louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03843008: Melatonin in Acute Stroke
Official title: Role of Melatonin in the Acute Phase of Stroke as Measured by Interleukin 6 Biomarker
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke, Acute
Ischemic Stroke
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will receive 3mg of melatonin or no melatonin for up to seven days or for the duration of his or hospital stay for a maximum total of 21mg of melatonin.
Primary purpose: TREATMENT

Brief summary: This study will measure Interleukin 6 (IL-6), a well-documented inflammatory biomarker that is increased in the acute phase of stroke, and to compare its levels after the administration of melatonin - a well-documented anti-inflammatory and anti-oxidant - that regulates circadian rhythm, which helps promote sleep.

Detailed description: Stroke is a major cause of debilitation in the first world, with few therapeutic options when it comes to improvement in quality of life and morbidity, besides physical and occupational therapy. It affects people of all nationalities, creeds, and socioeconomic classes through a narrow array of mechanisms. With all those mechanisms, a common outcome is shared: derangement of the brain parenchymal architecture. This derangement is non-selective in its destruction with obscuration of the blood brain barrier and the glymphatic system, and with bleeding as a common sequela; the oxidative stress of the hemoglobin-heme-iron compound causing further injury. This study will measure Interleukin 6 (IL-6), a well-documented inflammatory biomarker that is increased in the acute phase of stroke, and to compare its levels after the administration of melatonin - a well-documented anti-inflammatory and anti-oxidant - that regulates circadian rhythm, which helps promote sleep. Any increased time spent in a restful state because of melatonin increases the clearance of waste products after a catastrophic event, like in stroke.

Eligibility criteria: Inclusion Criteria:

* Adult patients admitted to the Neuroscience Critical Care Unit with a confirmed ischemic stroke
* Patients with a clinical history and examination consistent with an ischemic stroke (stroke must be confirmed by a brain CT and/or MRI scan)
* Eligible patients will have been treated with TPA and/or thrombectomy.

Exclusion Criteria:

* Prisoners
* Patients with severe cognitive impairment and/or aphasia (if no family member is available to sign consent)
* Recent (\<1 month) infection
* Pregnant females

Primary outcomes:
measure: Change in serum Interleukin 6 (IL 6)
timeFrame: Baseline, Week 1
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida College of Medicine-Jacksonville
state: Florida
Study officials:
affiliation: University of Florida
name: Andreja Packard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06147908: Clinical Trial to Evaluate the Pharmacokinetic Characteristics of DW5221 and DW5221-R
Official title: A Bioequivalence Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of DW5221 and DW5221-R in Healthy Adult Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Apetite Stimulants
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-28
Enrollment: 54
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A bioequivalence study to compare and evaluate the pharmacokinetic characteristics and the safety after administration of DW5221 and DW5221-R in healthy adult m ale volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy Male Volunteers who are ≥19 years old
* Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and

Exclusion Criteria:

* Clinically significant Medical History

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: up to 120 hour
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: up to 120 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
Study officials:
References:
Clinical trial NCT02483208: Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate
Official title: Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hemophilia A
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-06-26
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the pharmacokinetics of BAY81-8973 and Advate after intravenous administration.


Eligibility criteria: Inclusion Criteria:

* Males, age 18 to 65 years

  * Subjects with Severe hemophilia A with a documented plasma FVIII level of \<1%
  * ≥ 150 exposure days with FVIII concentrate(s) as supported by medical records

Exclusion Criteria:

* Evidence of current or past inhibitor antibody

  * History of any congenital or acquired coagulation disorders other than hemophilia A
  * Platelet count \<75,000/mm3
  * Abnormal renal function (serum creatinine \>2 times the upper limit of the normal \[ULN\] range)
  * Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5 times the ULN or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio (INR) \>1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.

Primary outcomes:
measure: AUC(0-tlast)
timeFrame: Pre-Dose, 0.25, 0.5, 1, 3, 6, 8, 24, 30, 48 hours after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Shah A, Solms A, Garmann D, Katterle Y, Avramova V, Simeonov S, Lissitchkov T. Improved Pharmacokinetics with BAY 81-8973 Versus Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method: A Randomized Pharmacokinetic Study in Patients with Severe Hemophilia A. Clin Pharmacokinet. 2017 Sep;56(9):1045-1055. doi: 10.1007/s40262-016-0492-2.
Clinical trial NCT04350008: BIO|CONCEPT.Renamic Neo Study
Official title: BIO|CONCEPT.Renamic Neo
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Devices
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2020-04-16
Enrollment: 110
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: Patients that are planned to receive or are already implanted with a programmable BIOTRONIK cardiac rhythm management (CRM) device.

Brief summary: The BIO\|CONCEPT.Renamic.Neo study is designed as a pre-market study to provide clinical data and supporting evidence of the safety, performance and usability of the Renamic Neo programmer system.


Eligibility criteria: Inclusion Criteria:

* Patient is planned for de novo implantation or already has a BIOTRONIK active, implantable device.
* Patient is able to understand the nature of the study and provides written informed consent.

Exclusion Criteria:

* Patient is implanted with a Stratos pacemaker.
* Patient is planned for implant exchange or upgrade.
* Patient is pregnant or breast feeding.
* Patient is less than 18 years old.

Primary outcomes:
measure: Number of Adverse Device Effects (ADE) and Device Deficiencies (DD) Per Number of Implantations and Per Number of PHD/Follow-up Cases
timeFrame: Patients participated from (I) implantation until the pre-hospital discharge (usually 1-2 days) or (II) only for the in-office follow-up (usually 1 day).
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Auchenflower
country: Australia
facility: GenesisCare Wesley
city: Bundaberg
country: Australia
facility: GenesisCare Bundaberg
city: Canberra
country: Australia
facility: The Canberra Hospital
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital (LMH)
city: Melbourne
country: Australia
facility: Monash Medical Centre
city: Mulgrave
country: Australia
facility: Mulgrave Private Hospital
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
Study officials:
References:
Clinical trial NCT03402308: Effect of Schisandra Chinensis Extract on Musculoskeletal Biomakers in Relatively Sarcopenic Adults: a RCT
Official title: Effect of Schisandra Chinensis Extract on Musculoskeletal Biomakers in Relatively Sarcopenic Adults: a Randomized, Double-blinded, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Sarcoidosis
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the SCE on muscle strength, muscle mass, and muscle function in healthy adults for 12 weeks.

Detailed description: Previous studies have indicated that Schisandra chinensis extract (SCE) may have the ability to prevent skeletal muscle atrophy. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the SCE on muscle strength, muscle mass, and muscle function in healthy adults; the safety of the compound are also evaluate. The Investigators examine the peak torque/body weight at 60°/s knee extension, handgrip strength, skeletal muscle mass, physical performance, and metabolic parameters at baseline, as well as after 4 and 12 weeks of intervention. Fifty-four healthy adults were administered either 1,000 mg of SCE or a placebo each day for 12 weeks;

Eligibility criteria: Inclusion Criteria:

* \<110% of the standard lean body mass as measured using the body composition analyzer InBody 720)
* Body-mass index (BMI) ranging from 18.5 to 30.0 kg/m2

Exclusion Criteria:

* Abnormal liver or renal function (i.e., serum aminotransferase activity \> 60 IU/L and serum creatinine concentrations \> 1.2 mg/dL)
* Diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dL)
* History of fracture during the previous year
* Uncontrolled hypertension
* History of serious cardiac disease such as angina or myocardial infarction
* History of gastrectomy
* History of medication for psychiatric disease
* Administration of oriental medicine including herbs within the past 4 weeks
* Evidence of relatively high skeletal mass (more than 110% of the standard lean body mass as measured using the body composition analyzer InBody 720)

Primary outcomes:
measure: muscle strength
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Ami-dong
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho YH, Lee SY, Lee CH, Park JH, So YS. Effect of Schisandra chinensis Baillon extracts and regular low-intensity exercise on muscle strength and mass in older adults: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2021 Jun 1;113(6):1440-1446. doi: 10.1093/ajcn/nqaa447.
Clinical trial NCT02231008: Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS
Official title: A Double-blind, Randomized, Two-period Crossover Study Evaluating the Effects of Tasimelteon vs. Placebo on Sleep Disturbances of Individuals With Smith-Magenis Syndrome (SMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Smith-Magenis Syndrome
Circadian
Keywords: SMS
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-09-03
Enrollment: 49
Sex: ALL
Minimum age (years): 3
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of individuals with Smith-Magenis Syndrome.


Eligibility criteria: Inclusion Criteria:

1. A confirmed clinical diagnosis of SMS
2. Informed consent from the patient or the legal guardian
3. Male or female between the ages of 3- 65 years of age
4. Recent history of sleep disturbances
5. Have an appointed care-giver complete the required outpatient assessments
6. Willing and able to comply with study requirements and restrictions

Exclusion Criteria:

1. Unable to dose daily with medication
2. Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever was longer) of screening
3. Any other sound medical reason as determined by the clinical investigator

Primary outcomes:
measure: To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvement in sleep parameters
timeFrame: 9 Weeks
Secondary outcomes:
measure: Safety and tolerability as measured by spontaneous reporting of adverse events (AEs).
timeFrame: up to 137 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
state: California
city: Baltimore
country: United States
state: Maryland
city: Chevy Chase
country: United States
state: Maryland
city: Houston
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT00161408: Psychological Intervention for Relapse Prevention in First Episode Schizophrenia
Official title: Psychological Intervention for Relapse Prevention in First Episode Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenic Disorders
Keywords: schizophrenia, first episode, cognitive behavioural therapy, psychoeducation
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a randomized clinical trial investigating the efficacy of a comprehensive psychological intervention for the treatment of first episode schizophrenia

Detailed description: Patients suffering from their first episode of schizophrenic disorders are randomly allocated to either a short "information centered psychoeducation" (ICP) of 8 sessions or a "cognitive behavioral treatment" (CBT). CBT includes 8 sessions of psychoeducation, 8 sessions of computer based cognitive training, 8 sessions with relatives and 20 sessions of focusing on stress management, relapse prevention and coping with persistent symptoms.

The primary endpoint is relapse at the one and two year follow up.

Eligibility criteria: Inclusion Criteria:

* diagnosis of schizophrenic disorder according to ICD 10: F20
* first episode
* age between 18 and 55
* willingness to give informed consent also to a double blind pharmacological treatment study

Exclusion Criteria:

* residence outside of the catchment area
* insufficient knowledge of the German language
* substance abuse or addiction as primary clinical problem
* serious physical illness
* organic brain disease
* pregnancy
* contraindications to neuroleptic treatment

Primary outcomes:
measure: relapse
Secondary outcomes:
measure: quantitative measures of symptoms
measure: social functioning
measure: cognitive functioning
measure: quality of life
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Department of Psychiatry and Psychotherapy, University of Bonn
city: Cologne
country: Germany
facility: Department of Psychiatry and Psychotherapy, University of Cologne
city: Duesseldorf
country: Germany
facility: Department of Psychiatry and Psychotherapy, University of Duesseldorf
city: Muenchen
country: Germany
facility: Department of Psychiatry and Psychotheray, University of Muenchen
city: Tuebingen
country: Germany
facility: Department of Psychiatry and Psychotherapy, University of Tuebingen
Study officials:
affiliation: University Hospital Tuebingen
name: Stefan Klingberg, PD Dr. phil. Dipl. Psych.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01061008: Handgrip Exercise for Arteriovenous Fistula Maturation
Official title: The Effects of Progressive Handgrip Exercise Training on Arteriovenous Fistula Maturation in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Exercise; arteriovenous fistula; chronic kidney disease
Lead sponsor: Bangor University
Sponsor class: OTHER
Collaborators: name: Betsi Cadwaladr University Health Board
First posted: 2010-02-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate whether post operative progressive forearm exercise is effective in improving arteriovenous fistula maturation in chronic kidney disease patients.

Detailed description: The arteriovenous fistula is considered to be the gold standard form of access for haemodialysis patients, however only 37% of haemodialysis patients have this form of access. A possible explanation for this could be the high fistula failure rate due to the lack of maturation. Therefore interventions aimed at enhancing fistula maturation are warranted. One such intervention could be forearm exercise, however this recommendation is not evidence based. Therefore, the purpose of this study is to investigate whether a program of post operative progressive hand grip exercise can improve fistula maturation.

Eligibility criteria: Inclusion Criteria:

* Stage 4-5 chronic kidney disease, attending for arteriovenous fistula creation in forearm

Exclusion Criteria:

* Are under the age of 18years;
* Not able to exercise forearm safely (as decided by the patients consultant)
* Have any other uncontrolled medical condition
* Unable to withstand transiently raised systolic blood pressure by 35 mmHg and diastolic by 25 mmHg
* Or are unable to give consent

Primary outcomes:
measure: Venous Diameter.
timeFrame: 3 months
Secondary outcomes:
measure: Maximum Handgrip Strength
timeFrame: 3 months
measure: Handgrip Endurance
timeFrame: 3 months
measure: Forearm Muscle Cross Sectional Area
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangor
country: United Kingdom
facility: Renal unit, Ysbyty Gwynedd, North West Wales NHS Trust
state: Gwynedd
Study officials:
References:
Clinical trial NCT00841308: Home Blood Pressure in Hypertension Management
Official title: Antihypertensive Drug Treatment Decisions Based on Home Blood Pressure Monitoring
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Essential Hypertension
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2009-02-11
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized study with two arms: the Conventional and Ambulatory blood pressure monitoring arm and the Home blood pressure monitoring arm. The study will include both previously treated and untreated individuals.

Before randomization and in the end of the study, measurements will be performed using all three blood pressure monitoring methods (Conventional, Ambulatory and Home) as well as assessment of target organ damage (microalbuminuria, electrocardiogram, echocardiogram, carotid-femoral pulse wave velocity and central blood pressure).

The participants will be randomized into one of the two arms. Diagnosis and titration will be decided according to either Conventional and Ambulatory blood pressure measurements or according to Home blood pressure measurements. Subjects will be followed up for one year.


Eligibility criteria: Inclusion Criteria:

* Untreated hypertensive adults
* Treated hypertensive adults with uncontrolled blood pressure

Exclusion Criteria:

* Stage III Hypertension
* Secondary Hypertension
* Cardiovascular or Renal disease
* Uncontrolled Diabetes

Primary outcomes:
measure: Intermediate target organ damage (Left Ventricular Hypertrophy, Microalbuminuria, carotid-femoral Pulse Wave Velocity, Central blood pressure)
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Blood Pressure Control, Cost-Effectiveness
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hypertension Center, Third Department of Medicine, University of Athens, Greece
Study officials:
affiliation: Hypertension Center, Third Depertment of Medicine, University of Athens, Greece
name: George S Stergiou, MD
role: STUDY_CHAIR
References:
citation: Nasothimiou EG, Karpettas N, Dafni MG, Stergiou GS. Patients' preference for ambulatory versus home blood pressure monitoring. J Hum Hypertens. 2014 Apr;28(4):224-9. doi: 10.1038/jhh.2013.104. Epub 2013 Oct 24.