louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04697134: Community-Based Conscious Discipline Program in Grenada
Official title: A Community-based Conscious Discipline Program to Reduce Corporal Punishment in the Caribbean
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Child
Neurocognition, Child
Development, Child
Lead sponsor: Windward Islands Research and Education Foundation
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: GRENCASE
name: St. George's University
First posted: 2021-01-06
Enrollment: 333
Sex: ALL
Minimum age (years): 22
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To improve neurocognitive outcomes in 2-year-old children by implementing a community-based intervention program that follows the principles of Conscious Discipline.

Detailed description: We aimed to introduce Conscious Discipline (CD) in Grenada as a means of improving neurodevelopment in 2-year-old children. The CD intervention promotes improved social-emotional connections between parents/guardians and children that reduces harsh discipline and corporal punishment and provides an ideal environment for the development of higher cognitive functioning (e.g. working memory, inhibition, emotional regulation).

The intervention is implemented by using a distributed local, train-the-trainer model in partnership with the Grenada Roving Caregiver Program, managed by GRENCASE. CD training was provided to 85 existing Roving Caregivers, 70 of whom were certified as Conscious Discipline Paraprofessionals (CDPPs). Certified CDPPs traveled out to communities and villages throughout Grenada, to impart knowledge and skills to new and expecting parents.

Following the intervention, parents who received CD training were assessed in their ability to implement CD skills with their child(ren). Neurocognition was assessed in children post-intervention using the INTERGROWTH 21st Neurodevelopmental Assessment (INTERNDA). Neurocognitive outcomes were compared between the intervention arm and the waitlist control arm of the study.

Eligibility criteria: Inclusion Criteria:

* Participants actively enrolled in the Roving Caregiver Program (0-2-year-olds living with parents in at-risk communities served by the RCP)

Exclusion Criteria:

* Not enrolled in the Roving Caregiver Program

Primary outcomes:
measure: INTERGROWTH 21st Neurodevelopment Assessment (INTER-NDA)
timeFrame: 22-30 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint George's
country: Grenada
facility: Windward Islands Research and Education Foundation
Study officials:
affiliation: Windard Islands Research and Education Foundation
name: Randall Waechter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04220034: Autoantibodies Prevalence During Checkpoint Inhibitor Treatment
Official title: Autoantibodies Prevalence and Their Related-diseases During Checkpoint Inhibitor Treatment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Autoimmune Adverse Effects of Anti-neoplasic Drug
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving inhibitor checkpoint treatment

Brief summary: The use of Checkpoint inhibitors (ICIs) is rapidly expanding to the treatment of many cancer types. Autoimmunity and clinical autoimmune diseases represent adverse events of ICIs with variable severity and consequences. Clinical trials using ICIs have largely excluded patients with preexisting autoimmune diseases but the rate of autoimmune flares has been reported to be high in patients with preexisting autoimmune diseases in retrospective cohort studies. Moreover numerous retrospective cases and series reported ICI-related autoimmune diseases in patients without any previous autoimmune event.

To date, no study has prospectively evaluated the rate of biological and clinical autoimmunity in patients. Moreover, guidelines concerning autoantibodies monitoring in patients are subject of debate.

Detailed description: The aim of this prospective study is to determine development or increase level frequencies of different types of autoantibodies in patients receiving ICI for the first time. The rate of clinical autoimmunes diseases development will also be recorded and correlated with autoantibodies prevalence before and during ICI treatment.

Results will help to determine the rate of biological and clinical autoimmune events induced by ICIs in unselected patients and will help to clarify autoimmunity screening strategy in this setting.

Eligibility criteria: Inclusion Criteria:

* patients receiving check point inhibitor for a neoplasic disease in a center that participates to the study during the inclusion period
* patients who agree to participate in the study
* adult patients (aged more than 18 years old)

Exclusion Criteria:

- previous treatment with check point inhibitor

Primary outcomes:
measure: development or increase level of anti-nuclear antibody
timeFrame: Month 6
measure: development or increase level of anti-cyclic citrullinated peptide antibodies
timeFrame: Month 6
measure: development or increase level of rheumatoid factor
timeFrame: Month 6
measure: development or increase level of Anti-glutamic acid decarboxylase antibodies
timeFrame: Month 6
measure: development or increase level of Anti-thyroperoxydase antibodies
timeFrame: Month 6
measure: development or increase level of Auto-antibodies associated with myositis
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT00274534: A Comparison of the Effects of Tiotropium Inhalation qd and Salmeterol Inhalation Bid on Arterial Blood Gases.
Official title: A Comparison of the Effects of Tiotropium (18 Mcg) Inhalation Capsule q.d. and Salmeterol (50 Mcg) Inhalation Aerosol b.i.d. on Arterial Blood Gases in a Double-blind, Double-dummy, 4-week Crossover Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-01-11
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to Salmeterol MDI in patients with moderate to severe COPD.



Primary outcomes:
measure: The change from baseline (Visit 2) in the PaO2 area under the curve (AUC) for the time period 0 to 105 minutes obtained through arterial blood gases (ABGs) at the end of each treatment period.
timeFrame: up to day 90
Secondary outcomes:
measure: Maximum decline in PaO2 from baseline
timeFrame: up to day 90
measure: Maximum increase in alveolar-arterial oxygen gradient from baseline
timeFrame: up to day 90
measure: Change from baseline (Visit 2) in FEV1 prior to insertion of catheter and 15 minutes post removal of catheter
timeFrame: up to day 90
measure: Change from baseline (Visit 2) in FVC prior to insertion of catheter and 15 minutes post removal of catheter
timeFrame: up to day 90
measure: Rescue medication use
timeFrame: up to day 90
measure: COPD symptom score
timeFrame: up to day 90
measure: Occurrence of adverse events
timeFrame: up to day 90
measure: Pulse rate and sitting blood pressure in conjunction with spirometry
timeFrame: up to day 90
Other outcomes:
Locations:
city: Hines
country: United States
facility: Hines Veterans Administration Hospital
state: Illinois
city: Richmond
country: United States
facility: Hunter Holmes McGuire Medical Center
state: Virginia
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References:
Clinical trial NCT01126034: Improving Metoclopramide Prescribing Practices at Penn Through a Physician-targeted Intervention
Official title: Improving Metoclopramide Prescribing Practices at Penn Through a Physician-targeted Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Diabetic Gastroparesis
Keywords: Metoclopramide
Randomized Controlled Trial
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 85
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators hypothesized that:

1) an intervention targeted at the prescribing physician would increase the rate of a metoclopramide discontinuation among patients prescribed the medication for questionable or unclear indications; and 2) the discontinuation would be durable.


Eligibility criteria: Inclusion Criteria:

* Physicians at University of Pennsylvania Health System who ordered an active metoclopramide prescription with a questionable indication.

Exclusion Criteria:

* Physicians-in-training (e.g., residents, fellows)
* Physicians how were investigators on this study
* Physicians serving on the the University of Pennsylvania Drug Use and Effects Committee or Information Technology Oversight Board

Primary outcomes:
measure: Discontinuation of metoclopramide therapy
timeFrame: 12 weeks after intervention period
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Center for Clinical Epidemiology and Biostatistics
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Yu-Xiao Yang, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01231334: A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-11-01
Enrollment: 286
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study comparing the topical application of Aczone® plus Differin® versus Duac® plus Differin® in patients with severe facial acne (facial acne vulgaris).


Eligibility criteria: Inclusion Criteria:

* Severe facial acne (acne vulgaris)

Exclusion Criteria:

* History of significant anemia or hemolysis
* History of enteritis (eg, regional enteritis, ulcerative colitis, pseudomembranous colitis, antibiotic-associated colitis)
* History of lupus, rosacea, or seborrheic dermatitis

Primary outcomes:
measure: Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in Total Lesion Count at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Miramar
country: United States
state: Florida
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04771234: Digital Psychological Self-care for Sleep Problems
Official title: Self-guided Digital Psychological Self-care for Individuals With Sleep Problems - Feasibility and Preliminary Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Insomnia
Keywords: Digital tool
Self-guided
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2021-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment Pragmatic, within-group pilot study
Primary purpose: TREATMENT

Brief summary: In this non-randomized treatment feasibility pilot we want to explore if a simplified version of CBT-i as a non-therapist-guided digital tool can work; if the digital tool is perceived as user friendly and if participants' insomnia severity is improved following four weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Insomnia complaints of at least medium severity (15 or above on the ISI)
* Insomnia disorder according to DSM-5
* Adequate language skills (Swedish)
* No foreseeable practical hinders to participate
* Can wear actigraph 24/7
* Daily access to the internet, via computer, smart phone or tablet

Exclusion Criteria:

* Sleep disorders requiring other treatment (e.g. sleep apnea)
* Somatic or psychiatric disorders that require other treatment (e.g. suicide risk, severe depression) or that decrease level of functioning enough to prevent working independently.
* Use of alcohol or drugs in a way that will affect sleep negatively, use of medications with a negative impact on sleep. (Stable use of anti depressants and stable use or tapering of hypnotics are allowed)
* Night work or shift work involving night work
* Ongoing or previous psychological treatment including sleep restricion and stimulus control

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: From base-line to 4 weeks
measure: Insomnia Severity Index
timeFrame: From base-line to 20 weeks
measure: Treatment acceptability/usefulness
timeFrame: From base-line to 4 weeks
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: From base-line to 4 weeks
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: From base-line to 20 weeks
measure: Generalized Anxiety Disorder Scale (GAD7)
timeFrame: From base-line to 4 weeks
measure: Generalized Anxiety Disorder Scale (GAD7)
timeFrame: From base-line to 20 weeks
Other outcomes:
measure: Adverse events and Negative effects questionnaire (NEQ)
timeFrame: From base-line to 4 weeks
measure: Actigraphy
timeFrame: From base-line to 4 weeks
Locations:
city: Stockholm
country: Sweden
facility: Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry
Study officials:
References:
Clinical trial NCT02717234: Appearance of Plasma Amino Acids Following Consumption of an Oral Nutrition Supplement
Official title: Appearance of Plasma Amino Acids Following Consumption of an Oral Nutrition Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2016-03-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To assess the effect of consumption of an oral nutrition supplement on Arginine, a blood marker of nutritional intake


Eligibility criteria: Inclusion Criteria:

* Healthy subject (absence of metabolic disorder, heart disease, endocrine disease, cancer)
* Discontinued use of omega 3 fatty acid supplements - 10 days prior to testing
* Willing to provide signed informed consent

Exclusion Criteria:

* Smoker
* Patients with potential for non-compliance
* Patients with allergy to ingredients in test products (i.e. milk protein, fish oil)
* Subject who in the Investigator's assessment cannot be expected to comply with study protocol
* Currently participating in another conflicting clinical trial.

Primary outcomes:
measure: Change in plasma arginine levels in µmol/L
timeFrame: Pre-consumption, 30, 60, 120, 180, 240 minutes
Secondary outcomes:
measure: Change in plasma-free phospholipid Eicosapentaenoic acid (EPA) in µg/ml
timeFrame: Pre-consumption, 30, 60, 120, 180, 240 minutes
measure: Change in plasma phospholipid Eicosapentaenoic acid (EPA) in µg/ml
timeFrame: Pre-consumption, 30, 60, 120, 180, 240 minutes
Other outcomes:
measure: Change in plasma-free phospholipid Docosahexaenoic acid (DHA) in µg/ml
timeFrame: Pre-consumption, 30, 60, 120, 180, 240 minutes
measure: Change in plasma phospholipid Docosahexaenoic acid (DHA) in µg/ml
timeFrame: Pre-consumption, 30, 60, 120, 180, 240 minutes
Locations:
Study officials:
affiliation: Diabetes & Glandular Disease Clinic, PA
name: Sherwyn Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02691234: Safety and Efficacy of Low Intensity Shockwave Therapy in Treating Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetic Foot Ulcers
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low intensity shockwaves for treating diabetic foot ulcers (DFUs) have been in evaluation for the past 5 years. Many researchers showed the effectiveness of Low intensity shockwaves of in accelerating the healing rate of non-ischemic chronic DFUs. Wang et al. showed, the use of Low intensity shockwaves on DFUs, significantly improved topical blood flow perfusion rate, increased cell proliferation and cell activity and decreased cell apoptosis.

The present study deals with the effect of low intensity shockwaves on DFUs. Shockwave treatment will be done together with the standard conventional treatment for DFUs, compared to a control group who will receive the same conventional standard of care.


Eligibility criteria: * Inclusion Criteria:

  1. Chronic non-healing diabetic foot ulcers for more than 2 months.
  2. Age 18-80 years
  3. Ankle Brachial Index (ABI) ≥0.6
  4. Diabetic Foot Ulcer with the long diameter of ≤7cm and a short diameter of ≥1cm
  5. The target ulcer is up to Wagner's grade 3
  6. Albumin level ≥25g/L
  7. Hemoglobin level ≥90g/L
  8. Estimated Glomerular Filtration Rate (eGFR) ≥30ml/min/1.73m2
  9. The patient agrees to comply with study protocol requirements, including the shockwave procedure, self-care of the ulcer (dressings, orthotics etc.) and all follow-up visit requirements
* Exclusion Criteria:

  1. Pregnancy or lactation
  2. ABI \<0.6
  3. The long diameter of the target ulcer is \>7cm and the short diameter is \<1cm
  4. The target ulcer is of Wagner's grade 4 or above
  5. Severe Hypoalbuminemia \<25g/L
  6. Severe anemia, Hemoglobin level \<90g/L
  7. eGFR \<30ml/min/1.73m2
  8. Patients suffering from acute Charcot foot
  9. Severe edema of the treated limb
  10. Patient with present malignancy or past malignancy in the treated area
  11. Systemic chemotherapy/ radiation treatment within the last 6 months
  12. Deep vein thrombosis within the last 6 months
  13. Any other experimental treatment or participation in other studies

      -

Primary outcomes:
measure: To assess initial closure rate of the wound 4 weeks after the last treatment session, as compared to the control group receiving conventional standard of care.
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03385434: Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate?
Official title: Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Adenoma
Colonic Polyp
Colonic Neoplasms
Colonoscopy
Keywords: Colonoscopy; adenoma detection rate; endorings-2; endorings; device-assisted colonoscopy
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Screening colonoscopy for colorectal cancer is essential to diagnose and remove adenomas, precancerous stages of colorectal cancer. Unfortunately approximately 25 % of all adenomas are missed during the examination. Recently a new colonoscopy accessory, the Endorings-2 (EndoAid Ltd., Casearea, Israel), has been designed to improved the detection of adenomas during colonoscopy (adenoma detection rate).

Endorings-2 is a silicone-rubber device that is fitted on the colonoscope and is equipped with circular flexible silicon rings mechanically stretching the colonic folds during withdrawal.

This study aims to evaluate the efficacy of Endorings-2 to improve the adenoma detection rate in a prospective, blinded clinical trial. 292 patients with an indication for a screening colonoscopy shall be included (1:1 randomization in standard colonoscopy versus Endorings-2-assisted colonoscopy).


Eligibility criteria: Inclusion Criteria:

* Patients with an indication for a screening colonoscopy.

Exclusion Criteria:

* Patients under 18 years, pregnancy
* Patients with prior colectomy or partial colectomy
* Patients with a history of colorectal cancer
* Patients with hereditary polyposis syndromes (FAP, HNPCC)
* Patients with a stricture of the colon
* Patients receiving anticoagulation prohibiting a colonoscopy
* inability to have a patient education
* bad conditions prohibiting a colonoscopy

Primary outcomes:
measure: Evaluation of the adenoma detection rate during screening colonoscopy
timeFrame: Intraoperative. Adenomas detected directly during the examination.
Secondary outcomes:
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Unversity Clinic Muenster
state: NRW
Study officials:
References: