolong duration .

81 participants divided into three groups 27 patient in each group with inclusion criteria :

* Patients aged from 21 to 60 years.
* Patients ASA I to II undergoing Vitreoretinal Surgeries.
* Patient with axial globe length below 26 mm.
* Patients consented with Local anesthesia.

The three groups:

group I : will receive Peribulbar anesthesia block via 25G needle is inserted transcutaneously through the inferotemporal approach at the junction between the medial two third and the lateral third of the lower orbital margin in such a way the bevel is facing the globe and the tip towards the floor of the orbit until the needle passes through the orbital septum it is directed then posteriorly tangential to the floor of the orbit for 25mm length at which the 8 ml local anesthetic mixture is injected ( 4 ml of bupivacaine + 3 ml of mixture of Lidocaine \& Hyaluronidase +1ml of Dexmedetomidine equivalent to 25 mcg).

Ocular compression is applied for 5 minutes by Honan intraocular pressure IOP reducer adjusted at 20mmHg.

Group II :

Will recieve ( 4 ml of bupivacaine + 3 ml of mixture of Lidocaine \& Hyaluronidase +1ml of Neostigmine equivalent to 0.5 mg)

Group III :

( 4 ml of bupivacaine + 3 ml of mixture of Lidocaine \& Hyaluronidase +1ml Normal Saline 0.9%)

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 21 to 60 years.
* Patients ASA I to II .
* Patient with axial globe length below 26 mm.
* Patients consented with Local anesthesia.

Exclusion Criteria:

* Patient refusal.
* Patients below or above the age.
* Patients with bleeding disorders.
* Patient with axial globe length more than 26 mm.
* history of relevant drug allergy to any of the used drugs
Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery

The purpose of this study is to compare the macular volume of patients treated with a 3-month course of topical Nepafenac (0.1% solution) to patients treated with a placebo course following epiretinal membrane surgery.


Eligibility Criteria:
Inclusion Criteria:

* 18 year of age or older, of any race and either sex.
* Able to understand and sign an informed consent that has been approved by an Institutional Review Board.
* Must agree to comply with study visit schedule and other study requirements.
* Must have vision loss associated with idiopathic epiretinal membrane and secondary retinal edema.
* Must have pre-operative central foveal thickness greater than 300 microns.
* Prior cataract surgery must be at least 6 months postoperative.

  * Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Vision loss associated with maculopathies other than idiopathic epiretinal membrane and secondary retinal edema (e.g. branch retinal vein occlusion, central retinal vein occlusion, wet macular degeneration, diabetic retinopathy, posterior uveitis).
* Dry macular degeneration (drusen) with central geographic atrophy.
* Concomitant cataract surgery performed at the time of study vitrectomy.
* Prior vitrectomy surgery in the study eye(s).
* Prior macula laser treatment in the study eye(s).
* Prior periocular steroid injections in the study eye(s) within preceding 6 months.
* Prior cataract surgery in the study eye(s) within the last 6 months.
* Any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
* Use of topical ocular medications during the study period.
* Antibiotics (systemic or topical) outside of study protocol may not be used within 7 days of preoperative/baseline visit or anytime after this visit for the duration of the study.
* Women of childbearing potential not using reliable means of birth control.
* Women who are pregnant or lactating.
* Enrollment of more than one person per household at the same time.
* Enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
* Participation in any investigational drug or device study within 30 days of entering this study. Note: Patients may have both eyes enrolled in this study provided that 2nd eye enrollment takes place 30 days after completion of the first eye. Second eye will receive the same study treatment as first eye.

  * Other protocol-defined exclusion criteria may apply.
Treatment Outcome After Ankle Joint Surgeries

Osteochondral lesion of talus (OLT), osteoarthrosis and impingement/instability syndrome are most common ankle joint pathologies. This study analyses outcome after various different operative treatment of aforementioned pathologies. Investigators hypothesis is that patient characteristics, type of lesion and surgical technique affect the result of treatment. The investigators will compare subjective (questionnaire) and objective (clinical examination) status of patient before and after operation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with OLT treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana.
* Patients with ankle joint osteoarthritis treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana.
* Patients with ankle instability syndrome treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana.
* Patients with ankle impingement syndrome treated operatively in Department of Orthopaedic Surgery, UMC Ljubljana.

Exclusion Criteria:

* patient refuse to participate in study
* no respond of patient after invitation to answer a standardized questionnaire (EQ-5D, FAOS, Tegner activity score)
* no respond of patient after invitation to control examination after operation
FACEFI : Cardiac Fatigue During Intense Exercises - Pilot Study

To attest if a cardiac fatigue appears (and to measure it if it does) during intense physical exercises in two groups of subjects:

* Canoeists from a training center of the French canoeing team during an intensive session of three weeks of endurance training;
* Young recruits in military school of officers in ground forces of the French army during an intensive.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men between 18 and 35 years old;
* Giving their writing informed consent;
* And affiliated to the French social security.

Exclusion Criteria:

* To be a smoker.
* To present any known pathology that forbids the realisation of any test, or that can alter the measurements: cardiovascular risk factors treated or not (diabetes, dyslipidaemia, arterial hypertension, obesity), cardiac arrhythmia, coronary disease, heart failure, cardiac pacemaker or defibrillator, valvular disease after surgery or not, kidneys failure with dialyse or not, kidney pulmonary cardiac or liver transplantation, chronic bronchopneumopathy, asthma, etc.
* To take any medication that could alter autonomic nervous system or cardiovascular adaptation to maximal exercise (anti-arrhythmia, anti-hypertensive, anti-inflammatory,...).
* Drinking exciting drinks (coffee or tee for example) in the 12h before the tests.
* To be under legal protection (trusteeship, guardianship) or to be deprived of liberty.
Copenhagen Obesity Risk Assessment Study

The aim of the present study is to assess the effect of a high intake of industrially produced trans fatty acids for 16 weeks on abdominal obesity and risk markers of type 2 diabetes and heart disease in healthy, moderately overweight, postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Age 45-70 years
* BMI 25-32
* Waist circumference \> 80 cm
* Postmenopausal for at least 1 year

Exclusion Criteria:

* BP \> 160/100 mmHg
* Fasted blood glucose \> 7 mM
* Fasted LDL-cholesterol \> 6 mM
* Fasted triglycerides \> 3 mM
* Diabetes mellitus or other chronic diseases
* Current or previous cardiovascular disease
* Weight change \> 3 kg within last 2 months
* Use of anti-hypertensive drugs
* Use of statins/fibrates
* Use of fish oil supplements
* Smoking
* Hard physical activity \> 10 h/week
Hypoxemia in Infants After Palliative Surgery

Congenital heart disease is a major cause of morbidity and mortality in infants. Many cardiac defects require surgical palliation or repair in the newborn period. The effects of chronic hypoxia on growth and development are unclear. Infants with very severe cardiac defects may undergo surgery in infancy, but often this cardiac surgery can provide only palliation, not correction. As a result, these infants are exposed to a physiology of chronic hypoxia during the neonatal period through infancy, a critical period of growth and development. The optimal oxygen saturations for infants with palliated cardiac defects is unknown. The purpose of this study is to analyze the growth and development of infants with post-surgical palliation in infancy and assess variations in oxygenation saturations and hemodynamics as they relate to weight gain, linear growth and increases in head circumference during the first three years of life.

We wish to do a retrospective review of clinical data on infants who have undergone surgical palliation for the following cardiac defects over the past five years (from January 1, 2001 through March 31, 2006):

Hypoplastic left heart syndrome Pulmonary atresia Severe pulmonary stenosis.

The patient charts, between the dates of 01.01.2001and 03.31.2006, will be reviewed from Children's Healthcare of Atlanta, Egleston Hospital and the Sibley Heart Center Cardiology clinics of Children's Healthcare of Atlanta.

We will review approximately 180 charts.

We will collect the following information on each patient:

Medical Record Number Account number Dates of admission, discharge, treatment or death, date of birth Information regarding cardiac signs and symptoms, medication information Age, weight , diagnoses and results of imaging studies Clinic visit information during routine follow up appointments such as weight, length, head circumference, oxygen saturations, vital signs, medications, diet, blood pressures, symptoms,blood tests, chest x-ray findings, dates and types of procedures Readmissions, feeding regimen, cardiac catheterization data, surgical data Parent histories of developmental milestones, physical therapy and speech therapy consultations, feeding history, evaluations of swallowing function Airway symptoms Noncardiac procedures and noncardiac medical problems Family history and social history as it relates to care of the infants at home, complications of medical or surgical treatment and cerebral oximetry.

Eligibility Criteria:
Inclusion Criteria:

* patient charts from 01/01/2001 through 03/31/2006 seen at Children's Healthcare of Atlanta or Sibley Heart Center Cardiology for surgical palliation for Hypoplastic left heart syndrome or surgical palliation for Pulmonary atresia or surgical palliation for Severe pulmonary stenosis

Exclusion Criteria:

* Those who do not meet inclusion criteria