louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01719211: Genetic Basis of Mitral Valve Prolapse
Official title: Genetic Basis of Mitral Valve Prolapse
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Valve Prolapse
Keywords: MVP, mitral valve
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Leducq Foundation
First posted: 2012-11-01
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for 2D echo for MVP

Brief summary: The investigators have successfully identified two novel genetic loci for MVP on chromosomes 11 and 13 and are searching for altered genes in these regions. This requires recruiting large families who may have MVP linked to these or other chromosomes; and obtaining DNA samples from 1,000-1,500 individually affected patients to study the relation between DNA markers throughout the genome and MVP. It is our expectation that the results of this study will lead to the discovery of gene(s) responsible for MVP. This will lead to improved understanding of the disease and, in turn, improved ability to treat and prevent progression in genetically susceptible individuals.

Detailed description: This is a genome-wide association study.

Eligibility criteria: Inclusion Criteria:

* Mitral valve prolapse

Exclusion Criteria:

* Other mitral valve diseases

Primary outcomes:
measure: Discovery of the genetic basis of Mitral Valve Prolapse
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mass General Hospital
state: Massachusetts
Study officials:
affiliation: Mass. General Hospital
name: robert a levine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01191593: The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty
Official title: The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Knee Arthroplasty
Keywords: Adductor-Canal-Blockade
postoperative pain
US-guided nerve block
revision knee arthroplasty
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2010-08-31
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing pain and morphine consumption after revision knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Revision Knee Arthroplasty in general anaesthesia
* American society of anesthesiologists (ASA) 1-3
* BMI 18-40
* Written informed consent

Exclusion Criteria:

* Can not cooperate to the exam
* Do not speak or understand Danish
* Drug allergy
* Alcohol or drug abuse

Primary outcomes:
measure: Pain during 45 degrees active flexion of the knee
timeFrame: 4 hours postoperative
Secondary outcomes:
measure: Pain during 45 degrees active flexion of the knee
timeFrame: 1-8 hours postoperative
measure: Pain during 45 degrees active flexion of the knee
timeFrame: 24 hours postoperative
measure: Pain during rest
timeFrame: 1-8 hours postoperative
measure: Pain during rest
timeFrame: 24 hours postoperative
measure: Total morphine consumption
timeFrame: 0-24 hours postoperative
measure: Postoperative nausea
timeFrame: 1-8 hours postoperative
measure: Postoperative nausea
timeFrame: 24 hours postoperative
measure: Postoperative vomiting
timeFrame: 0-24 hours postoperative
measure: Zofran consumption
timeFrame: 0-24 hours postoperative
measure: Sedation
timeFrame: 1-8 hours postoperative
measure: Sedation
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Anaesthesia and Surgery, HOC, Rigshospitalet, Denmark
state: København Ø
Study officials:
affiliation: Rigshospitalet, Denmark
name: Pia Jæger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaeger P, Koscielniak-Nielsen ZJ, Schroder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014 Nov 11;9(11):e111951. doi: 10.1371/journal.pone.0111951. eCollection 2014.
Clinical trial NCT05876793: Effective Dose of Remimazolam Combined With Propofol in Painless Gastroscopy
Official title: Effective Dose of Remiazolam Tosylate Combined With Propofol in Upper Gastrointestinal Endoscopy Sedation: a Dose-determination Study Using Dixon's Up-and-down Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of Drug
Keywords: combination
effective dose
remimazolam
propofol
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: We will use the Dixon's up and down method.
Primary purpose: TREATMENT

Brief summary: This study used sequential method（Dixon's up and douwn） to determine the effective dose of remiazolam combined with propofol in painless upper gastrointestinal endoscopy

Detailed description: Remimazolam tosylate is a novel benzodiazepine drug that can be used for gastrointestinal sedation. However, some studies have reported that the sedative effect of using remimazolam alone is poor, and the patient's body movements are obvious, which affects the operation of endoscopists. Propofol, as a commonly used sedative drug, has good sedative effects, but has a high incidence of adverse events, especially cardiovascular system inhibition. Therefore, this study will explore the effective dose of remimazolam combined with propofol, reduce the adverse events of propofol and increase the sedative efficacy of remimazolam. This study only set up one study group, fixed the dosage of propofol, adjusted the dosage of Remimazolam to meet the appropriate sedation requirements for patients. Patients with successful sedation were judged to have a negative reaction, while patients with failed sedation were judged to have a positive reaction. A sequential chart was drawn based on the sedation situation until 7 positive negative reaction intersections were found, and the study ended

Eligibility criteria: Inclusion Criteria:

* ASA grading I to II, with a BMI of 18 to 30 kg/m2

Exclusion Criteria:

* Uncontrolled severe hypertension, previous history of abnormal anesthesia, unstable angina and myocardial infarction, abnormal liver and kidney function, acute upper respiratory tract infection, suspected difficulty in the airways, allergies to opioids, milk, eggs, and propofol, long-term use of sedative and analgesic drugs.

Primary outcomes:
measure: Incidence of body movements or coughing
timeFrame: Day 1
Secondary outcomes:
measure: Sedation success time
timeFrame: Day 1
measure: Inspection time
timeFrame: Day 1
measure: full alert time
timeFrame: Day 1
measure: incidence of adverse events
timeFrame: Day 1
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT00410293: NT-proBNP in Acute Dyspnea: Effects on Treatment, Hospitalisation and Costs
Official title: NT-proBNP Testing in Patients Presenting to the Emergency Department With Acute Dyspnea: Evaluation of Effects on Treatment, Hospitalisation Rate and Costs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Dyspnea
Keywords: Heart failure
Diagnostic
Natriuretic peptide
NT-pro B-type natriuretic peptide
Length of stay
Costs
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2006-12-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Diagnostic uncertainty in patients with complaints of shortness of breath presenting to the Emergency Department of a hospital may delay treatment and proper care. In patients with shortness of breath due to heart failure increased plasma levels of NT-pro-B-type natriuretic peptide (NT-proBNP) can be demonstrated. The use of NT-proBNP as a biomarker for heart failure in patients presenting to the emergency department with dyspnea might improve care and reduce length of hospital stay.

To investigate the effect of NT-proBNP testing on patient care and time to discharge the NT-proBNP test will be randomized. In patients in the study group, the NT-proBNP plasma level is determined at admission and the physician in charge will immediately receive the result of the test. In patients in the control group blood will be sampled but the physician will recieve no information on the NT-proBNP plasma level.

In our study we will investigate the effect of introduction of NT-proBNP as biomarker for heart failure on treatment, time to discharge and costs.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Acute dyspnea as their most prominent complaint

Exclusion Criteria:

* Acute dyspnea due to a trauma
* Acute dyspnea due to cardiogenic shock
* Renal failure requiring dialysis

Primary outcomes:
measure: Time to discharge
measure: Cost of treatment
Secondary outcomes:
measure: Duration of stay at the ED
measure: Proportion of patients admitted to the hospital
measure: Proportion of patients admitted to an intensive or coronary care unit
measure: Specialist consultations
measure: Medical treatment
measure: Diagnostic investigations
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: Anton H. van den Meiracker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05680493: Comparison of Dry Needling and Manual Pressure Release for Managing Low Back Pain
Official title: Comparison of Dry Needling and Manual Pressure Release for Managing Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control trial which will consist of two groups, control and experimental
Primary purpose: TREATMENT

Brief summary: This study will compare the effect of dry needling and manual pressure in patients having low back pain in terms of pain and disability. There will be two groups ; experimental and control. Half of study group will receive dry needling session along with hot pack. Half of study group will receive manual pressure technique along with hot pack.

Detailed description: The study is Randomized Control Trail , which is being conducted in fauji foundation hospital and Foundation University College Of Rehabilitation (oct 2022-feb 2023) . Sample size of 50 individual was calculated using epitool with 95% confidence interval (CI), and power 80%. sample will be collected through pilot study .

both groups will recieve conventional physiotherapy protocol (hot pack) Assessment will be done on baseline, and 4th week .

Eligibility criteria: Inclusion Criteria:-

* age between 30-60
* pateint with subacute and chronic low back pain at least last 6 months.
* pateint with active MTrps.

Exclusion Criteria:

* patient with fibromyalgia
* pregnant females
* patient with chronic diseases (osteoporosis, lungs disease and diabetes)
* patient with musculoskeletal injuries
* patient that are using any medication to relief pain like analgesic or muscle relaxants
* Any treatment for back pain in same period of research.
* patient having any radiculopathies or discogenic low back pain

Primary outcomes:
measure: pain intensity
timeFrame: 4 weeks
measure: functional disability
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation University College of Physical Therapy
state: Punjab
Study officials:
References:
Clinical trial NCT04799093: Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication
Official title: Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impairment
Cannabis Intoxication
Lead sponsor: Oculogica, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-16
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy habitual cannabis-smoking subjects, i.e., smoke or consume cannabis at least three times a week, and healthy occasional cannabis-smoking subjects, i.e., smoke or consume once a week will be recruited from the local area.

Brief summary: The purpose of this study is to determine the accuracy of an impairment algorithm based on eye tracking while watching a short film clip, in comparison to a clinical reference standard of impairment.


Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent.
2. Have the ability to provide a complete ophthalmologic, medical and neurologic history as well as report medications/drugs/alcohol consumed within the 24 hours prior to tracking.
3. Be at least 18 years old.

Exclusion Criteria:

1. Be blind (no light perception), have missing or non-functional eyes.
2. Be unable to open their eyes.
3. Have a history of unresolved strabismus, diplopia, amblyopia.
4. Have a history of unresolved cranial nerve III, IV, or VI palsy.
5. Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
6. Have a history of extensive prior eye surgery (examples include strabismus surgery, scleral buckle repair of retinal detachment, repair of blow out fractures of the orbit and any procedures that would interfere with extraocular muscle movements; prior cataract surgery or Lasik are not exclusions) or scarring.
7. Have a prior history of unresolved ocular-motor dysfunctions.
8. Have used cannabis, alcohol etc. 24 hours before study commences.
9. Be 100% naïve to cannabis usage.
10. Be pregnant.

Primary outcomes:
measure: Impairment assessment correlation with EyeBOX assessment
timeFrame: Within an hour
Secondary outcomes:
Other outcomes:
Locations:
city: Westport
country: United States
facility: Integrated Medicine LLC
state: Connecticut
Study officials:
affiliation: Oculogica, Inc.
name: Rosina Samadani, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00091793: Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
Official title: A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Osteoporosis
Keywords: Osteoporosis
Postmenopausal
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-09-21
Enrollment: 332
Sex: FEMALE
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population.


Eligibility criteria: Eligibility Criteria

- Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between 1.0 and -2.5)

Primary outcomes:
measure: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
timeFrame: 24 Months
Secondary outcomes:
measure: Total Hip Bone Mineral Density Percent Change From Baseline at Month 24
timeFrame: 24 Months
measure: Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24
timeFrame: 24 Months
measure: Trochanter Bone Mineral Density Percent Change From Baseline at Month 24
timeFrame: 24 months
measure: Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24
timeFrame: 24 months
measure: Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24
timeFrame: 24 months
measure: Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
timeFrame: 24 months
measure: Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
timeFrame: 24 months
measure: Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Bone HG, Bolognese MA, Yuen CK, Kendler DL, Wang H, Liu Y, San Martin J. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab. 2008 Jun;93(6):2149-57. doi: 10.1210/jc.2007-2814. Epub 2008 Apr 1.
citation: Engelke K, Libanati C, Liu Y, Wang H, Austin M, Fuerst T, Stampa B, Timm W, Genant HK. Quantitative computed tomography (QCT) of the forearm using general purpose spiral whole-body CT scanners: accuracy, precision and comparison with dual-energy X-ray absorptiometry (DXA). Bone. 2009 Jul;45(1):110-8. doi: 10.1016/j.bone.2009.03.669. Epub 2009 Apr 2.
citation: Bone HG, Bolognese MA, Yuen CK, Kendler DL, Miller PD, Yang YC, Grazette L, San Martin J, Gallagher JC. Effects of denosumab treatment and discontinuation on bone mineral density and bone turnover markers in postmenopausal women with low bone mass. J Clin Endocrinol Metab. 2011 Apr;96(4):972-80. doi: 10.1210/jc.2010-1502. Epub 2011 Feb 2.
Clinical trial NCT06836193: Do Emotions Affect Mechanical Pain Thresholds in Individuals with Chronic Pain?
Official title: Do Emotions and Pain Combined Affect Mechanical Pain Thresholds and Other Pain-related Variables in Individuals with Chronic Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PRESSURE PAIN THRESHOLD
Keywords: Pressure Pain Threshold
Pain
Emotion
Lead sponsor: Linnaeus University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 152
Sex: ALL
Minimum age (years): 19
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 if different emotional states could influence mechanical pain thresholds in individuals with chronic pain.

Detailed description: Participants will be randomized into 4 different groups watching different short video-clips (2.20 min). The negative emotions group will watch an uncomfortable short video containing violence and blood, the positive emotions group will watch a video containing a stand-up comedy show, the neutral emotions group will watch a video about how to paint a house, and the control group will just wait for 2.20 min, without any instructions about what to think about. Pressure pain thresholds will be measured with an algometer before and after the video-clips.

Eligibility criteria: Inclusion criteria

* Above 18 years of age
* Fluent in Swedish
* Persistent chronic pain with duration \> 6 months Exclusion criteria
* Known neurological disease

Primary outcomes:
measure: Pressure pain thresholds will be measured in kPa
timeFrame: The measurement takes place at the intervention session. First a baseline measurement is conducted, then comes the intervention and then the intervention measurement takes place.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05738993: A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers
Official title: A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2023-02-22
Enrollment: 100
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: This is a double-blind, comparative, randomized phase I study comparing pharmacokinetics, safety and immunogenicity profiles of a biosimilar pertuzumab (BCD-178) and Perjeta after a single intravenous infusion in healthy male volunteers


Eligibility criteria: Inclusion Criteria:

* Signed informed consent;
* Men aged 18-45 years;
* Body mass index (BMI) in the range of 18.5 30.0 kg/m2;
* The confirmed "healthy" status;
* Left ventricular ejection fraction (LVEF) \> 50 % based on the results of EchoCG at screening;
* Willingness of the volunteers and their sexual partners of childbearing potential to use reliable methods of contraception, starting from signing the informed consent form, during the study, and for 6 months after the drug administration;

Exclusion Criteria:

* Known allergy or intolerance to monoclonal antibody products (murine, chimeric, humanized, fully human) or any other components of the study drugs;
* Values of standard laboratory and instrumental parameters exceeding the normal limits accepted at the study site;
* History or evidence of any chronic disease

Primary outcomes:
measure: AUC0-∞
timeFrame: pre-dose to day 91, 23 timepoints
Secondary outcomes:
measure: Cmax
timeFrame: pre-dose to day 91, 23 timepoints
measure: Tmax
timeFrame: pre-dose to day 91, 23 timepoints
measure: T½
timeFrame: pre-dose to day 91, 23 timepoints
measure: Kel
timeFrame: pre-dose to day 91, 23 timepoints
measure: CL
timeFrame: pre-dose to day 91, 23 timepoints
measure: Vd
timeFrame: pre-dose to day 91, 23 timepoints
measure: safety assessment
timeFrame: Day 1 to day 91
measure: immunogenicity assessment
timeFrame: pre-dose to day 91, 5 timepoints
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic №77
city: Saint Petersburg
country: Russian Federation
facility: X7 Clinical Research
Study officials:
References: