louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01326585: Study Trial of Dexamethasone Use for Alleviation of Symptoms After Scleral Buckle Eye Surgery
Official title: Effect of Dexamethasone on Postoperative Symptoms of Scleral Buckling Surgery Patients: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Retinal Detachment
Keywords: Scleral Buckling
Dexamethasone
Post-operative Nausea and Vomiting
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2011-03-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Dexamethasone is a medication that has been shown to have clear anti-nausea, anti-inflammatory, and painkilling properties. Dexamethasone is currently used to manage postoperative symptoms of a variety of surgical procedures. However, its effect has not been validated for scleral buckling surgery, which is used to treat retinal detachment, a medical emergency that can lead to permanent blindness. In this study, the investigators will randomly administer dexamethasone to half of scleral buckling surgery patients, and a placebo to the other half. The investigators will then compare the postoperative symptoms of the two groups in order to determine whether dexamethasone should be used for scleral buckling surgeries.


Eligibility criteria: Inclusion Criteria:

* Age 18-79 years old
* Scheduled for scleral buckle surgery to treat a retinal detachment
* Consent to participate in study

Exclusion Criteria:

* Pregnant or nursing
* Prior treatment with steroids
* Severe diabetes mellitus (HbA1c \> 8%)
* Use of opioids, sedatives, or any kind of analgesics \<1 week before scleral buckling surgery
* History of alcohol or drug abuse

Primary outcomes:
measure: Subjective Level of Postoperative Nausea
timeFrame: At 1 and 7 days post-surgery
measure: Subjective Level of Postoperative Pain
timeFrame: 1 and 7 days post-surgery
Secondary outcomes:
measure: Subjective rating of post-operative lid edema
timeFrame: At 1 and 7 days post-surgery
measure: Subjective rating of postoperative chemosis
timeFrame: 1 and 7 days post-surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Mark Mandelcorn, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Rajeev Muni, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Daniel B Rootman, MSc MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01629485: Part vs Whole Task Mastery Training for Laparoscopic Hernia Repair
Official title: Part vs Whole Task Mastery Simulation Training for Laparoscopic Hernia Repair: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia
Keywords: Mastery Learning
Surgical Education
Laparoscopic Hernia Repair
Part vs Whole Task
Contextual Interference
laparoscopy
training
curriculum
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators will perform a randomized controlled trial with a stratified-block design to compare the effect of the part versus whole task simulation training for TEP repairs.


Eligibility criteria: Inclusion Criteria:

* Study Participants: Only residents who have achieved mastery of the TEP training curriculum (in either arm) will be eligible for OR assessment
* Patients: All patients deemed fit by the staff supervising surgeon to undergo a TEP repair will be considered for this study.

Primary outcomes:
measure: Operative Time
timeFrame: Measured in Seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto Hernandez-Irizarry, BS
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: David Farley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Benjamin Zendejas, MD/MsC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01368185: Impact of MK-0954A on Uric Acid in the Management of Hypertension (MK-0954A-366)
Official title: A Retrospective Survey to Evaluate the Impact of Hyzaar on Uric Acid in the Management of Hypertensive Patients in Normal Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Essential hypertension Uric acid Retrospective Hyzaar
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 1705
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data from 33 physicians from different levels of hospitals were invited to provide information on patients who received MK-0954A and had pre- and post-treatment serum uric acid and lipid profile reports during the study period. Each physician could provide up to 30 clinical charts of patients matching the inclusion criteria for the study.

Brief summary: This was a retrospective, chart review, observational study to assess the effect of MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg \[Hyzaar(R)\]) treatment for a period of at least three months on serum uric acid levels.


Eligibility criteria: Inclusion criteria:

* Participant was \>20 years and \<75 years of age on the index date (i.e., the date of initiating MK-0954A therapy)
* Diagnosed with hypertension and had received MK-0954A 50/12.5 mg for at least 3 months
* Had at least one serum uric acid measurements at baseline and one at 3 months after using MK-0954A 50/12.5 mg
* Had the following records documented in the chart during the data collection period:

  * medical history and co-morbidities (if available)
  * sitting blood pressure, serum uric acid, lipid profile test results before and after using MK-0954A 50/12.5 mg
  * serum electrolytes, serum creatinine, and pre-meal sugar (if available)
  * prescription information of all antihypertensive regimens

Exclusion criteria:

* Had been treated with diuretic or angiotensin-receptor blockers (ARBs) 2 weeks before initiated treatment with MK-0954A 50/12.5 mg
* Serum creatinine \>2 mg/dL

Primary outcomes:
measure: Serum Uric Acid (SUA) Level
timeFrame: Baseline and Month 3
Secondary outcomes:
measure: The Percentage of Patients With Hyperuricemia
timeFrame: Baseline and Month 3
measure: Diastolic Blood Pressure (DBP)
timeFrame: Baseline and Month 3
measure: Systolic Blood Pressure (SBP)
timeFrame: Baseline and Month 3
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06526585: Stress Management Program
Official title: Examining the Immediate and Training Effects of Regular Stress Reduction Practices on Psychophysiological Markers of Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Anxiety
Keywords: Stress
Breathwork
Cyclic Sighing
Box Breathing
Hypnosis
Mood
Anxiety
Physiology
Heart Rate Variability
Respiratory Rate
fMRI
Brain Activity
Sleep
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized prospective
Primary purpose: TREATMENT

Brief summary: This study will test the immediate and long term (post 4 weeks of daily practice) effectiveness of two breathwork practices, cyclic sighing and box breathing, in comparison to hypnosis and an audiobook about stress, on psychological and physiological variables.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* No contraindications to MRI imaging (like ferromagnetic metal in their body)

Exclusion Criteria:

* Pregnant or planning to get pregnant during study participation.
* Not able or willing to come to research location twice for MRI assessments

Primary outcomes:
measure: Neural Activation
timeFrame: Baseline Scan (Day 0) and and Follow-up Scan (From day 29 up to 4 weeks later, depending on the Scan scheduling availability)
Secondary outcomes:
measure: Respiratory Rate
timeFrame: Daily from Baseline (Day 0) to a day prior to Endpoint (Day 28)
measure: Heart Rate Variability
timeFrame: Immediate: Baseline Scan (Day 0) and Follow-up Scan (From day 29 up to 4 weeks later, depending on the Scan scheduling availability); Daily: from Baseline (Day 0) to a day prior to Endpoint (Day 28)
measure: State Anxiety scale score
timeFrame: Immediate: Baseline Scan (Day 0) and Follow-up Scan (from day 29 up to 4 weeks later, depending on the Scan scheduling availability); Daily: from Baseline (Day 0) to a day prior to Endpoint (Day 28)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Psychiatry & Behavioral Sciences
state: California
Study officials:
affiliation: Stanford University
name: David Spiegel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01551485: Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement
Official title: Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Duration on the First Night After Surgery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2012-03-12
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Sleep after surgery has been found to be very distrubed immediately after major surgery. This is also seen after fast-track hip and knee replacement with length of stay of less than 3 days. Disturbed sleep has many adverse effects i.e. fatigue, possible hyperalgesia and decline in cognitive abilities.


Eligibility criteria: Inclusion Criteria:

* Total hip or knee replacement in fast-track setup
* Age 60 years or above
* ASA class 1-3

Exclusion Criteria:

* Anesthesia within the pas 30 days
* Daily use of alcohol \> 21 units / week
* Use of anxiolytics or hypnotics within the past 30 days
* Inability to read and understand Danish
* Marked reduction of sight or hearing
* Parkinson's disease or other neurological disaese causing function deficits
* Inability to cooperate to sleep monitoring
* allergy to the drug tested

Primary outcomes:
measure: Change in sleep time on the first postoperative night compared to preoperatively.
timeFrame: first night postoperatively - 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Gentofte Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lene Krenk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krenk L, Jennum P, Kehlet H. Postoperative sleep disturbances after zolpidem treatment in fast-track hip and knee replacement. J Clin Sleep Med. 2014 Mar 15;10(3):321-6. doi: 10.5664/jcsm.3540.
Clinical trial NCT04752085: Prognosis and Course of COVID-19 Infection in Hospitalised Patients
Official title: Prognosis and Course of COVID-19 Infection in Hospitalised Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
SARS-CoV Infection
Keywords: COVID-19
chitotriosidase
SARS-CoV Infection
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 300 patients hospitalised with COVID-19 infection

Brief summary: The aim of the cohort prospective observational study is to define the major factors influencing the course of COVID-19 infections and its prognosis in hospitalised patients.

The investigators plan to include 300 patients hospitalised with COVID-19 infection.

The phone contacts with patients are due after 90 and 180 days after discharge.


Eligibility criteria: Inclusion Criteria:

* Hospitalisation with COVID-19

Exclusion Criteria:

* History of hospitalisation with COVID-19 infection
* Discharge from the hospital before the end of the treatment course
* Transfer to another hospital

Primary outcomes:
measure: Need in biological therapy or/and respiratory support
timeFrame: Up to 1 month
Secondary outcomes:
measure: Number of days spent in hospital
timeFrame: Up to 1 month
measure: All-cause death
timeFrame: 90 days
measure: All-cause death
timeFrame: 180 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: University Hospital #1
city: Moscow
country: Russian Federation
facility: University Hospital #4
Study officials:
affiliation: Sechenov University
name: Olga Mironova, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sechenov University
name: Ekaterina Schelkanovtseva, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00577785: Study to Obtain Full Thickness Bladder Tissue From Subjects Undergoing Cystectomy Surgery
Official title: A Multi-Center Study to Obtain Full Thickness Bladder Tissue Specimen From Subjects Undergoing Cystectomy Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystectomy
Keywords: cystectomy
Lead sponsor: Tengion
Sponsor class: INDUSTRY
First posted: 2007-12-20
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients otherwise undergoing cystectomy

Brief summary: The objective of this study is to obtain bladder tissue specimens from patients otherwise undergoing cystectomy for use in research and training of personnel at Tengion, Inc.


Eligibility criteria: Inclusion Criteria:

* Subjects 18 to 90 years and undergoing a cystectomy surgery
* Willing and able to give signed informed consent

Exclusion Criteria:

* Known active infection
* Known colonization with MRSA or VRE
* Receipt of blood or blood products for transfusion during the previous 3 months

Primary outcomes:
measure: Evaluation of bladder tissue from patients underogoing radical cystectomy
timeFrame: ongoing throughout study
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: Tengion, Inc
name: Sunita Sheth, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03233685: Visual Training and and Reaction Time in Tennis
Official title: Effect of Visual Training on Reaction Time and Timing in Tennis Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visuomotor Skills
Keywords: Tennis
Reaction Time
Visual training
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial.
Primary purpose: TREATMENT

Brief summary: Tennis is situational sport in which the result of the game is directly influenced by the interaction with the opponent. In fact, athletes have to respond in a short-time period to change the way of playing by fast analyzing speed, rotation and direction of the tennis ball. Therefore, it is extremely complicated to predict exactly what will happen during games and matches. According to literature goof visual skills, players can receive and process information quickly and can optimize the performance with extreme precision and dexterity. For this reason, visuomotor training aims to improve reaction times, but its efficiency during playing tennis has not yet been investigated. Therefore, the aim of this study is to investigate how this training method could affect the improvement of visuomotor performance in young people between 12 and 18 years old.

Detailed description: Two armed, parallel group, randomized control trial.

Eligibility criteria: Inclusion Criteria:

* Age ≥12 years old.
* Playing career of 4 years.

Exclusion Criteria:

* Serious injury in the 6 mouth before the study.
* Subject that already took part to a visual training

Primary outcomes:
measure: Reaction Time
timeFrame: After 12 weeks of training
Secondary outcomes:
measure: Analysis of tennis skills
timeFrame: After 12 weeks of training
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Università degli Studi di Milano
state: Italia
Study officials:
affiliation: University of Milan
name: Matteo Bonato, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004785: Phase III Randomized, Double-Blind Study of Dexamethasone Vs Dexamethasone/Methylprednisolone Vs Placebo for Bronchopulmonary Dysplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchopulmonary Dysplasia
Keywords: bronchopulmonary dysplasia
cardiovascular and respiratory diseases
neonatal disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Iowa
First posted: 2000-02-25
Enrollment: 54
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Compare the efficacy of dexamethasone (DM) vs. DM/methylprednisolone treatment vs. placebo, initiated within the first month of life, on long-term pulmonary and developmental outcomes in premature infants with evolving bronchopulmonary dysplasia.

II. Compare the toxicities of these treatments. III. Assess treatment effects on adrenal function.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to 1 of 3 treatment groups. The first group receives intravenous dexamethasone tapered over 42 days.

The second group receives daily intravenous dexamethasone for 6 days, then intravenous methylprednisolone (MePRDL) tapered over the next 34 days, beginning on day 8. A placebo is given on "off" MePRDL days.

The third group receives an intravenous placebo for 42 days, with a tapering schedule beginning day 35.

All patients may receive 6 days of dexamethasone rescue therapy beginning day 15 and/or 30, as clinically indicated. Study drugs are suspended during rescue therapy.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Premature infants with evolving bronchopulmonary dysplasia on chest x-ray Requirement for mechanical ventilation Fraction of inspired oxygen greater than 0.30 Ventilator at least 15 cycles/minute No signs of weaning within 72 hours prior to entry No serious congenital anomaly --Prior/Concurrent Therapy-- No prior postnatal corticosteroids --Patient Characteristics-- Cardiovascular: No congenital heart disease Other: Birth weight no greater than 1500 g Gestational age no greater than 30 weeks No contraindication to corticosteroids, e.g., culture-proven bacterial sepsis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Richard C. Ahrens
role: STUDY_CHAIR
References:
Clinical trial NCT07011485: A Safety and Efficacy Study of PDFE-2304 Topical Solution for the Treatment of Androgenic Alopecia.
Official title: A Triple-Blind, Randomized, Efficacy and Tolerability Comparison Study of PDFE-2304 Topical Solution Versus Minoxidil 5% Topical Solution for the Treatment of Androgenic Alopecia (AGA).
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Alopecia, Androgenetic
Baldness
Androgenetic Alopecia (AGA)
Keywords: Double Blind
Randomized
Efficacy
Tolerability
Comparison
Treatment
Lead sponsor: PDFE Pharma Innovations FZCO
Sponsor class: INDUSTRY
First posted: 2025-06-08
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-group (2:1)
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of PDFE-2304 compared with Minoxidil 5% in men with androgenic alopecia (AGA).


Eligibility criteria: Inclusion Criteria -

* Men who have a presentation of androgenetic alopecia (Norwood II - V).
* Age between 18 to 60 years of age (both inclusive).
* Have no abnormal findings during physical examination.
* Able to comply with the study procedures in the opinion of the PI/CI.
* Able to give written consent for participation in the study.

Exclusion Criteria -

* Known hypersensitivity or idiosyncratic reaction to the API´s.
* Clinical diagnosis of non-AGA forms of alopecia.
* History of hair transplants.
* Subject having dyed or bleached hair 12 months prior to study start.
* Use of any topical product in the target region in the last 6 months.
* A medical history of receiving chemotherapy/cytotoxic agents.
* Uncontrolled hypertension.
* Any dermatological disorders (eczema, psoriasis, sun damage, skin cancer).
* Hormonal diseases such as thyroid disorders or diabetes.
* Liver and kidney disease.
* Smokers.
* Drug or alcohol abuse within 12 months.
* No written consent.
* The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study drug.

Primary outcomes:
measure: Change From Baseline in Target Area Hair Count (TAHC)
timeFrame: Baseline, Week 16 (Day 112)
Secondary outcomes:
measure: Percentage of Participants in Each Response Category of the Subject Self-Assessment in Alopecia (SSA) Score
timeFrame: Week 16 (Day 112)
measure: Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
timeFrame: Week 16 (Day 112)
measure: Change From Baseline in Target Area Hair Width (TAHW)
timeFrame: Baseline, Week 16 (Day 112)
measure: Change From Baseline in Target Area Hair Darkness (TAHD)
timeFrame: Baseline, Week 16 (Day 112)
measure: Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
timeFrame: Week 16 (Day 112)
measure: Adverse Events
timeFrame: Baseline, Week 16 (Day 112)
Other outcomes:
Locations:
city: Koppal
country: India
facility: Koppal Institute of Medical Sciences
state: Karnataka
Study officials:
References: