louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04030858: The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery
Official title: The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Issue
Addiction
Lead sponsor: Northern Arizona University
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial with an intervention and control group comparison.
Primary purpose: TREATMENT

Brief summary: The trial will be placed within an ongoing addiction recovery program at Infinite Recovery in Austin, TX. Members with any addiction enrolling in an inpatient treatment program at Infinite Recovery will be recruited into this 1-year study to evaluate the effectiveness of a plant-based diet to aid drug and/or alcohol addiction recovery. Volunteers willing to participate in the trial will be randomly assigned to a treatment or control group. Those in the treatment group will follow the standard protocol offered by Infinite Recovery, with the exception that they will be provided with only plant-based meals. Both groups will also receive nutrition education to support their dietary plan. Several health and wellbeing endpoints will be assessed as part of the standard care at Infinite Recovery, combined with a few additional measurements described within this study protocol.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Entering inpatient treatment at Infinite Recovery Addiction Treatment Facility

Exclusion Criteria:

* Pregnant
* Psychiatrically unstable.

Primary outcomes:
measure: Resilience
timeFrame: Change from baseline to week 3
measure: Resilience
timeFrame: Change from baseline to week 10
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02179996: Diphtheria, Tetanus, Poliomyelitis -Pertussis-Hib Immunisation in Preterm-born Neonates
Official title: Comparison of Two Vaccinal Schemes for DTP-Pertussis-Hib Primo-immunisation in Very Preterm-born Neonates: a Randomised Bicentric Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hib Immunisation in Very Preterm-born Infants
Pertussis Immunisation in Very Preterm-born Infants
Keywords: Vaccination
Very preterm-born infants
Hib immunisation
Pertussis immunisation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 160
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Preterm neonates are fragile to infections. Their immune system is immature, yet in France, primary vaccines are injected at two months of age, as in term infants.

Recommendations for vaccinations in infants have changed in France in 2013, suppressing the second injection at three months after birth. Preterm and full-term born infants are now vaccinated at two and four months of age, but no data regarding efficacy in very preterm infants have been registered.

The investigators hypothesize that two vaccine injections (at two and four months) would be less efficient than three injections (two, three and four months) in very preterm-born infants.


Eligibility criteria: Inclusion Criteria:

* infants born \< 33 weeks gestation in Nancy and Thionville Maternity Wards
* signed parental consent

Exclusion Criteria:

* immunodeficiency
* vaccine contra-indication

Primary outcomes:
measure: Hib antibody dosage in blood sample
timeFrame: 5 months after birth
Secondary outcomes:
measure: Pertussis antibody dosage in blood sample
timeFrame: 5 months after birth
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre Hospitalier Regional et Universitaire, Maternite Regionale
city: Thionville
country: France
facility: Centre Hospitalier de Thionville
Study officials:
References:
Clinical trial NCT04970758: Differential Diagnosis Athlete's Heart From Cardiomyopathy
Official title: Differential Diagnosis Athlete's Heart From Hypertrophic Cardiomyopathy With T1 Mapping
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Athlete's Heart
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Athletes

Brief summary: Assess the effects of strength sport to heart structure and function by T1 mapping with cardiac resonance imaging.


Eligibility criteria: Inclusion Criteria:

* Same exercise

Exclusion Criteria:

* Intolerance test

Primary outcomes:
measure: T1 value in ms (Unit)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: xinyu wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00261196: Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)
Official title: Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Adhesive Capsulitis
Frozen Shoulder
Keywords: Frozen Shoulder
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2005-12-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test collagenase injection therapy to dissolve adhesions causing frozen shoulder.

Detailed description: In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to lyse the adhesions associated with the shoulder capsule in adhesive capsulitis (frozen shoulder).

Treatment success may obviate the need for extensive physical therapy and/or shoulder arthroscopy (surgery) to correct this condition and restore normal and pain free shoulder motion.

Eligibility criteria: Inclusion Criteria:

* diagnosis of frozen shoulder of at least one month duration

Exclusion Criteria:

* shoulder arthritis
* rotator cuff tears
* any chronic, serious, uncontrolled medical condition
* inability to conform to study visits (20-30 per year)

Primary outcomes:
measure: Active elevation of the affected shoulder
timeFrame: 30 days
Secondary outcomes:
measure: Active and passive shoulder motions in internal/external rotation, passive elevation, pain and function.
timeFrame: 30 days
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Dept. Orthopaedics, SUNY@Stony Brook
state: New York
Study officials:
affiliation: Dept. Orthopaedics, SUNY@Stony Brook, NY 11794
name: Marie A Badalamente, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01202396: The Interaction Between Intestinal Microbiota, Innate Defense and Epithelial Integrity in the Development of Pouchitis
Official title: The Interaction Between the Intestinal Microbiota, Innate Defense and Epithelial Integrity in the Development of Pouchitis: a Multifactorial Approach
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pouchitis
Keywords: pouch
pouchitis
ulcerative colitis
microbiota
defensins
epithelial integrity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2010-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing proctocolectomy with the construction of an ileal pouch anal anastomosis will be asked to participate in the study

Brief summary: Pouchitis is a common complication following proctocolectomy with ileal pouch anal anastomosis (IPAA) in patients with ulcerative colitis (UC). It affects the quality of life and can become a chronic problem. The aetiology of pouchitis is not completely understood. A crucial role of the intestinal microbiota has been suggested, but no causative agent has been identified so far. Furthermore, the defensin expression and the epithelial integrity are altered in inflammatory bowel diseases and may play an important role in the development of intestinal inflammation. Therefore, it has been hypothesized that the interaction between an altered microbiota composition, a defective epithelial integrity and changes in innate defense parameters such as defensins has a pivotal role in the development of pouchitis in UC patients.


Eligibility criteria: Inclusion Criteria:

* patients with ulcerative colitis undergoing a total colectomy with IPAA for steroid dependent disease, therapy-refractory disease, colorectal cancer or severe dysplasia
* 18-65 years of age

Exclusion Criteria:

* unable to give informed consent
* pregnant or breastfeeding

Primary outcomes:
measure: Differences in the intestinal microbiota composition between pouch patients with and without pouchitis
timeFrame: 24 months.
Secondary outcomes:
measure: The expression of defensins in the intestinal mucosa
timeFrame: 24 months
measure: The intestinal permeability
timeFrame: 24 months.
measure: Inflammatory mediators
timeFrame: 24 months
measure: The expression of tight-junction associated proteins
timeFrame: 24 months.
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center, div. Gastroenterology-Hepatology
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: A. Masclee, Prof MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01917396: Influence of Preoperative Enema Application on Return of Gastrointestinal Function After Elective Cesarean Section: A Randomized Controlled Study
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Postoperative Bowel Sounds
Bowel Gass Passage
Keywords: caesarean, bowel, gass
Lead sponsor: Istanbul Bakirkoy Maternity and Children Diseases Hospital
Sponsor class: OTHER_GOV
First posted: 2013-08-06
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: The researchers investigate that use of preoperative enema to the effect postoperative bowel gas passage.


Eligibility criteria: Inclusion Criteria:

1. elective cesarean
2. no history of previous abdominal operation(except cs)

Exclusion Criteria:

1. Emergency cesarean delivery
2. Refusal to participate.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Tepecik Education and Research Hospital,
state: Yenisehir
Study officials:
affiliation: Tepecik Education and Research Hospital
name: İbrahim Egemen Ertaş, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lurie S, Baider C, Glickman H, Golan A, Sadan O. Are enemas given before cesarean section useful? A prospective randomized controlled study. Eur J Obstet Gynecol Reprod Biol. 2012 Jul;163(1):27-9. doi: 10.1016/j.ejogrb.2012.03.034. Epub 2012 Apr 17.
Clinical trial NCT00510796: Combined Colon and Endometrial Cancer Screening in Women With HNPCC
Official title: A Pilot Study for Combined Colon and Endometrial Cancer Screening in Women at High-Risk for Colon and Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Keywords: Hereditary Non-Polyposis Colon Cancer
Colon Cancer
Endometrial Cancer
Cancer Screening
Interview
HNPCC
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-08-02
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UT MDACC Female patients determined to be in a high risk group for either colon and/or endometrial cancer.

Brief summary: Primary Objectives:

To test the feasibility of combined colon and endometrial cancer screening in women with increased risk for colon and endometrial cancer.

To measure patient satisfaction for the combined procedure.

Detailed description: Women with certain medical conditions have an increased risk for colon and endometrial cancer. Currently, women go through separate screening procedures. Endometrial biopsies are performed at a separate visit to the gynecologist, and patients are not sedated for the procedure. This study will involve performing an endometrial biopsy while you are sedated for your colonoscopy.

Women who are able to have children must have a negative blood or urine pregnancy test before they can take part in this study.

As part of the study, you will be asked about your past experience with endometrial biopsy and colonoscopy. You will be asked about your perception of pain, your expectations, and the benefits and barriers to the combined screening.

You will then be sedated. The colonoscopy will be performed first by a gastroenterologist. This will be followed by the endometrial biopsy, which will be performed by a gynecologic oncologist.

A telephone interview will be performed two weeks after this procedure. The interview will last about 15 minutes. You will be asked about your perception of pain and the benefits and barriers to the combined screening.

This is an investigational study. A total of 50 women will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility criteria: Inclusion Criteria:

1) Women with medical indications for colonoscopy and endometrial biopsy.

Exclusion Criteria:

1) Must be 18 years of age and older.

Primary outcomes:
measure: Feasibility to perform both colon and endometrial cancer screening at the time of colonoscopy in women at high risk for colon and endometrial cancer.
timeFrame: 8 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Karen H. Lu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01892696: Effects of Inspiratory Flow Waveforms on Preload
Official title: Arterial Pulse Pressure Variation and Inferior Vena Cava Distensibility Affected by Inspiratory Flow Waveforms in Mechanically Ventilated Patients: Time for a Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Output, Low
Keywords: inspiratory flow pattern
mechanical ventilation
cardiac preload
arterial pulse pressure variation
inferior vena cava collapsibility
Lead sponsor: Military Hospital of Tunis
Sponsor class: OTHER
First posted: 2013-07-04
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The clinical usefulness of inspiratory flow pattern manipulation during mechanical ventilation remains unclear. The aim of this study was to investigate the effects of different inspiratory flow waveforms, i.e. constant and decelerating, on cardiac preload in mechanically ventilated patients assessed by arterial pulse pressure variation (PPV) and inferior vena cava distensibility.

Detailed description: During mechanical ventilation the lungs can be inflated with different pressure and flow waveforms. Originally the piston-driven mechanical ventilators generated a quasi-sinusoidal flow waveform, whereas the newer electronically controlled ventilators can also produce constant and decelerating waveforms. According to several theoretical,animal and clinical studies,the inspiratory flow waveform affects the distribution of the inspired gas as well as respiratory mechanics and gas exchange. However, other studies failed to show any significant effect.But there is no study interested to the effects of inspiratory flow waveforms on cardiac preload. Thus, the clinical usefulness of inspiratory flow pattern manipulation remains unclear, though the capacity for selection of different inspiratory flow waveforms is provided by most modern, microprocessor-equipped ventilators. Therefore, the purpose of this study was to compare the effects of flow patterns (sinusoidal, constant and decelerating) on dynamic measurements of cardiac preload dependence such as arterial pulse pressure variation (ΔPP) and distensibility index of the inferior vena cava (dIVC).

Eligibility criteria: Inclusion Criteria:

* mechanical ventilation
* Volume AssistControl Ventilation
* sinus rhythm

Exclusion Criteria:

* pressure mode
* arrhythmia

Primary outcomes:
measure: change in pulse pressure variation (ΔPP) and distensibility index of the inferior vena cava (dIVC)when varying inspiratory flow waveforms
timeFrame: 2h
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Military hospital of tunis
state: Mont Fleury
Study officials:
affiliation: Military Hospital of Tunis
name: zied hajjej, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00960596: Preventive Medicine Study of Childhood Atopic Diseases
Official title: Preventive Medicine Study of Childhood Atopic Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: educational intervention
asthma
Environmental Tobacco Smoke(ETS)
children
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2009-08-18
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Under environmental intervention programs, to explore the associations between Environmental Tobacco Smoke (ETS) and changes of pulmonary function, cytokines and new-onset asthma between different groups.

Detailed description: Environmental intervention programs:

We will both interview by telephone and mail the health education leaflets, in order to achieve the following aims:

-Smokers living with the children will change where smoking takes place for reducing the children's ETS exposure.

Data collection:

We will contact participants individually to get informed consent before data collection. No matter what intervention, non-intervention or reference group, all participants will test as follows:

* Blood sample collection: We will test the total IgE, specific IgE, cytokines, such as IL-4, IL-13, TNF-α, ECP and EOS.
* Questionnaire collection
* Pulmonary function test

After intervention programs applied, all participants will test pulmonary function, and total IgE, specific IgE and cytokines by blood sample after six months by school approaches. Then, we can compare the pulmonary function, total IgE, specific IgE and cytokines before and after intervention programs.

Eligibility criteria: Inclusion Criteria:

* Only one smokers living in the same household
* Having smoking exposure during the past 12 months while questionnaire surveying
* Child without smoking habit

Exclusion Criteria:

* None of above

Primary outcomes:
measure: urine cotinine level
timeFrame: six months, one year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
affiliation: Institute of Preventive Medicine, College of Public Health, National Taiwan University
name: YungLing Lee, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01704196: A Multi-Center Trial of Nepicastat for Cocaine Dependence
Official title: Phase 2, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial of Nepicastat for Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine Dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2012-10-11
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving the number of subjects that achieve abstinence from cocaine and reducing cocaine use in subjects with cocaine dependence.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age
* Is seeking treatment for cocaine dependence
* Is able to understand and provide written informed consent
* Has completed all psychological assessments and procedures required during the 7 - 14 day screening period
* If female, agrees to use an acceptable method of birth control
* Is, in the opinion of the Investigator, likely to complete the 11-week Treatment Phase of the study

Exclusion Criteria:

* Please contact the study site for more information

Primary outcomes:
measure: Abstinence (Weeks 10 - 11)
timeFrame: Weeks 10 - 11
Secondary outcomes:
measure: Reduction in Use (Weeks 1 - 11)
timeFrame: Baseline through week 11
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Matrix Institute on Addictions
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: Denver
country: United States
facility: VA Medical Center - Denver, CO
state: Colorado
city: Baltimore
country: United States
facility: Mountain Manor Treatment Center at Baltimore
state: Maryland
city: Albuquerque
country: United States
facility: Pacific Institute for Research and Evaluation
state: New Mexico
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Addiction Research Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania - Treatment Research Center
state: Pennsylvania
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: George E. Wahlen VA Medical Center
state: Utah
Study officials:
References: