cyrilzakka/clinical-trials huggingface dataset:
SegwayPD: The Effect of Sensory-augmented Postural Training Using Segway on Motor and Cognitive Function in Individuals With Parkinson's Disease

The purpose of this study is to examine the safety and efficacy of postural training emphasized on the integration of multiple sensory information into motor control in individuals with PD. This project is a proof-of-concept study to assess the effectiveness of postural training using Segway, which serves a platform to provide augmented and continuous proprioceptive and visuospatial information during postural training.

The purpose of this study is to examine the safety and efficacy of postural training emphasized on the integration of multiple sensory information into motor control in individuals with PD (Parkinson's disease). This project is a proof-of-concept study to assess the effectiveness of postural training using Segway, which serves a platform to provide augmented and continuous proprioceptive and visuospatial information during postural training. Specifically, we will measure postural sway during quiet standing, single and dual-task walking performances, and brain activation during single and dual-task walking from the regions involved in planning and execution of locomotion; these include dorsolateral prefrontal cortex, premotor cortex and primary motor cortex. The changes in visuospatial function and proprioception after training will also be assessed. Individuals with moderate disease stage of PD exhibiting postural instability will be recruited. The participants will receive 1-week training and be assessed at 3 time points: 1-week before, before, and after the training.

Eligibility Criteria:
Inclusion Criteria:

* a clinical diagnosis of idiopathic PD with moderate disease stage presenting balance alterations (Hoehn and Yahr stage III)
* being stable on medication for at least 1 month
* the ability to stand and walk unsupported for 5 min both on and off medication
* age between 50 and 85

Exclusion Criteria:

* neurological disorders other than PD
* major unstable medical illnesses
* sensory or musculoskeletal disorders (e.g., diabetes, uncorrected visual problems, arthritis, severe hearing impairments) that will prohibit the ability to perform the assessment tests and receive training
Modified Fraility Index in Patients Undergoing Arthroplasty

The authors aimed to evaluate the relation between Modified Fraility Index (MFI) and postoperative complications (myocardial infarction, cardiac arrest, pulmonary embolism, septic shock, postoperative dialysis requirement, cerebrovascular event, reintubation, prolonged mechanical ventilation, surgical wound complications), duration of hospitalization, requirement for intensive care unit (ICU) admission and rehospitalization and 30th day mortality in patients undergoing arthroplasy.

Fraility index is calculated according to 70 parameters which are present in national surgical quality improvement programme (NSQIP) of American College of Surgeons. This model defines fraility as a cumulative effect of individual defects depending on clinical symptoms, disease states and disabilities which provides more accurate evaluation of aging. These 70 parameters present in NSQIP database were matched with 11 variables to create a modified fraility index.

There are 11 parametres in Modified Fraility Index (MFI) (Exacerbation of chronic obstructive pulmonary disease or history of pneumonia (within last 30 days), exacerbation of congestive heart failure (within last 30 days), diabetes mellitus, dependant functional status (partially or totally dependant), history of angina, percutaneous coronary intervention or coronary bypass grefting) (within last 30 days), medically treated hypertension, acute impaired sensorium, history of peripheral vascular disease, history of myocardial infarction (within last 6 months), cerebrovascular disease with neurological deficit, cerebrovascular disease without neurological deficit or transient ischemic attack (TIA).

Presence of one of the above MFI parameters has taken 1 point. The total point that each individual achieved according to the presence of the parameters is calculated and the total score divided by 11 is defined as MFI value.

145 patients aged between 45-85 who had undergone primary or revision total knee and hip arthroplasty were included to the current prospective study. In all patients MFI was calculated.

Patients were classified as nonfrail (MFI\<0,27), and frail patients (MFI≥0.27) according to MFI value.

All patients were followed up for 30 days during postoperative period. The presence of myocardial infarction, cardiac arrest, pulmonary embolism, septic shock, postoperative dialysis requirement, cerebrovascular event, reintubation, reoperation, prolonged mechanical ventilation, surgical wound complications; duration of hospitalization; requirement for intensive care unit (ICU) admission and rehospitalization and 30th day mortality were questioned.

Eligibility Criteria:
Inclusion Criteria:

patients aged between 45-85 undergoing primary or revision total knee and hip arthroplasty

Exclusion Criteria:

Emergent surgery, patients aged below 45 and above 85, patients with cognitive dysfunction
Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients

To evaluate the pharmacokinetic and safety for the esomeprazole use for schizophrenia

Investigators prepare to recruit 30 schizophrenia patients in one year. Investigators will conduct a 8-week open label clinical trial for evaluation of the pharmacokinetic and safety of esomeprazole use for the schizophrenia. Investigators will give 40 mg/day esomeprazole in the first two weeks and 80 mg/day from the third week to the end of the trial. Investigators will check the area under the concentration of metabolites of esomeprazole on Day 1, Day 14 and Day 56 and the genotype of CYP2C19. The GI symptoms and related drug side effects will be evaluated.

Eligibility Criteria:
Inclusion criteria

1. 20-65 years old
2. Diagnosed as DSM-IV schizophrenia
3. No adjustment of dose of major antipsychotics for at least 4 weeks
4. Competence for inform consent

Exclusion criteria

1. Diagnosed with schizoaffective disorder or bipolar affective disorder or organic psychotic disorder
2. Meet the diagnostic criteria of any substance abuse or dependence in the past 6 months
3. History or evidence of any clinically significant medical or neurological disease, such as autoimmune disease, cancer, epilepsy, etc.
4. Mental retardation or pervasive developmental disorders
5. Past history of allergy to Esomeprazole
6. patient who is taking clozapine、 Depakin or Diazepam
7. Pregnant
8. The patient is under the order of involuntary admission
A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy

The purpose of this study is to compare the effectiveness and safety of topiramate to standard antiepileptic drugs in children and adults with newly diagnosed epilepsy.

Topiramate is a drug that is currently widely used for the treatment of seizures in adults and pediatric patients (2 to 16 years of age). This is a randomized, double-blind, parallel-group study to evaluate the effectiveness and safety of two dosages of topiramate (100 or 200mg per day) compared with standard antiepileptic drugs (carbamazepine or valproate) in patients with newly diagnosed epilepsy. The study is composed of three phases: baseline (up to 7 days), double-blind treatment, and a blinded extension. The double-blind phase is divided into two periods: titration, in which the dose of drug is gradually increased (approximately 35 days), and stabilization (of variable duration, with regular scheduled visits up to 92 days and then every 3 months thereafter). The dose of study drug remains constant during the stabilization period. In the blinded extension, patients completing the double blind phase are given the opportunity to take the other study medication in a blinded fashion (patient unaware of identity of the drug). This phase continues until the patient leaves the study or the data base for the double blind phase is finalized. The primary assessment of effectiveness is the time to first seizure from Day 15 of the study. Safety assessments include the frequency of adverse events during the study, results of clinical laboratory tests (hematology and biochemistry), measurements of vital signs and body weight, and physical examination findings. The study hypothesis is that the 200mg dose of topiramate is superior to the 100mg dose in delaying the time to first seizure and is well-tolerated. Oral topiramate (25milligram \[mg\] or 50mg capsules or tablets),starting at 25mg/day (Week 1),increasing to 100mg or 200mg/day (Week 5).Increasing carbamazepine to 600mg/day or valproate to 1250mg/day (Week 5).Maximum dosages continue for a variable time and then taper over 4 weeks to starting dose.

Eligibility Criteria:
Inclusion Criteria:

* Body weight of at least 30 kilograms
* New epilepsy diagnosis and at least one unprovoked seizure within 3 months before study entry
* No history of antiepileptic drug use or taking a single antiepileptic drug for no longer than 6 weeks
* Females must be sexually abstinent, surgically sterile, or using adequate birth control measures, and have a negative pregnancy test before study entry

Exclusion Criteria:

* Patients who do not have epilepsy
* Have progressive or degenerative disorders (for example, certain hereditary conditions)
* Have a significant history (within last 2 years) of unstable medical diseases (heart, kidney, hormone, or liver diseases)
* Have mental retardation or other condition that could make interpretation of the study results difficult
* alcohol or drug abuse within the previous year
Intravenous BCAA for HE in ACLF (BCAA-HE-ACLF)

This multi-centric study analyses the effect of intravenous branched-chain amino acids (BCAA) on overt HE in patients with ACLF. The investigators aim to study the efficacy of combining intravenous BCAA with lactulose versus lactulose alone, ammonia measures, endotoxin, metabolomics, and cerebral edema in the medical management of overt HE in patients with ACLF. The study will also access the impact on overall survival and improvement in the grade of HE.

Treatment of HE in ACLF is based on extrapolation of data available from cirrhotic patients with HE. The mainstay of treatment remains Lactulose. Rifaximin is added on to therapy who have a breakthrough episode of HE on lactulose. BCAA is used as an add-on therapy if patients have minimal/covert encephalopathy, are protein intolerant or have recurrent HE. No studies are available assessing the adjuvant effect of intravenous BCAA on ammonia reduction in HE in patients with ACLF. So, this study has been designed to analyze the effect of intravenous BCAA on hepatic encephalopathy in patients with ACLF. This study will also analyze the systemic and neuronal inflammation, metabolomics, and cerebral edema under the effect of intravenous BCAA in HE patients with ACLF.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years
2. Either gender
3. Patients with ACLF (CANONIC definition) of any etiology with HE ≥grade 2 as per West-Haven Criteria

Exclusion Criteria:

1. Those who do not consent to participate in the study
2. Patients with structural brain lesions or stroke
3. Inability to obtain informed consent from patient or relatives
4. Severe preexisting cardiopulmonary disease
5. Renal dysfunction (S. Creatinine ≥ 2mg/dL)
6. Pregnancy/Lactation
7. Post liver transplant patients
8. HIV infection
9. Patients who are on psychoactive drugs, like sedatives or antidepressants
10. Patients who are too sick to carry out the protocol.
Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With Aortic Stenosis.

Atherosclerosis and aortic stenosis share inflammatory etiopathogenic characteristics in common. We hypothesized that statins therapy would decrease inflammatory markers concentrations in patients with degenerative aortic stenosis and halt the haemodynamic progression of the disease.

This study will be a prospective, phase IV-III, randomized, double blinded, active controlled study, to evaluate the efficacy of fluvastatin on inflammatory markers in the haemodynamic progression of degenerative aortic stenosis. We hypothesized that statins therapy would decrease inflammatory markers concentrations in patients with degenerative aortic stenosis and halt the haemodynamic progression of the disease. Eligible patients with degenerative aortic stenosis will be randomized 1:1 to fluvastatin 80 mg once daily or placebo. The treatment should be continued until the study end (12 months). Follow up investigations will be performed after 3 months and at the end of the study (12 months).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Asymptomatic
3. Aortic stenosis defined as aortic valve leaflet thickening with reduced systolic opening (maximum aortic jet velocity \>2 m/s)
4. Written informed consent to participate in the study
5. Patients capable to follow all conditions along the study.

Exclusion Criteria:

1. Symptomatic patients caused by aortic stenosis.
2. Patients on statins anytime in the year before inclusion.
3. Patients diagnosed of dyslipidemia requiring statins.
4. Temperature ³37,8 ºC in the week before inclusion.
5. Any cardiovascular event succeeding in the three months before inclusion
6. Known thyrotoxicosis
7. Renal failure requiring hemodialysis
8. Any inflammatory noncardiac diseases or other reasons known to influence the study biomarkers concentrations.
9. Any surgery succeeding in the three months before inclusion.
10. Patients with any hepatopathy that in the view of the investigator prohibits participation in the study.
11. Patients with known muscular disease.
12. Patients with any severe medical condition that in the view of the investigator prohibits participation in the study
13. Use of corticoids, immunosuppressors or non steroid drugs.
14. Any known sensitivity to study drug (fluvastatin) or class of study drug.
15. Patients participating in any study in the last year.
16. Women of childbearing potential not using the contraception method(s) specified in this study, suspicion of pregnancy, as well as women who are breastfeeding
Cognitive Therapy for Recurrent Depression

This study determined the effectiveness of continuation phase cognitive therapy versus antidepressant medication in preventing relapse of depression in people with recurrent depression.

Cognitive therapy (CT) is a short-term talking therapy that focuses on changing negative thinking patterns and helping patients develop coping skills to deal with their experiences. Evidence suggests that CT is effective in treating a number of psychiatric conditions, including anxiety and anger. This study will determine the effectiveness of cognitive therapy versus antidepressant medication or placebo in preventing relapse of depression in people with recurrent depression.

This study lasted approximately 36 months and comprised three phases. For the first 12 weeks, all participants received between 16 and 20 CT sessions. Participants were then randomly assigned to receive additional CT sessions, antidepressants, or placebo for an additional 8 months. Upon completing treatment, participants entered follow-up study visits once every 4 months for the next 24 months. Clinician-rated scales and questionnaires were used to assess depressive symptoms of participants at study start and at the end of each study phase.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent unipolar major depressive disorder
* Have experienced at least two episodes of major depression
* Have experienced at least one period of recovery during a depressive episode or have a history of dysthymia (a mood disorder characterized by depression) prior to the onset of current or past depressive episodes
* Willing and able to comply with all study requirements
* Able to speak and read English

Exclusion Criteria:

* Active alcohol or other substance dependence within 6 months prior to study entry
* Currently at risk for suicide
* Mood disorders due to a medical condition or substance abuse
* Bipolar, schizoaffective, obsessive compulsive, or eating disorders
* Schizophrenia
* Unable to stop mood-altering medications
* Current use of medication or diagnosis of a medical disorder that may cause depression (e.g., diabetes, head injury, stroke, cancer, multiple sclerosis)
* Previous failure to experience a reduction in depressive symptoms after 8 weeks of cognitive therapy with a certified therapist
* Previous failure to experience a reduction in depressive symptoms after 6 weeks of 40 mg of Prozac
* Pregnancy or plan to become pregnant in the next 11-12 months
* Unable to attend clinic twice weekly during business hours
* Unable to complete questionnaires
Efficacy and Safety of Sub-tenon Ranibizumab for Recurrent Pterygia

Ranibizumab, an effective antineovascular drug, will be studied for safety and efficacy in pterygium, a neovascular disorder of the ocular surface.

Ptergyia are chronic fibrovascular lesions of the ocular surface. This study is designed to look for a signal of efficacy when the lesions are in a phase of active vascular growth. This phase is most often caught in a newly recurring pterygia post-operatively.

Patients identified with actively growing lesions, will be offered local injections directly beneath the lesions. They will be examined for any adverse side effects and regression of the lesion.

Eligibility Criteria:
Inclusion Criteria:

Patients with actively growing pterygia, either surgical recurrences, or non-surgical primary lesions.

Exclusion Criteria:

* Pregnancy
* History of CVA
* Monocular patients
* Minors
NeuroReAlign Therapy for Balance and Gait Rehabilitation in Stroke Survivors

The goal of this randomized controlled trial is to investigate the effects of NeuroReAlign Therapy on balance and gait in stroke survivors in the chronic stage (\>6 months). The study will include male and female participants aged 18-70 years.

The main questions it aims to answer are:

Does NeuroReAlign Therapy improve balance in stroke survivors compared to conventional physiotherapy? Does NeuroReAlign Therapy enhance gait performance more effectively than conventional physiotherapy? Researchers will compare NeuroReAlign Therapy to conventional physiotherapy to determine its effects on balance and gait.

Participants will:

Undergo NeuroReAlign Therapy or conventional physiotherapy for 4 weeks. Have their balance assessed using the Berg Balance Scale (BBS), Activities-Specific Balance Confidence Scale (ABC Scale), and Fear of Falling Questionnaire (FoFQ).

Have their gait evaluated using the Dynamic Gait Index (DGI), Rivermead Mobility Index (RMI), Timed Up and Go (TUG), 6-Minute Walk Test (6MWT), and 10-Meter Walk Test (10MWT).

Complete outcome assessments at baseline and after the intervention (week 4).


Eligibility Criteria:
Inclusion Criteria:

* Patients with ischemic or hemorrhagic stroke
* Have a stroke more than 6 months
* Age between 18 and 70

Exclusion Criteria:

* Patients with severe cognitive impairments
* Patients cannot walk independently
The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions

The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting PTCA-balloon in combination with bare-metal stenting for treatment of chronic total occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.


Eligibility Criteria:
Inclusion Criteria:

* chronic total occlusion
* Thrombolysis in Myocardial Infarction (TIMI) flow 0 or 1
* occlusion in native coronary artery
* indication for percutaneous coronary intervention based on symptoms, prognosis or evidence of ischemia
* reference diameter 2.5 mm to 4.0 mm

Exclusion Criteria:

* saphenous vein graft
* bifurcation lesion with need to stent main and side branch
* left main occlusion
* de-novo stenosis (no occlusion)
* restenosis
* in-stent restenosis
* contraindication for dual antiplatelet therapy with acetylsalicylic acid and clopidogrel for 6 months
* coronary aneurysm at target lesion
Assessing Patient Response to Therapeutic Exercise Based on Clinical Prediction Rule (CPR) for Spinal Manipulation

The purpose of this study is to determine whether patients who meet the criteria of the clinical prediction rule for spinal manipulation may respond more favorably to repeated exercises according to a direction of preference (what makes the symptoms decrease). The investigators do not know which of these two commonly-used treatments (manipulation or specific exercise) is better to treat low back pain.

With the trends in health care focusing on treatment effectiveness, it is important for physical therapists to select the most appropriate intervention according to patient classification. Physical therapy interventions for management of LBP include therapeutic exercises and spinal manipulation.

The purpose of this study is to determine whether patients who fit the Clinical Prediction Rule (CPR) for spinal manipulation may respond instead to exercise according to repeated lumbar movements in the direction of preference.

The subjects for this study will be comprised of individuals referred for treatment of low back pain and data will be collected by physical therapists with certification in MDT who had experience treating patients through the use of spinal manipulation. Patient functional questionnaires and impairment measures will be used to analyze the patient's perceived level of function and outcome.

Following the completion of an informed consent, subjects will undergo a physical therapy examination by a licensed physical therapist. Patients will be included in the study if they meet the CPR for spinal manipulation as describe in earlier research 6,11. Following the examination, all qualified subjects will be randomly assigned to either the (1) spinal manipulation group or (2) the McKenzie (MDT) group and will receive treatment in accordance with their assigned group. The assessment tools administered at the initial examination will be readministered for follow-up analysis.

Eligibility Criteria:
Inclusion Criteria:

* people who meet the clinical prediction rule for spinal manipulation

Exclusion Criteria:

* people receiving worker's compensation
* those who have had spinal surgery
The Effect of Endurance Training on Body Composition and Insulin Sensitivity in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

The purpose of the present study is to investigate if endurance training can be used as a therapeutic action against the adverse metabolic disturbances and unfavourable changes in body composition that accompany the androgen deprivation therapy (ADT) treatment in prostate cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer patients receiving ADT for at least 3 months
* Healthy age and BMI matched controls

Exclusion Criteria:

* severe cardiovascular disease
* severe arthritis
* severe neuropathy
* severe hypertension
* therapy with antidiabetic agents
* VO2max \> 30.