louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01781962: A Study of Quantitative Assessments of Angle Width in Chinese Patients With Open-angle Glaucoma and/or Ocular Hypertension
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Open-angle Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-02-01
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese patients with Open-angle Glaucoma and/or Ocular Hypertension

Brief summary: This study will assess angle width in Chinese patients with Open-angle Glaucoma and/or Ocular Hypertension.


Eligibility criteria: Inclusion Criteria:

* Of Chinese descent
* Open-angle Glaucoma or Ocular Hypertension in each eye

Exclusion Criteria:

* History of a narrow-angle or angle closure glaucoma
* Angle abnormalities in either eye

Primary outcomes:
measure: Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT)
timeFrame: Day 1
Secondary outcomes:
measure: Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens
timeFrame: Day 1
measure: Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
timeFrame: Day 1
Other outcomes:
Locations:
city: Beijing
country: China
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05380362: Prospective Randomized Endovascular Therapy in Multiple Sclerosis
Official title: Prospective Randomized Endovascular Therapy in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Lead sponsor: University at Buffalo
Sponsor class: OTHER
Collaborators: name: Volcano Corporation
First posted: 2022-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1. To assess the safety of endovascular therapy (balloon angioplasty) for venous stenoses in MS patients with CCSVI as documented by sonographic (extracranial echocolor-Doppler (ECD) and transcranial color Doppler (TCD)
2. To study the morphology of the venous anomalies by using intraluminal ultrasound (IVUS).
3. To evaluate preliminary efficacy of endovascular therapy (angioplasty) as measured by clinical (relapse rate, disability progression (EDSS)), sonographic (ECD/TCD) and MRI/MRV parameters.
4. To evaluate change in patients self-reported QOL following the therapeutic angioplasty
5. To evaluate whether changes in QOL, fatigue, MSFC or attention following therapeutic angioplasty are associated with brain changes as measured by functional MRI (fMRI).


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years

  * EDSS 0-6.5
  * Diagnosis of relapsing MS according to the McDonald criteria (Polman et al., 2005)
  * Be on treatment with currently FDA approved disease-modifying treatments
  * Evidence of ≥2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see Table 1 background and 1.5 section)
  * Demonstration of venous occlusive disease on cervical MRV
  * Normal renal function: creatinine clearance level of \>60:

Constant= 1.23 for men; 1.04 for women

Exclusion Criteria:

* • Relapse, disease progression and steroid treatment in the 30 days preceding study entry

  * Pre-existing medical conditions known to be associated with brain pathology (e.g., neurodegenerative disorder, cerebrovascular disease, positive history of alcohol abuse, etc.)
  * Severe peripheral chronic venous insufficiency
  * Abnormal renal function
  * Contrast allergy (anaphylaxis)
  * Not accepting to undergo the endovascular treatment
  * Peripheral Vascular Disease

Primary outcomes:
measure: SAE
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Gates Circle Hospital
state: New York
Study officials:
affiliation: University at Buffalo Neurosurgery
name: Adnan H Siddiqui, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01538862: Efficacy of Granulocyte Colony Stimulating Factor (GCSF) In Patients With Dystrophic Epidermolysis Bullosa
Official title: Efficacy of Granulocyte Colony Stimulating Factor (GCSF) In Patients With Dystrophic Epidermolysis Bullosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dystrophic Epidermolysis Bullosa
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2012-02-24
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a feasibility study to see if Granulocyte Colony Stimulating Factor (GCSF) is effective as a treatment of Dystrophic Epidermolysis Bullosa (EB). Patients will receive one course of treatment with the study drug. The course will be 7 days in length. After receiving GCSF, patients will be followed at 7 and 30 days following the discontinuation of the drug. Thirty day follow up can be done via telephone communication with the patient or family.

Detailed description: Each patient will be given 10 micrograms per kilogram per day of G-CSF subcutaneously for 6 consecutive days. On day 7 each patient will be seen and evaluated in the same manner as on day 0. Patients or their parents (if children are too young to reliably respond themselves) will also be asked to rate the following via a visual analog scale of 1-9- oral pain, pruritus, oral pain, swallowing, and overall sense of well-being. A telephone follow-up will be conducted on all patients 28 days after G-CSF so as to evaluate if the effect noted on day 7 was sustained.

Eligibility criteria: Inclusion Criteria:

* Each patient must have the diagnosis of severe generalized recessive dystrophic EB (formerly known as Hallopeau-Siemens RDEB) confirmed by clinical criteria and either of the following:

  1. transmission electron microscopy
  2. immunofluorescence antigenic mapping and type VII collagen monoclonal antibody staining
  3. COL7A1 mutational analysis

Exclusion Criteria:

* The patient must not have a history of squamous cell carcinoma or any internal malignancy.
* Female patients who are pregnant.
* Patients with active signs and symptoms of infection.

Primary outcomes:
measure: Percent Change of Active Blisters and in Total Blister/Erosion Counts
timeFrame: 7 days
Secondary outcomes:
measure: Surface Area of Nonhealing Erosions
timeFrame: 7 days
measure: Overall Improved Symptomatology
timeFrame: 28 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Haydar Frangoul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04556162: Evaluation of Salt Status in Patients With Cystic Fibrosis
Official title: Evaluation of Salt Status in Patients With Cystic Fibrosis and the Influence on Nutritional Status and Pulmonary Function. Looking for the Best Surrogate Urinary Markers for Fractional Sodium or Chloride Excretion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Salt; Deficit (or Low)
Cystic Fibrosis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 222
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cystic fibrosis patients for whom a complete analysis of both blood and urine is available at the time of their annual check-up

Brief summary: The results of the annual check-up will be collected to evaluate the best urinary marker for fractional sodium excretion and salt status will be correlated to clinical outcome measures.

Detailed description: Patients with cystic fibrosis need extra salt as they have increased losses through sweat. Current advices are to follow and supplement if needed, however the way to follow salt depletion is unclear.

The best way is to calculate fractional salt excretion. This needs a simultaneous blood and urine sample for electrolytes and creatinin. Urinary surrogate markers have been validated on only 10 patients.

At the annual check-up patients with cystic fibrosis receive these measurements. The investigators will collect the measurements and calculate fractional excretion and the possible surrogate markers on urine. Further this will be correlated to nutritional and pulmonary status and patient subgroups at risk will be identified.

Eligibility criteria: Inclusion Criteria:

* all cystic fibrosis patients followed at the Gent University Cystic fibrosis centre
* Providing a paired urine and blood sample at the time of their annual check-up

Exclusion Criteria:

* transplantation

Primary outcomes:
measure: fractional sodium excretion (percent)
timeFrame: 1 year
measure: Urinary sodium/urinary creatinin (mmol/mmol)
timeFrame: 1 year
measure: Fractional Chloride excretion (percent)
timeFrame: 1 year
measure: Fractional Potassium excretion (%)
timeFrame: 1 year
measure: ratio urinary sodium/urinary potassium
timeFrame: 1 year
Secondary outcomes:
measure: Body mass index
timeFrame: 1 year
measure: Forced expiratory volume in 1 second
timeFrame: 1 year
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Gent University Hospital
Study officials:
affiliation: Gent University hospital
name: Stephanie Van Biervliet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01020162: Treatment of Ilioinguinal Entrapment Syndrome - an Often Overlooked Cause of Chronic Pelvic Pain
Official title: Treatment of Ilioinguinal Entrapment Syndrome - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pelvic Pain
Keywords: Chronic pelvic pain
ilioinguinal nerve entrapment
randomized study
Chronic pelvic pain in women
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 19
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Neuralgic pain caused by entrapment of peripheral nerves is an often overlooked cause of chronic pelvic pain. The objective of the present study was to assess pain and quality of life in women with pain caused by entrapment of the ilioinguinal nerve, iatrogenic after surgery but also found without previous surgery. In a controlled prospective cross-over study 19 women were randomized either to medical treatment or to resection of the nerve. Statistically significant improvements were found after surgical resection.


Eligibility criteria: Inclusion Criteria:

* Pelvic pain in which a careful investigation has shown signs of ilioinguinal nerve entrapment

Exclusion Criteria:

* Drug abuse

Primary outcomes:
measure: Improvements in pain according to Visual Analogue Scales. Improvements in quality of life according to Psychological General Well-Being-scales.
timeFrame: At least one year after intervention,in some cases more then five years.
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept Obstetrics&Gynecology/East Hospital
Study officials:
affiliation: Dept Obstetrics&Gynecology, Sahlgrenska Academy at the University of Gothenburg, Sweden
name: Ian Milsom, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01593462: Comparative Effectiveness of MR Enterography
Official title: Comparative Effectiveness of MR Enterography, Enteric Ultrasound, and Ultrasound Elastography Imaging in the Evaluation of Pediatric Small Bowel Crohn Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohns Disease
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the efficacy of ultrasound imaging compared to MRE (Magnetic Resonance Enterography) a form of magnetic resonance imaging (MRI) in accurately diagnosing and following Small Bowel Crohn Disease (SBCD) in children.

Detailed description: Computed Tomography (CT) is an imaging tool that exposes patients to radiation, and until recently it was the most commonly used imaging method to evaluate small bowel Crohn disease. Recently, Magnetic Resonance Enterography (MRE) which is a form of magnetic resonance imaging that provides detailed images of the bowel and less frequently, Ultrasound (US) are replacing CT as the standard of care imaging tool at some institutions.

The investigators would like to determine how effective US imaging is compared to MRI imaging in accurately diagnosing and following SBCD in children. Along with enteric ultrasound (EnUS) we will also be comparing a new ultrasound technology called Ultrasound Elastography Imaging (UEI) for this study in which we will be using a second form of UEI called Acoustic Radiation Force Impulse (ARFI). This technique uses sound waves to asses the stiffness properties of soft tissue. The study will compare costs, patient preferences, and imaging accuracy.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients under 18 years age.
* Recently diagnosed with small bowel crohn's disease and have not received any prior treatment for this condition

Exclusion Criteria:

* Are pregnant.
* Require sedation to have the MRE exam.
* Cannot tolerate small enclosed spaces for 60 minutes.
* Have kidneys that are poorly functioning (eGFR \<30ml/min)

Primary outcomes:
measure: Effectiveness of MR Enterography, Enteric US, US Elastography Imaging with ARFI
timeFrame: 6 months
Secondary outcomes:
measure: Cost effectiveness and patient imaging preferences
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Jonathan Dillman, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Jonathan Dillman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steien DB, Dillman JR, Lopez MJ, Ehrlich P, Adler J. Morphometric Changes in Children With Small Bowel Crohn Disease During Induction of Therapy: A Pilot Study. J Pediatr Gastroenterol Nutr. 2021 Apr 1;72(4):603-609. doi: 10.1097/MPG.0000000000003009.
Clinical trial NCT04952662: Candidate Gene Association Study With Injury in Elite Male Youth Football Players
Official title: Candidate Gene Association Study With Injury, Non-Contact Injury, Non-Contact Muscle Injury, Fracture and Apophysitis Injury in Elite Male Youth Football Players
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Injuries
Genetic Change
Keywords: SNP
Apophysitis
Fracture
Strain
Sprain
Genetic
Injury
Lead sponsor: St Mary's University College
Sponsor class: OTHER
Collaborators: name: Fulham Football Club
First posted: 2021-07-07
Enrollment: 123
Sex: MALE
Minimum age (years): 8
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elite male youth football players

Brief summary: Understanding how candidate genes, previously associated with injury susceptibility, influence the incidence of muscle, bone, ligament, and tendon injuries across the development pathway of elite footballers may provide valuable insight into inherent injury predisposition to support the long-term development of every individual. Therefore, the aim of the present study was to investigate the association between candidate genetic variants and muscle, bone, ligament, and tendon injuries in elite football with sub-analysis of the influence of age and maturation on injury susceptibility.

Detailed description: Genetic variants in several candidate genes which code for structural constituents (COL1A1 rs1800012, COL1A2 rs412777, COL5A1 rs12722 and ACTN3 rs1815739), regulatory components (ACE rs1799752, ESR1 rs2234693 and MMP3 rs679620) and transcription factors (VDR rs2228570 and GDF5 rs143383) affecting the form, function and injury susceptibility of muscle, bone, ligament, and tendon tissue will be associated with overall injury, non-contact, bone, ligament, tendon and apophysitis injury risk in elite male youth and adult footballers.

Eligibility criteria: Inclusion Criteria:

* Elite Male Footballer Player Registered at Fulham Football Club

Exclusion Criteria:

* Female no longer registered at Fulham Football Club

Primary outcomes:
measure: Number of non-injured and injured participants with injury risk alleles
timeFrame: 8 Years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Fulham Football Club
state: New Malden
city: London
country: United Kingdom
facility: St Mary's University, Twickenham
state: Twickenham
Study officials:
References:
Clinical trial NCT00401362: A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients
Official title: A Double-Blind Placebo-Controlled Study of Methylnaltrexone (MNTX) for the Relief of Constipation Due to Chronic Opioid Therapy in Patients With Advanced Medical Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Illness Patients With Opioid Induced Constipation
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2006-11-20
Enrollment: 154
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: To test the effectiveness of MNTX in advanced illness subjects.

Detailed description: To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids.

Eligibility criteria: Inclusion Criteria:

1. Advanced medical illness with a life expectancy of 1 to 6 months
2. No clinically significant laxation within 48 hours prior to the first dose of study drug
3. On stable opioid and laxative regimen for a least 3 days prior to treatment
4. Age greater than 18years
5. Females of child-bearing age must have a negative pregnancy test.

Exclusion Criteria:

1. Females who are pregnant or nursing.
2. Previous treatment with MNTX or prior treatment with naltrexone or naloxone for treatment of OIC
3. Any disease process suggestive of gastrointestinal obstruction
4. Fecal ostomy.

Primary outcomes:
measure: Efficacy of SC MNTX compared with placebo in inducing laxation
timeFrame: 29 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Tage Ramakrishna, MD
role: STUDY_DIRECTOR
References:
citation: Chamberlain BH, Rhiner M, Slatkin NE, Stambler N, Israel RJ. Subcutaneous methylnaltrexone for opioid-induced constipation in advanced-illness patients with or without active cancer. Pain Manag. 2020 Mar;10(2):73-84. doi: 10.2217/pmt-2019-0045. Epub 2020 Jan 17.
citation: Janku F, Johnson LK, Karp DD, Atkins JT, Singleton PA, Moss J. Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer. Ann Oncol. 2016 Nov;27(11):2032-2038. doi: 10.1093/annonc/mdw317. Epub 2016 Aug 29.
citation: Nalamachu SR, Pergolizzi J, Taylor R Jr, Slatkin NE, Barrett AC, Yu J, Bortey E, Paterson C, Forbes WP. Efficacy and Tolerability of Subcutaneous Methylnaltrexone in Patients with Advanced Illness and Opioid-Induced Constipation: A Responder Analysis of 2 Randomized, Placebo-Controlled Trials. Pain Pract. 2015 Jul;15(6):564-71. doi: 10.1111/papr.12218. Epub 2014 May 10.
citation: Slatkin N, Thomas J, Lipman AG, Wilson G, Boatwright ML, Wellman C, Zhukovsky DS, Stephenson R, Portenoy R, Stambler N, Israel R. Methylnaltrexone for treatment of opioid-induced constipation in advanced illness patients. J Support Oncol. 2009 Jan-Feb;7(1):39-46.
Clinical trial NCT03744962: MSI in Circulatory DNA of Endometrial Cancer
Official title: A Compare of Microsatellite Instability in Circulatory DNA and Tumor Tissue of Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microsatellite Instability
Lynch Syndrome
Endometrial Cancer
Circulating Tumor Cell
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients confirmed primary endometrial cancer before any surgical or chemotherapy treatment will be all included.

Brief summary: This study aims to analyze the microsatellite instability (MSI) in the circulatory tumor DNA and in the tumor tissue in the patients diagnosed with uterine endometrial cancer. These data will be used for the study of "Cohort Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer" (NCT03291106, clinicaltrials.gov).


Eligibility criteria: Inclusion Criteria:

* Confirmed primary endometrial cancer before any surgical or chemotherapy treatment
* Signed an approved informed consents
* Feasible for sampling

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Primary outcomes:
measure: Frequency of microsatellite instability
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: