cyrilzakka/clinical-trials huggingface dataset:
Impact of Support Groups for Patients With Non-Cystic Fibrosis Bronchiectasis

BronchConnect is a prospective trial to investigate the impact of support groups on health care related quality of life in those with noncystic fibrosis bronchiectasis (NCFBE). It has been well demonstrated that participation in patient support groups improves quality of life in those who suffer from interstitial lung disease and chronic obstructive pulmonary disease, but the impact is largely unknown for those who live with NCFBE, a chronic lung disease with rising prevalence with no targeted FDA-approved therapy. NCFBE causes chronic cough, dyspnea, recurrent infections, and leads to anxiety and uncertainty. This study seeks to evaluate the impact of a virtual patient support group for patients with NCFBE through questionnaires to assess change of quality of life and anxiety, and exacerbation rates through clinical assessment.

Non-cystic fibrosis bronchiectasis (NCFBE) is a chronic disease of the airways characterized by progressive damage to the airways that impairs the ability to clear mucus leading to repeated cycles of inflammation and infection. The condition is associated with chronic cough, sputum production, and exacerbations requiring antibiotics and/or hospitalizations, and as such can have a significant effect on quality of life. Incidence and prevalence have been increasing in the past twenty years, with a concurrent worsening in socioeconomic burden. Chronic cough and sputum production, use of devices for airway clearance, decreased exercise tolerance, and frequent exacerbations can all lead to embarrassment and isolation. Per the European Respiratory Society (ERS) guidelines, impairment in quality of life in patients with bronchiectasis is "equivalent in terms of scores on the St George's Respiratory Questionnaire (SGRQ) to severe chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis and other disabling respiratory diseases." Patient support groups are well established for those living with these other chronic pulmonary diseases, but their efficacy is not well defined for NCFBE. This is a single center prospective interventional non-randomized pre-post study to evaluate the impact of a virtual patient support group and multidisciplinary educational program for patients with NCFBE using a mixed-methods approach seeking to compare how support groups affect quality of life, anxiety, and exacerbation rates for patients living with NCFBE. Participants will complete a series of questionnaires and will undergo assessment for severity of disease, comorbidities, and exacerbations before and after attending the group.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bronchiectasis on computed tomography (CT) chest scan
* Bronchiectasis is the primary respiratory disease as determined by a clinician

Exclusion Criteria:

* Age \< 18 years old
* Cystic fibrosis
* Traction bronchiectasis in the context of pulmonary fibrosis
* Solid organ transplant recipient
* Ability to provide informed consent
* Due to constraints of this pilot study, inability to engage in a full conversation in English
Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept in Canada

The primary objective of this study is to measure physician knowledge and understanding of the key safety information contained in the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph.

The source of information for the study will be self-reported data collected from physicians using standard questionnaires with closed-ended response choices. Questionnaires for physicians will be developed and tested using best practices for instrument development. The questions will be tailored to the study aims and the information provided in the the vial preparation instruction card, the intravitreal injection procedure video, and the Eylea product monograph.

Other questions will obtain information needed to assess potential differences across subgroups and identify any biases (e.g., demographics, experience with Eylea).

The questionnaire will be tested through cognitive interviews with physicians. Questionnaires will be tested in local languages, to assure that the introductory material, consent forms, and questionnaire items (question stems and response choices) are culturally appropriate and easily and correctly understood by individuals similar to those who will participate

Eligibility Criteria:
Inclusion Criteria:

This study will be conducted with retinal specialists and ophthalmologists in Canada who have prescribed and/or administered aflibercept to at least 1 patient in the past 6 months.

Exclusion Criteria:

* None applied
Weight Management of Dialysis Patients

The goal of this clinical trial is to Improve the quality of life in Hemodialysis patient. The main questions it aims to answer are:

* \[Improve the self-compliance of dialysis patients with weight management\]
* \[alleviate the volume load of dialysis patients and reduce cardiovascular complications\] Participants will be divided into two groups based on a weight management regimen： Control group: received routine outpatient management. Specific methods: The dialysis doctor registered the information of the patient\&#39;s weight and blood pressure at the end of dialysis, and informed the patient of the purpose, role and importance of weight management.

Intervention group: On the basis of routine outpatient management, patients or their family members were subjected to remote follow-up management based on wechat, and the follow-up time was 6 months. Specific methods: Same as the control group, the information of weight and blood pressure of the patients was registered at the end of dialysis, and the purpose, role and importance of weight management were informed to the patients. On this basis, a special wechat signal is set up to add patients or patients\&#39; family members as wechat friends and establish a wechat interaction platform with patients. In the interdialysis period, remind patients to weigh themselves through wechat (the time of each weighing is fixed, preferably consistent with the time of weighing in the hemodialysis center), control the weight gain during the interdialysis period not to exceed 4.5% of dry weight, and inform patients again about the purpose, role and importance of weight management.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18;
* Dialysis age ≥3 months;
* Survival ≥12 months;
* Patients themselves or family members can use wechat;
* Informed consent

Exclusion Criteria:

* Have a cognitive or intellectual disability unable to read and understand SMS;
* Have mental illness;
* Other serious complications occurred
Effects of Plant Based Lipids on Glucose Regulation and Cognitive Variables

The overall goal is to increase the knowledge that can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the primary purpose of this project is to evaluate effects in healthy humans on acute postprandial glucose regulation of plant based lipids. Due to the tight connection between cardiometabolic health and cognitive functions, a secondary issue is to investigate effects of test foods on cognitive test variables and mood parameters.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy subjects
* Between 20 and 40 years old
* Body mass index between 19-28 kg / m2),
* Consuming a non-vegetarian diet generally in line with the Nordic nutrition recommendations.

Exclusion Criteria:

* Fasting blood glucose concentration \>6.1 mmol/L
* Known metabolic or gastrointestinal disorder (eg diabetes, high cholesterol, high blood pressure, IBS), or other disease that may affect the study results.
* Regular medication, except for long-term and stable medication for the lack or reduced production of thyroid hormone (eg Levaxin).
* Antibiotics or probiotics for at least four weeks before the start of the study,
* The use of tobacco products
Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)

This is a multi-center, prospective, parallel-group, open-label, randomized clinical study in one hundred and twenty-six (126) neonates and infants diagnosed with CH.

Subjects will be randomized in a 2:1 ratio to Treatment (Tirosint®-SOL) or Control (conventional therapy with levothyroxine sodium crushed tablets).

Newly diagnosed neonates will be randomly assigned to start therapy with LT4 at the initial dose recommended by the Standard of Care (SOC). Infants already on LT4 therapy will continue at the same daily dose within the randomly assigned treatment group (dose adjustments are allowed, if needed based on laboratory parameters and clinical response). Once enrolled, subjects will be treated and followed for 12 months (±1.5 months), participating in 7-8 study visits, consisting of 6-7 inclinic and 1-2 (or more if follow-up visits are required) telemedicine (TM) visits. The total number of visits depends on the age at inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patient aged 0 to 9 months
* Primary CH diagnosis with elevated TSH and low or normal FT4, requiring treatment with LT4, under either of the following conditions:

  * Neonates newly diagnosed with primary CH and needing to initiate LT4 therapy, or
  * Infants previously diagnosed with primary CH and who are already on LT4 therapy for at least 3 weeks;
* Provide and comply with the informed consent.

Exclusion Criteria:

* Preterm neonates with a gestational age \< 37 weeks;
* Low birth weight (LBW) or very low birth weight (VLBW) neonates (weight \< 2.5 kg) or VLBW infants (weight \< 1.5 kg);
* Neonates in neonatal intensive care units or requiring admission to NICU or neonates/infants hospitalized or requiring hospitalization or in fragile health conditions (e.g. with serious health problems or complications);
* Neonates with CH diagnosis \> 4 weeks after delivery;
* Diagnosis of primary gastrointestinal disease:

  * Gastroesophageal reflux requiring medical therapy (beyond thickening of formula or position);
  * Anatomic defects (e.g. intestinal atresia, malrotation, tracheoesophageal fistula, pyloric stenosis, Hirschsprung's disease, gastroschisis);
  * Dietary allergy (e.g. cow's milk protein allergy);
  * Malabsorption related to cystic fibrosis, celiac disease and others;
  * Necrotizing enterocolitis requiring surgical resection;
* Known or suspected adrenal insufficiency (e.g. congenital adrenal hyperplasia, hypopituitarism);
* Diagnosis of congenital cardiac disease, cardiac insufficiency or risk for cardiac failure;
* Diagnosis of chromosomopathy;
* Diagnosis of central hypothyroidism;
* Hypersensitivity to glycerol;
* Concomitant anticonvulsant medications, liothyronine, combination of LT4 and liothyronine, thyroid extracts and/or chronic or long-term use of systemic glucocorticoids
* History of nonadherence with medication or medical visit schedule; or
* Any condition for which, participation would not be in the best interest of the patient or that could limit protocol specified assessments.
Identification of CETP as a Marker of Atherosclerosis

The reverse cholesterol transport (RCT) pathway, which involves the centripetal movement of free cholesterol from peripheral tissues, including the vessel wall, to the liver represent the primary mechanism by which HDL protects against atherosclerosis and by which it may induce plaque regression. Recent data reveal that the capacity of HDL to efflux cholesterol from macrophages, a metric of HDL function reflecting the initial step of the RCT, is clinically relevant, displaying a strong inverse association with both carotid intima-media thickness and the severity of angiographic CAD; such observations were independent of HDL-C levels.

In human, the Cholesteryl Ester Transfer Protein (CETP), represents a key protein of the RCT pathway and mediates redistribution of neutral lipids between lipoproteins, has been identified as a potential therapeutic target against atherosclerosis. It is known that CETP activity correlates with HDL-C levels and represents a key modulator of the ability of whole plasma to mediate free cholesterol efflux from human macrophages.

Recent studies showed that 23% of endogenous plasma CETP activity variability is explained by plasma LDL-C (12.0%), HDL-C (6.4%) and TG (4.4%) whereas sex and BMI accounted together for only 0.7% of its variability. Scoring patients for cardiovascular risk on the basis of their plasma lipid levels (TC, TG, LDL-C and HDL-C), revealed that patients with high cardiovascular risk (score ≥3) displayed a mean endogenous plasma CETP activity above 34%. Therefore plasma CETP activity represents a potent indicator of cardiovascular risk in patients with metabolic disorders since it integrates major independent risk factors.

The objective of this study is to decipher the relationship between CETP, HDL efflux capacity and the development of atherosclerosis in humans in order to identify CETP as a potent biomarker of atherosclerosis distribution.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to initiation of the study
* Men and women aged 18 or more years
* Patients displaying at least one abnormal plasma lipid parameter and/or receiving a lipid-lowering therapy unchanged for at least 3 months.

Exclusion Criteria:

* Current significant renal disease, including: nephrotic syndrome; chronic renal failure and/or serum creatinine \>1.7 x upper limit of the reference range (ULRR)
* Uncontrolled hypothyroidism defined as TSH \>2 x ULRR
* Active hepatobiliary disease, including chronic hepatitis B or hepatitis C infection (confirmed by serology); or an aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) \>3.0 x ULRR
* Any prior history of malignancy or current cancer
* Current chronic or acute inflammatory syndrome defined as CRP\>10 mg/l
The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter

The investigators investigated the ability of narrowband ultraviolet B (nbUVB) treatment in the maintenance of vitamin D levels achieved during the summer in Finland. The investigators randomized 37 subjects into groups of 17 and 18 subjects. The other group received 2 standard erythema doses (SED) nbUVB exposure every other week until week 24, and serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30. The control group was not illuminated and serum samples were analyzed correspondingly. Punch biopsies were taken at the onset and at week 14 for CYP27A1 and CYP27B1 enzyme expression level analyses.

The investigators investigated the ability of narrowband ultraviolet B (nbUVB) treatment in the maintenance of vitamin D levels achieved during the summer in Finland. The investigators randomized 37 subjects into groups of 17 and 18 subjects. The other group received 2 standard erythema doses (SED) nbUVB exposure every other week until week 24, and serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30. The control group was not illuminated and serum samples were analyzed correspondingly. 6mm punch biopsies were taken at the onset and at week 14 for CYP27A1 and CYP27B1 enzyme expression level analyses.

Eligibility Criteria:
Inclusion Criteria:

* age over 18
* Fitzpacker's skin type II-IV

Exclusion Criteria:

* age under 18
* diseases that inhibit vitamin D metabolism or absorption
* Fitzpacker's skin type I
* history of skin cancer
* vitamin D substitution 1 month before baseline or during study
* sun holidays 1 month before baseline or during study
Stroke Recovery Research Based on EEG-fMRI

This study is aimed to investigate the post-stroke motor recovery of patients with ischemic stroke based on their neural features extracted from EEG-fMRI data.

A group of patients with ischemic stroke and age/gender matched healthy controls would be enrolled in this study. Their features of neural activities based on EEG-fMRI fusion scan would be extracted to investigate the mechanisms of motor recovery after stroke. Particularly, the correlations of their features of neural networks or local activities to their motor function (defined as their Fugl-Meyer scores) at enrollment and their recovery time courses consisted of Fugl-Meyer scores in follow-up time points. Data of T1 structural, DSI fiber image and pure EEG (without MRI) would also be collected along with EEG-fMRI fusion data.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 and below 75 years
* Motor impairment in National Institutes of Health Stroke Scale
* 7-14 days since stroke attack
* First-ever ischemic stroke

Exclusion Criteria:

* Motor impairment induced by non-stroke aetiology
* Claustrophobia; recognition disorder
* History of other severe central nervous system diseases
* Any signs unfit for MRI/EEG scan
Refreshing Recess: Staff and Student Feedback Outcome Study (EMCRR)

A mixed methods design was used to explore the outcomes of a 6-week, occupational therapy-led Refreshing Recess program designed to build capacity of recess supervisors to create a positive recess experience so that all students can successfully participate in and enjoy active play and socialization with peers.

A mixed methods design was used to explore the outcomes of a 6-week, occupational therapy-led Refreshing Recess program designed to build capacity of recess supervisors to create a positive mealtime environment so that all students can successfully participate in and enjoy recess and socialization with peers. Occupational therapy practitioners provide weekly information and coaching to recess supervisors and embed weekly activities into the recess experience (e.g. team building games, strategies for including students with disabilities, etc.).

Eligibility Criteria:
Inclusion Criteria:

* all kindergarten through 4th grade students in school where the Refreshing Recess program was offered based on principal approval
* all recess supervisors who supervised recess during program implementation

Exclusion Criteria:

- students who did not receive the school-sponsored Refreshing Recess program
Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase

The purpose of this phase is to evaluate the long-term safety and tolerability of BTDS. Qualified subjects are started on BTDS 5 and the dose may be titrated, if necessary, to a maximum of BTDS 20 to achieve stable pain control.

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed all visits of the double-blind phase on study drug and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase.

Exclusion Criteria:

* Subjects who prematurely discontinue study drug in the double-blind phase due to adverse event, subject's choice, administrative reason or lost to follow-up are NOT eligible to enter the extension phase
* Subjects with electrocardiograms (ECGs) that show any QT data corrected for heart rate using Fridericia formula (QTcF) interval ≥ 500 millisecond (msec) will be discontinued from the extension phase.
* Subjects requiring long-acting opioid analgesics (once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug) or transdermal fentanyl during the extension phase should be discontinued from the study.

Refer to core study for additional inclusion/exclusion information.
The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus

The aim of the present study is to assess the clinical efficacy of topical minocyclin in managing of symptoms associated with oral lichen planus (OLP). The rationale of the study is based on our previous studies demonstrating the beneficial effect of minocyclin mouthwash on recurrent aphthous stomatitis. The planned study will be a randomized controlled, cross-over trail. Patients with symptomatic OLP will randomly receive minocycline or dexamethasone rinses.

The patients will rinse and expectorate 5 ml of the 1st mouthwash 4 times daily for 14 days. Subjects will complete a daily follow-up form that includes data regarding the daily intensity of pain (using VAS) caused by OLP and regarding possible side effects. After a washout period (at least 14 days) the patients will repeat the protocol with the second mouthwash.


Eligibility Criteria:
Inclusion Criteria:

* OLP patients (Biopsy proven)

Exclusion Criteria:

* Known allergy to Dexamethasone or Minocycline
* Pregnancy
Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222

This is a single dose, open-label, randomized, crossover study in subjects with severe Hemophilia A to compare the bioavailability of 2 different strengths of Kogenate FS (BAY 14-2222).


Eligibility Criteria:
Inclusion Criteria:

* Males, age 18 to 65 years
* Subjects with Severe hemophilia A with a documented plasma FVIII level of \<1%
* \>/= 150 ED (exposure days) with FVIII concentrates(s) as supported by medical records

Exclusion Criteria:

* Evidence of current or past inhibitor antibody
* History of any congenital or acquired coagulation disorders other than hemophilia A
* Platelet count \<75,000/mm3
* Abnormal renal function (serum creatinine \>2 times the upper limit of the normal range)
* Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5x the upper limit of normal or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio (INR) \>1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices