louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02565472: Effects of Juice on Gastrointestinal Tolerance and Breath Hydrogen Response in Human Subjects
Official title: Effect of a White Grape Juice Compared to Apple Juice on Gastrointestinal Tolerance and Breath Hydrogen Response in Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Selection
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The goal of this study is to determine subjective gastrointestinal tolerance response and differences in breath hydrogen response following the consumption of two types of juice. This double-blind crossover study requires participants to arrive to the lab 12 hours fasted, consume 12 oz of juice and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen analysis at various time points over the next 3 hours. Subjects will be asked to complete additional questionnaires at 12 and 24 hours post consumption, from home. Subjects will also be asked to keep a food record for 24 hours prior to their scheduled visit times to assure compliance.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-65 Body mass index between 18-29 kg/m2 Demonstrates spoken and written English literacy and able to provide written, informed consent after review of study protocol and procedures

Exclusion Criteria:

* • Use of enemas, laxatives, proton pump inhibitors, or antibiotics within the past 3 months

  * Smoker
  * Not a regular breakfast or eater
  * Self-reported history of a past or current gastrointestinal disease
  * High fiber eater (≥3 servings of high fiber foods per day)
  * Concurrent or recent (within 30 days) participation in an intervention trial
  * Recent weight fluctuations
  * Allergies to any of the test products

Primary outcomes:
measure: Change in gastrointestinal tolerance from baseline
timeFrame: 24 hours
Secondary outcomes:
measure: Change in Breath Hydrogen from baseline
timeFrame: 2 hours
Other outcomes:
Locations:
city: St Paul
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT06174272: Transitional Care Program for Fluid Overload in Cirrhosis
Official title: Transitional Care Program vs Standard of Care in Cirrhosis With Volume Overload: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cirrhosis, Liver
Keywords: ascites
anasarca
edema
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 20
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 goal of this clinical trial is to learn about an intensive monitoring plan (transitional care program) in patients with cirrhosis and excessive swelling that are going to be discharged from the hospital.

The main question\[s\] it aims to answer are:

* How much time and what resources are needed to run such a program
* How well do patients follow up with the phone calls, bloodwork, and doctor appointments?
* Do the patients enrolled in the program have less need for hospitalization later, less kidney injury, better fluid control, and/or better survival compared to patients that are not in the program?

Participants will

* Be given a digital scale and a binder with educational material and a log to monitor their weights after discharge from the hospital
* Receive a phone call from the study team within 72 hours of discharge and weekly
* Be given a follow up appointment with hepatology within 4 weeks of discharge

Researchers will compare participants in this program to patients that receive normal care to see if there are differences in need for hospitalization later, kidney injury, fluid control, and/or survival.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years of age.
* Inpatient at Penn State Health, Milton S. Hershey Medical Center.
* Diagnosis of cirrhosis.
* Hospitalized with fluid overload (ascites and/or significant anasarca/edema) requiring diuretic therapy.
* English speaking

Exclusion Criteria:

* Placement of a TIPS.
* Ascites from an etiology other than cirrhosis, such as malignancy, heart failure, pancreatitis, nephrotic syndrome.
* Non-English speaking

Primary outcomes:
measure: feasibility of the program
timeFrame: all 8 weeks of each participant
measure: Number of instances of weight monitoring
timeFrame: 8 weeks for each participant
measure: Number of successful phone calls
timeFrame: 8 weeks for each participant
measure: Number of follow up visits
timeFrame: 8 weeks for each participant
Secondary outcomes:
measure: Number of Hospitalizations per participant
timeFrame: 12 months
measure: Number of subjects that develop Acute Kidney Injury
timeFrame: 12 months
measure: Number of subjects that continue to have volume overload
timeFrame: 12 months
measure: Number of subjects that expire
timeFrame: 12 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Karen L Krok, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00092872: A 1-Year Study of an Investigational Drug in Obese Patients (0557-012)(COMPLETED)
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of MK0557 in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 359
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: This is a 1-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients after a very low calorie diet.


Eligibility criteria: Inclusion Criteria:

* Obese men and nonpregnant women between the ages of 18 and 65 years with a body mass index (height to weight ratio) as required by the study.

Exclusion Criteria:

* Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)

Primary outcomes:
measure: Body weight after 1 year of treatment.
timeFrame: After 1 year of treatment
measure: Safety and tolerability.
timeFrame: After 1 year of treatment
Secondary outcomes:
measure: Waist circumference; Blood pressure, body fat mass, biochemical markers (fasting plasma, lipid profile, fasting plasma glucose, leptin, insulin, insulin sensitivity); body weight after 2 years
timeFrame: After 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Erondu N, Gantz I, Musser B, Suryawanshi S, Mallick M, Addy C, Cote J, Bray G, Fujioka K, Bays H, Hollander P, Sanabria-Bohorquez SM, Eng W, Langstrom B, Hargreaves RJ, Burns HD, Kanatani A, Fukami T, MacNeil DJ, Gottesdiener KM, Amatruda JM, Kaufman KD, Heymsfield SB. Neuropeptide Y5 receptor antagonism does not induce clinically meaningful weight loss in overweight and obese adults. Cell Metab. 2006 Oct;4(4):275-82. doi: 10.1016/j.cmet.2006.08.002.
Clinical trial NCT02506972: Effect of Serving Size and Addition of Sugar on the Glycemic Response Elicited by Oatmeal
Official title: Effect of Varying Amounts of β-glucan and Sucrose in Oatmeal on Glycemic Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Blood glucose
Humans
Postprandial
Sugar
Carbohydrate
Oat beta-glucan
Lead sponsor: Glycemic Index Laboratories, Inc
Sponsor class: INDUSTRY
Collaborators: name: PepsiCo Global R&D
name: Applied Statistics and Consulting
First posted: 2015-07-23
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to determine the impact of serving size and the addition of sugar on the glycemic response elicited by oatmeal compared to that elicited by cream of rice cereal.


Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) 20.0 - 34.9 kg/m²

Exclusion Criteria:

* known to have diabetes
* use of medications considered by the principal investigator to influence glycemic responses

Primary outcomes:
measure: Incremental area under the blood glucose response curve
timeFrame: For 2 hours after consuming each test meal
Secondary outcomes:
measure: Peak rise of blood glucose
timeFrame: During 2 hour period after consuming each test meal
measure: Time to peak
timeFrame: During 2 hour period after consuming each test meal
measure: Mean rate of decline in blood glucose
timeFrame: During 2 hour period after consuming each test meal
measure: Maximum rate of decline in blood glucose
timeFrame: During 2 hour period after consuming each test meal
measure: Time to baseline
timeFrame: During 2 hour period after consuming each test meal
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Glycemic Index Laboratories, Inc.
state: Ontario
Study officials:
affiliation: Glycemic Index Laboratories, Inc
name: Thomas MS Wolever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolever TMS, van Klinken BJ, Spruill SE, Jenkins AL, Chu Y, Harkness L. Effect of serving size and addition of sugar on the glycemic response elicited by oatmeal: A randomized, cross-over study. Clin Nutr ESPEN. 2016 Dec;16:48-54. doi: 10.1016/j.clnesp.2016.07.003. Epub 2016 Sep 1.
Clinical trial NCT00567372: POSTERIOR SUB-TENON'S Avastin
Official title: POSTERIOR SUB-TENON'S CAPSULE INJECTION OF BEVACIZUMAB FOR TREATMENT OF DIFFUSE DIABETIC MACULAR EDEMA
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Diffuse Diabetic Macular Edema
Keywords: Diffuse diabetic macular edema
sub-tenon
Bevacizumab
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2007-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Posterior sub-tenon's injection of bevacizumab decreased diffuse diabetic macular edema


Eligibility criteria: Inclusion Criteria:

Patients with diffuse diabetic macular edema non-proliferative diabetic retinopathy Maculat thickness ≥250 μ BCVA ≥ 20/400 Without any treatment

Primary outcomes:
measure: macular volume
timeFrame: baseline, 3,6 and 12 weeks
Secondary outcomes:
measure: macular thickness
timeFrame: baseline,3,6 and 12 weeks
measure: best corrected visual acuity
timeFrame: baseline, 3,6 and 12 weeks
Other outcomes:
Locations:
city: Mexico DF
country: Mexico
facility: Asociación para Evitar la Ceguera en Mexico
state: DF
Study officials:
affiliation: Asociación para Evitar la Ceguera en Mexico
name: Sandra Vera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Denver Health Medical Center
name: Hugo Quiroz-Mercado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asociación para Evitar la Ceguera en Mexico
name: Adai Pérez-Montesinos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06742372: Effects of Combined Exercise Training Modality
Official title: Effects of Combined Exercise Training Modality on Diaphragm Function and Performance
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Individuals (Controls)
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-12-19
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: This study aims to investigate the effects of combined Inspiratory Muscle Training and aerobic exercise on diaphragm and pulmonary functions, respiratory muscle function, performance, and body composition


Eligibility criteria: Inclusion Criteria:aged between 18 and 40 years who have physical activity levels above 600 MET-min/week -

Exclusion Criteria:Individuals who were diagnosed with any cardiopulmonary or other chronic diseases, have any infections or limitations preventing them from doing an activity during assessment or intervention, do exercise regularly, and have smoked over 10 pack-years

-

Primary outcomes:
measure: Respiratory muscle strength
timeFrame: First day
measure: diaphragm thickness
timeFrame: Second day
measure: diaphragm stiffness
timeFrame: Second day
Secondary outcomes:
measure: Inspiratory muscle endurance
timeFrame: First day
measure: FEV1
timeFrame: First day
measure: FVC
timeFrame: First day
measure: FEV1/FVC
timeFrame: First day
measure: PEF
timeFrame: First day
measure: FEF2575
timeFrame: First day
measure: Running Based Anaerobic Sprint Test (RAST test)
timeFrame: Second day
Other outcomes:
Locations:
city: Amasya
country: Turkey
facility: Amasya University
Study officials:
References:
Clinical trial NCT01810172: Digital Air Leak Monitoring for Patients Undergoing Lung Resection
Official title: Digital Air Leak Monitoring for Patients Undergoing Lung Resection: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumothorax
Atelectasis
Keywords: lobectomy
segmentectomy
pneumothorax
pleural
digital
air leak
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 216
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: Often the decision for chest tube removal or trial of chest tube clamping is based on subjective assessment. This can lead to delay in chest tube removal. Recently, monitoring and recording of air leaks has been done using digital pleural drainage devices. This provides us with objective and continuous recording of air leaks as well as changes in pleural pressure. Our hypothesis is that the use of the ATMOS digital pleural drainage system will result in shorter hospital stay in comparison to traditional pleural drainage systems.

Detailed description: Technology has become a driving force in surgery. From robotics to digital monitoring of oxygen saturation, it has revolutionized the way we care for patients. However, new technology comes at a cost to our healthcare system. It is therefore important to ensure that new devices actually improve outcomes. One example of this is minimally invasive surgery, which decreases morbidity to patients and reduces length of hospital stay. Unfortunately, despite this advance in lung surgery, delays in discharge from hospital are still prevalent due to prolonged air leaks. Many intra-operative methods have been explored in order to limit this issue with underwhelming success. This is why we are proposing a randomized controlled trial comparing a digital pleural collection system by ATMOS to traditional pleural collection devices by Atrium.

Our research question is: Can the use of a digital air leak monitoring system decrease hospital stay in patients undergoing anatomical lung resection when compared to traditional pleural drainage systems?

Eligibility criteria: Inclusion Criteria:

* Patients 18 or older
* Patients undergoing a lobectomy or segmentectomy

Exclusion Criteria:

* Patients under the age of 18
* Patients undergoing pneumonectomy, wedge resection or bullectomy
* Patients who require additional procedures to control intraoperative air leak
* Patients who require mechanical ventilation post-operatively

Primary outcomes:
measure: length of hospital stay
timeFrame: one year
Secondary outcomes:
measure: duration of chest tube insertion
timeFrame: one year
Other outcomes:
measure: post chest tube removal complications
timeFrame: one year
Locations:
city: Halifax
country: Canada
facility: Capital Health District Authority
state: Nova Scotia
Study officials:
affiliation: CDHA
name: Madelaine M Plourde, MD,MSc,FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03444272: Effect of Direct-acting Antiviral Drugs on Erectile Function
Official title: Effect of Direct-acting Antiviral Drugs on Erectile Function Among Hepatitis c Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatitis C
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Benha University
First posted: 2018-02-23
Enrollment: 105
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: Effect of direct-acting antiviral drugs on erectile function

Detailed description: Effect of direct-acting antiviral drugs on erectile function in HCV patients

Eligibility criteria: Inclusion Criteria:

* HCV infected patients
* Male

Exclusion Criteria:

* HCC
* Age below 18 years

Primary outcomes:
measure: Number of patients with improved erectile functions
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Tanta University
name: Sherief Abd-Elsalam, MD
role: STUDY_CHAIR
affiliation: Tanta University Faculty of medicine
name: Mohamed Alhefnawy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University
name: Khaled Almekaty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05450172: Impact of Postoperative Transitional Pain on Recovery After Thoracic Surgery
Official title: Impact of Postoperative Transitional Pain on Recovery After Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Recovery
Keywords: Postoperative transitional pain
postoperative pain trajectory
postoperative neuropathic pain
thoracic surgery
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2022-07-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for thoracic surgery (thoracotomy or video-assisted thoracic surgery or surgery for thoracic outlet syndrome).

Brief summary: Postoperative transitional pain corresponds to the pain occuring between acute postoperative pain and chronic postsurgical pain (defined as pain persisting for at least 3 months after surgery). We hypothesized that both trajectory and neuropathic component of transitional pain may influence the quality of recovery after thoracic surgery. To test this, we designed an observational study to identify risk factors for incomplete recovery assessed through the QoR-15 questionnaire.


Eligibility criteria: Inclusion Criteria:

* adult patients
* patients scheduled for thoracic surgery (thoracotomy or video-assisted thoracic surgery or surgery for thoracic outlet syndrome)
* patients who do not object to the study

Exclusion Criteria:

* patients non francophone
* emergency surgery or revision surgery
* patients already included in the study during the previous 6 months

Primary outcomes:
measure: Impact of pain trajectory and neuropathic component of pain on quality of recovery.
timeFrame: 3 months after surgery.
Secondary outcomes:
measure: Description of trajectory and neuropathic component of postoperative transitional pain.
timeFrame: Between postoperative day 2 and 3 months after surgery.
measure: Impact of the type of surgery on quality of recovery.
timeFrame: 3 months after surgery.
measure: Impact of pain trajectory, neuropathic component of pain and type of surgery on chronic postsurgical pain prevalence.
timeFrame: 3 and 6 months after surgery.
measure: Predictive accuracy of neuropathic pain trajectory on incomplete recovery and chronic postsurgical pain prevalence.
timeFrame: 3 and 6 months after surgery.
measure: Correlation between neuropathic componente of chronic postsurgical pain and quality of recovery.
timeFrame: 3 and 6 months after surgery.
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU
Study officials:
References:
Clinical trial NCT06202768: Role of the Intrapartum Grobman Nomogram in the Indication of Attempted Vaginal Delivery After Cesarean Section
Official title: Role of the Intrapartum Grobman Nomogram in the Indication of Attempted Vaginal Delivery After Cesarean Section
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vaginal Delivery
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 800
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population of women who gave birth at the Nancy maternity ward and met the inclusion criteria, from January 2014 to January 2021.

Brief summary: The rate of pregnant patients with a history of cesarean section is increasing. Caesarean section is a surgery which is not without risk and in particular concerning the risk of uterine rupture and malplacentation during a new pregnancy.

Considering the outcome of a new birth following a cesarean section is not easy. There is no reliable score to predict the success rate of vaginal delivery with a history of scarred uterus. The aim of our study would be to validate the intrapartum Grobman nomogram within the population of the Nancy University Hospital and thus to target the population for whom vaginal delivery could be offered.


Eligibility criteria: Inclusion Criteria:

* Vertex singleton pregnancy
* Full-term delivery (beyond 37 weeks)
* A history of cesarean section (segmental transverse scar)

Exclusion Criteria:

* Fetal death in utero

Primary outcomes:
measure: Modified Grobman score
timeFrame: per-partum, 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternity
Study officials:
affiliation: Hospital, Nancy, France
name: Charlotte COTTEZ
role: STUDY_DIRECTOR
References: