cyrilzakka/clinical-trials huggingface dataset:
Effect of Exercise-based Rehabilitation on Circulatory Functions in Patients With Diastolic Heart Failure

The purpose of this study is to investigate how exercise-base rehabilitation influences circulatory functions in patients with diastolic heart failure (DHF).

A quasi-experimental design will be used in this investigation. Eighty DHF patients will be recruited from Chang Gung Medical Foundation, Keelung Branch after they have provided informed consent. These subjects will be randomized into the trained (n=40) and the control groups (n=40). The trained subjects will be trained on a bicycle ergometer at about 60-70%of heart rate reserve for 35-55 minutes (that will include 10-min warm-up, 15-35-min main exercise, and 10-min cool-down) per day, 3 days per week for 12 weeks. The control subjects will maintain their normal living pattern. Subjects' physical fitness, oxygen transport and utilization of exercising skeletal muscles, cardiovascular functions and hemodynamics, blood cell parameters, RBC deformity and aggregation, plasma biomarkers of myocardial damage, and thrombotic factors/reactions will be measured at pre-training stage and following the 8th and 12th week of the training program. Experimental results were analyzed by descriptive statistics (percentage, mean, and standard deviation), independent t-test, two-way ANOVA, and two-way ANCOVA. Previous researches were mainly focus on systolic heart failure, less on diastolic heart failure. We study the above parameter to realize the physiological response to exercise of these patients and discover the appropriate exercise intensity for prescription.

Eligibility Criteria:
Inclusion Criteria:

* cardiac event with optimal medial treatment within 3 months and have 4 more weeks spared from heart disease attack or major cardiac procedure.
* LVEF\>50%

Exclusion Criteria:

* unstable angina pectoris,
* uncompensated heart failure,
* myocardial infarction during the past 4 weeks,
* complex ventricular arrhythmias,
* orthopedic or neurological limitations to exercise.
The Effect of Rehabilitative Games with SmartPose on Upper Extremity Recovery in Stroke Patients

The goal of this clinical trial is to investigate the effects of SmartPose games on upper extremity motor, functional, and sensory recovery in patients with stroke. The main question it aims to answer is:

* Does the use of rehabilitative games with the SmartPose application work to treat upper extremity motor, functional, and sensory recovery in stroke patients?

Researchers will compare the experimental group with the control group, which receives only conventional exercises with proven effectiveness, to determine whether SmartPose has an effect on upper extremity motor, functional, and sensory recovery in stroke patients.

The experimental group will receive 30 minutes of neuromuscular therapy and 30 minutes of SmartPose, 3 times a week for 8 weeks.

The control group will receive 60 minutes of neuromuscular therapy, 3 times a week for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Mini Mental State Examination score ≥ 24
* Age between 35 and 75 years
* Medical condition sufficiently stable to allow participation in active rehabilitation
* Brunnstrom Upper Extremity Stage ≥ 3
* Minimum sixth week post-stroke
* Ability to perform shoulder abduction and flexion against gravity with a minimum of 20°

Exclusion Criteria:

* Presence of secondary impairments affecting upper extremity movement
* Modified Ashworth Scale score of 4 or 5
* Inability to maintain independent sitting balance
* Visual impairment or loss that prevents the perception of visual materials
Mid-term Evaluation of Metamorphopsia in Epiretinal Membrane Surgery

This study evaluates the safety and efficacy simultaneous, trans-conjunctival, 25-Gauge vitrectomy and phacoemulsification with intraocular lens implant in patients with metamorphopsia and visual impairment due to idiopathic epiretinal membrane and cataract. All 30 patients recruited underwent complete ocular examination, visual acuity measurement with ETDRS, metamorphopsia assessment with M-Charts and Metamorphometry® and foveal thickness evaluation by sd-OCT preoperatively, at 30, 90, 180 days postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* age \> 55 years
* visual acuity ≤ 20/40
* idiopathic epiretinal membrane
* cataract
* Amsler test positive for metamorphopsia.

Exclusion Criteria:

* previous ocular interventions
* other ocular diseases.
Folinic Acid in Children With Autism Spectrum Disorders

The investigator planned to study the efficiency of folinic acid treatment on autistic symptoms in children suffering from autism spectrum disorder.

The aim of this study is to realise a pilot study in France in order to evaluate the efficiency of folinic acid in treatment of autism spectrum disorder and get first estimations about prevalence of auto antibodies anti-FRα in France.

The study is a randomized controlled trial monocentric,evaluating folinic acid 10mg per day versus placebo, in single-blind during 12 weeks.

Primary objective : The primary objective is to evaluate the efficiency of folinic acid (calcium folinate) 5mg twice a day during 12 weeks on reduction of autistic troubles, particularly on communication and social interaction

Secondary objective :

* Evaluate the efficiency of folinic acid on reduction of autistic symptoms perceived by parents
* Evaluate the constancy of auto antibodies anti-FRα rates

Eligibility Criteria:
Inclusion Criteria:

1. Children with autism spectrum disorders defined by : Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview (ADI), Childhood Autism Rating Scale (CARS) or diagnosed by a physician (pediatrician, child psychiatrist)
2. Children aged 3 to 10 years
3. Weight\> 10 kg
4. Language impairment (based on the medical assessment)
5. Ability to maintain other therapies started before the study
6. No changes of therapeutic treatments within the 8 weeks before the start of the study

Exclusion Criteria:

1. Treatment may impair folate metabolism (methotrexate, anticonvulsivants : phenobarbital sodium valproate, phenytoin, primidone, carbamazepine, valproic acid, divalproex, antibiotics : tetracycline, trimethoprim, pyrimethamine, inhibitors of proton pump inhibitors of histamine-2)
2. Antipsychotic treatment (including treatment with Risperidone)
3. Vitamin or mineral supplementation exceeding guidelines
4. Children with severe irritability (Aberrant Behavior Checklist\> 17)
5. Gastroesophageal reflux disease
6. Any known renal or liver disease
7. Child born premature (\<37SA)
8. Known intolerance to lactose
9. Hypersensitivity / allergic reaction to calcium folinate
10. The sibling children with autism spectrum disorders
Investigation of Musculoskeletal System Disorders Seen in Automotive Industry Workers

The aim of this study is to examine the musculoskeletal disorders seen in automotive industry workers.

This study will be conducted as a face-to-face survey. Surveys will be created with Google Forms and will be filled out by the physiotherapist according to the participant's response.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 25-60
* Not having any psychological or neurological disorders
* Being able to communicate in Turkish (written, verbal)
* Being able to communicate cognitively adequately
* Working full-time
* Being employed in an automotive industry for at least 5 years

Exclusion Criteria:

* Being under 18 or over 60
* Working part-time
* Being employed in the same business for less than 5 years
Mechanisms and Treatment of Intradialytic Hypertension - Sodium

The purpose of this study is to determine the role of dialysate exposure and fluid removal during hemodialysis in the pathophysiology of intradialytic hypertension.

Specific Aim #1 To determine in a crossover study of 15 maintenance hemodialysis patients with intradialytic hypertension whether standard dialysis with ultrafiltration (dialysate Na of 140), dialysis without ultrafiltration (dialysate Na of 140), or ultrafiltration alone (no dialysate) is associated with the an increase in systolic blood pressure during hemodialysis

Specific Aim #2 To determine in a crossover study of 15 maintenance hemodialysis with intradialytic hypertension whether standard dialysis with ultrafiltration, dialysis without ultrafiltration, or ultrafiltration alone is associated with change in either endothelin-1 or nitric oxide during hemodialysis

SUBSTUDY AIMS

Specific Aim #1 To determine in a randomized 3-week, 2 period crossover study of 15 maintenance hemodialysis patients with intradialytic hypertension whether high vs low dialysate-to-serum Na gradients impairs release of NO, increases ET-1 or causes an acute intradialytic increase in systolic BP,.

Specific Aim #2 TO determine in a randomized 16-week, 2-period crossover study of 30 hemodialysis patients with intradialytic hypertension the effects of 8 weeks of high dialysate-to-plasma Na gradients to 8-weeks of low Na gradients on EC function (FMD and ADMA) and 44 hour ambulatory BP.

Eligibility Criteria:
Inclusion Criteria:

* on hemodialysis \> 30 days
* male and female participants, aged 18 to 85 years old, of all races and ethnic origin
* ability to provide informed consent
* Primary nephrologist deems patient is at target dry weight
* KDOQI defined hypertension (predialysis SBP \>140 or postdialysis SBP\>130) AND
* pre to post hemodialysis SBP increase (\>10 mmHg) during 4/6 last HD session

Exclusion Criteria:

* Patients with active cancer or active wounds
* Patient currently on antibiotics or on IV antibiotics within the last month
* BP unable to be measured by routine mechanisms in the upper extremity
* Life expectancy \< 6 months
* Inability to provide informed consent
* Larger interdialytic weight gain (\>5 kg/treatment on average)
Evaluation of Leveling and Alignment of Maxillary Anterior Teeth Assisted With MOPs :A Comparative Clinical Study

The aim of the study will be directed to evaluate the effect of micro-osteoperforation on orthodontic tooth movement during leveling and alignment of the maxillary anterior teeth.

The current study will be conducted on a group of orthodontic patients attending the out patients clinic, Orthodontic Department, Faculty of Dental Medicine (Boys), AL- Azhar University, Cairo

The patient will be randomly assigned into two equal groups:

1. Experimental group: Flapless micro-osteoperforations will be performed interproximally on the alveolar bone equidistant between upper right canine to upper left canine at every interdental alveolar bone except at the midline

   alveolar bone to prevent trauma to the soft tissue frenum before placing the initial leveling archwire.
2. Control group: leveling and alignment will be commenced without micro- osteoperforations.

Eligibility Criteria:
Inclusion Criteria:

* 1. Class 1 skeletal pattern with normal facial proportions. 2. Patients with age range between 13 -19 years. 3. Moderate crowding of maxillary anterior region assessed by Little Irregularity Index (LII) that require treatment with fixed appliance using non extraction approach.

  4. All permanent teeth erupted (excluding 3rd molars). 5. No previous orthodontic treatment. 6. Good oral hygiene with no previous periodontal surgery.

Exclusion Criteria:

* 1. Transverse and/or vertical skeletal dysplasia or craniofacial malformation. 2. Retained primary or missing permanent teeth in the maxillary anterior area. 3. Poor oral hygiene 4. Present or history of periodontal diseases. 5. Physical or mental disability. 6. Systemic diseases or regular use of medications that could interfere with orthodontic tooth movement.
Comparison of the Videolaryngoscopes With Manual In-line Stabilization

Videolaryngoscope is useful to improve the laryngeal view, especially during difficult intubation. There are several kinds of videolaryngoscopes and it is applicable during nasotracheal intubation. In this study, the investigators will compare the McGrath videolaryngoscope and Pentax-AWS with Macintosh laryngoscope for nasotracheal intubation in patients with manual in-line stabilization.


Eligibility Criteria:
Inclusion Criteria:

* oral or maxillofacial surgery
* ASA class I, II

Exclusion Criteria:

* anticipated difficult intubation
* necessity for rapid sequence induction
* cervical spine injury
* bleeding tendency
Effects of Foot Exercises and Hydrotherapy on Pedal Edema & Lower Extremity Function

To determine the Effects of foot exercises with and without hydrotherapy on pedal Edema \& lower extremity function in antenatal women.


Eligibility Criteria:
Inclusion Criteria:

* Normal singleton pregnancy
* Gestational age 30-40 weeks
* Pitting edema in feet

Exclusion Criteria:

* presence of any under lying disease e.g.

  * Diabetes,
  * Hypertension,
  * High risk pregnancy
  * Any wound or skin lesion
ProMRI AFFIRM Study of the EVIA/ENTOVIS Pacemaker With Safio S Pacemaker Leads

This investigation is designed to demonstrate the clinical safety of the EVIA/ ENTOVIS pacemaker system when used under specific MRI conditions.

In the past, MR scans were always contraindicated for pacemaker patients. If particular prerequisites and conditions are fulfilled, MR scans can now be conducted on patients with BIOTRONIK's EVIA/ENTOVIS pacemakers in combination with the Safio S pacemaker leads, scheduled to be part of this clinical study.

The specific MRI conditions for this investigation with the EVIA/ENTOVIS pacemaker family and Safio S pacemaker leads are defined in the study protocol

Eligibility Criteria:
Inclusion Criteria:

* Pacemaker system consisting solely of the EVIA/ENTOVIS pacemaker and Safio S pacemaker leads
* The pacemaker system has to be implanted, repositioned or exchanged at least 5 weeks prior to enrollment
* Age more than 18 years
* Understand the nature of the procedure
* Able and willing to complete MRI testing
* Able and willing to activate and use the Cardio Messenger
* Give written informed consent
* Able to complete all testing required by the clinical protocol
* Ability to measure atrial and/or ventricular pacing threshold(s)\* (at 0.4 ms)
* All pacing thresholds do not exceed 2.0V @0.4ms.
* Available for follow-up visit at the investigational site
* Patient body height greater or equal to 140 cm
* Pectoral implantation
* The ascertained lead impedance is between 200 and 1500 Ohms.

Exclusion Criteria:

* No EVIA/ENTOVIS /Safio S pacemaker system implanted
* Pacing threshold(s) (at 0.4 ms) and sensing amplitudes are not measurable
* Meet one or more of the contraindications
* Being pregnant
* Have a life expectancy of less than three months
* Cardiac surgery already scheduled in the next three months
* Enrolled in another cardiac clinical investigation
* Have other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, other active medical devices, non-MRI compatible devices (e.g. mechanical tricuspid valve)
* Have other metallic artifacts/components in body that may interact with MRI
Impact of Life-size Growth Charts on Understanding of Stunting

Randomized control trial testing whether exposure to a wall hanging (growth mat) enabling parents to physically compare their children's height against the World Health Organization (WHO) standards for height-for-age in combination with normal messaging on stunting increases parents' understanding and retention of those messages. Both intervention and control groups will receive messages about stunting over a 3-month period, but the intervention group will also be exposed to the growth mats during the 3-month intervention period. Parents in both groups will be tested post intervention on the messages about stunting and scores will be compared.

This study is embedded within a development program implemented by a consortium led by Catholic Relief Services. The program aims to improve child nutrition, in part, through behavior change messaging. Parents have difficulty understanding that stunting is a problem because the high prevalence (57%) means the entire population curve has shifted to the left - a stunted child appears normal when compared to others in the community.

Through previous work, we have designed a wall-hanging like a life-size, color coded growth chart. Using 2 stage sampling, with parents clustered in neighbor groups, neighbor groups have been randomly assigned to intervention or control. Both groups will receive standard lessons on stunting while only the intervention group will have the growth mats incorporated into the lessons. After 3 months of exposure to the lessons, parents will be tested on their understanding of the key lesson points. Scores between groups will be tested for statistical differences. Qualitative focus groups throughout the intervention period will collect information on perception of the message delivery and the utility of the growth mats.

Eligibility Criteria:
Inclusion Criteria:

* membership and regular participation in the selected neighbor groups

Exclusion Criteria:

* extended absence from the village during the intervention period
Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma

RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue.

PURPOSE: This phase II trial is studying how well proton beam radiation therapy works in treating young patients who have undergone biopsy or surgery for medulloblastoma or pineoblastoma.

OBJECTIVES:

* Determine the 3-year incidence and severity of ototoxicity in young patients with medulloblastoma or pineoblastoma treated with adjuvant proton beam craniospinal and posterior fossa radiotherapy.
* Determine the incidence of primary hypothyroidism and other endocrine dysfunction (neuroendocrine and end organ) in patients treated with this regimen.
* Determine the incidence and severity of neurocognitive abnormalities in patients treated with this regimen.
* Determine the acute side effects of this regimen, including esophagitis, upper and lower gastrointestinal tract disease, and weight loss, in these patients.
* Determine the 3-year progression-free survival rate of patients treated with this regimen.

OUTLINE: Patients are stratified according to risk (standard vs high).

Patients receive proton beam craniospinal and posterior fossa radiotherapy once daily 5 days a week for 6-8 weeks\*.

NOTE: \*Unless otherwise specified by a co-existing protocol.

Patients undergo neurocognitive evaluation at baseline or within 3 months after completion of radiotherapy and then at 1, 3, and 5 years. Patients also undergo endocrine evaluation at baseline and then annually for 5 years; and audiology evaluation at baseline, before each course of cisplatin-based chemotherapy (if receiving this), and then annually for 5 years.

After completion of study treatment, patients are followed every 3-6 months for 2-5 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed medulloblastoma or pineoblastoma

  * Standard-risk or high-risk disease
* Must have undergone biopsy or attempted surgical resection of the tumor within the past 35 days
* Requires craniospinal irradiation

PATIENT CHARACTERISTICS:

Age

* 3 to 21

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No more than 1 prior chemotherapy regimen
* No prior IV or intrathecal methotrexate
* No prior intrathecal thiotepa
* Concurrent cisplatin-based chemotherapy, including chemotherapy administered on another study, allowed

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy

Surgery

* See Disease Characteristics
Neurobehavioral Moderators of Post-traumatic Disease Trajectories

The research goal is to uncover the neurocognitive moderators of PTSD trajectories, by documenting clinical symptoms, cognitive functioning, and brain structure and function, one-, six- and fourteen months following a traumatic event, in a large population of survivors at initial high risk for PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65 years
* Able to read and comprehend Hebrew
* Arrived in the ER because of one of the following: car accidents, terrorist attacks, work accidents, home accidents, burns, physical assault, large-scale disaster.

Exclusion Criteria:

* Individuals with known claustrophobia
* Individuals with history of substance abuse
* Individuals with current or past psychotic or bipolar I disorder
* Individuals with chronic PTSD at the time of the current trauma
* Individuals on psychotropic medication or recreational drugs in the week that precedes the MRI
* Individuals with hearing problems
* Individuals with head trauma with coma exceeding 30 minutes
* Individuals which can't perform MRI due to safety reasons (e.g. irremovable metals in their body)
Sensitivity Study of Diagnostic for Detection of Chagas Infection

This study is a multi-site trial assessing the sensitivity of Chagas Detect™ Plus rapid test versus standard reference tests (e.g. IFA, IHA, RIPA) for Chagas diagnosis.

The Chagas Detect™ Plus rapid test serves as an aid in the clinical laboratory diagnosis of Chagas infection in patients. This test is intended to be used on human whole blood or serum samples. Chagas Detect™ Plus results (positive or negative) must be confirmed by testing with a reference standard test.

Subjects will be patients at clinical sites located in Chagas-endemic areas. After informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected. One is blood from finger prick, and the other is blood from venous puncture (drawn from vein in arm).

Rapid tests and reference tests will be performed by different operators who are laboratory staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently.


Eligibility Criteria:
Inclusion Criteria:

* All age groups and both sexes for archive samples, adults only and both sexes for prospective samples.
* Samples collected from subjects living in T. cruzi endemic regions.
* Information must be available about symptoms, age, and sex of patient from which samples are collected.
* The location of sample collection must be recorded.

Exclusion Criteria:

* Archived samples with linked personal identifiers or any sample for which personal information can be discovered.
* Prospective samples from nursing home residents; inmates/subjects in police custody; participants who are unable to understand verbal or written local language in which a certified translation of the informed consent is available, or requires a Legal Authorized Representative (LAR) for consent.
* Subject serum specimens that have undergone more than 2 freeze-thaw cycles or that have not been stored frozen.