louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05872308: Hemorrhagic Myocardial Infarction Detection by Biomarkers
Official title: Hemorrhagic Myocardial Infarction Detection With Biomarkers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: STEMI
Troponin
Intramyocardial Hemorrhage
Cardiac MRI
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of individuals aged 18 to 80 who have been diagnosed with acute ST-elevation myocardial infarction (STEMI) and are scheduled for emergency percutaneous coronary intervention (PCI).

Brief summary: Pilot trial to determine diagnostic efficacy of post-reperfusion troponin kinetics in detection of hemorrhagic myocardial infarction


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Index STEMI
3. Coronary angiogram with PCI to occur irrespective of the onset of the symptoms.
4. Ability to provide informed consent for themselves

Exclusion Criteria:

1. History of prior myocardial infarction,
2. Cardiogenic shock,
3. Patients who present with current cardiac arrest
4. Any contraindication to cardiac CMR (claustrophobia, pacemaker or cardiac defibrillator, known allergy to gadolinium),
5. Presence of permanent atrial fibrillation,
6. Unconscious patient,
7. Severe renal insufficiency (creatinine clearance ≤ 30 ml/min/m2 or renal replacement therapy),
8. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test.

Primary outcomes:
measure: Diagnostic Threshold
timeFrame: 48 hours
Secondary outcomes:
measure: Peak levels of serum troponin-I
timeFrame: 48 hours
measure: Area under the curve (AUC) for serum troponin-I
timeFrame: 48 hours
measure: Hemorrhagic infarct size
timeFrame: 48 hours
measure: Hemorrhagic infarct volume
timeFrame: 48 hours
measure: Hemorrhagic infarct microvascular obstruction
timeFrame: 48 hours
measure: Hemorrhagic infarct area at risk
timeFrame: 48 hours
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Methodist Hospital
state: Indiana
city: Rājkot
country: India
facility: Synergy Superspecialty Hospital
Study officials:
affiliation: Faculty
name: Keyur Vora, MD FACC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01181908: Alcohol Interaction Study
Official title: A Study to Investigate the Psychomotor and Cognitive Effects of Alcohol When Co-administered With GSK1144814 or Matching Placebo in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcoholism
Keywords: alcohol
drug interaction
pharmacodynamic
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is understand the effects of GSK114814 and alcohol in healthy volunteers when taken together.

Detailed description: The primary objective of this study is to investigate the CNS effects of co-administration of GSK1144814 with alcohol. Healthy volunteers who meet the eligibility criteria will be randomized to receive GSK1144814 or placebo with alcohol.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female
* Body weight 50 kg or higher and BMI within the range 19 - 29.9 kg/m2
* Willing to use appropriate contraception methods

Exclusion Criteria:

* Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody result
* Any serious medical disorder or condition
* Any history of an endocrine disorder.
* Any clinically significant laboratory abnormality.
* History of psychiatric illness.
* Any history of suicidal attempts or behavior.
* Positive urine drug screen or positive blood alcohol
* Pregnant, nursing or potential to have a child
* Past history of alcohol dependence or abuse.
* History of increased sensitivity to the effects of alcohol or violent behaviour/aggression when intoxicated.
* smokers

Primary outcomes:
measure: pharmacodynamic measures for various psychomotor/cognition function and subjective effects
timeFrame: pre and post study drug administration
Secondary outcomes:
measure: alcohol level
timeFrame: during and post alcohol administration
measure: blood level of GSK1144814
timeFrame: pre and post study drug administration
measure: safety and tolerability as measured by adverse events, vital signs, clinical laboratory measurements and validated clinical assessment scales
timeFrame: throughout the study pre- and post dose
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: te Beek ET, Hay JL, Bullman JN, Burgess C, Nahon KJ, Klaassen ES, Gray FA, van Gerven JM. Pharmacokinetics and central nervous system effects of the novel dual NK1 /NK3 receptor antagonist GSK1144814 in alcohol-intoxicated volunteers. Br J Clin Pharmacol. 2013 May;75(5):1328-39. doi: 10.1111/bcp.12004.
Clinical trial NCT01135108: Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Spinal Cord Injury
Official title: A Double-Blind, Randomized, Placebo-Controlled, Single-Dose Two-Period Crossover Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion in Subjects With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Cord Injury
Keywords: Analgesics. Non-narcotic / therapeutic use
Spinal Cord Injuries
Pain
Pain measurement / drug effect
Pain postoperative / drug therapy
Lead sponsor: KAI Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Trident Clinical Research Pty Ltd
First posted: 2010-06-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether KAI-1678 is effective in the treatment of pain associated with spinal cord injury.


Eligibility criteria: Inclusion Criteria:

* spinal cord injury at least 1 year prior and nonprogressive ofr at least 6 months
* central neuropathic pain for at least 3 months or with relapses and remissions for at least 6 months
* pain score at least 4 on 11-point numerical rating scale (0-10)
* stable doses of analgesic medications for at least 1 month

Exclusion Criteria:

* history of chronic alcoholism or chronic substance abuse
* tolerance to opioid analgesics
* clinically significant abnormality on laboratory tests or ECG

Primary outcomes:
measure: The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6).
timeFrame: 6 hours
Secondary outcomes:
measure: The effect of KAI-1678 on the proportion of subjects achieving at least a 1 point improvement in pain intensity at 6 hours
timeFrame: 6 hours
measure: The effect of KAI-1678 on patient global impression of change
timeFrame: 6 hours
measure: The effect of KAI-1678 on symptoms of neuropathic pain assessed by the Neuropathic Pain Scale (NPS)
timeFrame: 6 hours
measure: The number of participants with adverse events as a measure of safety and tolerability of KAI-1678
timeFrame: Two weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
state: New South Wales
Study officials:
affiliation: KAI Pharmaceuticals, Inc
name: Gregory Bell, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04957108: Comparing Sensitivity and Specificity of Pacemaker ID Application and Cardiac Rhythm Management Device-Finder Application.
Official title: Comparing Sensitivity and Specificity of Pacemaker ID Application and Cardiac Rhythm Management Device-Finder Application in Identifying Cardiac Implantable Electronic Device Manufacturer Using Chest Radiograph - an Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmia
Lead sponsor: Aga Khan University Hospital, Pakistan
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 547
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing CIED implantation and having post-device Xray were included.

Brief summary: Smart phone-based applications to identify cardiac implantable electronic devices (CIED) are extremely useful in circumstances where urgent device interrogation is needed and device identification card is not available. Few studies have provided insight regarding the utility of these applications. We have studied two widely available applications i.e., Pacemaker ID app (PMIDa) or Cardiac Rhythm Management Devices-Finder (CRMD-f) to identiy device manufacturers in CIEDs.

Detailed description: Smart phone-based applications to identify cardiac implantable electronic devices (CIED) are extremely useful in circumstances where urgent device interrogation is needed and device identification card is not available. Few studies have provided insight regarding the utility of these applications. We have studied two widely available applications i.e., Pacemaker ID app (PMIDa) or Cardiac Rhythm Management Devices-Finder (CRMD-f) to identiy device manufacturers in CIEDs.

547 patients who underwent CIED implantation from year 2016 - 2020 in our institute were enrolled. There were 438 Medtronic and 109 St. Jude's devices. All chest radiographs were de-identified and resized into 225\*225 pixels focusing on the CIED. PMIDa and CRMD-f applications were used to identify CIED. Accuracy, sensitivity, specificity, negative predictive value, and positive predictive value for both applications were calculated and compared.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing CIED implantation and having xray post-implant at any point and time.

Exclusion Criteria:

* Patients with CIED for whome Xray was not available.

Primary outcomes:
measure: Accuracy sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app.
timeFrame: Upto 6 months of enrollment
Secondary outcomes:
measure: sensitivity, specificity, negative predictive value, and positive predictive value for both Pacemaker ID app and CRMD finder app.
timeFrame: Upto 6 months of enrollment
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Aga Khan University
Study officials:
affiliation: The Aga Khan University Hospital
name: Yawer Saeed, MBBS, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04369508: PD-L1-expressing Regulatory T Cells in Localized Prostate Cancer Patients Undergoing Iodine-125 Permanent Brachytherapy
Official title: PD-L1-expressing Regulatory T Cells in Blood and Urine of Localized Prostate Cancer Patients Undergoing Iodine-125 Permanent Brachytherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 20
Sex: MALE
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: localized prostate cancer patients

Brief summary: Immunotherapy is currently revolutionizing the field in oncology. However, prostate cancer is poorly responsive to immune checkpoint inhibition. The combination of immunotherapy and radiotherapy is an emerging clinical treatment aradigm. X-ray radiation treatment can activate both the adaptive and innate immune systems through directly killing tumor cells, causing mutations in tumor-derived peptides, and causing localized inflammation that increases immune cell trafficking to tumors. Recently, preclinical study reported that immune checkpoint inhibition combined with radiotherapy treats CPRC with significant increases in median survival compared to drug alone.

Detailed description: Permanent brachytherapy is one of those standard treatments for localized prostate cancer patients.

Biopsy confirms prostate cancer. Blood and urine of localized prostate cancer patients will be collected before and at different time points after permanent brachytherapy (1, 3, 6, and 12 months)

Eligibility criteria: Inclusion Criteria:

- Biopsy confirms prostate cancer

Localized Prostate Cancer, ≤cT3

No chemotherapy or Hormonal therapy before Permanent Brachytherapy

Exclusion Criteria:

- Unacceptable operative risk

Poor anatomy which in the opinion of the radiation oncologist could lead to a suboptimal implant (e.g.,large or poorly healed transurethral resection of the prostate (TURP) defect, large median lobe, large gland size).

Pathologically positive lymph nodes

Significant obstructive uropathy

Distant metastases

Use steroids regularly

The diagnosis was accompanied by immune-related diseases

Allergic constitution

Abnormal white blood cell and lymphocyte counts

Ever underwent other treatments for prostate cancer, such as chemotherapy or Hormonal therapy

Accompanied by other malignancies

Splenectomy

HIV positive

Receive an anti-infective vaccine for the last 6 months

Primary outcomes:
measure: the level of PD-L1-expressing regulatory T cells in blood and urine
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Tongwen Ou, MD.
role: STUDY_CHAIR
References:
Clinical trial NCT03076008: The Impact of Tibial Tubercle-trochlear Groove Distance and Patellar Height on the Outcome of Isolated Medial Patellofemoral Ligament Reconstruction
Official title: The Impact of Tibial Tubercle-trochlear Groove Distance and Patellar Height on the Outcome of Isolated Medial Patellofemoral Ligament Reconstruction
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Patellar Dislocation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine
name: Ohio State University
name: OrthoSport Victoria
First posted: 2017-03-09
Enrollment: 201
Sex: ALL
Minimum age (years): 13
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing MPFL reconstruction for patella instability

Brief summary: The investigators plan to perform a prospective observational cohort study of patients undergoing MPFL reconstruction for the treatment of episodic patellar instability in the absence of significant degenerative disease. The investigators will follow these study subjects for a minimum of two years to monitor their functional and clinical outcome.


Eligibility criteria: Inclusion Criteria:

* MPFL Reconstruction

Exclusion Criteria:

* Trochleoplasty Required
* Prior ipsilateral knee surgery
* Iwano grade 2+
* CHondral injury requiring surgical treatment beyond debridement
* Major ligamentous injury to the knee

Primary outcomes:
measure: Recurrent Dislocation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT01414023: Assessing the Effects of a Neurobehavioral Intervention on Symptoms of Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive Compulsive Disorder
Keywords: High OCI-R scores
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This experiment will examine if the use of computerized tasks that train individuals to control their attention more effectively will predict individual differences in obsessive-compulsive symptoms, rumination and BDNF change. After giving consent, filling out self-report forms, and giving blood for the BDNF test, 80 participants will be randomized to Cognitive Control Training (CCT) or Peripheral Vision Task (PVT) (described below) which will be administered three times over a two week period. At the third visit, participants will also complete an anagram task and repeat the blood draw for BDNF testing. The investigators hypothesize that computerized tasks that train individuals to control their attention more effectively will reduce Obsessive Compulsive (OC) symptoms. Additionally, individuals training in CCT will show increased ability to disengage from unattainable goals as assessed by responses to an unsolvable anagram task. Finally, individuals training in CCT will show a greater increase in BDNF levels as compared to individuals training in PVT.


Eligibility criteria: Inclusion Criteria:

* Adults ages 18-65 years
* OCI-R total score ≥ 16
* Ability to read and provide informed consent.
* Familiarity with a computer keyboard and mouse.

Exclusion Criteria:

* BDI-II suicidality score of \> 1

Primary outcomes:
measure: OCI-R scores
timeFrame: up to two weeks
Secondary outcomes:
measure: BDNF serum levels
timeFrame: up to two weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
References:
Clinical trial NCT06785103: IBIS Megastudy- Pilot
Official title: Transformative Approaches to Rapidly and Efficiently Test Demand Creation Interventions to Promote HIV Retesting in Adults at Increased Risk of HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Keywords: behavioral economics
&#34;nudge&#34; interventions
Uganda
Kenya
HIV retesting
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Kenya Medical Research Institute
name: Infectious Diseases Research Collaboration, Uganda
name: University of California, Berkeley
name: Makerere University
name: National Institute of Mental Health (NIMH)
First posted: 2025-01-21
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: In this pilot study, the investigators will determine the feasibility and acceptability of multiple low-cost behavioral interventions, designed with end-user input, to promote HIV retesting among adults in rural Kenya and Uganda who have higher risk of HIV exposure.

Detailed description: HIV re-testing is crucial in ensuring early identification of disease to promote well-being of an individual as well as preventing onward spread of infection by treating those identified to have disease promptly. The proposed study aims to identify approaches that would encourage individuals aged 15 years and above at high risk of HIV infection to retest. This IBIS Megastudy pilot trial will pilot 11 intervention prototypes for acceptability, feedback, and implementation outcomes prior to using the interventions in a larger-scale Megastudy trial (main trial to be submitted as a separate CT.gov record).

Eligibility criteria: Inclusion Criteria:

* at least 15 years of age
* At increased risk of HIV infection (defined by self-reported risk \[at least one of the following over the 3 months prior to enrollment: \>1 sexual partner, known HIV-positive sexual partner, diagnosed with a sexually transmitted infection, or paid or received gifts or money in exchange for sex\] or by Kenya or Uganda MoH criteria for priority group)
* Documented negative HIV antibody test within 7 days of enrollment
* No intent to migrate out of community in next 3 months
* Daily access to a mobile phone (required since some of the interventions will be delivered by phone)

Exclusion Criteria:

* HIV-positive

Primary outcomes:
measure: 8-11 locally adapted nudge interventions for inclusion in an upcoming randomized-controlled trial (IBIS Megastudy RCT)
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mbita
country: Kenya
facility: Kenya Medical Research Institution (KEMRI)
city: Mbarara
country: Uganda
facility: Infectious Diseases Research Collaboration (IDRC)
Study officials:
affiliation: University of California, San Francisco
name: Gabriel Chamie, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04389203: Pregnancy Rate After Unilateral Tubal Disconnection
Official title: Pregnancy Rate After Laparoscopic Unilateral Tubal Disconnection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Rate
Keywords: pregnancy rate
Lasparosocpy
Unilateral tubal disconnection
Intracytoplasmic sperm injection
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 110
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Unilateral tubal disconnection and spontaneous pregnancy
Primary purpose: BASIC_SCIENCE

Brief summary: Unilateral disconnection of one tube that had hydrosalpinx

Detailed description: In cases suffering from infertility and all other factors were normal except hysterosalpingogram that showed hydrosalpinx.

We either did intracytoplasmic sperm injection (ICSI) in one group and spontaneous follow up for 2 years after laparoscopy Pregnancy rate in both groups was assessed

Eligibility criteria: Inclusion Criteria:

* infertile women either primary or secondary Hydrosalpinx

Exclusion Criteria:

* other factors of infertility

Primary outcomes:
measure: Pregnancy rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Adel Elgergawy
state: Gharbia
Study officials:
References: