louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00555074: Sodium Tungstate in Obesity
Official title: Efficacy of Oral Sodium Tungstate (200 mg/Day)on Weight Loss in Subjects With Grade I-II Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Fundacio Clinic Barcelona
First posted: 2007-11-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and safety of sodium tungstate versus placebo in patients with obesity (grade I and II).


Eligibility criteria: Inclusion Criteria:

* BMI: 30-39.9 Kg/m2
* In case of male gender, 18 to 65 years old
* In case of female gender, diagnosis of menopause
* Body weight changes \< 3 kg in the last 3 months
* In case of arterial hypertension or dyslipemia, no changes in dose in the last 2 months

Exclusion criteria:

* In case of female gender, absence of menopause
* Evidence of secondary causes of obesity
* Diabetes, type II
* Concomitant treatment with drugs affecting body weight
* Previous surgical intervention of obesity

Primary outcomes:
measure: weight loss
timeFrame: six weeks
Secondary outcomes:
measure: changes in lipids
timeFrame: 6 weeks
measure: changes in caloric intake and in hungry sensation
timeFrame: 6 weeks
measure: resting metabolic rate
timeFrame: 6 weeks
measure: changes in body composition
timeFrame: 6 weeks
measure: adverse events
timeFrame: 6 weeks
measure: changes in hormonal parameters
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospiral Clinic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Josep Vidal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hanzu F, Gomis R, Coves MJ, Viaplana J, Palomo M, Andreu A, Szpunar J, Vidal J. Proof-of-concept trial on the efficacy of sodium tungstate in human obesity. Diabetes Obes Metab. 2010 Nov;12(11):1013-8. doi: 10.1111/j.1463-1326.2010.01293.x.
Clinical trial NCT03508674: Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System
Official title: Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Lead sponsor: Levita Magnetics
Sponsor class: INDUSTRY
First posted: 2018-04-26
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing bariatric procedures

Detailed description: Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in bariatric procedures.

Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* scheduled to undergo bariatric procedure

Exclusion Criteria:

* Am Soc Anesthesiology score of III or IV
* significant comorbidities
* subjects contraindicated for use of magnetic system
* clinical history of impaired coagulation
* hepatic abnormality or anatomical abnormality

Primary outcomes:
measure: Number and Types of Additional Tools Required to Mobilize the Liver During Procedure
timeFrame: During planned bariatric procedure. (approximately 2 hours on a single day.)
measure: Number of Participants With Adverse Events and Device Related Adverse Events
timeFrame: Through 30 days post bariatric procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital La Florida
Study officials:
affiliation: Duke Regional Hospital
name: Dana Portenier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luengas R, Galindo J, Castro M, Marambio A, Watkins G, Rodriguez Del Rey M, Davanzo C, Portenier D, Guerron AD. First prospective clinical trial of reduced incision bariatric procedures using magnetic liver retraction. Surg Obes Relat Dis. 2021 Jan;17(1):147-152. doi: 10.1016/j.soard.2020.08.017. Epub 2020 Aug 26.
Clinical trial NCT03334474: Shnaghai Shengkang Medical Center
Official title: Shnaghai Shengkang Medical Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vascular Diseases
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study population It will be the urban population attached to the Health Center of Shanghai. Using a random sampling stratified by age groups and gender, 300 subjects will be selected in each group (150 males and 150 females), aged 35 to 85 years.

Brief summary: The process of population aging that is occurring in developed societies represents a major challenge for the health system. The aim of this study is to analyze factors that have an influence on early vascular aging (EVA), estimated by carotid-femoral pulse wave velocity (cf-PWV) and Cardio Ankle Vascular Index (CAVI), and to determine differences by gender in a Chinese population.


Eligibility criteria: Inclusion Criteria:

* • Patients aged 35 to 85 years who agree to participate in the study and do not meet any of the exclusion criteria.

Exclusion Criteria:

* • Subjects who are in terminal condition, who cannot travel to the health centers to undergo the corresponding examinations, and those who do not wish to sign the informed consent.

  * Subjects with a history of CVD (ischemic heart disease or stroke, peripheral arterial disease or heart failure), diagnosed renal failure in terminal stages (glomerular filtration rate below 30%), chronic inflammatory disease, or acute inflammatory process in the past three months.
  * Patients treated with estrogens, testosterone, or growth hormone.

Primary outcomes:
measure: Cardio-ankle vascular index
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00004474: Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia
Official title: Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Aplastic Anemia
Keywords: Hematologic Disorders
Rare Disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
First posted: 1999-10-19
Enrollment: 224
Sex: ALL
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Compare outcome, including graft failure, graft versus host disease, and survival of HLA-identical sibling bone marrow transplants for aplastic anemia using cyclophosphamide with or without antithymocyte globulin as a conditioning regimen.

Detailed description: PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive cyclophosphamide IV over 60 minutes on days -5 to -2 with or without antithymocyte globulin IV over 4 hours.

All patients then receive bone marrow over 60-120 minutes on day 0, 36 hours after the last dose of cyclophosphamide.

Patients are followed at day 100, at 6 months, and at 1 year posttransplant.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Severe aplastic anemia with the following criteria:

Hypocellular bone marrow with cellularity less than 20%

At least 2 of the following hematologic abnormalities:

* Neutrophil count no greater than 500/mm3
* Platelet count no greater than 20,000/mm3
* Reticulocyte count no greater than 50,000/mm3

HLA-identical sibling donor available

No clonal cytogenetic abnormalities, paroxysmal nocturnal hemoglobinuria, or myelodysplastic syndrome within 3 months of diagnosis of aplastic anemia

No congenital or constitutional aplastic anemia or Fanconi anemia

--Patient Characteristics--

Hepatic: Bilirubin less than 3 times upper limit of normal (ULN)

Renal: Creatinine less than 2 times ULN

Cardiovascular: Normal cardiac function

Other:

* No uncontrolled infection
* No severe concurrent disease
* HIV negative
* Fertile patients must use effective contraception

Primary outcomes:
measure: Graft failure, graft versus host disease, and survival
timeFrame: Measured at Day 100, Month 6, and Year 1 post-transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Midwest Children's Cancer Center
state: Wisconsin
Study officials:
References:
Clinical trial NCT00232674: Efficacy Study of the Effect of Budesonide on Emphysema
Official title: The Effect of Inhaled Corticosteroids on the Development of Emphysema in Smokers Assessed by Computed Tomography (CT).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 240
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effect of up to 4 years treatment with budesonide on progression of emphysema in patients with Chronic Obstructive Lung Disease.


Eligibility criteria: Inclusion Criteria:

* Clinical Chronic Obstructive Pulmonary Disease diagnosis
* smoker

Exclusion Criteria:

* No exacerbation within the last 30 days
* no long term use of oral corticosteroids

Primary outcomes:
measure: The primary variable in the study was change in lung density measured by Computed Tomography annually.
Secondary outcomes:
measure: Decline in lung Function (FEV1) and exacerbation rate were measured biannually and decline in diffusion capacity (TLCO) annually.
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Astra Zeneca
role: STUDY_DIRECTOR
References:
Clinical trial NCT05960474: Coronary Microvascular Disease (CMD) Registry
Official title: Coronary Microvascular Disease (CMD) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Microvascular Dysfunction
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects to be enrolled in either objective for this registry includes patients, 18 years or older, with coronary microvascular disease.

Brief summary: The purpose of this project is to provide appropriate administrative and technical supports for the warehousing and use of a database of patients with coronary microvascular disease (CMD). This protocol will outline the process for identification and capture of data, storage, as well as data use and sharing internally and externally for research purposes.


Eligibility criteria: Inclusion Criteria:

* Those with Coronary Microvascular Disease

Primary outcomes:
measure: Establish a Registry of CMD patients
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Clinton
country: United States
facility: MedStar Southern Maryland
state: Maryland
Study officials:
References:
Clinical trial NCT06645574: Towards a Health Promotion for Children Engaged in Sport Intensive Practice for a Healthy Adult
Official title: Towards a Health Promotion for Children Engaged in Sport Intensive Practice for a Healthy Adult
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prevention
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This project aims to elucidate the complexities of the preventive approach among young people involved in intensive sports activities, providing valuable recommendations to optimize their physical, mental, and social health both in the present and in the long term. The multidisciplinary skills of a team of researchers in sports science and health will contribute their recognized disciplinary expertise through international publications, as well as solid experience in the demands of elite sports, along with a commitment to transferring innovative knowledge toward a preventive approach to sports training.

The main objective is to determine whether a somatotype aligned with the discipline's expectations protects the athlete in terms of self-perception and, consequently, reduces health-risk behaviors. Secondary objectives will include linking somatotype, growth, psychological changes (self-perception), and the emergence of health-risk behaviors or injuries in these young athletes.


Eligibility criteria: Inclusion Criteria:

* Children aged 8 to 15 years old
* Intensive athletes: that is to say they practice a competitive sporting activity with a number of hours of weekly training greater than their age in years.(For example, a 10 year old child will need to train more than 10 hours per week to be included.)
* Sport at an early age
* Obtaining written and signed informed consent from one of the two parents or the holder of parental authority
* Affiliation to a social security system

Exclusion Criteria: menstruation for more than a year at the time of inclusion

-

Primary outcomes:
measure: Determine whether a somatotype in harmony with the expectations of the discipline protects the athlete in terms of self-perceptions and, consequently, reduces risky behaviors for her health.
timeFrame: 2 times a year for up to 84 months of follow-up
Secondary outcomes:
measure: 1. How does the somatotype of athletes change over time and in response to training? Are these modifications uniform among athletes of the same sex practicing the same sport?
timeFrame: 2 times a year for up to 84 months of follow-up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00727974: Genetic Analysis of Children With Cyclic Vomiting Syndrome (CVS) and Migraines
Official title: Genetic Analysis of Children With Cyclic Vomiting Syndrome and Migraines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vomiting
Migraines
Keywords: Genome Wide Scan (GWS)
Mitochondrial scan
Family trios
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Health System Foundation, Wisconsin
First posted: 2008-08-05
Enrollment: 586
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cyclic vomiting syndrome (CVS) may be the most severe recurrent vomiting disorder in humans. CVS is characterized by a sudden onset of rapid-fire vomiting, usually beginning in the early morning hours or upon wakening. It has a peak vomiting intensity of every 5-10 minutes (6-12 emeses) and episodes last between 2 hours and 10 days. These episodes of acute vomiting occur on average once every 2 to 4 weeks. The child returns to completely normal health between vomiting episodes. Children are diagnosed based on their specific vomiting pattern and a lack of positive findings on laboratory testing.

Brief summary: The purpose of this study is to determine if there are genetic variations that can explain a genetic basis for cyclic vomiting syndrome (CVS).

Detailed description: The purpose of this study is to determine if there are genetic variations that can explain a genetic basis for cyclic vomiting syndrome (CVS), various phenotypes of CVS (e.g. menstrual, Sato, calendar-tied) and migraine headaches (e.g. with aura, without aura, hemiplegic migraine). This information will allow physicians to improve care for patients who have been diagnosed with this disease and to provide their parents with more complete information regarding the cause of this disease. This research is being done because many unanswered questions remain regarding children with CVS.

Eligibility criteria: Inclusion Criteria:

* Subjects age 0-21 years old with CVS (different phenotypes). Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent.

Exclusion Criteria:

* Subjects age \> 22 years old Vomiting is not due to CVS or other related condition

Primary outcomes:
measure: Identify novel genes that contribute to the risk of CVS using genomewide association analysis approach.
timeFrame: 3 years
Secondary outcomes:
measure: Perform genotype-phenotype correlations between genetic profiles and various phenotypes of CVS (e.g. menstrual, Sato, calendar-tied) and migraine headaches (e.g. with aura, without aura, hemiplegic migraine)
timeFrame: 3 years
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wiconsin
name: Katja Kovacic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01738074: Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Randomized
Double-blind
Placebo Control Design
Keywords: rotavirus
trivalent genetic reassortment vaccine
Phase three clinical trials
Lead sponsor: Center for Disease Control and Prevention, Henan Province
Sponsor class: OTHER_GOV
First posted: 2012-11-30
Enrollment: 10020
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Assessment and evaluation the rotavirus gastroenteritis prevention effect and severe rotavirus diarrhea reducing effectiveness of human body, which inoculate trivalent rotavirus genetic reassortment vaccine.


Eligibility criteria: Inclusion Criteria:

* 6 to 13 weeks aged healthy baby;
* Guardian volunteer to participate in the study and sign informed consent;
* have use thermometer as required and the ability to fill in the diary table;
* Subjects guardian can abide by the requirements of clinical research scheme;
* The past has not been vaccinated rotavirus vaccine;
* Normal term eutocia, birth weight up to standard;
* Axillary temperature is 37.0 ℃ or less.

Exclusion Criteria:

* With allergy, convulsion, epilepsy, encephalopathy and spirit history or the family history;
* Be allergy to any ingredients in the vaccine;
* Known immunology function damage or low person;
* Immunosuppressant therapy Accepter;
* Suffering from congenital malformation and developmental disorder;
* Known or suspected also suffer from diseases including: digestive system disease, respiratory system disease, acute infection, mother or I have HIV infection, cardiovascular diseases, malignant tumor during treatment, skin disease;
* Inoculation other vaccine within 7 days.

Primary outcomes:
measure: Antibody titer differences in serum
timeFrame: 4 weeks after full vaccination
measure: Incidence differences of rotavirus diarrhea
timeFrame: 2 years after full vaccination.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02792374: Psychological Profile of Dental Patients
Official title: Psychological Profile of Dental Patients. A Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Indication for Modification of Patient Psychological Status
Keywords: Dental patients
Psychological Profile
Lead sponsor: Talebian, Alireza, M.D.
Sponsor class: INDIV
First posted: 2016-06-07
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who referred to a dental office in Isfahan city, Iran. The chief complaints of them were not the same.

Brief summary: The objective of this descriptive investigation was to evaluate the psychological profile of dental patients in three levels: global level, the dimensional level, and the discrete symptom level and to compare it with a control group.

Detailed description: Many people is afraid of dental treatment specially local anesthesia and do not refer to dental clinics until they are obliged due to dental pain. There are so many articles in the literature about dental phobia and fear of anesthetic injection. Due to these evidences, dental people are supposed to show elevated psychological dimensions such as anxiety, and somatization.

We are going to know which psychological dimensions of dental patients may be elevated when they refer to dental clinics.

Eligibility criteria: Inclusion Criteria:

Must:

be ≥ 18 years old and have high school degree or higher

Exclusion Criteria:

insufficient verbal capacity to comprehend the items of the questionnaire.

Primary outcomes:
measure: Nine psychological dimensions measured using a self-administered scale (SCL-90-R)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cheif
name: Alireza Talebian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eli I, Baht R, Kozlovsky A, Rosenberg M. The complaint of oral malodor: possible psychopathological aspects. Psychosom Med. 1996 Mar-Apr;58(2):156-9. doi: 10.1097/00006842-199603000-00010.