cyrilzakka/clinical-trials huggingface dataset:
Translation, Cross-cultural Adaptation, Reliability, Validity and Responsiveness of Short Form 36 (SF-36) Questionnaire in Stroke Survivors

The type of the study is an observational study to test in stroke survivors. The main questions it aims to answer are

1. What is a Burmese version, content validity, convergent validity, divergent validity, and reliability of SF-36 questionnaire in stroke survivors?
2. Does the Burmese version of SF-36 have the responsiveness in stroke survivors? Participants will be interviewed the questionnaire by the research team.

Cross-cultural adaptation of a subjective questionnaire is required for use in a different country, culture, and/or language. Although the majority of questionnaires were created in English-speaking nations, researchers must nonetheless take into account non-native populations in health studies, particularly when their omission could result in a systematic bias in studies of health care usage (Beaton et al., 2000). For the purpose of translating and culturally adapting, it is crucial to achieve equality between the target and original sources of the questionnaire.

As it relates to the authors' perspective, the Short Form 36 (SF-36) has not yet been translated and cross-culturally adapted to be used in Myanmar. As a result, the features of a Burmese version's reliability and validity among individuals with a history of stroke have not been studied in the previous research work. In addition, the questionnaire should also be tested for its responsiveness to provide clinical meaningful for health care professions. Therefore, the aim of this study is to develop a Burmese version of the SF-36 (SF-36-Burmese) according to translation and cross-cultural adaption guidelines and evaluate its reliability, validity, and responsiveness (i.e., the instrument's capacity to identify changes over time in the construct being assessed) and the minimum clinical important difference (MCID, ie., the smallest change in an outcome that a patient would perceive as clinically meaningful) among stroke survivors.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and above (Coppers et al., 2021; Soto-Vidal et al., 2021; Wayessa et al., 2023)
2. Hemiplegia induced by both ischemic and hemorrhagic stroke at least 1 month duration (Wayessa et al., 2023; Vincent-Onabajo, Owolabi \& Hamzat, 2014)
3. Ability to understand the study and respond to questions (on the Mini- Mental State Examination \> 23) (Wongchaisuwan et al., 2005; Muangpaisan et al., 2015)
4. Stable medical conditions

Exclusion Criteria:

1. Other neurological diseases such as Parkinson's disease, dementia, Alzheimer's disease, peripheral neuropathy according to medical history and record
2. Recurrent stroke
3. Participants with dysphasia, intellectual impairments, traumatic head injury, and psychiatric diseases (Wayessa et al., 2023)

3) Participants who cannot understand Burmese language
Comparison of Therapeutic Effect of Different Brace Fixed Time After Novel Achilles Tendon Rupture Surgery

This study is a prospective randomized controlled clinical study. After the novel Achilles tendon rupture repaired , patients were randomly divided into 4 groups according to immobilisation duration of 0, 2, 4, and 6 weeks, respectively. All patients underwent the same suture technique with a similar rehabilitation protocol and were examined clinically at 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks to study the difference in efficacy among the groups.

This prospective randomized controlled clinical study is designed to compare the treatment outcomes of different immobilisation duration by dividing the patients into four groups according to immobilisation duration of 0, 2, 4, and 6 weeks after a similar suture technique. The primary outcome was the time of return to light sports activity (LSA). Secondary outcomes included range of motion (ROM) and single-legged heel rise height (SHRH). Data on operation time, complications, visual analogue pain scale (VAS), American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score, and Achilles tendon Total Rupture score (ATRS) were also collected. Demographic baseline data were analysed using one-way analysis of variance; outcome parameters were analysed using Kruskal-Wallis H test, and complications were analysed using Fisher's exact test. Statistical significance was considered at P ≤ 0.05.

The inclusion criteria were patients aged 18 to 60 years with an acute closed single-legged complete ATR who underwent open surgery with our suture technique.

The excluded criteria were patients with prior ATR and those without rehabilitation or follow-up outcomes. Other situations that affected patients' lower limb functions or tendon healing (e.g. autoimmune disease, diabetes mellitus, systemic corticosteroid treatment) were also excluded.

Eligibility Criteria:
Inclusion Criteria:

patients aged 18 to 60 years with an acute closed single-legged complete ATR who underwent open surgery with our suture technique.

Exclusion Criteria:

* patients with prior Achilles tendon rupture or other situations that affected their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment).

  * an inability to complete our suture technique (e.g., the distance from the rupture site to the Achilles tendon insertion was less than 3.5 cm) .
  * those without rehabilitation or follow-up outcomes.
The Relationship Between Voiding Dysfunction and Intravesical Sensory Threshold in Diabetes Women

The investigators will recruit a cross-sectional group of diabetic women in internist clinics. UDS will be applied for voiding function in each case. Intravesical electrical stimulation will be used to test CPT per 5 Hz, 250 Hz, 2000 Hz for the patients. The differences of intravesical CPT between diabetic women with and without voiding dysfunction will be determined.

Diabetes is a common metabolic disease of multiorgan involvement. The American Diabetes Association reported that the prevalence of diagnosed and undiagnosed diabetes mellitus (DM) in the United States is currently 6% and rising. The increase is secondary to a rising incident in obesity, as well as a change in the criteria for the diagnosis of DM from a fasting blood glucose 140 mg/dl to 126 mg/dl. Besides impaired blood glucose regulation, many direct and indirect sequelae of DM can occur. Triopathy of diabetes including retinopathy, neuropathy, and nephropathy are familiar to every internist. Lower urinary tract dysfunction is one of the most common complications in this group of patients.

We look at the difference of intravesical sensation in diabetic women by current perception test; then, we can find the patient with diabetic cystopathy in early stage. We compare the groups of diabetic women with or without voiding dysfunction by urodynamic study. CPT test for intravesical sensation will be applied.

Eligibility Criteria:
Inclusion Criteria:

* The diabetic women followed up in specialist clinics over one year at National Taiwan University Hospital (NTUH)

Exclusion Criteria:

* Concurrent neurological problems or other medical conditions that might interfere with voiding function
* Acute urinary tract infection (UTI)
* Previous pelvic surgery
* Vaginal prolapse
Effects of Isotretinoin on CYP2D6 Activity

Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases CYP2D6 activity in adolescent patients.

In this aim, we will conduct a drug-drug interaction study evaluating the effects of 13-cis-retinoic acid on non-induced CYP2D6 activity in adolescent patients. Secondary analysis will evaluate the relationship between retinoid concentrations and CYP2D6 activity in these special populations

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant
* ≥ 12 years
* Patients with severe acne that are expected to receive isotretinoin for therapeutic reasons

Exclusion Criteria:

* Weight \< 80 lbs
* Allergy or adverse reaction to dextromethorphan, vitamin A or isotretinoin
* Pregnant or planning to become pregnant
* Unable to follow isotretinoin risk evaluation and mitigation strategies (REMS) program (also known as iPLEDGE program)
* Chronic or persistent cough accompanying asthma, smoking or chronic obstructive pulmonary disease,
* Productive cough,
* Fever,
* Known kidney disease,
* Known liver disease,
* Diabetes
* Obesity, body mass index ≥ 30 kg/m2
* Bipolar disease,
* Attention deficit disorder,
* Social phobia,
* Concurrent or use within 14 days of drugs known to interact with dextromethorphan or cytochrome P450 2D6 (CYP2D6) or drugs known to increase the risk of adverse effects from dextromethorphan
* Concurrent use of any other product containing dextromethorphan
* Consuming foods, beverages or dietary supplements known to interact with dextromethorphan or CYP2D6
* Unable to give written informed consent/assent,
* Inability to fast for 4 hours prior to study.
* Wards of the State
Digital BIOmarkers for the Assessment of Motor Status in Parkinson's Disease Patients with CLInical and ThErapeutic Application

The goal of this observational study is to define digital biomarkers of motor symptoms in Parkinson's disease patients using wearable devices. The main questions it aims to answer is:

* Is there a biomarkers that allows the identification of PD from healthy controls?
* Is there a biomarkers that can identify the severity of the disease?
* Is there a biomarkers with clinical and therapeutic application that can be used in clinical and free living conditions to monitor the evolution of the disease?

Participants have to perform a set of guided exercises related to the MDS-UPDRS guide and daily living tasks, in supervised and unsupervised conditions.

The participants must perform a set of exercises related to the MDS-UPDRS III scale and some free-living activities. These tasks must be performed wearing a smartwatch.

The activities will be done in supervised clinical and unsupervised free-living environments. The participants must perfom a baseline and a final assesment in supervised conditions and a week of free living monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease based on the UK Brain Bank criteria.
* Affiliated with Asociación Parkinson Madrid.
* Minimal or mild disease severity, defined by a Hoehn and Yahr scale score of ≤ 2.5.
* Be capable of performing the prescribed exercises independently.
* Maintain daily functioning without dependence on caregivers.

Exclusion Criteria:

* Hoehn and Yahr scale score of \> 2.5.
* Have undergone deep brain stimulation, used dopamine infusion pumps, or have conditions mimicking PD symptoms (e.g., progressive supranuclear palsy, Lewy body dementia, multiple system atrophy, or other parkinsonian syndromes)
* Experience motor symptom fluctuations throughout the day.
Surgical Stress Index as a Tool for Monitoring Analgesia and/or Sedation in Critically Ill Patients

The hypothesis of the study is: Does the Surgical Stress Index (SSI) correlate with the Behavioral Pain Scale (BPS), the Ramsay Sedation Scale (RSS)and/or the Behavioral Pain Scale(BPV) and can therefore be used to monitor the quality of analgosedation in noncommunicative intensive care unit patients?

The Surgical Stress index (SSI) was developed as a bedside tool to measure 'pain' during surgery. First trials showed a good correlation between SSI and aching procedures and a negative correlation to the dosage of Remifentanil. The first evaluation studies were performed under Propofol and Remifentanil anaesthesia. A different site of use for the Surgical Stress Index could be the intensive care medicine. 'Analgesia and Sedation are essential elements of intensive care treatment and relevant for patient outcome... There is therefore a need to monitor and define the level of sedation and pain and to provide the critically ill patient with adequate analgesia and sedation.' (j. martin 2002). Although the Ramsey Sedation Scale was never proven for validity and reliability it is an often used score for measurement of sedation quality. (Ramsay 74, Hansen-Flaschen 94, Jacobi 02, Martin 04). The Behavioral Pain Scale showed , apart from systolic blood pressure and heart rate, to be reliable and valid for measuring pain in noncommunicative, mechanical ventilated intensive care unit patients. (Payen 01, Jacobi 02, Aissaoui 05) These scales need to be performed a few times a day to be up to date and therefore time consuming for the intensive care staff. The Surgical Stress Index could be a non-invasive, bedside and online tool for measurement of sedation and/or analgesia in this complex patient group.

Eligibility Criteria:
Inclusion Criteria:

* analgosedated, mechanically ventilated patients on the ICU

Exclusion Criteria:

* neurological disorder
* age under 18
* lack of sinus rhythm
Open-Label Trial of Sulforaphane in Premutation Carriers With FXTAS

FXTAS is a rare genetic progressive neurodegenerative disorder, linked to a trinucleotide repeat expansion in the FMR1 gene. FXTAS is characterized by tremor and ataxia in addition to atrophy and white matter disease in the central nervous system (CNS). In addition to the major clinical observations of intention tremor and gait dysfunction, minor symptoms of parkinsonism, neuropathy, and cognitive decline also significantly impact individuals with FXTAS.

The dietary supplement being tested in this study is called Sulforaphane. It is found in broccoli and similar cruciferous vegetables and may cause some gas and discomfort. This is not a study looking at clinical efficacy but instead a study of molecular outcome measures. Investigators want to get more information about how Sulforaphane affects specific biomolecular markers captured in blood.

In this study, participants will be taking an increasing amount of the Sulphoraphane supplement pills (238mg/tablet), starting at 1 and increasing to 6, every morning at breakfast for 6 months. In addition, there will be a total of 3 visits (Initial, 3-month and 6-month) to the MIND Institute where participants will be evaluated. At each visit (3 total) participants will undergo a battery of medical and neurologic exams which make take 2-3 days to complete each time. Participants and/or their caregivers will also be asked to fill out questionnaires/surveys. At the initial visit and at 6 months, we will collect blood for analysis. Two MRI scans will be done, also at the initial visit and at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of FXTAS
* Presence of a FMR1 premutation (55 to 200 CGG repeats)

Exclusion Criteria:

* Individuals with severe renal failure (GFR is \<60 ml/min/1.73 m\^2)
* Significant and current reported substance abuse
* Individuals with substance use disorder (meets 6 or more symptoms of substance use disorder criteria)
* Any subject on hospice or on home oxygen
* Individuals who are pregnant
Evaluation of Recurrence Risk of Atrial Fibrillation After Cryoballoon Ablation

The recurrence of atrial fibrillation(AF) after pulmonary vein ablation with cryoballoon is conducted by many factors . The previous studies found larger left atrial and longer AF duration are tied to higher risk of AF recurrence. The characters of ablation procedure is also of critical importance to durable clinical success such as temperature features and time-to-isolation (TTI). The aim of our study is to develop an tool of recurrence risk evaluation with both pre-procedure and procedure factors.


Eligibility Criteria:
Inclusion Criteria:

Patients with paroxysmal AF and accept cryoballoon ablation.

Exclusion Criteria:

* left atrium (LA) diameter (anterior-to-posterior)\>55mm on transthoracic echocardiography (TTE)
* the presence of thrombus in the LA or left atrial appendage (LAA) on transesophageal echocardiography (TEE)
* uncorrected heart failure (NYHA class III or IV),
* concomitant moderate or severe valvular heart disease or bioprosthetic valve,
* malignancy necessitating chemotherapy.
Effects of Milk Proteins on Protein Synthesis in Healthy Male Subjects Fed a Hypercaloric, High Sucrose Diet

This study aims at assessing the hypothesis that dietary protein content is a major factor regulating lean body mass gain and energy expenditure during overfeeding, and thus long term body weight gain

To test this hypothesis, healthy normal weight male and female subjects will before and after a 7-day hypercaloric, high-sucrose diet (+40% excess energy as sucrose) and either a low (5% total energy) or a high (20% total energy) protein intake. Each subject will be studied with both low- and high protein diets according to a randomized, crossover study. On each occasion the following measurements will be done in basal conditions (after 2-day isoenergetic, controled diet) and at the end of the 7-day overfeeding:

* whole-body protein turnover, oxidation and synthesis in fasting conditions and fed conditions (13C-labelled leucine)
* intrahepatic and intramuscular fat concentration (1H-Magnetic Resonance Spectroscopy)
* Energy metabolism in fasted and fed conditions (indirect calorimetry)
* plasma concentration of glucose, non-esterified fatty acids, total triglyceride, very-low density lipoprotein (VLDL)-triglyceride, insulin, glucagon, growth hormone (GH), insulin-like growth factor 1 (IGF1), insulin-like growth factor binding protein (IGFBP) 1,2 and 3 in fasting and fed conditions The effects of high-protein and low-protein sucrose overfeeding on whole body protein synthesis will be compared using two-way ANOVA; relationships between changes in whole body protein synthesis on one hand, and intrahepatic/intramuscular fat concentrations, total energy expenditure, and plasma concentration of metabolic variables on the other hand, will be evaluated by linear regression analysis


Eligibility Criteria:
Inclusion Criteria:

* good apparent health
* low physical activity
* non-smokers

Exclusion Criteria:

* vegans or following any special diet
* consumption of \> 3 dl/day sweetened beverages
* changes in body \> +/- 3Kg over the past 3 months
* contra-indications to magnetic resonance spectroscopy
* drug or substance abuse
* consumption \> 10g/day alcohol
* lactose intolerance
High-Field MRI Characterization of Wrist and Hand Cartilage Abnormalities in Inflammatory and Chronic Rheumatisms

The present project aims at evaluating the diagnostic potential of high-field MRI (3 Teslas) for joint disease. At this field, given that isotropic image resolution of 400 microns can be obtained, one could expect an early detection of joint abnormalities. The additional aim of this project will be to develop a quantitative analyse of the corresponding high-resolution images.


Eligibility Criteria:
Inclusion Criteria:

* gp Suspects or affected by rheumatoid polyarthritis

  1. Morning articular Stiffness of at least 15 minutes.
  2. Arthalgias or Arthritises of at least three joints(articulations), among which those of the hand.
  3. Possible rheumatoid Presence of a factor(mailman) and\\or Antibody anti peptides positive citrullinés.
  4. Typical possible radiological Hurts on the standard clichés(pictures) of the reached(affected) joints(articulations).
* gp Affected by stiffening spondylitis with axial and peripheral infringement :

  . Lumbago and steepness lumbar vertebra inflammatory. 2. Arthralgias and\\or peripheral arthritises 3. Possible presence of an allèle HLA 4. Possible presence of a sacro-illite 5. Absence of the other rheumatic markers
* gp Affected by connectivity with anti-nuclear antibody positive and / or specific antibodies, suffering of polyarthralgias with or without arthritis
* gp Healthy control
* gp Presenting a degenerative osteoarthritis of the wrist traumatic comment, noticed radiologically, which will serve as not inflammatory control.

Exclusion Criteria:

* Claustrophobia,
* metallic foreign bodies,
* pacemakers The pregnant women,
* parturients or who breast-feed are excluded from the study
Soft Tissue Volume, Dimensions and Tomographic Alveolar Ridge Classification System for Dental Implant Treatment.

Despite the importance of soft tissue dimensions for periodontal, restorative, implant, and orthodontic treatment, the current classifications of tomographic alveolar ridge topography lack the soft tissue component(Tolstunov, 2014). Therefore, the present study will be to evaluate the relationship between soft tissue volume and the dimensions \& tomographic alveolar ridge classes as well as to incorporate the soft tissue volumetric evaluation in the classification system.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients in a healthy systemic condition who required comprehensive dental treatment.
2. Both genders with age group \> 18 years old.
3. Patients should have at least a single missing tooth that requires dental implant placement.
4. Healing period of 3 months after extraction prior to surgical procedures.
5. CBCT scans will be obtained as a part of the comprehensive dental treatment.
6. Patients should approve to deliver a signature to a written consent after studying nature explanation.

Exclusion Criteria:

1. Patients with severe smoking habits \>10 cig \\ day.
2. Pregnant females, decisional impaired individuals, Prisoners, and handicapped patients.
3. Patients having poor oral hygiene or not wanting to carry out oral hygiene measures.
4. Patients on any medication affecting the soft tissue health (e.g., amlodipine, Cyclosporine A, hydantoin)
5. Patients with infections either periodontally or periapically
Dietetic Intervention With Soluble Fiber in Type 2 Diabetes Mellitus (DM) Patients With Metabolic Syndrome (MS)

Metabolic Syndrome (MS) is an clinical condition with high cardiovascular risk. More than 80% of DM patients had MS. Dietary factors can be associated to both, DM and MS. Therefore the aim of this study is to evaluate the effects of add soluble fiber (goma-guar) in the usual diet of type 2 DM with MS and compare this intervention with an usual diet without this supplement.

The aim of this study was to evaluate the effect of soluble fiber (guar gum) on the MS components (International Diabetes Federation-2005 and WHO): blood pressure, plasma glucose, triglycerides, HDL, central obesity (waist, BMI),and albuminuria. Secondary objectives are: effect of guar gum on serum fatty acids, , PCR, endothelin 1, and fibrinogen. Primary outcomes were alterations on MS components.

Forty-four type 2 diabetic outpatients were included in a randomized clinical trial: treatment 1- guar gum (10g/day) + usual diet; treatment 2- usual diet. The duration of each treatment was six weeks. Three days weight diet records with concurrent 24h urinary collections (protein intake estimative), clinical and laboratory evaluation were performed at baseline and after 4 and 6 weeks. Serum fatty acids were measured in total triglycerides fractions by gas chromatography.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes
* Using metformin and/or Insulin

Exclusion Criteria:

* serum triglycerides \> 400 mg/dl
* serum creatinine \> 2 mg/dl
* gastrointestinal malabsorption