louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02182934: Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Healthy Recreational Sports People
Official title: Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Recreational Sports People: a Double-blind, Placebo Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 26
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: To assess the efficacy of Ginsana in improving hemoglobin re-oxygenation in healthy, recreational sports people and to assess the safety of the product.


Eligibility criteria: Inclusion Criteria:

* Male and female volunteers between 18 and 40 years old
* Females must test negative for pregnancy
* Recreational athletes according to the american college of sports medicine (ACSM) definition
* Familiar with the cycle ergometer exercise methodology
* Written inform consent according to good clinical practice (GCP) and local regulations

Exclusion Criteria:

* Pre treatment and/or concomitant treatment with any drug that any drug that may influence the trial symptomatology
* Alcohol and drug abuse as stated in the clinical trial manual
* Smokers
* Known hypertension
* Known hypercholesterolemia (moderate/severe)
* Female volunteers taking oral or injectable contraceptives
* Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills \[intrauterine devices (IUDs)\]
* Pregnancy and/or lactation
* Liver and/or renal and/or vascular disease
* Relevant allergy or known hypersensitivity to the investigational drug or its excipients
* Participation in another clinical trial within the last 4 weeks before the date of inclusion or concurrent participation in another clinical trial

Primary outcomes:
measure: Baseline-adjusted half-time hemoglobin re-oxygenation
timeFrame: day 84
Secondary outcomes:
measure: Baseline-adjusted half-time hemoglobin re-oxygenation
timeFrame: day 21, 42 and 63
measure: maximum endurance time
timeFrame: day 21, day 42, day 63 and day 84
measure: Change from baseline in respiratory threshold
timeFrame: Baseline, up to day 84
measure: Change from baseline in thiobarbituric acid (TBARS)
timeFrame: Baseline, up to day 84
measure: Change from baseline in glutathione superdismutase/glutathione superdismutase oxidised (GSG/GSSG) ratio
timeFrame: Baseline, up to day 84
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02563834: A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism
Official title: A Novel Positron Emission Tomography (PET) Approach to Measuring Myocardial Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-09-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Studies of myocardial fuel selection using a novel palmitate-based PET probe

Detailed description: A novel Positron Emission Tomography (PET) probe, 16- 18-F-fluoro-4-thiapalmitate, will be used to evaluate myocardial atty acid uptake. Studies will be done in humans with type 2 diabetes mellitus, and in controls. Studies will take place on 2 separate days, under fasting conditions and under insulin clamp conditions.

Eligibility criteria: Inclusion Criteria:

* Lean:

  * BMI\<25 kg/m2
  * normal glucose tolerance by 75g oral glucose tolerance test
* Type 2 diabetes mellitus:

  * BMI \>25 kg/m2
  * previously diagnosed type 2 diabetes mellitus
  * on oral and/or injected insulin treatment.

Exclusion Criteria:

* Lean:

  \*Use of any chronic medications
* Type 2 diabetes mellitus

  * known microvascular disease
  * known coronary or other macro vascular disease
  * use of PPARgamma class antidiabetic agents within 6 months

Primary outcomes:
measure: Myocardial Fatty Acid Uptake Rate
timeFrame: 4 Hours
Secondary outcomes:
measure: Myocardial Oxidation Rate
timeFrame: 4 Hours
measure: Myocardial Perfusion Rate
timeFrame: 4 Hours
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital GCRC
state: Indiana
Study officials:
affiliation: Indiana University
name: Kieren J Mather, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mather KJ, Hutchins GD, Perry K, Territo W, Chisholm R, Acton A, Glick-Wilson B, Considine RV, Moberly S, DeGrado TR. Assessment of myocardial metabolic flexibility and work efficiency in human type 2 diabetes using 16-[18F]fluoro-4-thiapalmitate, a novel PET fatty acid tracer. Am J Physiol Endocrinol Metab. 2016 Mar 15;310(6):E452-60. doi: 10.1152/ajpendo.00437.2015. Epub 2016 Jan 5.
Clinical trial NCT03843034: Endometrial Markers in Autoimmune Diseases
Official title: Endometrial Markers in Women With Autoimmune Diseases Receiving Assisted Reproduction
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Endometrial Receptivity
Fertility
Autoimmune Diseases
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with thyroid diseases, rheumatoid arthritis, inflammatory bowel diseases, multiple sclerosis, diabetes mellitus, and psoriasis will be included in the study Group (Age: 20-40 years old). Healthy women receiving assisted reproduction due to male infertility will be included in the control Group (Age: 20-40 years old).

Brief summary: Autoimmune diseases cause a decreased endometrial receptivity during the implantation window, most likely changing the endometrial cytokines pattern due to dysregulation of the inflammatory processes.Therefore, endometrial cytokine profiles will be compared in women with autoimmune disease and normal, fertile women.

The collected endometrial tissue and blood samples will be examined for the cytokines profiling using commercially available ELISA kits.

The sample size was calculated choosing, as primary outcome, changes in endometrial LIF concentration between the disease and control Group, which is our main goal. Given a type I error of 5%, a maximum of 21 women are needed for each Group to reach the desired power of 80% to detect the least changes in concentrations.


Eligibility criteria: Inclusion Criteria:

Study group:

\* Females with infertility combined with autoimmune disease and in fertility treatment.

Control group:

\* Female from couples with severe male infertility and in fertility treatment.

Exclusion Criteria:

* Language problems to such an extent that the subjects do not understand the scope of the study.
* Abnormal follicle stimulating hormone (FSH),
* Abnormal antral follicles Count
* Genital infections
* Endometriosis
* Tubal occlusion
* Polycystic ovarian syndrome

Primary outcomes:
measure: Endometrial cytokine LIF concentration (pg/ml)
timeFrame: February 18, 2019 - August 31, 2020
Secondary outcomes:
measure: Blood concentration of cytokines such as LIF, IL6, TNFα TGFα (pg/ml)
timeFrame: February 18, 2019 - August 2020
measure: endometrial concentration of cytokines such as, IL6, TNFα TGFα (pg/ml)
timeFrame: February 18, 2019 - August 2020
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital
Study officials:
References:
Clinical trial NCT04273334: Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders
Official title: Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders, Including Lymphedema, Lymphangioma, Lymphangioleiomyomatosis, Plastic Bronchitis, Lymphadenopathy Caused by Rheumatoid Arthritis, Etc.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Lymphatic Disorders
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an open-label whole-body PET/CT study for investigating the value of 68Ga NEB PET imaging in the diagnosis and evaluation of lymphatic disorders including lymphedema, lymphangioma, lymphangioleiomyomatosis, plastic bronchitis, lymphadenopathy caused by rheumatoid arthritis, etc.

Detailed description: No fasting, hydration or other specific preparation was requested on the day of imaging.

Patients for lymphatic drainage disorders imaging underwent whole-body PET/CT acquisitions 20-40 min after subcutaneously injected into first and second interdigital spaces of both feet or hands of 74-111 MBq (2-3 mCi) 68Ga-NEB with each bed position lasted for 2 min.

A MIM workstation was used for post-processing. The visual method was used to evaluate the lymphatic system, including the morphology and the distribution of the lymphatic system. Semiquantitative methods were applied for image analysis.

Eligibility criteria: Inclusion Criteria:

* Must be able to provide a written informed consent; Males and females, ≥18 years old； Diagnostic CT or MRI suggesting a diagnosis of lymphatic system lesion(s). In suspicion of lymphedema, lymphangioma, lymphangioleiomyomatosis, plastic bronchitis, lymphadenopathy caused by rheumatoid arthritis, etc.

Exclusion Criteria:

* Females planning to bear a child recently or with childbearing potential; Known severe allergy or hypersensitivity to IV radiographic contrast； Inability to lie still for the entire imaging time because of cough, pain, etc. Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.

Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.

Primary outcomes:
measure: Standardized uptake value of 68Ga NEB in lymphatic lesion
timeFrame: 1 years
Secondary outcomes:
measure: Adverse events collection
timeFrame: 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Zhaohui Zhu, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06056934: Pain Management in Elderly Patients With or Without Cognitive Frailty Hospitalized "ALGOGER"
Official title: Retrospective Study of Protocol-based Pain Management in Elderly Patients With or Without Cognitive Frailty Hospitalized at UPOG for Fracture of the Upper Extremity of the Femur in 2022
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Deterioration
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 350
Sex: ALL
Minimum age (years): 76
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients hospitalized at UPOG for fracture of the upper end of the femur between January 1 and December 31, 2022.

Brief summary: Today, the standard treatment is to operate on patients suffering from a fracture of the upper end of the femur. The aim of treatment is to enable immediate mobilization and weight-bearing, and as rapid a return as possible to normal living conditions.

Surgery is the best treatment option. It maximizes the chances of functional recovery and, by stabilizing the fracture, reduces pain: it is the most effective and longest-lasting analgesic.

Adequate analgesia in elderly patients with femoral neck fractures has a beneficial effect. In particular, a lower probability of death has been shown in cervical fracture patients receiving opioids than those not receiving them.

Pain management is a matter of protocol in the UPOG department of the CHU de Nîmes.

Pain prevention appears to improve morbidity and mortality. Cognitive fragility, such as neurocognitive disorders, confusion or long-term use of psychotropic drugs, appear to be confounding factors in pain management.

The investigators therefore wished to observe whether the presence of cognitive fragility has an impact on pain management on the ward, despite protocol-based management.


Eligibility criteria: Inclusion Criteria:

* Patients aged \> 75 years
* Hospitalized for a fracture of the upper extremity of the femur at the UPOG of the CHU de Nîmes during 2022

Exclusion Criteria:

* Opioid allergy
* No surgical management of fracture
* Long-term treatment with high-dose opiates
* Patient has objected to the use of his or her data.

Primary outcomes:
measure: Morphine sulfate equivalent rate in each group, mg/day
timeFrame: Pre-operative
measure: Morphine sulfate equivalent rate in each group, mg/day
timeFrame: Early post-operative between Day 0 and Day 3
measure: Morphine sulfate equivalent rate in each group, mg/day
timeFrame: Late post-operative between Day 4 and day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: GAULTIER
state: CHU De Nîmes
Study officials:
References:
Clinical trial NCT01063634: Comparison of a Plastic Stent Without Central Lumen With Self Expandable Metal Stents in Patients With Malignant Distal Biliary Obstruction
Official title: Comparison of a Plastic Stent Without Central Lumen With Self Expandable Metal Stents in Patients With Malignant Distal Biliary Obstruction. A Randomized, Controlled Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: To Evaluate Patency of the Viaduct Stent in Comparison to Metal Stents
Keywords: malignant biliary obstruction
viaduct
self-expandable metal stents
Lead sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH
Sponsor class: OTHER
Collaborators: name: Klinikum Ludwigshafen
name: Universitätsmedizin Mannheim
First posted: 2010-02-05
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with malignant obstruction of the common bile duct

Brief summary: This is a non-inferiority randomized study to compare a plastic stent without central lumen (VIADUCT) with self-expandable metal stents for treatment of malignant obstruction of the common bile duct. It is a non-interventional study, a CE mark for the VIADUCT stent exists.


Eligibility criteria: Inclusion Criteria:

* histologically proven malignant biliary stenosis
* signs of biliary obstruction
* informed consent

Exclusion Criteria:

* age under 18
* Operations like Roux-Y, biliodigestive Anastomosis, BII
* life expectancy less than 3 months
* Karnfosky index less than 60%

Primary outcomes:
Secondary outcomes:
measure: time to stent obstruction
timeFrame: 1 year
Other outcomes:
Locations:
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
Study officials:
References:
citation: Schmidt A, Riecken B, Rische S, Klinger C, Jakobs R, Bechtler M, Kahler G, Dormann A, Caca K. Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study. Endoscopy. 2015 May;47(5):430-6. doi: 10.1055/s-0034-1391232. Epub 2015 Jan 15.
Clinical trial NCT03926234: Effectiveness of a Four-level Chinese Emergency Triage Scale in Mainland China
Official title: The Reliability and Validity of a Four-level Chinese Emergency Triage Scale in Mainland China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Triage
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Beijing Chao Yang Hospital
name: Tongji Hospital
name: Henan Provincial People's Hospital
name: Second Affiliated Hospital of Chongqing Mecical University
name: First People's Hospital of Hangzhou
name: Second People's Hospital of Hangzhou
name: Changxing People's Hospital
First posted: 2019-04-24
Enrollment: 30687
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All eligibility emergency patients

Brief summary: Inter-rater reliability between experts and triage nurses was assessed in 484 emergency patients. The criterion-related validity was evaluated in other 30687 emergency patients, based on emergency department (ED) mortality, the length of stay in ED, the number of discharge, and hospitalization (intensive care/general ward).


Eligibility criteria: Inclusion Criteria:

* Patients, older than 14 years and admitted to the ED, were eligible for this study.

Exclusion Criteria:

* Gynecologic and obstetric emergencies
* Patients, who left against medical advice or hadn't been aided by a doctor

Primary outcomes:
measure: Inter-rater reliability
timeFrame: 2019-10-1
measure: emergency department (ED) mortality
timeFrame: 2019-12-31
measure: the number of discharge
timeFrame: 2019-12-31
Secondary outcomes:
measure: the number of hospitalization
timeFrame: 2019-12-31
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: SAHZhejiangU
Study officials:
References:
Clinical trial NCT01825434: Effect of Yogurt With Polydextrose,L Acidophilus and B Lactis in Chronic Constipation
Official title: Effect of Yogurt Containing Polydextrose, Lactobacillus Acidophilus NCFM and Bifidobacterium Lactis HN019: a Randomized, Double-blind, Controlled Study in Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: chronic constipation
Lactobacillus acidophilus NCFM
Bifidobacterium lactis HN019
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background and aims:Constipation is a frequent complaint and the combination of a prebiotic and probiotics would have a potentially synergic effect on the intestinal transit. The present study therefore aims to investigate the combination of polydextrose (Litesse®), L. acidophilus NCFM® and B. lactis HN019 in a yogurt on intestinal transit in subjects who suffer from constipation.

Methods: Patients with constipation were randomly divided into two groups, Placebo Group (PG) and Treatment Group (TG), and had to eat 180 ml of unflavored yogurt every morning for 14 days. Those in the CG received only yogurt, while the TG received yogurt containing polydextrose, L. acidophilus NCFM® (ATCC 700396) and B. lactis HN019 (AGAL NM97/09513). Expect that patients who took a combination of polydextrose has a decrease in the colonic transit time (CTT) when comparing initial and final transit time.


Eligibility criteria: Inclusion Criteria:

* Patients with chonic constipation
* agachan between 10 and 20
* bowel transit time with ingestion of 24 radiopaque markers (Sitzmarks) and retention of 80% of them on day 5

Exclusion Criteria:

* Patients with hypothyroidism
* antidepressant users
* normal colonic
* transit time (24 hrs or less) as well as higher than 96 hours were

Primary outcomes:
measure: Colonic transit
timeFrame: Colonic transit time and Agachan score will be evaluated before and in day15 aftler yogurt ingestion. All particIpants will be followed for 30 days after the end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: University of Campinas
state: São Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Claudio SR Coy, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT00993434: The Impact of Educational Materials on Family Behavior
Official title: The Impact of Educational Materials on Family Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Child
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2009-10-12
Enrollment: 95
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the research is to learn whether written materials or handouts that are given to parents are helpful in changing knowledge or behavior.

Detailed description: Few written resources for families have been tested in the primary care setting. Kid STRIDE (STRiving to Improve Diet \& Exercise) is an educational booklet designed for parents of overweight children. We hypothesize that this booklet will benefit a small percentage of the overweight and obese population of children as a first-tiered approach to treatment of overweight and obese children.

Eligibility criteria: Inclusion Criteria:

* Children with a BMI greater than or equal to 85% along with a parent.
* All subjects must speak English.

Exclusion Criteria:

* Genetic conditions associated with overweight.
* Endocrine conditions associated with overweight.
* Chronic steroid therapy.
* Current enrollment in a professional weight management program.

Primary outcomes:
measure: Assess the effectiveness of written materials on changing knowledge and behavior regarding diet, exercise, and other weight factors.
timeFrame: 3 months
Secondary outcomes:
measure: Assess the impact of the intervention on height and weight as reflected in a change in BMI z-score.
timeFrame: 3 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: GHC Capitol Pediatric Clinic
state: Wisconsin
city: Madison
country: United States
facility: UW Health East Towne Pediatrics
state: Wisconsin
city: Madison
country: United States
facility: UW Health West Towne Pediatrics
state: Wisconsin
city: Madison
country: United States
facility: UW Health Park Street Pediatrics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Madison Dept of Pediatrics
name: Ellen R Wald, MD
role: PRINCIPAL_INVESTIGATOR
References: