louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05420870: Effect of Exercise on Bowel Function in Colorectal Cancer Survivors
Official title: A Randomized Controlled Trial to Examine the Effect of Exercise on Bowel Function in Colorectal Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Low Anterior Resection Syndrome
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The survival rate of colorectal cancer patients is increasing due to the development of medical technology. However, many colorectal cancer survivors (CRCs) have bowel dysfunction unlike other cancer survivors. After bowel dysfunction of CRCs was known, many previous studies were conducted to improve bowel dysfunction. Medication, probiotics, Biofeedback training (BFT), Kegel exercise, and sacral nerve stimulation were the methods of intervention research to improve bowel movements in CRCs. Research on randomized control trial of BFT and Kegel exercise is very insufficient. Surgery, chemo, and radiation have a lot of influence on the bowel process of CRCs. In particular, damage to the abdominal muscles, pelvic floor muscles, and autonomic nervous system can also be caused by secondary symptoms such as increased fatigue, reduced physical strength, and musculoskeletal diseases. Therefore, the investigators examine that exercise which can improve fatigue, physical fitness, and musculoskeletal disease affects bowel symptoms of colon cancer survivors.


Eligibility criteria: Inclusion Criteria:

1. Adults aged 19 to 70 who have been diagnosed with Sigmoid colon cancer or rectal cancer have surgery for 6 months or more to less than 3 years
2. Three months after chemo and radiation therapy.
3. Six month after stoma take-down
4. Colorectal cancer patients with a LARS (Low Anterior Reservation Syndrome) questionnaire score of 21 or higher

Exclusion Criteria:

1. Subjects who have problems reading or understanding Korean or who have problems communicating with researchers
2. Subjects who plan to undergo surgery at the same time other than colorectal cancer surgery
3. Metastatic colorectal cancer patients.
4. Subjects who have stoma
5. People who are difficult to exercise in the judgment of the medical staff

Primary outcomes:
measure: Anorectal manometry
timeFrame: Baseline (0 week)
measure: Anorectal manometry
timeFrame: endline (7 week)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Dept. of Internal Medicine, Division of Gastroenterology, Sinchon sevarance Hospital, Younsei university College of Medicine
name: Jae Jun Park
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03819270: A Safety Study of LY3372689 Given By Mouth to Healthy Participants
Official title: Single-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3372689
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-01-28
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being conducted to determine the safety profile of the study drug after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3372689 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive up to 3 doses of LY3372689 or placebo. The study will last about 12 weeks, including screening.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy male or a female who cannot get pregnant
* Have a body mass index (BMI) of at least 18.5 kilogram per square meter (kg/m²), inclusive, at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
* Have veins suitable for ease of blood sampling

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking for study procedure
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Have long exposure to sunlight routinely or use tanning beds regularly

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Observed by the Investigator During Study Drug Administration
timeFrame: Baseline through final follow-up at approximately Week 12
Secondary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY3372689
timeFrame: Baseline through to final follow-up at approximately Week 12
measure: Pharmacokinetics: Time to Maximum Blood Concentration (Tmax) of LY3372689
timeFrame: Baseline through final follow-up at approximately Week 12
measure: Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3372689
timeFrame: Baseline through final follow-up at approximately Week 12
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03128970: Synchronizing Blastocyst in Frozen Embryo Transfer
Official title: Synchronizing Blastocyst at Hatching Stage in Frozen Embryo Transfer Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embryo Implantation
Lead sponsor: Al-Yasmeen Fertility and Gynecology Center
Sponsor class: OTHER
Collaborators: name: Ganna Fertility Center
First posted: 2017-04-25
Enrollment: 742
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the present study is to determine if implantation rate could be increased in women undergoing frozen embryo transfer cycles in case of adjusting their embryo development at hatching stage.


Eligibility criteria: Inclusion Criteria:

1. Patients who will agree to participate and assign an informed consent form
2. Only blastocyst transfer FET cycles
3. Patients undergoing FET after their 1st IVF or ICSI cycle with no pregnancy at the fresh transfer
4. Freeze-all cycles due to OHSS
5. Freeze-all cycles due to poor endometrium
6. Age 19-33 at the time of randomization.
7. Their frozen blastocysts are 3 or less grade of expansion.
8. Female with a ≥12 AFCs
9. Endometrial thickness ≥ 8mm at the time of ovulation
10. Women with their male partners will give only fresh semen
11. Women who have no uterine abnormality by ultrasound
12. BMI ≤ 31

Exclusion Criteria:

1. Cycles undergoing preimplantation genetic diagnosis.
2. Women who have previous two cycles of implantation failure at fresh transfer
3. Women who have previous two FET failed cycles
4. Any uterine pathology (myomas, adenomyosis, endocrinopathies, thrombophilia, chronic pathologies, acquired or congenital uterine abnormalities)
5. Patients with severe endometriosis
6. Presence of uni- or bilateral hydrosalpinx
7. Recurrent pregnancy loss.
8. Any medical condition that affect fertility.

Primary outcomes:
measure: Ongoing implantation rate
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Al-Yasmeen fertility and gynecology center
city: Cairo
country: Egypt
facility: Ganna Fertility and Gynecology Center
Study officials:
References:
Clinical trial NCT00778570: Advanced Surface Ablation (ASA) vs Laser-Assisted In Situ Keratomileusis (LASIK)
Official title: A Combined Retrospective and Prospective Chart Review Analysis of Visual Outcomes Following Excimer Laser Vision Correction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nearsightedness
Farsightedness
Astigmatism
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2008-10-23
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female participants from the Ottawa/Gatineau region requesting laser vision correction to correct nearsightedness, farsightedness, and/or astigmatism.

Brief summary: The purpose of this combined retrospective and prospective chart review analysis is to investigate the safety, efficacy, and predictability obtained via Laser-Assisted In Situ Keratomileusis (LASIK) and Advanced Surface Ablation (ASA) over a wide range of refractive errors

The working hypothesis is that there will be no difference in clinical outcomes between patients treated with LASIK or ASA.

Detailed description: Excimer laser vision correction (LVC) is a widely used procedure to correct nearsightedness, farsightedness, and astigmatism by reshaping the surface of the eye (cornea). Laser-Assisted In Situ Keratomileusis (LASIK) and Advanced Surface Ablation (ASA) and are techniques currently used to prepare the cornea for Excimer LVC.

This review is intended to study whether LASIK is equal in visual outcome (null hypothesis), more effective (alternate hypothesis 1) or less effective (alternate hypothesis 2) than ASA in clinical outcome up to one year.

Eligibility criteria: Inclusion Criteria:

* Eyes that were treated for LASIK or ASA Excimer laser vision correction before December 1st 2006 and newly recruited eyes that qualify for LASIK or ASA Excimer laser vision correction may be enrolled in this study.

Exclusion Criteria:

* There are no exclusion criteria; all patients that went forward with Excimer laser vision correction may be included.

Primary outcomes:
measure: Visual Acuity
timeFrame: 1 day, 1W, 1M, 3M, 6M, 9M, 12M
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Eye Institute
state: Ontario
Study officials:
affiliation: University of Ottawa Eye Institute
name: George Mintsioulis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00935870: Bioactive Glass as Bone Graft Substitute in Operative Treatment of Bone - a 10 Years Follow-up Study
Official title: Bioactive Glass (S53P4) as Bone Graft Substitute in Operative Treatment of Depressed Lateral Condyle Fractures, Benign Bone Tumour Cavities and in Spinal Fusion - a 10 Years Follow-up and Bone Density Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressed Lateral Condyle Fracture
Benign Bone Tumour Cavity
Spinal Fusion
Lead sponsor: Vivoxid Ltd
Sponsor class: INDUSTRY
First posted: 2009-07-09
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who participated to previous clinical investigations with bioactive glass about 10 years ago.

Brief summary: The main aim is to evaluate the long-term safety and bone healing in the operated area and to compare bioactive glass granules with autogenous bone as a filler material.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained; Participation of previous clinical investigation with bioactive glass

Exclusion Criteria:

* The subject is unlikely to adhere to study procedures
* Concurrent disease or condition that in the opinion of the investigator is contraindicating participation
* Simultaneous participation in another medical device or investigational drug trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital/Helsinki University Hospital
name: Nina Lindfors, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01267370: Soy Polysaccharide Fiber for the Treatment of Chronic Constipation in Children: a Randomized, Double-blind Trial
Official title: Soy Polysaccharide Fiber for the Treatment of Chronic Constipation in Children: a Randomized, Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Keywords: clinical trial
dietary fiber
constipation
children
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Maria Eugênia Farias Almeida Motta
name: Soraia Tahan
name: Mauro Batista de Morais
First posted: 2010-12-28
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study tested the hypothesis that soy polysaccharide fiber reduces clinical symptoms of chronic constipation.

Detailed description: The study was performed out at outpatient clinic of Pediatric Gastroenterology at the Federal University of São Paulo (São Paulo, Brazil), located in the southeastern region of Brazil. It is a public referral hospital for pediatric gastroenterology attendance in the Metropolitan area of the São Paulo and in Brazil. In general, the patients go to consultation after a referral from a primary care center.

Study design and sample size The design was a randomized double-blind trial, placebo-controlled study. Sample size was calculated by the formula of comparison of two proportions, using clinical improvement as a primary outcome. It had been previously calculated that a minimum of 14 patients in each group will give a power of 80% to detect a effect size of 50% with significance at the level of 5% (one-sided).

Eligibility criteria: Inclusion Criteria:

* Patients over two years of age at first consultation and chronic functional constipation were included. Chronic constipation was defined by the occurrence of any of the following, for at least 2 weeks, independently of stool frequency: passage of hard, scybalous, pebble-like or cylindrical cracked stools, straining or painful defecation, passage of large stools that may clog the toilet, or stool frequency less than 3 per week.

Exclusion Criteria:

* The exclusion criteria applied were organic constipation, regular use of dietary fiber in the preceding 30 days or drugs causing constipation.

Primary outcomes:
measure: Clinical response
timeFrame: 6 weeks
Secondary outcomes:
measure: total and segmental colonic transit time and fecal weight and moisture
timeFrame: 6 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Division of Pediatric Gastroenterology UNIFESP
Study officials:
References:
Clinical trial NCT00229970: MK0476 Study in Adult Patients With Acute Asthma (0476-322)
Official title: MK0476 Phase II/III Placebo Controlled Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-30
Enrollment: 225
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy and safety of MK0476 intravenous administration in adult patients with acute asthma.


Eligibility criteria: Inclusion Criteria:

* Adult Patients With Acute Asthma Attacks

Exclusion Criteria:

* Patient Has Any Known Or Suspected, Acute Or Chronic Cause For Their Pulmonary Symptoms Other Than Asthma (E.G., Copd, Chronic Heart Failure, Etc.)
* Patient Has A Smoking History (20 Cigarettes Per Day) Of More Than 15 Years
* Patient Has A Disease Of The Cardiovascular, Hepatic, Renal, Hematologic Systems, Or Other Severe Disease

Primary outcomes:
measure: The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)
timeFrame: baseline over the first 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Adachi M, Taniguchi H, Tohda Y, Sano Y, Ishine T, Smugar SS, Hisada S. The efficacy and tolerability of intravenous montelukast in acute asthma exacerbations in Japanese patients. J Asthma. 2012 Aug;49(6):649-56. doi: 10.3109/02770903.2012.690479. Epub 2012 Jun 28.
Clinical trial NCT00887770: A Study to Investigate the Potential for AZD5672 to Affect the Electrical Conduction Pathways in the Heart
Official title: A Single-centre, Double-blind, Double-dummy, Randomised, Placebo-controlled, Four-period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600 mg and 150 mg) on QT/QTc Interval, Compared to Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: QTcF
Crossover
ICH E14
QT/QTc prolongation
Moxifloxacin
QT/QTc Interval
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2009-04-24
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being performed to investigate the potential for AZD5672 to affect the electrical conduction pathways in the heart. AZD5672 will be compared against a drug (moxifloxacin - a licensed antibiotic) known to have a detectable but safe change on the electrical conduction of the heart.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) between 18 and 30 kg/m2 and a minimum weight of 50kg.
* Non-smoker

Exclusion Criteria:

* Marked QTc prolongation at baseline e.g. repeated demonstration of QTc interval \>450ms or marked shortening of QTcF \<350ms
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of the QTc Interval changes
* Use of concomitant medications that prolong QT/QTc interval

Primary outcomes:
measure: Evaluate time-matched QTcF intervals of single dose AZD5672 600mg compared to placebo.
timeFrame: Up to 24 hours postdose
Secondary outcomes:
measure: Evaluate time-matched QTcF Intervals of single dose AZD5672 150mg compared to placebo.
timeFrame: Up to 24 hours postdose
measure: To evaluate the change in time matched ECG parameters (QTcB, QTcX, RR, PR and QRS) of single dose AZD5672 600mg and 150mg compared to placebo
timeFrame: Up to 24 hours postdose
measure: To further evaluate the safety and tolerability of single dose AZD5672 600mg and 150mg
timeFrame: Adverse events assessed throughout the whole study. Safety monitoring (BP, safety blood samples and ECG) conducted frequently throughout study and up to 72 hours post dose on treatment visits.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Alderley Park, UK
name: Mark Layton
role: STUDY_DIRECTOR
affiliation: Guys Drug Research Unit, Newcomen St, London
name: Darren Wilbraham
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01875770: Continuing Assessment of Patients Treated With ranibizUmab for REtinal Vein Occlusion (CAPTURE)
Official title: Continuing Assessment of Patients Treated With ranibizUmab for REtinal Vein Occlusion (CAPTURE)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Retinal Vein Occlusion
Keywords: Retinal Vein Occlusion
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have been enrolled in the following three trials will be included in the study:

A) "A Pilot, Open-Label Study of the Safety, Tolerability, and Bioactivity of Multiple Intravitreal Injections of Ranibizumab in Subjects with Macular Edema Secondary to Vein Occlusions.", B) "Extended follow-up of patients with macular edema due to bRanch rETinal vein occlusion (BRVO) or centrAl retinal veIn occlusioN (CRVO) previously treated with intravitreal ranibizumab (RETAIN) " C) "RanibizumabDosE Comparison (0.5mg and 2.0mg) and the Role of LAser in the ManagemenT of REtinal Vein Occlusion - A Pharmacodynamic Approach (RELATE)"

Brief summary: This research is being done to assess the long term prognosis of patients treated with ranibizumab for edema due to retinal vein occlusion.

Detailed description: People treated with ranibizumab for edema due to retinal vein occlusion as part of previous studies at the Wilmer Eye Institute and who are currently being seen by their ophthalmologist at the Wilmer Eye Institute are followed up to assess long term outcomes

Eligibility criteria: Inclusion Criteria:

* All patients who have been enrolled in the following three trials will be included in the study:

A) "A Pilot, Open-Label Study of the Safety, Tolerability, and Bioactivity of Multiple Intravitreal Injections of Ranibizumab in Subjects with Macular Edema Secondary to Vein Occlusions.", B) "Extended follow-up of patients with macular edema due to bRanch rETinal vein occlusion (BRVO) or centrAl retinal veIn occlusioN (CRVO) previously treated with intravitreal ranibizumab (RETAIN) " C) "RanibizumabDosE Comparison (0.5mg and 2.0mg) and the Role of LAser in the ManagemenT of REtinal Vein Occlusion - A Pharmacodynamic Approach (RELATE)"

Exclusion Criteria:

* None

Primary outcomes:
measure: Mean change from baseline in BCVA at 5 and 10 years.
timeFrame: 10 years
Secondary outcomes:
measure: Mean change from baseline in foveal thickness at 5 and 10 years
timeFrame: 10 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Wilmer Eye Institute
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Peter Campochiaro, MD
role: PRINCIPAL_INVESTIGATOR
References: