louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00638560: Changes of Biomarkers in Response to Training and Antioxidant Treatment
Official title: Effects of Training and Antioxidant Treatment on Circulating Markers of Oxidative Stress and Skeletal Muscle mRNA Expression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Type 2 Diabetes
Keywords: PGC-1alpha
PPARgamma
oxidative stress
training intervention
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: University of Jena
First posted: 2008-03-19
Enrollment: 40
Sex: MALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to compare the effects of an intensive 4 weeks exercise training program with or without additional treatment with antioxidants. 16 volunteers are included into the study and randomized into a treatment (n=8,Vitamine E 400 IU od + vitamine C 1g twice daily) and a non-treatment (n=8, training only) group. Before and after the training program, skeletal muscle biopsies will be taken to measure PGC-1alpha and PPARgamma mRNA expression. In addition before and after the training program individuals will have the following measurements: body weight, waist circumference, body fat content (DEXA scan), euglycemic-hyperinsulinemic clamps, ergospirometer (VO2 max), routine laboratory measurements, serum malondialdehyde concentrations.


Eligibility criteria: Inclusion Criteria:

* Must be able to swallow tablets
* signed informed consent
* no concommitant medication
* male
* age between 25 - 35 years

Exclusion Criteria:

* drug, tobacco or alcohol abuse
* any chronic disease
* any acute or chronic inflammatory disease as determined by a leucocyte count \> 7000 Gpt/l, C-reactive protein (CrP) \> 5.0 mg/dl or clinical signs of infection
* systolic blood pressure (SBP) \> 140mmHg and diastolic blood pressure (DBP) was \> 85mmHg
* cardiovascular or peripheral artery disease
* thyroid dysfunction

Primary outcomes:
measure: PGC-1alpha mRNA expression in skeletal muscle PPARgamma mRNA expression in skeletal muscle Serum malondialdehyde concentration
timeFrame: after 4 weeks
Secondary outcomes:
measure: body weight glucose infusion rate during the steady state of an euglycemic-hyperinsulinemic clamp VO2max
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig
Study officials:
affiliation: University of Leipzig
name: Matthias Blüher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ristow M, Zarse K, Oberbach A, Kloting N, Birringer M, Kiehntopf M, Stumvoll M, Kahn CR, Bluher M. Antioxidants prevent health-promoting effects of physical exercise in humans. Proc Natl Acad Sci U S A. 2009 May 26;106(21):8665-70. doi: 10.1073/pnas.0903485106. Epub 2009 May 11.
Clinical trial NCT04821960: Memory and Fear Study (Fear of Memory Loss Study)
Official title: Improving Emotional Well-being and Quality of Life in Older Adults Experiencing Dementia-related Fear.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety and Fear
Keywords: Mindfulness
Fear of memory loss
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 81
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized control study to determine the impact of a tailored, web-based mindfulness program to reduce anxiety and increase the quality of life in older adults experiencing dementia-related fears, relative to a conventional meditation program.

Detailed description: The study will test two different types of online mindfulness programs to see if an online self-paced mindfulness program can help reduce anxiety related to memory loss. Participants will be involved in the study for a total of 10 weeks. Participants will log on to an online mindfulness program 4 days per week for about 10-20 minutes each. The total program will last 3 weeks. Participants will also be asked to complete questionnaires before starting the program, during the program, and after they complete the program.

Eligibility criteria: Inclusion Criteria:

* 55 years of age or older
* Elevated dementia-related fear
* Able to read/write in English
* Willingness to be randomized to intervention group
* Willingness to complete three weeks of self-guided intervention, questionnaires, and cognitive tests.
* Access to a reliable internet connection

Exclusion Criteria:

* Diagnosis of mild cognitive impairment, Alzheimer's Disease, or dementia by a healthcare provider.
* Impaired cognitive or neurologic function
* Unstable medical condition
* Severe depression
* Current treatment for anxiety or depression
* Current participation in another psychotherapy
* Current use of psychiatric medication
* Current substance use disorder
* Inadequate vision or hearing to interact with study materials

Primary outcomes:
measure: Fear and Avoidance of Memory Loss (FAM) Scale Score at Follow-up
timeFrame: 10 Weeks Post-Baseline
measure: Fear of Alzheimer's Disease Scale (FADS) Score at Follow-up
timeFrame: 10 Weeks Post-Baseline
Secondary outcomes:
measure: Memory Failure Scale (MFS)
timeFrame: 10 Week Post-Baseline
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
citation: O'Loughlin P, Pavithra P, Regan J, Bennett M, Knight R, Lenaert B, Marquez M, Taddeo M, Griffith J, Shapiro R, Farina F. A Randomized Controlled Trial Investigating the Feasibility of a Low-Intensity Psychological Intervention for Fear of Memory Loss and Quality of Life in Older Adults: Protocol for the Reducing Fear and Avoidance of Memory Loss (REFRAME) Study. JMIR Res Protoc. 2021 Jul 30;10(7):e30514. doi: 10.2196/30514.
Clinical trial NCT01756560: Effect of Dexamethasone on Duration of Lower Extremity Blocks With Bupivacaine in Subjects Having ACL Repair
Official title: A Study of the Effect of Dexamethasone on Duration of Lower Extremity Blocks With Bupivacaine in Subjects Having ACL Repair
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Duration of Pain Relief
Keywords: anterior cruciate ligament
block duration
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2012-12-27
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anterior cruciate ligament reapair is a painful procedure. Single shot femoral and sciatic nerve block only last 12-16 hrs. Since dexamethasone prolongs brachial plexus block, using it in lower extremity blocks will prolong the analgesia to provide better outpatient pain relief after surgery at home.


Eligibility criteria: Inclusion Criteria:

* age 18-75, no contraindication to regional anesthesia

Exclusion Criteria:

* peripheral neuropathy

Primary outcomes:
measure: Analgesia Duration
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Tariq Malik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06355973: A Pilot Study for Efficacy of Cognitive and Physical Training in Patients With Mild Cognitive Impairment
Official title: A Pilot Study for Efficacy of Cognitive and Physical Training in Patients With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patients With Mild Cognitive Impairment (MCI)
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is to find out the effectiveness of cognitive and physical function training for patients with mild cognitive impairment.

It is for the prevention and treatment of dementia in the future. randomized, Pilot Study.


Eligibility criteria: Inclusion Criteria:

1. men and women aged 60 or older
2. A person who falls within the abnormal range of the Montreal Cognitive Assessment (MoCA) test
3. a person who can independently carry out daily life
4. If the subject or legal representative voluntarily decides to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical study

Exclusion Criteria:

1. A person diagnosed with Alzheimer's dementia or other causes (stroke, brain tumor, cerebral palsy, dementia, Parkinson's disease, etc.)
2. A person with unstable cardiovascular system, digestive system, respiratory system, endocrine system, etc. and poor general condition
3. Patients who have participated in other treatment clinical studies or who have participated in other treatment clinical studies within the last 30 days
4. Other cases where the researcher determines that participation in this clinical study is not appropriate

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: screening - 6 weeks - 3 months
Secondary outcomes:
measure: Korean-Mini Mental Status Examination (K-MMSE)
timeFrame: Baseline - 6 weeks - 3months
measure: Clinical Dementia Rating (CDR)
timeFrame: Baseline - 3months
measure: Clinical Global Impressions of Change (CGIC)
timeFrame: Baseline - 6 weeks- 3months
measure: Instrumental Activities of Daily Living (I-ADL)
timeFrame: Baseline - 6 weeks- 3months
measure: Berg Balance Scale (BBS)
timeFrame: Baseline - 6 weeks- 3months
measure: Geriatric Quality of Life-Dementia (GQOL-D)
timeFrame: Baseline - 6 weeks- 3months
measure: Geriatric Depression Scale (GDSd)
timeFrame: Baseline - 6 weeks- 3months
measure: Global Deterioration Scale (GDS)
timeFrame: Baseline - 3months
measure: Electroencephalography
timeFrame: Baseline - 6 weeks- 3months
Other outcomes:
Locations:
Study officials:
affiliation: CHA Bundang Medical Center
name: MinYoung Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00860873: Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis
Official title: Randomized Study of Two Dosage Forms (Oral Powder and Capsule) of "Chondroitin + Glucosamine Sulfate" Produced by the Laboratory EMS When Compared to the Product Condroflex (Oral Powder and Capsules) Produced by Laboratory Zodiac in the Treatment of Osteoarthrosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthrosis
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2009-03-12
Enrollment: 280
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study objective is to check the non-inferiority of the 2 formulations produced by EMS when compared with the same substances and pharmaceuticals forms of the product Condroflex (Zodiac), by promoting the relief of osteoarthrosis symptoms such as pain, stiffness and functional capacity that will be periodically measured by using the "Visual Analog Scale" of pain (VAS) and the questionnaire of Lequesne.


Eligibility criteria: Inclusion Criteria:

* Patients who agree with all aspects of the study and sign the Informed Consent;
* Patients of both sexes;
* Age above 30 years;
* Clinical and radiological diagnosis of osteoarthritis;
* Osteoarthritis in grades 1-2;
* Patients who are conducting medical treatment and that, for trial of Investigator, is eligible for the study.

Exclusion Criteria:

* Patients with a history of trauma clinically significant;
* Patients who underwent surgery on joints affected;
* Coexistence of diseases that might impede the successful conclusion of the trial (rheumatism and others);
* Pregnant patients and / or breastfeeding;
* Patients with phenylketonuria;
* Patients with clinical diagnosis of severe renal failure;
* Patients with clinical diagnosis of severe liver disease;
* Patients with clinical diagnosis of clotting disorders;
* Patients who are being treated with anti-aggregating and / or anticoagulants;
* Patients with sensitive components of the formula;
* Patients with emotional disorders that interfere with the capture of data;
* Patients who do not agree with the purposes of the study and did not sign the Informed Consent.

Primary outcomes:
measure: Decrease in pain.
timeFrame: V0 (Screening); V1 (Inclusion); V2 (2 weeks); V3 (4 weeks); V4 (8 weeks); V5 (12 weeks); V6 (24 weeks).
Secondary outcomes:
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: Lal Clinica Pesquisa E Desenvolvimento Ltda
state: Sao Paulo
Study officials:
References:
Clinical trial NCT06734273: Randomized Control Trial of Sleeve Gastrectomy with Tirzepatide in Maximizing Weight Loss
Official title: Randomized Control Trial of Sleeve Gastrectomy with Tirzepatide in Maximizing Weight Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Obesity and Obesity-related Medical Conditions
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 42
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 study examines whether adding tirzepatide-a medication that helps with weight loss-after sleeve gastrectomy surgery can help people lose more weight after the surgery; better improve conditions like Type 2 diabetes, high blood pressure, high cholesterol, and sleep apnea after surgery and; whether this causes more complications or side effects compared to surgery alone.


Eligibility criteria: Inclusion Criteria:

* Adult 18 to 65 years of age
* Body Mass Index \>35 with comorbidity of Type 2 Diabetes and/or Hypertension and/or Hyperlipidemia and/or Obstructive Sleep Apnea OR Body Mass Index \>40 with or without comorbidity
* Undergoing primary sleeve gastrectomy

Exclusion Criteria:

* Prior metabolic and bariatric surgery
* Prior use of GLP-1 agonist
* Prior history of pancreatitis
* Personal/family history of medullary thyroid cancer or MEN type 2
* Secondary cause of obesity
* Any eating disorder
* Pregnancy/lactation
* History of acute coronary syndrome or myocardial infarction
* History of stroke
* Hepatic dysfunction: AST/ALT \>3 ULN
* Renal dysfunction eGFR\<45ml/min/1.73m2
* Active malignancy
* History of diabetic retinopathy
* History of gastroparesis

Primary outcomes:
measure: Weight Loss
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Weight Loss
timeFrame: 18 months after surgery
measure: Type 2 Diabetes
timeFrame: 12 months after surgery
measure: Type 2 Diabetes
timeFrame: 18 months after surgery
measure: High Blood Pressure
timeFrame: 12 months after surgery
measure: High Blood Pressure
timeFrame: 18 months after surgery
measure: High Cholesterol
timeFrame: 12 months after surgery
measure: High Cholesterol
timeFrame: 18 months after surgery
measure: Sleep Apnea
timeFrame: 12 months after surgery
measure: Sleep Apnea
timeFrame: 18 months after surgery
measure: Complications/Side Effects
timeFrame: 12 months after surgery
measure: Complications/Side Effects
timeFrame: 18 months after surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Nicholas Skertich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02041273: Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions
Official title: A Phase 1, Open-label 6 Sequence 3 Period Crossover Study of Palbociclib (PD- 0332991) in Healthy Volunteers to Estimate the Relative Bioavailability of Palbociclib Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: bioavailability
bioequivalence
AUC
Cmax
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-01-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A relative bioavailability study of commercial palbociclib free base hard capsules to the isethionate salt palbociclib capsules ( used in Phase 1 and 2 studies) under different fasting conditions.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years.
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Any condition possibly affecting drug absorption.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 7 days
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 7 days
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 7 days
measure: Apparent Oral Clearance (CL/F)
timeFrame: 7 days
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 7 days
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 7 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01834573: Impact of Physical Exercise on Quality of Life in Patients With Inflammatory Bowel Disease - a Pilot Study.
Official title: Impact of Physical Exercise on Quality of Life in Patients With Inflammatory Bowel Disease - a Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life in Patients With Inflammatory Bowel Disease
Keywords: inflammatory bowel disease
IBD
quality of life
Inflammatory Bowel Disease Questionnaire
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2013-04-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with inflammatory bowel disease (IBD) suffer from a diminished quality of life compared to healthy adults. This is due to the chronic course of disease accompanied with diarrhea, stomach pains but also with psychological stress.

It is known that physical education may improve course of disease and quality of life in a multitude of diseases. These include coronary heart disease, malignancies and also depression. The investigators believe that sport is as effective supportive tool in improving quality of life in IBD patients. But data is lacking with regard to controlled randomized clinical trials. Because of the small amount of data available the investigators considered a feasibility study. Our hypothesis is that IBD patients will cope with moderate exercise. The investigators further suspect that these patients improve their quality of life compared with patients in the control group.


Eligibility criteria: Inclusion Criteria:

* \>18 years
* proven colitis ulcerosa (CU)
* proven crohns disease (CD)
* diagnosis \>= 1 year before start of the study
* low or moderate disease activity

Exclusion Criteria:

* \< 18 years
* high disease activity
* regular exercise \> 2 hours per week
* diagnosis of CU oder CD \< 1 year before start of the study

Primary outcomes:
measure: Quality of life
timeFrame: 10 weeks
Secondary outcomes:
measure: disease activity
timeFrame: 10 weeks
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum rechts der Isar
state: Bayern
Study officials:
affiliation: II. Medizinische Klinik, Klinikum rechts der Isar München, Germany
name: Peter Klare, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: II Medizinische Klinik, Klinikum rechts der Isar München, Germany
name: Wolfgang Huber, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01963273: Video Assisted Ablation of Pilonidal Sinus
Official title: Video Assisted Ablation of Pilonidal Sinus. Evaluation of Safety and Efficacy of a New Minimally Invasive Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pilonidal Sinus
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators supposed that the complete video assisted ablation of pilonidal sinus (VAAPS) could be an effective minimally invasive treatment of pilonidal sinus. This new minimally invasive treatment allows the identification of the sinus cavity with its lateral tracks, the destruction and the removal of all infected tissue and the removing of any hair.


Eligibility criteria: Inclusion Criteria:

Diagnosis of chronic pilonidal sinus

Exclusion Criteria:

Inability to consent to the study Recurrent pilonidal sinus after an outmidline technique

Primary outcomes:
measure: Infection
timeFrame: 1 month
Secondary outcomes:
measure: Recurrence
timeFrame: 1 year
Other outcomes:
measure: time off work
timeFrame: 1 month
measure: Time to sitting on toilet without pain
timeFrame: 1 month
measure: satisfaction
timeFrame: 6 months
measure: Aesthetic appearance
timeFrame: 6 months
measure: Pain
timeFrame: 1 day, 1 week and 1 month
measure: time to walk without pain
timeFrame: 1 month
Locations:
city: Naples
country: Italy
facility: Milone Francesco
state: Italiy
Study officials:
References:
citation: Milone M, Fernandez LM, Musella M, Milone F. Safety and Efficacy of Minimally Invasive Video-Assisted Ablation of Pilonidal Sinus: A Randomized Clinical Trial. JAMA Surg. 2016 Jun 1;151(6):547-53. doi: 10.1001/jamasurg.2015.5233.