louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01514539: Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk
Official title: Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Obesity Syndrome
Keywords: Human milk, Ghrelin,PYY and maternal obesity.
Lead sponsor: University of Wyoming
Sponsor class: OTHER
First posted: 2012-01-23
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk Studies suggest that childbearing is an important contributor to the development of obesity in many women and that breastfeeding may be protective.

Ghrelin and peptide YY (PYY) are gut hormones involved in appetite regulation and energy homeostasis and are biological neuroendocrine signals that potentially affect body weight and adiposity/

Detailed description: Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk.

This study evaluated whether fasting or postprandial ghrelin or PYY is different between lactating and nonlactating postpartum women matched for age, body weight, and adiposity.

Eligibility Criteria: Healthy females, 18+ years old, non-smokers, no major food allergies, first-time mom, currently pregnant or within 1 month of giving birth.

Eligibility criteria: Inclusion Criteria:

* Healthy women (non-smokers) at least 18 years old who did not have any pregnancy complications, and gave birth to their first child within one month.
* The study is open to women who are breastfeeding or formula feeding.

Exclusion Criteria:

* Smoker,
* had twins or triples,
* had any major complication of pregnancy(example,
* gestational diabetes);
* have kidney, liver, hormonal, stomach, intestine,lung, heart or blood disease. This also includes high blood pressure;
* use prescription or over-the-counter medicine or herbal drinks or pills.
* History of depression, anxiety, disordered eating, other psychological problems, alcoholism or other substance abuse.
* Severely claustrophobic.
* Having a strong fear of needles and/or do not feel you can have blood drawn every 30 minutes from a plastic catheter.
* Are not able to or willing to fully participate in the study, and are pregnant, anemic or have a thyroid problem.

Primary outcomes:
measure: "Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk"
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Laramie
country: United States
facility: Nutritional and Exercise Lab University of Wyoming
state: Wyoming
Study officials:
affiliation: University of Wyoming
name: Dawine E. Larson-Meyer, Phd, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03034239: The Effect of Insect Protein on Performance and Hypertrophy
Official title: The Effect of Insect Protein on Performance and Hypertrophy During Eight Weeks of Resistance Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein Supplementation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Purpose: to study the effect of insect protein on performance and hypertrophy during 8 weeks of resistance training.

Hypothesis: Insect protein supplementation enhances the effect of resistance training on muscle mass and muscle strength.

Primary outcome: Muscle hypertrophy and muscle strength

Design: Two groups of healthy young men (age: 18-30 years) with resistance training experience, but no structural resistance training performed for the last 12 months. Randomized controlled intervention study +/- insect protein (placebo group ingest isocaloric carbohydrate). Both groups perform 8 weeks of progressive resistance training (4/week) aiming to induce muscle hypertrophy.


Eligibility criteria: Inclusion Criteria:

* Healthy young men (age: 18-30 years) with experience in resistance training
* 2 hours of physical exercise per week or more

Exclusion Criteria:

* No structural resistance training for the last 12 months
* No injuries
* No smoking
* No ingesting of protein or creating supplementations
* No use of medicine which may influence the adaptation to strength training

Primary outcomes:
measure: Muscle hypertrophy
timeFrame: 8 weeks
Secondary outcomes:
measure: Muscle Strength
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department for Public Health, Section for Sport Science
Study officials:
affiliation: University of Aarhus
name: Mette Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00725439: An Open Label Trial to Assess the Safety and Efficacy of Oral R115866 in the Treatment Facial Acne
Official title: An Open Label Pilot Trial to Assess the Safety and Efficacy of Oral R115866 in the Treatment of Moderate to Severe Facial Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 16
Sex: MALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is looking at a new oral drug to treat acne. All patients in the study will get active drug, there is no placebo arm.


Eligibility criteria: Inclusion Criteria:

* Male subject
* Presence of moderate to severe facial acne vulgaris: having a minimum of 15 papules and/or pustules and at least 2 nodulocystic lesions
* In good general health and free of any disease state or physical condition which, in the investigator's opinion, might have impaired evaluation of acne or exposed the subject to an unacceptable risk by trial participation

Exclusion Criteria:

* Subjects with types of acne other than acne vulgaris
* Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, or a history indicating adrenal cortex dysfunction or any other serious disease (including cancer and subjects known to be HIV positive)
* History of any malignancy in the past 5 years, except for adequately treated basal cell carcinoma of the skin
* History of heart failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders
* Clinically significant abnormal ECG-intervals or morphology of the ECG; QT or QTc \>470 ms in females or \>450 ms in males
* Use of vitamin A (\>1000 microgram/day), phenytoin, carbamazepine, warfarin, rifampicin, tetracyclines, ketoconazole, itraconazole, astemizole, terfenadine, cisapride, anti-psychotics, anti-depressants, lithium, antimalarials, alpha-blocking drugs, angiotensin-converting enzyme inhibitors, cyclosporin A, glucocorticosteroids and non-steroid anti-inflammatory drugs, non-potassium-sparing diuretics
* Use of oral retinoids 6 months prior to Visit 1
* Use of other oral/topical therapy for acne unless stopped at Visit 1
* Use of ultraviolet light (including artificial UVA and UVB as well as excessive natural sun exposure) unless stopped at Visit 1

Primary outcomes:
measure: Facial Lesion Count
timeFrame: Post 12 weeks treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Department of Dermatology, UZ Brussel
city: Vilvoorde
country: Belgium
facility: Private Practice in Dermatology
city: Zwijndrecht
country: Netherlands
facility: Albert Schweitzer Hospital, Dermatology
Study officials:
affiliation: Department Dermatology, University Hospital Brussel (UZ Brussel)
name: Prof. Dr. D. Roseeuw, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00265239: Pilot Study of Edaravone to Treat Acute Myocardial Infarction
Official title: Effects of Edaravone in Patients With Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Reperfusion Injury
Keywords: Edaravone
Randomized Control Trial
ST-Elevation Myocardial Infarction
Coronary Angioplasty
Lead sponsor: Kumamoto University
Sponsor class: OTHER
Collaborators: name: Japan Heart Foundation
First posted: 2005-12-14
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Early reperfusion therapy has improved the clinical outcomes of patients with acute myocardial infarction (AMI), but these benefits are limited in some patients by reperfusion injuries. There is now increasing evidence that reactive oxygen species cause reperfusion injury. This study was designed to examine the effects of edaravone, a novel free radical scavenger, in patients with AMI.

Detailed description: Initial AMI patients were randomly assigned to receive 30 mg of edaravone or a placebo intravenously just before reperfusion. We compared infarct size, using serial determination of serum biomarkers and Q wave formations, and the incidence of reperfusion arrhythmia between the groups. Cardiovascular event-free curves were estimated by Kaplan-Meier method. In addition, we determined serum thioredoxin levels, an oxidative stress marker, to assess the antioxidant effect of edaravone.

Eligibility criteria: Inclusion Criteria:

* Initial AMI patients admitted to the investigators' institution within 6 hours of symptom onset and treated primary percutaneous coronary intervention.

Exclusion Criteria:

* Renal insufficiency defined as serum creatinine \> 1.2 mg/dl and altered hepatic function defined as serum asparate aminotransferase \> 50 IU/L, alanine aminotransferase \> 50 IU/L and total bilirubin \> 1.2 mg/dl.

Primary outcomes:
measure: Cardiac Death
timeFrame: 415±32 days
measure: Nonfatal Myocardial Reinfarction
timeFrame: 415days
measure: Refractory Angina Pectoris
timeFrame: 415days
measure: Nonfatal Ischemic Stroke
timeFrame: 415days
Secondary outcomes:
Other outcomes:
Locations:
city: Kumamoto
country: Japan
facility: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Study officials:
affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
name: Hisao Ogawa, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04650139: Coronary Interventions Ulm - Coronary Chronic Total Occlusions
Official title: Coronary Interventions Ulm - Coronary Chronic Total Occlusions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Total Occlusion of Coronary Artery
Chronic Total Occlusion
Lead sponsor: University Hospital Ulm
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with CTO

Brief summary: The aim of the proposed project is to provide the long-term results after a recanalization attempt of chronically occluded coronary arteries.

To investigate recanalization attempt of chronically occluded coronary arteries at the Ulm University Hospital. As shown, it is known that successful recanalization of a chronic occlusion is associated with a lower event rate (reduced mortality and the need for operative myocardial revascularization) compared to unsuccessful recanalization (drug therapy). The standard in the therapy of successfully recanalized chronic occlusions is the use of drug-releasing vascular supports.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years

Coronary intervention in chronic coronary artery occlusion

Occlusion \> 3 months

Indication for PTCA or recanalization according to guidlines

such as:

Symptoms of the patient

Evidence of myocardial ischemia (stress ECG, scintigraphic

Methods, magnetic resonance imaging, stress echocardiography)

pathological intracoronary flow reserve, prognostic

Exclusion Criteria:

* No chronic occlusion,
* Contraindication to anti-platelet therapy

Acetylsalicylic acid plus clopidogrel for at least 3 months such as e.g.

with florid gastrointestinal ulcer disease,

History of hemorrhagic stroke

or urgent non-postponable surgical intervention.

Basic disease with a life expectancy of less than 12 months (here as a rule

no indication for PTCA or reopening available)

Primary outcomes:
measure: MACE
timeFrame: 1 year
Secondary outcomes:
measure: TLR
timeFrame: 1 year
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University Ulm
Study officials:
References:
Clinical trial NCT00803439: Randomized Study to Compare the Bioavailability of Two Clobetasol Propionate 0.05% Topical Foams
Official title: Bioequivalence of Two Clobetasol Propionate 0.05% Topical Foams
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Bioequivalence
Clobetasol Propionate
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Community Volunteers

Brief summary: The purpose of this study was to compare the relative vasoconstrictive effects of test and reference Clobetasol Propionate 0.05% Topical Foam in healthy, female subjects.


Eligibility criteria: Inclusion Criteria:

* Non-tobacco using female subjects, 18 to 50 years of age
* Demonstrated blanching response to Reference Drug
* Body Mass Index (BMI) of 30 or less
* Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator
* Signed and dated informed consent form which meets all criteria of current FDA regulations

Exclusion Criteria:

* History of allergy to systemic or topical corticosteroids
* Presence on any skin condition or coloration that would interfere with the placement of test sites or the response or assessment of skin blanching
* Presence of medical condition requiring regular treatment with prescription drugs
* Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing
* Use of any tobacco products in the 30 days prior to study dosing
* Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
* Receipt of any drugs as part of a research study within 30 days prior to study dosing
* Pregnant or lactating

Primary outcomes:
measure: Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter
timeFrame: Over the course of two days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04161586: Prilocaine for Spinal Anesthesia in Ambulatory Setting
Official title: Prilocaine for Spinal Anesthesia in Ambulatory Setting: an Observational Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Spinal
Prilocaine
Ambulatory Surgical Procedures
Keywords: Spinal Anesthesia
Prilocaine
Ambulatory Surgery
Safety
Lead sponsor: Ospedale di Circolo - Fondazione Macchi
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 3291
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Single Center Ambulatory Surgical Patients

Brief summary: The purpose of this study is to retrospectively analyze data from more than 3000 procedures, to better define the safety profile of spinal prilocaine and the incidence of complications and side effects.

Detailed description: We designed a retrospective cohort study to analyze the safety profile and the incidence of side effects associated with prilocaine for spinal anesthesia in ambulatory settings.

Data will be obtained from an internal database where are prospectively recorded clinical data from spinal anesthesia consecutively performed with prilocaine at our institution for ambulatory surgery from 2011 to 2019. Variables recorded in the database and analyzed will include demographic data, type of surgery, presence of surgical, anesthesiological or general complications, need for unplanned admission and percentage of completed database records.

Eligibility criteria: Inclusion Criteria:

* Ambulatory surgical procedures performed under spinal anesthesia with Prilocaine

Exclusion Criteria:

* General Anesthesia
* Procedures lasting longer than 2 hours

Primary outcomes:
measure: anesthesia-related complication
timeFrame: 2011-2019
Secondary outcomes:
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Department of Day Surgery Ospedale di Circolo Varese
state: VA
Study officials:
References:
Clinical trial NCT00964886: Efficacy of Antidepressants in Chronic Back Pain
Official title: Efficacy of Antidepressants in Chronic Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Back Pain
Keywords: chronic pain
back pain
antidepressants
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of California, San Diego
First posted: 2009-08-25
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 12 week placebo controlled clinical trial tests the individual and combined effects of an antidepressant medication and cognitive behavioral therapy for chronic back pain.

Detailed description: This is a 4 arm 12 week randomized clinical trial comparing the efficacy of 1) low concentration desipramine (\< 60 ng/ml); 2) cognitive behavioral therapy; 3) low concentration desipramine + cognitive behavioral therapy; and 4) placebo medication (benzotropine mesylate).

Eligibility criteria: Inclusion Criteria:

* Chronic back pain (daily pain for \> 6 months)

Exclusion Criteria:

* Major medical conditions which might contraindicate antidepressant treatment

Primary outcomes:
measure: Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity
timeFrame: 12 weeks after baseline (or last observation carried forward)
Secondary outcomes:
measure: Roland and Morris Disability Questionnaire
timeFrame: 12 weeks after baseline (or last observation carried forward)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Joseph H Atkinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gould HM, Atkinson JH, Chircop-Rollick T, D'Andrea J, Garfin S, Patel SM, Funk SD, Capparelli EV, Penzien DB, Wallace M, Weickgenanta AL, Slater M, Rutledge T. A randomized placebo-controlled trial of desipramine, cognitive behavioral therapy, and active placebo therapy for low back pain. Pain. 2020 Jun;161(6):1341-1349. doi: 10.1097/j.pain.0000000000001834.
Clinical trial NCT04071886: Effect of Short-Term Mindfulness-Based Training For Major Depression Disorder: An Eye-Tracking Study
Official title: Effect of Short-Term Mindfulness-Based Training For Major Depression Disorder: An Eye-Tracking Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: MDD
Keywords: eye-tracking
eye movement
mindfulness
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the short-term effects of mindfulness-based training in individuals suffering from major depressive disorder (MDD) as assessed by clinical interviewing, self-report assessment, cognitive evaluation and eye-tracking task.


Eligibility criteria: Inclusion Criteria:

* Meet Diagnostic and Statistical Manual (DSM-IV) diagnosis of depression
* Consent to participate in the study and to be randomized to one of two groups

Exclusion Criteria:

* Current or past substance abuse, psychotic disorder,obsessive compulsive disorder , Post-Traumatic Stress Disorder, in the past 6 months
* History of epilepsy or head trauma
* Eye disorders
* History of electroconvulsive therapy in the past 4 weeks.

Primary outcomes:
measure: Mean Change from Baseline in Eye Movement Performance During Free-View Task at 2 Weeks
timeFrame: at baseline and in 2 weeks
Secondary outcomes:
measure: Mean Change from Baseline in the Symptoms of Major Depression as Measured by BDI-II at 2 Weeks
timeFrame: at baseline and in 2 weeks
measure: Mean Change from Baseline in the Symptoms of Major Depression as Measured by HAM-D at 2 Weeks
timeFrame: at baseline and in 2 weeks
measure: Mean Change from Baseline in State Mindfulness at 2 Weeks
timeFrame: at baseline and in 2 weeks
measure: Mean Change from Baseline in Tendency to Engage in Ruminative Responses at 2 Weeks
timeFrame: at baseline and in 2 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University
state: Hunan
Study officials:
References: