louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01364129: The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy
Official title: The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Keywords: Diabetes
Diabetic Retinopathy Screening
Ophthalmic Telemedicine
Comparative Effectiveness Research
Lead sponsor: Legacy Health System
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Oregon Health and Science University
First posted: 2011-06-02
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This project aims to: 1) evaluate the long-term effectiveness of telemedicine to detect diabetic retinopathy when compared to traditional surveillance methods, 2) identify the health belief factors related to adherence with annual diabetic eye exams, and 3) determine the cost-effectiveness of the telemedicine system from the perspective of the community clinic, the third-party payer, and the individual patient.


Eligibility criteria: Inclusion Criteria:

* diabetic, at least 18 years old, patient at a participating health clinic

Primary outcomes:
measure: Proportion of Participants that Receive Annual Eye Exam
timeFrame: Baseline; Change from Baseline at 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years (number of follow-up exams depends on number of years enrolled in the study)
Secondary outcomes:
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Hunter Health Clinic
state: Kansas
city: Pendleton
country: United States
facility: Yellowhawk Tribal Health Center
state: Oregon
Study officials:
affiliation: Legacy Health System, Devers Eye Institute
name: Steven L Mansberger, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Thomas M Becker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park DW, Mansberger SL. Eye Disease in Patients with Diabetes Screened with Telemedicine. Telemed J E Health. 2017 Feb;23(2):113-118. doi: 10.1089/tmj.2016.0034. Epub 2016 Jun 21.
citation: Mansberger SL, Sheppler C, Barker G, Gardiner SK, Demirel S, Wooten K, Becker TM. Long-term Comparative Effectiveness of Telemedicine in Providing Diabetic Retinopathy Screening Examinations: A Randomized Clinical Trial. JAMA Ophthalmol. 2015 May;133(5):518-25. doi: 10.1001/jamaophthalmol.2015.1.
Clinical trial NCT03983629: Registry of Congenital Dyserythropoietic Anemia
Official title: French National Registry of Congenital Dyserythropoietic Anemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Dyserythropoietic Anemia
Keywords: Congenital Dyserythropoietic Anemia
French registry
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with confirmed CDA

Brief summary: Congenital dyserythropoietic anemia is a heterogeneous inherited disease. Hyperplasic erythropoiesis is ineffective and associated with morphological abnormalities of some of the erythroblasts that form the basis of cytological classification. The cumulative incidence is not very clear, but varies between countries from 0.08 million in Scandinavia to 2.6 cases/million inhabitants in Italy where it appears to be the most reported.

The common manifestation is moderate chronic congenital anemia. This anaemia is either normocytic or discreetly macrocytic, non-regenerative or inappropriate regarding anaemia, contrasting with signs of hemolysis with moderate unconjugated hyperbilirubinemia. Diagnosis is usually made in the pediatric period, but because of the great heterogeneity, the diagnosis sometimes may be delayed. Splenomegaly and jaundice are mostly present. Secondary hemochromatosis is common in the absence of transfusion due to hyper-intestinal absorption of iron induced by the dyserythropoiesis.

The transmission mode for Type I and II is autosomal recessive, while it is autosomal dominant or sporadic for Type III.

Several clinical questions remain concerning this disease :

* the median survival of patients is not well known, neither the causes of death
* benefit/risk of splenectomy
* iron overload quantification and consequences

The idea is to stablish a French registry of congenital dyserythropoietic anemia in order to help to understand the correlation between phenotype and genotype of this disease.


Eligibility criteria: Inclusion Criteria:

* Patient with confirmed CDA
* No opposition to the use of health data for research purposes

Exclusion Criteria:

* Patient opposed to participate in the study

Primary outcomes:
measure: Percentage of mutations
timeFrame: up to three years
Secondary outcomes:
measure: Median survival
timeFrame: up to three years
measure: Prevalence of different causes of death
timeFrame: up to three years
measure: Rate of Interferon treatment efficacy
timeFrame: up to three years
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Saint-Vincent de Paul
state: Hauts-de-France
Study officials:
affiliation: GHICL
name: Benjamin Carpentier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05836129: Lowering Stress Levels of Women in Lebanon
Official title: Effects of Transcendental Meditation on Rural Women of Lebanon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Resilience
Self Efficacy
Happiness
Keywords: Transcendental Meditation
Rural women in Lebanon
Lead sponsor: Maharishi International University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to compare the experiences of women who learn the TM technique to those who do not. The main questions it aims to answer are:

1. Do women in rural Lebanon who practice the TM technique experience lower stress levels compared to those who do not.
2. Do women in rural Lebanon who practice the TM technique experience increased happiness, self-efficacy, and resilience levels compared to those who do not.

Participants will:

* complete baseline surveys
* be divided into experimental and active-control groups
* those in the experimental group will learn the TM technique, the control group will be offered an online didactic course on stress reduction
* both groups will complete post-test surveys at the end of 1 and 3 months

  * Researchers will compare experimental and control groups to see if the intervention effects stress levels.

Detailed description: Methods: We will measure the effects of TM on 62+ women of the Chouf region of Lebanon using the following measures: Perceived Stress Scale, Connor-Davidson Resiliency Scale, New General Self-Efficacy Scale, and the Arabic Scale of Happiness. This is a randomized controlled trial with an experimental group and an active wait-list control group.

Measurements will be taken at baseline (pre-test) and at 1 and 3 months post-test.

Eligibility criteria: Inclusion Criteria: Females living in the Chouf region of Lebanon between the ages of 18-95.

-

Exclusion Criteria: Anyone: not female, under 18 or over 95, not in sound mental condition.

-

Primary outcomes:
measure: Change from baseline to 1 and 3-months on the Perceived Stress Scale(PSS-10)
timeFrame: Change = (week 12-baseline)
measure: Change from baseline to 1 and 3-months on the Connor-Davidson Resilience Scale (CDRS-10)
timeFrame: Change = (week 12-baseline)
measure: Change from baseline to 1 and 3-months on the Arabic Scale of Happiness (ASH-20)
timeFrame: Change = (week 12-baseline)
measure: Change from baseline to 1 and 3-months on the New General Self-Efficacy Scale (NGSE-8)
timeFrame: Change = (week 12-baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: TM Home of Pure Knowledge Center
Study officials:
affiliation: Chouf Development Council and the Ladies Foundation for Pure Knowledge
name: Ghada Fakhreddine, BA
role: STUDY_DIRECTOR
References:
Clinical trial NCT00356629: Development of a Noninvasive Method of Evaluation of Pulmonary Inflammation in the Condensates of Exhaled Air
Official title: Development of a Noninvasive Method of Evaluation of the Pulmonary Inflammation in the Condensates of Exhaled Air
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bronchopulmonary Ignition
Condensate of Exhaled Air
Mucoviscidosis
Asthma
Keywords: bronchopulmonary ignition
condensate of exhaled air
Mucoviscidosis
Asthma
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2006-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ubjects suffering from CF, COPD, asthma and tobacco exposure

Brief summary: The aim of the study is identify biological parameters reflecting proteolytic activity in the exhaled condenstaes which might be useful to follow up pulmonary inflammation in various conditions including cystic fibrosis, COPD, asthma, tobacco exposure. Three proteases will be analyzed, i.e. elastase, proteinase 3 and cathepsin G. Results in the condensates will be compared to those obtained in sputum.

Detailed description: 5 groups of 20 individuals each: group 1 CF, group 2 COPD, group 3 asthma, group 4 tobacco exposure, group 5 control subjects.

Collection of exhaled condensates in all subjects and of sputum in subjects belonging to groups 1 and 2.

Clinical examination and PFTs in all patients.

Eligibility criteria: Inclusion criteria

* Subjects suffering from CF, COPD, asthma and tobacco exposure (groups 1 to 4) and controls (group 5)
* aged more or equal to 18
* stable disease
* able to perform PFTs
* informed consent signed
* affiliated to french social insurance

Exclusion Criteria:

* acute exacerbation of the disease during the last 2 weeks
* IV or oral steroids or antibiotics during the last 2 weeks
* hospitalization during the last 2 weeks
* colonization by S aureus methicillin resistant and/or Burkholderia cepacia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: Service de Pneumologie et EFR CHRU Tours
Study officials:
affiliation: service de Pneumologie et EFR CHRU Tours
name: DIOT Patrice, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Attucci S, Gauthier A, Korkmaz B, Delepine P, Martino MF, Saudubray F, Diot P, Gauthier F. EPI-hNE4, a proteolysis-resistant inhibitor of human neutrophil elastase and potential anti-inflammatory drug for treating cystic fibrosis. J Pharmacol Exp Ther. 2006 Aug;318(2):803-9. doi: 10.1124/jpet.106.103440. Epub 2006 Apr 20.
citation: Grimbert D, Vecellio L, Delepine P, Attucci S, Boissinot E, Poncin A, Gauthier F, Valat C, Saudubray F, Antonioz P, Diot P. Characteristics of EPI-hNE4 aerosol: a new elastase inhibitor for treatment of cystic fibrosis. J Aerosol Med. 2003 Summer;16(2):121-9. doi: 10.1089/089426803321919889.
Clinical trial NCT03813329: Effects of Novel Sodium Bicarbonate Ingestion of Buffering Capacity
Official title: The Effects of a Novel Bicarbonate Loading Protocol on Elite Running Performance. A Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: PERFORMANCE-ENHANCING EFFECT
Lead sponsor: Long Island University
Sponsor class: OTHER
Collaborators: name: California State University, Los Angeles
First posted: 2019-01-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: One purpose of the present study was to evaluate the effect of elevating serum bicarbonate concentration more than had been achieved in previous studies without inducing potentially ergolytic GI distress. In order to do so, a modified SB ingestion protocol (ModSB) of 4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) was administered. It was hypothesized that ModSB would significantly elevate serum bicarbonate concentration to a greater extent than would an acute SB ingestion protocol (AcuteSB).

This study was also designed to corroborate the results of previous studies regarding the ergogenic effects of sodium bicarbonate ingestion. Most studies have administered sodium bicarbonate in solutions, which would make the participants aware of the substance ingested due to the distinctive flavor of SB, possibly inducing a placebo effect. All doses in the present study were administered in gelatin capsules to mask the flavor of the ingested substances, maintaining participant blindness to the procedure.

Blood samples were collected at baseline and following placebo (CaCO3), acute sodium bicarbonate ingestion, and modified sodium bicarbonate ingestion to determine the effects of the ingestion protocols on serum bicarbonate, sodium and lactate concentrations, as well as on serum pH and blood hematocrit. The study design was a randomized double-blind crossover.


Eligibility criteria: Inclusion Criteria:

* Peak oxygen consumption greater than 60 ml·kg-1·min-1 (men) or 50 ml·kg-1·min-1 (women)
* Currently training; defined as at least 5 days·week-1 of running
* Elite-level performance (750 or more points on the International Associations of Athletics Federations Scoring Table) for an 800m-5000m race during the preceding 6 months.

Exclusion Criteria:

-

Primary outcomes:
measure: Concentration of serum sodium bicarbonate (mmol·L-1)
timeFrame: 24 hours
Secondary outcomes:
measure: Concentration of serum sodium (mmol·L-1)
timeFrame: 24 hours
measure: pH
timeFrame: 24 hours
measure: Blood hematocrit (%)
timeFrame: 24 hours
measure: Likert scale for self-reported gastrointestinal distress (1-10)
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Marcus A, Rossi A, Cornwell A, Hawkins SA, Khodiguian N. The effects of a novel bicarbonate loading protocol on serum bicarbonate concentration: a randomized controlled trial. J Int Soc Sports Nutr. 2019 Sep 18;16(1):41. doi: 10.1186/s12970-019-0309-4.
Clinical trial NCT01799629: Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial
Official title: Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infant, Very Low Birth Weight
Keywords: Glycerin suppositories
Feeding intolerance
preterm infants
prophylactic use
elimination of meconium
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
Collaborators: name: Dr. Sulaiman Alhabib Medical City, Riyadh
name: Security Forces Hospital
First posted: 2013-02-27
Enrollment: 220
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the efficacy of prophylactic glycerin suppositories will accelerate the elimination of meconium from the large intestine and thus reduce the incidence of feeding intolerance in very low birth weight (VLBW) infants


Eligibility criteria: Inclusion Criteria:

1. Preterm infants with birth weight \< 1250g.
2. Inborn or outborn infants
3. Less than 72 hours of age.

Exclusion Criteria:

1. Congenital malformations.
2. Acute abdomen needing surgical intervention.
3. Severity of illness such that death is likely in the first few days after birth.
4. Inability to get the parental consent.

Primary outcomes:
measure: days to achieve full tolerated feeding (breast milk or formula) by NGT or by mouth (140cc/kg/day)
timeFrame: 2years
Secondary outcomes:
measure: Incidence of feeding intolerance
timeFrame: 2years
measure: Incidence of necrotizing enterocolitis (NEC)
timeFrame: 2years
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Centre
city: Riyadh
country: Saudi Arabia
facility: Security Forces Hospital
city: Riyadh
country: Saudi Arabia
facility: Sulaiman Al habib Medical Center
Study officials:
affiliation: King Faisal Specialist Hospital & Research Center
name: Emad M Khadawardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02545829: Evaluating the Bioequivalence of HIP1302, HGP1406
Official title: A Randomized, Open, 2-way Cross-over, Single Dose Study to Evaluate and Compare Safety and Pharmacokinetics of the HIP1302 and HGP1406 (Tenofovir) in Healthy Korean Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2015-09-10
Enrollment: 38
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the bioequivalence after administration of HIP1302 and HGP1406 in healthy male volunteers.

Detailed description: A Randomized, Open, 2-way cross-over, Single dose study to Evaluate and Compare Safety and Pharmacokinetics of the HIP1302 and HGP1406 in Healthy Korean Male Volunteers

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers, age 19 to 50 years
* The result of Body Mass Index(BMI) is not less than 18.0 kg/m2, no more than 27.0 kg/m2
* Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.

Primary outcomes:
measure: Tenofovir Cmax
timeFrame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)
measure: Tenofovir AUClast
timeFrame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)
Secondary outcomes:
measure: Tenofovir Tmax
timeFrame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)
measure: Tenofovir t1/2
timeFrame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)
measure: Tenofovir CL/F
timeFrame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)
measure: Tenofovir AUCinf
timeFrame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)
measure: Tenofovir MRT
timeFrame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)
measure: Tenofovir Vd/F
timeFrame: 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04590729: Interrupting Sitting Time During Postprandial State
Official title: Redistributing Intermittent Physical Activity Breaks to Target Postprandial Glucose Excursion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Lead sponsor: Franklin Pierce University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: three-by-three crossover design
Primary purpose: TREATMENT

Brief summary: The literature has shown that interrupting sitting time with frequent physical activities (e.g., cycling on a stationary bike for 3 minutes every 30 minutes of sitting) is effective for decreasing blood sugar levels. However, the optimal frequency and distribution of sitting interruption remains less clear. The purpose of this study is to compare the effects of two different protocols of sitting interruption (i.e., 3 minutes of cycling every 30 minutes versus 3 minutes of cycling every 15 minutes) on blood sugar levels.

Detailed description: This study will involve two different physical activity conditions and a control condition. Each participant will undergo the three conditions in a random order. The first protocol involves 3 minutes of cycling on a stationary bike at moderate intensity every 30 minutes for 6 hours, totaling 36 minutes of cycling exercise. The second protocol involves 3 minutes of cycling on a stationary bike at moderate intensity every 15 minutes for 3 hours to match the total exercise duration in the first protocol. Participants will remain seated for 3 hours to match to the total time spent in the lab. For the control condition, participants will remain seated. For each condition, participants will be provided with two meals, one before the protocol and another one in the middle of the protocol. The meals will be purchased from the cafeteria on campus based on the participant's own choice as long as carbohydrates account for 55-65% of total calories. Participants will eat identical meals across the three conditions.

Eligibility criteria: Inclusion Criteria:

* Apparently healthy persons
* Sedentary lifestyle

Exclusion Criteria:

* Cardiovascular diseases
* Pulmonary diseases
* Metabolic diseases
* Other contraindications to exercise

Primary outcomes:
measure: Postprandial glucose levels
timeFrame: three and a half hour after the carbohydrates intake
Secondary outcomes:
Other outcomes:
Locations:
city: Rindge
country: United States
facility: Franklin Pierce University
state: New Hampshire
Study officials:
affiliation: Franklin Pierce University
name: Tongyu Ma, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: