louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01546545: Insulin Variance Throughout the Day
Official title: Testing Whether Insulin Resistance Varies Throughout a Day A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin Sensitivity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Jenny Craig, Inc.
First posted: 2012-03-07
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy participants with blood sugar between normal and diabetes.

Brief summary: This study is designed to determine whether the sensitivity of a participant's insulin varies from the morning to the evening.

Detailed description: Study visit 1: about 16 hours - The participant will arrive to the visit fasting.

The participant will have an oral glucose tolerance test which takes about 3 ½ hours.

An IV line will be placed in the participant's arm vein for blood draw purposes and will remain there throughout the testing. A blood sample will be drawn 15 minutes and just before the participant will drink a sugar solution consisting of 75 grams of glucose. Blood will be drawn at specific times after the participant consumes the drink.

The participant will have a second oral glucose tolerance test which takes about 3 ½ hours. An IV line will be placed in the participant's arm vein for blood draw purposes and will remain there throughout the testing. A blood sample will be drawn 15 minutes and just before the participant drinks a sugar solution. Blood will be drawn at specific times after the participant consumes the drink.

Eligibility criteria: Inclusion Criteria:

* Are a healthy male or female
* Have a fasting blood sugar that is between normal and diabetes.
* Are between 18 and 70 years of age, inclusive.

Exclusion Criteria:

* Are pregnant or breast-feeding a child
* Take a medication for diabetes
* Take a medication like cortisone that can change your blood sugar.
* Take a medication chronically that has not been at a stable dose for at least 1 month
* Take medication for psychosis that is known to change timing in the day - night cycle

Primary outcomes:
measure: Difference in Glucose Tolerance Between Morning at 7:00 AM and Evening at 7:00 PM
timeFrame: 24 hours
measure: Difference Between Morning at 7:00 AM and Evening at 7:00 PM 2-hour AUC Insulin Levels During an OGTT
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Jeffrey Gimble, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03128645: The Effect of the Abdominal Corset on Colonoscopy
Official title: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy
Complete Colonoscopy
Cecum Intubation Time
İleum Intubation Time
Lead sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2017-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who were remotely applying to our clinic and planned for colonoscopy according to ASGE colonoscopy indications.

Brief summary: In patients with central obesity, the effect of the abdominal corset on colonoscopy completeness, cecum and ileum intubation time will be investigated.


Eligibility criteria: Inclusion Criteria:

* Above 18 years, Meeting the central obesity criteria Cases where colonoscopy is performed under elective conditions

Exclusion Criteria:

* In case of emergency, The process is terminated due to bad bowel preparation, Inflammatory bowel disease, Serious arrhythmia, Chronic obstructive pulmonary disease Coronary artery disease The previous abdominal surgery

Primary outcomes:
measure: Central Obesity
timeFrame: 01/04/2017- 01/06/2017
measure: Cecum intubation time
timeFrame: 01/04/2017- 01/06/2017
measure: İleum intubation time
timeFrame: 01/04/2017- 01/06/2017
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kartal Kosuyolu Yuksek Ihtisas Education and Research
Study officials:
References:
Clinical trial NCT03185845: The Appropriate Anticoagulation Duration for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism
Official title: The Appropriate Anticoagulation Duration for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism-- A National Multicenter, Prospective, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD Exacerbation
PTE - Pulmonary Thromboembolism
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 392
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anticoagulation is the most important treatment for pulmonary thromboembolism (PTE). The thromboembolism risk is especially high in patients with chronic obstructive pulmonary disease (COPD) exacerbations. However, there's no agreement on the most appropriate duration of anticoagulation in COPD with PTE to balance the risk of recurrence of thrombosis and bleeding. This randomized, controlled trial aims to evaluate the risk and benefit of prolonged anticoagulation compared with the regular 3-month anticoagulation in COPD with PTE.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients due to chronic obstructive pulmonary disease exacerbation and diagnosed as newly developed pulmonary thromboembolism
* Regular anticoagulation for 3 months and got CT pulmonary angiography

Exclusion Criteria:

* Patients with major bleeding during prior anticoagulation
* Patients need long term anticoagulation to treat other diseases
* Patients unwilling to receive prolonged anticoagulation

Primary outcomes:
measure: Venous thromboembolism recurrence
timeFrame: 3 years
Secondary outcomes:
measure: Chronic obstructive pulmonary disease exacerbations
timeFrame: 3 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04304547: Clinical Study to Evauate the Pharmacokinetic Profiles and Safety of CKD-348 in Healthy Volunteers
Official title: Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-03-11
Enrollment: 15
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D097 and D337 in healthy adult volunteers


Eligibility criteria: Inclusion Criteria:

1. 19 ≤ age ≤ 45
2. Health Volunteers
3. Subject who agreeds to participate in this clinical trial voluntarily

Exclusion Criteria:

1. Subject who cannot participate in a clinical trial based on the PI's judgment

Primary outcomes:
measure: Cmax
timeFrame: 0 hour ~ 144 hr
measure: AUCt
timeFrame: 0 hour ~ 144 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jae Yong Chung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01790347: Physical Exercise Controls Gestational Weight Gain
Official title: The Role of a Supervised Physical Exercise Program as a Alternative on the Control of Maternal Gestational Weight Gain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Exercise
Aerobic
Resistance training
Pregnancy
Maternal weight gain
IOM recommendations
Lead sponsor: Technical University of Madrid
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 2350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: An estimated two-thirds to three- quarters of women experience gestational weight gain outside of IOM's 2009 recommendations: 40-60% of women experiencing excessive gain and 15-30% inadequate gain. Not gaining the adequate weight gain is strongly associated with several maternal and fetal complications..

Detailed description: The aim of this study was to assess the role of a supervised exercise programme on the control of maternal gestational weight gain and its consequences.

Eligibility criteria: Inclusion Criteria:

* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
* Being able to communicate in spanish

Exclusion Criteria:

* Obstetrician complications
* Being interested in the study after 18 weeks
* Not being regular in physical exercise program
* Younger than 18 years old

Primary outcomes:
measure: Maternal gestational weight gain
timeFrame: 40-42 weeks
Secondary outcomes:
measure: Maternal gestational diabetes
timeFrame: From 24 to 26 week
measure: Fetal body mass index
timeFrame: 38-42 weeks
Other outcomes:
measure: Gestational age
timeFrame: 36-42 weeks
measure: Fetal outcome
timeFrame: 36-42 weeks
Locations:
city: Madrid
country: Spain
facility: Universidad Politécnica de Madrid
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Ruben Barakat, PhD
role: STUDY_DIRECTOR
References:
citation: Ruiz JR, Perales M, Pelaez M, Lopez C, Lucia A, Barakat R. Supervised exercise-based intervention to prevent excessive gestational weight gain: a randomized controlled trial. Mayo Clin Proc. 2013 Dec;88(12):1388-97. doi: 10.1016/j.mayocp.2013.07.020.
Clinical trial NCT05348447: Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection
Official title: Randomized Trial of Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cryotherapy Effect
Pain, Postoperative
Keywords: pulmonary
resection
cryotherapy
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
Collaborators: name: AtriCure, Inc.
First posted: 2022-04-27
Enrollment: 110
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: This is a research study designed to test whether a treatment called Intercostal Nerve Cryotherapy is an effective way to help control post-surgical pain for patients undergoing minimally invasive pulmonary resection.

There are two treatment groups in this study, a cryotherapy group and control group. Cryotherapy is a method of controlling pain by freezing nerves between the ribs that would transmit pain impulses to the brain.


Eligibility criteria: Inclusion Criteria:

1. Patients 18 year and older.
2. Undergoing elective minimally invasive (VATS or robotic) lung resection for nodules (wedge resection, segmentectomy, lobectomy).
3. Performance status of 1 or 2.

Exclusion Criteria:

1. Patients with ejection fraction less than 40%
2. Patients with creatinine greater than 1.5.
3. Patients with Child's B or C cirrhosis
4. Patients on chronic narcotics for other reasons
5. Patients diagnosed with fibromyalgia
6. Patients who had previous thoracic surgery on the same side.
7. Patients who cannot communicate in English.
8. Patients unable to provide informed consent for the study.

Primary outcomes:
measure: Total morphine dose
timeFrame: to discharge (up to 14 days)
measure: Pain control
timeFrame: to discharge (up to 14 days)
Secondary outcomes:
measure: pulmonary complications
timeFrame: through 1 year
measure: pain control
timeFrame: 2 weeks and 3 months post-operatively
measure: total morphine equivalent dose of narcotics
timeFrame: 2 weeks and 3 months post-operatively
measure: Presence of neuropathy in the surgical site
timeFrame: 2 weeks, 3 months, 6 months and 1 year postoperatively
measure: Incentive Spirometer Volume
timeFrame: to discharge (up to 14 days)
measure: Hospital length of stay
timeFrame: to discharge (up to 14 days)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: AHN Allegheny General Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02518347: Strawberries and Knee Osteoarthritis (OA)
Official title: Effects of Freeze-dried Strawberries on Systemic Markers of Inflammation and Knee Function in Participants With Osteoarthritis (OA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
Collaborators: name: University of Oklahoma
First posted: 2015-08-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The proposed study aims to examine the hypothesis that strawberry supplementation will lower serum biomarkers of inflammation and improve knee function in patients with symptomatic osteoarthritis (OA).

Detailed description: The investigators propose the following two specific aims in a randomized crossover placebo-controlled trial in participants with two or more features of the metabolic syndrome and symptomatic osteoarthritis in this 12-week efficacy study:

Aim 1: To assess the effects of strawberries on biomarkers of inflammation \[serum levels of C-reactive protein: CRP; inflammatory cytokines: interleukin-6: IL-6; interleukin 1β: IL-1β; tumor necrosis factor-alpha: TNFα\] Aim 2: To assess the effects of strawberries on knee function as assessed by overall musculoskeletal examination and pain score (ICOAP, KOOS and HAQ-DI).

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of knee osteoarthritis
* Must have waist circumference \>35 inches for women and \>40 inches for men

Exclusion Criteria:

* Cancer
* Heart disease
* Smoking
* Berry allergy

Primary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: six months
measure: Inflammatory Biomarkers in Serum
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Stillwater
country: United States
facility: Oklahoma State University
state: Oklahoma
Study officials:
affiliation: Oklahoma State University
name: ARPITA BASU, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02433847: Effect of Mosapride on Gut Transit in Patients With Chronic Constipation or Constipated Irritable Bowel Syndrome and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Constipated Irritable Bowel Syndrome
Chronic Constipation
Healthy
Keywords: mosapride
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Effect of mosapride 30mg/day on the small bowel and colon transit time in patients with chronic constipation or constipated irritable bowel syndrome.


Eligibility criteria: Inclusion Criteria:

* Functional constipation or constipated irritable bowel syndrome patients according to Rome III criteria

Exclusion Criteria:

* Intolerable or hypersensitive to mosapride
* Known Parkinson's ds
* Cardio- or cerebrovascular disease within 3 months
* Malignancy requiring surgery or chemotherapy or radiation within 5 years
* History of GI surgeries except hernia repair, appendectomy, primary closure due to perforation
* Refractory diabetes mellitus/hypertension/thyroid diseases
* Symptomatic heart failure, renal failure, arrhythmia

Primary outcomes:
measure: colonic transit time
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02604147: Inspiratory Muscle Training in Wheelchair Basketball Players
Official title: Inspiratory Muscle Training in Wheelchair Basketball Players: Effects on Physical Performance and Cardiopulmonary Variables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Muscles
Breathing Exercises
Athletic Performance
Athletes
Aerobic Capacity
Lead sponsor: Universidade Metodista de Piracicaba
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigate the effects of Inspiratory Muscle Training on the physical performance and cardiorespiratory variables of wheelchair basketball players.

Detailed description: The respiratory system has been touted as a limiting factor of physical performance during high intense physical exercises. This limitation is related, among other things, with the fatigue of respiratory muscles. The fatigue of these muscles during physical exercise generates many physiological reflex activation culminating in reduced blood flow to the limb muscles, resulting in decrease in muscle performance. Researchers showed that the inspiratory muscle training (IMT) is able to generate improved of athlete's physical performance. However, when it comes to wheelchair athletes there are still divergent views on the effects of IMT on the physical performance. Thus, this study aims to evaluate the effects of IMT on the physical performance and cardiorespiratory variables of wheelchair basketball players. For this purpose, the investigators will select 40 wheelchair basketball players of both genders. The participants will be allocated blindly and randomly into two groups that differ by the proposed interventions. In IMT Group, the participants will be submitted to a IMT program with inicial load of 50% of maximal inspiratory pressure (MIP); the SHAM Group will be submitted to a simulated IMT with load of 15% of MIP. All participants will pass through the same evaluation procedures before and after the interventions, so that the investagators can evaluate the benefits generated by the IMT on the physical performance and cardiorespiratory variables of wheelchair basketball players.

Eligibility criteria: Inclusion Criteria:

* training wheelchair basketball for more than one year.

Exclusion Criteria:

* cardiovascular or respiratory disease.
* motor or cognitive impairments that influencing the results of evaluations.
* smoking.

Primary outcomes:
measure: Aerobic Capacity
timeFrame: 3 months
Secondary outcomes:
measure: Pulmonary Function
timeFrame: 3 months
measure: Respiratory Muscle Strength
timeFrame: 3 months
measure: Thoracic mobility
timeFrame: 3 months
measure: Heart rate variability
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06180447: Peri-conceptional or Pregnancy Exposure of Vaccination and the Risk of Adverse Pregnancy Outcomes
Official title: Peri-conceptional or Pregnancy Exposure of Vaccination and the Risk of Adverse Pregnancy Outcomes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vaccine Adverse Reaction
Keywords: Vaccine
birth defect
adverse pregnancy outcomes
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 150000
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For women who are pregnant during the study period, the exposed population is pregnant women who have been vaccinated during the study period.

Brief summary: Uing data from a population based cohort in China, we will conduct retrospective cohort study to evaluate the risk of vaccine (e.g., HPV/influenza/rabies vaccine) administered during pregnancy (especially during first trimester) for adverse pregnancy outcomes (e.g., birth defects, preterm birth and low birth weight)

Detailed description: We will develop a vaccination cohort by linking population-based pregnancy registries (i.e., REPRESENT) with population-based vaccine databases.

The researchers will use data from this cohort to examine vaccine use 90 days before the last menstrual period and throughout pregnancy. This study will investigate whether maternal vaccination during pregnancy is associated with the risk of adverse pregnancy outcomes. Poisson regression based on propensity scores will be used to estimate the relative risk. To ensure the robustness of the results, the researchers will perform several sensitivity analyses and negative control analyses, such as the risk of adverse pregnancy outcomes in pregnant women who have been vaccinated several times and pregnant women who have been vaccinated in mid and late pregnancy as negative control groups.

Eligibility criteria: Inclusion Criteria:

* All pregnant women in Xiamen who registry in our database.

Exclusion Criteria:

* Pregnant women who were lost to follow-up. Pregnant women exposed to related factors of known congenital malformation.

Primary outcomes:
measure: Birth defects
timeFrame: From pregnancy to 42 days after delivery
Secondary outcomes:
measure: Incidence of Adverse pregnancy outcomes
timeFrame: From pregnancy to 42 days after delivery
Other outcomes:
Locations:
city: Chengdu
country: China
facility: The West China Hospital of Sichuan university
state: Sichuan
Study officials:
affiliation: Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University
name: Xin Sun, PhD
role: STUDY_CHAIR
References: