louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01231217: Green Tea in Crohn's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn's Disease
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess whether green tea or coffee influence the course and life quality of patients with mild to moderately active Crohn's disease.


Eligibility criteria: Inclusion Criteria:

* Women and men ≥ 18 years with signed informed consent,
* Patients with proven Crohn's disease,
* Chronic-active course ≥ 3 months,
* Current CDAI ≥ 150 and ≤ 350,
* All medications for Crohn's disease have to be on a constant dosage for at least 4 weeks prior to study entry (i.e. 5-ASA, steroids),
* Ability of the participant to understand character and individual consequences of the study.

Exclusion Criteria:

* Pregnancy or the wish to become pregnant, breastfeeding,
* Concomitant treatment with methotrexate, azathioprine or 6-mercaptopurine for \< 3 months,
* Treatment with TNF-alpha-antagonists, cyclosporine or tacrolimus \< 4 weeks prior to study entry,
* Participation in another study within the last 4 weeks,
* Ulcerative colitis or indeterminate colitis,
* Infectious colitis, including cytomegalovirus or Clostridium difficile induced colitis,
* Colitis for other reasons like known diverticulitis, radiation colitis, ischemic colitis or microscopic colitis,
* Malabsorption syndromes, lactose intolerance, celiac disease, exocrine pancreas insufficiency,
* Bleeding hemorrhoids,
* Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,
* Intolerance / aversion to tea and/or coffee,
* Current treatment with antibiotics.

Primary outcomes:
measure: Crohn's Disease Activity Index
timeFrame: week 16
Secondary outcomes:
measure: Harvey-Bradshaw-Index
timeFrame: week 16
measure: Inflammatory Bowel Disease Questionnaire
timeFrame: week 16
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
affiliation: University Hospital Heidelberg
name: Max Karner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005717: Medication Adherence in COPD--A Self-Regulation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases, Obstructive
Bronchitis
Emphysema
Chronic Obstructive Pulmonary Disease
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To test the effectiveness of a self-management program for chronic obstructive disease (COPD) patients. The program to improve adherence could be conducted by nurses or other clinic staff in settings where comprehensive rehabilitation services were not available.

Detailed description: BACKGROUND:

In 1990, the available data on medication adherence among chronic obstructive pulmonary disease (COPD) patients consistently indicated that adherence was a significant problem. This was a particularly distressing finding, considering that pharmacological therapy was considered the backbone of COPD management in settings where comprehensive rehabilitation services were limited. Despite the importance of this issue and a large data base on how to enhance medication adherence among medical populations, there had been no empirical investigations evaluating the implementation of these strategies with COPD patients.

DESIGN NARRATIVE:

The prospective, controlled study randomized 230 emphysema and chronic bronchitis patients from an urban university medical center into either a "usual care", control group or into a self-management skills training program for improving adherence. The training program was based on self-management procedures for enhancing adherence which had proven efficacious with diverse populations.

Self-reported and objective measures of adherence were examined during the two month baseline period and the one year follow-up in the controlled study. A range of possible covariates including demographics, patient characteristics, treatment, and therapeutic outcome variables were also collected during the baseline phase and at the 6-month and 12-month follow-up visits in the controlled study to evaluate their relationship to the observed adherence levels.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04321317: Validation of BodPod in Pediatric Anorexia Nervosa
Official title: Accuracy of Air Displacement Plethysmography Compare to Dual X-ray Absorptiometry (DXA) in Girls With Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 10
Sex: FEMALE
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Anorexia nervosa is a severe cause of undernutrition. It leads to a dramatic decrease of weight with an important modification of the body composition. During the renutrition phase, disharmonious body composition recovery is a relapse factor. Dual X-ray absorptiometry (DXA) is the gold standard to study body composition in children with anorexia nervosa. But, due to technical limits, DXA analysis needs to take in account a potential failure to thrive with an adjustment on height. Moreover DXA needs an irradiation which does not allow close repeat measurements. Since several years, a simple, non-invasive, non-irradiant method for measure of body composition has been developed in pediatrics: the air displacement plethysmography (ADP). Actually, only one device is available for this measurement: the BodPod®. However, feasibility and accuracy of ADP compare to DXA have not been evaluated in pediatric anorexia nervosa. The aim of this study is to compare the accuracy of BodPod® compare to DXA in girls with anorexia nervosa.


Eligibility criteria: Inclusion Criteria:

* Female patients aged between 8 and 18 years
* Female with a diagnosis of anorexia nervosa according to the DSM V classification, restrictive type or hyperphagic / purgative access type, evolving for less than 3 years.
* Female who received explanations adapted to their level of understanding for this study
* Female who expressed their consent to participate to this study
* Female whose parents or holders of parental authority have been informed and signed free and informed consent
* Female affiliated to a social security scheme

Exclusion Criteria:

* Patients with psychotic symptoms
* Patients with claustrophobia
* Patients with severe respiratory disease

Primary outcomes:
measure: Accuracy of Air Displacement Plethysmography (ADP) for body fat mass measurement
timeFrame: 1 year
Secondary outcomes:
measure: Acceptability of Air Displacement Plethysmography (ADP) by the patient compared to Dual X-ray Absorptiometry (DXA)
timeFrame: 1 year
measure: Accuracy of Air Displacement Plethysmography (ADP) compare to Bio Electrical Impedance (BEI)
timeFrame: 1 year
measure: Longitudinal evolution of the percentage of body fat mass
timeFrame: 1 year
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon) - Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT01942317: The Role of Balneotherapy in Obese Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis, Obesity
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 74
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to evaluate the role of balneotherapy in obese patients with knee osteoarthritis in terms of pain relief, improving joint function and deambulation, on endocrinological parameters, quality of life and of reduction the costs to "Servizio Sanitario Nazionale" (NHS).


Eligibility criteria: Inclusion Criteria:

* obesity II-III grade (BMI 35-45 kg/m2)
* knee pain
* patient compliance to the treatment

Exclusion Criteria:

* BMI\<34,9kg/m2 or BMI\> 45,1kg/m2
* previous knee surgery
* complicated diabetes mellitus
* ischemic cardiomyopathy and heart failure
* acute phase of osteoarthritis
* varicose veins, deep venous thrombosis (DVT)
* cancer
* cutaneous lesions
* NSAIDs administration \<1 week before the treatment
* knee infiltration \<2 months before the treatment

Primary outcomes:
measure: Knee pain measurement with Visual Analogue Scale (VAS)
timeFrame: At the begining and at the end of the treatment. After 6 months of the end of therapy
Secondary outcomes:
measure: Knee range of motion
timeFrame: At the begining and at the end of the treatment. After 6 months of the end of therapy
Other outcomes:
Locations:
city: Padua
country: Italy
facility: Azienda Ospedaliera-Università degli studi di Padova
Study officials:
References:
Clinical trial NCT00180817: Longitudinal Study of the Clinical and Haematological Cause of Women With Antiphospholipid Antibodies.
Official title: Longitudinal Study of the Clinical and Haematological Cause of Women With Antiphospholipid Antibodies in Women Presenting as Recurrent Miscarriages.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antiphospholipid Syndrome
Keywords: Antiphospholipid syndrome
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 250
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: This study is being done to see if there are any long term health related issues in women with APA and recurrent miscarriages.

Detailed description: The association between APA and thrombosis is well documented. Both LA and ACA are often detected in individuals with SLE but there is no prospective data on the risk of thrombosis in women who present with recurrent miscarriages in association with APA. This study should significantly advance medical knowledge of the natural history of primary antiphospholipid syndrome (PAPS) which is essential to enable optimal management of relatively young women who may be at risk of complications, some of which are potentially life threatening.

Eligibility criteria: Inclusion Criteria:

Antiphospholipid syndrome History of recurrent miscarriages

Exclusion Criteria:

Previous thromboembolic disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St. Mary's Hospital
Study officials:
affiliation: Imperial College London
name: Lesley Regan
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Raj Rai, MRCOG
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Mary's NHS Trust, London
name: Winnie Lo
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Mary's NHS Trust, London
name: Preeti Jindal, MRCOG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00044317: Health Effects of Particulate Acids in Late Adolescence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Obstruction
Cough
Keywords: FEV
Smoking
antioxidents
lung growth
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2002-08-27
Enrollment: 1500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: This study was designed to follow a group of adolescents who were previously examined by questionnaire and pulmonary function tests when they were aged 8-10 years old. Approximately 50% of the population in 10 towns were seen again at age 17-18. Questionnaires and pulmonary function were repeated. The hypotheses being tested related to whether the previously seen levels of pulmonary function that were related to pollution levels in the towns persisted as the lungs of these children grew and whether dietary antioxidants influences level of attained pulmonary function.


Eligibility criteria: Children seen in a previous study at ages 8-10 from selected cities

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02961517: Format of Patient Education for Different Sociodemographic Groups
Official title: The Influence of Socio-demographic Characteristics on the Preferred Format of Patient Education Delivery in Individuals With Type 2 Diabetes Mellitus or Cardiovascular Disease: a Questionnaire Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type2 Diabetes Mellitus
Cardiovascular Diseases
Lead sponsor: University of Leicester
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient aged 18 years or over, Diagnosed with cardiovascular disease (defined as heart disease, peripheral vascular disease or stroke) or Type 2 diabetes who has not already completed the questionnaire and is able and willing to complete questionnaire

Brief summary: Questionnaire study to investigate the effect of individual characteristics such as age, sex, ethnicity, educational level and socioeconomic status on the preferred format of patient education delivery, for patients with diabetes and/or cardiovascular disease

Detailed description: An anonymous questionnaire will be used to collect basic demographic data for patients with the conditions of interest, in addition to information about their preferences for the format in which they receive patient education information. This data will be statistically analysed to address the primary and secondary outcomes of the study:

1. To investigate the effect of individual characteristics such as age, sex, ethnicity, educational level and socioeconomic status on the preferred format of patient education delivery.
2. To identify reasons for preference of patient education delivery, and whether these are associated with sociodemographic factors.
3. To assess the distribution of sociodemographic factors from participants who prefer online education, in order to identify whether preference for online education is associated with particular sociodemographic factors.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or over.
* Diagnosed with cardiovascular disease (defined as heart disease, peripheral vascular disease or stroke) or Type 2 diabetes
* Has not already completed the questionnaire
* Able and willing to complete questionnaire

Exclusion Criteria:

* Participant unable or unwilling to complete questionnaire
* Under the age of 18
* Not diagnosed with any of the conditions of interest
* Participant has already completed the questionnaire
* Unable to communicate (assisted or otherwise) in written English

Primary outcomes:
measure: Effect of sociodemographic characteristics
timeFrame: 9 Months
Secondary outcomes:
measure: Reasons for preferences
timeFrame: 9 months
measure: Preference for online
timeFrame: 9 months
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Leicester Diabetes Centre
Study officials:
References:
Clinical trial NCT00504517: Preparing the Personal Physician for Practice (P4)
Official title: Preparing the Personal Physician for Practice (P4)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Outpatient continuity training
Relevant, Patient-centered curriculum
Evaluation
New graduation requirements
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2007-07-20
Enrollment: 35
Sex: ALL
Minimum age (years): 26
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Family medicine residents who accept employment as a resident in the Dept of Family Medicine will be part of the study population. These residents are interviewed prior to acceptance. Acceptance can occur via the NRMP or osteopathic match process or outside of the match

Brief summary: We would like to better understand how different educational strategies may influence the practice of family medicine. More specifically, we are interested in participant satisfaction with the educational program, participant retainment in this career, and to see if the curricular change better prepares participants for contemporary clinical practice.

Detailed description: In 2004, the Future of Family Medicine report called for implementation of innovative strategies in residency education, allowing translational key insights from the national demonstration project toward new approaches to family medicine training. Taking full advantage of the P4 Project will require careful evaluation planning and implementation. A comprehensive evaluation plan for the P4 Project will be implemented by a core evaluation team that will interact with site-specific evaluators.

The P4 evaluation program represents an observational case series assessment of selected residency programs. It is not an intervention trial; rather each residency program will systematically enroll cohorts of learners who will be exposed to curricular content and learning approaches that will likely be innovative and unique. In the absence of a rigorous study design, core data elements should be obtained from each program including: learner characteristics, program characteristics, and both nationally available data and targeted validated instruments that can link specific educational interventions to learners knowledge, attitudes and skills.

Eligibility criteria: Inclusion Criteria:

* Medical Residents at Christiana Care's Residency Program

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Christiana Care Health System
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Lisa C Maxwell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05448417: Exploration of Non-invasive High-frequency Oscillations in Human-machine Asynchrony in Healthy Subjects
Official title: Exploration of Non-invasive High-frequency Oscillations in Human-machine Asynchrony in Healthy Subjects : a Clinical Crossover Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-invasive Ventilation
Healthy Subjects
Keywords: Noninvasive high frequency oscillatory ventilation
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients were randomized to receive one hour each of the two non-invasive ventilation modes before and after, and one hour of washout after receiving the first mode of ventilation before receiving the second intervention.
Primary purpose: TREATMENT

Brief summary: High-frequency oscillatory ventilation (HFOV), as an ideal lung-protecting ventilation method, has been gradually applied to neonatal intensive care treatment, and is currently recommended as a rescue method for neonatal acute respiratory distress syndrome (ARDS) after conventional mechanical treatment fails. ventilation. Non-invasive high-frequency oscillatory ventilation (nHFOV) combines the advantages of HFOV and non-invasive ventilation methods, and has become a research hotspot in this field. Recommended to avoid intubation after failure of conventional non-invasive ventilation therapy. There is a lack of large-scale clinical trials systematically exploring its efficacy for intubation therapy. The increasing clinical application of nHFOV has also enriched its application in the treatment of other diseases. Human-machine asynchrony during non-invasive ventilation will seriously affect its efficacy, but no one has reported on the research related to nHFOV human-machine asynchrony.


Eligibility criteria: Inclusion Criteria:

1. Age 25-40, males and females;
2. Pulmonary function test found that the subject's lung function was normal;
3. Pulmonary disease not related to the results of the experiment;
4. Willing to participate in the study;
5. Able to provide informed consent.

Exclusion Criteria:

1. Bronchiectasis; post-tuberculosis sequelae; rib cage deformities; neuromuscular disorders; and bronchial carcinoma.
2. Intolerant with NIV

Primary outcomes:
measure: Asynchrony index
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Guangdong
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University.
Study officials:
References:
Clinical trial NCT06003517: Retrospective Study on Perioperative Safety and Quality Control Based on Real World Data
Official title: Retrospective Study on Perioperative Safety and Quality Control Based on Real World Data
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perioperative Complication
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Perioperative patients with anesthesia electronic records that can analysis the patient safety incident.

Brief summary: Based on the data from the anesthesia record electronic system, patient safety incident (PSI) electronic reporting system and related PSI retrospective cohort in the past 10 years, this project intends to carry out structured and consistent (real world data)RWD processing, and conduct (real world evidence)RWE research related to perioperative safety and quality control in order to characterize the epidemiology of perioperative PSIs, explore the related factors, and construct a prediction model, and on the basis of which to construct a standardized platform for reporting and analysis of perioperative PSIs based on RWD. On this basis, a standardized platform for PSI reporting and analysis was constructed based on RWD.


Eligibility criteria: Inclusion Criteria:

* perioperative patients with anesthesia electronic records.
* aged more than 18 years old.

Exclusion Criteria:

* data incomplete
* data missing

Primary outcomes:
measure: Occurrence of PSI
timeFrame: Perioperative period, from the beginning of the surgery to 7 days after the surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Anesthesiology, Peking Union Medical College Hospital
state: Beijing
Study officials:
References: