louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00175435: Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator
Official title: Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatitis B
Keywords: Topical Immune Modulator
resiquimod gel
Hepatitis B booster response
Vaccine Evaluation
Prevention of Hepatitis B disease
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 39
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will look at what happens to the level of protection against hepatitis B (HB) disease if a 'helper' gel is applied to the skin over the injection site of a small dose of hepatitis B vaccine.


Eligibility criteria: Inclusion Criteria:

* Previously vaccinated with conventional hepatitis B vaccine series 10 or more years ago
* Generally healthy
* Is and has been free of HB disease and/or is negative to core antibody
* Known to have sero-converted to positive after vaccine series (without extra doses)
* Speaks and understands English adequately
* Available for all 4 visits within the designated timelines (30 days)
* No allergies to HB vaccine or components
* No blood or blood components within previous 6 months
* Not pregnant or breastfeeding

Primary outcomes:
measure: A single application of an immune modulating gel will enhance the protective response against hepatitis B disease when vaccination is given at the same time as gel as evidenced by increased HB antibody and T-cell response.
timeFrame: at 30 days after vaccination
Secondary outcomes:
measure: Minimal adverse effects to gel application as noted by laboratory assessment of liver enzyme and complete blood count (CBC) and physical assessment of the site/surrounding area and solicited local and general post vaccine events.
timeFrame: at 7 and 30 days post vaccine
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital Vaccine Education Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jan Dutz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05081635: Consenso2_F1 Delphi Consensus Study on Post-graduate Medical Education Success and Failure and Its Influencing Factors
Official title: Definitions of Success and Failure in Post-graduate Medical Education and Its Influencing Factors: A Delphi Consensus Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Education
Lead sponsor: Centro Hospitalar do Baixo Vouga
Sponsor class: OTHER
Collaborators: name: Conselho Nacional do Internato Médico
First posted: 2021-10-18
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Experts in Post-graduate medical education

Brief summary: The objective of this study is to generate expert consensus statements on the definitions of success and failure and its influencing factors in Post-graduate medical education.

Detailed description: A study will be performed using a e-Delphi process with Portuguese expert panel to generate recommendation statements related to the definitions of success and failure in Post-graduate medical education and its influencing factors and to determine the level of agreement for each statement from the panel as a whole. The following topics will be covered:

1. Success in Post-graduate medical education: definition, influencing factors
2. Failure in Post-graduate medical education: definition, influencing factors
3. Management Consensus is achieved through iterative rounds of survey and revision to the statements until a pre-determined level of agreement is met (75% agreement).

Part 1: planning and evidence review

* Series of planning sessions with study investigators
* Literature is reviewed/summarized
* Initial statements will be developed based on Round 1 results. Round 1 will be composed of 4 open-ended questions

Part 2: Survey to achieve consensus

* Survey, based on the initial statements developed on Round 1 results
* At least 2 additional rounds of review (remote rounds using an online platform) will be held to achieve consensus on each topic of interest and finalize consensus statements

Eligibility criteria: Inclusion Criteria:

* residency programs directors,
* members of the medical residents representing committee,
* members of patients representing associations,
* members of health institutions management teams,
* members of Portuguese Medical Association,
* authors of relevant scientific articles on medical education

Exclusion Criteria:

• Panelists who are not able to commit to all rounds of the modified Delphi process will be excluded.

Primary outcomes:
measure: Consensus
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Conselho Nacional do Internato Médico
Study officials:
affiliation: Centro Hospitalar do Baixo Vouga
name: Nuno L Fernandes
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01058135: Effects of Hi-maize Resistant Starch on Insulin Sensitivity
Official title: A Randomized, Controlled, Double-blind Crossover Study to Assess the Effects of a Dietary Fiber Ingredient, at Two Doses, on Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: insulin resistance
dietary fiber
resistant starch
Lead sponsor: Ingredion Incorporated
Sponsor class: INDUSTRY
First posted: 2010-01-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effects of a dietary fiber, resistant starch, on insulin sensitivity. Low insulin sensitivity is a risk factor for some diseases including type 2 diabetes and heart disease. This study will show if consuming resistant starch can help improve insulin sensitivity in overweight and obese people.


Eligibility criteria: Inclusion Criteria:

* Stable body weight
* No serious health conditions
* Waist circumference \> or = to 89 cm (females) and 102 cm (males)

Exclusion Criteria:

* Diabetes
* other serious illnesses
* use of medications that affect outcomes
* BMI \> or = 35.0 kg/m2

Primary outcomes:
measure: insulin sensitivity
timeFrame: 4 weeks
Secondary outcomes:
measure: Inflammatory markers, glycemia, serum lipids
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Glen Ellyn
country: United States
facility: Provident Clinical Research and Consulting, Inc
state: Illinois
Study officials:
References:
citation: Maki KC, Pelkman CL, Finocchiaro ET, Kelley KM, Lawless AL, Schild AL, Rains TM. Resistant starch from high-amylose maize increases insulin sensitivity in overweight and obese men. J Nutr. 2012 Apr;142(4):717-23. doi: 10.3945/jn.111.152975. Epub 2012 Feb 22.
Clinical trial NCT02762435: Acupressure in Hospitalized Patients
Official title: Randomized Controlled Trial of Acupressure to Improve Patient Satisfaction and Quality of Recovery in Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acupressure
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After written informed consent eligible hospitalized patients will be randomized to one of 3 arms (1:1:1:): control, sham, accupressure (3 points on the hand and wrist three times per day). Quality of recovery and other measures of patient satisfaction will be recorded.

Detailed description: After written informed consent eligible hospitalized patients will be randomized to one of 3 arms (1:1:1:): control (no touch), sham (light touch), acupressure (2 minutes moderate pressure each at PC6, LI4, and HT7 three times per day). Quality of recovery using the validated Quality of Recovery (QOR) 15 score and other measures of patient satisfaction (nausea score, pain score) will be recorded at baseline and after their 6 study sessions.

Eligibility criteria: Inclusion Criteria:

1. adults
2. patients at Stony Brook hospital
3. expected to be hospitalized for at least 3 days
4. able to sign informed consent and participate in the study

Exclusion Criteria:

1. Under 18 years of age
2. Do not have access to the 3 points on the hand and wrist due to skin breakdown, ulcers, cellulitis, broken bone, indwelling catheter within 5 cm radius of the pressure points.
3. Significant dementia or altered mental status that would prevent assessment of the QOR survey
4. Allergic reaction to ink
5. Stroke or other neurologic condition which precludes sensation in both upper extremities.
6. Ongoing use of regional anesthetic technique
7. Pregnancy

Primary outcomes:
measure: Change in Quality of Recovery score
timeFrame: Time Frame: Day 0, Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
Study officials:
affiliation: Stony Brook Medicine
name: Elliott Bennett-Guerrero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Noll E, Shodhan S, Romeiser JL, Madariaga MC, Page C, Santangelo D, Guo X, Pryor AD, Gan TJ, Bennett-Guerrero E. Efficacy of acupressure on quality of recovery after surgery: Randomised controlled trial. Eur J Anaesthesiol. 2019 Aug;36(8):557-565. doi: 10.1097/EJA.0000000000001001.
citation: Noll E, Shodhan S, Madariaga MC, Page CR, Santangelo D, Guo X, Al Bizri E, Pryor AD, Romeiser J, Bennett-Guerrero E. Randomized trial of acupressure to improve patient satisfaction and quality of recovery in hospitalized patients: study protocol for a randomized controlled trial. Trials. 2017 Mar 7;18(1):110. doi: 10.1186/s13063-017-1839-1.
Clinical trial NCT03714035: Measurement of Mandibular Radio Morphometric Indices in Egyptian Population at Different Ages
Official title: Measurement of Mandibular Radio Morphometric Indices in Egyptian Population at Different Ages Using Cone Beam Computed Tomography: A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mandibular Fractures
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 360
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a sample of egyptian population

Brief summary: this study aims to correlate mandibular indices and different ages in a sample of Egyptian population.

Detailed description: this study is an observational cross sectional study to correlate the mandibular radiomorphometric indices with age in sample of egyptian population using CBCT scans at faculty of dentistry cairo university

Eligibility criteria: Inclusion Criteria:

* Egyptian individuals with different ages starting from 10 - 70 years.
* Females and males of the mentioned ages.

Exclusion Criteria:

* Individuals younger than 10 and older than 70 years old.
* Presence of a large pathological lesions in the mandible at the areas intended for measurements.
* Patients of severely resorbed mandibular bone.
* Patients with any bony deformity at the inferior border of the mandible.
* Patients with fracture at the areas to be examined.
* Patients with evident radiographic asymmetry.
* Patients with evident radiographic abnormality suggestive of systemic disease predisposing to osteoporosis.
* Patients with current postoperative surgical defect healing at the areas intended for measurements.
* Patients with mandibular reconstruction

Primary outcomes:
measure: panoramic mandibular index
timeFrame: 2018-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry cairo univeristy
Study officials:
affiliation: Ethical committee faculty if dentustry cairo unveristry
name: Dentistry Cairo, Univeristy
role: STUDY_CHAIR
References:
Clinical trial NCT01033435: The Influence of Cessation of Pomegranate Juice Intake on Inflammation and Oxidative Stress Markers and Glucose Control in Diabetic and Non Diabetic Chronic Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation
Oxidative Stress
Keywords: Inflammation
Oxidative stress
HbA1c
Hemodialysis
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2009-12-16
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: chronic Hemodialysis patients, treated in our unit.

Brief summary: The current study will investigate chronic hemodialysis patients who were treated in our unit with pomegranate juice intake for 1 year - compared to a control group.

Markers will be taken 3 months after cessation of pomegranate juice intake, for inflammation and oxidative stress and Hb A1c.


Eligibility criteria: Inclusion Criteria:

* Chronic Hemodialysis patients three months after termination of study which is currently carried out at our unit; which compared patients taking pomegranate juice three times a week for 1 year to a group that received placebo juice.

Exclusion Criteria:

* Patients who do not currently participate in above mentioned trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee Hospital
state: Western Galilee
Study officials:
References:
Clinical trial NCT04527835: Presentation, Clinical Course and Patterns of Myocardial Damage Due to Viral Myocarditis
Official title: Presentation, Clinical Course and Patterns of Myocardial Damage Due to Viral Myocarditis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Viral Myocarditis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients complained of symptoms of moderate to severe heart disease including atypical chest pain, fatigue, reduced physical capacity, recently occurring cardiac arrhythmia, and/or dyspnea on exertion suggesting myocardial inflammation.

Brief summary: Presentation, Clinical Course and Patterns of Myocardial Damage due to Viral Myocarditis

Detailed description: 1. Determine the pattern of myocarditis in hospitalized patients with acute HF within the last 3 months.
2. Determine the pattern of broad spectrum cardiotropic viruses in patients with acute HF within the last 3 months. These viruses like enteroviruses, adenoviruses and parvo B19 virus, HBV, HCV and Covid 19 virus due to its increased prevelance nowadays.

Eligibility criteria: Inclusion Criteria: All patients admitted with symptoms , signs and echocardiographic finding suggesting myocarditis within 3 months from start of the symptoms. as acute heart failure, arrhythmias, typical chest pain with ST segment deviation in ECG . dilated cardiomyopathy associated with normal Coronary Angiography, history of upper respiratory tract infection within the last 3 months.

Exclusion Criteria:

1. Patients with significant coronary artery disease.
2. Patient with family history suggesting familial DCMP
3. Critically ill patients.
4. Patients who refuse to do coronary angiography . .
5. Patients with severe valvular heart disease.
6. Pregnant women
7. Patients with raised renal chemistry.
8. Echocardiographic finding showing LVEDD more than 6.5cm

Primary outcomes:
measure: Determine the pattern of myocarditis in hospitalized patients with acute HF within the last 3 months
timeFrame: 6 months
Secondary outcomes:
measure: determination of the caustive organism
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Shery Refaat Asaad
Study officials:
affiliation: Assiut University
name: Ayman khairy, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Mohamed El Mokhtar, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05417035: Pubertal Replacement In Boys Study Nebido and Testoviron Depot Treatment
Official title: Pubertal Replacement In Boys Study Pubertal Induction in Boys With Delayed Puberty: Comparison Between Testosterone Enanthate and Testosterone Undecanoate Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Puberty Delayed
Lead sponsor: NU-Hospital Organization, Sweden
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 27
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective open clinical study
Primary purpose: TREATMENT

Brief summary: In this prospective open clinical study, Pubertal Replacement in Boys Study (PRIBS), boys 14-16 years with delayed puberty in terms of slow pubertal progression, were randomized to SoC treatment with TE: Testostoviron depot® 75 mg intramuscularly (i.m) / month (6 injections), or low dose TU: Nebido® 250mg i.m. / 3 months (2 injections). Our goal was to implement a study similar to clinical routine.

Detailed description: Boys 14-16 years with pubertal delay were randomized to standard treatment with TE (Testosterone enanthat 75mg /month 6 injections)or newer treatment TU(Testosterone Undecanooat 250mg 2 injections 3 months apart) for pubertal induction. Our study PRIBS (pubertal replacement in boys study) was academically sponsored, monitored and approved by the medical products agency in Sweden. Between 2014 -08 and 2019-07 27 boys were randomized to treatment with TE (12 boys) or TU (15 boys). Testosterone levels were measured twice before study start and after 2,7,30,60,90,180 and 365 days. Boys with delayed puberty \> 14 years with morning testosterone levels 0,5 - 3 Nmol/L and testicular volume ≤ 6 mL were included.Primary Outcome was testicular enlargement ≥ 8mL after 12 months. The new treatment was considered clinically similar if the treatment result were in the 80-125% interwall of the traditional group. Fishers exact chi square test was used for this analysis. Our intention was to recruit 20 boys in each armInformed consent was signed before study start by parents and assent by the boys. PRIBS was approved by the regional ethic committee 2012-09-14 Dnr 506-12 and approved by Union Drug Regulating Authorities Clinical Trials Database EudraCT nr 2012-002337-11 and the Swedish drug authorities (Läkemedelsverket) All study personal was trained in ICH GCP (good clinical practice).

Eligibility criteria: Inclusion Criteria:

* • Signed informed consent

  * Two morning testosterone values (07.30-09.00) of 1-3 nmol/L and at start \< 4 mmol/L ¹
  * Testicular volume 4-6 mL bilaterally²

Exclusion Criteria:

* • Growth spurt

  * Untreated hypothyroidism, celiac disease or steroid medication
  * Training doses \> 10 hours a week
  * Use of anabolic steroids or other drugs

Primary outcomes:
measure: Testicular Volume 8ml
timeFrame: 12 months after induction
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02770235: Evaluation of Advanced Glycation End-products (AGE) and the Erectile Dysfunction (DE) in Diabetic Patients
Official title: Evaluation of Advanced Glycation End-products (AGE) and the Erectile Dysfunction (DE) in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Erectile Dysfunction
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 97
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In diabetics there is an abnormally increased production of AGEs due to hyperglycemia. An association was shown between AGE measured by biopsy (invasive) and DE patients with diabetes (increase of AGE level in the corpora cavernosa). To date no studies have explored the link between DE and the measure of AGE by a non-invasive method of Auto-fluorescence (AF) Skin (AGEReaderTM).

If the hypothesis of an association between DE and AGE measured by AF was checked, screening for erectile dysfunction and measurement of AGEs could help to improve the overall management of diabetic patient (including cardiovascular) and their quality of life.


Eligibility criteria: Inclusion Criteria:

* Diabetes Type 2

Exclusion Criteria:

* skin hyperpigmentation

Primary outcomes:
measure: erectile dysfunction and AGE levels
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Jean-Daniel LALAU, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00254735: Quetiapine Augmentation in Severe Obsessive Compulsive Disorder
Official title: Quetiapine Augmentation in Severe Obsessive Compulsive Disorder (OCD) - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obsessive Compulsive Disorder
Keywords: Obsessive Compulsive Disorder (OCD)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-17
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy of quetiapine or placebo added to baseline treatment of SSRI/clomipramine for the treatment of OCD in adult subjects.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent, men and women aged ³18 to £65 years with diagnosis of OCD, at least 12 weeks of treatment with SSRI or clomipramine

Exclusion Criteria:

* Substance abuse or dependence, female patients who are pregnant, lactating or at risk of pregnancy, known intolerance or lack of response to quetiapine, use of antihypertensive medication with changing doses

Primary outcomes:
measure: Absolute change of OCD symptoms from baseline to endpoint on the total Y-BOCS score.
Secondary outcomes:
measure: Change of comorbid psychiatric symptoms and measures of quality of life from baseline to endpoint documented by different scales.
measure: Evaluation of the safety and tolerability profile of quetiapine compared to placebo added to a baseline medication of SSRI/clomipramine.
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Research Site
city: Lübeck
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Germany Medical Director, MD
role: STUDY_DIRECTOR
References: