cyrilzakka/clinical-trials huggingface dataset:
Translation and Validation of Malay Version of painDETECT Questionnaire

The translation and cultural adaptation process of the English version of PDQ will be performed based on international guidelines. Subsequently, patients with neuropathic and nociceptive pain based on clinician's diagnoses will be recruited to complete three-type numeric rating scale (NRS) of pain followed by PDQ-M and SF-36 questionnaire. Patients' socio-demographic data and clinical characteristics will be reported using frequency for categorical variables and mean with standard deviation for continuous variables. Normality will be assessed using Shapiro Wilk test and histograms for continuous variables. Data will be compared between groups using chi-square test (for categorical variables) and t-test or Mann-Whitney's U test (for continuous variables). Suitability of PDQ-M data for factor analysis will be verified using the Bartlett's test of sphericity and the Kaiser-Mayer-Olkin (KMO) measure of sampling adequacy. Parallel analysis will performed to obtain the suitable factors. Construct validity will be investigated by exploratory factorial analysis (EFA) with varimax rotation. A factor loading of \>0.40 will be used to determine the items for each factor. The internal consistency of the questionnaire will be assessed using Cronbach's alpha test. A p value of \<0.05 is taken as statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* able to read and understand the Malay language
* diagnosed to have neuropathic or nociceptive pain by clinician
* stable disease condition
* pain duration of at least 4 weeks

Exclusion Criteria:

* acute illness
* poor mental health status that prevents them from understanding or responding to the proposed questions
* cultural or language barrier
Phase I Study of Umbilical Cord Blood Transplantation Followed by Third Party Thymus Transplantation

The objective of this trial is to assess the toxicity of thymus transplantation following unrelated umbilical cord blood transplantation. Emphasis will be placed on adverse events that are not typically associated with umbilical cord blood transplantation. Also, to determine whether engraftment of a third party thymus allograft is feasible in patients who have undergone unrelated umbilical cord blood transplantation.

The objective of this trial is to assess the toxicity of thymus transplantation following unrelated umbilical cord blood transplantation. Emphasis will be placed on adverse events that are not typically associated with umbilical cord blood transplantation. Also, to determine whether engraftment of a third party thymus allograft is feasible in patients who have undergone unrelated umbilical cord blood transplantation. Thymic engraftment will be determined by biopsy of the thymus allograft and immunohistochemical evidence of thymopoiesis. In addition, we would like to assess thymic function by measuring the number of naive T cells and the number of T cell receptor rearrangement excision circles (TRECS), and by assessing the diversity of the T cell receptor beta chain. These data will be compared to age, stem-cell donor source and disease matched historical controls whose stem cell transplants were not followed by a thymus transplant. This will be done in descriptive fashion. Other immune parameters will be followed including T, B, and NK cell numbers, T cell responses to mitogens, antigens, and immunoglobulin production.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who received a dual cord blood transplant are eligible and must have achieved donor cord blood chimerism of \> 75% in both T-cell and myeloid lineages
* At the time of thymus transplantation, subjects cannot have active grade II-IV acute graft versus host disease.
* At the time of thymus transplantation, the subject must have an absolute neutrophil count of \> 500/ul and a platelet count of 50,000/ul (even if achieved via transfusion).
* At the time of thymus transplantation, the subject must have \< or equal to 50 circulating CD 34+ cells/ul (as measured within 3 weeks of transplant date).
* At the time of thymus transplantation, subjects cannot be on greater than 2 mg/kg/day methylprednisolone or its equivalent of steroids.
* At the time of thymus transplantation, PT and PTT must be less that 1.5 times the ULN or must be correctable to this level.
* At the time of thymus transplantation, subjects cannot require oxygen or have pulmonary disease that would be thought to make general anesthesia a high risk.
* Subjects must be between the ages of 18 and 60 years of age.

Exclusion Criteria:

* Subjects cannot have bone marrow flow cytometry demonstrating residual leukemia
* Subjects cannot have insufficient subcutaneous tissue and muscle mass to be able to accept and heal a thymus transplant, as assessed by a surgeon.
* Prior to thymus transplantation, subjects cannot have evidence of active disease with HHV6, West Nile Virus, EBV, and CMV.
TRIAD Appendicitis Decision-making Surveys

While appendectomy has been the main treatment of appendicitis for over 100 years, recent European studies found that, at least among highly selected patients, antibiotics alone can be an effective alternative. Surgeons and patients alike have a difficult time deciding if surgery or antibiotics are the best choice to treat appendicitis. The goal of the TRIAD is to evaluate the patients who are a part of the TRIAD implementation program and assess satisfaction and decisional regret for patients with appendicitis. This information will be used to inform the design of decision-support interventions to help patients improve their ability to make an informed decision in-line with their preferences and values.

TRIAD Patient Surveys is a cross-sectional survey design that will lead to more informed decision making and better outcomes related to antibiotics for appendicitis.

TRIAD was developed from questions raised by the University of Washington CODA Trial that addressed many of the methodological issues in the European studies and included diverse, adult patients (n=1552) with almost all types of presentations of appendicitis.

TRIAD surveys will be carried out in clinics and hospitals across the United States. Patients who are diagnosed with appendicitis will be recruited for study participation regardless of which treatment (appendectomy or antibiotics) they receive. Investigators invite patients to participate in a survey designed to identify awareness of treatment options and levels of decisional conflict (measured with the Ottawa Decisional Conflict Score \[DCS\]). Participants will complete a baseline survey via a convenient electronic platform, and follow-up surveys will be sent at 30 days.

By implementing the TRIAD surveys, researchers hope to obtain a better understanding of patients' perspectives, knowledge, and decision-making processes regarding the choice between appendectomy and antibiotic treatment for appendicitis. This data can contribute to more informed decision-making and potentially improve outcomes related to antibiotic use for this condition.

Eligibility Criteria:
Inclusion Criteria:

* Any patient the clinical team feels is appropriate for considering either surgery or antibiotics for their initial appendicitis treatment

Exclusion Criteria:

* Pregnant patients
* Immunocompromised patients
* Patients with high complication risk of recurrent infections
* Evidence of severe phlegmon or walled off abscess or free air on imaging
* Septic shock
* Diffuse peritonitis
* Patients under 18 years old
Clinical Value of Microvascular Ultrasonography in Real-time Differential Diagnosis of Thyrotoxic Patients

This study aims to verify the clinical value of thyroid ultrasound with microvascular flow imaging in thyrotoxic patients for differential diagnosis between hyperthyroidism and thyroiditis. We intend to use the RS85 Ultrasound device manufactured by Samsung Medison. Graves' disease and painless thyroiditis/subacute thyroiditis are the main cause of thyrotoxicosis.

Precise discrimination between Graves' disease and painless thyroiditis/subacute thyroiditis is clinically very important in determining treatment methods, such as the prescription of antithyroid drugs. Primary endpoint was to verify the value of vascularity index, defined by Blood pixel in range of image / Total pixel in range of image .Seondary endpoint was to verify the superiority value of Microvascular flow imaging to discriminate thyrotoxicosis patients compared with Color doppler/ Power doppler ultrasound imaging and conventional ultrasound imaging.

Thyrotoxicosis refers to the appearance of various clinical symptoms or signs due to and excessive increase of thyroid hormone in the body. Graves' disease, which causes thyrotoxicosis, is one of the most common autoimmune diseases and is known to account for 0.5% of the population. Precise discrimination between Graves' disease and painless thyroiditis/subacute thyroiditis is clinically very important in determining treatment methods.

The Microvascular flow imaging technology is expected to show higher sensitivity and accuracy than conventional color Doppler images in differentiating patients between Graves' disease and painless thyroiditis/subacute thyroiditis. We enrolled thyrotoxicosis patients in their initial presentation and used RS85 Ultrasound device manufactured by Samsung Medison to discriminate Graves' disease and painless thyroiditis/subacute thyroiditis. Power / Color doppler ultrasound imaging and conventional ultrasound imaging were used. Tranverse and longitudinal plane of the dominant lobe were selected for imaging. Doppler Adler's method was used to asscess vascularization. To assess the vascularity index, which is defined by Blood pixel in range of image / Total pixel in range of image, we selected the total tranverse plane of the thyroid as range of image.

Eligibility Criteria:
Inclusion Criteria:

* Initial presentation with thyrotoxicosis

Exclusion Criteria:

* Past history of thyroidectomy
* Factitious thyrotoxicosis
* Unable for ultrasound
Vacuum vs Manual Drainage During Unilateral Thoracentesis

The purpose of this study is to determine if there are any differences in terms of safety, pain, or drainage speed between thoracenteses via manual drainage vs vacuum suction.

Patients with pleural effusions routinely undergo thoracentesis in which a catheter is placed into the pleural space to remove the fluid both for diagnostic and therapeutic reasons. In this setting, large amounts (often liters) of fluid are removed to palliate the patient's symptoms of breathlessness.

Thoracentesis is the most commonly performed and least invasive method to remove pleural fluid. These frequently performed using a catheter drainage system where a small, flexible temporary catheter is inserted over a needle into the pleural cavity. After insertion of catheter into the pleural space, the operator has two drainage system options: 1. Manual drainage via syringe-pump that connects to drainage bag or 2. Drainage into a vacuum bottle. Both are routinely performed in almost every hospital in the United States.

Pleural pressure (Ppl) is determined by the elastic recoil properties of the lung and chest wall. Normal pleural pressure is estimated to be -3 to -5 cm H20 at functional residual capacity. During drainage of pleural fluid, negative pressure is applied either via syringe during manual drainage or via vacuum using vacuum drainage bottle. Hypothetically more negative pressure can translate to increased perception of pain or visceral pleural injury.

Two techniques (manual vs vacuum drainage) are used based on the operator preference and both are standard of care. To our knowledge there is no head to head comparison of these two available systems of drainages during thoracentesis of pleural effusions. Knowing if one is superior to the other will aid future clinicians.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral therapeutic thoracentesis

Exclusion Criteria:

* Patients with a history of prior significant pleural or lung based procedures/surgeries (not a simple thoracentesis)
* Prior enrollment in this study
* Patients ability to comprehend and consent to this procedure and clearly communicate any pain or other symptoms that arise from this procedure
Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients

The purpose of this study is to evaluate efficacy of phlebotomy on insulin sensitivity as evaluated by euglycemic-hyperinsulinic clamp in insulin resistance-associated hepatic iron overload patients.

The main objective of this study is to evaluate in patients with HSD effects of treatment with phlebotomy rules with lifestyle and dietary rules versus lifestyle modifications alone on peripheral insulin resistance (assessed by hyperinsulinemic clamp).

Secondary objectives are:

* to study in all patients with HSD the relationship between the amount of iron intrahepatic and degree of peripheral insulin resistance and liver before therapeutic intervention.
* to study and compare the effects of phlebotomy treatment versus no treatment on:

  * Plasma levels of adipocytokines,
  * Plasma concentrations of inflammatory markers and markers of insulin resistance,
  * The serum ferritin,
  * The post-hepatic clearance of insulin,
  * The surface of the abdominal visceral fat and subcutaneous abdominal.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years
* Ferritin between 450 and 1000 µg/L
* Hepatic iron overload proved by MRI (CHF \>36 µmol/g)
* Body mass index \> 25 kg/m²
* Fasting glycemia \<1,26 g/L
* HbA1c \< 6,5%
* Signed written and informed consent

Exclusion Criteria:

* Other causes of hyperferritinemia:

  * Inflammatory syndrome (CRP \>10 mg/L) or inflammatory, immune or malignant diseases
  * Hyperferritinemia-cataract syndrome (familial cataract or personal history of cataract before 50 years old)
  * Low ceruloplasmin level
  * Porphyria (cutaneous signs)
  * Haemochromatosis established by the genotype (C282Y homozygous or C282Y/H63D coumpound heterozygous genotypes)
* Contraindication of phlebotomy

  * Haemoglobin \<13,5 g/dL (threshold established by the Etablissement Français du Sang)
  * Heart failure or coronary heart diseases
  * Hepatic failure, renal (GFR \<50mL/min) or respiratory insufficiency (chronic dyspnea)
  * Poor venous system
* Viral, immune, genetic, vascular, malignant or toxic chronic hepatic disease
* Alcohol consumption more than 21 doses per week during 5 years or more
* Type 1 or type 2 diabetes
* Oral anti-diabetic, corticoids or immune suppressor drugs
* Hepatic severe disease
* Claustrophobia, having a pace-maker or intracerebral clips
* Subjects deprived of their liberty by judicial or administrative decision, subjects that are not affiliated to social security or topics exclusion period of a previous study
Clinical Performance Evaluation of DxN HCV Assay

The DxN Hepatitis C Virus (HCV) Assay is an in vitro diagnostic assay intended as an aid in the management of of HCV-infected individuals undergoing antiviral therapy. The purpose of the study is to establish the clinical performance of the DxN HCV Assay for plasma samples in the intended use population.

Same as brief

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older
* Subject has measurable HCV-RNA at baseline (prior to treatment start)
* Subject is genotype 2 or 3 and plans to undergo treatment with Peginterferon (PEG) plus Ribavirin (RBV) or Sofosbuvir (SOF) plus RIB
* Subject is genotype 1 and plans to undergo treatment with Telaprevir (TEL) or SOF plus PEG+RBV or, SOF plus Ledipasivr (LED)
* Subject is able to under information given, and willing and able to voluntarily give their consent to participate in study including signing consent form.

Exclusion Criteria:

* Co-infection with HIV or Hepatitis B (HBV)
* Prior participation in study
* Current participation in an investigation drug or device study
Comparison of FEETME® Soles and GAITRITE® Walkway for the Evaluation of Gait Disorders in CIDP.

Chronic Inflammatory Demyelinating Polyneuropathies (CIDP) are acquired, autoimmune and inflammatory neuropathies leading mainly to gait disorders in patients. Assessment of gait disorders is a major component of therapeutic management, but evaluation is sometimes difficult due to the fluctuating nature of the symptoms. The principal objective of this study is to compare the walking speed of patients with a reference method (GAITRITE® walkway) and an innovative one (FEETME® connected soles) with the aim of validating the use of theses connected soles in CIDP gait disorders evaluation.

Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) present multifactorial gait disorders (motor deficit, fatigability, sensory and proprioceptive disorders with ataxia). Gait disorders are the main cause of disability in these patients. Assessment of gait disorders is a major component of therapeutic management, but evaluation is sometimes difficult due to the fluctuating nature of the symptoms. For many patients, there is indeed a fluctuating nature of gait disorders depending on the administration of treatments (reappearance of symptoms between two immunoglobulin -IgIV- infusions) conditioning the interval of two infusions. In the context of a shortage of IgIV and given the high cost of this treatment, it is of major importance to adapt the treatment as closely as possible to the needs of the patients.

Objective evaluation methods of gait disorders used in current practice have several drawbacks: chronophagy, operator-dependency, heterogeneity of data, implementation in hospital. Moreover, these methods often lack sensitivity to detect some changes. Portable evaluation methods with pressure sensors (including FEETME® connected soles) have been developed and studied in several neurological pathologies. These systems allow one-off evaluations with standardised tests but also continuous monitoring in an ecological environmentBy comparing several walk parameters with a reference method (GAITRITE® walkway) and an innovative one (FEETME® connected soles) , we want to validate the use of the connected soles in gait dirorders evaluation for CIDP patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, aged 18 to 75 years old.
* Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) defined or probable according to the EFNS/PNS (European Federation of Neurological Societies/Peripheral Nerve Society) diagnostic criteria proposed in 2010.
* Patients treated with intravenous polyvalent immunoglobulins.
* Patients with gait impairment related to CIDP, not requiring technical assistance, with an ONLS (Overall Neuropathy Limitations Scale) score of 1 or 2/7 on the lower limbs at inclusion.
* Patients affiliated to or benefiting from a social security scheme.
* Patients giving their free and informed consent to participate after information about the research.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Patients placed under guardianship, curatorship or safeguard of justice.
Multisensory Environment Stimulation Therapy on Postural Control in Cerebral Palsy

To investigate the Effect of Multisensory environment stimulation therapy on postural control in spastic hemiplegic cerebral palsy.

Fortypatients with spastic hemiplegic cerebral palsy will participate in this study.

The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to Multisensory environment stimulation therapy, three times per week for three months. The evaluation methods are BIODEX, The Pediatric Balance Scale, and multidirection reach test

Eligibility Criteria:
Inclusion Criteria:

* - Forty children with cerebral palsy,
* Age will range as (9:12) years old
* spastic hemiplegic cerebral palsy
* Normal body mass index standardmore than 50th and less than 85th for age and sex compared to standard Egyptian growth charts adopted by the Faculty of Medicine, Cairo University and National Research Centre.
* Gross motor function classification system: level I\&II

Exclusion Criteria:

* • difficulty to communicate or to understand program instructions

  * any other neurological deficits or orthopaedic abnormalities,
  * secondary musculoskeletal complication
  * vestibular problems
Boosting the HRQoL Among HIV+ Mothers and Children

The goal of this randomized controlled trial is to test the effectiveness of a resilience intervention and an adherence intervention in improving health-related quality of life (HRQoL) among perinatally infected HIV positive children and their HIV positive mothers in China.

The main questions it aims to answer are:

1. Whether baseline resilience and treatment adherence are associated with the HRQoL;
2. Whether the resilience intervention will improve the mediators associated with intervention sessions, such as positive coping and social support, the proximal outcome of resilience factors, the distal outcome of HRQoL, and dyadic level outcomes such as dyadic coping;
3. Whether the adherence intervention will improve the mediators associated with intervention sessions, such as adherence information and behavioral skills, the proximal outcome of self-reported adherence, the distal outcome of HRQoL, and dyadic level outcomes such as dyadic coping;
4. Whether the enhanced mediators (e.g., positive coping and social support) associated with the resilience-intervention sessions at the end of the intervention will transmit the effect of the resilience intervention on the increases in resilience factors during follow-ups;
5. Whether the improved mediators (e.g., adherence information and behavioral skills) associated with the adherence-intervention sessions at the completion of the intervention will transmit the effect of the adherence intervention on the increases in adherence in follow-ups.

Participating mother-child dyads in the two intervention arms will receive two sessions of dyadic intervention. Researchers will compare the above-described outcomes between participants in the two intervention arms and the control arm (treatment as usual) to see the effectiveness of the interventions.


Eligibility Criteria:
Inclusion Criteria:

1. the child is HIV positive and perinatally infected, and receives HAART;
2. the biological mother of the child is HIV positive and receives HAART;
3. the mother is a primary caregiver of the child.

Exclusion Criteria:

1. cannot complete the assessment due to a low education level or physical constraints;
2. have been diagnosed with another life-threatening disease (e.g., cancer);
3. have experienced a traumatic event (e.g., a severe car accident or bereavement) in the past 12 months.