louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02241681: Medium Chain Triglycerides Plasma Profile and Their Metabolites After Oral Peptamen Intake
Official title: Medium Chain Triglycerides Plasma Profile and Their Metabolites After Oral Peptamen Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Medium Chain Triglycerides
Medium Chain Triglycerides metabolites
Peptamen 1.5
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Medium Chain Triglycerides (MCT) have been used for many years as a good source of lipid to decrease potential for fat malabsorption. However, the pharmacokinetics of MCT and of their metabolites have not been explored in details.

This is an exploratory study aiming at determining the plasma level of MCT and their metabolites after oral intake of Peptamen.

Detailed description: 20 subjects will be given 250mL of peptamen 1.5 twice, with 4 hours of interval, on a single day.

Plasma kinetics of MCTs and their metabolites will be made over 8 hours from baseline

Eligibility criteria: Inclusion Criteria:

* Healthy males and females
* Aged between 20 and 65 years old
* BMI in the normal range (18.5 to 25.0 kg/m2)
* Having signed his/her consent form

Exclusion Criteria:

* Clinically relevant digestive (including malabsorption or major surgery), renal, hepatic, pancreatic or metabolic disease (diabetes, hypo or hyperthyroidism, hypo or hypercorticism), as determined by the medical (screening) visit and a standard blood chemistry analysis (glucose, total cholesterol, ALDL, AHDL, triglycerides, ASAT, ALTI, gamma GT, RCRP, creatinine)
* Medically diagnosed anemia based on a blood formula
* Food allergy, lactose intolerance and intolerance to milk proteins (anamnesis)
* Smokers (anamnesis)
* Pregnancy (anamnesis)
* Under corticoids or hormone (adrenal, thyroid) treatment
* Alcohol intake: \> 2 units a day (anamnesis)
* Consumption of illicit drugs (anamnesis)
* Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
* Subject who cannot be expected to comply with the study procedures, including consuming the test product
* Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study.

Primary outcomes:
measure: Measure of plasma Medium Chain Triglycerides (MCT)
timeFrame: over 8 hours post intake
Secondary outcomes:
measure: Measure of plasma MCT metabolites such as free fatty acids
timeFrame: over 8 hours post intake
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Metabolic unit, clinical Development unit, Nestec
Study officials:
affiliation: Metabolic Unit, Clinical Development Unit,Nestec
name: Maurice Beaumont, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01792895: Different Types of Manual Therapy Techniques in Patients With Chronic Neck Pain
Official title: Is Better the One Type of Manual Therapy Than Others for to Treat the Patients With Chronic Neck Pain? : A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Posterior Neck Pain
Cervical spine pain
Manual therapy
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
Collaborators: name: Universidad Europea de Madrid
First posted: 2013-02-15
Enrollment: 61
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: The purpose of this study was to investigate the comparative effectiveness of high velocity and low amplitude (HVLA)vs Mobilization (Mob) vs Mobilization with movement technique (MWMT) in sample of patients with chronic neck pain (CNP). Secondly to evaluate the immediate effects in range of motion and pain thresholds, and the interaction between psychological factors and the outcomes of these three types of manual therapy.

The hypothesis is that all manual therapies techniques will produce similar effects.

Detailed description: The randomized controlled trial included patients with mechanically reproducible CNP, ≥ age 18-years who are randomized into three groups of treatment. The main outcome measures were the Visual Analogue scale (VAS), and, with secondary measures of Neck Disability Index (NDI), Global Rating Of Change (GROC), Cervical Range Of Motion (CROM), Pressure Pain Threshold (PPT), State Trait Anxiety Inventory (STAI-T), Beck depression Inventory (BDI-II), Tampa Scale for Kinesiophobia, Pain Catastrophizing Scale (PCS).

Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of Chronic neck pain

Exclusion Criteria:

* Neck pain is associated with whiplash injuries.
* Resting blood pressure greater than 140/90 mmHg.
* Cervical radiculopathy.
* Cervical disc herniation.
* Fibromyalgia syndrome.
* Previous neck surgery.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: The Patients will be followed for 12 weeks after treatment
Secondary outcomes:
measure: Neck disability
timeFrame: The Patients will be followed for 12 weeks after treatment
measure: Active Cervical Range of Motion
timeFrame: The Patients will be followed for 12 weeks after treatment
measure: Pressure Pain thresholds (PPTs)
timeFrame: pre-treatment and post-treatment
Other outcomes:
measure: Satisfaction
timeFrame: The Patients will be followed for 12 weeks after treatment
measure: Anxiety
timeFrame: pre-treatment
measure: Depression
timeFrame: pre-treatment
measure: Kinesiophobia
timeFrame: Pre-treatment
measure: Catastrophizing
timeFrame: Pre-Treatment
Locations:
city: Alcorcon
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Universidad Europea de Madrid/Universidad Rey Juan Carlos
name: Josue Fernandez-Carnero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00243581: The Effects of an Intensive Lifestyle Modification Program on Carotid Artery Intima-Media Thickness
Official title: The Effects of an Intensive Lifestyle Modification Program on Carotid Artery Intima-Media Thickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: a Myocardial Infarction
Coronary Artery Bypass Graft Surgery Percutaneous Transluminal Coronary Angioplasty Stent Placement
Lead sponsor: SwedishAmerican Health System
Sponsor class: OTHER
First posted: 2005-10-24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the effect of the Ornish Program on cardiovascular disease as measured by the IMT of the common carotid artery, and to compare this effect to outcomes from patients participating in traditional cardiac rehabilitation.


Eligibility criteria: Inclusion Criteria:

Patients will be accepted into the study if they demonstrate one or more of the following within the previous 12 months: a myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty, stent placement, or rotoblator procedures. Patients will also accepted if they have stable angina as determined by the Rose Questionnaire or pacemaker associated with one or more of the previously mentioned diagnoses. For the purposes of this study, myocardial infarction is defined as the presence of at least two of the following three criteria: continuous chest pain lasting at least 30 minutes; electrocardiogram changes expressing an evolving myocardial infarction (ST segment elevation or depression, evolving Q waves, or symmetric inversion of T waves); or elevated cardiac enzyme levels (at least twice the I levels).

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SwedishAmerican Health System
name: Steven G. Aldana, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03059381: Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adolescence Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures
Official title: Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adolescence Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Partial Seizures (With or Without Secondary Generalized Seizures)
Primary Generalized Tonic-clonic Seizures
Keywords: adolescent epilepsy participants
partial seizures
primary generalized Tonic-clonic seizures
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 519
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with epilepsy who will receive Fycompa per the approved indication in routine clinical practice

Brief summary: The objective of this study is to identify the following in adolescent epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa:

1. unknown adverse drug reactions (ADRs);
2. occurrence of ADRs;
3. factors that are likely to affect safety and efficacy;
4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items;
5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression).


Eligibility criteria: Inclusion Criteria:

* Epilepsy participants from 12 to 17 years of age with:

  * Partial seizures (with or without secondary generalized seizures)
  * Primary generalized Tonic-clonic seizures

Exclusion Criteria:

* Participants previously treated with Fycompa

Primary outcomes:
measure: Number of participants with any serious adverse event
timeFrame: from 0 to 104 weeks
measure: Number of participants with any non-serious adverse event
timeFrame: from 0 to 104 weeks
Secondary outcomes:
measure: Number of participants experiencing seizures
timeFrame: from 0 to 104 weeks
measure: Overall improvement rating in seizure frequency
timeFrame: from 0 to 104 weeks
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
References:
citation: Inoue Y, Sumitomo K, Matsutani K, Ishii M. Real-world evaluation of perampanel effectiveness in Japanese adolescents with epilepsy. Epileptic Disord. 2022 Oct 1;24(5):813-821. doi: 10.1684/epd.2022.1454.
Clinical trial NCT05230381: Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection
Official title: Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Brain Meningioma Resections: Study Protocol of a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tranexamic Acid
Intraoperative Blood Loss
Meningioma
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 228
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: PREVENTION

Brief summary: Intra-operative blood loss of huge meningioma resection patients on average was over 1000ml. Intra-operative massive hemorrhage was associated with longer hospital of stay, higher expense, and higher mortality. Previous studies indicated intra-operative tranexamic acid infusion would decrease blood loss for cardiac, trauma and obstetric procedures. However, limited researches focusing on the effect of tranexamic acid in neurosurgery population, with heterogenous pathologies. The purpose of this study was to investigate the effect of tranexamic acid on intra-operative blood loss in patients undergoing huge meningioma resection.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective supratentorial meningioma resection with estimated tumor diameter \>5cm on brain image.
* Age between 18-65 years.
* American Society of Anaesthesiologist (ASA) physical status Ⅰ to Ⅲ
* Obtain written informed consent.

Exclusion Criteria:

* Allergic to tranexamic acid.
* History of thrombotic disease.
* History of chronic kidney disease
* Receiving other anticoagulation or antiplatelet treatment.
* Refuse to provide written informed consent

Primary outcomes:
measure: Estimated intra-operative blood loss
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Shu Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00766181: Satisfaction With Pediatric Intravenous Catheter Placement in the Emergency Department
Official title: An Evaluation of Parent and Nurse Satisfaction Associated With Pediatric Peripheral Intravenous Catheter Placement Using Standard of Care vs. ZingoTM in the Emergency Department
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Intravenous Placement Procedure
Keywords: IV placement; Parent satisfaction level
Lead sponsor: Anesiva, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Covance
First posted: 2008-10-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients in Emergency Department requiring peripheral IV catheter placement.

Brief summary: The purpose of this study is to determine the satisfaction among parents and nurses of pediatric patients with IV catheter placement in the Emergency Department.

Detailed description: The objectives of this study are to evaluate whether the proportion of parents satisfied with their child's IV placement procedure is higher after the introduction of Zingo compared to standard of care and to evaluate changes in nursing staff satisfaction with performing IV placement procedures after using Zingo prior to IV placement compared to standard of care.

Eligibility criteria: Inclusion Criteria:

* PHASE A: Parent of a pediatric patient from the age of 3 to 18 years of age who requires a peripheral IV placement in the Emergency Department
* Parent must be able to read and understand English and provide written informed consent
* Parent must be present during the IV placement
* PHASE B: Parent did not participate in Phase A
* Nurse has completed Zingo TM in-service training prior to participation
* Zingo is used prior to performing the IV placement procedure

Exclusion Criteria:

- Parent of patient with a serious unstable medical or psychological condition that would compromise participation in the study

Primary outcomes:
measure: Parent's satisfaction with IV placement procedure
timeFrame: 18 weeks
Secondary outcomes:
measure: Nurse'e satisfaction with performing IV placement
timeFrame: 18 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01539681: Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy
Official title: Sorafenib Treatment Modalities for HEpatoceLLular Carcinoma Patients in ItAly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Cancer, Liver
Sorafenib
Nexavar
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 234
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: Hepatocellular Carcinoma Patients treated in Italy

Brief summary: Prospective, non-interventional, multi-center study. Patients affected by Hepatocellular Carcinoma (HCC) who are candidates for systemic therapy and in whom a decision to treat with sorafenib has been made. Aim of this non-interventional, post-marketing study is to evaluate the efficacy of sorafenib in terms of overall survival rate at 12 months in patients with HCC under daily-life treatment conditions.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically/cytologically confirmed HCC or radiographically diagnosed as per AASLD criteria, who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made
* Patients must have signed the informed consent form
* Patients must have a life expectancy of at least 8 weeks Inclusion criteria must follow the approved local product information.

Exclusion Criteria:

* Prior treatment with sorafenib
* Concomitant participation in other clinical studies Exclusion criteria must follow the approved local product information.

Primary outcomes:
measure: Efficacy (analyzed by overall survival rate) of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.
timeFrame: at 1 year
Secondary outcomes:
measure: Adverse event collection of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.
timeFrame: every 4 months on average within approx. 2 years
measure: Overall survival
timeFrame: at 1 year
measure: Time to Progression
timeFrame: every 4 months on average within approx. 2 years
Other outcomes:
Locations:
city: Many Locations
country: Italy
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01602081: Ligation of the Intersphincteric Fistula Tract (LIFT) + Biodesign for Anal Fistula
Official title: Ligation of the Intersphincteric Fistula Tract With Tissue Graft Placement for Treatment of Persistent Trans-sphincteric Anal Fistula
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anal Fistula
Keywords: Anal fistula
Ligation of the intersphincteric fistula tract
LIFT
Tissue graft
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2012-05-18
Enrollment: 28
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: Regional and Community Hospitals

Brief summary: The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of fistula closure in patients with persistent trans-sphincteric anal fistula who receive the Biodesign® Tissue graft as part of their LIFT procedure.


Eligibility criteria: Inclusion Criteria:

* Persistent primary or recurrent trans-sphincteric anal fistula

Exclusion Criteria:

* Patients with prior fistulotomy, fistulectomy, LIFT, cutting seton or advancement flap procedure
* Fistula with multiple tracts
* Recto-vaginal fistula
* Active infection in the anal fistula
* Physical allergies or cultural objections to porcine products
* Patient is not medically fit to undergo the LIFT procedure as judged by the treating physician
* Previous diagnosis of collagen disorder
* History of Crohn's Disease, Irritable Bowel Syndrome, radiation therapy in the rectoanal region

Primary outcomes:
measure: Closure of the anal fistula
timeFrame: 6 months
Secondary outcomes:
measure: Closure of the anal fistula
timeFrame: 12 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Hospitals
state: Indiana
city: Indianapolis
country: United States
facility: Kendrick Regional Center
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Cleveland
country: United States
facility: Case Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00113581: Safety Study of EMD 72000 in Combination With ECX (Epirubicin, Cisplatin and Capecitabine) in Oesophagogastric Cancer
Official title: A Phase I Study to Determine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Three Doses of Humanised EGFR Antibody EMD 72000 in Combination With ECX in Patients With Advanced Oesophagogastric Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Esophageal Cancer
Gastric Cancer
Keywords: EMD 72000
matuzumab
Esophageal adenocarcinoma
Gastric adenocarcinoma
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2005-06-10
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to test the safety and tolerability and effectiveness of a new treatment, EMD 72000 (matuzumab), for advanced oesophagogastric cancer in combination with the chemotherapy regimen ECX (epirubicin, cisplatin and capecitabine).

In addition the study will look at pharmacokinetic (how the the body takes up the drug) and pharmacodynamic parameters (what the drug does in the body).


Eligibility criteria: Inclusion Criteria:

* Advanced, recurrent or metastatic gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus
* EGFR positive tumor
* KPS greater than 60
* Normal cardiac function
* Adequate liver and bone marrow function
* GFR greater than 60 ml/minute

Exclusion Criteria:

* Previous chemotherapy
* Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrythmias
* Clinically significant ECG or cardiac history
* Radiotherapy or surgery within last 4 weeks

Primary outcomes:
measure: Safety and tolerability
Secondary outcomes:
measure: Pharmacodynamic parameters
measure: Pharmacokinetic parameters
measure: Response rate
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
Study officials:
affiliation: The Royal Marsden Hospital, Sutton, UK
name: David Cunningham, Professor
role: PRINCIPAL_INVESTIGATOR
References: