cyrilzakka/clinical-trials huggingface dataset:
Effects of a Personalized Standardized Rehabilitation Program in Systemic Sclerosis

Systemic sclerosis (SSc) is a connective-tissue disease characterized by excessive collagen deposition, vascular hyper-reactivity and obliterative microvascular phenomena leading to disability, handicap, and worsening of quality of life. Pharmacological treatments are mainly used for vascular involvement. To date, no pharmacological treatment have been shown to be effective for the fibrosis leading to skin, tendon, and joint disability. Our hypothesis is that rehabilitation could be an interesting non pharmacological treatment in order to decrease the handicap of SSc patients. Our objective is to evaluate the effect of a personalized standardized rehabilitation program on the quality of life of SSc patients in a multicentric randomized controlled trial. This trial will compare a personalized standardized rehabilitation program to the usual non pharmacological treatment. The primary outcome measure will be the HAQ DI (Health Assessment Questionnaire Disability Index). A Zelen design will be used for this study.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged from 18 years or more, with diagnostic of SSc considering the ACR and/or Leroy and Medsger's criteria.
* HAQ greater than or equal to 0.5
* A perception of limitation of mouth opening and/or at least one limitation in range of motion due to illness
* Good understanding of the French language

Exclusion Criteria :

* Associated chronic handicap diseases (stroke, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, amputated ....)
* Any underlying disease that may be incompatible with the management, discovery at the inclusion visit
* Cognitive problems making it impossible to assess the primary outcome measure
* Patients with a standardized rehabilitation program within 6 months prior to inclusion
* Impairment of comprehension or expression of the French language
* Patients participating in another clinical trial or participated in another clinical trial in the previous 3 months.
A Phase 2 Basket Study of Vosoritide in Children With Turner Syndrome, SHOX Deficiency and Noonan Syndrome With an Inadequate Response to Human Growth Hormone

The purpose of this basket study in children with Turner syndrome, SHOX deficiency, and Noonan syndrome is to evaluate the effect of 3 doses of vosoritide versus hGH on growth as measured by AGV after 6 months of treatment. The long-term efficacy and safety of vosoritide at the therapeutic dose will be evaluated up to FAH.

This is a Phase 2, randomized, active-controlled, multicenter, basket study of vosoritide in children with Turner syndrome, short stature homeobox-containing gene (SHOX) deficiency, or Noonan syndrome who have an inadequate response to human growth hormone (hGH) treatment. The study is intended to characterize the short-term efficacy and safety of 3 dosing regimens of vosoritide versus hGH. The efficacy and safety of the vosoritide therapeutic dose will be further evaluated, with a comparison to hGH after 2 years of treatment, and an analysis of the impact of vosoritide on final adult height (FAH).

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be ≥ 3 years old, and \< 10 years old (females) or \< 11 years old (males),at the time of signing the informed consent form
2. A genetically confirmed diagnosis of Turner syndrome, SHOX deficiency or Noonan syndrome.
3. A height assessment corresponding to a height Z score of ≤ -2.00 SDs in reference to the general population of the same age and sex.
4. Tanner Stage 1, at time of signing the ICF.
5. Have been receiving continuous hGH for the treatment of short stature associated with their condition for a minimum of 1 year immediately prior to enrollment.
6. Are willing to continue on hGH for the Baseline Growth Phase, and for 2 years post randomization if randomized to the hGH arm.
7. Inadequate response to prior hGH treatment.

Exclusion Criteria:

1. Participants with Turner syndrome known to have Y-chromosome material unless they have undergone gonadectomy and have fully external female genitalia.
2. Diagnosis of systemic disease or condition that may cause short stature other than Turner syndrome, SHOX deficiency, or Noonan syndrome, eg, renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic and metabolic disease.
3. Bone age advanced beyond chronological age by more than 2 years.
4. Congenital heart disease which places the participant at increased risk of an adverse cardiac outcome in the setting of hypotension,
5. Have an unstable condition likely to require surgical intervention during the study.
6. Evidence of decreased growth velocity (AGV \< 1.5 cm/year) as assessed over a period of at least 6 months and growth plate closure assessed using bilateral lower extremity X-rays.
7. Previous limb-lengthening surgery, or planned or expected to have limb lengthening surgery during the study period.
8. Planned or expected bone-related surgery (ie, surgery involving disruption of bone cortex, excluding tooth extraction), during the study period.
Asthma in the Delta Region of Arkansas (ADRA): Prevalence and Morbidity

The purpose of the study is to conduct a cross-sectional study to examine asthma prevalence and morbidity in a predominately minority, low-income population in rural Arkansas.

Asthma is the leading chronic disease of childhood in the United States and an important public health concern in Arkansas. Arkansas, a predominately rural state, has one of the leading mortality rates in the nation for African Americans. The specific aims of the study will examine asthma prevalence in children age 4-17 years old in public schools in Eudora and Marvell Arkansas. The study will also examine asthma morbidity among identified asthmatics by characterizing activity limitation, days missed from school, daytime and nocturnal symptoms, healthcare utilization and medication use. The specific aims of the current study will provide novel data on an understudied population of asthmatics and will test our working hypotheses that pediatric asthma prevalence in the Delta region of Arkansas is higher than national estimates; and asthma diagnosis is related to significant morbidity among rural asthmatics.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 4-17 years, enrolled in the public schools in Eudora and Marvell Arkansas.

Exclusion Criteria:

* Children aged 18 or older enrolled in the public schools in Eudora and Marvell Arkansas were excluded.
Electroacupuncture as an Adjunct to Non-Surgical Periodontal Therapy

The aim of this randomized, single-masked, controlled clinical trial study was to determine if the administration of electro acupuncture improves the outcomes obtained in combination with non-surgical periodontal therapy.

Participants will get non-surgical periodontal therap with/without electro acupuncture.

Researchers will compare EA and control groups to see if there is any relationship between acupuncture application clinical periodontal parameters,serum and saliva cytokine levels.

Periodontitis is a prevalent complex chronic inflammatory oral disease that can result in the progressive destruction of tooth supporting tissues and eventual loss of teeth. Although pathogenic bacteria are the triggers and provokers of periodontal inflammation, the main determinant of the destruction is the host immunoinflammatory response. The host response is modified by many genetic and environmental factors as well as various systemic diseases.

Electroacupuncture (EA) has effects on both the immune system and inflammatory processes. The effect of acupuncture on the regulation of cytokine production has been mentioned in the literature. .

No study has been found in the literature about the effects of EA on the host modulation in periodontitis patients. In this study, the investigators aimed to examine the effect of electroacupuncture application on the host modulation at periodontitis.

Eligibility Criteria:
Inclusion Criteria:

* absence of any systemic disease,
* pregnancy or breast feeding;
* not receiving anti-inflammatory drug therapy in the last 6 months, chemotherapy or radiotherapy;

Exclusion Criteria:

* Having a systemic disease such as cardiovascular, diabetes, hypertension, thyroid organ pathologies, chronic kidney failure
* pregnant/breastfeeding
* medication for any reason
* smoker/tobacco user
* other periodontal disease other than periodontitis
* chronic inflammatory disease (COPD, asthma)
Pharmacists' Interventions to Improve Blood Pressure in Chronic Kidney Disease

The aims of the study were to determine whether pharmacists' interventions combining patient home-based self-measured BP monitoring improve blood pressure reduction and control compared with usual care in chronic kidney disease (CKD) patients

This is a prospective randomized two-group pharmacist-led interventional study that was conducted in two public nephrology clinics. The study involved the introduction of pharmaceutical care to improve blood pressure and adherence to the prescribed medications among patients with chronic kidney disease (CKD).

Recruited patients were randomly divided into two groups; the intervention group and the control group, with baseline evaluation of outcomes measured.

The Control group was provided with usual care. An intervention group was provided in addition to the usual care, face-to-face education on CKD, hypertension as a co-morbidity and its management, and antihypertensive medication adherence at baseline (group education), 6 months and 12 months (individualized according to each patient's needs), CKD patient educational infographic leaflet at baseline, a calibrated sphygmomanometer digital blood pressure monitor (Chidalex®) for home-based self-measured BP monitoring, a BP logbook at baseline for the recording of blood pressure values daily and hands-on training on BP self-measurement. Also, antihypertensive medication adherence and home-based self-measured BP monitoring, reminder cell phone text messages were sent biweekly throughout the trial period, while phone-in inquiries from the participants and phone-out reinforcement interventions were utilized throughout the trial period.

Both groups were followed for a period of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* CKD stages 1 - 4,
* Voluntary written informed consent,
* Willingness to abide by the rules of trial, and
* Availability during the trial duration

Exclusion Criteria:

* Patients with acute renal failure,
* CKD stage 5,
* Pregnant or lactating women,
* Post-renal transplant patients,
* Patients with HIV infection,
* Critically ill patients or patients known to have cognitive impairment.
Effects of Physical Activity on the Brain in Parkinson's Disease (PD)

The aim of the study is to investigate whether exercise improves cognitive and motor functions in Parkinson's disease. To test this hypothesis, the researchers study general brain functions in subjects with PD during a 6-months exercise program.


Eligibility Criteria:
Inclusion Criteria:

* UPDRS \<15
* L-DOPA responsive
* \<5 yrs since diagnosis

Exclusion Criteria:

* severe other diseases
* MMSE \< 26
* treatment with psychiatric medication
Clinical Characteristics of Patients Developing Chronic Dry Eye After Refractive Surgery

In recent years, many scholars have studied the ocular surface damage of patients with dry eye disease（DED）after FS-LASIK, but there has been a lack of comprehensive observation and research on the relationship and difference between dry eye （DE）patients with and without LASIK. Therefore, the purpose of this study was to investigate the characteristics of ocular surface and cytokines after FS-LASIK, and further explain the pathogenesis of chronic dry eyes after FS-LASIK. In addition, we will also compare clinical characteristics and tear neuropeptide concentrations in patients with dry eye disease (DED) with and without chronic ocular pain following FS-LASIK, and to investigate correlations between ocular pain, clinical characteristics, and tear neuropeptide levels.

A single visit cross-sectional study was performed. Approximately 40 chronic dry eye participants who had FS-LASIK more than 12month prior were recruited. Approximately 40 dry eye participants without refractive surgery history and 40 healthy participants without dry eye were also recruited as control groups. In addition, the patients with post-FS-LASIK DED were categorized into two groups based on the presence or absence of chronic ocular pain: (1) post-FS-LASIK DED patients with chronic ocular pain and (2) post-FS-LASIK DED patients without chronic ocular pain.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18years to 40 years
2. Male or female
3. DED patients based on Chinese Dry Eye Diagnosis Standard (2020) with or without FS-LASIK
4. Provision of written informed consent.

Exclusion Criteria:

1. active ocular infection, ocular inflammation, active ocular allergy, severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment of the investigator may interfere with the interpretation of the study results.
2. Pregnant and lactating women, or those planning a pregnancy over the course of the study
3. Uncontrolled systemic disease
4. Suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.
Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA

This study aimed to address the impact of lymphedema duration on the quality of lymphatic vessels as well as the outcome after LVA using propensity score matching.

With an increase in the incidence and treatment of breast and gynecological cancers, an increase in the prevalence of secondary lymphedema has been witnessed1. As a consequence of lymphadenectomy and adjuvant radiotherapy, swollen limbs result from the accumulation of protein rich fluid2. Lymphedema is predicted to arise in 20-40% of patients with cervical and breast cancer3, which is a chronic disease that can significantly hamper quality of life4-6. Affected limbs may suffer from lifelong swelling with functional impairment and repeated cellulitis, and some may eventually progress to late-stage diseases such as elephantiasis and lymphorrhea7-9.

Supermicrosurgical lymphaticovenous anastomosis (LVA) is a well-documented minimally invasive treatment modality that bypasses lymph into the venous system to alleviate lymphedema10-14. It was a common belief that a longer lymphedema duration (LD) may be associated with inferior lymphatic vessel (LVs) quality, as well as excess fibrous components in the affected limbs, which are characteristics of advanced lymphedema. Consequently, owing to inferior LV quality, LVA is considered unsuitable for advanced cases; instead, vascularized lymph node transfer (VLNT) or excisional procedures are recommended7,15.

However, growing evidence has demonstrated the effectiveness of LVA for the treatment of severe lymphedema16-19. These findings, contrary to common beliefs, raise questions regarding the association between LD, LV quality, and outcomes after LVA. This study aimed to address the impact of LD on the quality of LV as well as the outcome after LVA using propensity score matching.

Eligibility Criteria:
Inclusion Criteria:

* This study including patients diagnosed with lymphatic-related diseases at Kaohsiung Chang Gung Memorial Hospital from September 2015 to March 2023.

Patients who underwent LVA for unilateral lower-limb lymphedema.

Exclusion Criteria:

* Primary lymphedema, bilateral lower limb lymphedema, history of previous LVA, vascularized lymph node transfer (VLNT), liposuction, or excisional therapy such as the Charles procedure, and those that were lost to follow-up.
A Usability Study of a Smoking Cessation Decision Aid in People With a Recent First Episode of Psychosis

The investigators propose to recruit patients who have experienced a recent first episode of psychosis who have a chart diagnosis of Schizophrenia, Schizophrenifom, Schizoaffective Disorder, Psychosis NOS, or Bipolar I Disorder with psychotic features and self identify themselves as a current cigarette smoker. Aiding this population with smoking cessation is crucial as the majority of people with schizophrenia spectrum disorders (50-90%) smoke, which is leading to early mortality. While these individuals can benefit from standard evidence-based treatment, these treatments are underutilized. Web based programs, such as the EDSS and thetruth.com, can provide education and motivational tools to help people with a recent onset of psychosis use evidence-based smoking cessation treatments. This study aims to test these two web-based programs among young people with a recent episode of psychosis for usability and likeability and to explore whether use of these two programs will motivate users to seek smoking cessation treatment or to engage in other quitting behaviors in the month following use of the programs. Information gathered from this proposal will be used to help the researchers decide whether either of these two programs will be reasonable to include in a larger study of a comprehensive treatment for individuals with first episode psychosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnoses of Schizophrenia, Schizophrenifom, Schizoaffective Disorder, Psychosis NOS, or Bipolar I Disorder with psychotic features
* Diagnosed with one of above diagnoses within the past five years
* Ages 15-30 years old.
* Self-identified current cigarette smokers
* 5th grade reading level
* Willing to be audio recorded.
* Willing and legally able to provide informed consent to participate in the study or have a guardian provide informed consent with assent of a minor

Exclusion Criteria:

* Physically unable to use a computer with assistance.
Study Of Airway Physiology In Adults. SERETIDE DISKUS® Inhaler and FLIXOTIDE® Inhaler Are Trademarks of GSK Croup of Companies.

Comparison of two asthma treatments by lung function measures.

Single centre, randomised, double-blind, comparator study to demonstrate superiority of salmeterol/fluticasone propionate combination product 50/100mcg bd over fluticasone propionate 100mcg bd with respect to improvements in airway physiology (sRAW) in adults with persistent asthma treated for 4 weeks.

Eligibility Criteria:
Inclusion:

* Physician documented diagnosis of asthma which has been present for at least 6 months.
* Receiving a total daily dose of 200-500mcg/day beclomethasone dipropionate or equivalent for at least 4 weeks prior to the start of the run-in period.

Exclusion:

* Has had 3 or more courses of oral corticosteroids in the 12 months previous to visit 1
Effects of APIXaban on BRAIN Protection in Patients With Sinus Rhythm and Heart Failure: APIXBRAIN-HF Trial

objectives: The primary aim of APIXBRAIN-HF Trial is to explore the effects of apixaban on brain protection in patients with sinus rhythm and heart failure

Primary / Secondary Endpoint

1. New occurrence of brain pathology 1) Cortical cerebral microinfarcts 2) Silent lacunar infarction 3)Progression of white matter hyperintensities
2. Secondary endpoint 1) The change of cognitive function evaluated by MMSE-2 2) Individual variable of primary endpoint
3. Safety Endpoint Evaluation 1) Cerebral microbleeds on imaging

This study is a double-blind, parallel-group, and randomization study. The investigators will enroll the patients with heart failure who demonstrated LV systolic dysfunction (LVEF ≤ 40%) and sinus rhythm with a CHA2DS2-VASc score ≥ 3. All patients would be randomly assigned to either the apixaban group or placebo group. Patients assigned to the apixaban group will receive 5mg bid or 2.5mg bid (patients with at least 2 of the following characteristics: aged≥80-year, bodyweight ≤60kg, serum creatinine 1.5 ml/dL) and patients in the placebo group will receive a placebo of apixaban. Both drugs will be maintained for 6 months. During the study period, all patients will be carefully monitored for thromboembolic events, including stroke. At the beginning of the study and 6 months after randomization, 3T Brain MRI and MMSE-2 test will be performed to identify changes in brain structure and cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 19 years old
* Patients with sinus rhythm
* Newly diagnosed of heart failure or aggravated heart failure symptom

  1. Dyspnea (≥ NYHA II)
  2. plasma BNP ≥ 200 pg/ml or NT-proBNP ≥ 800 pg/ml
* LV systolic dysfunction on echocardiography within 3 month of enrollment

  1) LVEF ≤ 40%
* Those with CHA2DS2-VASc ≥ 3
* Modified Rankin Score ≤ 4

Exclusion Criteria:

* Patients already subscribed warfarin or antiplatelet therapy or have clear indication for warfarin or antiplatelet therapy
* At high risk for bleeding
* Patients with atrial fibrillation
* Estimated glomerular filtration rate (CKD-EPI formula) \< 15 ml/min/1.73 m2)
* Recent stroke or brain hemorrhage (within 3 months)
* Patients who was diagnosed of myocardial infarction or who has plan to PCI/CABG at enrollment
* End stage heart failure with life expectancy ≤ 6 months
* Patients with bed ridden status (Modified Rankin Score ≥ 5)
* Patients with liver dysfunction (AST, ALT \> 2 times of upper normal limits or total bilirubin \> 1.5 of upper normal limits)
* At of pregnancy or breastfeeding
* Patients who disagree with the use of medically acceptable contraception during the clinical trial period
* Patients with contraindication of apixaban
Deformation of the Diaphragm Zone of Apposition

The assessment of the work of the respiratory muscles is a fundamental clinical data in intensive care, especially to guide the management of patients requiring ventilatory support. This data is difficult to access in current practice. The reference technique to estimate the work of breathing (transdiaphragmatic pressure) is not feasible in clinical routine and evaluates only the respiratory work of the diaphragm, not that of the accessory muscles. The ultrasound technique of speckle tracking allows a fine and multidimensional analysis of the deformation of the respiratory muscles during the respiratory cycle.

The investigators hypothesize that the analysis of the multidimensional deformation of the diaphragm at the level of the apposition zone can produce a robust and reproducible index, which is correlated with the work of breathing. The performance of this index will be compared to that of the thickening fraction of the diaphragm. On the other hand, the investigators will evaluate the feasibility of measuring the thickening of the accessory respiratory muscles (scalene and intercostal).

Fifteen healthy subjects will be equipped with a double-balloon esophagogastric tube and subjected to increasing and gradual loading of the respiratory system by a negative-pressure inspiration device. The respiratory work will be recorded continuously by measuring the transdiaphragmatic pressure (reference technique).

The recording of the deformation of the diaphragmatic apposition zone by speckle tracking technique will make it possible to define a multi-dimensional deformation index of this muscular portion.

The reproducibility and the repeatability of this index will be evaluated then this index will be compared to the reference technique, as well as to the fraction of thickening. The deformation of the accessory muscles will also be evaluated in a second step.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer (male or female)
* Free and informed consent

Exclusion Criteria:

* known pregnancy, parturient or nursing mother
* Under 18 years old
* Age\> 45 years
* Incapable major
* Non-affiliation to the social security system
* Any history of respiratory pathology
* Any history of coagulation disorder or platelet function