louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00991458: Study of Cyclosporine in Post-LASIK Patients
Official title: Study of Cyclosporine in Post-LASIK Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Laser In Situ Keratomileusis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-10-08
Enrollment: 621
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of Cyclosporine 0.005% and 0.010% eye drops administered twice daily before and following LASIK surgery.


Eligibility criteria: Inclusion Criteria:

* Patient is scheduled for bilateral LASIK surgery
* Patient is in good general health
* Eye glasses prescription of -1 to -8

Exclusion Criteria:

* Significant Dry Eye
* Presence of eye disease
* Uncontrolled systemic disease
* Previous use of RESTASIS®

Primary outcomes:
measure: Time to Cure
timeFrame: 6 Months
Secondary outcomes:
measure: Time to Worst Outcome Post-LASIK Surgery in Tear Film Assessment
timeFrame: Months 3 to 6
measure: Percentage of Patients With Cumulative Poor Vision
timeFrame: Month 3, Month 4, Month 5, Month 6
measure: Worst Outcome Post-LASIK Surgery in Reading Speed Assessment
timeFrame: Months 3 to 6
Other outcomes:
Locations:
city: Overland Park
country: United States
state: Kansas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00743158: Transfer Impedance in Cystic Fibrosis
Official title: Transfer Impedance in Cystic Fibrosis (Ztr)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cystic Fibrosis
Keywords: ztr
transfer impedance
cystic fibrosis
pulmonary function test
pft
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2008-08-28
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cystic Fibrosis Patients

Brief summary: This study aims to determine whether respiratory system transfer impedance (Ztr) may fill an important clinical function by providing a reproducible, valid, and sensitive measure of airway obstruction in people with CF.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 2 to 25 Confirmed diagnosis of Cystic Fibrosis

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Childrens Hospital, Boston
state: Massachusetts
Study officials:
References:
Clinical trial NCT01156558: Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves
Official title: Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Revision Total Knee Replacement
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
Collaborators: name: DePuy Orthopaedics
First posted: 2010-07-05
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: Sequential assessment of 100 patients who have received a revision knee surgery for which metaphyseal sleeve was used in femoral and/or tibial side starting August 2007. Patients must meet inclusion/exclusion criteria for enrollment.

Brief summary: Metaphyseal sleeves, through their design, could allow reconstruction of the knee in cases of severe bone loss by allowing rigid internal fixation and proper alignment of the extremity and components.


Eligibility criteria: Inclusion Criteria:

1. Revision knees with bone defect for which metaphyseal sleeve in femoral and/or tibial side is used
2. Cases with at least 2 year follow-up
3. Cases with regular follow-up visits completed

Exclusion Criteria:

1. Cemented sleeves
2. Patients with less than two year follow-up completed
3. Cases lost to follow-up

Primary outcomes:
measure: Implant survivorship 2 years following revision TKA
Secondary outcomes:
measure: Knee Society Score
measure: KOOS score
measure: Radiographic assessment 1 and 2 years following revision surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06559358: Subthreshold Stimulation Versus Suprathreshold Stimulation in People With Chronic Low Neck Pain
Official title: Subthreshold Stimulation Versus Suprathreshold Stimulation in People With Chronic Low Neck Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Trigger Point Pain, Myofascial
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this trial will involve three groups. Group 1 will receive subthreshold stimulation. Group 2 will receive suprathreshold stimulation. Group 3 will receive shame treatment.


Eligibility criteria: Inclusion Criteria:

* Age from 40 to 65 years old participated in this study, 2
* Having neck pain for more than 6 months with a grade five or greater on the visual analog scale
* Having one or more trigger points in the upper trapezius muscle,
* A significant increase in neck muscle EMG activity indicates the presence of tender points.

Exclusion Criteria:

* Taking non-pharmacological therapies (e.g., acupuncture, physical therapy, osteopathy)
* Taking oral or intravenous pain therapy, intramuscular or subcutaneous injection of cortisone, or local anesthetics during the study period,
* Presence of any contraindication to electrical current including pregnancy, epilepsy, cardiac arrhythmia, cardiac surgery, implanted pacemaker or defibrillator, previous surgery in the spinal cord, infectious diseases of the spinal cord, malignant tumors with or without secondary blastomas in the spinal cord, severe radicular pain with acute paralysis in the extremities

Primary outcomes:
measure: Pain intensity
timeFrame: 2-3 months
measure: Pressure threshold
timeFrame: 2-3 months
measure: Electromyography
timeFrame: 2-3 months
measure: Range of motion
timeFrame: 2-3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02002858: Smoking Cessation for Depression and Anxiety Treatment
Official title: Integrated Smoking Cessation Treatment for Emotional Dysregulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking
Anxiety Disorders
Depression Disorders
Keywords: smoking
cessation
anxiety
anxious
depression
depressed
smoker
stress
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-12-06
Enrollment: 12
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: The primary aim of this research study is to enhance smoking cessation outcome among smokers with elevated anxiety and depression. We are comparing two group treatment approaches: (1) An educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An integrated smoking cessation, and anxiety and depression management treatment program (SDAT). Both treatments also utilize nicotine replacement therapy.


Eligibility criteria: Inclusion Criteria:

* Ages 18-65 years old
* Capable of providing informed consent
* Willing to attend all study visits and comply with the protocol
* Daily smoker for at least one year
* Currently smoke an average of at least 6 cigarettes per day
* Report a motivation to quit smoking in the next 6 weeks of at least 5 on a 10-point scale
* Elevated anxiety or depression

Exclusion Criteria:

* Use of other tobacco products
* Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol
* Currently suicidal or high suicide risk
* Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt
* Concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression
* Current or intended participation in a concurrent substance abuse treatment
* Current non-nicotine substance dependence
* Insufficient command of English to participate in assessment or treatment

Primary outcomes:
measure: Smoking Status using the Timeline Follow-Back Assessment
timeFrame: Change from baseline at 2, 4, 8, 10, 16, and 24 weeks post quit day.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Anxiety and Health Research Laboratory and Substance Use Treatment Clinic
state: Texas
Study officials:
affiliation: University of Houston
name: Michael J Zvolensky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02960958: Metabolome Analysis in Patients With Rheumatoid Arthritis
Official title: Metabolome Analysis in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: RheumatoId Arthritis
Keywords: Rheumatoid arthritis
Metabolomics
urine
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2016-11-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with rheumatoid arthritis and healthy individuals

Brief summary: The aim of this study is to investigate discriminant metabolites in urine from patients with rheumatoid arthritis (RA) from healthy individuals. Then we determine if the patient's metabolic fingerprint could predict the development or flare-up of RA.

Detailed description: Compare metabolites between RA patients and healthy individuals.

1. Collection urine sample
2. Assessing urine metabolites by 1H NMR spectroscopy
3. Analyzing the relationships between metabolites and clinical variables

Eligibility criteria: Inclusion Criteria:

* All patients with rheumatoid arthritis meet 2010 American College of Rheumatology/European League against Rheumatism classification criteria.

Exclusion Criteria:

* Comorbid with other autoimmune diseases
* Confirmed with amyloidosis
* Chronic kidney disease (estimated GFR \< 60 ml/min/1.73m2)
* Chronic liver disease
* Thyroid disease
* Pregnancy
* Solid tumor/hematologic malignancy within 5 years

Primary outcomes:
measure: Metabolic fingerprint of rheumatoid arthritis
timeFrame: 1 years
Secondary outcomes:
measure: Correlations between specific metabolites and disease activity/severity of RA
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Seoul St.Mary's hospital, The Catholic university of Korea
name: Jung Hee Koh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06504758: The Effects of Breathing Exercises and Postural Exercises in Young Adults With Asthma.
Official title: The Effects of Breathing Exercises and Postural Exercises Via Telerehabilitation on Respiratory Parameters, Posture, and Quality of Life in Young Adults With Asthma.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthma
Keywords: Asthma
Young Adults
Breathing Exercises
Postural Exercises
Quality of Life
Posture
Asthma Control
Telerehabilitation
Oxygen Saturation
Respiratory Rate per Minute
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study was to investigate the effects of breathing exercises and postural exercises via telerehabilitation on respiratory parameters, posture, and quality of life in young adults with asthma.

Detailed description: 12 young adult (18-25 years old) individuals diagnosed with asthma participated in our study (all female). All of the participants are University students.

Participants included in the study were evaluated with Asthma Control Test, Mini Asthma Quality of Life Questionnaire, International Physical Activity Questionnaire (short form) via Google Forms; Sit to Stand Test, Respiratory Rate per Minute and Oxygen Saturation were assessed at Yeditepe University Physiotherapy and Rehabilitation Laboratory both at baseline and at the end of the 5th week. Breathing and postural exercises were given to the participants for the duration of 5 weeks.

Eligibility criteria: Inclusion Criteria:

* Voluntary participation in research.
* Patients in young adults (18-26 years old)
* Stable asthma.
* Modified Medical Counsel Research Dyspnea Test (mMRC) is 2 and above
* To stay consistent with an exercise program.

Exclusion Criteria:

* Being younger than 18 years old.
* Patients with severe asthma.
* Modified Medical Counsel Research Dyspnea Test (mMRC) is below 2

Primary outcomes:
measure: Mini - Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: 5 weeks
measure: New York Posture Scale
timeFrame: 5 weeks
measure: Asthma Control Test
timeFrame: 5 weeks
measure: International Physical Activity Questionnaire - Short Form (IPAQ-SF)
timeFrame: 5 weeks
measure: Oxygen Saturation
timeFrame: 5 weeks
measure: Respiratory Rate Per Minute
timeFrame: 5 weeks
measure: Sit to Stand Test
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University
state: Ataşehir
Study officials:
affiliation: Yeditepe University
name: Irmak Sıla Çetinel
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeditepe University
name: Elmas Teker
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeditepe University
name: Beyda Ceyran
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02539758: The Effect of Ocular Massage on the Management of Elevated Intraocular Pressure After Acute Angle Closure
Official title: The Effect of Ocular Massage on the Management of Elevated Intraocular Pressure After Acute Angle Closure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure
Keywords: acute angle closure
ocular massage
Lead sponsor: Tianjin Medical University Eye Hospital
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lowering intraocular pressure remains the mainstay of therapy in the management of glaucoma. The effect of ocular massage on intraocular pressure in patients with acute primary angle closure was the important thing.This was a prospective study, in which 20 eyes from 20 patients had acute angle closure. When they went to the hospital, ocular massage was performed without any medication. Intraocular pressure was detected by Goldmann tonometer, and Lenstar LS900 optical biometry observed changes of anterior chamber depth before and after ocular massage. Anterior chamber depth, anterior chamber angle and ciliary body were observed by Ultrasound biomicroscopy after massage, and anterior chamber angle was also checked by gonioscope after massage.

Detailed description: Background: Primary angle closure glaucoma is still the most common type in Asia. Lowering intraocular pressure remains the mainstay of therapy in the management of glaucoma, since it has been shown to be effective in reducing optic nerve damage and loss of vision. The objective of this study was to evaluate to assess the effect of ocular massage on intraocular pressure in patients with acute primary angle closure.

Methods : This was a prospective study, in which 20 eyes from 20 patients had acute angle closure. When they went to the hospital, ocular massage was performed without any medication. Intraocular pressure was detected by Goldmann tonometer, and Lenstar LS900 optical biometry (Lenstar LS900) observed changes of anterior chamber depth before and after ocular massage. Anterior chamber depth, anterior chamber angle and ciliary body were observed by Ultrasound biomicroscopy (after massage, and anterior chamber angle was also checked by gonioscope after massage.

Eligibility criteria: Inclusion Criteria:

* All of them had documented evidence of acute angle closure.

Exclusion Criteria:

-

Primary outcomes:
measure: observed changes of anterior chamber depth before and after ocular massage
timeFrame: before ocular massage and 15 minutes after massage
Secondary outcomes:
measure: observed changes of intraocular pressure before and after ocular massage
timeFrame: before ocular massage and 15 minutes after massage
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Eye Hospital
name: yingjuan Lv
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03053258: Diagnostic Breath Analysis for Detection of Ventilator Acquired Pneumonia (VAP)
Official title: Pilot Study to Evaluate Diagnostic Breath Analysis for Early Detection of Ventilator Acquired Pneumonia (VAP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infections
Lead sponsor: Landon Pediatric Foundation
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mechanically ventilated patients with suspected VAP infection

Brief summary: Breath samples from patients with Ventilator Acquired Pneumonia (VAP) will be analyzed to identify Volatile Organic Compounds (VOC) that have been specifically associated with VAP in previous animal models.

Primary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis System in the early detection of VOC's associated with VAP.

Detailed description: On clinical suspicion of VAP, breath samples will be collected from the expiratory limb of the patient's ventilator tubing circuit. A sterile Tedlar collection bag will be used to connect to the sample port and collect the breath sample. The expiratory limb sample port will be utilized to ensure maintenance of the integrity of the ventilator circuitry. The breath samples will be analyzed via the ZNose breath analysis system.

Immediately following collection of breath samples, bronchoalveolar lavage fluid (BALF) will be collected and subjected to bacteriology testing for confirmation of VAP-positive and VAP-negative patients.

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 48 hours of ventilation with suspected VAP infection. Suspicion of VAP infection based on clinical evaluation criteria:

  1. Three or more positive out of the following:

     1. Tympanic temperature \> 38 °C or \< 35.5 °C
     2. Blood leukocytosis (10,000/µl)
     3. More than ten leukocytes in Gram stain of tracheal aspirate (in high-flow field)
     4. Positive culture of tracheal aspirate
  2. New, persistent, or progressive infiltrate on chest radiograph

Exclusion Criteria:

Patients with pre-existing structural lung disease (COPD, asthma, lung cancer, etc.), thrombocytopenia (\< 40,000/µL) and other coagulation abnormalities.

Primary outcomes:
measure: Diagnostic Breath Analysis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: Ventura County Medical Center
state: California
Study officials:
affiliation: Ventura County Medical Center
name: Chris Landon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04149158: Evaluation of Sinetrol® Xpur in Fat Mass Reduction on Overweight and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Change in Total Body Fat Mass Percentage Loss Versus Body Weight
Lead sponsor: Fytexia
Sponsor class: INDUSTRY
First posted: 2019-11-04
Enrollment: 77
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate effects of a 16-week supplementation with a polyphenol rich extract, Sinetrol® Xpur, on fat mass accumulation and body weight management improvement.Subjects were overweight or obese and received polyphenol supplement or placebo. A 4-week follow-up as performed to evaluate its effect after supplementation stop.


Eligibility criteria: Inclusion Criteria:

* overweight or obese (25 kg.m-2\<BMI\<42.5kg.m-2)
* healthy

Exclusion Criteria:

* metabolic or chronical disease with treatments (i.e.: diabetes, dyslipidemia, thyroiditis, inflammatory disease, immunological disease, infectious disease, asthma, anxiety and depression)
* food allergy to the ingredients of the product (grapefruit, orange, caffeine, guarana)
* involved in the prior 6 months in a chronic treatment program, eating disorders history, subjected to weight reduction by surgery
* start or quit smoking, high alcohol consumption
* pregnant, breastfeeding, wanting to have a baby,
* menopausal women

Primary outcomes:
measure: Change in total body fat percentage loss versus bodyweight
timeFrame: week1; week16; week20
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: UCAM
Study officials:
affiliation: UCAM
name: Pedro Alcaraz Ramon
role: PRINCIPAL_INVESTIGATOR
References: