louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04579835: Twin A Breech External Cephalic Version Intervention Trial (TWEXIT)
Official title: Twin A Breech External Cephalic Version Intervention Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breech Presentation
Twin; Complicating Pregnancy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting with Twin A breech presentation to the antenatal clinic

Brief summary: A prospective study assessing the use of external cephalic version for the management of Twin A breech presentation in twin pregnancy.

Detailed description: The primary goal of the study is to determine the success rate of Twin A external Cephalic Version in our obstetric clinic and to determine new favorable sonographic criteria associated with a successful attempt that have not been investigated before.

Eligibility criteria: Inclusion Criteria:

* Presence of the written consent of the patients.
* The patients must be over 18 years old .
* No limit in the ability to consent.

Exclusion Criteria:

* Age under 18
* Limited ability to consent
* Placenta previa
* Fetal abnormalities

Primary outcomes:
measure: Success rate of external cephalic version Twin A
timeFrame: 4 hours after external cephalic version
Secondary outcomes:
measure: Fetal weight
timeFrame: 30 Minutes before external cephalic version
measure: Fetal Doppler Umbilical Pulsatility Index
timeFrame: 30 Minutes before external cephalic version
measure: Fetal Doppler Umbilical Resistance Index
timeFrame: 30 Minutes before external cephalic version
measure: Incidence of pathological cardiotocogramm
timeFrame: 60 Minutes after external cephalic version
measure: Incidence of emergency delivery
timeFrame: 60 Minutes after external cephalic version
measure: Incidence of bleeding
timeFrame: 60 Minutes after external cephalic version
measure: Incidence of contractions
timeFrame: 60 Minutes after external cephalic version
measure: Incidence of rupture of membranes
timeFrame: 60 Minutes after external cephalic version
measure: Pain scores
timeFrame: 60 Minutes after external cephalic version
measure: Mode of Delivery
timeFrame: 6 weeks after delivery
Other outcomes:
Locations:
city: Berlin-Mitte
country: Germany
facility: Charité University Hospital
Study officials:
affiliation: Charité University Hospital
name: Larry Hinkson, FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06410235: The Effect of Thoracic Manipulation on Upper Body Stability in Basketball Athletes
Official title: The Effect of Thoracic Manipulation on Upper Body Stability in Basketball Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athletic Injuries
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 58
Sex: MALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Basketball is the most popular sport in the world and has become even more popular as a result of the attention it has received.

Detailed description: The aim of our study was to see the effects of thoracic manipulation on upper body balance in addition to exercise programs of athletes.

Eligibility criteria: Inclusion Criteria:

* Male individuals aged 14-19 years
* Being a basketball athlete
* Regular participation in training

Exclusion Criteria:

* Known neurological disorder
* Serious orthopedic conditions that prevent exercise
* Cognitive impairment

Primary outcomes:
measure: Upper Quarter Y Balance Test
timeFrame: 8 weeks
measure: 90 Degree Push Up Test:
timeFrame: 8 weeks
measure: Closed Kinetic Chain Upper Extremity Stability Test:
timeFrame: 8 weeks
measure: Polar H10:
timeFrame: 8 weeks
measure: Sorensen Test:
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahçehir University
Study officials:
References:
Clinical trial NCT04912635: Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo
Official title: Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2021-06-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a prospective, open-label study to evaluate the effectiveness of providing a dashboard with merged health metrics of CPAP (continuous positive airway pressure/ PAP) usage, self-reported sleepiness, blood pressure (BP) and activity (steps).


Eligibility criteria: Inclusion Criteria:

* Participant is at least 18 years old.
* Participant is using a ResMed AirSense 10 device and ResMed myAir mobile app.
* Participant has been using CPAP therapy for less than 2 weeks.
* Participant has been enrolled in myAir for less than 2 weeks.
* Participants have self-reported resistant hypertension and they take 3 or more drugs to treat their hypertension.
* Participant owns a mobile device compatible with the Neo app (Android Jelly Bean, v16, 4.1.x or newer, and iOS 8 or newer)
* Participant is somewhat to fairly confident about being able to use Bluetooth connected devices and apps
* Participant consents to download the Neo app, Withings app, create a Withings account, and sync Withings data to ResMed's Project Neo.
* Willing and able to give informed consent
* Can read and comprehend written and spoken English

Exclusion Criteria:

* Are participating in another app-based research study
* Cannot participate for the full duration of the study (at least 45 days)
* Unable to read or write English
* Participant is pregnant
* Participant is on Medicare

Primary outcomes:
measure: Mean CPAP use hours
timeFrame: 6 weeks
Secondary outcomes:
measure: App Use
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bella Vista
country: Australia
facility: ResMed
state: New South Wales
Study officials:
References:
Clinical trial NCT03123835: Outcome Analysis of POEM and Endoluminal Therapies
Official title: Outcome Analysis of Endoluminal Therapies for Gastrointestinal Conditions Compared to Current Treatment Paradigms
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Achalasia
Gastric Fistula
Weight Gain After Primary Weight Loss Surgery
Marginal Ulcer
Stenoses
Gastric Nec
Keywords: Achalasia
Fistula
Obesity
POEM
GERD
endoscopic
treatments
post bariatric surger weight gain
endoluminal
Bariatric Surgery
Barretts
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of current and newly developed endoluminal therapies in the management of Upper and Lower GI conditions.

Detailed description: Over the last few years there have been numerous advances in the use of endoscopic equipment and related treatments in the identification and intervention of gastrointestinal diseases. Many of these treatments using flexible endoscopes have either complimented or replaced surgical approaches to these same benign and malignant disease processes with the potential of being the standard of care for many of these clinical conditions. The initial primary focus of this study will be the use of endoscopic myotomy for achalasia, endoscopic treatment of post bariatric weight gain, endoscopic gastro-gastric fistula treatments, and other endoluminal therapies for gastrointestinal and post-operative conditions. These treatments have been validated by prior surgery studies.

Eligibility criteria: Inclusion Criteria:

* Adult male and female patients 18-80 years of age
* Meet the criteria for surgery of benign and/or malignant gastrointestinal pathology(s)
* Gastrointestinal Reflux Disease
* Achalasia
* Barrett's Esophagus
* Post Bariatric Surgery conditions
* Other gastrointestinal and postsurgical disorders.

Exclusion Criteria:

* Adults unable to consent
* Individuals that do not meet inclusion criteria or qualify for endoluminal treatment paradigms and internees.

Primary outcomes:
measure: Decrease in GERDDQ
timeFrame: 3-6 months
Secondary outcomes:
measure: Decrease in Eckardt scoring
timeFrame: 30 days
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Univesity of California Davis Health System
state: California
Study officials:
affiliation: U.C. Davis Medical Center
name: Mohamed R Ali, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01332435: Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use
Official title: Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Keywords: Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, early, costs
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 6896
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study aims to identify eligible patient data between July 1, 2000, and December 31, 2006, and allows for patient data to be followed for 6 months prior to and up to 1 year following index prescription date.

Brief summary: This retrospective study aims to assess the economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI and alpha-blocker (AB) combination therapy. Both the Integrated Health Care Information Solutions and PharMetrics databases will be utilized for this study (2000-2007).


Eligibility criteria: Inclusion Criteria:

* Male patients aged 50 years or older
* a medical claim of EP
* a prescription claim for a 5ARI and AB (provided both are within 180 days of index date)
* continuously eligible for 6 months prior to and at least 12 months after index prescription date.

Exclusion Criteria:

* diagnosis of prostate or bladder cancer
* any prostate-related surgical procedure within 5 months of index date
* prescription claim for finasteride indicative of male pattern baldness
* 5ARI therapy initiated prior to initiating AB therapy

Primary outcomes:
measure: Number of Participants With Clinical Progression
timeFrame: Day 1 of a 1-day study
measure: Number of Participants With Acute Urinary Retention
timeFrame: Day 1 of a 1-day study
measure: Number of Participants Who Needed Prostate-Related Surgery
timeFrame: Day 1 of a 1-day study
Secondary outcomes:
measure: Total BPH-related Costs
timeFrame: Day 1 of a 1-day study
measure: BPH-related Medical Costs
timeFrame: Day 1 of a 1-day study
measure: BPH-related Pharmacy Costs
timeFrame: Day 1 of a 1-day study
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01506635: Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After LASIK: a Randomized Clinical Trial
Official title: Effect of Timolol on Refractive Outcomes in Eyes With Myopic Regression After Laser in Situ Keratomileusis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopic Regression
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-01-10
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized controlled clinical trial, we compare the effects of timolol versus placebo for treatment of myopic regression after LASIK


Eligibility criteria: Inclusion Criteria:

* Patients with myopic regression equal or more than 0.5 D with minimum age of 20 years,
* cylinder ≤ -1.00 D,
* corrected distance visual acuity (CDVA) of at least 20/40 were included.

Exclusion Criteria:

* Patients with a history of previous ocular surgery,
* keratoconus or any ectatic corneal disorder,
* keratoconus suspect by topography,
* preoperative corneal opacity,
* any corneal dystrophies,
* presence of pterygium,
* retinal disorders,
* collagen vascular disorders,
* diabetes mellitus,
* glaucoma,
* cataract,
* pregnancy,
* breast feeding
* systemic corticosteroid therapy were excluded.

Primary outcomes:
measure: Spherical Equivalent
timeFrame: spherical equivalent at month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
citation: Shojaei A, Eslani M, Vali Y, Mansouri M, Dadman N, Yaseri M. Effect of timolol on refractive outcomes in eyes with myopic regression after laser in situ keratomileusis: a prospective randomized clinical trial. Am J Ophthalmol. 2012 Nov;154(5):790-798.e1. doi: 10.1016/j.ajo.2012.05.013. Epub 2012 Aug 28.
Clinical trial NCT00137735: Gabapentin for Carpal Tunnel Syndrome
Official title: Gabapentin for Carpal Tunnel Syndrome: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel syndrome
gabapentin
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2005-08-30
Enrollment: 150
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 this study is to determine whether gabapentin is safe and effective in the treatment of carpal tunnel syndrome (CTS).

Detailed description: A variety of treatment options exist at present for carpal tunnel syndrome (CTS) with no universal agreement. Recent reports suggested that untreated CTS might improve or remain stationary. In this respect, treatment directing towards symptom suppression alone may have a role in the initial management of CTS. Gabapentin (1-\[aminomethyl\]-cyclohexaneacetic acid; Neurontin, Pfizer) is an effective drug for treatment of neuropathic pain and has been reported to be effective in case series for the treatment of CTS with relatively benign side effects profile. The purpose of this study was to evaluate the safety and efficacy of gabapentin in the treatment of CTS.

Eligibility criteria: Inclusion Criteria:

* Sensory symptoms over median nerve distribution for more than three months.
* Confirmatory electrophysiologic results defined as prolonged median nerve distal motor latencies (DML) \> 4 ms or median-ulnar palmer sensory latency differences \> 0.5 ms.

Exclusion Criteria:

* Patients with evidence of severe CTS: fibrillation potentials or reinnervation on needle examination of the abductor pollicis brevis muscle or clinical examination showing wastage of the thenar muscles. (These patients were referred for surgical decompression on presentation.)
* Clinical or electrophysiological evidence of accompanying conditions that could mimic CTS or interfere with its evaluation, such as proximal median neuropathy, cervical radiculopathy, or significant polyneuropathy.
* Known epilepsy.
* Patients who have received previous steroid injection or oral steroid therapy for CTS.

Primary outcomes:
measure: Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: GSS at 2 weeks
timeFrame: 2 weeks
measure: Grip strength as functional assessment at 2 and 8 weeks
timeFrame: 2 weeks, 8 weeks
measure: Tolerability
timeFrame: throughout subject's participation in trial
Other outcomes:
Locations:
city: Shatin, New Territories
country: Hong Kong
facility: Prince of Wales Hospital
city: Sheung Shui, New Territories
country: Hong Kong
facility: North District Hospital
Study officials:
affiliation: Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong
name: Andrew CF Hui, FHKAM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01336335: The Effects of Continuous Positive Airway Pressure (CPAP) on Sympathetic Activity in Different Sites of Activation
Official title: The Effects of Continuous Positive Airway Pressure (CPAP) on Sympathetic Activity in Different Sites of Activation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Radionuclide Imaging (MIBG Scintigraphy)
Exercise Test
Blood Pressure Monitoring, Ambulatory
Sympathetic Nerve Activity
Catecholamines
Keywords: sleep apnea, obstructive
sympathetic nerve activity
treatment
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-04-15
Enrollment: 20
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent evidences suggest that obstructive sleep apnea (OSA) can contribute to cardiovascular disease even in the absence of hypertension. However, there are few data regarding the impact of OSA on the sympathetic system in apparently normotensive patients with OSA as well as the impact of treatment with continuous positive airway pressure in different sites of activation (heart, peripheral nerves and circulating catecholamines)


Eligibility criteria: Inclusion Criteria:

* Severe OSA males

Exclusion Criteria:

* Smoking

  * Sustained Hypertension
  * Heart failure
  * Diabetes
  * Renal diseases
  * Under use of any medication
  * Under treatment for OSA

Primary outcomes:
measure: improvement in sympathetic activity in muscle sympathetic nerve activity (MSNA)
timeFrame: 3 months
Secondary outcomes:
measure: improvement in sympathetic activity evaluated in different sites of activation
timeFrame: 3 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute
Study officials:
affiliation: Heart Institute (InCor)
name: Rodrigo Pedrosa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00903435: Quantitative Studies of Urinary Bladder Sensation
Official title: Quantitative Studies of Urinary Bladder Sensation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Cystitis
Keywords: Cystitis
Urinary
Bladder
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-healthy subjects will be recruited from Kirklin Clinic Urology Clinic and Pain Treatment Center. Healthy subjects will be recruited via advertisements.

Brief summary: The purpose of this study is to determine whether more than one subpopulation exists of patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to determine if subjects with IC have normal counterirritation-related modulatory systems.

Detailed description: To determine whether more than one subpopulation exists of patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to determine if subjects with IC have normal counterirritation-related modulatory systems. Previous studies by the PI suggest that two populations of subjects are present in the IC population but a larger number of subjects with IC would need to be tested in order to determine if this were indeed true. Other studies have demonstrated that counterirritation-related effects are absent in several chronic pain populations including fibromyalgia and chronic headaches. Identification of a subset of IC patients or the identification of a failure of counterirritation-related effects may predict responses to therapeutic interventions.

Eligibility criteria: Inclusion Criteria:

* Must be able to read and speak English
* 19 years or older
* IC Diagnosis

Exclusion Criteria:

* Over 65 years old
* Pregnant
* Children younger than 19
* Significant cardiac disease

Primary outcomes:
measure: The study proposes to examine the sensations that are produced by warming the skin, poking the skin, pressure on the muscles or by applying a blood pressure cuff.
timeFrame: One and a half to two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Kirklin Clinic
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Timothy Ness, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05440435: Application of Mobile DR in the Diagnosis of Bone Trauma in High Cold Environment
Official title: Application of Mobile DR in the Diagnosis of Bone Trauma in High Cold Environment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Injury
Artificial Intelligence
Keywords: Artificial intelligence
Digital radiography
Lead sponsor: General Hospital of Chinese Armed Police Forces
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population in the surrounding areas of the five centers set up in this study.

Brief summary: In the high cold environment, mobile digital radiography (DR) is used to collect the imaging of bone injury patients, and the artificial intelligence diagnosis module is used to diagnose the injury. The quality of images obtained by mobile or conventional DR and the consistency between artificial intelligence and pure artificial diagnosis will be analyzed respectively. Finally, the application value of mobile DR loaded with artificial intelligence diagnosis function in high cold environment is determined.


Eligibility criteria: Inclusion Criteria:

* Patients with new bone injury

Exclusion Criteria:

* Life threatening.
* Head injury and fracture.
* There are congenital malformations in the bone injury site.

Primary outcomes:
measure: The image quality rating scale score.
timeFrame: Immediately after inclusion in the study.
measure: Difference of fracture detection rate (sensitivity and specificity) between artificial intelligence and expert diagnosis.
timeFrame: Immediately after the diagnosis is completed.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Center A
state: Beijing
city: Neimeng
country: China
facility: Xucheng He
city: Xinjiang
country: China
facility: Center C
city: Xizang
country: China
facility: Center
Study officials:
affiliation: Third center of PLA General Hospital
name: Guisheng Wang, Doctor
role: STUDY_CHAIR
References: