cyrilzakka/clinical-trials huggingface dataset:
Optimizing CBT Implementation Among Community Providers Through Internet-based Consultation and Networking (i-CAN)

Although anxiety is one of the most common and debilitating mental health conditions affecting children and adolescents, the vast majority of sufferers do not receive effective treatment. Cognitive-behavioral therapy (CBT) is an evidence-based, frontline treatment for pediatric anxiety, yet many community-based practitioners do not implement CBT with high fidelity, which can detrimentally affect its clinical impact. The goal of this study is to develop and test an online platform to support community providers' effective use of CBT for pediatric anxiety.

Stemming from implementation science and, specifically, the Theory of Planned Behavior, investigators are working alongside community stakeholders to develop a novel, online consultation platform. This platform, termed Internet-based Consultation or Networking (or i-CAN) will utilize a professional navigator (i.e., a provider with CBT expertise), online support and resources, and parallel peer consultation to create a user-friendly and supportive community for providers to get support as they implement CBT. Once finalized, the platform will be tested in the context of a preliminary randomized controlled trial (RCT) with approximately 100 mental healthcare providers who work with anxious children and adolescents. Providers who enroll will be randomly assigned to either the experimental condition (i-CAN) or the control condition (wait-list for i-CAN). The primary outcome of interest is change in intentions to use CBT.

Eligibility Criteria:
Inclusion Criteria:

* provide direct mental healthcare to anxious youth
* practice in general community within state of Alabama
* agree to try i-CAN

Exclusion Criteria:

* None
Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. Placebo

This study will evaluate the safety and efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as a short term analgesic treatment for the primary symptoms of pain or burning when passing urine associated with uncomplicated urinary tract infections (uUTI)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of uncomplicated urinary tract infection (uUTI)
* Must have one of the following uUTI diagnosis
* Cystitis
* Urethritis
* A Positive urine dipstick test showing nitrate or leukocyte esterase (LE)
* Negative pregnancy test (if applicable)
* Must have one or both of the following symptoms of
* pain upon urination
* burning upon urination
* In addition, one of the following symptoms
* Not being able to empty bladder completely
* Pain or discomfort in lower abdomen, or pelvic areas
* Frequent urge to urinate
* Blood in urine
* None

Exclusion Criteria:

* Any diagnosis of a urinary tract or kidney disorder that is not a uUTI
* A diagnosis of Pyelonephritis (kidney infections when lower uUTI spreads to the upper tract)
* Women with a history of prior use of phenazopyridine hydrochloride
* Women who have taken any systemic anti-infectives within seven days of study participation
* Women with a history of G-6-PD deficiency or hemolytic anemia
* Women who have a known history of anatomical genitourinary (GU) anomalies or GU surgery within the past 6 months
* Women of child bearing age who do not consent to a pregnancy test
* Women who are lactating
* Chronic infection of the urinary tract requiring an intravenous pyelogram (IVP), ultrasound or cystoscopy
* Subjects with clinically significant abnormal results or finding on the screening physical examination, laboratory tests, vital signs or ECG.
* Subjects unable to comprehend the language of the informed consent and the self evaluation scales.
* Subjects with serious acute illness (e.g. pneumonia) or an untreated or unstable medical illness that would likely interfere with assessments of uUTI
* Subjects who have received an investigational medication as part of a drug trial 3 months prior to the baseline study visit
* Subjects with a history of severe drug allergy or hypersensitivity
* Subjects with a known sensitivity to Phenazopyridine, Hyoscyamine, Butabarbital and antibiotics.
* Employees of the investigator or the institution who have direct involvement in the trial or other trials under the direction of the investigator or their associates.
HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)

This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Serum hepatitis C virus ribonucleic acid (HCV RNA) quantifiable at greater than (\>) 600 IU/mL
* Liver biopsy consistent with chronic hepatitis C infection obtained within 2 years of enrollment
* Compensated liver disease without cirrhosis
* Participants with end-stage renal disease undergoing hemodialysis
* Negative serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
* All fertile participants must have been using effective contraception during treatment with study drug

Exclusion Criteria:

* Interferon therapy at any previous time
* Liver cirrhosis
* Signs and symptoms of hepatocellular carcinoma
* History or other evidence of decompensated liver disease
* Any investigational drug less than or equal to 6 weeks prior to the first dose of study drug
* History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
* Poorly controlled diabetes
* Thyroid dysfunction not adequately controlled
* Evidence of severe retinopathy or clinically relevant ophthalmological disorder
* Severe hyperparathyroidism defined as intact Parathyroid Hormone (PTH) \> 800 picogram/milliliter (pg/mL)
* Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment ≤ 6 months prior to the first dose of study drug
* Acute renal failure
* Women with ongoing pregnancy or breast feeding
* Positive test at screening for anti-HAV IgM Ab (hepatitis A virus immunoglobulin M antibody), hepatitis B surface antigen (HBsAg), anti-HBc (hepatitis B core) IgM Ab, anti-HIV (human immunodeficiency virus) Ab
Amplitude and Rate of Intrinsic Feedback During Treadmill Training for Parkinson's Disease

Treadmill training has been shown to be beneficial for reducing motor symptoms of Parkinson's disease (PD). The mechanisms for the therapeutic effects of treadmill training remain unknown. However, specific types of intrinsic feedback generated from muscle spindles (detect changes in length of muscle) and golgi tendon organs (detect muscle force) seem to be an important factor for achieving the reductions in motor scores. This study will compare a treadmill program that generates a high rate of intrinsic feedback to a treadmill program focused on generating a high magnitude of intrinsic feedback.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Parkinson's disease
* must be able to walk unassisted for 10 metres

Exclusion Criteria:

* cardiovascular disease/history of stroke
* Dementia
* lower body injury that would be worsened by repetitive walking
Intermittent Fasting in Hypertriglyceridemic Overweight or Obese Subjects

some studies have shown similar effects of intermittent fasting and continuous caloric restriction on body weight and plasma lipid profile, but there is still a wide controversy. Therefore,due to limited human studies and the lack of a study on hypertriglyceridemic patients, the present study aimed to determine the effects of using low-calorie diets in comparison with continuous caloric restriction on weight loss and plasma lipid profile in obese or overweight hypertriglyceridemic patients.

a randomized clinical trial will be conducted in National Nutrition and Food Technology Research Institute, Tehran, Iran. after the review of inclusion and exclusion criteria, a written consent form will be completed. the participants will be 90 hypertriglyceridemic patients aged between 18-60. half of the participants will be under intermittent low-calorie diet which they will have 3 alternate days in the week eating only 30% of their total energy requirement and on the other days of the week they receive a total calorie of 100% of their energy requirement , therefore there will be a total of -210% TEE reduction in their received energy in the week. the other group will be under continuous calorie restriction meaning on all the days of the week they will be eating 70% of their total energy requirement resulting in a total of -210% TEE reduction in their received energy in the week. both groups will receive 3 consultation sessions with a nutritionist, also to prevent any deficiency, multi-vitamin-mineral supplements will be given to both groups participants.

Eligibility Criteria:
Inclusion Criteria:

* hypertriglyceridemic : TG\>150 mg/dL
* BMI\>24.9
* age 18-60
* non-smoker
* haven't been under any diet at least 3 months before participating in the study
* not starting any new exercise program or changing the previous exercise while in the study

Exclusion Criteria:

* chronic kidney disease stage 3-5
* consuming Insulin or Insulin-inducing drugs.
* consuming triglycerides lowering drugs or Omega 3
* a history of cholecystitis
* Heart arrhythmia
Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ?

The chronic fatigue is observed in approximately 40 % of the patients with a chronic quiet inflammatory bowel disease (IBD) and impacts the quality of life of the patients. The beneficial role of a regular physical activity on the quality of life of patients having an IBD was demonstrated in 5 studies including only 1 controlled one \[Bilski, on 2013\]. The mechanism by which the physical activity could improve the quality of life of the patients remains unknown (stress decreased, reduction of the inflammatory process) \[Bilski, on 2014\]. Several studies concerning other chronic pathologies such as fibromyalgia, have demonstrated the beneficial effect of a regular physical exercise to reduce the fatigue of patients. It was recently demonstrated that the chronic fatigue observed in patients with IBD came along with a physical reduction in the performances during the exercise test and a reduction in the physical activity of the patients \[Vogelaar, 2015\].

Our hypothesis is that a regular moderate physical activity could improve physical performance during an effort et could reduce the chronic fatigue and improve their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* Patients suffering from IBD
* Patients with a FACIT score \< 30
* Patients with BD in remission with a C-reactiv protein dose \< 5
* Patients with Hemoglobin dosage \> 10g/dl
* Patients with 18\<BMI\<30 kg/m2
* Informed consent given by the patients
* Patients affiliated to the social security
* Patients living not far from the centre where the rehabilitation program will be performed
* Women with no risk of pregnancy (menopausal women or with contraceptive drugs).

Exclusion Criteria:

* Patients ≥ 45 years old
* Inability to walk or to ride a bike
* Contraindication to practice physical exercise
* Contraindication to exercise test
* Participation to another research study within the week preceding the beginning of the protocol
* Patients unstable smokers
* Patients unable to keep their medical treatment stable along the study
* Patients with a regular intensive physical practice
* Patients with depression (HAD\>11/21)
* Patients with bad sleep quality (PSQI score \>5)
* Pregnant or breast-feeding patients
* Patients under legal protection
Dairy and Inflammation Study

The purpose of this study is to determine whether 6-weeks of increased dairy consumption can reduce inflammation and other markers of chronic disease while fasted or following a high-fat meal.

Following the acquisition of informed consent, eligibility to participate in the study will be determined using questionnaires, and certain parameters determined from a finger-prick blood sample. Eligible participants will be assigned to complete two 6-week dietary interventions in random order, with at least a 4 week "wash out" period (i.e. their habitual eating) in between. The two dietary interventions are: 1) Participants normal, low-dairy diet; and 2) A higher dairy diet where 3 servings per day of dairy foods are provided. Prior to beginning either 6-week diet intervention, participants will be asked to attend the laboratory at York University after an overnight fast to undergo baseline testing.

Following baseline testing, participants will meet with a registered dietitian (RD) to discuss each diet arm. Specifically, if they are on the dairy diet, participants will receive advice on how to incorporate these dairy foods into their diet by replacing other foods of similar energy content so as to not increase their total energy intake and body weight. They will meet with the RD at several other times throughout the study. During each 6-week diet period, they will be asked to keep their physical activity levels constant and to not adopt any other major dietary changes during the study.

At the end of each 6-week intervention period, participants will be asked to return to York University to repeat the initial set of tests performed at baseline. In addition to the fasted tests, a number of tests will be performed after asking participants to consume a high-fat test meal (i.e. a fast-food breakfast). Various measurements will continue to be taken for around 6 hours after this meal is consumed.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥ 25 kg/m2
* ≤ 2 structured exercise sessions/week
* Habitual low dairy consumption (≤ 1 serving/day)
* Having at least two other metabolic risk factors based on clinical guidelines:

  * Elevated blood pressure (≥130/≥85 mm Hg)
  * Impaired fasting glucose (≥5.6 mmol/L) measured using a finger prick sample
  * Impaired fasting triglycerides (≥1.7 mmol/L) or high-density lipoprotein (\<1.03 mmol/L for males, \<1.3 mmol/L for females) measured using a finger prick blood sample.
  * Increased waist circumference (≥102 cm for males and ≥88 cm for females).
  * Borderline high fasting low-density lipoprotein (≥3.5 mmol/L) or total cholesterol (≥5.2 mmol/L).

Exclusion Criteria:

* Allergy to dairy foods, diagnosed lactose intolerance or an aversion to foods provided during the study
* Previous history of diabetes and/or related cardiovascular disease
* The use of multiple medications for managing lipids, glucose and/or blood pressure
TetricCAD Crown Clinical Study

This investigation will be a clinical trial to study the performance of a new resin-based ceramic material for crowns. The material has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.

The study will be composed of 50 crowns placed in adult patients that have been identified as requiring at least one crown on a posterior tooth. A maximum of two crowns per patient will be completed. All the crowns will be made from the same resilient ceramic CAD/CAM block(Tetric CAD/Ivoclar Vivadent). The crowns are placed using an adhesive bonding process including a total etch process with a universal adhesive (Adhese by Ivoclar Vivadent) and dual-cured resin cement (Variolink Esthetic by Ivoclar Vivadent). The crowns are planned to be evaluated at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. At each appointment, an examination of the crown will be completed as well as clinical photographs, an intraoral digital scan, and impression of the crown.

Eligibility Criteria:
Inclusion Criteria:

* must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar
* reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration
* Teeth to be vital and asymptomatic prior to treatment
* No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth.

Exclusion Criteria:

* Devital or sensitive teeth
* Teeth with prior endodontic treatment of any kind
* Teeth with a history of direct or indirect pulp capping procedures
* Patients with significant untreated dental disease to include periodontitis and rampant caries
* Pregnant or lactating women
* Patients with a history of allergies to any of the materials to be used in the study
* Patients unable to return for the recall appointments
Bone Mineral Density (BMD) in HIV Infection

Osteopenia and osteoporosis are increasingly reported in HIV-infected patients, and appear to be more frequent than in general population. However, pathogenesis remains unclear, and published studies still give non concordant results.

We therefore started a prospective study, to assess the potential role of ARV in the occurrence of osteopenia and osteoporosis. BMD evolution over a 2-years period of follow-up, will be compared between patients starting ARV therapy, and subjects without HAART (no indication of treatment). A correlation between BMD and several factors will be looked at (see below).

This study with individual direct benefice, is conducted in 3 outpatients clinics (Strasbourg, Colmar, Mulhouse) in collaboration with the rheumatologic teams. 60 patients are planned to be included over a 3-years inclusion period


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected men, Caucasian, age \> 18 years, ARV-naïve

Exclusion Criteria:

* HIV-infected women, subjects \< 18 years, non-Caucasian men, ARV-experienced patients, subjects not able or willing to give informed consent, endocrine disease or treatment which could affect bone metabolism
Transcriptomic and Biochemical Changes During a Migraine Attack

Despite the fact that migraine is a common disorder, the pathogenesis is still not fully elucidated. Studying transcriptomic and biochemical changes during induced and spontaneous migraine-attacks will enhance our understanding and may point to new targets for drug development.

Migraine is a common neurological disorder affecting approx. 16 % of the European population. Despite the fact that migraine is a common disorder, the pathogenesis is still not sufficiently known.

Studying transcriptomic and biochemical changes during spontaneous migraine-attacks will greatly enhance our understanding of migraine mechanisms and may point to new targets for drug development.

Two blood samples (one for RNA analysis and one for biochemical analysis) are taken on minimum 15 patient with migraine with aura and 15 patients with migraine without aura when they experience a spontaneous migraine attack. A second sample is taken 2 hours after treatment with subcutaneous sumatriptan. Another two blood samples are taken when the patient has been migraine free for at least 5 days and had no other headache for at least 24 hours. A fourth set of blood samples are collected after a cold pressor test.

Eligibility Criteria:
Inclusion Criteria:

* Migraine patients who meet IHS criteria for migraine with or without aura of both sexes,
* 18-70 years,
* 45-95 kg.

Exclusion Criteria:

* any other type of headache then migraine without aura (except episodic tension-type headache \< 1 day per week),
* serious somatic or psychiatric disease,
* pregnancy,
* and intake of daily medication (except oral contraceptives).
Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria

OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria.

II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.

Patients receive potassium phosphate or potassium citrate tablets twice a day for 3 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Absorptive hypercalciuria Intestinal hyperabsorption of calcium, i.e.: Exaggerated calciuric response to oral calcium load OR Fractional calcium-47 absorption greater than 0.61 Calciuria greater than 200 mg/day on random and calcium-restricted diet Normal or high fasting urinary calcium Normal serum calcium Normal serum parathyroid hormone No primary hyperparathyroidism At least 1 calcium oxalate stone within the past 3 years No struvite or carbonate apatite stones No noncalcareous stones No numerous stones making precise quantitation difficult No renal tubular acidosis --Prior/Concurrent Therapy-- No concurrent drug therapy for nephrolithiasis --Patient Characteristics-- Creatinine clearance at least 0.7 mL/min per kilogram No hyperkalemia No hyperphosphatemia No urinary tract infection Other: No predisposition to hyperkalemia, including concurrent use of the following drugs: Potassium-sparing diuretics Angiotensin-converting enzyme inhibitors Nonsteroidal anti-inflammatory drugs No active peptic ulcer disease No chronic diarrhea
A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula

Cow's Milk Allergy (CMA) affects between 2-3% of young children but its severity varies between regions/countries. While the long-term prognosis for CMA is good, with the majority (80-90%) of children outgrowing their allergy by around 3-5 years. Breast feeding is the most optimal form of feeding for all infants, regardless of their condition, and in those with CMA maternal dairy exclusion is recommended as first line treatment. In non-breast fed or mixed feeding, a hypoallergenic milk substitute is recommended for young infants. The AAP and other societies such as EAACI and ESPGHAN considers a formula to be 'hypoallergenic' if at least 90% of children with documented CMA tolerate it, with a 95% CI, under double-blind, placebo-controlled conditions.This equates to at least 29 children who should tolerate the product following blind and open challenge.

A prospective, multi-centre double blind randomised placebo-controlled study to demonstrate the safety and tolerance of a new rice-based hydrolysate in children with diagnosed Cow's Milk Allergy (CMA). The test product being a new milk substitute hydrolysed rice-based formula with new ingredient. The results will satisfy the safety requirement when tolerated by 90% of children with proven CMA, with a confidence of 95%. New, and previously diagnosed children with confirmed CMA who meet the inclusion criteria will be eligible to participate in the study. Those included in the intervention phase will have IgE testing and an oral food challenge (OFC) to test and placebo products, in a randomised double-blind design. Children with a negative reaction to both test and placebo products will receive the test product for a period of 7 days (open challenge).

Eligibility Criteria:
Inclusion Criteria:

1. Children \<10 yrs of age
2. Proven IgE-mediated CMA
3. \>2500g at birth
4. \> 37 weeks gestation
5. Written informed consent provided by parent(s)/guardian

Exclusion Criteria:

1. Infants/children with severe concurrent illness (other than food allergy/CMA)
2. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
3. Participation in other studies involving use of milk replacement products designed to treat/manage CMA within two weeks prior to entry into this study
4. Current participation in OIT to Cow's Milk
5. Diagnosis of anaphylaxis to Cow's Milk
6. Diagnosis of rice allergy