louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00483847: TYGRIS - ROW: TYSABRI Global Observational Program in Safety - Rest of World
Official title: TYGRIS - ROW: TYSABRI® Global Observational Program in Safety - Rest of World
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: TYGRIS - Rest of World (ROW)
TYSABRI
natalizumab
Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2007-06-07
Enrollment: 4296
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple Sclerosis (MS) participants treated with TYSABRI outside of North America

Brief summary: The primary objective of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAEs) in participants with multiple sclerosis (MS) treated with TYSABRI (natalizumab).

Detailed description: The TYSABRI Global Observational Program in Safety for Rest of World (TYGRIS - ROW)is a safety observational cohort program designed to obtain long-term safety data in multiple sclerosis (MS) participants treated with TYSABRI in a clinical practice setting in countries other than the United States and Canada.

The Prescribing Physician will collect participant information at routine clinic visits (using standard data collection tools) at approximately 6-month intervals for 5 years from the first TYSABRI infusion.

Eligibility criteria: Key Inclusion Criteria:

* All Multiple Sclerosis (MS) participants in Rest of World (ROW) who are prescribed and receiving TYSABRI in normal clinical practice at centers that are taking part in the study are eligible to participate in TYGRIS - ROW. Participants must have received at least 1 and not more than 3 infusions of TYSABRI.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Number of participants with serious infections, malignancies, and other serious adverse events (SAEs)
timeFrame: 5 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: There are multiple sites throughout Europe in this clinical trial. Contact Advanced Medical Services (AMS).
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05800847: Effect of Gabapentin on Sleep and Opioid Use Following Rotator Cuff Repair
Official title: Gabapentin Following Arthroscopic Rotator Cuff Repair: Evaluation of Postoperative Opioid Use and Sleep Quality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rotator Cuff Tears
Keywords: Rotator Cuff Repair
Gabapentin
Opioid Use
Lead sponsor: Hughston Clinic
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2023-04-06
Enrollment: 130
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: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to compare the effects of gabapentin in patients undergoing rotator cuff repair surgery. The main question it aims to answer is whether gabapentin can improve postoperative pain and sleep quality. Participants in this study will be randomized to either take gabapentin after surgery or a placebo after surgery.

Detailed description: Perioperative gabapentin use has been established in prior literature to decrease postoperative opioid use; however, all of these studies have evaluated gabapentin given by an anesthesia team in the immediate pre- or intraoperative period. No known literature exists regarding scheduled post-operative oral gabapentin use in regards to pain control and opioid use. Sleep quality still tends to be a frequent concern associated with rotator cuff injury and shoulder surgery in general. The added known benefit of somnolence or drowsiness, in addition to aid in sleep, with use of gabapentin may also contribute to improved sleep quality following rotator cuff repair.

Eligibility criteria: Inclusion Criteria:

* diagnosed traumatic or degenerative rotator cuff tear undergoing primary arthroscopic repair
* between the ages of 18 and 65 years old

Exclusion Criteria:

* chronic pre-operative narcotic pain medication use
* undergoing superior capsular reconstruction / balloon interposition etc
* \< 18 y/o or \> 65 y/o
* bilateral rotator cuff tear
* currently taking prescribed sleep-aid medications
* history of fibromyalgia or chronic pain syndrome
* pain management patient
* narcolepsy diagnosis
* diagnosis of cervical radiculopathy
* reported non-shoulder pain interfering with sleep

Primary outcomes:
measure: Usage of Opioids for Pain Control
timeFrame: Up to 12 weeks postoperatively
measure: Change in Sleep Quality
timeFrame: Up to 12 weeks postoperatively
Secondary outcomes:
measure: Change in Pain
timeFrame: Up to 12 weeks postoperatively
measure: Change in Functional Outcome (Based on Prior Baseline)
timeFrame: Up to 12 weeks postoperatively
measure: Change in Functional Outcome (Based on Survey)
timeFrame: Up to 12 weeks postoperatively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01816347: Evaluation of Pre-deployment Device-to-artery Relative Axial Motion in Coronary Catheterizations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Disease
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-03-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing routine PCI

Brief summary: The cyclic movement of the heart and the coronary arteries induces relative axial movement between the artery and a pre-deployed intra-luminal stent which may cause malpositioning. Using a new imaging algorithm to indicate the position of a stent in patients undergoing percutaneous coronary intervention (PCI), the investigators will measure the pre-deployment relative, intra-luminal stent axial movement in the different coronary arteries to facilitate the precise deployment site.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing routine PCI

Exclusion Criteria:

* Unstable patients

Primary outcomes:
measure: Relative axial movement of predeployed stent
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT00386347: A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.
Official title: A Single Dose, Randomized, 5-Period, Balanced, Crossover Study to Assess the Relative Bioavailability of Three Formulations and Food Effect on GSK364735 and Pharmacokinetics Following a Double Blind, Placebo Controlled, Repeat Dose Administration to Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infection
Infection, Human Immunodeficiency Virus
Keywords: HIV
repeat dose
pharmacokinetics
bioavailability
single-dose
food effect
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-10-11
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is a two-part study. Part one is designed to see how different formulations of GSK364735 are absorbed in the body and To see how food affects how GSK364735 is absorbed in the body. Part two is designed to see how repeat dosing affects how GSK364735 is absorbed in the body.


Eligibility criteria: Inclusion criteria:

* The subject is healthy with no clinically significant problems identified by the physician.
* Females of non-childbearing potential and males surgically sterile or agrees to birth control.
* Body mass Index (BMI) of 19-29.9 (kg/m2).

Exclusion criteria:

* As a result of the physical examination, lab results the Investigator considers the subject unfit for the study.
* Blood pressure and electrocardiogram is not normal
* A history of alcohol or illicit drug abuse.
* Tobacco use within 3 months.
* Positive for Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody.
* Current use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements.
* Has participated in a clinical trial within 30 days prior to the first dose of study medication.
* Donated a pint of blood within a 56 day period.
* History of allergy to study drug.

Primary outcomes:
measure: Part 1: PK parameters Day 1: AUC(0-t), AUC(0-t), Cmax, and C12 and C24 Part 2: PK parameters on Day 6: AUC(0-t), Ct, and Cmax
Secondary outcomes:
measure: Part 1 and 2 safety measures: AE, Clinical labs, con meds, ECGs, and Vital signs Part 1: PK parameters Day 1: tmax, t1/2, tlag and CL/F Part 2: PK parameters Day 1&6: AUC 0-t, AUC 0-infinity, AUC 0-12, Cmax, C12 or C24, tmax, t1/2, CL/F, and tlag.
Other outcomes:
Locations:
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05920447: Safety and Limitation of the 2nd Generation Laryngeal Mask Airway in the Lithotomy Position: An Obsevational Study
Official title: Safety and Limitation of the 2nd Generation Laryngeal Mask Airway in the Lithotomy Position: An Obsevational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Management
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients in group L were intubated with an Igel LMA (Intersurgical) , the size was selected based on the body weight according to the manufacturer's instructions, the patients in group T were intubated with ETT (flexicare) size 7 for female and 8 for male

The patients were then ventilated with a volume-controlled mode of ventilation at a Tidal Volume (TV) 7ml/kg, Respiratory Rate 12 /min, I: E 1:2. The patient was then positioned in the lithotomy position and secured

Ventilatory parameters including expired TV, peak airway pressure, TV inspired- TV expired and the end-tidal CO2 were all monitored and recorded every 5 min.

The incidence of aspiration as revealed clinically( witnessed vomiting followed by decreased oxygen saturation, increased airway pressure, tachycardia, etc..) and confirmed radiologically, Failure of insertion or intubation, sore throat and air leak were reported as a complications.

Brief summary: Laryngeal mask airway is used in different types of surgery requiring different position, recommendation was raised regarding the use of LMA in Lithotomy position with pressure controlled mode of ventilation. This raise a concern whether the mode of ventilation is a limitation for the use of LMA in these position, especially with the use of the i-gel LMA with the characteristic non-inflatable jelly cuff, that provides an excellent seal.


Eligibility criteria: Inclusion Criteria:

* Aged over 18 years
* Both gender
* Surgery mandating lithotomy position

Exclusion Criteria:

* Patients' refusal
* Pregnant women
* Obesity (BMI \> 39)
* Trendelenburg position
* Moderate to severe GERD
* Lengthy procedures (more than 120 min)

Primary outcomes:
measure: Assess the safety of volume-controlled mode of ventilation.in the Lithotomy position during the procedure
timeFrame: During the Procedure
Secondary outcomes:
measure: THE incidence of complication among the two groups
timeFrame: through the procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT03780647: Assessment of the Impact of Thoracic Outlet Syndromes on the Performance at Work
Official title: Assessment of the Impact of Thoracic Outlet Syndromes on the Performance at Work
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Thoracic Outlet Syndrome
Keywords: Thoracic outlet syndrome
Performance at work
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients sent to the University Hospital radiology department or to an angiologist with private practice for a suspicion of thoracic outlet syndrome, with diagnosis confirmed by Echo-Doppler

Brief summary: Thoracic outlet syndrome may associate neurologic, arterial and venous symptoms. The responsibility of repetitive movements and postural factors has been mentioned for long. Some tasks are hard to perform, and it seemed interesting to assess the consequences of this syndrome on the work capacity by a questionnaire, at the moment of diagnosis by Echo-Doppler


Eligibility criteria: Inclusion Criteria:

* A stenosis of at least 80% of arterial stenosis at Echo-Doppler examination during abduction-retropulsion of the arm
* Actually employed or having been employed

Exclusion Criteria:

* Cognitive or mental impairment
* Illiteracy
* Visual impairment
* Patients having been diagnosed with fibromyalgia, chronic fatigue syndrome or ehler-Danlos syndrome

Primary outcomes:
measure: Frequency of an impairment at work
timeFrame: Baseline: one session
Secondary outcomes:
measure: Frequency of job loss
timeFrame: Baseline: one session
measure: Frequency of income loss
timeFrame: Baseline: one session
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Swynghedau, CHU
Study officials:
affiliation: University Hospital, Lille
name: André THEVENON, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04229147: Ledderhose Disease - Long Term Effects of Radiotherapy Treatment. LedRad LTE - Study
Official title: Ledderhose Disease - Long Term Effects of Radiotherapy Treatment. LedRad LTE - Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ledderhose Disease
Keywords: Radiotherapy
Pain
Side effect
Satisfaction
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Ledderhose disease and treated with radiotherapy at least 2 years ago at the UMCG

Brief summary: The aim of the LedRad LTE study is to determine the current complaints, late side effects and satisfaction of patients who were treated with radiotherapy for Ledderhose disease at least two years ago.


Eligibility criteria: Patients treated with radiotherapy for Ledderhose disease at the UMCG at least 2 years ago

Primary outcomes:
measure: Current pain
timeFrame: at least 2 years after treatment
Secondary outcomes:
measure: Worst pain
timeFrame: at least 2 years after treatment
measure: Quality of Life
timeFrame: at least 2 years after treatment
measure: Late side effects of treatment
timeFrame: at least 2 years after treatment
measure: Satisfaction with radiotherapy treatment for Ledderhose disease
timeFrame: at least 2 years after treatment
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
Clinical trial NCT05052047: Brisk Walk on Chronic Obstructive Pulmonary Disease
Official title: Effects of 30 Min Brisk Walk on HRLQ and Pulmonary Functions on COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Aerobic Exercise
Brisk Walk
Health-related quality of life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 74
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine the effects of 30 min brisk walk on Pulmonary Functions on COPD patients To determine the effects of 30 min brisk walk on Health related Health-related quality of life (HRLQ) on Chronic obstructive pulmonary disease (COPD) patients


Eligibility criteria: Inclusion Criteria:

* COPD patients (GOLD criteria Mild and Moderate).

Exclusion Criteria:

* Dyspnea more than 4
* Walking issues
* Rheumatoid arthritis
* Musculoskeletal disorder
* Acute infections.

Primary outcomes:
measure: 6 min walk test: Distance (meters)
timeFrame: 4th Week
measure: Peak VO2max with formula
timeFrame: 4th Week
measure: Health-related quality of life scale (HRLQ)
timeFrame: 4th week
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 4th week
measure: Forced vital Capacity (FVC)
timeFrame: 4th week
measure: Peak Expiratory Flow (PEF)
timeFrame: 4th week
Secondary outcomes:
measure: Quality of life: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 4th week
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Capital Hospital Islamabad
state: Fedral
Study officials:
affiliation: Riphah International University
name: Muhammad Iqbal Tariq, MSCPPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01218347: Influence of Organic Anion Transporting Polypeptide1B1(OATP1B1) Genotype on Rosuvastatin PK, PD and Lipid Profiles
Official title: Influence of OATP1B1 Genotype on the Pharmacokinetics,Lipid Lowering Effect, and Lipid Profiles After Rosuvastatin Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Organic Anion Transporting Polypeptide1B1 (OATP1B1)
Rosuvastatin
Keywords: OATP1B1
rosuvastatin
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-10-11
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed to explore the influence of organic anion transporting polypeptide1B1 (OATP1B1) genotype on pharmacokinetics, lipid lowering effect and lipid profiles after rosuvastatin administration.

Detailed description: Open, one arm, single sequence study for healthy volunteers are investigated. Thirty four subjects may be enrolled.

Rosuvastatin are administered once a day for 21 days. Before and after rosuvastatin administration, PK, PD and lipid profiles are investigated.

Eligibility criteria: Inclusion Criteria:

* Age: Between 20 to 50 years of age, inclusive (age based on the date to give the informed consent)
* Weight: Over 55 kg, within ±20% of ideal body weight
* Must be reliable and willing to make themselves available during the study period
* Must be willing to give blood sample for genotyping

Exclusion Criteria:

* History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease
* History of a significant surgical resection of gastrointestinal tract except appendectomy
* History or evidence of drug abuse
* Use any medication during the last 14 days period before first dosing
* Hypersensitivity to HMG-CoA reductase inhibitor
* Judged to be inappropriate for the study by the investigator

Primary outcomes:
measure: pharmacokinetic parameters(Tmax,Cmax,AUC) of rosuvastatin
timeFrame: Day 21 0h, 1h, 2h, 3h, 4h, 5h, 8h, 12h, 24h
Secondary outcomes:
measure: lipid panel(LDL,HDL,TG,Total cholesterol)
timeFrame: Day 1 0h, Day 22 0h
measure: lipid metabolites
timeFrame: Day -1 0h, Day21 0h, 4h, 8h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trials Center, Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine and Hospital
name: Kyung-Sang Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05366647: GATT Versus Canaloplasty (GVC)
Official title: Longterm Comparison of Gonioscopy-assisted Transluminal Trabeculotomy and Canaloplasty in Open-angle Glaucoma Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma, Open-Angle
Keywords: Gonioscopy-assisted Transluminal Trabeculotomy
Canaloplasty
Glaucoma
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
Collaborators: name: Medical University of Lublin
First posted: 2022-05-09
Enrollment: 100
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: Study aims to compare the effectiveness and safety profile of Gonioscopy-assisted Transluminal Trabeculotomy and canaloplasty, in order to find out if one operation is superior to the other. Both procedures are performed in patients with medically uncontrolled open-angle glaucoma. Canaloplasty is a recently newly introduced procedure, which showed encouraging results without antimetabolite usage intra- and postoperatively. Gonioscopy-assisted Transluminal Trabeculotomy is the procedure that aims the same mechanism of aqueous outflow, however is perform with ab interno approach, which comprise it to the minimally invasive glaucoma surgery techniques. Purpose of the study is to compare both surgeries concerning success rate, intraocular pressure, medication burden and complications rate. So far there is no comparison of the Gonioscopy-assisted Transluminal Trabeculotomy and canaloplasty available.


Eligibility criteria: Inclusion Criteria:

* 18 Years and older (Adult, Older Adult)
* patients with confirmed uncontrolled open angle glaucoma
* no prior glaucoma surgery (once laser trabeculoplasty or cyclophotocoagulation) allowed

Exclusion Criteria:

* angle closure glaucoma
* congenital glaucoma
* inflammatory glaucoma

Primary outcomes:
measure: success rate (complete and qualified success)
timeFrame: 12 months
measure: success rate (complete and qualified success)
timeFrame: 24 months
Secondary outcomes:
measure: IOP, medication, complications
timeFrame: 12 months
measure: IOP, medication, complications
timeFrame: 24 months
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Ophthalmology Clinic Medical University of Bialystok
Study officials:
affiliation: Medical University of Bialystok, Poland
name: Joanna Konopińska
role: PRINCIPAL_INVESTIGATOR
References: