louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06429137: A Study in Healthy Men to Test How Well Different Doses of BI 3731579 Are Tolerated
Official title: A Partially Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3731579 Administered as Tablet to Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-05-24
Enrollment: 63
Sex: MALE
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: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3731579 in healthy male subjects.


Eligibility criteria: Inclusion criteria

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 45 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
4. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply

Primary outcomes:
measure: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
timeFrame: up to 14 days
Secondary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
timeFrame: up to 4 days
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: up to 4 days
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: up to 4 days
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: Humanpharmakologisches Zentrum Biberach
Study officials:
References:
Clinical trial NCT00575237: A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain
Official title: A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Keywords: Laparoscopic Surgery
Shoulder pain
PDNV
Anesthesia
Residual CO2
Postoperative Pain
Female ASA 1 and 2 outpatients who were scheduled for elective gynecologic laparoscopic surgery
Lead sponsor: Phelps, Paul, M.D.
Sponsor class: INDIV
Collaborators: name: University of California, San Francisco
First posted: 2007-12-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A pulmonary recruitment maneuver at the end of surgery reduced shoulder pain as well as nausea and vomiting after laparoscopic surgery.

Detailed description: With IRB approval and informed consent, 100 female ASA 1 and 2 outpatients who were scheduled for elective gynecologic laparoscopic surgery were randomly allocated to either the current standard (control group) or to additional efforts to remove residual CO2 at the end of surgery (intervention group; power analysis yielded 45 patients necessary per group). In the control group, CO2 was removed by passive deflation of the abdominal cavity through the holes of the trocar. In the intervention group, CO2 was removed by means of Trendelenburg position (\> 30 degrees) with 5 manual pulmonary recruitment maneuvers. Postoperative shoulder pain was assessed prior to discharge and 12, 24, 36 and 48 hours later using a visual analog scale (VAS). In addition, positional characteristics of the shoulder pain and incidence of postdischarge nausea and vomiting (PDNV) were recorded 48 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* female
* age 15-65
* ASA I-II
* scheduled for outpatient gynaecological procedure

Exclusion Criteria:

* previous laparatomy
* patients requiring hospitalisation
* procedure required conversion to laparatomy
* 48h follow-up no feasible

Primary outcomes:
measure: Intensity of shoulder pain
timeFrame: 48 hours after discharge
Secondary outcomes:
measure: Incidence of Nausea and Vomiting
timeFrame: 24hrs after discharge
Other outcomes:
Locations:
city: Wildomar
country: United States
facility: Inland Valley and Rancho Springs Medical Centers
state: California
Study officials:
affiliation: Department of Anesthesia, Southwest Healthcare System, Murrieta, California
name: Paul Phelps, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.
Clinical trial NCT02023437: Long-term (3 Months) Safety of Femtosecond-laser Assisted Cataract Surgery
Official title: A Prospective, Post-Market-Clinical-Follow-Up Study to Investigate the Long-term (3 Months) Safety of Femtosecond-laser Assisted Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Lead sponsor: Technolas Perfect Vision GmbH
Sponsor class: INDUSTRY
First posted: 2013-12-30
Enrollment: 132
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study is a prospective, post-market-clinical-follow-up study to investigate the long-term (3 months) safety of femtosecond laser assisted cataract surgery as a study follow-up extension to the Study #1304 titled as "A Multi-centre, Multi-surgeon, Randomized, Controlled, Prospective, Post-Market-Clinical-Follow-Up Study to Investigate the Impact of Cataract Grade on the Efficacy and Safety of Femtosecond-laser Assisted Lens Fragmentation Procedure".


Eligibility criteria: Only the patients who were successfully enrolled in Study #1304 are eligible for this follow-up extension study.

Primary outcomes:
measure: Adverse Events
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Zlin
country: Czech Republic
facility: Gemini Eye Clinic
city: Hyderabad
country: India
facility: MaxiVision Laser Centre Private Limited
Study officials:
affiliation: Gemini clinic, Zlin, Czech Republic 76001
name: Pavel Stodulka, Dr. Med.
role: PRINCIPAL_INVESTIGATOR
affiliation: MaxiVision Laser Centre Private Limited, Hyderabad, India
name: Kasu P Reddy, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: MaxiVision Laser Centre Private Limited, Hyderabad, India
name: N Sreelakshmi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Slade & Baker Vision Center
name: Steve Slade, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00167037: Fast Stepping in Stroke Patients for Fall Prediction and Prevention:Control Mechanisms and Clinical Implications
Official title: Fast Stepping in Stroke Patients for Fall Prediction and Prevention:Control Mechanisms and Clinical Implications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Hemiplegia
Waist pulling perturbation
Reactive balance strategy
Trajectory of center of pressure
Parameters of center of pressure
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2005-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: The purpose of this study was to compare the balance strategy, as well as center of pressure (COP) trajectory and parameters between healthy adults and patients with hemiplegia in response to slow- and fast-speed waist- pulling perturbations in forward, left, right, and backward directions.

Detailed description: The ability to quickly respond to external perturbations is an important capacity of stroke patients to maintain dynamic balance in activities of daily living. The purpose of this study was to compare the balance strategy, as well as center of pressure (COP) trajectory and parameters between healthy adults and patients with hemiplegia in response to slow- and fast-speed waist- pulling perturbations in forward, left, right, and backward directions.

Eligibility criteria: Inclusion Criteria:

Healthy adults

* Age ang Sex are correspond with the stroke subjects(between 40 and 75 years old)
* being willing to accept one-year follow-up examination
* being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital Stroke patients
* between 40 and 75 years old
* stroke confirmed by ICD-10-CM (including I60, I61, I62, I63, I67, and I69)
* first stroke with single side hemiplegia and received acute treatment at NTUH
* being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital
* able to step forward, laterally and backward independently without assistive device

Excursion criteria:

Healthy adults

* - having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases those would influence the belance or motor ability Stroke patients
* having unstable vital sign, unconsciousness, or obvious cognitive, perception, and language impairment, and couldn't communicate with the experimenters
* having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal or cardiovascular disorders, or disorders from systematic diseases other than stroke

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Pei-Fang Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00564837: Home Vs. Physiotherapy Supervised Rehabilitation After ACL Reconstruction
Official title: Comparison of Home Vs. Physiotherapy-Supervised Rehabilitation Programs Following Reconstruction of the Anterior Cruciate Ligament (ACL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACL Reconstruction
Keywords: Anterior cruciate ligament
Reconstruction
Rehabilitation
Home-based
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Calgary Health Region
name: Olympic Oval Endowment Fund
name: AirCast LLC
name: Fitter International Inc.
First posted: 2007-11-28
Enrollment: 145
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to determine whether or not there were any differences in knee range of motion, both statically and during gait, sagittal plane knee laxity, and quadriceps and hamstrings strength in patients three months post-ACL reconstruction with a bone-patellar tendon-bone autograft based on their performance of a primarily home based rehabilitation program or a standard physiotherapy-supervised program.


Eligibility criteria: Inclusion Criteria:

1. 16 years of age or older
2. Surgery at least 6 weeks after injury to allow for a return of full range of motion, minimize swelling, and offset strength deficits due to pain/swelling14,28
3. ACL reconstruction with a bone-patellar tendon-bone autograft

Exclusion Criteria:

1. Previous or concomitant reconstruction of any knee ligament to either knee
2. Ongoing knee abnormality unrelated to the ACL injury (eg, evidence of changes on radiographs consistent with osteoarthritis)
3. Professional athletes or workers' compensation patients
4. Complications during surgery (eg, inadequate graft fixation requiring protocol modification)
5. Patients without access to local physical therapy services

Primary outcomes:
measure: Active assisted knee flexion and passive knee extension range of motion
timeFrame: pre-op, 6 & 12 weeks post-op
Secondary outcomes:
measure: Knee flexion and extension range of motion during gait
timeFrame: pre-op, 6 & 12 wks post-op
measure: Sagittal plane laxity of the knee
timeFrame: pre-op, 6 & 12 wks post-op
measure: Isokinetic quadriceps and hamstrings strength
timeFrame: pre-op and 12wks post-op
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary Sport Medicine Centre
state: Alberta
Study officials:
affiliation: University of Calgary Sport Medicine Centre
name: Nicholas G. Mohtadi, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grant JA, Mohtadi NG, Maitland ME, Zernicke RF. Comparison of home versus physical therapy-supervised rehabilitation programs after anterior cruciate ligament reconstruction: a randomized clinical trial. Am J Sports Med. 2005 Sep;33(9):1288-97. doi: 10.1177/0363546504273051. Epub 2005 Jul 7.
Clinical trial NCT01594437: Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody
Official title: Phase 1 Study of TCN-202 (Human Anti-Cytomegalovirus Monoclonal Antibody) in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cytomegalovirus Infections
Keywords: Cytomegalovirus
Monoclonal antibody
Lead sponsor: Theraclone Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-09
Enrollment: 48
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: The purpose of this study is to compare the safety profile in healthy adult volunteers of single or multiple intravenous administrations of TCN-202 as compared with placebo.

Detailed description: Human cytomegalovirus (HCMV) disease remains an unmet medical need: In the US, the estimated prevalence of congenital HCMV infection is \~1% and is one of the leading causes of permanent hearing loss and neurological deficits in children. In immunocompromised individuals such as transplant recipients it can cause serious life-threatening disease and may significantly increase the risk of graft rejection. As existing therapies for HCMV can have serious side effects, there remains a medical need for safe and effective treatment of HCMV disease.

Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers
* Normal lab tests

Exclusion Criteria:

* Prior treatment with monoclonal antibody

Primary outcomes:
measure: Number and severity of adverse events
timeFrame: 60 days post infusion
Secondary outcomes:
measure: Peak serum concentration (Cmax) of TCN-202
timeFrame: 1 day post infusion
measure: Number of subjects who develop anti-TCN-202 anti-drug antibodies (immunogenicity)
timeFrame: 60 days post infusion
measure: Area under the concentration time curve (AUC) of TCN-202
timeFrame: 60 days post infusion
measure: Time to maximum serum concentration (Tmax) of TCN-202
timeFrame: 1 day post infusion
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: SNBL Clinical Pharmacology Center
state: Maryland
Study officials:
affiliation: SNBL Clinical Pharmacology Center
name: Mohamed Al-Ibrahim, MD, FACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01240837: Effect of Palm Sugar on Blood Glucose Concentrations
Official title: Investigation of the Glycaemic Index of Arenga Pinnata Palm Sugar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Keywords: glycaemic index
arenga pinnata sugar
palm sugar
diabetes
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2010-11-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine by how much, the ingestion of palm sugar increases blood glucose concentrations and what the corresponding glycaemic index is. The investigators estimate that the glycaemic index will be 68 (equal to that of sucrose).


Eligibility criteria: Inclusion criteria:

* Healthy: as judged by the participant;
* Age: 18 to 35.

Exclusion criteria:

* Pregnant or lactating females
* Presence of a chronic disease such as diabetes, illness, dysmetabolic syndrome
* 18.5 \< BMI \< 25
* Allergy or intolerance to palms or coconuts
* Weight loss or gain of more then 5 kg in the last two months
* Fasting blood glucose levels \<100 mg/dl or 5.6 mmol/l
* Smokers
* Use of medications other then birth control
* Previous problems with blood sampling

Primary outcomes:
measure: Blood glucose concentrations
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
state: Gelderland
Study officials:
affiliation: Wageningen University
name: Lydia Afman, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02843737: Multicenter Observational Study to Validate a New Index for Sleep Fragmentation Analysis: Sleep Diversity Index (SDI)
Official title: Multicenter Observational Study to Validate a New Index for Sleep Fragmentation Analysis: Sleep Diversity Index (SDI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Fragmentation
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
Collaborators: name: Toulon University
name: bio N com Association
First posted: 2016-07-26
Enrollment: 300
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 who performed a spontaneous breathing polysomnography

Brief summary: The investigators want to validate the Sleep Diversity Index as a diagnosis tool of sleep fragmentation on 405 patients who will perform a polysomnography under spontaneous breathing.

Detailed description: Sleep fragmentation is one of the main problems of sleep disorders especially in respiratory failure. During this last decade, several indicators of sleep fragmentation were introduced but none of them seems to take into account the succession of sleep stages. To tackle with this problem, The investigators used the Shannon entropy index for modelling sleep stages diversity from an hypnogram and for assessing more accurately sleep quality by quantifying its fragmentation. The investigators developed a new tool we called Sleep Diversity Index (SDI).

In a retrospective study, the investigators calculated Sleep diversity index for 55 healthy subjects and 56 patients with suspected sleep apnea syndrom. Using the receiver operating characteristic (ROC) curves the threshold of fragmentation was determined at 20%. If SDI is lower than 20%, then sleep is considered as non-fragmented and otherwise, sleep is considered as fragmented.

To validate our SDI it is necessary to compare this diagnosis tool to a "gold standard" based on the clinician diagnosis and a mathematical diagnosis index created from objective criteria of polysomnography. The investigators propose a multicenter study to validate the SDI as a diagnosis tool of sleep fragmentation.

Eligibility criteria: Inclusion Criteria:

* Spontaneous polysomnography

Exclusion Criteria:

* Insomnia
* Patients with psychoactive drug having an important effect on sleep

Primary outcomes:
measure: Comparison between mathematical analysis and clinician interpretation of polysomnographic datas recorded under spontaneous breathing
timeFrame: One night
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon
city: Poitiers
country: France
facility: CHU Poitiers
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (CHITS)
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur mer
name: Daniel D'AMORE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06676137: An Observational Study of Coronary Microvascular Disease of China
Official title: China Coronary Microvascular Disease(CCMD) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Microvascular Disease
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient had obvious symptoms of angina pectoris, but coronary angiography showed no obvious epicardial stenosis, and auxiliary examinations such as ultrasound, CTP,CMR, PET, SPECT, and coronary function examination indicate the presence of microcirculation dysfunction

Brief summary: Non-obstructive coronary heart disease refers to patients with angina pectoris without significant narrowing of the epicardial vessels. Coronary microvascular disease(CMD) is a kind of non-obstructive coronary heart disease, and its clinical detection rate is increasing, seriously affecting the quality of life of patients, and increasing the risk of cardiovascular adverse events, but its mechanism has not been fully understood. This study will prospectively collect patients who meet the diagnosis of CMD, observe the development and outcome of the disease, and explore its occurrence and development mechanism.


Eligibility criteria: Inclusion Criteria:

1. Angina symptoms
2. Objective evidence of myocardial ischemia
3. Coronary angiography was normal,irregular tube wall, or stenosis \<50%

Exclusion Criteria:

1. People under the age of 18
2. Non-cardiogenic chest pain and other heart conditions such as variant angina, cardiomyopathy, myocarditis or valvular heart disease

Primary outcomes:
measure: Establish a Registry of CMD patients in China
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Fuwai central China cardiovascular hospotial
Study officials:
affiliation: Fuwai central China cardiovascular hospotial
name: muwei li, Ph.D
role: STUDY_CHAIR
References: