louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01541982: Virtual Autopsy for Quality Control on Intensive Care Medicine
Official title: Virtual Autopsy for Quality Control on Intensive Care Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Value of Virtual Autopsy for Quality Control in Icu
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2012-03-01
Enrollment: 160
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: patients dying in the icu

Brief summary: The study aimed to compare CT-based virtual autopsy with classic autopsy as a tool for quality control in intensive care medicine.

Detailed description: The study aimed to compare CT-based virtual autopsy with classic autopsy as a tool for quality control in intensive care medicine. Especially with respect to complications during intervention like catheter pacement.

Eligibility criteria: Inclusion Criteria:

* age \>18
* all patients dying in the icu during the study period

Exclusion Criteria:

* relatives refuse participation in the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
name: Dominic Wichmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wichmann D, Heinemann A, Zahler S, Vogel H, Hopker W, Puschel K, Kluge S. Prospective study of device-related complications in intensive care unit detected by virtual autopsy. Br J Anaesth. 2018 Jun;120(6):1229-1236. doi: 10.1016/j.bja.2018.02.031. Epub 2018 Apr 4.
Clinical trial NCT06137482: A Study to See How Safe and Tolerable Different Doses of REGN13335 Are When Administered Intravenously (IV) or Subcutaneously (SC) to Healthy Adult Participants
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN13335, a Platelet-Derived Growth Factor-B Antagonist, in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is researching an experimental drug called REGN13335. This is the first time that REGN13335 will be given to people. This study will enroll healthy adults.

The aim of the study is to see how safe and tolerable REGN13335 is in healthy volunteers.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How much study drug is present in the blood of study participants at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)


Eligibility criteria: Key Inclusion Criteria:

1. Has a body mass index between 18 and 32 kg/m\^2, inclusive, at the screening visit
2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, laboratory safety tests, and electrocardiograms (ECGs) performed prior to administration of study drug (ie, screening and baseline visit)

Key Exclusion Criteria:

1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply.

Primary outcomes:
measure: Incidence of treatment emergent adverse events (TEAE's) through the end of the study (EOS) visit
timeFrame: Baseline to day 113
measure: Severity of TEAE's through the EOS visit
timeFrame: Baseline to day 113
Secondary outcomes:
measure: Concentrations of functional REGN13335 in plasma through the EOS visit
timeFrame: Baseline to day 113
measure: Incidence of anti-drug antibodies (ADA) to single doses of REGN13335 over time
timeFrame: Baseline to day 113
measure: Titer of ADA to single doses of REGN13335 over time
timeFrame: Baseline to day 113
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: New Zealand Clinical Research
state: Canterbury
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT03473782: Overactive Bladder (OAB) Voiding Diary and Urodynamics Correlation Study
Official title: Overactive Bladder (OAB) Voiding Diary and Urodynamics Correlation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen regularly with Overactive Bladder (OAB)

Brief summary: This is a prospective cohort study study with the primary aim of identifying the strongest correlating parameters between voiding diaries and UDS studies most predictive for each type of urologic condition. Investigators will focus on OAB related conditions, as these are symptoms


Eligibility criteria: Inclusion Criteria:

* completing a bladder diary
* undergoing VUDS

Exclusion Criteria:

* have a urinary tract infection
* neurogenic bladder
* history of pelvic irradiation
* prolapse alone without LUTS
* pregnant
* incarcerated
* hospital employee
* unable to give consent

Primary outcomes:
measure: Measure of urgency incontinence using Voiding Diary
timeFrame: 60 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Benjamin Brucker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02250482: An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.
Official title: An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilia A
Lead sponsor: Bio Products Laboratory
Sponsor class: OTHER
First posted: 2014-09-26
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to investigate the safety and efficacy of Optivate®, administered in appropriate dosage to present bleeding and achieve haemostasis in patients with Haemophilia A undergoing surgery.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Haemophilia A, at least 12 years of age, due to undergo surgery and have a lifetime exposure of at least 20 exposures to a FVIII concentrate.

Exclusion Criteria:

-

Primary outcomes:
measure: Incremental Recovery for plasma Factor VIII
timeFrame: 90 minutes after pre-operative bolus dose
Secondary outcomes:
Other outcomes:
Locations:
city: Debinki 7, 80-211 Gdansk
country: Poland
facility: Klinika Haematologii, Akademia Medyczna w Gdansku, ul.
city: Dr K Jaczewskiego 8, 20-090, Lublin
country: Poland
facility: Klinika Haematologii, Akademia Medyczna w Lublinie, ul.
city: Szkolna 8/12, 61-833 Poznan
country: Poland
facility: Klinika Haematologii, Akademia Medyczna w Poznaniu, ul.
city: Cambridge
country: United Kingdom
facility: Haemophilia Centre, Addenbrooke's Hospital, Hills Road
city: Manchester
country: United Kingdom
facility: Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary
city: Nottingham
country: United Kingdom
facility: Haemophilia Centre, University Hospital, Queens Medical Centre, Clifton Boulevard
city: Sheffield
country: United Kingdom
facility: Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital, Glossop Road
city: Southampton
country: United Kingdom
facility: Haemophilia Centre, Southampton General Hospital, Tremona Road
Study officials:
References:
Clinical trial NCT02214082: Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention
Official title: Feasibility and Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention (PCI) in a Tertiary Care Hospital in Karachi, Pakistan.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angioplasty
Coronary
Lead sponsor: Indus Hospital and Health Network
Sponsor class: OTHER
First posted: 2014-08-12
Enrollment: 210
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study intends to determine if there is any difference in the occurrence of major adverse cardiology events in patients discharged on the same day as their elective cardiac angioplasty or discharged one day after their angioplasty.

Hypothesize that same day discharge is as safe as a day later discharge.


Eligibility criteria: Inclusion Criteria: :

* Low risk lesion (according to the ACC classification)
* Normal Pre Catheterization laboratory investigation
* Procedure performed before 3 pm
* procedure performed with ≤ 6 French guiding Catheter
* EF ≥ 35%
* living at a distance of within 15 kilometers from hospital
* caregiver present at home
* elective procedure

Exclusion Criteria:

* Acute PCI
* high risk lesions (according to the ACC classification)
* deranged Pre Catheterization laboratory investigations
* Age \>70
* Severe LV dysfunction, CVA
* procedure to be performed with a guiding catheter \>6F
* Use of IIb/IIIa inhibitor
* Creatinine clearance of \< 50

Primary outcomes:
measure: Mortality
timeFrame: Within 30 days post angioplasty
measure: Number of patients who require a 2nd angioplasty
timeFrame: within 30 days of 1st angioplasty
measure: Number of patients with bleed from the angioplasty site
timeFrame: within 30 days post angioplasty
Secondary outcomes:
measure: number of hospital re-admissions
timeFrame: within 30 days of initial angioplasty
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Indus Hospital
state: Sind
Study officials:
affiliation: Indus Hospital and Health Network
name: Sajid Dhakam
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06808282: Effects of Dark Chocolate on the Risk Factors of Cardiovascular Diseases
Official title: Effects of Dark Chocolate on the Risk Factors of Cardiovascular Diseases
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cardiovascular disease (CVD) is the number one cause of death in the US. Epidemiologic evidence supports that antioxidant-rich diets promote health and attenuate or delay the onset of CVD. Cocoa and chocolate products have among the highest antioxidant concentrations compared to other antioxidant food sources. The objective of this study is to examine the effects of regular dark chocolate, bloomed dark chocolate, and white chocolate on cardiovascular health markers.


Eligibility criteria: Inclusion Criteria:

* Generally healthy subjects

Exclusion Criteria:

* Smoker
* Pregnant woman
* Lactose intolerance
* Required dietary supplement use
* Required medication of metabolic disorders
* Allergy to cacao

Primary outcomes:
measure: Change of systolic and diastolic blood pressure
timeFrame: Baseline and Day 15
measure: Change of skin blood flow level
timeFrame: Baseline and Day 15
measure: Change of HDL cholesterol level
timeFrame: Baseline and Day 15
measure: Change of antioxidant levels
timeFrame: Baseline and Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
References:
Clinical trial NCT05629182: Potential Injury Incidents At the FIFA World Cup Qatar 2022
Official title: Potential Injury Incidents At the FIFA World Cup Qatar 2022
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Injury;Sports
Lead sponsor: Federation Internationale de Football Association
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 832
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The tournament includes 32 national teams, and each team is allowed to select 26 players, giving at total of 832 potential participants. In total, 64 matches will be played over 29 days.

Brief summary: This is an exploratory observational study.

Video footage is used to review all 64 matches in the football tournament.

All players actions are registered using the FIFA football language, such as, pass completed, clearance, etc.

Potential injury incidents are registered, and for each incident the injury location, contact type, player reaction, velocity, location, game reaction, referee reaction, medical staff on pitch, and outcome (e.g. substitution) are also registered.

Detailed description: Video footage is used to review all 64 matches in the FIFA World Cup Qatar 2022.

All players actions are registered using the FIFA football language, such as, pass completed, clearance, etc.(https://www.fifatrainingcentre.com/en/resources-tools/football-language/index.php)

Potential injury incidents are registered, and for each incident the injury location, contact type, player reaction, velocity, location, game reaction, referee reaction, medical staff on pitch, and outcome (e.g. substitution) are also registered.

Simple descriptive statistics are used to create overviews of the outcomes described above, including comparisons between actions which do or do not lead to potential injury incidents.

A secondary analysis may be performed including injury diagnoses, if players consent as part of another study on injury surveillance allowing video analysis of their injuries.

No a priori sample size calculation was performed, as all potential injury incidents are included.

Eligibility criteria: Inclusion Criteria:

* All participating football players at the FIFA World Cup Qatar 2022.

Exclusion Criteria:

* None

Primary outcomes:
measure: Potential injury incidents
timeFrame: November-December 2022
Secondary outcomes:
measure: Injury inciting circumstances
timeFrame: November-December 2022
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Fèdèration Internationale de Football Association
Study officials:
References:
Clinical trial NCT04147182: Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder Tumor Resection
Official title: Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: TCC
Lead sponsor: Kaplan Medical Center
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypertonic saline at the concentration of 3% (hypersel) has been injected for years into echinococcal cysts to kill live scolices, and is also known to kill suspended cells by means of a steep osmotic gradient and the investigators postulate that perioperative intravesical instillation of hypersel for patients with low grade bladder cancer is safe and may be active against shedded and suspended tumor cells and thus may decrease recurrence risk.


Eligibility criteria: Inclusion Criteria:

1. Patients of 18 years or older able to sign informed consent
2. A previous diagnosis of low grade bladder cancer
3. A pyelographic imaging examination (CTU, MRU, IVP, antegrade/retrograde pyelography) showing normal upper urinary tract in the 12 months prior to inclusion
4. Serum creatinine levels ≤ 2.0 mg/dl
5. Serum sodium levels \<146 mg/ml
6. Current bladder tumor diagnosed by endoscopy or imaging in the last 3 months
7. Patient is candidate for TURBT

Exclusion Criteria:

1. Previous history of high grade bladder cancer including carcinoma in situ
2. Presence of upper urinary tract tumor on imaging
3. Renal failure with serum creatinine \>2.0 mg/dl prior to inclusion
4. Hypernatremia \>146 mg/dl prior to inclusion
5. Contra-indication to undergo TURBT

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events as assessed by Common Terminology Criteriafor Adverse Events of Renal and urinary disorders (CTCAE)Version 5.0,2017, Satisfaction assessed by Clavien-Dindo.
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Reẖovot
country: Israel
facility: Kaplan MC
Study officials:
References:
Clinical trial NCT04552782: PTSD, AUD, and Interpersonal Conflict: Within-person Associations
Official title: PTSD, AUD, and Interpersonal Conflict: Within-person Associations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Alcoholism
Lead sponsor: University of South Dakota
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Sioux Falls VA Health Care System
name: Bay Pines VA Healthcare System
First posted: 2020-09-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The present study seeks to increase understanding of Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD) among veterans, an important public health concern. We will study the effects of regulatory deficits and sleep disturbance on the dynamic course of PTSD and AUD. The study will investigate whether a short, computerized training in the laboratory will alter maladaptive response biases and reduce associations between sleep disturbance, affect and behavioral dysregulation, AUD symptoms, and PTSD symptoms in the real world.


Eligibility criteria: Inclusion Criteria:

* OIF/OEF/OND veterans
* At risk for PTSD (i.e., PCL-5 ≥33) and/or AUD (i.e., AUDIT ≥ 7 (women) ≥ 8 (men))

Exclusion Criteria:

* Psychosis or severe Alcohol Use Disorder that contraindicates participation (based on interview)
* Active suicidal or homicidal ideation that contraindicates participation (based on interview)
* \[exclusion criteria removed 6/2022\] - Severe risk for sleep apnea (a positive score in three categories of the Berlin Questionnaire), or reported treatment for sleep apnea

Primary outcomes:
measure: Rate of Alcohol Use Disorder Symptoms
timeFrame: 2 years
measure: Rate of PTSD Symptoms
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bay Pines
country: United States
facility: Bay Pines VA Health Care System
state: Florida
city: Sioux Falls
country: United States
facility: Sioux Falls VA Health Care System
state: South Dakota
city: Vermillion
country: United States
facility: The University of South Dakota
state: South Dakota
Study officials:
References:
Clinical trial NCT04386382: Interchangeable Guide in Ridge Splitting Flapless Technique for Implant Placement
Official title: Evaluation of Interchangeable Guide in Flapless Ridge Splitting With Simultaneous Implant Placement (Clinical Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Maxillary Narrow Ridge
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A clinical trial was conducted to evaluate the accuracy of dental implant placement in narrow ridges after ridge splitting flapless technique using an interchangeable guide.

Detailed description: A sample was selected conveniently to fulfill a list of inclusion and exclusion criteria. Then the selected participants underwent ridge splitting with the aid of interchangeable guide. After ridge splitting, all patients had simultaneous implant placement followed by clinical and radiographical evaluation over a period of 6 months.

Eligibility criteria: Inclusion Criteria:

* Patients with anterior maxillary narrow ridge
* Patients with adequate alveolar ridge bone height
* Age ranging from 20-40 years.
* Patients should have adequate oral hygiene
* Patients should be free of soft tissue or oral dental pathology
* Patients who accept to participate in the study.

Exclusion Criteria:

* Patients suffering from relevant systemic and/or metabolic diseases
* Patients suffering from immunosuppressive and/or autoimmune diseases
* Heavy smokers.

Primary outcomes:
measure: Clinical evaluaion
timeFrame: After 1 week
measure: Postoperative Pain
timeFrame: After 1 week
measure: Change of bone width from baseline measurements
timeFrame: Baseline, 1 week, 3 months and 6 months
Secondary outcomes:
measure: operation time
timeFrame: During the procedure
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
state: Azarita
Study officials:
References: