louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02802917: To Evaluate Eye Installation-Tear Free
Official title: Evaluation of the Stinging Potential of Products in Human Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Keywords: Eye stinging potential
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-06-16
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary objective of this study was to compare the human eye stinging potential of experimental formulas of sun care products \[Sun Protection Factor (SPF) 50 Y49 091, SPF 50 X15 158, SPF 50 X15 160 and SPF 50 X57 162 compared to an industry standard shampoo mixture.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females, 18 to 60 years with no medical conditions of the eyes as determined by the subject's medical history and confirmed by an ophthalmologist
* Subjects not under any doctor's care for ocular or peri orbital diseases
* The subject will refrain from using contact lenses, any topical facial products, any eye drops, false eyelashes, make up, over the counter products, or cosmetics on their eyes, eyelids, eyelashes, or the periorbital areas of the face during the study.

Primary outcomes:
measure: Subjective discomfort
timeFrame: up to 10 days
measure: Objective lacrimation
timeFrame: up to 10 days
measure: Objective conjunctival inflammation
timeFrame: up to 10 days
measure: Objective cornea and iris inflammation
timeFrame: up to 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
state: Florida
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01003717: Registry Experience at the Washington Hospital Center, DES - Endeavor for Myocardial Infarction
Official title: REWARDS-EMI (Registry Experience at the Washington Hospital Center, DES - Endeavor for Myocardial Infarction)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2009-10-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who receive at least one Endeavor, zotarolimus-eluting, Stent as the primary treatment for acute coronary syndrome, at the Washington Hospital Center.

Brief summary: Single-center registry of patients treated with at least one Endeavor, zotarolimus-eluting, Stent as the primary treatment for acute coronary syndrome at the Washington Hospital Center, with the aim of assessing clinical success and safety at 30 days, 6 months and annually for up to 3 years post Endeavor Stent implantation.

Detailed description: Interventional cardiology was revolutionized by the invention of stents, initially with the bare-metal stents (BMS) and recently with the drug-eluting stents (DES).Zotarolimus-eluting stents have shown promising results in randomized clinical trails, demonstrating a reduction of clinical and angiographic restenosis in comparison to BMS, and comparable clinically-driven target lesion revascularization rates in comparison with Sirolimus-eluting stents. While short-term and 1 year registry data is available from outside of the United States, it will be important to collect "real-world" data regarding the stent usage and outcomes in the United States. In this study we propose to follow patients who received at least one Endeavor® Stent as primary treatment for ACS for up to 3 years post initial stent implantation.

Eligibility criteria: Inclusion Criteria:

* Patients, male or female, \>18 years of age
* Patients presenting with acute coronary syndrome (ACS), where ACS is defined as ST segment deviation of \>1mm or an elevation of the isoenzymes greater than 2x upper limit of normal
* Patients who received at least one Endeavor drug-eluting stent at the Washington Hospital Center

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Evaluation of Major Adverse Cardiac Events following implantation of at least one Endeavor, zotarolimus-eluting, Stent as the primary treatment for acute coronary syndrome
timeFrame: Follow Up
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Research Institute/Cardiovascular Research Institute
name: Ron Waksman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01691417: Pneumatic Sleeves and Congestive Heart Failure
Official title: The Impact of Intermittent Sequential Pneumatic Compression (ISPC) Leg Sleeves on Cardiac Performance in Patients With Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2012-09-24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Based on the reversal of the adverse cardiovascular parameters during Laproscopic Surgery and its influence on cardiac activity in healthy subjects, the investigators expect to improved cardiac function in patients suffering from congestive heart failure.


Eligibility criteria: Inclusion Criteria:

* CHF (as clinically evaluated and asessed by TTE)
* Gave informed consent
* NYHA Class II-III
* LVEF equal or less than 40%

Exclusion Criteria:

* Patients who could not sign informed consent
* NYHA Class IV
* Oxygen saturation less than 90% under room air

Primary outcomes:
measure: Cardiac Output
Secondary outcomes:
measure: Systemic vascular resistance
Other outcomes:
measure: Stroke volume
Locations:
city: Nahariya
country: Israel
facility: Western Galilee Hospital
Study officials:
References:
Clinical trial NCT06286917: Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency
Official title: Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventilation Therapy
ALS
Chronic Respiratory Failure
Lead sponsor: Tampere University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This research will study whether noninvasive ventilation (NIV) used to treat chronic respiratory insufficiency in patients with amyotrophic lateral sclerosis (ALS) can be initiated as successfully in the outpatient setting as in the conventional inpatient setting, and what the costs of these alternative initiation methods are.


Eligibility criteria: Inclusion Criteria:

* ALS diagnosed by a neurology and
* chronic respiratory insufficiency or significant respiratory muscle weakness caused by ALS

Exclusion Criteria:

* impaired cognition to give informed consent to participation
* contraindication to NIV therapy
* another severe disease with a prognosis of less than one year
* ventilation via an artificial airway, tracheostomy

Primary outcomes:
measure: NIV usage hours according to different initiation locations in patients with ALS
timeFrame: 5 years
measure: Compliance with NIV according to NIV initiation setting in patients with ALS
timeFrame: 5 years
measure: Decrease in blood carbon dioxide levels in patients with ALS depending on the place of NIV initiation.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
measure: Costs of initiation of NIV in outpatient setting compared with inpatient setting in patients with ALS
timeFrame: 5 years
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
References:
Clinical trial NCT06767917: A Post-Market Clinical Follow-Up on Safety and Performance of the Ophthalmic Viscoelastic Devices Eyefill SC and Eyefill MB
Official title: Safety and Performance of the Ophthalmic Viscoelastic Devices Eyefill SC and Eyefill MB - a Post-Market Clinical Follow-Up
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cataract
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2025-01-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, Non-comparative, Post Market Clinical Follow Up Study to demonstrate safety and performance of Eyefill® S.C. and Eyefill® M.B. as viscoelastic devices for cataract surgery


Eligibility criteria: Inclusion Criteria:

* Adult subjects scheduled for cataract surgery with im-plantation of a posterior chamber intraocular lens;
* Signed informed consent;
* Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

* Known hypersensitivity to sodium hyaluronate;
* Corneal endothelial cell density \<1500 cells/mm2;
* Corneal abnormalities;
* Cataract density of grade 4+;
* Previous intraocular or corneal surgery;
* Chronic or recurrent inflammatory eye diseases (e.g., iritis, scleritis, iridocyclitis, or rubeosis iridis);
* Clinically significant, uncontrolled glaucoma with expected negative impact on visual acuity outcomes;
* Ongoing systemic or ocular steroid therapy;
* Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity loss to 20/30 or worse in one or both eyes;
* Active ocular or systemic infection (bacterial, viral, or fungal), including fever
* Subjects who may be expected to require a combined or other secondary surgical procedure
* Females of childbearing potential (those who are not surgically sterilized or not postmenopausal for at least 12 months) if they meet one of the following conditions: Pregnant, lactating or unwilling to use effective birth control over the course of the study;
* Concurrent or previous (within 30 days) participation in another drug or device investigation.

Primary outcomes:
measure: Mean change in corneal endothelial cell density between baseline and postoperative visits
timeFrame: Assessed on Day 30 and Day 90
Secondary outcomes:
Other outcomes:
measure: Safety outcome - Adverse event rate
timeFrame: Assessed up to Day 90
Locations:
city: Madrid
country: Spain
facility: Site 102
city: Zaragoza
country: Spain
facility: Site 103
Study officials:
References:
Clinical trial NCT00630617: Childhood Obesity Prevention
Official title: Project FAMILIA Giya Marianas: Childhood Obesity Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Diabetes
Keywords: Obesity
Prevention
Childhood
Children
Primary care-giver
Lead sponsor: Western Michigan University
Sponsor class: OTHER
Collaborators: name: Hillblom Foundation
name: Commonwealth of the Northern Marianna Islands Public School System
First posted: 2008-03-07
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To develop and evaluate a culturally appropriate childhood obesity prevention program targeting primary care-givers of third grade students. The cognitive-behavioral lifestyle intervention consisted of eight, 90-minute sessions at the elementary schools.

Primary outcome: body mass index of third graders and their primary care-givers Primary objective: To engage primary care-givers of third grand children in identifying and creating health promoting culturally appropriate environments for young children.

Detailed description: The sessions include information about energy balance, portion control, appropriate amounts and types of physical activity, physical inactivity, nutrition and self-esteem. The influence of the primary care-giver on the children's physical activity and nutritional behaviors may lead to greater or lesser rates of obesity in childhood and eventually lead to adult obesity. Therefore, the intention of this intervention is to educate primary care-givers so as to effect change (in a positive way) in the children they care for. Assessment on steps taken, BMI, percent body fat, diet, self reported physical activity and diet will be used to evaluate the impact of the sessions.

Eligibility criteria: Inclusion Criteria:

* Currently having a third grader attending public school

Exclusion Criteria:

* None

Primary outcomes:
measure: Body Mass Index
timeFrame: 3 years
Secondary outcomes:
measure: steps
timeFrame: 3 years
measure: Percent body fat
timeFrame: 3 years
measure: Basal metabolic rate
timeFrame: 3 years
measure: Diet information (child and primary care-giver)
timeFrame: 3 years
measure: Physical Activity and Inactivity information (child and primary care-giver)
timeFrame: 3 years
measure: Self esteem measures
timeFrame: 3 years
measure: Knowledge and attitudes
timeFrame: 3 years
Other outcomes:
Locations:
city: Saipan
country: Northern Mariana Islands
facility: Commonwealth of the Northern Mariana Islands Public School System
Study officials:
affiliation: Western Michigan University
name: Mozhdeh B Bruss, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04989517: Study of Efficacy and Safety of Investigational Treatment in Patients With Hidradenitis Suppurativa
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1b Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of AT193 in the Treatment of Patients With Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hidradenitis Suppurativa
Lead sponsor: Azora Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-04
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, parallel-group phase 1b study to evaluate AT193 in approximately 44 participants with HS. The treatment period will be 8 weeks followed by a 2-week nontreatment follow-up. The primary objective of this study is to evaluate the safety and tolerability of AT193. The secondary objectives of this study are to evaluate the preliminary efficacy in the treatment of HS.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of HS or signs and symptoms consistent with HS for at least 3 months before screening in the judgment of the investigator.
* Stable disease for at least 2 months before screening in the judgment of the investigator.
* A woman of childbearing potential must use appropriate contraceptive measures during the study period.
* A woman of childbearing potential must have a negative urine pregnancy test result at screening.
* Written informed consent must be obtained before any study procedure is performed.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Any active skin disease that may interfere with evaluation of study drug or outcome assessment.
* History or evidence of a clinically significant disorder, condition, or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion in the judgment of the investigator.
* Change in smoking or marijuana history within 3 months before Day 1 or planned during study period.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phillip
country: Australia
facility: Woden Dermatology
state: Australian Capital Territory
city: Darlinghurst
country: Australia
facility: East Sydney Doctors
state: New South Wales
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Kogarah
country: Australia
facility: Premier Specialists
state: New South Wales
city: Kotara
country: Australia
facility: Novatrials
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Campbelltown
country: Australia
facility: North Eastern Health Specialists
state: South Australia
Study officials:
References:
Clinical trial NCT05549817: Synchronous and Asynchronous Telerehabilitation Methods in Patients With Shoulder Tendinopathy
Official title: Synchronous and Asynchronous Telerehabilitation Methods in Patients With Shoulder Tendinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tendinopathy
Shoulder Pain
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized controlled trial conducted to compare the effects of synchronous and asynchronous telerehabilitation programs on pain, disability, and quality of life parameters in patients with shoulder tendinopathy in the Marmara University Physiotherapy and Rehabilitation Department.


Eligibility criteria: Inclusion Criteria:

* Participants between the ages of 18-65,
* Who had access to the internet and smartphone,
* Had the ability to conduct video calls included in the study.

Exclusion Criteria:

* Participants were excluded if they had COVID-19,
* Had surgery in the last 6 months,
* Had neurological and psychological disorders,
* Received physiotherapy treatment.
* Had surgery in the last 6 months,
* Had a condition that prevented them from exercising.

Primary outcomes:
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: The pain was measured at baseline.
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: The pain was measured at mid-treatment in the 4th week.
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: The pain was measured at the end of treatment in the 8th week.
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: The pain was measured at long-term follow-up assessment in the 16th week.
Secondary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: The disability was measured at baseline.
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: The disability was measured at mid-treatment in the 4th week.
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: The disability was measured at the end of treatment in the 8th week.
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: The disability was measured at long-term follow-up assessment in the 16th week.
measure: Short Form-36 (SF-36)
timeFrame: The quality of life was measured at baseline.
measure: Short Form-36 (SF-36)
timeFrame: The quality of life was measured at mid-treatment in the 4th week.
measure: Short Form-36 (SF-36)
timeFrame: The quality of life was measured at the end of treatment in the 8th week.
measure: Short Form-36 (SF-36)
timeFrame: The quality of life was measured at long-term follow-up assessment in the 16th week.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Faculty of Health Sciences
state: Maltepe
Study officials:
References:
Clinical trial NCT00677417: Diagnostic Value of Hyperbilirubinaemia as a Predictive Factor for Appendiceal Perforation in Acute Appendicitis
Official title: A Retrospective Study Investigating the Diagnostic Value of Hyperbilirubinaemia as a Predictive Factor for Appendiceal Perforation in Acute Appendicitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perforated Appendicitis
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2008-05-14
Enrollment: 538
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are appendectomied and who received preoperative Liver function test (bilirubin, liver transaminases GOT and GPT)

Brief summary: The values of laboratory examinations which are useful for the diagnoses of appendicitis are white blood cell count (WBC), C-reactive protein (CRP) and erythrocyte blood sedimentation rate (ESR). However up to date there is no laboratory marker for the pre-operative diagnosis of appendiceal perforation in acute appendicitis. Recently hyperbilirubinaemia has been associated with appendiceal perforation. Aim of this retrospective study is therefore to investigate if hyperbilirubinaemia has a diagnostic value for the pre-operative diagnosis of appendiceal perforation in patients with appendicitis.

Detailed description: We identified 538 patients with histologically proved acute appendicitis who underwent laparoscopic or conventional appendicectomy between January, 2004 and December, 2007 in a surgical department of an academic teaching hospital. A retrospective multiple chart review of the medical records including laboratory values (bilirubin, CRP, white blood count) and histological results was conducted.

Eligibility criteria: Inclusion Criteria:

* Appendicitis and a preoperative laboratory workup with Leukocytes, C-reactive Protein, Bilirubin and liver transaminases GOT and GPT

Exclusion Criteria:

* Alcoholism
* A history of viral hepatitis
* Gilbert's disease
* Dubin Johnson syndrome
* BRIC (benign recurrent intra-hepatic cholestasis) and other documented biliary
* Hemolytic or liver diseases associated with hyperbilirubinaemia.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum, Germany
name: Benno Mann, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum, Germany
name: Michael Sand, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sand M, Bechara FG, Holland-Letz T, Sand D, Mehnert G, Mann B. Diagnostic value of hyperbilirubinemia as a predictive factor for appendiceal perforation in acute appendicitis. Am J Surg. 2009 Aug;198(2):193-8. doi: 10.1016/j.amjsurg.2008.08.026. Epub 2009 Mar 23.