cyrilzakka/clinical-trials huggingface dataset:
Telehealth Interventions for Daily Routine Activities in Children and Adolescents With Disabilities

Performance of activities during daily routines is an important outcome of rehabilitation services for children and adolescents with physical disabilities, independent of their health condition or functional level. The aim of this study was to evaluate the effect of a telehealth intervention using WhatsApp text, audio, and video messaging on achievement of individualized goals for performance of activities in daily routines in children and adolescents with physical disabilities. The intervention is an eight-week participation-based intervention for children and adolescents with physical disabilities consisted of a goal-oriented, family-centred, collaborative, strength-based, ecological, and self-determined intervention.

Performance of activities during daily routines is an important outcome of rehabilitation services for children and adolescents with physical disabilities, independent of their health condition or functional level. The International Classification of Functioning, Disability, and Health defines activity as whole-body actions and participation as involvement in life situations. Telehealth is a method of service delivery that might enable service providers and families to collaborate on goals for performance of activities during daily routines. The aim of this study was to evaluate the effect of a telehealth intervention using WhatsApp text, audio, and video messaging on achievement of individualized goals for performance of activities in daily routines in children and adolescents with physical disabilities.

The intervention is an eight-week participation-based intervention for children and adolescents with physical disabilities consisted of a goal-oriented, family-centred, collaborative, strength-based, ecological, and self-determined intervention. It is a pragmatic intervention where goals for physical activities in daily routines took into consideration the difficulty of the goal, the family's daily routines, opportunities for practice, and time available for practice. The therapist is a consultant, sharing information, educating, and instructing in ways that encouraged engagement of participants in the intervention process. There are two follow-ups: first after twelve weeks y the last two years later.

Eligibility Criteria:
Inclusion Criteria:

* Participants between five and 21 years old.
* Participants with a physical disability.
* Participants with the ability to walk with or without an assistive device.

Exclusion Criteria:

* Participants with orthopedic surgery within the past 6 months.
* Participants with a health condition limiting physical activity.
* Participants with contraindications to exercise.
* Participants unable to understand the instructions to complete the outcome measures.
RCT of an Integrative Intervention for Non-Treatment-Seeking Meth Users

In the era of HIV treatment as prevention (TasP), efforts are needed to identify evidence-based combination prevention approaches that achieve greater decreases HIV viral load among populations that are more likely to engage in HIV transmission risk behavior. Because methamphetamine-using men who have sex with men (MSM) are at greater risk for acquiring and transmitting HIV, interventions targeting stimulant use in this population of high-risk men could boost the effectiveness of TasP. At present, only conditional cash transfer approaches such as contingency management (CM) have demonstrated short- term efficacy in reducing stimulant use among substance-using MSM who are not actively seeking formal treatment. The proposed RCT will examine the efficacy of a positive affect intervention that is designed to optimize the effectiveness of CM to achieve long-term reductions in stimulant use and HIV viral load in this population. the team will examine the efficacy of this integrative intervention in a randomized controlled trial (RCT) with 110 HIV-positive, methamphetamine-using MSM. After enrolling in CM, participants will be randomized to receive either: 1) the positive affect intervention; or 2) a attention-matched control condition. Follow-up data will be collected at 3, 6, 12, and 15 months post-randomization. This RCT will provide an opportunity to examine the efficacy of an integrative intervention designed to promote long-term reductions in HIV viral load as the primary outcome. Secondary outcomes that will be examined include: increases positive affect, reductions in stimulant use, improvements in T-helper (CD4+) count, unsuppressed viral load, and decreases HIV transmission risk behavior. Identifying an efficacious intervention approach to decrease HIV viral load among methamphetamine-using MSM would substantially support the goals of the National HIV/AIDS Strategy to reduce HIV incidence and mitigate HIV-related health disparities.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Documentation of HIV-positive serostatus
* Speak English
* Biological verification of recent methamphetamine use
* Completion of at least three contingency management (CM) visits
* Self reported anal sex with a man (MSM) in the past 12 months

Exclusion Criteria:

* Inability to provide informed consent, evidenced by cognitive impairment
* HIV negative serostatus
Copeptin in Differentiation of Polyuria and Polydipsia

The differential diagnosis of patients with polyuria/ polydipsia is often complex, but important for the therapeutic strategy.

Challenging is in particular the clinical differentiation between patients with a partial Diabetes insipidus centralis and patients with primary polydipsia as underlying disease, because both groups are associated with similar urinary osmolalities.

The determination of plasma arginine vasopressin is unusual in this context, since measurement of AVP is not reliably.

C-terminal ProVasopressin (copeptin) is secreted stoichiometrically with AVP from the neurohypophysis, but has a longer half life in the circulation, and is thus easier to measure.

Therefore, the investigators will analyze in that study the diagnostic utility of plasma copeptin in the differential diagnosis of polyuria and polydipsia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with polydipsia/ polyuria, with indication for performing a deprivation test
* \> 18 years

Exclusion Criteria:

* dDAVP during the last 14d
* pregnancy
A Prediction Model of Postoperative Anxiety Symptom in Elderly Patients Undergoing Major Noncardiac Surgery

A multicentre, prospective observational study to develop and validate a predictive model for postoperative anxiety symptoms in elderly Chinese patients undergoing non-cardiac major surgery.

In 2015, the WHO introduced the concept of "healthy ageing" for global ageing, with a focus on the mental health of older people at its core. More than 20 million elderly patients undergo surgery each year in China, accounting for a quarter of the population who undergo surgery. Previous studies have found high risk of anxiety in older perioperative patients, especially for non-cardiac major surgery patients. Therefore, it is necessary to construct a predictive model of anxiety in elderly patients undergoing non-cardiac major surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Elderly patients (age ≥ 65 years).
2. Undergoing elective surgery with a planned overnight hospital stay following surgery.
3. Major non-cardiac surgery, non-neurosurgical surgery.

Exclusion Criteria:

1. History of previous severe mental illness or long-term use of psychotropic medications.
2. Immediately admitted to ICU after surgery.
3. Death within 7 days after surgery.
4. Grade of surgery ≤ 2.
5. Failure to complete the postoperative anxiety assessment.
Optimal PEEP in Pediatric Patients Under 17 Years of Age.

This study aimed to investigate the differences in positive end-expiratory pressure titration in the supine and prone positions by age in pediatric patients under 17 years of age who received general anesthesia and then evaluate the hemodynamic stability.


Eligibility Criteria:
Inclusion Criteria:

* patients who are scheduled to undergo general anesthesia in the prone position
* patients who are in age under 17 years

Exclusion Criteria:

* had cyanosis or chronic respiratory failure
* had respiratory distress syndrome or bronchopulmonary dysplasia
* had laryngotracheal diseases
* had pulmonary hypertension
* receiving oxygen therapy
Inflammatory Markers in Preeclampsia

This is an investigation of inflammatory markers in women destined to develop preeclampsia.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian origin

Exclusion Criteria:

* Previous diseases e.g. cardiovascular disease, diabetes, hypertension, inflammatory bowel disease, serious organ disease
Effects of Low Medial Ramus Osteotomy on Neurosensorial Recovery During Post-Operative Period

The aim of this study is to compare the post-operative neurosensorial disturbances of Hunsuck-Epkerr and "low and short medial osteotomy" modifications of sagittal split ramus osteotomy. Patients at the ages of 18-35 with dentofacial deformity who applied for orthognathic surgery were included in the present study. The present study performed with split-mouth randomised controlled trial design, therefore osteotomies on one side were performed with Hunscuk-Epkerr modification and the contralateral side with low and short medial osteotomy modification. Double blinded evaluations of neuro sensorial alterations were performed at the 1st, 3rd and 6th months post-operatively. Painful stimuli, two-point discrimination, pressure and brush stroke direction tests were evaluated. Subjective neurosensorial recovery was also evaluated with VAS scores given by patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with dentofacial deformity who needs orthognatic surgery

Exclusion Criteria:

* The patients with medical conditions that may affect the potential of nerve regeneration,
* The patient who need additional osteotomies such as genioplasty or mandibular subapical segmental osteotomies
* The patients with bad split or interrupted IAN
* The patients with more than 5 mm expected buccal osseous gap between proximal and distal segments
SAFE-PCI for Women

The hypothesis of the SAFE-PCI for women trial is that, compared with transfemoral PCI, transradial PCI will result in a significant reduction in bleeding and vascular complications. The primary objective is to compare the efficacy and feasibility of the transradial approach to percutaneous coronary intervention (PCI) in women compared with the transfemoral approach.

This study is a multicenter, randomized, open-label active controlled study. Three thousand women undergoing urgent or elective PCI from at least 50 centers will be randomized to either transradial or transfemoral PCI. Patients who are enrolled at sites performing ad hoc PCI will be randomized before diagnostic angiography. A total of approximately 3000 women will be randomized to obtain a cohort of approximately 1800 patients undergoing PCI.

The Data Safety Monitoring Board has alerted us that the bleeding event rate overall in our trial is very low, making it unlikely that there will be statistical power to show a difference between the randomized arms in the SAFE PCI for Women study using the BARC bleeding definition per protocol. Based on this statistical futility, the DSMB has recommended stopping enrollment. They also noted, however, that as this is not based on any safety issues, and since there are a variety of key secondary endpoints (contrast and radiation exposure, quality of life) that are of clinical and scientific interest, the DSMB left it to the discretion of the Steering Committee to continue enrollment to meet sufficient power for these outcomes. On March 1, 2013, the Steering Committee met to discuss these issues and voted to continue enrollment until the planned sample size for the Quality of Life substudy was met (300 patients).


Eligibility Criteria:
Inclusion Criteria:

* Have the capacity to understand and sign an informed consent form
* Age ≥ 18 years
* Female patient undergoing urgent or elective PCI or undergoing diagnostic angiography to evaluate ischemic symptoms with the possibility of PCI

Exclusion Criteria:

* Peripheral arterial disease that prohibits vascular access
* Bilateral abnormal Barbeau tests
* Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (note that the opposite arm may be used for radial access in case a dialysis graft is present in one arm provided that the opposite arm has a normal Barbeau test)
* International normalized ratio (INR) ≥ 1.5 in a patient treated with oral vitamin K antagonists (i.e., warfarin).
* Receipt of oral Factor Xa or IIa inhibitors ≤ 24 hours prior to the procedure
* Planned staged PCI within 30 days of index procedure
* Valvular heart disease requiring valve surgery
* Planned right-heart catheterization
* Primary PCI for ST-segment elevation myocardial infarction
* Presence of bilateral internal mammary artery coronary bypass grafts
* Unable to provide informed consent
* Participation in any investigational drug or device study currently or within 30 days prior to enrollment
Evaluation of iMmune Function in Post-surgical and AuToimmune HYpoparathyroidism (EMPATHY)

This is an observational pilot study for the evaluation of immune function, infectious diseases, psychometric status and quality of life in patients with hypoparathyroidism compared to healthy controls.

This is an observational pilot study for the evaluation of immune function, infectious diseases, psychometric status and quality of life in patients with hypoparathyroidism compared to healthy controls.

All patients with Hypoparathyroidism will be on established conventional therapy with calcium supplements and calcitriol. According to guidelines, possible confounding factors (i.e. Vitamin D, serum magnesium levels) will be evaluated at screening visit. Age-, sex- and BMI- matched healthy controls will be enrolled.

Patients and controls will undergo a screening visit (V0) and a baseline visit (V1) in the following month.

The primary outcome will be the immune profiling of patients with hypoparathyroidism compared to healthy controls by the quantification of peripheral blood mononuclear cells (PBMC) subpopulations assessed by flow cytometry.

Secondary Outcome Measures will be:

Functional evaluation of PBMC cytokine secretion assessed by flow cytometry

Evaluation of calcium signaling components expression compared to healthy controls

Evaluation of PTHR1 expression in immune cells compared to healthy controls

Evaluation of inflammatory cytokines production compared to healthy controls.

Evaluation of quality of life compared to healthy controls. Quality of life will be measured by Short Form (SF)-36-Item Health Survey total score, SF-36-Item Health Survey physical component summary score and SF-36-Item Health Survey mental component summary score.

Evaluation of infectious diseases frequencies and severity compared to healthy controls. Infectious diseases will be evaluated by an adaptation of Infectious Diseases Questionnaire (GNC).

Psychometric evaluation by self-administered questionnaires: Beck depression Index, Middlesex Hospital Questionnaire.

Sleep disturbances evaluation by The Pittsburgh Sleep Quality Index (PSQI) self reported questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed (at least 6 months before enrolment) hypoparathyroidism which required daily calcium (≥1000mg/die) and calcitriol therapy;
* Signed informed consent to participate in the study.

Exclusion Criteria:

* Transient hypoparathyroidism;
* History of neoplasms, radiotherapy or chemotherapy in the last 5 years;
* Clinical or laboratory signs of significant respiratory, hepatobiliary, or pancreatic disease;
* Severe infections, surgery, trauma requiring hospitalization within 3 months before enrolment;
* Severe chronic kidney disease (stage 4-5);
* Any active blood or rheumatic disorders in the last 5 years
Retinal Care Data Repository

The Retinal Care Data Repository's primary objective is to make data available for Retinal Care to develop algorithms that improve the care of people with retinal diseases.

The initial focus is to develop algorithms that prevent, delay the progression, or improve treatment of diabetic retinopathy (DR) and age-related macular degeneration (AMD). Examples include but are not limited to: describing the incidence, prevalence, and severity distribution of DR and AMD in the overall population and subgroups; diagnosing specified severity thresholds for DR and AMD; predicting the development and progression of DR and AMD for the overall population, subgroups, and individuals; and recommending tests and treatments to prevent or delay the progression of DR and AMD for the overall population, subgroups, and individuals.

Data will be collected retrospectively and prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes or age 65 years and older

Exclusion Criteria:

* None
Post Marketing Surveillance of JARDIANCE in Chronic Kidney Disease

Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic kidney disease under real-world use.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CKD who are prescribed JARDIANCE® Tablets for CKD according to the current Japanese package insert and who provided written informed consent prior to enrolment in this study.
* Patients who have never been treated with JARDIANCE® Tablets (including treatment for Type 2 diabetes mellitus (T2DM) and/or chronic heart failure (CHF)) before enrolment.

Exclusion Criteria:

* None
Patient Research Cohort: Rapidly Evolving Multiple Sclerosis

The primary goal of the research cohort is to facilitate patient access to clinical trials testing new therapeutic interventions, or access to second- line treatments.

Secondary objectives of the research cohort study are to obtain detailed clinical phenotyping and immunological analysis of blood samples, aiming to identify and validate biomarkers of disease activity and response to treatment and prognostic markers.


Eligibility Criteria:
* Male or Female, aged 18-65
* Able to give informed consent
* Diagnosis of MS according to to the revised McDonald's criteria (Polman et al. Ann Neurol 2005)
* Relapsing-remitting or secondary progressive MS form
* Disease duration ≤15 years from diagnosis
* Expanded disability status scale (EDSS) score 2.0 to 6.0 at screening evaluation
* Highly active and/or treatment-refractory MS activity defined as:

  1. Two or more clinical exacerbations in the previous 12 months, regardless of treatment; OR:
  2. One clinical exacerbation and sustained increase in EDSS of at least 1 point in the previous 12 months after receiving immune-modifying treatment, OR:
  3. Evidence of gadolinium (contrast)-enhancement or increase of T2 lesion load at MRI after receiving immune-modifying treatment. OR
  4. Not tolerating or not wishing to receive any of the available immune-modifying treatments and meeting one of the stated criteria (b or c) for MS activity in treated subjects (1 relapse and increase in EDSS of at least 1 point in the previous 12 months; or evidence of contrast-enhancement or increase of T2 lesion load at MRI).

Exclusion Criteria:

* Contraindication to MRI including but not limited to intracranial aneurism clips (except Sugita), history of intra-orbital metal fragments that have not been removed by an MD (as confirmed by orbital X-Ray), pacemaker and non-MR compatible heart valves, inner ear implants, history of claustrophobia or subject feels unable to lie still on their back for a period of 1.5 hours in the MRI scanner.
* If female, positive urine pregnancy test
* History or presence of renal impairment (e.g. serum creatinine clearance less than 30ml/min)
* Inability to give informed consent/comply with study procedures
Diagnosis of Spontaneous Bacterial Peritonitis

The study is aimed to revise the current criteria for the diagnosis of spontaneous bacterial peritonitis and the decisional thresholds to start treatment. The accuracy of current diagnostic tests will be compared with that of new tests, which could potentially become more accurate reference standards. This could lead to the definition of a more accurate and effective diagnostic algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhosis and ascites with clinical indication to carry out a diagnostic and/or therapeutic paracentesis.

Exclusion Criteria:

* Etiology of ascites other than cirrhosis
Retrospective Review of Anesthetic Considerations for Pulmonary Artery Rehabilitation

Pulmonary artery rehabilitation procedure is done frequently in the catheterization suite for patients with pulmonary artery stenosis or small pulmonary arteries following surgical repair for patients with tetralogy of Fallot with pulmonary atresia and major aortopulmonary collaterals. Considering that the investigators' institution is a major center for treating these cases, the investigators wanted to do a retrospective review of the investigators' data to share the investigators' anesthetic management of these procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent pulmonary artery angioplasty during the period between October 1st 2010 and October 1st 2015 at NCH.

Exclusion Criteria:

* None
Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair

Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair

Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair

Eligibility Criteria:
Inclusion Criteria:

* 50 patients with ASA grade I to II, posted for open inguinal hernia surgery, elective , 18 to 60 years old , will be included in double blinded randomized study.

Exclusion Criteria:

* Patient refusal
* Patient with significant neurological , psychiatric or neuromuscular disease.
* Pregnancy or lactating women.
* Suspected Coagulopathy .
* Morbid obesity.
* Known allergy to some medications .
* Septicaemia and local infection at the block site .
* Alcoholism .
* Drug abuse