louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00585624: Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy
Official title: Preoperative Nutritional Support Reduces Postoperative Stay and Incidence of Complications in Patients Undergoing an Esophagectomy or Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophagectomy
Pancreaticoduodenectomy
Keywords: Esophagectomy
Pancreaticoduodenectomy
Whipple
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2008-01-03
Enrollment: 344
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: We are proposing to evaluate the benefit of preoperative nutritional support with Impact Advanced Recovery in the most vulnerable group of elective gastrointestinal surgery patients who may experience a complication, esophagus and pancreas resections, and hypothesize that oral supplementation with 3 servings (0.75 L) Impact Advanced Recovery will reduce postoperative stay by 10-20% and reduce the incidence of major complications by 25%.


Eligibility criteria: Inclusion Criteria:

1. Male or female age 18 years or older of any race-ethnicity who will undergo an elective esophagectomy or pancreaticoduodenectomy.
2. Surgery will be scheduled 5-7 days after consent date -

Exclusion Criteria:

1. Surgery is urgent or emergent and/or patient would be unable to consume nutritional supplement for 5-7 days
2. Patient is currently receiving enteral (tube) or parenteral (IV) nutritional support
3. Patients with known pre-existing renal failure requiring a low protein diet
4. Patient is unable to drink 3 servings/day of a liquid supplement -

Primary outcomes:
measure: Postoperative stay in days
timeFrame: Postoperative stay in hospital & 30 days
Secondary outcomes:
measure: Incidence of major complications
timeFrame: Postoperative stay in hospital & 30 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin School of Medicine & Public Health
name: Kenneth A Kudsk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00853034: Effects of Arabinoxylan-Oligosaccharides Compared to Other Prebiotics in Healthy Subjects
Official title: Effects of Arabinoxylan-Oligosaccharides on Colonic Metabolism and Microbial Composition Compared to Other Prebiotics in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: gastrointestinal effects
prebiotic
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2009-02-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effects of arabinoxylan-oligosaccharides (AXOS) on the colonic metabolism and microbial composition, and to compare these effects with the reference prebiotic fructo-oligosaccharide enriched inulin.


Eligibility criteria: Inclusion Criteria:

* healthy
* 18-45 years
* regular eating pattern

Exclusion Criteria:

* gastrointestinal complaints
* antibiotic intake
* medication influencing gut transit or microbiota
* abdominal surgery
* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Gastrointestinal Research, Laboratory Digestion and Absorption
Study officials:
affiliation: KU Leuven
name: Kristin Verbeke, PhD
role: STUDY_DIRECTOR
References:
citation: Cloetens L, De Preter V, Swennen K, Broekaert WF, Courtin CM, Delcour JA, Rutgeerts P, Verbeke K. Dose-response effect of arabinoxylooligosaccharides on gastrointestinal motility and on colonic bacterial metabolism in healthy volunteers. J Am Coll Nutr. 2008 Aug;27(4):512-8. doi: 10.1080/07315724.2008.10719733.
Clinical trial NCT02024334: Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis
Official title: Study of Therapeutic Effects and Side Effects of Leflunomide in Methotrexate Refractory Juvenile Idiopathic Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Juvenile Idiopathic Arthritis
Keywords: JIA
LEFLUNOMIDE
EFFICACY
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized double blind clinical trial to assess efficacy of leflunomide in treatment of refractory juvenile idiopathic arthritis.

Patients are randomly divided into two groups. In group 1 leflunomide and in group 2 placebos will be added to conventional treatment for three months. therapeutic responses will be evaluated by ACRpedi (American College of Rheumatology Pediatric) scores every 4 weeks.

Detailed description: 30 Patients(2-19 y) are randomly divided into two groups. In group 1 leflunomide will be added to conventional treatment, 5-20 mg daily based on weight.

In group 2 placebo will be prescribed as same as leflunomide. The course of treatment is 3 months. Every 4 weeks ACRped 30, 50, 70 should be determined to evaluate therapeutic response. Side effects of treatment will be assessed by physical examination and lab tests every 4 weeks.

Eligibility criteria: Inclusion Criteria:

* JIA based on ACR criteria
* age between 2- 19 y
* polyarticular, oligoarticular(\> or = 3 active joints) or extended oligoarticular subtypes
* resistance to conventional treatment

Exclusion Criteria:

* pregnancy
* malignancy
* severe active infection
* other rheumatic diseases or overlap
* ALT(Alanine transaminase) or bilirubin \> 3 folds
* IVIG (Intravenous immunoglobulin) treatment during last 2 weeks
* biologic agents during last 3 months

Primary outcomes:
measure: thirty percent changes in the ACR Pediatric core set of disease activity measures in at least three of the six response variables (ACR Pedi 30)
timeFrame: baseline, week 4, week 8, week 12
Secondary outcomes:
measure: 50% and 70% changes in the ACR Pediatric core set of disease activity measures in at least three of the six response variables (ACR Pedi 30)
timeFrame: baseline, week 4, week 8, week 12
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
state: Khorasan Razavi
Study officials:
affiliation: Rheumatic Diseases Research Center, Ghaem Hospital, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
name: Zahra Rezaieyazdi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06955234: Berbevis Dose-finding Study in Subjects With Impaired Fasting Glucose
Official title: Berbevis Project: Multitarget Dose-finding Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Impaired Fasting Glucose (IFG)
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessing the effects of a nutraceutical supplement (Berbevis™) in adults with impaired fasting glucose (100-126 mg/dL) and BMI between 25 and 35. Ninety participants will be assigned to three parallel groups receiving Berbevis™ at increasing daily doses (500 mg, 750 mg, and 1000 mg) for 2 months.


Eligibility criteria: Inclusion Criteria:

* fasting blood glucose between 100 and 126 mg/dl
* BMI between 25 and 35 kg/m\^2

Exclusion Criteria:

* Fasting blood glucose below 100 mg/dl
* BMI \< 25 or \> 35 kg/m\^2

Primary outcomes:
measure: Change in fasting blood glucose levels from baseline after 4 weeks of Berbevis™ supplementation
timeFrame: 4 weeks
Secondary outcomes:
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs) during 4 weeks of Berbevis™ supplementation at different dosages
timeFrame: 4 weeks
measure: Change from baseline in lipid profile (total cholesterol, HDL, LDL, Apo A, Apo B, triglycerides)
timeFrame: 4 weeks
measure: Change from baseline in fasting blood glucose
timeFrame: 4 weeks
measure: Change from baseline in fasting insulin
timeFrame: 4 weeks
measure: Change from baseline in HOMA-IR index
timeFrame: 4 weeks
measure: Change from baseline in glycated hemoglobin (HbA1c)
timeFrame: 4 weeks
measure: Change from baseline in C-reactive protein (CRP)
timeFrame: 4 weeks
measure: Change from baseline in AST levels
timeFrame: 4 weeks
measure: Change from baseline in ALT levels
timeFrame: 4 weeks
measure: Change from baseline in Gamma-GT levels
timeFrame: 4 weeks
measure: Change from baseline in alkaline phosphatase levels
timeFrame: 4 weeks
measure: Change from baseline in serum protein fractions (protein electrophoresis)
timeFrame: 4 weeks
measure: Change from baseline in lean mass and fat mass assessed by DEXA
timeFrame: 4 weeks
measure: Change from baseline in visceral adipose tissue assessed by DEXA
timeFrame: From may 2025 to may 2026
Other outcomes:
measure: Change from baseline in body weight
timeFrame: 4 weeks
measure: Change from baseline in Body Mass Index (BMI)
timeFrame: 4 weeks
measure: Change from baseline in waist circumference
timeFrame: 4 weeks
Locations:
Study officials:
References:
Clinical trial NCT06275334: Dinutuximab Beta at the HUS and the Toulouse Oncopole
Official title: Dinutuximab Beta at the Strasbourg University Hospitals (HUS) and the Toulouse Oncopole: Comparative Analysis of Patient Pathways, Associated Costs and Quality of Life According to Traditional Hospitalization or Hospital at Home (HAD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuroblastoma
Keywords: Neuroblastoma
Dinutuximab Beta
DNB
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 25
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects aged 2 years to 25 years suffering from neuroblastoma and treated at the HUS or at the Oncopole center in Toulouse during the period from January 1, 1998 to December 31, 2023.

Brief summary: In this study the investigators wish to describe the cohort of pediatric patients suffering from neuroblastoma and treated with Dinutuximab and to compare the costs and quality of life between the two French centers, the University Hospital of Strasbourg (HUS) and the Oncopole of Toulouse.


Eligibility criteria: Inclusion Criteria:

* Subjects aged 2 years to 25 years
* Male or female gender
* Subjects suffering from neuroblastoma and treated at the HUS or at the Oncopole center in Toulouse during the period from January 1, 1998 to December 31, 2023.
* Subject (and/or holders of parental authority) not opposing, after information, the reuse of the child's data for the purposes of this research and agreeing to respond to the quality of life survey.

Exclusion Criteria:

* Patient or parents of the minor having expressed their opposition to participating in the study.
* specific clinical forms of the disease,
* interfering treatments and associated diseases.

Primary outcomes:
measure: Comparison of two methods of treating a pediatric pathology in two French health establishments, the HUS and the Oncopole of Toulouse.
timeFrame: The period concerned is from January 1, 1998 to December 31, 2023.
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pharmacie - Stérilisation - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT03178734: Foley Catheter vs a Self-contained Valved Urinary Catheter
Official title: Foley Catheter vs a Self-contained Valved Urinary Catheter for Patients Who Are Being Discharged Home With a Catheter After Urogynecologic Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter-Related Infections
Urinary Tract Infections
Urogynecologic Surgery
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study aim is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter vs a valved catheter in patients who are being discharged home with a catheter after urogynecologic proecures via a Randomized Clinical Trial.
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial.

Detailed description: The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial. Total number of participants will be 100. Inclusion criteria is all patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter. Exclusion criteria is intra-operative bladder injury during index surgery; intra-operative complication requiring continuous bladder drainage; and/or dementia/altered cognitive function.

Eligibility criteria: Inclusion Criteria:

All patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter.

Exclusion Criteria:

* Intra-operative bladder injury during index surgery
* Intra-operative complication requiring continuous bladder drainage
* Dementia / altered cognitive function

Primary outcomes:
measure: Number of urinary tract infections
timeFrame: Up to 4 weeks after surgery
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Up to 5 days after surgery
measure: Number of days until spontaneous void/Number of calls for device-related issues
timeFrame: Up to 4 weeks after surgery
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Atlantic Urogynecology Associates
state: New Jersey
Study officials:
affiliation: Atlantic Health System
name: Charbel G Salamon, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
Clinical trial NCT00582634: Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer
Official title: Phase II Study of Adjuvant Cisplatin and Docetaxel in Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: non small cell lung cancer
adjuvant
cisplatin
docetaxel
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * To determine if docetaxel and cisplatin can be administered in a dose intense manner in the adjuvant setting in resected non-small cell lung cancer
* To evaluate the time to progression and overall survival
* To evaluate toxicities of this chemotherapy combination in the adjuvant setting
* To correlate XPD and ERCC1 polymorphisms with time to progression and toxicities in patients treated with this regimen


Eligibility criteria: Inclusion Criteria:

* Stage IB to IIIA non-small cell lung cancer completely resected within 4 to 8 weeks of initiating treatment on study
* Performance Status ECOG 0 or 1
* Peripheral neuropathy: \< grade 1
* Adequate blood cell counts
* Adequate liver and hepatic function
* Women of childbearing potential must have a negative pregnancy test.
* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter

Exclusion Criteria:

* Patients with a history of severe hypersensitivity reaction to Docetaxel® or other drugs formulated with polysorbate 80.
* Women who are breast-feeding.
* Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively)
* Uncontrolled cardiac disease or uncontrolled hypertension

Primary outcomes:
measure: Time to progression
timeFrame: 36 months
measure: Overall survival
timeFrame: 36 months
measure: Incidence of adverse events
timeFrame: Baseline to 36 months
Secondary outcomes:
measure: Correlate XPD and ERCC1 polymorphisms with time to progression and toxicities
timeFrame: 36 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Anne Traynor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04941534: This Clinical Study Evaluates the Performance and Safety of Biorithm Research Kit Versus CTG in Prenatal Monitoring of Pregnant Participants.
Official title: AMBulatory Fetal ECG Monitoring in High Risk Pregnancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: antepartum monitoring
Lead sponsor: Biorithm Pte Ltd
Sponsor class: INDUSTRY
First posted: 2021-06-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants would be recruited at the Day Assessment Unit who require CTG monitoring and meet the inclusion criteria

Brief summary: This clinical study will evaluate the safety and comparative performance of Biorithm Research Kit vs CTG (gold standard) in prenatal monitoring of pregnant participants.

Detailed description: The Biorithm Research Kit system used in this study consists of femom fetal monitor (known as fetal monitor), a digital gateway and a cloud storage. It's intended for monitoring of maternal and fetal physiological parameters. It includes non-invasive fetal monitor or device, that monitors fetal heart rate (FHR), maternal heart rate (MHR), and uterine activity (UA) in the antepartum period.

Eligibility criteria: Inclusion Criteria:

* Have a singleton pregnancy
* Should be at and above 28 weeks of pregnancy
* Should have a valid indication for antenatal FHR monitoring as part of their pregnancy management, as per local hospital policy
* Able to speak English or have access to an interpreter and provide Informed Consent

Exclusion Criteria:

* Participants with an intellectual or mental impairment
* Participants with a known allergy or hypersensitivity to ECG gel electrodes
* Participants in pain, with contractions or in labour
* Known fetal cardiac or genetic abnormality
* Participant with a pacemaker

Primary outcomes:
measure: Fetal Heart Rate (FHR)
timeFrame: 60 minutes
measure: Maternal Heart Rate (MHR)
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's University Hospital
Study officials:
affiliation: St-George's University Hospital
name: Baskaran Thilaganathan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05934734: Influence of Thoracic Outlet Syndrome Severity on Upper Extremity Function and Neural Integrity
Official title: The Influence of Thoracic Outlet Syndrome Severity on Upper Extremity Function and Neural Integrity: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Outlet Syndrome
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 100 individuals (n=25 per cohort), aged 18-65 years, diagnosed with thoracic outlet syndrome will be recruited for this study. Participants will be recruited from local physical therapy clinics and physician offices. Participants will be screened for eligibility prior to being enrolled in the study and stratified into one of four cohorts based on the severity of self-reported symptoms using a visual analog scale: mild (scores 1-3), moderate (scores 4-6), severe (scores 7-9) and very severe (score 10). Exclusion criteria include a history of upper extremity surgery or other upper extremity disorders not related to thoracic outlet syndrome. All participants will provide written informed consent prior to participating in the study assessments.

Brief summary: The purpose of this study is to investigate the relationship between the severity of thoracic outlet syndrome and upper extremity function, as well as neural integrity.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Diagnosed with thoracic outlet syndrome
* Willing and able to provide informed consent

Exclusion Criteria:

* History of upper extremity surgery unrelated to thoracic outlet syndrome
* Other upper extremity disorders unrelated to thoracic outlet syndrome

Primary outcomes:
measure: Range of Motion (ROM) of the Shoulder joint
timeFrame: Baseline
measure: Range of Motion (ROM) of the Elbow joint
timeFrame: Baseline
measure: Range of Motion (ROM) of the Wrist joint
timeFrame: Baseline
measure: Isometric Muscle Strength of shoulder
timeFrame: Baseline
measure: Isometric Muscle Strength of elbow
timeFrame: Baseline
measure: Isometric Muscle Strength of wrist
timeFrame: Baseline
measure: Self-reported upper extremity function
timeFrame: Baseline
measure: Nerve Conduction Studies of ulnar nerve
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_DIRECTOR
References: