louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02531451: The Effects of COX-inhibiting Drugs on Skeletal Muscle Adaptations to Resistance Exercise in Healthy Adults
Official title: The Effects of COX-inhibiting Drugs on Skeletal Muscle Adaptations to Resistance Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skeletal Muscle Mass Regulation
Keywords: Muscle mass
strength
NSAID
Ibuprofen
resistance exercise
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-08-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, healthy human subjects (18-35 yrs) are be randomised to consume 1200 mg ibuprofen or 75 mg acetylsalicylic acid daily during a training period of 8 weeks. During these weeks, subjects perform 2-3 supervised strength training sessions (knee extensions). Before and after training, muscle volume is measured by MRI, and muscle strength is assessed by isokinetic and isoinertial ergometers. Muscle biopsies are obtained from m. vastus lateralis to study gene and protein expression of markers regulating muscle protein turnover and prostaglandin synthesis.


Eligibility criteria: Inclusion Criteria:

* Considered healthy
* Moderately trained
* 18-35 yrs

Exclusion Criteria:

* Cardiovascular disease
* Impaired kidney or liver function
* Lower limb injury
* Pregnancy
* Ulcer or gastrointestinal upsets
* Previous reactions to use of NSAID

Primary outcomes:
measure: Change in Quadriceps muscle volume
timeFrame: Baseline and after 8 weeks training
Secondary outcomes:
measure: Change in muscle gene expression
timeFrame: Baseline, 4 weeks and after 8 weeks training
measure: Change in muscle protein expression
timeFrame: Baseline, 4 weeks and after 8 weeks training
measure: Change in Quadriceps muscle strength
timeFrame: Baseline and after 8 weeks training
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Tommy Lundberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03289351: Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis
Official title: Randomized Control Trial: Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Perforated Appendicitis
Postoperative Infection
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
First posted: 2017-09-20
Enrollment: 162
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After appendix has been removed for perforated appendicitis, patients will receive postoperative antibiotics. In the last 5 years, the literature has transitioned from a 3 -drug therapy to 2-drug therapy. Now there is a recent literature suggesting a single-drug therapy may be safe and adequate. In fact, using zosyn (piperacillin-tazobactam) as a single-drug therapy, there are additional benefits of simplicity, compliance, and lower infectious complications. Currently surgeons are already using both 2-drug regimen (ceftriaxone/metronidazole) and single-drug regimen (zosyn) interchangeable as both are FDA approved and regulated antibiotics for intra-abdominal infection. There is a clear need to compare outcomes between these two options.

Detailed description: The diagnosis of perforated appendicitis will be documented intraoperatively with photos of extraluminal fecal contents or visible holes on the appendix. Patients will be randomized to 121 in each arm. Postoperative antibiotic therapy option will be decided based on blinded sequence model. 30 day postoperative follow up visit or calls will be made to assess and collect infectious complications.

Eligibility criteria: Inclusion Criteria:

* Postoperative Perforated Appendicitis (documented by intraoperative photo)
* Postoperative Laparoscopic Appendectomy

Exclusion Criteria:

* Nonperforated Gangrenous Appendicitis
* Nonperforated Purulent Appendicitis
* Open Appendectomy

Primary outcomes:
measure: Number of Participants With a Postoperative Intra-abdominal Abscess
timeFrame: 30 days
Secondary outcomes:
measure: Number of Participants With Postoperative Surgical Site Infection
timeFrame: 30 days
measure: Number of Participants With a Postoperative Readmission
timeFrame: 30 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Phoenix Childrens Hospital
name: Justin Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05344651: Comparing the Baerveldt and Paul Glaucoma Drainage Devices and Their Effects on the Corneal Endothelium
Official title: Comparing the Baerveldt and Paul Glaucoma Drainage Devices and Their Effects on the Corneal Endothelium
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Lead sponsor: Oogziekenhuis Rotterdam
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rationale: The Baerveldt glaucoma drainage device (GDD) successfully reduces intraocular pressure but also involves a risk of corneal endothelial deterioration. Supposedly, the tip of a GDD tube with a thinner diameter, such as the Paul implant, will remain at a larger distance from the cornea and, thereby, cause less damage.

Objective: To determine whether the Paul tube induces less damage to the corneal endothelium than the Baerveldt GDD.

Study design: Randomized clinical trial. Study population: Phakic patients scheduled for surgical GDD implantation. Intervention: Either a Baerveldt or a Paul GDD implant. Main study parameters/endpoints: Endothelial cell density and tube position at 24 months.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The Paul GDD may have a less harmful effect on corneal endothelium. Otherwise, both GDDs will probably have a similar risk/benefit profile. The risks of study-related assessments are negligible, burden is low, extra time is about 5 x 1.5 h (total 7.5 h) in two years.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years.
* Informed consent.
* Caucasian ethnicity (to facilitate comparison of results with those of earlier work). Ethnicity will be based on self-reported origin of subject and/or parents.
* Primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma.

Exclusion Criteria:

* History of intraocular surgery (e.g. vitrectomy, cataract surgery, cyclodestructive procedures etc).
* History of ocular comorbidity (e.g. active uveitis, proliferative diabetic retinopathy).
* Pseudophakia.
* Functionally monocular patients.
* Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, keratoplasty, or retinal surgery) or an anticipated need for additional ocular surgery.
* Narrow anterior chamber angle.
* Best corrected visual acuity less than 0.1.
* Severe blepharitis.

Primary outcomes:
measure: Change of endothelial cell density (ECD).
timeFrame: Baseline and 2 years
Secondary outcomes:
measure: Endothelial cell density (ECD).
timeFrame: Baseline, 3, 6, 12, 24 months.
measure: Intraocular pressure.
timeFrame: Baseline, 1, 3, 6, 12, 24 months.
measure: Orthoptic assessment.
timeFrame: Baseline, 3, 6, 12, 24 months.
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Oogziekenhuis Rotterdam
Study officials:
References:
Clinical trial NCT03408951: Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
Official title: Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tachyarrhythmia
Arrhythmias, Cardiac
Lead sponsor: NewPace Ltd
Sponsor class: INDUSTRY
First posted: 2018-01-24
Enrollment: 91
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 with high chance of having a cardiac tachyarrhythmia

Brief summary: Recorded cutaneous ECG containing arrhythmia events are separately analysed by an expert Electrophysiologist and the ISSD detection algorithm, to allow assessment of the correct detection of tachyarrhythmia events and discrimination of supra-ventricular arrhythmia of the algorithm,m compared to the expert.

Detailed description: cutaneous ECG electrodes positioned near the sternum and on the midaxillary line, at the approximate positions of the ISSD sense electrodes, are used to record patients undergoing Defibrillation Threshold (DFT) studies or Electrophysiology (EP) studies of different types. Two separate copies of the recordings undergo parallel and separate analysis: one is sent to an expert Electrophysiologist for determination and classification of arrhythmia events of at least 5 seconds and at least 170 beats per minute. the other is fed to the ISSD detection algorithm, with a low cutoff rate of 170 beats per minute. the results are compared to establish the accuracy of the detection algorithm and the rate of false detection / classification of arrhythmia events.

Eligibility criteria: Inclusion Criteria:

* candidate for ICD implantation
* candidate for an ICD DFT study
* candidate for an EP study

Exclusion Criteria:

* age \<18

Primary outcomes:
measure: ISSD algorithm detection rates
timeFrame: through study completion, expected at 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roslyn
country: United States
facility: St Francis Hospital Heart Center
state: New York
Study officials:
affiliation: St Francis Hospital Heart Center
name: Joseph H Levine, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: St Francis Hospital Heart Center
name: David Hoch, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05464251: Prospective Analysis of Spinal Epidural Abscess
Official title: Prospective Analysis of Spinal Epidural Abscess Associated Outcomes at the University of Kentucky
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Epidural Abscess
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include all patients, over the age of 18, who will undergo treatment for spinal epidural abscess infections at the University of Kentucky during the study period.

Brief summary: This is a prospective study involving all patients treated at the University of Kentucky for spinal epidural abscess over a 2-year period. Based on ongoing referrals of patients with SEA, we expect that 200 patients will be enrolled during this time window. We propose to study all available clinical, pathological, radiological, and socioeconomic data of patients diagnosed with a spinal infection with or without a history of drug abuse over this study period. All patients' charts will be prospectively reviewed starting at the time of presentation for a period of 1 year.


Eligibility criteria: Inclusion Criteria:

* All patient with ICD codes for pyogenic vertebral osteomyelitis, discitis, and spinal epidural abscess will be reviewed for inclusion.

Exclusion Criteria:

* Patients unwilling or unable to attend follow up appointments.

Primary outcomes:
measure: Correlation between employment status and infection reoccurrence.
timeFrame: 1 year
measure: Correlation between income and infection reoccurrence.
timeFrame: 1 year
measure: Correlation between insurer and infection reoccurrence.
timeFrame: 1 year
measure: Correlation between living situation and infection reoccurrence.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
References:
Clinical trial NCT06586151: Testing a Gender-inclusive HIV Prevention Program
Official title: Harnessing the Power of Technology to Develop a Population-based HIV Prevention Program for Trans Girls
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention
Keywords: HIV
Adolescence
mHealth
Lead sponsor: Center for Innovative Public Health Research
Sponsor class: OTHER
Collaborators: name: University of Miami
name: Ann and Robert H Lurie Childrens Hospital of Chicago
First posted: 2024-09-19
Enrollment: 200
Sex: MALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: If, over time, data suggest the intervention impacts HIV preventive behavior at the population level, it will be unique in that it can be quickly and cost effectively scaled up to impact thousands of trans girls and nonbinary youth assigned male at birth.


Eligibility criteria: Inclusion Criteria:

1. assigned male sex at birth and currently have a non-cisgender identity (e.g., transgender girl, non-binary, gender fluid, unsure);
2. aged 14-18 years and have not yet graduated high school;
3. English-speaking;
4. the sole user of a cell phone with an unlimited text messaging plan;
5. have access to the Internet to complete online surveys;
6. intend to have the same cell number for the next 6 months;
7. provide informed assent;
8. not have taken part in a previous #TranscendentHealth study activity or know someone who is in the study to increase the diversity of input from transgirls, and
9. agree to enroll over the phone with study staff.

Exclusion Criteria:

* None beyond not meeting inclusion criteria

Primary outcomes:
measure: Number testing for HIV and/or sexual transmitted infections
timeFrame: At any time after baseline through 8-months.
Secondary outcomes:
measure: Number Taking PreExposure Prophylaxis (PrEP) for HIV
timeFrame: At any time after baseline through 8-months.
Other outcomes:
Locations:
city: San Clemente
country: United States
facility: Center for Innovative Public Health Research
state: California
Study officials:
References:
Clinical trial NCT01393951: A Study to Evaluate the Immune Response to the ASP7374 and Its Safety in Healthy Adult Volunteers
Official title: Study for Immunogenicity and Safety of ASP7374 for Subcutaneous and Intramuscular Vaccination in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Immunogenicity of ASP7374
Keywords: Recombinant Influenza hemagglutinin vaccine
Lead sponsor: UMN Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-14
Enrollment: 165
Sex: ALL
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial is designed as a blinded, randomized and parallel group study to investigate the clinically recommended dosage for ASP7374 based on the comparison of the immunogenicity and safety among two doses of subcutaneous ASP7374 and one dose of intramuscular ASP7374 in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Body weight: Female: ≥40.0 kg, \<70.0 kg, Male: ≥50.0 kg, \<80.0 kg
* BMI: ≥17.6, \<26.4
* Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained

Exclusion Criteria:

* Scheduled to receive another vaccine during study participation period
* Received influenza vaccine within 180 days prior to the study
* Received or scheduled to receive a live vaccine within 28 days prior to vaccination of the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination of the study vaccine
* Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome
* Past history of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥ 39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
* Female subjects who are breastfeeding, pregnant, possibly pregnant, and planning to become pregnant during the study period

Primary outcomes:
measure: Immunogenicity: HI antibody titer
timeFrame: Day 29
measure: Safety: Incidence of Adverse events, vital signs and laboratory tests
timeFrame: 28 days post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT03293251: Trabeculectomy With MMC and I Stent in Uveitic Glaucoma and POAG : Outcomes and Prognostic Factors
Official title: Trabeculectomy With MMC and I Stent in Uveitic Glaucoma and POAG : Outcomes and Prognostic Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Outcomes of Trabeculectomy With MMC
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: The Queen Elizabeth Hospital
First posted: 2017-09-26
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cohort of patient documented on the database system of Queen Elizabeth hospital

Brief summary: 1. determine whether cataract surgery has a major effect on outcomes of trabeculectomy with MMC or not.
2. Success rates of trabeculectomy with MMC in Queen Elizabeth hospital.
3. recurrence rate of uveitis after glaucoma surgery

Detailed description: 1. determine different success rates of trabeculectomy with MMC undergone in QE hospital, UK.
2. determine different complications and effect of cataract surgery on the outcome of glaucoma surgery

Eligibility criteria: Inclusion Criteria:

* Fesh trabeculectomy surgeries

Exclusion Criteria:

* recurrent surgeries

Primary outcomes:
measure: Success rates
timeFrame: 5 year period
Secondary outcomes:
Other outcomes:
Locations:
city: Egypt
country: Egypt
facility: Maha Said
state: Assiut
Study officials:
affiliation: Assiut University
name: Dr Kamel Soliman, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05641051: Metoclopramide on Gastric Emptying in Mechanically Ventilated Patients
Official title: Effects of Metoclopramide Administration on Gastric Emptying in Mechanically Ventilated Critically Ill Patients : A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastric Emptying
Mechanically Ventilation
Randomized Controlled Trial
Metoclopramide
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the prokinetic effect of metoclopramide on gastric emptying in critically ill mechanically ventilated patients .

Detailed description: More than 50% of patients in ICU have gastric dysmotility, which leads to slow gastric emptying(GE) and high gastric residual volume (GRV) and is associated with increased mortality in these patients

Eligibility criteria: Inclusion Criteria:

1. Patients' age 20 - 60 years.
2. Either gender.
3. Mechanically ventilated head trauma patients.
4. Patients receiving enteral feeding via nasogastric tube.

Exclusion Criteria:

1. Patients with contraindications to enteral feeding.
2. Patients with extrapyramidal manifestations.
3. Patients with known allergy to metoclopramide.
4. Patients with seizures.
5. Patients with renal or hepatic diseases.

Primary outcomes:
measure: Assessment of the risk of aspiration
timeFrame: 8 hours interval during first 5 days of enteral feeding
Secondary outcomes:
measure: Incidence of ventilator associated pneumonia
timeFrame: 8 hours interval during first 5 days of enteral feeding
measure: Time of weaning from mechanical ventilation
timeFrame: From the start of enteral feeding till intensive care discharge through study completion, an average of 6months
measure: Hospital stay
timeFrame: From the start of enteral feeding till intensive care discharge through study completion, an average of 6months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: ElGharbiaa
Study officials:
References:
Clinical trial NCT02480751: TRK-100STP PhaseII Clinical Study -Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Insufficiency, Chronic
Keywords: Chronic Renal Failure
Prostaglandin
Prostacyclin
Glomerular Disease; Nephrosclerosis
Lead sponsor: Toray Industries, Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Inc
First posted: 2015-06-24
Enrollment: 113
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
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 the recommended dose of the sustained-release form of BPS (TRK-100STP low dose or high dose) in Japanese patients with CRF (Primary glomerular disease/nephrosclerosis).


Eligibility criteria: Inclusion Criteria:

* The CRF patient with primary glomerular disease or nephrosclerosis as the primary disease
* The patient with progressive CRF

Exclusion Criteria:

* The patient with secondary glomerular disease
* The patient with CRF caused by pyelonephritis, interstitial/tubular nephritis, gouty kidney, polycystic kidney disease, or nephroureterolithiasis

Primary outcomes:
measure: Difference between the run-in and treatment periods in the slope of the regression line of 1/SCr versus time
timeFrame: 50 weeks (Run-in 22weeks, Treatment 28 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Koyama A, Fujita T, Gejyo F, Origasa H, Isono M, Kurumatani H, Okada K, Kanoh H, Kiriyama T, Yamada S. Orally active prostacyclin analogue beraprost sodium in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled, phase II dose finding trial. BMC Nephrol. 2015 Oct 16;16:165. doi: 10.1186/s12882-015-0130-5.