louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01340456: Cholesterol Metabolites as Markers for CYP3A Induction
Official title: Induction of Drug Metabolism by Rifampicin to Compare the Endogenous Biomarker 4beta-OHcholesterol With the Probe Drug Midazolam as Quantitative Markers for Cytochrome P450 3A4 Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CYP3A4 Induction
Keywords: 4beta-OHcholesterol
Midazolam
CYP3A4
Enzyme induction
Drug metabolism
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2011-04-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The objectives of this study are:

* To investigate if the endogenous cholesterol metabolite, 4beta-OHcholesterol could be used as a marker for induction of cytochrome P450 (CYP) 3A4.
* To compare 4beta-OHcholesterol with midazolam as a marker for induction of CYP3A4.


Eligibility criteria: Inclusion Criteria:

1. Females and males.
2. Age of 18 and above.
3. Caucasians.
4. Healthy as assessed by medical history and examination by principal investigator or delegated personnel.
5. Accept to refrain from herbal drugs, natural preparations, and grapefruit juice 48 hours before and during the study period.
6. Accept to completely refrain from alcohol during day -1 to 1 and R14-R16. During the rest of the study moderate alcohol use is permitted (equal to 1 glass of wine or 1 beer per day).
7. Women of childbearing age should accept using a reliable barrier contraceptive method throughout the study.
8. Women of childbearing age should have a negative pregnancy test at the screening visit.
9. Capable of following given instructions.
10. Has given written informed consent after receiving both oral and written study information.

Exclusion Criteria:

1. Predisposal to allergic drug reactions.
2. Anamnestic and/or visual signs of infection.
3. Women are not allowed to use oral hormone-based contraceptives 2 weeks before start of study and during the study.
4. Participation in another study within one month before entering the present study.
5. Intake of any other drug that can influence the enzyme activity of CYP3A4.
6. Pregnancy.
7. Breast-feeding.
8. A history of liver disease.

Primary outcomes:
measure: Change in 4beta-OHcholesterol
timeFrame: Directly before treatment with rifampicin and 14 days after the end of treatment with rifampicin
Secondary outcomes:
measure: Ratio between midazolam AUC induced and midazolam AUC uninduced
timeFrame: Before treatment with rifampicin and after 14 days of treatment with rifampicin
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Clinical Pharmacology Trial Unit (CPTU), Karolinska University Hospital
Study officials:
affiliation: Department of Clinical Pharmacology, Karolinska University Hospital
name: Tobias Bäckström, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01881256: The BabyGrow Longitudinal Study of Nutrition and Growth in Preterm Infants
Official title: The BabyGrow Longitudinal Study of Nutrition and Growth in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth of Newborn
Malnutrition; Intrauterine or Fetal, Small-for-dates
Keywords: Preterm birth
Parenteral and enteral nutrition
Body composition in preterm infants
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: Cork University Hospital
First posted: 2013-06-19
Enrollment: 70
Sex: ALL
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants admitted to Cork University Maternity Hospital Neonatal Unit

Brief summary: This is a longitudinal, observational study on nutrition, growth and body composition in preterm infants. Aims to determine the adequacy of actual nutrient intake during the preterm period by investigating associations between macronutrient supply, growth, and body composition at 34-weeks gestation, term equivalent and 2-month corrected gestational age.

Detailed description: Infants between 23 and 24 weeks gestation and with a birth weight of 500 to 1500 g are recruited to a longitudinal, observational study of nutrition, growth and body composition in Cork University Maternity Hospital, Ireland.

Eligibility criteria: Inclusion Criteria:

* Babies with a birth weight ≤1.5kg and gestational age ≤34 weeks were considered eligible.

Exclusion Criteria:

* presence of congenital abnormalities or conditions that interfere with growth or body composition (congenital diseases, chromosomal abnormalities, chronic lung disease, cardiac or gastrointestinal diseases).

Primary outcomes:
measure: Actual nutrient intake vs recommended nutrient requirements in preterm infants
timeFrame: 19 months
Secondary outcomes:
measure: Longitudinal data on body composition in Irish preterm neonates
timeFrame: 19 months
measure: Longitudinal data on vitamin D intake and circulating 25(OH)D
timeFrame: 19 months
Other outcomes:
Locations:
Study officials:
affiliation: University College Cork
name: Mairead E Kiely, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04689256: Pilot Randomized Controlled Study of the Impact of MedRhythms' MR-010 in Acute Stroke
Official title: Pilot Randomized Controlled Study of the Impact of MedRhythms' MR-010 in Acute Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke, Acute
Keywords: rehabilitation
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: MedRhythms, Inc.
First posted: 2020-12-30
Enrollment: 4
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: The purpose of this clinical pilot study is to evaluate the effects of the MR-010 on tolerability, biomechanics and walking speed in the acute stroke care setting in addition to its impact on length of stay.


Eligibility criteria: Inclusion Criteria:

* Must be 18 years of age or older.
* Must be able to read and speak English fluently.
* Be within 24 hours from admission for confirmed stroke event.
* Currently able to walk at a speed greater or equal to 0.4m/s, but less than 1.0m/s, as determined by a 10-meter walk test for comfortable walking speed (the average of three trials).
* Demonstrates some level of asymmetry in gait.
* Is expected to be discharged from the acute care setting requiring physical therapy per standard of care and participant has verbally committed to receiving at least one therapy session.
* Able and willing to consent with proposed study schema (verbal commitment), including consent to participate in communication with the treating clinician (as needed) during the study period.
* Score ≤1 on question 1b and a 0 on question 1c on the NIH Stroke Scale.
* Able to safely participate in protocol-defined walking therapy sessions of 30-minute duration as determined by the Investigator.

Exclusion Criteria:

* Participant unable or unwilling to provide informed consent.
* Has a known history of neurologic (excluding stroke) injury.
* Has severe aphasia and/or a speech/language disorder, limiting ability to express needs and comprehend instructions.
* Has an external lower limb prosthetic ("artificial limb").
* Has a hearing impairment.
* Had orthopedic surgery in the last year.
* Has co-morbidities that prevent participation in exercise (for example: musculoskeletal, cardiovascular, pulmonary and neurological - other than stroke).
* Vulnerable populations as deemed inappropriate for study by site Principal Investigator.

Primary outcomes:
measure: Change in Gait Speed (m/s)
timeFrame: 90 days
measure: Adherence to MR-010 Therapy Schedule
timeFrame: 90 days
Secondary outcomes:
measure: Length of Stay
timeFrame: Duration of hospital stay, up to 14 days
measure: Readmission to Hospital
timeFrame: 90 days
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Brian Silver, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03320356: Transcultural Validation of the Oxford Shoulder Score for the French-speaking Population
Official title: Transcultural Validation of the Oxford Shoulder Score for the French-speaking Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Pain
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting inflammatory, degenerative, or post-traumatic shoulder pain and consulting at Orthopaedic Department, Reims Teaching Hospital (France) between November, 2014 and March, 2015.

Brief summary: Degenerative lesions of the shoulder occur very frequently and their incidence increases with age. The Constant-Murley score is currently considered the gold standard in Europe to assess the shoulder and is widely used by the orthopaedic community to follow up on shoulder pathologies. However, healthcare professionals are taking an increasing interest in self-administered patient-reported out-come measures. Several self-administered questionnaires are available to assess the shoulder. Among these questionnaires, the OSS (Oxford Shoulder Score) is considered to be quick, simple, and reliable for the English-speaking population. This score was initially developed at the University of Oxford in 1996. It is a self-administered questionnaire designed to evaluate pain and shoulder function through 12 questions. This score has since been adapted in different languages but not in French.

Detailed description: The aim was to develop a translation and a transcultural adaptation of the OSS and to assess its validity in native French-speaker patients with shoulder pain.

Eligibility criteria: Inclusion Criteria:

* patients receiving chemotherapy for solid tumors in Ambulatory Medicine Unit of the Reims University Hospital (France) between May 14, 2012 and July 31, 2013
* native French speakers

Exclusion Criteria:

* Patients who presented shoulder's instability problems

Primary outcomes:
measure: Acceptability of the French version of the Oxford Shoulder Score
timeFrame: Day 0
measure: Feasibility of the French version of the Oxford Shoulder Score
timeFrame: Day 0
Secondary outcomes:
measure: Convergent validity of the French version of the Oxford Shoulder Score
timeFrame: Day 0
measure: test/retest reliability of the French version of the Oxford Shoulder Score
timeFrame: Day 0
measure: Internal coherence of the French version of the Oxford Shoulder Score
timeFrame: Day 0
Other outcomes:
Locations:
Study officials:
References:
citation: Tuton D, Barbe C, Salmon JH, Drame M, Nerot C, Ohl X. Transcultural validation of the Oxford Shoulder Score for the French-speaking population. Orthop Traumatol Surg Res. 2016 Sep;102(5):555-8. doi: 10.1016/j.otsr.2016.05.010. Epub 2016 Jul 22.
Clinical trial NCT05126056: Lipid Lowering Effect of Plant Stanol Ester in a Drinkable Non-dairy Product
Official title: Lipid Lowering Effect of Plant Stanol Ester in a Drinkable Non-dairy Product
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypercholesterolemia
Lead sponsor: Raisio Group
Sponsor class: INDUSTRY
First posted: 2021-11-18
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to determine the effect of investigational products on serum LDL cholesterol.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Mildly or moderately elevated plasma cholesterol levels (plasma total cholesterol 5.5-8.0 mmol/l)
* Plasma triglyceride levels ≤ 4.0 mmol/l
* Age 18-65 years

Exclusion Criteria:

* Intolerance to oats or other ingredients of the test products
* Severe obesity (BMI ≥ 32 kg/m2)
* Consumption of lipid/cholesterol lowering medication (e.g. ezetimibe, PCSK9 inhibitors, resins, fibrates) 1 month prior to the screening visit and throughout the study. Statin treatment is allowed at stable dose.
* Consumption of plant stanol or plant sterol containing food products or supplements or other foods or supplements such as beta-glucan enriched foods, red rice, berberine or any combination of these used for cholesterol lowering purpose 1 month prior the study entry (baseline blood sample)
* History of malignant diseases like cancer within five years prior to recruitment
* History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months
* Diagnosed type 1 or type 2 diabetes requiring medical treatment
* Celiac disease
* Medically prescribed diet/treatment for slimming or a special diet like very low calorie diet or use of prescribed an obesity drug (e.g. Orlistat, Victoza)
* Alcohol abuse (\> 4 portion/per day) or recreational drug abuse
* Pregnancy or planned pregnancy or lactating
* Clinically significant abnormalities in screening labs
* Participation in another clinical trial in the preceding 3 months

Primary outcomes:
measure: Change in low-density lipoprotein (LDL) cholesterol concentration (%)
timeFrame: 0 vs 3 weeks
Secondary outcomes:
measure: LDL cholesterol concentration
timeFrame: 0 vs 3 weeks
measure: total cholesterol concentration
timeFrame: 0 vs 3 weeks
measure: High density lipoprotein (HDL) cholesterol concentration
timeFrame: 0 vs 3 weeks
measure: non-HDL cholesterol concentration
timeFrame: 0 vs 3 weeks
measure: Total triglyceride concentration
timeFrame: 0 vs 3 weeks
measure: Nuclear magnetic resonance (NMR) blood biomarkers
timeFrame: 0 vs 3 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Nightingale Health plc
Study officials:
affiliation: Helsinki University Hospital, Helsinki, Finland
name: Helena Gylling
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01523756: A Clinical Investigation of New Ostomy Appliances
Official title: An Open-labelled Randomized Cross-over and Controlled Exploratory Investigation Comparing Several Variants of a Newly Developed Ostomy Appliance With Regard to Performance in 20 Patients With Ileostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leakage
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2012-02-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks. During the test a questionaire is to be filled out and interviews will take place. Primary parameter is leakage. A Study nurse will visit the participants in their homes every two week during the test.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years.
2. Have had an ileostomy for more than 3 months.
3. Have used convex products for the last 1 month.
4. Has given written Informed Consent.
5. Have an ileostomy with a diameter between 15 and 33 mm.
6. Have inward peristomal area

Exclusion Criteria:

1. Have loop ostomy
2. Pregnant or breastfeeding.
3. Known allergy towards any of the product components or ingredients.
4. Currently receiving or have within the last 2 months received radio- and/or chemotherapy.
5. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
6. Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)

Primary outcomes:
measure: Leakage Under the Base Plate Using a 24-point Scale
timeFrame: Each product will be tested 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebaek
country: Denmark
facility: Coloplast A/S
Study officials:
References:
Clinical trial NCT04175756: CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery
Official title: CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery. An Observational, Prospective, Post-marketing Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: colorectal cancer
laparoscopic surgery
Seal & Cut
Total Mesorectal Excision (TME)
Partial Mesorectal Excision (PME)
Complete Mesocolic Excision (CME)
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2019-11-25
Enrollment: 61
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: adult patients

Brief summary: This voluntary study is part of a Post-Market-Surveillance plan to proactively collect clinical data for the use of Caiman 5 articulating Maryland in colorectal surgery under daily clinical routine.


Eligibility criteria: Inclusion Criteria:

* Patient´s written informed consent
* Planned laparoscopic colorectal cancer surgery using Caiman 5 articulating Maryland (according to the IfU)
* Age ≥18 years

Exclusion Criteria:

* Emergency surgery
* Pregnancy
* Participation in another surgical study, which might influence the intraoperative process
* Conversion to open surgery
* Conversion to another sealing / cutting instrument (instead of Caiman 5 articulating Maryland)

Primary outcomes:
measure: Total operative time
timeFrame: intraoperatively
Secondary outcomes:
measure: Complications
timeFrame: up to 4 months postoperative
measure: Handling characteristics
timeFrame: intraoperative
measure: Estimated intraoperative blood loss
timeFrame: intraoperative
measure: Time needed for TME
timeFrame: Intraoperative
measure: Time needed for PME
timeFrame: Intraoperative
measure: Time needed for CME
timeFrame: Intraoperative
measure: Time needed for right / hepatic colic flexure mobilization
timeFrame: Intraoperative
measure: Time needed for left / splenic colic flexure mobilization
timeFrame: Intraoperative
measure: Stay in intensive care unit postop
timeFrame: up to discharge (approximately 10 days postoperative)
measure: Stay in intermediate care unit stay postop
timeFrame: up to discharge (approximately 10 days postoperative)
measure: First postoperative oral intake
timeFrame: up to discharge (approximately 10 days postoperative)
measure: First postoperative stool
timeFrame: up to discharge (approximately 10 days postoperative)
measure: Quality of excision: M.E.R.C.U.R.Y. criteria
timeFrame: up to discharge (approximately 10 days postoperative)
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Alfried Krupp Krankenhaus Rüttenscheid
Study officials:
affiliation: Alfried Krupp Krankenhaus, 45131 Essen
name: Niedergethmann, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02815956: Tibial Nerve Stimulation and Postoperative Ileus
Official title: InteresT And Mechanisms of Percutaneous Posterior tIbial Nerve Stimulation to Prevent pOstoperative Ileus in ColorectAl Surgery: A Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Ileus
Keywords: percutaneous tibial nerve stimulation
randomized
controlled study
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative ileus (POI) causes patient's discomfort and leads to an increase of cost of management after colorectal surgery because of an increase of the morbidity rate or of the rate of early rehospitalization after discharge.

Enhanced recovery programs allowed a reduction of its rate but 20 to 30% of patients will experiment POI.

A new approach during preoperative era, using mastication or preoperative physical activity, has been proposed to improve postoperative course. This leads to a vagal activation (action especially on upper GI).

Sacral stimulation using percutaneous tibial nerve stimulation (PTNS) has an effect on lower GI.

The aim of this study was to assess the efficacy and the feasibility of PTNS during perioperative course, to prevent POI with respect with placebo.


Eligibility criteria: Inclusion Criteria:

* patients \> 18 years
* elective colectomy or proctectomy
* agreement for the research

Exclusion Criteria:

* chronic inflammatory bowel disease
* irritable bowel disease documented
* history of surgery on oesophagus or stomach
* acetylcholine dysfunction
* enterostoma
* patient holder of pace-maker

Primary outcomes:
measure: delay before solid food tolerance and first stool recovery (expressed in days afters surgery). Day 0 (D0) is the day of surgery.
timeFrame: data collected from 6 hours after the end of surgery to the recovery. This recovery is expected to be between 1 and 6 days after surgery. Recovery will be assessed 3 times a day (7.00 am, 12.00 am, 6.00 pm)
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital Center
Study officials:
affiliation: University Hospital Center of Angers
name: Aurélien Venara, MD
role: PRINCIPAL_INVESTIGATOR
References: