louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01373034: The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome
Official title: The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome: Double-blind, Randomized, Placebo-controlled, Cross Over Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diarrhea Predominant Irritable Bowel Syndrome
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-06-14
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators will evaluate the efficacy of soy dietary fiber in adults with diarrhea predominant irritable bowel syndrome.


Eligibility criteria: Inclusion Criteria:

* willing to consent/undergo necessary procedures
* between the age of 19 and 75 years
* diarrhea predominant irritable bowel syndrome (satisfied with Rome II criteria)

Exclusion Criteria:

* uncontrolled hypertension (Blood pressure \> 170/100 mmHg)
* uncontrolled diabetes mellitus (FBS \> 180 mg/dL)
* malignancy, cerebrovascular disease, cardiovascular disease
* history of abdominal surgery except appendectomy and hernia repair
* inflammatory bowel disease
* clinically or laboratory-confirmed gastroenteritis
* the use of motility drug or dietary fiber supplement in 2 weeks
* allergy to soy fiber
* serum Cr \> 2 x Upper normal limit
* AST or ALT \> 2 x Upper normal limit
* Pregnancy, Lactating woman

Primary outcomes:
measure: sum of irritable bowel syndrome symptom score
timeFrame: after 4 weeks
Secondary outcomes:
measure: irritable bowel syndrome symptom score
timeFrame: after 2 weeks and 4 weeks
measure: Stool frequency and form
timeFrame: after 2 weeks and 4 weeks
measure: Symptom control of irritable bowel syndrome
timeFrame: after 2 weeks and 4 weeks
measure: Improvement of overall symptom in patient with irritable bowel syndrome
timeFrame: after 2 weeks and 4 weeks
measure: Severity of overall symptom in patient with irritable bowel syndrome
timeFrame: after 2 weeks and 4 weeks
measure: Severity of diarrhea
timeFrame: after 2 weeks and 4 weeks
measure: Assessment for quality of life related with irritable bowel syndrome
timeFrame: after 2 weeks and 4 weeks
measure: Assessment for patient satisfaction after administration completion
timeFrame: after 2 weeks and 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Joo Sung Kim, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01705834: Dataglove to Measure Joint Stiffness in Patients With Arthritis
Official title: The Evaluation of a Dataglove to Measure Joint Stiffness in Patients With Arthritis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Arthritis, Rheumatoid
Keywords: Arthritis
Stiffness
Range of movement
Goniometry
Digital
Dataglove
Outcome
Lead sponsor: Western Health and Social Care Trust
Sponsor class: OTHER
Collaborators: name: University of Ulster
First posted: 2012-10-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Rheumatoid arthritis causing pain and stiffness in their hands.

Brief summary: This study will investigate if an electronic dataglove can be used to measure joint stiffness in patients with Rheumatoid Arthritis.

Detailed description: We will use a dataglove to record joint movements in a small number of patients with rheumatoid arthritis. The aim of the study is to find out if changes in dynamic movements measured by the glove will correlate with symptoms of joint stiffness in the hands of patients with rheumatoid arthritis.

Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 18 to 80
* Diagnosis of Rheumatoid arthritis
* Patients who have significant pain and stiffness in their hands
* Correct hand size to achieve a good fit to the dataglove
* Able to follow instructions for use of dataglove/computer

Exclusion Criteria:

* Severe pain in the right hand
* Severe swelling in the right hand (rated as such by the investigator)
* Severe permanent deformity or loss of function in the fingers of the right hand
* Broken or infected skin in the right hand
* Known to have been MRSA positive currently or in the past
* Unable to don and doff the disposable lining glove and the dataglove without significant discomfort
* Poor fit for the disposable lining glove or the dataglove
* History of latex allergy

Primary outcomes:
measure: Correlation between maximum velocity of movement and the patient reported severity of joint stiffness
timeFrame: Maximum of 7 days
Secondary outcomes:
measure: Number of patients withdrawing from the study
timeFrame: Over the period of testing of the dataglove - 7 day timeframe
Other outcomes:
Locations:
city: Londonderry
country: United Kingdom
facility: Department of Rheumatology, Altnagelvin Hospital
state: N.Ireland
Study officials:
affiliation: Western Health and Social Services Trust
name: Philip Gardiner, MB BCh BAO MD
role: STUDY_CHAIR
affiliation: University of Ulster
name: Kevin Curran, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ulster
name: Joan Condell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ulster
name: James Connolly, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00648934: Fed Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
Official title: Single-Dose Fed Bioequivalence Study of Topiramate Sprinkle Capsules (25 mg; Mylan) and Topamax® Sprinkle Capsules (25 mg; Ortho-McNeil Neurologics) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsules to Ortho-McNeil's Topamax® Sprinkle 25 mg capsules following a single, oral 25 mg (1 x 25 mg) dose administered under fed conditions.


Eligibility criteria: Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study

Primary outcomes:
measure: The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
timeFrame: blood collections through 144 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Kendle International Inc.
state: West Virginia
Study officials:
affiliation: Kendle International Inc.
name: Dorian Williams, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05002634: Safety of Undenatured Collagen Type II (UCII) Supplement in Healthy Volunteer
Official title: Safety of Undenatured Collagen Type II (UCII) Supplement in Healthy Volunteer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health, Subjective
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will be evaluated safety of undenatured collagen type II (UCII) supplement in 60 healthy volunteer. Liver function test, renal function test, and adverse event will be assessed.

Detailed description: This study will be evaluated safety of undenatured collagen type II (UCII) supplement in 60 healthy volunteer. The undenatured collagen type II (UCII) supplement 40 mg will be taken once daily for 2 months. Liver function test, renal function test, and adverse event will be assessed before and after taking for 1 and 2 months.

Eligibility criteria: Inclusion Criteria:

* Age 20-60 years
* No taking collagen supplement more than 2 weeks
* No collagen and protein allergy
* No liver and renal disease
* Have a willingness to participate in the study

Exclusion Criteria:

* Uncontrolled disease
* Have complication symptom during study
* Pregnancy or lactation
* Cannot follow the protocol
* During participated in other studies

Primary outcomes:
measure: Aspartate aminotransferase value
timeFrame: 2 months
Secondary outcomes:
measure: Alkaline phosphatase value
timeFrame: 2 months
measure: Alanine transaminase value
timeFrame: 2 months
measure: Blood urea nitrogen value
timeFrame: 2 months
measure: Creatinine value
timeFrame: 2 months
measure: Adverse event
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01236534: Lubiprostone in Patients With Multiple Sclerosis Associated Constipation
Official title: Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-groups Study of Lubiprostone in Patients With Multiple Sclerosis-Associated Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Constipation
Keywords: Multiple Sclerosis
Constipation
Multiple Sclerosis Associated Constipation
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2010-11-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess how safe and effective the drug Lubiprostone is in people with Multiple Sclerosis (MS)and moderate to severe MS-associated constipation. Lubiprostone is approved by the FDA for the treatment of two common types of constipation in adults, chronic idiopathic constipation and irritable bowel syndrome.

Detailed description: Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system. Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the bowel. In people with MS, the covering around the nerve fibers deteriorates, causing nerve impulses to be slowed or stopped. as a result, patients with MS may experiences constipation.

Eligibility criteria: Inclusion Criteria:

* Multiple Sclerosis
* Chronic Constipation defined as \< 3 spontaneous bowel movements per week by history and confirmed by diary during the 14 day washout period.
* Women of child-bearing potential must agree to use adequate birth control.

Exclusion Criteria:

* history of other clinically significant medical or psychiatric disorders or suicidal ideation.
* Subjects who have a suspicion of a mechanical bowel obstruction by clinical evaluation prior to dosing that include nausea, vomiting, abdominal pain or distention.
* Subjects with a positive urine pregnancy test prior to dosing.
* Medication changes within one month prior to visit one.
* Corticosteroid use within 2 months prior to visit one.
* Age\<18.
* Known intolerance to lubiprostone.
* Inability to perform any required study procedures.

Primary outcomes:
measure: Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.
timeFrame: 21 days
Secondary outcomes:
measure: Number of Participants With Diarrheic Events.
timeFrame: 21 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Andrew D Goodman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03551834: Ahmed Glaucoma Valve Implantation; Graft-Free Short Tunnel Small Flap Versus Scleral Patch Graft
Official title: Ahmed Glaucoma Valve Implantation; Graft-Free Short Tunnel Small Flap Versus Scleral Patch Graft
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Glaucoma
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Glaucoma implants have been used for refractory glaucoma and are gaining popularity as a primary procedure in selected patients. In order to prevent tube erosion, a biologic material such as pericardium, cornea, and sclera is used as coverage over the tube. Despite this preventive measures, patch graft thinning and silicon tube exposure are still a serious complications and may occur in 1%-7% of eyes after glaucoma implantation. In this study we used a novel technique named short tunnel small flap (STSF) by tunneling the sclera without using any biological material . efficacy and safety of this technique is comparing with conventional scleral patch graft.

This randomized clinical trial, was performed at the Glaucoma Clinic of Labbafinejad Medical Center, Tehran, IRAN from September 2015 to January 2017 . The study was approved by the ethics committee at the Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran and followed the tenets of the Declaration of Helsinki. After explaining all therapeutic options and their side effects, the written consent form was obtained from all patient. 80 eyes of 80 patients with refractory glaucoma underwent AGV implantation by short tunnel small flap technique (group1) or scleral patch graft (group2) randomly. Primary outcome measure is Intraocular pressure(IOP) and Tube exposure, and secondary outcome measure is success rate that is defined as intraocular pressure (IOP) \> 5 mmHg, ≤ 21 mmHg, and IOP reduction ≥ 20% from baseline at two consecutive visits after three months, no reoperation for glaucoma. Outcome measures are compared at 1, 3 , 6 and 12 months postoperatively.


Eligibility criteria: Inclusion Criteria:

* Iranian patients with Caucasian ethnicity, and at least 25 years old who had inadequately controlled glaucoma.

Exclusion Criteria:

* Primary congenital glaucoma, thin sclera, no light perception vision, pregnant or nursing women, iridocorneal endothelial syndrome, epithelial or fibrous down growth, and unwillingness to participate in the study.

Primary outcomes:
measure: Intraocular pressure(IOP)
timeFrame: 12 months post operatively
measure: Tube exposure
timeFrame: 12 months post operatively
Secondary outcomes:
measure: success rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT06712134: The Factors Associated 30-day Mortality After Perioperative Cardiac Arrest in Adults Undergoing Non-cardiac Surgery.
Official title: The Factors Associated 30-day Mortality After Perioperative Cardiac Arrest in Adults Undergoing Non-cardiac Surgery: A 7-year Observational Study From a Tertiary Care University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Perioperative Complication
Keywords: Critical care
Perioperative cardiac arrest
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 105
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: Patients \>eighteen years that had non-cardiac surgery under anesthesia and a history of PCA between January 2015 and December 2021 were eligible for inclusion. Patients with a do not resuscitate (DNR) order, who did not receive cardiopulmonary resuscitation (CPR) during PCA, or with incomplete data regarding 30-day mortality were excluded. PCA was defined as the absence of mechanical heart function (determined by a central pulse) and loss of effective circulation between the administration of anesthesia until 24 hours after surgery

Brief summary: Perioperative cardiac arrest (PCA) in patients undergoing noncardiac surgery is a rare but potentially catastrophic event associated with high mortality. Several studies have highlighted the factors contributing to PCA in the surgical population. However, information on outcomes after PCA among the surgical population is still limited. Our study aims to identify the incidence of PCA, 30-days mortality and the factors associated with PCA and 30-day mortality after PCA in adults undergoing non-cardiac surgery


Eligibility criteria: Inclusion Criteria:

* patients aged\> 18 years old
* history of perioperative cardiac arrest
* non- cardiac surgery

Exclusion Criteria:

* did not receive cardiopulmonary resuscitation (CPR) during PCA
* incomplete data regarding 30-day mortality were excluded

Primary outcomes:
measure: incidence of 30 days mortality after perioperative cardiac arrest
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05744934: Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
Official title: Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Univentricular Heart
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 10
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The primary objective of this investigation is to evaluate the feasibility and safety of implantable loop recorder implantation (using the LUX-DX™) in newborns undergoing stage 1 palliation. The secondary objective of the investigation is to evaluate the feasibility of continuous measurement of heart rate and arrhythmia using an implantable loop recorder (LUX-Dx™) during the interstage period.

An implantable loop recorder will be placed at the time of chest closure following stage 1 palliation (either at the time of index surgery or delayed). The device will be placed in a subclavicular pouch through the existing sternotomy incision. Participants will be in the study for 6 months to 3 years.


Eligibility criteria: Inclusion Criteria:

* Patients with single ventricle physiology undergoing stage 1 palliation in the 1st month of life

Exclusion Criteria:

* Prematurity (\<36 weeks gestational age)
* Birth weight \<2.5 kg
* Hybrid stage 1 palliation (patent ductus arteriosus stenting, bilateral pulmonary artery bands)
* Presence and/or need for devices sensitive to magnetic fields such as hearing aids, pacemaker, and other implanted devices.
* Clinical team does not think that the patient is a good candidate

Primary outcomes:
measure: Number of patients with successful ILR implantation at the time of surgery
timeFrame: At the time of stage 1 surgery, typically the first week of life
measure: Number of patients with ILR related complication (any of: infection, erosion, device migration, foreign body rejection phenomena, formation of hematomas or seromas, local tissue reaction and/or tissue damage
timeFrame: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Secondary outcomes:
measure: Number of patient who completed >70% planned ILR transmissions
timeFrame: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
measure: Number of patients with arrhythmias
timeFrame: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
measure: Number of patients with interstage complication
timeFrame: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
measure: Complications at the time of ILR removal
timeFrame: At stage 2 or 3 palliation, typically between 4 months and 4 years of age
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT06186934: Post Marketing Surveillance Study to Observe Safety and Effectiveness of NEPHOXIL ® in S. Korea Patients
Official title: Post Marketing Surveillance Study to Observe Safety and Effectiveness of NEPHOXIL ® in S. Korea Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hyperphosphatemia
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-02
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic kidney disease undergoing hemodialysis and controlling hyperphosphatemia

Brief summary: The objective of this post-marketing surveillance (PMS) study is to assess the safety and effectiveness of Nephoxil capsule 500 mg (Ferric Citrate 500 mg, equivalent to 105 mg Ferric Iron) in routine clinical settings


Eligibility criteria: Inclusion Criteria:

1. Adults 19 years of age or older
2. CKD patients undergoing hemodialysis to whom Nephoxil capsule administration is deemed necessary for improvement of hyperphosphatemia as per the determination of the investigator
3. Patients who received Nephoxil capsule for the first time according to the national approval after conclusion of the contract with the study institution
4. Those (or his / her legal guardian) who have agreed in writing to participate in the survey

Exclusion Criteria:

1. Patients with contraindications to receive Nephoxil

   * Patients with hypersensitivity to the active substance or to any of the excipients
   * Patients with hypophosphatemia
   * Patients with abnormal iron metabolism or symptoms of excessive iron (e.g. hemochromatosis)
2. Patients who intend to use this drug for non-approved indications
3. Patients who participated in pre-market clinical trials with Nephoxil
4. Patients who took this drug before the starting day of this survey

Primary outcomes:
measure: Serum phosphorus levels
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jesus Hospital
Study officials:
References: