louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02727751: A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C
Official title: An Open Label Long-Term Safety Study of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation Predominant Irritable Bowel Syndrome
Lead sponsor: Ardelyx
Sponsor class: INDUSTRY
First posted: 2016-04-05
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase 3, open label study will evaluate the safety of tenapanor 50 mg BID in subjects with constipation-predominant irritable bowel syndrome (IBS-C) defined by the ROME III criteria. Subjects who have completed either TEN-01-301 (16 weeks) or TEN-01-302 (26 weeks) studies may be enrolled. Subjects will take tenapanor for approximately 52-55 weeks total based on previous protocol and this study.

Detailed description: During the treatment period of up to 39-weeks, subjects will return for study visits approximately every 13 weeks. Subjects will undergo safety assessments at these visits, which may include a physical exam, ECG, vital signs, and clinical labs. Adverse events and concomitant medications will be recorded. Medication compliance will be monitored and the subjects will be given additional study drug as appropriate.

Eligibility criteria: Inclusion Criteria:

* Subjects completed all 16 weeks of TEN-01-301 or all 26 weeks of TEN-01-302
* Subject demonstrated adequate compliance with the study procedures during either the TEN-01-301 or TEN-01-302 studies
* Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception
* Males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization

Exclusion Criteria:

* Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or TEN-01-302
* The subject reports using any prohibited medication and is not willing to abide by the restrictions for intake
* Pregnant or lactating women

Primary outcomes:
measure: Adverse Events in >2% Patients
timeFrame: 52-55 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Ardelyx Clinical Site
state: Florida
Study officials:
affiliation: Ardelyx, Inc.
name: David P Rosenbaum, Ph.D.
role: STUDY_CHAIR
References:
citation: Chey WD, Lembo AJ, Yang Y, Rosenbaum DP. Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2). Am J Gastroenterol. 2021 Jun 1;116(6):1294-1303. doi: 10.14309/ajg.0000000000001056.
Clinical trial NCT01848951: Comparison of Epidural and TAP Block in Abdominal Surgery
Official title: Comparison of Epidural Analgesia With Bilateral Dual TAP Infiltration Block With Liposomal Bupivacaine in Patients With Major Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pain
Surgery
Regional Anesthesia
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult subjects undergoing major abdominal surgery

Brief summary: This study will compare the infiltrative transversusabdominis plane (TAP) block with liposomal bupivacaine to epidural analgesia (EA) in major abdominal surgery . The efficacy of the TAP block for abdominal surgery is well documented in literature, but there are no studies utilizing long-acting bupivacaine. The investigators believe the study will demonstrate no difference between the two in terms of pain scores and opioid consumption, but TAP blocks will decreased costs, urinary retention, and hypotension.

Detailed description: This study intends to examine this rational by comparing the infiltrative transversusabdominis plane (TAP) block with liposomal bupivacaine to EA in major abdominal surgery. The efficacy of the TAP block for abdominal surgery is well documented in the literature, but there are no studies utilizing long-acting bupivacaine. The investigators believe the primary outcome will demonstrate no difference between the two in terms of pain scores and opioid consumption. The investigators anticipate that patients who have undergone TAP blocks will have improved secondary outcomes with respect to a decreased costs, urinary retention, and hypotension.

Eligibility criteria: Inclusion Criteria:

* subject \>/= 19 years of age
* Undergoing major abdominal surgery
* able to provide written informed consent

Exclusion Criteria:

* chronic opioid use
* allergies to amide anesthetics
* inability to undergo general anesthesia
* pregnancy
* any existence of contraindications to regional anesthesia in the presence of antiplatelet or anticoagulative drugs
* or evidence of gross neurological dysfunction of the lower extremity

Primary outcomes:
measure: Pain scores
timeFrame: 96 hours post-op
measure: Opioid Consumption in a 24-Hour period
timeFrame: 96 hours post-op
Secondary outcomes:
measure: Comparison of 96-hour hospital stay costs
timeFrame: 96 hours post-op
measure: Comparison of urinary failure/catheter acquired infection rates
timeFrame: 96 hours post-op
measure: Comparison of hypotension rates
timeFrame: 96 hours post-op
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Thomas A Nicholas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04909151: The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy Through Changing Gait Speed
Official title: The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Gait Disorders, Neurologic
Bilateral Spastic Cerebral Palsy
Lead sponsor: Sahmyook University
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 39
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Robot-assisted gait training (RAGT) improves the gait ability of children with cerebral palsy, and can provide treatment plans and guidelines through changed records of various gait variables. There is a lack of concrete explanations or arguments for gait speed, weight support ratio, support force, joint angle, etc. that can be set in the RAGT system, and intervention intensity for an appropriate intervention program has not been presented. Therefore, in this study, we would like to suggest clinically effective interventions for children with cerebral palsy in the second stage of the gross motor function classification system (GMFCS) by identifying gait variables according to differences in gait speed during RAGT.


Eligibility criteria: Inclusion Criteria:

* Patients 4-12 years old diagnosed with cerebral palsy
* Children who have not received botulinum toxin treatment or surgery within 3 months
* Children in stage 2 of the gross motor function system
* Children who can express pain, fear, or discomfort on their own

Exclusion Criteria:

* Severe lower extremity contracture and fracture
* Bone instability
* Osteoporosis
* Severe bones grow disproportionately
* Unhealed skin lesions on the lower extremities (thromboembolic disease)
* Thromboembolic disease
* Cardiovascular instability
* Mild scoliosis with a Cobb's angle of more than 20 degrees

Primary outcomes:
measure: Gait ability
timeFrame: Change from baseline gait ability at 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Paju
country: Korea, Republic of
facility: Pajucity convalescent Hospital
Study officials:
affiliation: The Wells Neuro Pain Clinic
name: Sun-Geon Park, Ph.D candidate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01713751: Surgical Site Infection Rates in Obese Patients After Cesarean Delivery
Official title: Surgical Site Infection Rates of Two Different Skin Closure Methods Used in Obese Patients After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Keywords: Surgical site infection
Cesarean section
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2012-10-25
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the surgical site infection rate and patient satisfaction for subcuticular versus interrupted mattress suture in closure of skin at Cesarean delivery in obese patients.

Detailed description: This is a randomized controlled trial conducted in Ain-Shams University Maternity Hospital on the period from March 2012 till August 2012. It included 130 pregnant women who underwent elective Cesarean section.

The aim of this study is to determine the surgical site infection rate and patient satisfaction for subcuticular versus interrupted mattress suture in closure of skin at Cesarean delivery in obese patients.

Eligibility criteria: Inclusion Criteria:

* Age: any female in childbearing period.
* Women planned for elective Cesarean section.
* Obese women (BMI ≥ 30 Kg/m2). Our study calculated the BMI of patients from their weight and height at admission, because the pre-pregnancy BMI was not available for all patients, and we hypothesized that the BMI at admission was a better indicator of body mass during the at-risk time for development of SSI than was the pre-pregnancy BMI.

Exclusion Criteria:

* Women who had concurrent overt infection (e.g.chorioamnionitis, pyelonephritis or chest infection).
* Women who had intraoperative events that may themselves predispose to perioperative infection (e.g. bowel injury, operative time more than 90 minutes, major blood loss).
* Women who had hemoglobin less than 10g/dl, preeclampsia, diabetes, rupture of membranes more than 12 hours, corticosteroid therapy.
* Patients who had non Pfannenstiel incision.

Primary outcomes:
measure: Surgical site infection
timeFrame: 30 days after the operative procedure
Secondary outcomes:
measure: Skin closure time
timeFrame: 15 minutes
measure: Postoperative pain
timeFrame: 48 hours
measure: Short-term cosmetic wound outcome
timeFrame: 30 days
measure: Overall women satisfaction
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Assistant Professor of Obstetrics & Gynecology Faculty of Medicine, Ain Shams University
name: Moustafa I. Ibrahim, MD
role: STUDY_DIRECTOR
References:
citation: Ibrahim MI, Moustafa GF, Al-Hamid AS, Hussein MR. Superficial incisional surgical site infection rate after cesarean section in obese women: a randomized controlled trial of subcuticular versus interrupted skin suturing. Arch Gynecol Obstet. 2014 May;289(5):981-6. doi: 10.1007/s00404-013-3098-z. Epub 2013 Nov 24.
Clinical trial NCT00932854: A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of MEDiastinal lymphadenopathY (REMEDY)
Official title: A Clinical tRial of Endobronchial Ultrasound for the Diagnosis of Isolated MEDiastinal lymphadenopathY (REMEDY)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Isolated Mediastinal Lymphadenopathy
Sarcoidosis
Tuberculosis
Lung Cancer
Lymphoma
Keywords: Mediastinal lymphadenopathy
EBUS
Bronchoscopy
Sarcoidosis
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
First posted: 2009-07-03
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Enlarged glands in the chest (mediastinal lymphadenopathy) is a common problem and may have a variety of different causes. In the past an operation (mediastinoscopy) was required to diagnose the glands. Endobronchial ultrasound (EBUS) is a new procedure that may be able to diagnose these glands without the need for mediastinoscopy. The REMEDY trial aims to examine whether EBUS can reduce the number of mediastinoscopies and healthcare costs in patients with enlarged glands in the chest.

Detailed description: Although the literature is replete with data on the utility of Endobronchial Ultrasound for lung cancer, there are very few data available on its role in the diagnosis of isolated mediastinal lymphadenopathy due to other causes such as sarcoid, tuberculosis or lymphoma. The REMEDY trial aims to evaluate the accuracy of EBUS in this setting and assess any reduction in the number of mediastinoscopies and healthcare costs.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with undiagnosed mediastinal lymphadenopathy (\>1cm in short axis) on CT or PET-CT scan for whom pathological evaluation is clinically indicated.

Exclusion Criteria:

* Patients without informed consent, those with anterior mediastinal lesions or with contra-indications to EBUS or mediastinoscopy will be excluded.

Primary outcomes:
measure: Number of mediastinoscopies prevented and healthcare costs
timeFrame: At diagnosis
Secondary outcomes:
measure: Length of hospital stay
timeFrame: At diagnosis
measure: Sensitivity and false negative rate of endobronchial ultrasound
timeFrame: At study completion
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
affiliation: University College, London
name: Sam Janes, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univeristy College London
name: Neal Navani, MD
role: STUDY_DIRECTOR
References:
citation: Navani N, Lawrence DR, Kolvekar S, Hayward M, McAsey D, Kocjan G, Falzon M, Capitanio A, Shaw P, Morris S, Omar RZ, Janes SM; REMEDY Trial Investigators. Endobronchial ultrasound-guided transbronchial needle aspiration prevents mediastinoscopies in the diagnosis of isolated mediastinal lymphadenopathy: a prospective trial. Am J Respir Crit Care Med. 2012 Aug 1;186(3):255-60. doi: 10.1164/rccm.201203-0393OC. Epub 2012 May 31.
Clinical trial NCT06554054: A Study of GZR18 Tablet in Chinese Healthy Subjects
Official title: A Randomized, Open Phase I Trial to Evaluate the Bioavailability, Pharmacokinetics, Pharmacodynamics, Safety and Tolerance of GZR18 Tablet and Evaluate the Effect of Meal Time on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerance of GZR18 Tablet in Chinese Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Gan and Lee Pharmaceuticals, USA
Sponsor class: INDUSTRY
First posted: 2024-08-14
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the trial is to investigate the the bioavailability, pharmacokinetics, pharmacodynamics, safety and tolerance of single and multiple doses of GZR18 tablet in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Subjects sign informed consent voluntarily.
2. Age 18-55 at screening (both included)，male or female（male only for part A）.
3. At screening, 20.0 kg/m2 ≤ BMI ≤ 24.9 kg/m2, body weight≥54.0 kg.
4. Female subjects were HCG negative at screening and baseline

Exclusion Criteria:

1. Female subjects who are pregnant or lactating at screening.
2. History of drug abuse within 1 year prior to screening, with a positive drug abuse screening result at screening or before dosing.
3. Abnormal fasting blood glucose at screening, or impaired glucose tolerance, or history of hypoglycemia within 3 months prior to screening.
4. History of the following diseases with a definite diagnosis within 6 months prior to screening: cardiovascular disease, hematologic disease, respiratory disease, abnormal liver function due to acute and chronic hepatitis or other reasons, abnormal renal function, endocrine and metabolic system disease, neuropsychiatric disease, skin and subcutaneous tissue disease, musculoskeletal system disease, immune system disease, or the presence of other diseases that may interfere with the interpretation of study results.
5. Those who have any food allergies or special dietary requirements and cannot follow a uniform diet.

Primary outcomes:
measure: AE and SAE
timeFrame: 22 days and 35 days
measure: Relative bioavailability of GZR18 tablet
timeFrame: 22 days and 35 days
measure: ADA and NAb
timeFrame: 22 days and 35 days
Secondary outcomes:
measure: Cmax
timeFrame: 22 days and 35 days
measure: AUC0-t
timeFrame: 22 days and 35 days
measure: AUC0-24h
timeFrame: 22 days and 35 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Study Site 01
Study officials:
affiliation: Gan & Lee Pharmaceuticals Co., Ltd
name: Xiao Min, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00454454: Virtual Reality Helmet to Test for Problems With Memory
Official title: Display Enhanced TEsting for Cognitive Impairment and Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Memory
Keywords: memory
display enhanced testing
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Wallace H. Coulter Foundation
First posted: 2007-03-30
Enrollment: 425
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: geriatric clinic, retirement facilities

Brief summary: The purpose of this research study is to compare a virtual reality display device with the standard neuropsychological evaluation for detecting mild cognitive impairment (problems with memory, concentration, reaction time, etc.).

Detailed description: Since many individuals with mild cognitive impairment (MCI) appear to function normally, MCI may often be recognizable through testing in advance of any changes noticed by family members or caregivers. Early and frequent testing can therefore trigger an earlier diagnosis, which may increase the effectiveness of currently available medications used to delay onset of Alzheimer's symptoms. Primary care and geriatric physicians currently lack the necessary tools required for quick and accurate MCI screening in the doctor's office environment. The current industry-standard is a battery of pen \& paper neuropsychological tests that require 1.5 hours in a quiet room with a neuropsychologist.

Comparison: virtual reality display device compared to the standard neuropsychological evaluation for detecting mild cognitive impairment (problems with memory, concentration, reaction time, etc.).

Eligibility criteria: Inclusion Criteria:

* 65 yrs of age and older
* MMSE of 18 or greater or mini-cog of 4 or greater
* Ability to read
* Informed consent given

Exclusion Criteria:

* Visual, hearing or physical impairment that would limit ability to use the virtual reality helmet or control device
* Non-English speaking

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Wesley Woods Health Center
state: Georgia
city: Atlanta
country: United States
facility: Wesley Woods Outpatient Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: David W Wright, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wright DW, Nevarez H, Kilgo P, LaPlaca M, Robinson A, Fowler S, Brumfield J, Goldstein FC. A novel technology to screen for cognitive impairment in the elderly. Am J Alzheimers Dis Other Demen. 2011 Sep;26(6):484-91. doi: 10.1177/1533317511426133. Epub 2011 Nov 22.
Clinical trial NCT04436354: The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy
Official title: The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Diseases
Keywords: vaginoscopic office hysteroscopy
lithotomy position
trendelenburg lithotomy position
visual pain score
procedural time
Likert scale
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-18
Enrollment: 157
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The present study revealed that the TL position is supposed to be more efficient not only for lowering pain score but also reducing the procedural time. Also, performing hysteroscopy in this position may be easier for doctors than in the lithotomy position.

Detailed description: VOH is a widely used diagnostic method and seems to be getting more into outpatient clinics. Despite its huge contribution to clinical practice, pain during the procedure is an important limiting factor. We aimed to investigate the effect of the trendelenburg lithotomy position to the pain and procedural time.However, there is a scarcity of research on this subject. Therefore, the rationale of the study was to enlighten the gap in the literature regarding the pain score and procedural time during VOH for diagnostic purposes in TL position. In order to gain scientific evidence, a randomized controlled trial was conducted to compare pain score and duration of procedure between the standard lithotomy position and TL position. Also, the convenience for the physician performing the procedure was assessed. To the best of our knowledge, this is the first study in the literature investigating the effect of the position of the patient during the procedure on both time, pain, and the convenience for the physician simultaneously.

Eligibility criteria: Inclusion Criteria:

* uterine disorders
* abnormal uterine bleeding
* infertility

Exclusion Criteria:

* pregnancy
* cervical disorders
* pelvic infections

Primary outcomes:
measure: Visual Analog Score for pain
timeFrame: 12 months
measure: procedural times
timeFrame: 12 months
Secondary outcomes:
measure: attitudinal Likert type survey
timeFrame: 12 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Saglik Bilimleri University Gaziosmanpasa Training and Research Hospital
Study officials:
References: