louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03464552: Celecoxib in Colposcopic Directed Biopsy
Official title: Role of Oral Celecoxib 200 mg in Reducing Pain Associated With Colposcopic Directed Biopsy: A Randomized Triple-blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colposcopy
Keywords: colposcopy - colposcopic directed biopsy - celecoxib
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Women often experience pain and discomfort during colposcopic examination especially at time of colposcopic directed excisional biopsy, pre-procedure anxiety, women pain threshold may also increase pain, woman's cooperation during the procedure is affected by all these factors, which also may hinder the colposcopist from obtaining adequate data and biopsies.

Several pharmacological and non-pharmacological methods have been studied to reduce pain associated colposcopic directed biopsy (CDB). We aim to study the effect of Celecoxib to reduce pain associated with CDB.


Eligibility criteria: Inclusion Criteria:

• Females 18-65 years old who undergoing colposcopic directed biopsy

Exclusion Criteria:

* A known allergy to Celecoxib, aspirin or another NSAID.
* Active peptic ulceration or gastrointestinal bleeding.
* Inflammatory bowel disease.
* Congestive heart failure (NYHA II-IV).
* Established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
* History of neurologic deficit.
* Known hepatic or renal impairment.
* Pregnancy.
* Breast-feeding.
* Post-hysterectomy.
* Bleeding disorders.
* Drug abuse.
* Cervical and vaginal infection.

Primary outcomes:
measure: Pain during the procedure
timeFrame: Immediately after the first biopsy
Secondary outcomes:
measure: Pain at time of vaginal speculum application
timeFrame: At time of introduction of vaginal speculum
measure: Post-procedure pain
timeFrame: At 30 minutes after completing the procedure
Other outcomes:
measure: Effect of pain score on duration of the colposcopic procure
timeFrame: At time of removal of vaginal speculum
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT02624752: Oral Nutrition Supplementation in Hospitalized Patients
Official title: Nutrition Supplementation in Hospitalized Patients (NutriSup Oral)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Oral Nutrition Supplementation
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 63
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized via REDCap (Research Electronic Data Capture), a secure, centralized web-based randomization module to:

1. Ensure Enlive (enhanced ONS) + standard menu; or
2. Standard of care (including standard menu and possibly ONS) Patients randomized will receive standard menu or standard menu plus enhanced oral nutritional supplements (ONS). Patients randomized to enhanced ONS, will receive one bottle of ONS Abbott Ensure Enlive (235 mL, 350 calories), or similar product, two times daily for 90 days.
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to determine the effect of 3 months use of enhanced Oral Nutritional Supplement (ONS) on physical function and functional performance in malnourished elderly patients.

Detailed description: The purpose of this pilot study is to determine the effect of 3 months use of enhanced Oral Nutritional Supplementation (ONS) on muscle accretion and functional performance in malnourished elderly patients. The objectives of this study are to determine feasibility of recruitment, adherence to intervention and retention of the sample, as well as the capacity of subjects to complete functional and muscle mass measures for a planned multi-centre Randomized Controlled Trial (RCT).

Eligibility criteria: Inclusion Criteria:

* admitted to a general medical ward and recruited within 48 hours
* over the age of 65 years
* malnourished (subjective global assessment categories B or C patients)

Exclusion Criteria:

* have an allergy or intolerance to any component of the oral supplement
* are designated palliative care
* are currently suffering from refeeding syndrome
* have a pre-existing medical condition that prevents oral intake of full fluids,
* have an expected length of stay of less than 48 hours from the time of assessment
* have suspected ischemic stroke as cause for admission
* reside in a residential care home
* are unable to walk prior to current illness.
* are pregnant/breastfeeding
* have a current diagnosis of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome

Primary outcomes:
measure: Hospital Readmission Rate
timeFrame: 90 days
Secondary outcomes:
measure: Successful recruitment
timeFrame: 1 year
measure: Adherence to treatment
timeFrame: 90 days
Other outcomes:
Locations:
city: London
country: Canada
facility: LHSC-University Hospital
state: Ontario
Study officials:
affiliation: St.Joseph's Health Care, London ON
name: Adam Rahman, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05799352: Effects of Endoscopic Lung Volume Reduction on Diaphragm Function and Conformation
Official title: Effects of Endoscopic Lung Volume Reduction on Diaphragm Function and Conformation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before and after study
Primary purpose: TREATMENT

Brief summary: Chronic obstructive lung disease (COPD) is a common disease that is frequently complicated by hyperinflation. The resulting increase in lung volume impairs the diaphragmatic function because of a shortening of the diaphragmatic fibers and an increase in the radius of curvature of the diaphragmatic domes. Lung volume reduction surgery (LVRS) has already shown an improvement in diaphragmatic function that could be explained by a change of the diaphragm conformation. More recently, endoscopic lung volume reduction (ELVR) has shown benefits in terms of respiratory function, exercise capacity and quality of life, but the mechanisms of these improvements are poorly understood. Therefore, we aim to evaluate the evolution of the diaphragmatic function and the changes in diaphragmatic conformation after unilateral ELVR.


Eligibility criteria: Inclusion Criteria:

* valves insertion

Exclusion Criteria:

* TLVR \< 50 %

Primary outcomes:
measure: Transdiaphragmatic pressure
timeFrame: before until 3 months after the valves insertion
measure: Diaphragmatic conformation
timeFrame: before until 3 months after the valves insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
Study officials:
affiliation: Hôpital Erasme, Université Libre de Brussels, Brussels, Belgium
name: Olivier Taton
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02863952: Quantitation of Left Ventricular Ejection Fraction Change From Early Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI
Official title: Quantitation of Left Ventricular Ejection Fraction Change From Early Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate early post-stress EF change (∆EF) and its relation to the severity of myocardial ischemia and angiographic coronary disease using CZT-SPECT MPI.

Detailed description: Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) is a well-established noninvasive procedure for the evaluation and risk stratification of patients with coronary artery disease (CAD). However, it has been recognized that in certain patients SPECT MPI is unable to detect the presence of CAD or underestimates its extent. The fact that moderate to severe perfusion defects are noted in less than half of the patients with significant left main disease has stimulated studies to improve the diagnostic accuracy of SPECT MPI. These studies have analyzed post-stress parameters such as left ventricular (LV) ejection fraction (EF), wall motion abnormalities and transient LV dilation. However, these parameters were derived from data acquired using conventional Anger cameras as long as 60 minutes after stress tracer injection. Such delayed assessment may miss early ischemic stunning as a result of its rapid transient changes. However, with highly sensitive detectors and short lived tracers, the ability of PET MPI to measure EF during peak of stress has been reported. Similarly, the novel cadmium-zinc-telluride (CZT) SPECT cameras with solid state cardiac-focused detectors are significantly more sensitive than the conventional Anger scintillation cameras giving to SPECT the "PET-like" ability to image rapidly right after the stress test. The aim of this study is to evaluate early post-stress EF change (∆EF) and its relation to the severity of myocardial ischemia and angiographic coronary disease using CZT-SPECT MPI.

Eligibility criteria: Inclusion Criteria: the patients who will be able to complete exercise treadmill testing will be enrolled and analyzed.

-

Exclusion Criteria:

* severe aortic stenosis
* resting heart rate \> 130 beats/min
* significant atrial or ventricular arrhythmia
* sepsis
* fever
* hemodialysis
* pregnancy

Primary outcomes:
measure: ischemia by SPECT
timeFrame: 15-30 minutes post stress
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02399852: Effects of Lomitapide on Carotid and Aortic Atherosclerosis
Official title: Effects of Lomitapide on Carotid and Aortic Atherosclerosis in Patients Treated With Lomitapide in Usual Care (CAPTURE)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Homozygous Familial Hypercholesterolemia
Lead sponsor: Aegerion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled in LOWER

Brief summary: Study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide.

Detailed description: This is a multi-center long-term open-label non-comparative study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide. Patients from countries in the EU, the US and Canada who are being treated with lomitapide and are enrolled in The Lomitapide Observational Worldwide Evaluation Registry (LOWER), will be invited by the LOWER enrolling physician to participate in this substudy.

Eligibility criteria: Inclusion Criteria:

• Adult patients (age ≥18 years) who are enrolled in LOWER

Exclusion Criteria:

* Patients with a prior history of carotid angioplasty, carotid stenting, or carotid atherectomy
* Patients with a contraindication to MRI examination (i.e., brain aneurysm, implanted neural stimulator, implanted cardiac pacemaker, pacemaker wires or defibrillator, prosthetic heart valves, cochlear implant, ocular foreign body, or other implanted body)
* Patients who have undergone a coronary stenting procedure in the preceding three weeks prior to enrollment
* Patients prone to claustrophobia or known anxiety disorders that will interfere with the ability to acquire quality MRI scans
* Patients with an implanted insulin pump
* Patients with metal shrapnel or bullet wounds
* Patients with a body mass index (BMI) \> 40 kg/m2 (since it may be difficult to position comfortably with the MRI scanner)
* Patients who work with metal lathes (unless an orbit x-ray performed prior to the enrollment MRI scan has been done to rule out metal fragments in the eye)

Primary outcomes:
measure: The percent change from baseline in cartoid vessel wall area at the two-year evaluation
timeFrame: 2 years
Secondary outcomes:
measure: The percent change from baseline to one and five years on therapy for carotid and aortic vessel wall area, and carotid and aortic vessel wall thickness.
timeFrame: 5 Years
Other outcomes:
Locations:
Study officials:
affiliation: Aegerion Pharmaceuticals, Inc.
name: Qing Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05564832: Pharmacological Treatment of Presbyopia
Official title: Pharmacological Treatment of Presbyopia by Pilocarpine 1.25% Eye Drops
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Near Vision
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this clinical trial, a total of 75 presbyopic patients in the age range of 40 to 60 years old will be participated. The right eyes of 45 patients will be treated by Biocarpine® and they will be considered as the case group, their left eyes will be defined as the controls. In another case group, the right eyes of 30 patients will received Vuity® eye drops and their left eyes will be considered as controls.


Eligibility criteria: Inclusion Criteria:

* Subjects with the best corrected visual acuity (BCVA) better than 0.3LogMAR
* Patients with the symptom of blurred vision at near distance

Exclusion Criteria:

Patients with amblyopia, cataract, corneal opacity, glaucoma, intraocular surgery, eye troma, congenital pupil anomalies and those with the history of headache and allergy to the eye drop will be excluded from the study.

Primary outcomes:
measure: The changes of near vision after one hour following pilocarpine eye drop
timeFrame: baseline to one hour after pilocarpine insillation
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hamideh Sabbaghi
Study officials:
References:
Clinical trial NCT02074332: Study on Obesity Intervention With Physical Exercise Among Students in Changping District, Beijing
Official title: Development and Application of Appropriate Technology for Obesity Prevention and Control -- Study on Personalized Aerobic and Appropriate Exercise Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: Obesity
Physical activity
Schoolchildren
Intervention Studies
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 921
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to assess the effectiveness of a school based physical activity programme on obesity and related health outcomes in young schoolchildren.


Eligibility criteria: Inclusion Criteria:

* Grade of 2 to 5 in elementary schools and grade of 1 to 2 in middle schools.

Exclusion Criteria:

* Suffering or any history of disabilities, cardiovascular diseases, asthma, metabolic diseases, etc.

Primary outcomes:
measure: Change in body mass index (BMI)
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: Change in obesity-related anthropometric measurements
timeFrame: Baseline, Month 3
measure: Change in serum lipids and fasting glucose
timeFrame: Baseline，Month 3
measure: Change in dietary and physical activity behaviors
timeFrame: Baseline, Month 3
measure: Change in physical fitness
timeFrame: Baseline, Month 3
measure: Change in percentage of overweight&obesity
timeFrame: Baseline, 3 Month
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Child and Adolescent Health,Peking University
name: Hai-Jun Wang, PhD
role: STUDY_DIRECTOR
References:
citation: Li XH, Lin S, Guo H, Huang Y, Wu L, Zhang Z, Ma J, Wang HJ. Effectiveness of a school-based physical activity intervention on obesity in school children: a nonrandomized controlled trial. BMC Public Health. 2014 Dec 16;14:1282. doi: 10.1186/1471-2458-14-1282.
Clinical trial NCT02577432: Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Simple Way to Achieve More Satisfactory Block and Less Hypotension
Official title: Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Controlled Randomized Study of a Simple Way to Achieve More Satisfactory Block and Less Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: spinal anesthesia
Lead sponsor: Dr. Soliman Fakeeh Hospital
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 124
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Poor spinal anaesthesia block is common and is difficult to manage; so a technique to minimize its incidence is advisable. Hypotension is the commonest problem with spinal anesthesia. Multiple trials to prevent or combat hypotension using positional changes, fluid therapy and the use of vasopressors were tried. However, the drug choice and mode of administration as either bolus or infusion is still a matter of debate.

Objectives: To compare the outcome of spinal injection of hyperbaric bupivacaine and fentanyl separately to standard injection of mixed fentanyl with hyperbaric bupivacaine.

Design: A randomized, controlled clinical trial.

Setting: Single medical center from 5/2013 to 10/2014.

Patients \& Methods: 124 parturient scheduled for elective cesarean section (CS) were randomly allocated into two groups, each 62 parturient: Group M received spinal anesthesia using 10 mg bupivacaine 0.5% premixed with 25 µg fentanyl in the same syringe and Group S received 25 µg fentanyl in one syringe and 10 mg bupivacaine 0.5% without barbotage in a second syringe. Intravenous fluid co-load with 15 ml/kg warm lactated ringer solution was started as fast drip during, and continued after spinal anesthesia.

Patients were monitored for hemodynamic parameters, time of sensory onset and height of maximum sensory block, lower limb motor blockade was scored using modified Bromage scale and the frequency of side effects.


Eligibility criteria: Inclusion Criteria:

* Parturient at full term.
* Must be elective cesarean section.
* Must be uncomplicated pregnancy

Exclusion Criteria:

* Body weight \<50 kg or \>90 kg
* Height ˂150 cm or \>170 cm.
* Pre-eclampsia.
* Any major systemic disease.
* Contraindication to regional anesthesia.
* Allergy to used medications.

Primary outcomes:
measure: Number of parturients needed more analgesics (unsatisfactory block) using Ochsner Health System.
timeFrame: intraoperative
measure: incidence of hypotension
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dr. Benha Faculty of Medicine
name: Amr A Keera, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01829932: The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study
Official title: The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Diet
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Irritable bowel syndrome (IBS) is a chronic gastrointestinal illness of unknown cause whose symptoms include abdominal pain, bloating and altered bowel pattern. Diet has been shown to influence the bacteria gut interaction. Our aim is to determine if components of the diet affect IBS symptoms by changing the bacteria gut interaction. In particular, we will measure whether after being on a diet high or low on certain factors there is a change in the timing and amount of hydrogen and methane produced by bacteria digesting lactulose and on IBS symptom severity.


Eligibility criteria: Inclusion Criteria:

* Meet Rome III criteria for IBS
* Willing to undergo dietary intervention

Exclusion Criteria:

* History of Gastric, Small Bowel or Colonic Surgery
* History of Inflammatory Bowel Disease
* Celiac Disease
* Unable to come off following medications: antibiotics, laxatives, narcotics, sedatives
* On a pre specified diet
* Pregnant

Primary outcomes:
measure: Area under the Curve of Hydrogen Gas on Lactulose Breath Test
timeFrame: 5 hours
Secondary outcomes:
measure: Change in Area Under the Curve on Lactulose Breath Test from Baseline
timeFrame: 5 hours
measure: Change in IBS Symptom Severity Score from Baseline
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Stephen Vanner, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: McIntosh K, Reed DE, Schneider T, Dang F, Keshteli AH, De Palma G, Madsen K, Bercik P, Vanner S. FODMAPs alter symptoms and the metabolome of patients with IBS: a randomised controlled trial. Gut. 2017 Jul;66(7):1241-1251. doi: 10.1136/gutjnl-2015-311339. Epub 2016 Mar 14.