louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05411913: Topical CBD for Musculoskeletal Pain
Official title: Immediate Effect of Topical CBD for Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain
Lead sponsor: Apothyx, Co.
Sponsor class: INDUSTRY
First posted: 2022-06-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Individuals are provided with a sample of topical substance to apply to a localized region of pain.
Primary purpose: TREATMENT

Brief summary: Various OTC and CBD containing topicals are evaluated in a double blind survey. Each sample has a QR code that is to be scanned before applying. The QR code links to a survey form with application instructions and collects participant information and feedback.


Eligibility criteria: Inclusion Criteria:

* has Pain

Exclusion Criteria:

-

Primary outcomes:
measure: Pain Before/After Application
timeFrame: 5 min post intervention
Secondary outcomes:
measure: Efficiency
timeFrame: 5 min post intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00598013: Effect of Pioglitazone on Insulin Resistance and Atherosclerosis in Renal Allograft Recipients Without Diabetes
Official title: A Randomized Controlled Trial of Pioglitazone on Insulin Resistance, Insulin Secretion and Atherosclerosis in Renal Allograft Recipients Without History of Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Insulin Resistance
Atherosclerosis
Keywords: Kidney Transplantation
Thiazolidinediones
Insulin Resistance
Atherosclerosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2008-01-18
Enrollment: 83
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: The aim of this study was to evaluate the effect of pioglitazone treatment on insulin secretion, insulin resistance, and progression of atherosclerosis in renal allograft recipients without preoperative history of diabetes.

Detailed description: This is a prospective, randomized, open-label study. The pioglitazone treatment group received 30mg pioglitazone at 2 weeks after renal transplantation for 12 months.

After treatment, we estimated insulin sensitivity index for transplantation,first phase and second phase insulin secretion, secretion area under the curve,and carotid intima-media thickness.

Eligibility criteria: Inclusion Criteria:

* Renal allograft recipients were eligible to participate in the study if they were aged ≥ 18 years, had no previous history of organ transplantation and were not currently using steroids or other immunosuppressants.

Exclusion Criteria:

* Diabetes before transplantation
* Severe metabolic or infectious disease
* Hepatic disease
* Congestive heart failure (New York Heart Association II-IV)
* Cadaver donor kidney donor transplantation
* Unstable condition of the transplanted kidney

Primary outcomes:
measure: Insulin Resistance and Insulin Secretion
timeFrame: 1 year
Secondary outcomes:
measure: carotid intima-media thickness
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
affiliation: Yonsei University
name: Hyun Chul Lee, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.
citation: Han SJ, Hur KY, Kim YS, Kang ES, Kim SI, Kim MS, Kwak JY, Kim DJ, Choi SH, Cha BS, Lee HC. Effects of pioglitazone on subclinical atherosclerosis and insulin resistance in nondiabetic renal allograft recipients. Nephrol Dial Transplant. 2010 Mar;25(3):976-84. doi: 10.1093/ndt/gfp567. Epub 2009 Oct 28.
Clinical trial NCT00254813: Fast Titration Of Quetiapine Versus Currently Approved Titration
Official title: Fast Titration Of Quetiapine Versus Currently Approved Titration: A Randomised, Multicentre, Parallel Group Open Trial In Schizophrenia And Schizoaffective Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psychotic Disorders
Keywords: Schizophrenia
Schizoaffective disorder
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of a more rapid dose titration in acute schizophrenic patients compared to the conventional titration.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent, male or female between 18 and 60 years old, having acute exacerbation of their schizophrenia or schizoaffective disorder requiring admission to hospital. Should stay in hospital for at least 7 days.

Exclusion Criteria:

* Patients treated with Risperdal consta or Clozapine last 28 days, pregnancy or breast-feeding, patients known to be intolerant or unresponsive to quetiapine, known arrhythmia, other serious medical conditions.

Primary outcomes:
measure: Proportion of patients with moderate and severe adverse events
Secondary outcomes:
measure: Mean daily level of somnolence and orthostatic dizziness as rated on AE intensity scale
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Research Site
city: Klepp Stasjon
country: Norway
facility: Research Site
city: Kristiansand
country: Norway
facility: Research Site
city: Nesttun
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Ottestad
country: Norway
facility: Research Site
city: Ålesund
country: Norway
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Norway Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03770013: Dexmedetomidine Versus Clonidine for Transversus Abdominis Plane Block in Patients Undergoing Elective Caesarean Section
Official title: Role of Co-administered Dexmedetomidine Or Clonidine With Bupivacaine for Transversus Abdominis Plane Block in Patients Undergoing Elective Caesarean Section: A Randomized, Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Bupivacaine
Dexmedetomidine
Clonidine
Transversus Abdominis Plane Block
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective Randomized Interventional double-blind study.
Primary purpose: PREVENTION

Brief summary: Aim to study the efficacy of co-administered Dexmedetomidine Or Clonidine with Bupivacaine and that of bupivacaine 0.25% alone for Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia in Patients Undergoing Elective Caesarean Section.

* Group 1: bupivacaine 0.25% + Dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml each side) was used for the TAP block.)
* Group 2: 20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml each side) was used for the TAP
* Group3: bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the TAP A prospective Randomized Interventional double-blind study.

Detailed description: Women, following Caesarean delivery, have even more compelling reasons to receive optimal post-operative pain relief, for improved maternal and neonatal well-being. Also, adequate pain relief helps the patient to ambulate early and prevent any thrombotic incidents . Dexmedetomidine, an imidazole compound, is the pharmacologically active dextroisomer of medetomidine that displays specific and selective α 2-adrenoceptor agonist activity and causes sedation, analgesia without any delirium, or respiratory depression. The mechanism of action is unique and differs from those of currently used agents, including clonidine.

Eligibility criteria: Inclusion Criteria:

* parturients scheduled to undergo cesarean section under spinal anesthesia

Exclusion Criteria:

* Patients who refused spinal anesthesia
* women with chronic pelvic pain or on chronic morphine use
* history of drug allergy
* coagulation disorder

Primary outcomes:
measure: The time for first rescue analgesia after the TAP block
timeFrame: 24 hours post operative
Secondary outcomes:
measure: Total dose of rescue analgesia
timeFrame: 24 hours postoperative
measure: Adverse effects
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
affiliation: Aswan University Hospital
name: hany f sallam, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00304213: Does Testosterone Improve Function in Hypogonadal Older Men
Official title: Does Testosterone Improve Function in Hypogonadal Older Men
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hypogonadism
Keywords: hypogonadism
testosterone
aging
Total testosterone < 300 ng/dL
Bioavailable testosterone < 70 ng/dL
Lead sponsor: North Florida Foundation for Research and Education
Sponsor class: OTHER
Collaborators: name: Solvay Pharmaceuticals
First posted: 2006-03-17
Enrollment: 0
Sex: MALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial of testosterone replacement therapy in hypogonadal men age \> 60 years. The goal is to assess the safety and efficacy of TRT in men age \> 60 years.


Eligibility criteria: Inclusion Criteria:

age 60-80 yrs serum total testosterone \< 300 ng/dL serum bioavailable testosterone \< 70 ng/dL

Exclusion Criteria:

unable to provide informed consent history of prostate or breast cancer untreated sleep apnea

Primary outcomes:
measure: Physical function
measure: Cognitive function
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Nf/Sg Vhs
state: Florida
Study officials:
affiliation: Director, GRECC
name: Thomas Mulligan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06692413: Withings Devices Follow-up Study - Hypertension
Official title: Withings Devices Follow-up Study - Hypertension
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hypertension
Lead sponsor: Withings
Sponsor class: INDUSTRY
First posted: 2024-11-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population meeting the inclusion criteria will all live in the US, regular and active users of one or several WITHINGS devices, who agreed to receive notifications from Withings Clinical Operations department, and who have previously acquired a WITHINGS device. They will receive a notification through their WITHINGS application, offering them the opportunity to participate in the study. In case of a positive answer, the user will be redirected to the study information sheet.

Brief summary: The primary objective is to evaluate the accuracy to predict uncontrolled hypertension with Withings device data.


Eligibility criteria: Inclusion Criteria:

* Male or female who are 21 years of age or older,
* Participant living in the United States,
* Participant with data recorded in WITHINGS database,
* Active WITHINGS device users having at least 2 years of data,
* Subject able to read, understand, and provide written informed consent,
* Subject willing and able to participate in the study procedures as described in the consent form,
* Subject able to communicate effectively with and willing to follow instructions from the study staff.

Exclusion Criteria:

* Minors under 21 years old,
* Subject who refused to participate in the study,
* Subject who did not reply to the questionnaire,
* Subject who objected to the processing of his or her data after the start of the study.

Primary outcomes:
measure: Prediction of uncontrolled hypertension
timeFrame: 2 years
Secondary outcomes:
measure: Correlation between Framingham risk score and EQ-5D-5L answers and Withings data
timeFrame: 2 years
measure: Number of Questionnaires answers per participant
timeFrame: 2 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University Medical School, Department of Neurology
state: Connecticut
Study officials:
affiliation: Yale University School of Medicine, Dept of Neurology
name: de Havenon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01532713: The Effect of Oxygen Administration on Regional Cerebral Oxygen Saturation (rSO2) in the Non-block Side After Stellate Ganglion Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SSNHL(Sudden Sensory Neural Hearing Loss)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-02-14
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Stellate ganglion block (SGB) is known to increase blood flow to the innervation area of the stellate ganglion. Near infrared spectroscopy reflects changes of blood volume and allows continuous, non-invasive, and bedside monitoring of regional cerebral oxygen saturation (rSO2). Previous studies have shown the increment of the rSO2 on the block side from the baseline and the decrement of the rSO2 on the non-block side after SGB. Patients with cerebral vascular disease undergoing SGB might be at risk a decrease in cerebral blood flow in the non-block side. The investigators researched the effect of oxygen administration on rSO2 in the non-block side using a near infrared spectroscopy after SGB. 5 L/min oxygen was supplied via nasal cannula from 15 minutes after SGB. The rSO2 in the non-block side were measured before SGB and 5, 10, 15, 20, 25 and 30 minutes after SGB.

The present study suggests that oxygen administration can increase the rSO2 of non-block side. In conclusion, it is our belief that oxygen supplement is helpful to the patient with cerebral vascular disease during SGB.


Eligibility criteria: Inclusion Criteria:

* ages between 20 and 70 years
* ASA PS 1,2
* disease entity : pain in the head, neck, upper extremity, and SSNHL ( sudden sensory neural hearing loss )

Exclusion Criteria:

* patient with the tendency to bleed
* patient who had cerebrovascular disease
* patient with respiratory disease ( COPD: chronic obstructive lung disease )
* patients who do not give written informed consent to participate in the study

Primary outcomes:
measure: increase on the regional cerebral oxygen saturation
timeFrame: 5 minutes after oxygen administration
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Park HM, Kim TW, Choi HG, Yoon KB, Yoon DM. The change in regional cerebral oxygen saturation after stellate ganglion block. Korean J Pain. 2010 Jun;23(2):142-6. doi: 10.3344/kjp.2010.23.2.142. Epub 2010 May 31.
citation: Kim EM, Yoon KB, Lee JH, Yoon DM, Kim DH. The effect of oxygen administration on regional cerebral oxygen saturation after stellate ganglion block on the non-blocked side. Pain Physician. 2013 Mar-Apr;16(2):117-24.
Clinical trial NCT05103813: Protective Effect of Beraprost Sodium Tablets on Reperfusion Therapy for Acute STEMI
Official title: Protective Effect of Beraprost Sodium Tablets on Coronary Microcirculation Function and Ventricular Remodeling After Reperfusion Therapy for Acute ST Segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Essential Hypertension
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Protective effect of Beraprost Sodium Tablets on coronary microcirculation function and ventricular remodeling after reperfusion therapy for acute ST segment elevation myocardial infarction


Eligibility criteria: Inclusion Criteria:

* It meets the diagnostic criteria of acute ST segment elevation myocardial infarction: ischemic chest pain lasts for more than 30 minutes and can not be relieved by taking nitroglycerin; ST segment elevation of ECG with two or more adjacent leads, limb lead ≥ 1mm, chest lead ≥ 2mm; Or new left bundle branch block; The serum markers of myocardial necrosis increased at least twice the normal value
* Acute myocardial infarction was confirmed by coronary angiography
* The clinical and angiographic data were complete
* Direct PCI was performed within 12 hours after onset

Exclusion Criteria:

* Those who do not cooperate in the inspection, have poor compliance and cannot guarantee the completion of the test
* Conscious disorder, obvious intellectual disorder and mental disorder
* With metal foreign bodies, such as metal prosthesis, intraocular metal foreign bodies, intracranial aneurysm clamp, etc
* People with claustrophobia
* Had a history of myocardial infarction, PCI and coronary artery bypass grafting
* Factors affecting ST segment changes of ECG: complete left bundle branch block, preexcitation syndrome, pacemaker ECG, etc

Primary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: 1 weeks after baseline
measure: Major Adverse Cardiovascular Events
timeFrame: 6 months after baseline
measure: Major Adverse Cardiovascular Events
timeFrame: 1 year after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People' S Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00653913: Evaluation of Potential for Drug Interaction Between SCH 58235 (Ezetimibe) and Pitavastatin (Study P03962)(COMPLETED)
Official title: Evaluation of Potential for Pharmacokinetic Drug Interaction Between SCH 58235 and Pitavastatin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-04-07
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the pharmacokinetic interaction and safety of coadministration of SCH 58235 (ezetimibe) and pitavastatin in healthy Japanese adult male subjects or adult male subjects having no obvious disease other than high cholesterol levels.


Eligibility criteria: Inclusion Criteria:

* Healthy adult male subjects meeting all the criteria below or adult male subjects having no obvious disease other than high cholesterol levels.
* Aged 20 years or over and 65 years or below when the informed consent is obtained.
* Weighing 50 kg or over and 80 kg or below on the day of the screening tests, with BMI \[Body Mass Index: body weight (kg)/height (m)2\] ranging from 16.5 to 27.5.

Exclusion Criteria:

Patients meeting any one of the following conditions are excluded from the study.

* Subjects with the triglyceride value at screening test exceeding 500 mg/dL.
* Subjects with past history of drug allergy (shock, anaphylactic symptom, and angioedema).
* Subjects with past history of alcohol or drug dependence.
* Subjects with past history of mental disorder.
* Subjects positive in the test for HBs antigen, HCV antibody, or HIV antibody or in the serological test for syphilis.
* Subjects who used any drug within 2 weeks of investigational product administration in Period 1.
* Subjects who have drawn more than 400 mL of blood within 12 weeks before administration day in Period 1.
* Subjects who participated in other study within 16 weeks of investigational product administration in Period 1 and was administered a investigational product.
* Subjects who cannot take contraceptive measures during the study period (from providing informed consent to completion of Period 3 examination)
* Subjects who the investigator judges are inappropriate to participate in the study.

Primary outcomes:
measure: Compare plasma concentrations of SCH 58235 (ezetimibe) and pitavastatin after administration of each drug alone and in combination, using Cmax and AUC(0-24h).
timeFrame: Day 7 of each period
Secondary outcomes:
measure: Compare plasma concentrations of SCH 58235 (ezetimibe) and pitavastatin administration of each drug alone and in coadministration, using Tmax, plasma concentration 24 h after last dose, and AUC(I).
timeFrame: Day 7 of each period
measure: Adverse events, laboratory tests results, and vital signs.
timeFrame: Throughout study
Other outcomes:
Locations:
Study officials:
References: