louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06102187: Cohort Study in Fujian Province
Official title: Fujian Cohort Study of cARdiomEtabolic Disease and Comorbidity(Fu-CARE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Disease
Keywords: Cardiovascular and metabolic disease comorbidity
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
Collaborators: name: Center for Disease Control and Prevention, Fujian
name: China National Center for Cardiovascular Diseases
First posted: 2023-10-26
Enrollment: 150000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 150,000 adult China aged 35 to 74 who have lived in urban or rural areas of Fuzhou, Putian, Quanzhou, Nanping, Xiamen, Zhangzhou, Longyan, Sanming and Ningde in Fujian Province for more than 6 months without cardiovascular disease history and major disability.

Brief summary: In this study, Chinese residents aged 35 to 75 years old were recruited from Fujian Province. Physical examination, questionnaire survey and biological sample collection were performed at baseline, and at least 4 years of follow-up were conducted. Information on newly discovered cardiovascular metabolic illnesses and comorbidities was collected during follow-up, and repeated surveys similar to baseline were conducted. To explore the relationship between environment, diet and lifestyle and the risk of cardiovascular metabolic diseases and concomitant disorders.


Eligibility criteria: Inclusion Criteria:

* Aged 35-75, having lived in Fuzhou, Putian, Quanzhou, Nanping, Xiamen, Zhangzhou, Longyan, Sanming, or Ningde in Fujian Province for more than 6 months.

Exclusion Criteria:

* Anyone diagnosed with coronary heart disease, stroke, or cancer.
* Anyone with a severe disability who is unable to participate in the study.

Primary outcomes:
measure: Coronary Disease
timeFrame: 5 years
Secondary outcomes:
measure: other metabolic diseases
timeFrame: 5 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT00004487: Phase III Study of Chondrocyte Alginate Gel Suspension in Pediatric Patients With Vesicoureteral Reflux
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Vesicoureteral Reflux
Keywords: rare disease
renal and genitourinary disorders
vesicoureteral reflux
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
Collaborators: name: Curis, Inc.
First posted: 1999-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine the safety and efficacy of chondrocyte alginate gel suspension in pediatric patients with vesicoureteral reflux.

II. Determine the long term efficacy of this treatment regimen in this patient population.

III. Evaluate the short and long term avoidance of surgery or antibiotic therapy after this treatment regimen in this patient population.

IV. Estimate the risk:benefit ratio of this treatment regimen in these patients.

Detailed description: PROTOCOL OUTLINE: This is a multicenter study. Patients undergo biopsy of the auricular cartilage for chondrocytes during cystoscopic evaluation on day 1. Chondrocyte alginate gel suspension is injected into the submucosa of the bladder at the vesicoureteral junction between days 40-50. Patients found to have post treatment reflux may be retreated once.

Patients are followed at 1, 3, and 12 months.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Confirmed grade 3 or 4 reflux in at least one ureter by voiding cystourethrogram Breakthrough urinary tract infection despite standard antibiotic therapy OR Persistent reflux unlikely to resolve spontaneously
* Grade 3: 2 year reflux duration OR 1 breakthrough infection Grade 4: 1 year reflux duration OR 1 breakthrough infection
* Coexisting grade 1 or 2 reflux OR Resolved reflux (i.e., contralateral to the existing grade 3 or 4 refluxing ureter) allowed
* No reflux secondary to obstruction or neuropathic disease
* No gross urological abnormalities (e.g., megaureter requiring ureteral tapering or duplicity of ureters)

--Prior/Concurrent Therapy--

* Surgery: No prior surgery for correction of reflux No recent prior urological device implantation

--Patient Characteristics--

* Hematopoietic: No history of bleeding disorders
* Cardiovascular: No history of hypertension or cardiac disease
* Pulmonary: No history of pulmonary disease
* Other: No known allergies to contrast dyes, iodine, or shellfish No contraindications to general anesthesia No prior infections (other than UTIs) No immunodeficiencies No metabolic disease No social situation that would interfere with follow up Not pregnant Negative pregnancy test

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Curis, Inc.
name: Frank T. Gentile
role: STUDY_CHAIR
References:
Clinical trial NCT02594787: The Effect of Phosphorus on Diet Induced Thermogenesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Imbalance of Constituents of Food Intake
Healthy
Lead sponsor: Lebanese American University
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The aim of the trial is to investigate the effect of ingestion of 75g of glucose (with or without phosphorus) on diet induced thermogenesis (using indirect calorimetry) and appetite (using visual analogue scales) in lean and obese healthy subjects


Eligibility criteria: Inclusion Criteria:

* Healthy
* Sedentary lifestyle
* Stable weight for the past 3 months
* On a balanced diet

Exclusion Criteria:

* Underweight (BMI\<18.5) or overweight/obese (BMI≥25)
* age \<18 or \> 30 years
* Inability to give valid consent
* Presence of a chronic or acute illness.
* Elevated physical activity level (assesses by the physical activity questionnaire)
* Heavy smokers (≥1 pack per day).
* Weight gain or loss of \> 3% in the past 3 months
* History of kidney stones

Primary outcomes:
measure: Diet Induced Thermogenesis
timeFrame: 180 minutes (measured every 30 min)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lebanese American University
name: Maya Bassil, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04578587: Reliability of Hand Held Dynamometer for Assessing Isometric Lumbar Muscle Strength in Asymptomatic Healthy Population
Official title: Reliability of Hand Held Dynamometer for Assessing Isometric Lumbar Muscle Strength in Asymptomatic Healthy Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Reliability
Lumbar region
Muscle strength dynamometer
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To determine intra-rater and inter-rater reliability of hand held dynamometer for assessing isometric lumbar

Detailed description: After being informed about the study and potential risks, all participants given informed consent underwent a 1-week screening period to determine eligibility for study entry. Two raters assessed isometric strength of lumbar flexor and extensor muscles, by a hand-held dynamometer. Strength was measured and recorded by each of the two raters and re-assessed after a week.

Eligibility criteria: Inclusion Criteria:

* age between twenty one to twenty five years

Exclusion Criteria:

* subjects with the history of acute, subacute or chronic low back pain, history of trauma, neurological disorders, spinal surgery, lumbar spine pathology were excluded.

Primary outcomes:
measure: Hand held dynamometer
timeFrame: 2 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Lahore
state: Punjab
Study officials:
References:
Clinical trial NCT00688987: The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight Regulation
Official title: Cortisol, Central Obesity, and Insulin Resistance: Long Term Studies in Addison's Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Addison's Disease
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2008-06-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Replacing glucocorticoid in a dose dependent manner (including doses within the physiological range) to subjects with adrenal insufficiency will increase visceral fat accumulation independently of total fat mass.

Detailed description: To measure total fat mass by DEXA scan, central (visceral) fat accumulation, insulin sensitivity by FSIVGTT, lipid levels, and adipocyte gene expression in subjects with AI receiving increasing doses of hydrocortisone replacement (15 mg, 25 mg, and 40 mg per day in split doses) for 4-months at a time during ad-lib feeding.

Eligibility criteria: Inclusion Criteria:

* Subjects with complete adrenal failure as defined as spontaneous serum cortisol of levels less than 5 g/dl after 12 hours without glucocorticoid replacement and peak serum cortisol of \< 5 g/dl 60 minutes after a 250 g ACTH stimulation test.
* Subjects who are at their usual weight (weight stable for at least 1 year)
* Subjects on stable replacement doses of any required hormone such as thyroid, sex hormones, mineralocorticoid replacement, growth hormone, and hydrocortisone for at least 6 months, and 4) have a normal body weight (BMI 19-27 kg/m2).

Exclusion Criteria:

* Possible confounders on body weight and insulin resistance
* Age less than 18 to exclude those who might be experiencing alterations in cortisol production or weight as a result of adolescent growth.
* Subjects who exercise \> 30 minutes/day, 3 times a week.
* Smokers.
* Heavy alcohol drinkers (\> 2 drinks/ day).
* Subjects with medical diagnosis including diabetes, heart disease, and cancer.
* Subjects with psychiatric illness (i.e., depression, psychosis, bipolar, schizophrenia; or are taking medications for these disorders).

Primary outcomes:
measure: Amounts of intra-abdominal fat and total fat at the end of the treatment period for each cortisol dose.
timeFrame: After 4 months on each dose
Secondary outcomes:
measure: Fasting Lipid levels, fat mass by DEXA, post-heparin lipase activity, insulin sensitivity, and fat biopsy
timeFrame: After 4-months on each dose
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
Clinical trial NCT02402387: The Influence of Head and Neck Position on the Oropharyngeal Leak Pressure Using Air-Q SP Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate the changes of the oropharyngeal leak pressure of the air-Q self-pressurizing masked laryngeal airway in the different head and neck positions. Moreover, the adequacy of ventilation will be assessed in the different head and neck positions.


Eligibility criteria: Inclusion Criteria:

* adult patients aged over 20 yrs who are scheduled for surgery under general anesthesia

Exclusion Criteria:

* anticipated difficult intubation
* body mass index more than 30 km/m2
* history of gastroesophageal reflux disease
* history of esophageal operation
* cervical spine disease
* mass in the oral cavity or neck

Primary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
Secondary outcomes:
measure: Peak airway pressure
timeFrame: Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
measure: Fiberoptic bronchoscope grade
timeFrame: Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: Kim HJ, Lee K, Bai S, Kim MH, Oh E, Yoo YC. Influence of head and neck position on ventilation using the air-Q(R) SP airway in anaesthetized paralysed patients: a prospective randomized crossover study. Br J Anaesth. 2017 Mar 1;118(3):452-457. doi: 10.1093/bja/aew448.
Clinical trial NCT00336687: Study of Incidence, of Mechanisms and Prognosis of the Thrombopenia From Patients of Reanimation.
Official title: Study of Incidence, of Mechanisms and Prognosis of the Thrombopenia From Patients of Reanimation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombopenia
Keywords: Thrombopenia
Reanimation
Thrombopenia in reanimation
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Moulins Hospital
name: Centre Hospitalier Universitaire de Saint Etienne
name: LA ROCHE SUR YON HOSPITAL
First posted: 2006-06-14
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of Reanimation

Brief summary: About 40 % of the patients in reanimation are thrombopenics and the causes are not well known (reduction in platelet's production, increase in their destruction...). This protocol studies the epidemiology of thrombopenia for these patients and the impacts of cost and mortality in order to bring patients best medical cares.

Detailed description: About 40 % of the patients in reanimation are thrombopenics and the causes are not well known (reduction in platelet's production, increase in their destruction...). This protocol studies the epidemiology of thrombopenia for these patients and the impacts of cost and mortality in order to bring patients best medical cares.

Eligibility criteria: Inclusion Criteria:

* Thrombopenia in reanimation

Exclusion Criteria:

* Pregnancy
* Contraindication of myelogram

Primary outcomes:
measure: Epidemiology of Thrombopenia and its consequences.
timeFrame: in reanimation
Secondary outcomes:
measure: The impact of cost and mortality of Thrombopenia in reanimation.
timeFrame: in reanimation
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
state: Auvergne
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Fabrice Thiolliere, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01376687: Osteopathic Manipulative Medicine and Kinetics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Spine
Keywords: Osteopathic Medicine
Cervical Spine
Kinetics
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2011-06-20
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HEalthy and no pain in cervical spine Pain of 3 or greater in cervical spine

Brief summary: Back pain affects the majority of the population at some time. Currently there are no published and scientifically accepted objective measures to support manual medicine diagnostic and treatment techniques for back pain. The purpose of this project is to collect and evaluate objective (pressure and motion) data from standard clinical diagnostic tests.


Eligibility criteria: Inclusion Criteria:

* HEalthy and no pain in cervical spine
* Pain of 3 or greater in cervical spine

Exclusion Criteria:

* pain of less than 3 in the cervical spine region
* pregnant

Primary outcomes:
measure: Feasibility of obtaining force data during clinical assessment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
References:
Clinical trial NCT00540787: A Comparison of Antiarrhythmic Drug Therapy and Radio Frequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation
Official title: A Randomized Comparison of the Efficacy of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation for the Maintenance of Sinus Rhythm In Patients With Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-08
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Paroxysmal atrial fibrillation for at least 6 months with at least 2 symptomatic episodes (patient history) during the previous month
* Atrial fibrillation (patient history or echocardiogram documented) resistant to at least one antiarrhythmic drug of Class I or III
* Documentation of at least one episode of atrial fibrillation on 12-lead echocardiogram or Holter Monitor

Exclusion Criteria:

* Contraindications to more than 2 antiarrhythmic drugs of different classes, or to oral anticoagulants
* History of any previous ablation for atrial fibrillation
* Intracardiac thrombus
* Atrial fibrillation due to reversible cause
* Pregnancy
* Contraindication to stopping oral anticoagulation (for example as a result of a mechanical cardiac valve)

Primary outcomes:
measure: Recurrence of Atrial Fibrillation
timeFrame: One year
Secondary outcomes:
measure: Efficacy of ablation and drug treatment
timeFrame: One year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Columbus
country: United States
facility: Mid-Ohio Cardiology
state: Ohio
city: Pessac
country: France
facility: Hôpital Haut Lèvêque
state: Paris
city: Paris
country: France
facility: Hopital Lariboisiere
city: Geneva
country: Switzerland
facility: Hopital Cantonal de Geneve
Study officials:
affiliation: Hôpital Haut Lèvêque
name: Pierre Jais, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jais P, Cauchemez B, Macle L, Daoud E, Khairy P, Subbiah R, Hocini M, Extramiana F, Sacher F, Bordachar P, Klein G, Weerasooriya R, Clementy J, Haissaguerre M. Catheter ablation versus antiarrhythmic drugs for atrial fibrillation: the A4 study. Circulation. 2008 Dec 9;118(24):2498-505. doi: 10.1161/CIRCULATIONAHA.108.772582. Epub 2008 Nov 24.
Clinical trial NCT06736587: A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Clinical Tiral in Healthy Male Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose, Dose-escalation Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP212525 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Autoimmune Diseases
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2024-12-16
Enrollment: 76
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The safety and tolerability of single and multiple administration of DWP212525

Detailed description: The safety and tolerability of single and multiple administration of DWP212525 will be evaluated in healthy adult male volunteers.

Eligibility criteria: Inclusion Criteria:

1. Healthy adult male volunteers aged 19 to 55 years, Caucasian
2. Those with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 30.0 kg/m2
3. Received a sufficient explanation on this study
4. Eligible as subjects in the study

Exclusion Criteria:

1. History of diseases such as clinically significant disease of hepatobiliary
2. Following conditions applicable to clinically significant acute or chronic infections or the past history confirmed via an interview
3. Hemato-oncologic diseases, including malignant tumor diagnosis
4. Past history of tuberculosis infection or confirmed tuberculosis in the IGRA test and chest X-ray test

Primary outcomes:
measure: Concentration of DWP212525 and metabolite M16
timeFrame: Day 1 0 hour (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72hours post-dose
measure: Concentration of DWP212525 and metabolite M16
timeFrame: Day 1 0 hour (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72hours post-dose
measure: Concentration of DWP212525 and metabolite M16
timeFrame: Day 1 0 hour (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72hours post-dose
measure: Concentration of DWP212525 and metabolite M16
timeFrame: Day 1 0 hour (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72hours post-dose
measure: Concentration of DWP212525 and metabolite M16
timeFrame: Day 1 0 hour (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72hours post-dose
measure: Concentration of DWP212525 and metabolite M16
timeFrame: Day 1 0 hour (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: