louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00758199: Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
Official title: Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataracts
Lead sponsor: Bp Consulting, Inc
Sponsor class: NETWORK
First posted: 2008-09-25
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: The objective of this study is to determine if an extension of bromfenac BID monotherapy is effective in the decreasing retinal thickening post cataract IOL placement surgery. No studies exist on how long to treat with an NSAID post cataract IOL placement surgery. Currently, NSAID therapy post IOL placement surgery is in conjunction with steroid treatment, lasting approximately 3 weeks. This study is designed to examine if there is benefit to extending NSAID monotherapy in regards to macular thickening and the incidence of CME.


Eligibility criteria: Inclusion Criteria:

* Male or female \>18 years of age scheduled to undergo bilateral cataract surgery
* Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (e.g. diabetics with normal retinal exams)
* Expected visual outcome of BCVA \> \[greater than or equal to\] 20/30 postoperatively
* Ability to provide informed consent, take study medications as directed, and likely to complete all study visits

Exclusion Criteria:

* Known contraindication to any study medication or any of their components
* Required use of ocular medications other than the study medications during the study
* Significant AMD, epi-retinal membrane, retinal vein occlusion, diabetic macular edema, or any macular disease predisposing them to cystoid macular edema.
* Posterior capsule rupture, Vitreous loss during surgery or any other complication that in the surgeon's opinion, could reduce potential for targeted visual outcome
* Anticipated need for mechanical iris dilating devices

Primary outcomes:
measure: OCT with macular thickening
timeFrame: 3-6 weeks
Secondary outcomes:
measure: Incidence of CME
timeFrame: 3-6 weeks
Other outcomes:
Locations:
city: Los Altos
country: United States
facility: Altos Eye Physicians
state: California
Study officials:
References:
Clinical trial NCT00856999: Botox Cosmetic and the Young Patient With Glabellar Furrows
Official title: Botox Cosmetic and the Young Patient With Glabellar Furrows
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glabellar Furrows
Keywords: Glabellar lines of moderate severity at maximum frown
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2009-03-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if consistent treatment with Botox will lead to longer lasting effects. Botox is an injectable liquid that is approved by the U.S. Food and Drug Administration to reduce wrinkles on the forehead in the area between the eyebrows. In this study a different dosing schedule of Botox injections will be used to see if the effects of the Botox treatment last longer than the effects of the standard injection regimen.


Eligibility criteria: Inclusion Criteria:

* Female
* Fitzpatrick Skin Types I-III
* Between 30 and 50 years of age
* At least moderate severity at maximum frown

Exclusion Criteria:

* Prior botulinum toxin treatment
* Any disorder (such as myasthenia gravis, Eaton-Lambert syndrome) or agent (such as aminoglycoside antibiotics) that might interfere with neuromuscular function
* Any other condition or situation that might put the subject at significant risk, confound the study results (such as significant pre-existing brow or eyelid ptosis)
* Allergy or sensitivity to any study component
* Participation in another clinical study within 30 days of the study start date
* Are planning other facial cosmetic procedures during the study period, or are pregnant, breastfeeding, or planning a pregnancy during the study.

Primary outcomes:
measure: Reduction of the Facial Wrinkle Scale
timeFrame: 26 months
measure: Patient Assessed Frown-line Improvement
timeFrame: 20 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health and Science University
name: Roger Dailey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00200499: A Study of the Safety and Efficacy of Long-Term Nebivolol Use in Hypertensive Patients
Official title: A Multi-Center, Parallel Group Extension Study to Determine the Safety and Efficacy of Long-Term Nebivolol Exposure in Patients With Mild to Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Nebivolol
Hypertension
Beta-Blocker
Lead sponsor: Mylan Bertek Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 845
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study was conducted to determine the long-term safety and efficacy of nebivolol in patients with mild to moderate hypertension. This was an extension of the Phase III dose ranging studies NEB 202, 302 and 305. Nebivolol was studied as monotherapy and in conjunction with add-on antihypertensive therapy.

Detailed description: This was an international, multicenter parallel group, 9-month extension study with a 4-week follow-up phase to evaluate the long-term safety and efficacy of nebivolol administered orally once daily in patients with mild to moderate hypertension (defined as an average sitting diastolic blood pressure greater then or equal to 95 mmHg and less then or equal to 109 mmHg when untreated, based on entry into NEB 202, NEB 302 or NEB 305). Patients were permitted protocol-defined concomitant use of diuretic or calcium antagonist. After successful completion of one of the 3-month efficacy "feeder" studies, patients were eligible to continue nebivolol treatment in this 9-month extension study. Patients who completed the extension phase and received only nebivolol monotherapy during the extension phase were eligible to enter the 1-month follow-up phase.

Eligibility criteria: Inclusion Criteria:

* To enter the long-term treatment phase, patients must have successfully completed NEB 202, NEB 302, or NEB 305. To enter the 4-week follow-up phase, patients must have completed NEB-306 (extension phase) and received only nebivolol monotherapy treatment during NEB 306.

Exclusion Criteria:

* Secondary hypertension
* myocardial infarction or stroke
* contraindications to beta-blocker therapy

Primary outcomes:
measure: The change in average sitting diastolic blood pressure measured at trough drug plasma level at the end of the extension phase compared to baseline of NEB 202, NEB 302 or NEB 305.
Secondary outcomes:
measure: Change in the average
measure: - sitting systolic blood pressure
measure: - supine and standing systolic and diastolic blood pressure
measure: - response rate of treatment groups
measure: - AEs
measure: - ECGs
measure: - laboratory parameters
measure: - heart rate
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Mylan Pharmaceuticals Inc.
state: West Virginia
Study officials:
affiliation: Mylan Pharmaceuticals Inc
name: Betty S. Riggs, MD, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT01344499: Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum
Official title: Clearance Rate of Peritoneal Fluid Assessed by Post-operative Ultrasound Decreases After Full Conditioning Pneumoperitoneum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Hysterectomy
Keywords: women
laparoscopic subtotal hysterectomy
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 20
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Measurement of residual peritoneal fluid after laparoscopic surgery

Detailed description: Primary endpoints

* to evaluate whether the clearance rate of peritoneal fluid is exponential or linear over time. (absorption rate expected for Adept \~30-60 ml/h)
* to evaluate the role of the mesothelial barrier in this clearance rate.

Knowing that diffusion to and from peritoneal fluid decreases with increasing molecular weight (MW), our hypothesis is that clearance rate will decrease following peritoneal conditioning. Indeed a decreased mesothelial trauma (either through hypoxia or through denudation) and retraction will expose less the basal membrane

Secondary endpoints:

-To confirm the decrease in post-operative pain as measured by VAS-score and inflammation as measured by CRP and leucocytosis with the full conditioning of the pneumoperitoneum.

Eligibility criteria: Inclusion Criteria:

* Women planned to undergo a total or subtotal laparoscopic hysterectomy and having signed the informed consent.
* No limitation in body mass index or uterine size is made.

Exclusion Criteria:

* pregnancy
* immunodeficiency
* refuse or unable to sign informed consent
* chronic disease (i.e. COPD, Crohn, cardiac...)
* known allergy for Adept©

Primary outcomes:
measure: clearance rate of peritoneal fluid
timeFrame: 3 days after surgery
Secondary outcomes:
measure: Pain and inflammation score
timeFrame: 3 days after surgery
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven, campus Gasthuisberg
Study officials:
affiliation: UZ Leuven
name: JAsper Verguts, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00318799: Impact of SH T00658ID as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D01155E) on Hemostatic Parameters
Official title: A Single-centre, Open-label, Crossover, Controlled, Randomized Study to Investigate the Impact of SH T00658ID as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D01155E) on Hemostatic Parameters in 30 Healthy Female Volunteers Over 3 Treatment Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pregnancy, Unplanned
Keywords: prevention of unintended pregnancies
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the impact of SH T00658ID (EV/DNG tablet) on hemostatic parameters in comparison to a reference oral contraceptive (OC) (SH D01155E) in a crossover design.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Healthy female volunteers

Exclusion Criteria:

* Pregnancy or lactation
* Any condition that might interfere with the outcome as all contraindications for OC use.

Primary outcomes:
measure: Intraindividual absolute changes from Baseline in the Parameters of thrombin and fibrin turnover
timeFrame: Baseline, Cycle 3 of each treatment period
Secondary outcomes:
measure: Intraindividual absolute changes from Baseline in Pro- and anti-coagulatory parameters and the parameter of thrombin and fibrin turnover (activation marker): Prothrombin (Factor II).
timeFrame: Baseline, Cycle 3 of each treatment period
measure: Adverse events
timeFrame: 2 treatment periods (3 cycles each), 2 cycles whash out-period and 14 days follow-up period
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Dinox B.V.
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Klipping C, Duijkers I, Parke S, Mellinger U, Serrani M, Junge W. Hemostatic effects of a novel estradiol-based oral contraceptive: an open-label, randomized, crossover study of estradiol valerate/dienogest versus ethinylestradiol/levonorgestrel. Drugs R D. 2011;11(2):159-70. doi: 10.2165/11591200-000000000-00000.
Clinical trial NCT06406699: Feasibility and Acceptability of Group Pain Reprocessing Therapy for Veterans With Chronic Neck/Back Pain
Official title: Feasibility and Acceptability of Group Pain Reprocessing Therapy for Veterans With Chronic Neck/Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Back Pain
Chronic Pain
Neck Pain
Back Pain
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: VA Eastern Colorado Health Care System
First posted: 2024-05-09
Enrollment: 40
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: The investigators are conducting a trial that evaluates the feasibility of telehealth group pain reprocessing therapy (PRT), with no comparison group, for the treatment of chronic back pain in a population of veterans. PRT is a psychotherapy for chronic pain that aims to help patients reconceptualize their pain as a non-dangerous signal. It has been shown to be effective in a previous RCT (n=151).


Eligibility criteria: Inclusion Criteria:

* At least 6 months of back pain with last week average back pain at least 4/10
* Able to attend at least 7/8 telehealth group sessions
* Access to safe living space, quite room, reliable internet, and electronic device that can be used to attend telehealth therapy sessions.

Exclusion Criteria:

* Leg pain that is worse than back pain
* Suicide attempt, SI, HI, or inpatient psychiatric hospitalization in the past 5 years
* Not receiving/has not received disability or workers compensation related to back pain in the past 2 years.
* Is not currently involved in litigation regarding chronic back pain.
* Current misuse or overuse of alcohol or drugs
* Major surgery or other major medical events in the next 6 months
* Known vertebral/spinal fracture or tumor.
* Back surgery within last 2 years
* Difficulty controlling bowel movements
* Current or recent diagnosis of cancer
* Current or recent diagnosis of severe cardiovascular disease
* Unexplained or unintended greater than 20 pound weight loss in the past year
* Diagnosis of rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus, polymyositis, or other specific inflammatory disorders

Primary outcomes:
measure: PEG-3 Average Pain in last week
timeFrame: Baseline, Post-treatment, and 2-months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado - Anschutz Medical Campus VA
state: Colorado
Study officials:
References:
Clinical trial NCT04374799: Heparin vs Placebo for Cardiac Catheterization
Official title: A Randomized Trial of Heparin vs Placebo in Patients Undergoing Cardiac Catheterization Via the Trans-radial Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cardiac Disease
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 3600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients undergoing cardiac catheterization will be randomized to 3 groups: no anticoagulant, low dose anticoagulant and high dose anticoagulant.

Detailed description: Patients undergoing diagnostic cardiac catheterization via the trans-radial approach will be randomly allocated (1:1:1) to receive either low-dose UFH (25 IU/Kg -maximal dose 3,000 IU), high-dose UFH 50 IU/kg -maximal dose 5,000 IU) or N/S 0.9%. After 30 minutes, patients will undergo a gradual wrist band release. Hematoma and radial artery occlusion will be assessed.

Eligibility criteria: Inclusion Criteria:

* diagnostic cardiac catheterization; Small size sheath; patency of the ulno-palmar circulation

Exclusion Criteria:

abnormal ulno-palmar circulation; Prior radial artery thrombosis; Prior surgery close to the access site; Emergent cardiac catheterization; History of HIT or allergy to heparin; Patients requiring anticoagulation

Primary outcomes:
measure: hematoma
timeFrame: 1 hour
measure: radial artery occlusion
timeFrame: 1 hour
Secondary outcomes:
measure: access site bleeding
timeFrame: 1 hour
measure: non access site bleeding
timeFrame: 1 day
measure: access site complications
timeFrame: 1 day
measure: wrist band duration
timeFrame: 3 hours
measure: time to discharge
timeFrame: 1 day
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References:
Clinical trial NCT06693999: Just in Time Intervention to Enhance Physical Activity Among Stroke Survivors
Official title: Automated Coping Interventions to Enhance Physical Activity Among Stroke Survivors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Physical Activity
Wearable tracker
Smart Phone
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A 3-month single-arm pilot trial to evaluate the feasibility of an automated and individualized coping intervention among stroke survivors.


Eligibility criteria: Inclusion Criteria:

1. Adult Patients Diagnosed with Stroke: Participants must be adults (age ≥ 18) who have been clinically diagnosed with a stroke between 3 months and 3 years.
2. Community-Dwelling: Participants should be living independently in the community rather than in institutional settings such as nursing homes or hospitals.
3. Independently Mobile: Participants must be able to walk without any aid or assistance, corresponding to a modified Rankin Scale (mRS) score of 0-2.
4. Physically Inactive: Participants should have engaged in less than 10 minutes of moderate-to-vigorous physical activity (MVPA) in the past week.
5. Internet Access: Participants must have access to the Internet for at least a few hours every day.
6. Medically Cleared to participate: Before enrollment, participants must obtain medical clearance to ensure they are fit to participate in the study.

Exclusion Criteria:

1. Participating in Another Research Project Involving Physical Activity: To avoid potential confounding variables that could affect the study's outcomes.
2. Planning to Move or Have Surgery in the Next 6 Months: Participants who plan to move or undergo surgery within the next six months may face disruptions that could affect their ability to complete the study.
3. Cognitive Impairment: Cognitive impairment can affect a participant's ability to understand and follow study protocols, which is crucial for informed consent and reliable data collection.

Primary outcomes:
measure: Number of participants retained
timeFrame: 3 months
Secondary outcomes:
measure: Number of subjects recruited for the study
timeFrame: 3 months
measure: Number of hours devices were worn
timeFrame: 3 months
measure: Number of prompts
timeFrame: 3 months
Other outcomes:
measure: Weekly Goal Adherence
timeFrame: 3 months
measure: Minutes of Physical Activity
timeFrame: 3 months
Locations:
Study officials:
References:
Clinical trial NCT01006499: Role of 'Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'
Official title: Phase 4 Study of Role of 'Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sepsis of the Newborn
Keywords: neonatal sepsis
pentoxyfilline
pentaglobin
biomarker
To reduce mortality in neonatal sepsis
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2009-11-01
Enrollment: 204
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The investigators aim is to investigate whether adjuvant Pentoxifylline , IgM enriched IVIG or Pentoxifylline plus IgM-enriched IVIG reduced mortality from Neonatal sepsis.


Eligibility criteria: Inclusion Criteria::

* All infants thought/diagnosed to have late or early onset sepsis.

Exclusion Criteria:

* Pentoxifylline or Pentaglobin has already been given
* Pentoxifylline or Pentaglobin is thought to be needed or contra-indicated
* Major congenital anomaly
* Intraventricular hemorrhage (Grade 3 veya 4)
* Congenital infections
* Inborn errors of metabolism

Primary outcomes:
measure: patient characteristics all cause mortality
timeFrame: two years
Secondary outcomes:
measure: Neurodevelopmental morbidity secondary to sepsis at the age of 18 months Difference in biomarker levels
timeFrame: two years
measure: Effect the production of pro-inflammatory bio-markers.
timeFrame: two years
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak
Study officials:
References: