louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00141076: Glycemic Index and CVD: a Crossover Feeding Study
Official title: Glycemic Index, Obesity, Insulin Resistance and CVD Risk, Part 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
glycemic index
insulin resistance
cardiovascular disease
diabetes
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Charles H. Hood Foundation
First posted: 2005-09-01
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study will compare the physiological effects of two isoenergetic, nutrient-controlled diets that differ in glycemic index. The diets will be studied in obese adults in a 10-day crossover feeding trial.

Detailed description: This study will compare the physiological effects of two isoenergetic, nutrient-controlled diets that differ in glycemic index. The diets will be studied in obese male adults in a 10-day crossover feeding trial. Hypothesis: Obese subjects will show improvements in clinical endpoints associated with risk for diabetes and cardiovascular disease (CVD) after consuming a controlled low (compared to high) glycemic index diet for 10 days. 1º endpoint: insulin sensitivity as measured by the modified Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT). 2º endpoints: CVD risk factors; postprandial studies of oxidative stress; thermic effect of food.

Eligibility criteria: Inclusion Criteria:

* age 18 to 35 years
* male
* BMI ≥ 27 ≤45 kg/m2
* willingness to refrain from alcohol and caffeinated beverage consumption for duration of study

Exclusion Criteria:

* major medical illness
* an abnormal screening laboratory test
* taking any prescription medications that might affect body weight
* current smoking (1 cigarette during any of the last 7 days)
* consuming special diets

Primary outcomes:
measure: Insulin sensitivity as measured by FS-IVGTT
Secondary outcomes:
measure: CVD risk factors
measure: Postprandial studies of oxidative stress
measure: Thermic effect of food
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: David S Ludwig, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Diego Botero, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00312676: Compare Tolerability of an Overnight Switch to Gradual Switch Between Two Different Forms of Depakote
Official title: Conversion From Multiple-Daily Dose Enteric-Coated Depakote to Once-Daily Depakote ER in Elderly Outpatients With Epilepsy or Behavioral Disturbances:
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Epilepsy
Behavioral Disturbance
Keywords: Tolerability
Depakote DR
Depakote ER
Elderly
Conversion
Lead sponsor: Veterans Affairs Medical Center, Miami
Sponsor class: FED
Collaborators: name: Abbott
First posted: 2006-04-10
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis is that the characteristics of extended release Depakote will allow overnight conversion of immediate release to extended release form of Depakote. This has been tested successfully in younger patients but not in individuals over the age of 60. We will include individuals between 60 and 80 years old.

Detailed description: Twenty patients will be randomily assigned to convert overnight (10 pts) or over six days (10 pts). Side effects will be formally evaluated by the UKU side effect rating scal which will be done 7 days before conversion (day -7), the day of conversion (day 0)and then at the start of days +2, +7 and +14. This investigator conducting the evaluation will be blinded to the conversion status of the patient. Secondary measures to be obtained will be a Quality of Life measure (QOLIE-89) on Day 0 and +14. Plasma samples will be obtained on Day 0 and +14 before dosing for total and free valproic blood level.

Eligibility criteria: Inclusion Criteria:

* 60 yo and older on stable dose of valproate (Depakote DR)

Exclusion Criteria:

* Unstable neurolgical, medical or psychiatric disorder

Primary outcomes:
measure: Between group comparisons of GI and CNS side effect burden
Secondary outcomes:
measure: Between group comparison of Quality of Life as measured bye the QOLIE-89
measure: Between group comparison of trough Total and Free valproic acid serum levels
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami VA Medical Center
state: Florida
Study officials:
affiliation: Miami Veterans Administration Medical Center
name: R. Eugene Ramsay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02094976: Comparison of Intraabdominal Pressure
Official title: Comparison of Intraabdominal Pressure and Respiratory Parameter Changes According to Positional Apparatus in the Prone Position
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prone Position
Keywords: Prone position
Intra-abdominal pressure
Respiratory system compliance
Jackson table
Wilson frame
Chest roll
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 138
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Increased intra-abdominal pressure(IAP) might influence on perioperative morbidity related to increased CVP, PVWP, SVR, PAP and decreased venous return and cardiac output. Prone position has been known to increase IAP. In clinical field, various apparatuses has developed to minimize IAP elevation during prone position operation.

In this study, we would compare the changes of IAP and respiratory system compliance according to positional apparatus in prone position.

Detailed description: In clinical field, Wison frame, chest rolls and Jackson table have been widely used for prone position surgery. Among those apparatus, Jackson table has padded supports under the chest and pelvis, so that the abdomen can hang freely and prevent the abdominal compression. By reducing abdominal and thoracic pressure, Jackson table would reduce blood loss, and less effects on pulmonary mechanics. But few studies has known to compare IAP with other positioning apparatus such as Wilson frame or chest roll.

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled for prone positioned spinal surgery
* ASA Physical Status Classification System class I or II

Exclusion Criteria:

* Patients who did not agree
* BMI \> 30kg/m2
* Patients who did not insert urinary foley catheter
* Patients who have COPD or emphysema
* Patients who have severe spine deformities such as scoliosis

Primary outcomes:
measure: changes of Intraabdominal presure (IAP)
timeFrame: 5 minute after position change
Secondary outcomes:
measure: Changes of IAP and total respiratory system comliance (Crs) accoridng to PEEP change
timeFrame: 1min after PEEP change
measure: changes of dead space ventilation after position change
timeFrame: 5 minute after prone position
measure: Hemodynamic change
timeFrame: 1min after PEEP change
Other outcomes:
measure: Estimated blood loss (EBL)
timeFrame: intraoperatively
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University of Hospital
Study officials:
affiliation: Professor
name: Hee Pyung Park, MD PhD
role: STUDY_DIRECTOR
affiliation: Clinical Instuctor
name: Eugene Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02269176: Efficacy and Safety of Telmisartan and Losartan in Primary Hypertension
Official title: 12 Week, Multi-center, Randomized, Double-blind, Double Dummy, Parallel Group Trial Comparing the Efficacy and Safety of 40 & 80 mg Telmisartan and 50 & 100 mg Losartan in the Treatment of 150 Pairs of Primary Hypertension Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-21
Enrollment: 330
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using Losartan as a comparator, to evaluate the efficacy and safety of telmisartan in the treatment of the mild to moderate primary hypertension patients in China


Eligibility criteria: Inclusion Criteria:

- Mild to moderate primary hypertension, the mean sitting valley value of diastolic blood pressure (DBP) ≥ 95 and \< 110 mmHg, and the mean sitting valley value of systolic blood pressure (SBP) \< 180 mmHg

Exclusion Criteria:

- Not specified

Primary outcomes:
measure: Changes in mean sitting valley value of DBP
timeFrame: 8 weeks after start of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03263676: Randomized Controlled Crossover Comparison of Icon Underwear to Disposable Pads
Official title: Randomized Controlled Crossover Comparison of Icon Underwear to Disposable Pads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reusable Underwear, Urinary Incontinence, Dispoable Pad
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2017-08-28
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized cross over trial to compare quality of life and product performance between Icon reusable underwear versus standard disposable pad in patients with mild to moderate urinary incontinence.

Detailed description: Urinary incontinence is estimated to affect approximately 1/5 of all women in the United States. Multiple studies have compared effectiveness, cost-effectiveness and comfort of a variety absorbent products but most of the current data compares daily disposable insert pads. Icon reusable underwear is a new product on the market for light incontinence (25-30mL daily). The primary objective of this randomized cross over trial is to compare quality of life and patient comfort and to determine patient preference using Icon reusable underwear versus standard incontinence pad in the management of urinary incontinence. The secondary objective is to compare the cost-effectiveness of ICON underwear to disposable pads. Women with small to moderate urinary incontinence to use either ICON underwear or pads for two days and then crossed over to use other product for two days. The primary outcome measures were Incontinence Quality of Life Instrument 3 (I-QOL) and Product Performance Questionnaire 4 (PPQ) after use of each product. A sample size of 70 was calculated to detect a difference of 10.0 in the I-QOL to achieve a power of 80% with a significance level of 0.05 and to account for a 20% attrition.

Eligibility criteria: Inclusion Criteria:

* Female patients who are at least 18yo
* Mild to moderate urinary incontinence, defined as a response "small" or "moderate" amount to the ICIQ-SF question - "How much do you leak?"

Exclusion Criteria:

* Active urinary tract infection
* Fecal incontinence, defined as a response "large" amount to the ICIQ-SF question - "How much do you leak?"

Primary outcomes:
measure: Incontinence Quality of Life Questionnaire
timeFrame: 2 days
Secondary outcomes:
measure: Product Performance Questionnaire
timeFrame: 2 days
Other outcomes:
Locations:
Study officials:
affiliation: Medstar Health Research Institute
name: Lee Richter
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04063176: Prospective Outpatient Registry of Myocardial Infarction Patients
Official title: Prospective Outpatient Registry of Myocardial Infarction Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: myocardial infarction, registry
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
First posted: 2019-08-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who have undergone AMI and applied no later than 6 months after discharge from the hospital to the outpatient clinic № 9 or its branches from March 1, 2014 to December 31, 2015;

Brief summary: The investigators enrolled 160 patients who visited Moscow state outpatient clinic №9 (and its two branches) within six months after acute myocardial infarction. The enrollment lasted from 01.03.2014 to 01.07.2015. The observation period is five years. During the first year after enrollment in the study, patients had follow-up visits every two months, from second-year every six months. Analysis of the prescribed therapy and its changes was carried out by the cardiologist in the clinic for the entire observation period, taking into account the concomitant diseases /indications/contraindications. Endpoints (the death, repeated cardiovascular complications (AMI, stroke), emergency hospitalization due to worsening of the main cardiovascular disease, the appearance of clinically significant cardiac arrhythmias, invasive interventions) were defined during out-patient visits and telephone contact


Eligibility criteria: Inclusion Criteria:

* patients who have undergone AMI and applied no later than 6 months. after discharge from the hospital to the Moscow outpatient clinic № 9 from March 1, 2014, to December 31, 2015;
* availability of discharge summary with confirmed AMI;
* permanent residence on the territory of Moscow and the Moscow region;
* the signing of informed consent to the processing of personal data.

Exclusion Criteria:

* patients with the absence of discharge summary from the hospital with a proven history of AMI;
* visit the clinic in a period exceeding six months from the AMI;

Primary outcomes:
measure: time to death, recurrent cardiovascular events (AMI, stroke), emergency hospitalization, lifethreatening arrhythmias.
timeFrame: 01.03.2014 - through study completion, an average of 5 year
Secondary outcomes:
measure: Total mortality
timeFrame: 01.03.2014 - through study completion, an average of 5 year
Other outcomes:
Locations:
Study officials:
affiliation: National Research Center for Preventive Medicine
name: Martsevich Yu Sergey, MD, PhD, professor
role: STUDY_CHAIR
affiliation: National Research Center for Preventive Medicine
name: Natalia P Kutishenko
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02874976: Phototherapy Applied in Combination With Aerobic Training
Official title: Phototherapy Applied in Combination With Aerobic Training: Evaluation of Different Irradiation Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Excessive Physical Exercise, Unspecified
Keywords: sedentary lifestyle
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2016-08-22
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Interventional

Detailed description: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care

Eligibility criteria: Inclusion Criteria:

* There were included in the study
* healthy individuals,
* aged between 18 and 35 years old,
* presenting no history of musculoskeletal injury.
* that are not making use of pharmacological agents and / or nutritional supplements, and that have at least 80% of attendance to training.

Exclusion Criteria:

* present some musculoskeletal injury during the study
* cardiac ou pulmonary disease severe

Primary outcomes:
measure: Time until exhaustion
timeFrame: change from baseline in the time until exhaustion at 12 weeks
Secondary outcomes:
measure: Maximum consumption of oxygen VO2
timeFrame: change from baseline in the Maximum consumption of oxygen at 12 weeks
measure: Body fat
timeFrame: change from baseline in the body fat at 12 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Nove de Julho
Study officials:
affiliation: Study Principal Investigator - Universidade Nove de Julho
name: Ernesto Leal-Junior, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT06033976: Endoscopic Submucosal Dissection Registry
Official title: Endoscopic Submucosal Dissection Patients Registry in "Agrippa Ionescu" Hospital, Bucharest, Romania
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neoplasm, Stomach
Neoplasm, Colorectal
Neoplasm, Esophagus
Neoplasm, Duodenal
Lead sponsor: Carol Davila University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed at or referred to Gastroenterology Clinic, University of Medicine and Pharmacy, "Agrippa Ionescu" Hospital, Bucharest, Romania

Brief summary: This is a patient registry for all cases of pre-neoplastic or early neoplastic digestive tract lesions treated with curative intention by endoscopic submucosal dissection (ESD) technique.

Detailed description: Cases will be registered one by one in an electronic record, with the consent of the patient and respecting all legal requirements.

Eligibility criteria: Inclusion Criteria:

* epithelial pre-neoplastic (eg. adenoma, dysplasia) lesion on the esophageal, gastric, duodenal or colorectal mucosa
* non-epithelial (eg. neuroendocrine tumor) lesion on the esophageal, gastric, duodenal or colorectal mucosa
* age \> 18 years old
* informed consent

Exclusion Criteria:

* age \< 18 years old
* no informed consent

Primary outcomes:
measure: Rate of curative resection
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Rate of R0 resection
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Rate of perforation
timeFrame: 30 days
measure: Rate of delayed bleeding
timeFrame: 30 days
Locations:
city: Bucharest
country: Romania
facility: "Agrippa Ionescu" Hospital
Study officials:
affiliation: Carol Davila University of Medicine and Pharmacy
name: Mihai L Ciocirlan, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00189176: Safety Study of Tetrathiomolybdate in Patients With Idiopathic Pulmonary Fibrosis
Official title: Phase I/II Trial of Tetrathiomolybdate (TM) in Patients With Usual Interstitial Pneumonia Refractory to Previous Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Coalition for Pulmonary Fibrosis
First posted: 2005-09-16
Enrollment: 23
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety of the administration of a copper chelating agent, tetrathiomolybdate, for patients with idiopathic pulmonary fibrosis that have failed previous treatment. The primary endpoint for this study is safety with secondary endpoints including change in pulmonary function, exercise capacity, and quality of life.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic pulmonary fibrosis
* Disease progression despite six months of treatment (steroids with/without azathioprine or cyclophosphamide) defined by at least one of the following:

  * Increased symptoms
  * Decline in forced vital capacity of at least 10%
  * Decline in diffusion capacity for carbon monoxide of at least 20%
  * Increased infiltrate on CXR or high resolution CT scan
* Taking \< 15 mg prednisone for at least 30 days prior to screening
* Age 35-80, inclusive
* Able to understand a written informed consent and comply with the study protocol

Exclusion Criteria:

* Significant environmental exposure
* Diagnosis of collagen vascular disease
* Evidence of active infection
* Clinically significant cardiac disease:

  * Myocardial infarction, coronary artery bypass or angioplasty within 6mo
  * Unstable angina pectoris
  * Congestive heart failure requiring hospitalization within 6 months
  * Uncontrolled arrhythmia
* Poorly controlled or severe diabetes mellitus
* Pregnancy or lactation
* Women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm, Norplant)
* Current enrollment in another experimental protocol

Physiologic Criteria:

* FEV1/FVC \< 0.60

Laboratory Criteria:

* Total bilirubin \> 1.5 X upper limit normal
* AST or ALT \> 3X upper limit normal
* Alkaline phosphatase \> 3X upper limit normal
* White blood cell count \< 2,500/mm3
* Hematocrit \< 30%
* Platelets \< 100,000/mm3
* Prothrombin time INR \> 1.5

Primary outcomes:
measure: Safety
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Kevin R Flaherty, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: