louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00916110: Study Of Single Dose Of ATN-103 Administered To Healthy Japanese Male Subjects
Official title: Ascending Single Dose Study Of The Safety, Tolerability, PK And PD Of ATN-103 Administered SC Or IV To Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy subjects
Lead sponsor: Ablynx, a Sanofi company
Sponsor class: INDUSTRY
First posted: 2009-06-09
Enrollment: 72
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the safety and tolerability of ascending single SC and IV doses of ATN-103 in healthy Japanese male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese male subjects aged 20 to 45 with health determined by the study investigator.
* BMI in the range of 17.6 to 26.4.
* Nonsmoker or male who smokes fewer than 10 cigarettes per day.

Exclusion Criteria:

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7 days before study day 1.

Primary outcomes:
measure: Safety and tolerability are evaluated from the reported AEs, vital sign, laboratory test, etc.
timeFrame: 24weeks
Secondary outcomes:
measure: Antibody in blood and drug concentration in blood and urine are evaluated.
timeFrame: 24weeks
Other outcomes:
Locations:
city: Toshima
country: Japan
facility: Investigational Site
state: Tokyo
Study officials:
affiliation: Ablynx NV
name: Josefin-Beate Holz, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01861210: Couples HIV Counseling and Testing for Male Couples in the United States
Official title: Couples HIV Counseling and Testing for Male Couples in the United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Homosexuality, Male
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-05-23
Enrollment: 216
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a study to determine whether testing for HIV together as a couple, as opposed to testing separately, in acceptable to men in male couples, and is a safe prevention service. Testing of couples together has been provided for decades in Africa, but has never been tested in the United States. In this study, male couples will be enrolled and randomly assigned to be tested together in the same room, or separately. At the time of testing, investigators will ask questions about how they felt about the service they received. Three months later, investigators will survey the men again, and determine whether they had any problems after the testing, like violence in the relationship or the relationship breaking up. The main outcomes are being satisfied with the testing service, and safety (lack of intimate partner violence or relationship termination). Although the study is not designed to determine if the service reduces risk behaviors for HIV transmission, investigators will examine data on risks just to explore that topic. The main hypotheses are: (1) men will be at least as satisfied with couples testing as they are with individual testing; and (2) men tested as couples will not experience higher rates of intimate partner violence or relationship dissolution, relative to men tested separately.


Eligibility criteria: Inclusion Criteria:

* male at birth
* currently self-identify as male
* at least 18 years of age
* have been in a couple with a man for at least 3 months
* willing to complete a follow-up study visit in 3 months
* able to complete study assessments in English.

Exclusion Criteria:

* known to be HIV-positive
* over 39 years of age
* either partner being unwilling to accept randomization to the couples testing arm
* either partner planning to move from the Atlanta area within 3 months of the initial study visit
* either partner reporting a history of intimate partner violence
* either partner reporting feeling coerced to tested with his partner

Primary outcomes:
measure: Intimate partner violence
timeFrame: 3 months
Secondary outcomes:
measure: Relationship dissolution
timeFrame: 3 months, or at the time of followup survey
Other outcomes:
measure: Satisfaction with counseling service
timeFrame: Within 30 minutes after the service
Locations:
city: Atlanta
country: United States
facility: AID Atlanta
state: Georgia
Study officials:
affiliation: Emory University Rollins School of Public Health
name: Patrick S Sullivan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00591110: Project inCharge: Increasing the Rate of Comprehensive Eye Care Utilization by Older African Americans Through Community-Based Eye Health Education Program
Official title: Project inCharge: Increasing the Rate of Comprehensive Eye Care Utilization by Older African Americans Through Community-Based Eye Health Education Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye Disease
Eye Care
Vision
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-01-11
Enrollment: 177
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study design is a randomized intervention evaluation. Ten senior centers in predominately African American communities in the Birmingham, Alabama will be selected as sites for the educational intervention. Five centers will be randomly assigned to receive an educational intervention communicating practical information about vision, eye conditions and eye care as pertinent to the older African American population. The other five centers will serve as social-contact controls, where participants will receive an engaging information session on a non-health related topic. The primary outcome of interest is the change in percentage of persons receiving comprehensive eye care from pre- to post- intervention. The secondary outcomes are the process outcomes of improvement in knowledge, attitudes, and values about vision, eye conditions, and eye care.


Eligibility criteria: Inclusion Criteria:

* African Americans ages \>=60 years residing in the communities targeted for intervention or control activities

Exclusion Criteria:

* Persons who do not speak English, persons who are not community-dwelling.

Primary outcomes:
measure: Change in the percentage of persons receiving comprehensive eye care from pre- to post- intervention
timeFrame: 6 months
Secondary outcomes:
measure: Improvement in knowledge, attitudes, and values about vision, eye conditions, and eye care and reduction in perceived barriers to care.
timeFrame: 18 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Cynthia Owsley, PhD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Owsley C, McGwin G Jr, Searcey K, Weston J, Johnson A, Stalvey BT, Liu B, Girkin CA. Effect of an eye health education program on older African Americans' eye care utilization and attitudes about eye care. J Natl Med Assoc. 2013 Spring;105(1):69-76. doi: 10.1016/s0027-9684(15)30087-0.
Clinical trial NCT05850910: Comparison Of The Immediate Effects Of Manipulation On The Autonomic Nervous System
Official title: Comparison Of The Immediate Effects Of Manipulation On The Autonomic Nervous System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vagus Nerve Autonomic Disorder
Keywords: manipulation
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High velocity low amplitude thrust applied at the vertebral level during spinal manipulation is thought to slide the vertebrae over each other and alter segmental biomechanics.

Detailed description: Evidence suggests that spinal HVLA techniques may produce acute changes in skin sympathetic nerve activity. There are studies reporting that thoracic HVLA manipulation causes a statistically significant increase in cardiac vagal activity in the immediate post-intervention period compared to sham administration.

Eligibility criteria: Inclusion criteria:

* People who volunteered to work and signed the consent form
* Not having any of the application contraindications or exclusion criteria.
* Being between the ages of 18-45

Exclusion criteria:

* Presence of tumor, infection, trauma, inflammation
* Neurological problems (Acute myelopathy, spinal cord compression, cauda equina syndrome, nerve root compression)
* Vascular disorders (Vertebrobasilar insufficiency or cervical artery abnormalities, aortic aneurysm, angina pectoris, acute abdominal pain with preservation)

Primary outcomes:
measure: Autonomic nervous system device
timeFrame: one day
measure: Finger Oximeter
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: HAZAL genç
state: None Selected
Study officials:
References:
citation: Rodrigues PTV, Correa LA, Reis FJJ, Meziat-Filho NA, Silva BM, Nogueira LAC. One Session of Spinal Manipulation Improves the Cardiac Autonomic Control in Patients with Musculoskeletal Pain: A Randomized Placebo-Controlled Trial. Spine (Phila Pa 1976). 2021 Jul 15;46(14):915-922. doi: 10.1097/BRS.0000000000003962.
Clinical trial NCT03270410: Design of a Non-invasive Multi-modal Neonatal Monitoring System
Official title: Design of a Non-invasive Multi-modal Neonatal Monitoring System: Preliminary Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Disorder
Keywords: neonates
non invasive monitoring
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 35
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is aimed at newborns hospitalized at the CHU in Rennes

Brief summary: This is a preliminary study whose objectives are to define the clinical use cases and the constraints of the implementation of a multi-sensor image-sound system.

Detailed description: 300 000 newborns per year are hospitalized in European neonatal units in the post-natal period. This is a critical period for neurobehavioral development and the establishment of an optimal model of sleep-wake cycle is fundamental for brain development.

The objective of the research is to develop new tools for computer-aided clinical and predictive diagnosis and real-time monitoring in neonatology.

The development of non-invasive sensors based on video and sound images aims to improve the short- and medium-term prognosis in perinatal patients.

To that aim, multi-modal composite indices integrating the image (which is used only to generate a quantification of the movement) and the sound to the bioelectric signals already available (electrocardiogram, oxymetry, temperature) will be developed to provide diagnostic and prognostic information.

Eligibility criteria: Inclusion Criteria:

* newborns less than 6 weeks old in corrected terms;
* newborns in one of the following situations:

  * persistent discomfort (apneas);
  * infection or suspicion of infection;
  * premature with uncomplicated evolution;
  * Premature brain lesion acquired in perinatal;
  * newborn having been exposed to premature rupture of the membranes.

Exclusion Criteria:

* Congenital malformation;
* Metabolic disease.

Primary outcomes:
measure: Evolution of the cardiac variability during the stay in the ward
timeFrame: Up to 2 months
Secondary outcomes:
measure: Evolution of the respiratory variability during the stay in the ward
timeFrame: Up to 2 months
measure: Evolution of the babies' movements during the stay in the ward
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: CHU Rennes
name: Patrick PLADYS, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00160810: Outcome Study of Complex Distal Radius Fractures
Official title: Outcome Study of Complex Distal Radius Fractures: Open Reduction Internal Fixation (ORIF) With A Volar Fixed Angled Plate Versus A Distal Radius Volar (DRV) Plate Versus External Fixation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Radius Fractures
Keywords: distal
radius
fractures
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 74
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Orthopaedic clinic

Brief summary: The purpose of this study is to collect information about how people do after different treatments of a broken wrist to see if one treatment has better results.

Detailed description: Complex distal radius fractures are a common problem treated by orthopaedic surgeons. The purpose of this study is to compare the outcome between complex distal radius fractures treated with open reduction and internal fixation using a volar fixed angled plate versus and external fixator versus DRV. The hypothesis is that the volar fixed angled plate will have a superior outcome both radiographically and clinically.

Eligibility criteria: Inclusion Criteria:

* distal radius fracture

Exclusion Criteria:

* none

Primary outcomes:
measure: Wrist Range of Motion
timeFrame: one year post-op
Secondary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH) and Patient Rated Wrist Evaluation (PRWE) scores
timeFrame: one year post-op
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF and Shands Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: University of Florida
name: Thomas W. Wright, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00315510: Rosuvastatin and Ischemia Reperfusion
Official title: Does Rosuvastatin Reduce Ischemia/Reperfusion Injury in Humans In-Vivo? A Randomized Double Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemia
Keywords: Ischemia-reperfusion
Annexin A5
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2006-04-18
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Statins, including rosuvastatin, are drugs that lower plasma cholesterol and prevent atherosclerotic disease. Recent preclinical evidence suggests that statins also increase tissue tolerance to ischemia-reperfusion injury.

This is a randomized, double blind, parallel designed study comparing the effect of 1 week treatment with rosuvastatin (20 mg, once a day) with placebo on forearm ischemia-reperfusion injury in healthy male volunteers. Forearm ischemia-reperfusion injury is quantified with Tc-99m-annexin A5 scintigraphy of the hands after a standardized ischemic exercise test. For this purpose, Tc-99m-rh-annexin A5 (400 MBq; \< 5 mSv) is injected intravenously upon reperfusion, followed by scintigraphy of both hands with a gamma camera at 1 and 4 hours after injection. Annexin A5 targeting is calculated as the percentage difference in activity (counts/pixel) between the thenar muscles of both hands.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (18-50 years of age)

Exclusion Criteria:

* Hypercholesterolemia
* Hypertension

Primary outcomes:
measure: annexin A5 targeting to ischemically exercised hand
Secondary outcomes:
measure: plasma lipid levels
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Clinical Research Centre Nijmegen; Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Dept. of Pharmacology-Toxicology; Radboud University Medical Centre
name: Gerard A. Rongen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rongen GA, Oyen WJ, Ramakers BP, Riksen NP, Boerman OC, Steinmetz N, Smits P. Annexin A5 scintigraphy of forearm as a novel in vivo model of skeletal muscle preconditioning in humans. Circulation. 2005 Jan 18;111(2):173-8. doi: 10.1161/01.CIR.0000151612.02223.F2. Epub 2004 Dec 27.
citation: Meijer P, Oyen WJ, Dekker D, van den Broek PH, Wouters CW, Boerman OC, Scheffer GJ, Smits P, Rongen GA. Rosuvastatin increases extracellular adenosine formation in humans in vivo: a new perspective on cardiovascular protection. Arterioscler Thromb Vasc Biol. 2009 Jun;29(6):963-8. doi: 10.1161/ATVBAHA.108.179622. Epub 2009 Apr 9.
Clinical trial NCT05134610: Effect of Perioperative OPEP Therapy on Post-operative Pulmonary Complications
Official title: Effectiveness of Perioperative Oscillating Positive Expiratory Pressure (OPEP) Therapy in Reduction of Post-operative Respiratory Morbidity in Patients Undergoing Colorectal Surgery: a Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Complication
Surgery--Complications
Surgery
Keywords: oscillating pulmonary expiratory pressure therapy
OPEP
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 150
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: For patients undergoing colorectal surgery, post-operative pulmonary complications (PPCs) are common. PPCs are associated with increased morbidity and mortality, as well as prolonged hospital stays and healthcare costs. Pulmonary exercise in the pre-operative setting is thought to improve pulmonary fitness and decrease incidence of PPCs. Use of an oscillating positive expiratory pressure (OPEP) device sees patients improve their respiratory fitness through prescribed usage of a handheld instrument that exercises pulmonary muscles while breathing. Here, the investigators propose a pilot randomized-controlled trial (RCT) to evaluate the feasibility of a large scale study that would examine the effect of preoperative OPEP device exercises in preventing PPCs for patients undergoing elective colorectal surgery.


Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years of age or older, and scheduled for an elective colorectal procedure at London Health Science Center (LHSC). Informed consent must be obtained.

Exclusion Criteria:

* Patients unable to perform written consent will be excluded. The investigators will not include colorectal procedures performed for urgent or emergent indications. Patients with advanced pulmonary disease necessitating home oxygen pre-operatively will be excluded. Patients that are pregnant will be excluded.

Primary outcomes:
measure: Trial feasibility: capacity for recruitment
timeFrame: 18 months
measure: Trial feasibility: device adherence
timeFrame: 18 months
measure: Trial feasibility: data collection
timeFrame: 18 months
measure: Trial feasibility: limited efficacy of the OPEP device
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00233610: Two Different Regimens of Nolvadex in Preventing Gynecomastia Induced by Casodex 150 mg in Patients With Prostate Cancer
Official title: A Comparative Trial of the Efficacy of Two Different Nolvadex (NDX) Dosing and Scheduling Regimens in Preventing Gynecomastia Induced by Casodex (CDX) 150 Monotherapy in Prostate Cancer Patients. An Open, Multicenter, Phase III Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Casodex monotherapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-06
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to investigate the efficacy of different dosing and scheduling of Nolvadex in preventing gynecomastia/mastalgia induced by Casodex 150 mg monotherapy in patients with prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed prostate cancer
* Locally advanced prostate cancer patients suitable for Casodex 150 mg monotherapy

Exclusion Criteria:

* Age \> 75 yrs
* No metastatic disease (M1).
* No presence of gynaecomastia and/or mastalgia at screening
* No therapy with medications able to provoke gynaecomastia and/or mastalgia within 6 months of trial entry.

Primary outcomes:
measure: Incidence of Gynecomastia and Breast pain at 2, 6 months and every 6 months thereafter and/or at withdrawal visit.
Secondary outcomes:
measure: Sexual functioning, Quality of life.
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Research Site
state: BA
city: Bologna
country: Italy
facility: Research Site
state: BO
city: Catania
country: Italy
facility: Research Site
state: CT
city: Bagno a Ripoli
country: Italy
facility: Research Site
state: FI
city: Firenze
country: Italy
facility: Research Site
state: FI
city: Genova
country: Italy
facility: Research Site
state: GE
city: Pisa
country: Italy
facility: Research Site
state: PI
city: Parma
country: Italy
facility: Research Site
state: PR
city: Udine
country: Italy
facility: Research Site
state: UD
city: Como
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Astra Zeneca
role: STUDY_DIRECTOR
References: