louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04410484: PREPARE-IBD: Physician Responses to Disease Flares and Patient Adaptation in Relation to Events in Inflammatory Bowel Disease During COVID-19 Pandemic
Official title: PREPARE-IBD: Physician Responses to Disease Flares and Patient Adaptation in Relation to Events in Inflammatory Bowel Disease During COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Coronavirus Infection
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2020-06-01
Enrollment: 3728
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: About 1 in 100- to 1 in 200 patients have IBD and up to 550,000 patients are estimated in the UK.

Brief summary: To find out what adaptations have been made by Inflammatory bowel disease physicians and patients in relation to therapies in flaring IBD patients during severe acute respiratory syndrome 2-COV and what the impact of these is on IBD patients with no symptomatic COVID-19 and in suspected/confirmed COVID-19. Also whether there any IBD related factors impacting the outcome of patients with COVID-19 symptoms or COVID-19 disease

Detailed description: An observational, retrospective, case-controlled study to determine the status of IBD during development of COVID-19 symptoms/positive COVID-19. The aim is to describe the adaptations in therapies for active IBD during SARS COV 2 in patients with active IBD and positive or negative COVID-19 symptoms. It will evaluate IBD outcomes following development of COVID-19 symptoms / positive COVID-19 and determine any predictors of outcomes in IBD patients with COVID-19 symptoms / positive COVID-19 as well as determine the impact on IBD outcomes resulting from adaptations to treatments during COVID-19

Eligibility criteria: Inclusion Criteria:

* Patients with IBD +/- flare +/- COVID 19 positivity

Exclusion Criteria:

* Patients below 16
* Patient with inactive IBD

Primary outcomes:
measure: Flare of IBD needing change in therapy or surgery
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust
Study officials:
affiliation: Hull and East Yorkshire NHS Trust
name: Shaji Sebastian
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02075684: Office-based Percutaneous Ultrasound-guided Renal Biopsy
Official title: Office-based Percutaneous Ultrasound-guided Renal Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Cortical Neoplasms
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: University of California, Los Angeles
name: Vanderbilt University
First posted: 2014-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this research study is to create a prospectively maintained, multicenter database of patients undergoing renal biopsy for renal masses performed percutaneously (through skin), via an 18 gauge biopsy needle (.048 inches). In this database, the investigators will collect and maintain the data from the biopsy procedure. This will allow us to evaluate our experience with this procedure as well as to participate in multi-institutional collaborative studies in the future. At University of California Irvine, the investigators routinely biopsy patients with renal masses under real-time ultrasound control. Percutaneous renal biopsy under ultrasound guidance is a routine procedure performed to diagnose renal mass histopathology. The safety and efficacy of this procedure has been well documented in the literature. The indications for percutaneous renal biopsy have expanded as there has been a substantial increase in the number of renal masses that are being diagnosed, and the acceptance of percutaneous biopsy continues to expand in parallel. The biopsy procedure is part of your normal standard of care and if not being done for this research project.


Eligibility criteria: Inclusion Criteria:

* Must be undergoing standard percutaneous renal biopsy
* Patients must be ≥18 years of age
* Must be able to understand and render voluntary, written informed consent

Exclusion Criteria:

* Patients \<18 years of age
* Pregnant women
* Coagulopathy
* Active urinary tract infection

Primary outcomes:
measure: Tumor Characteristics
timeFrame: Baseline
Secondary outcomes:
measure: Verbal analog pain scale
timeFrame: Baseline, 1 hour post procedure, and 3 days - 3 weeks post-procedure
Other outcomes:
Locations:
city: Orange
country: United States
facility: Universty of California Irvine Medical Center
state: California
Study officials:
affiliation: UCI Health Department of Urology
name: Jaime Landman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00215384: Study in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COPD
Keywords: COPD
formoterol
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 35
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which dose of the investigational drug is the most safe and effective compared to the control drug.


Eligibility criteria: Inclusion Criteria:

-History of COPD and cigarette smoking

Exclusion Criteria:

* Clinical diagnosis of asthma.
* Chest X-ray that is diagnostic of a significant pulmonary disease other than COPD
* Disease of other major organ systems

Primary outcomes:
measure: The primary outcome variable is the measure of lung function.
Secondary outcomes:
measure: Change in lung function will be examined as a secondary outcome, as well as vital signs, physical examination, adverse even reporting, etc.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Upland
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Hines
country: United States
facility: Research Site
state: Illinois
city: Missoula
country: United States
facility: Research Site
state: Montana
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Tacoma
country: United States
facility: Research Site
state: Washington
Study officials:
References:
Clinical trial NCT05518084: Liponovo Tissue Product in Healthy Volunteers
Official title: SAFETY STUDY EVALUATING THE SAFETY AND TOLERABILITY OF THE LIPONOVO TISSUE PRODUCT IN HEALTHY VOLUNTEERS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Safety Issues
Lead sponsor: Linio Biotech Oy
Sponsor class: INDUSTRY
First posted: 2022-08-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is a randomized, double blinded, bilaterally controlled trial.The aim is to evaluate the short- and mid term safety of Liponovo tissue product. The safety of the Liponovo tissue product is to be studied in 40 healthy volunteers. Liponovo tissue product is injected into superficial part of the subcutis with one injection to standardized area. The amount of the injection is 4,5 ml. As the control method same sized area is injected with plain Ringer-Acetat solution. The adverse events and serious adverse events are monitored in doctor visits, phone calls and e-diary.


Eligibility criteria: Inclusion Criteria:

* Adult (age 18 years or more)
* Healthy skin in the studied area (dorsal forearm, proximal third)
* Able and willing to give informed consent
* Reasonably accessible to the study clinic and compliant to follow-up visits

Exclusion Criteria:

* known allergy to any of the preparations used in the study (Liponovo tissue product and Ringer-Acetat) or earlier/known anaphylaxis reaction for any allergen
* hematologic or other bleeding disorder
* use of antitrombotic/ anticoagulation medicine
* autoimmune disease
* immunosupressive disease or medication
* cancer or neoplastic disease
* connective tissue disease
* diabetes type 1 or 2 or other metabolic diseases
* smoking
* pregnancy or nursing
* sunbathing during last 7 days
* a skin disease that is or has been symptomatic in the studied area
* test subjects with previous fat or hyaluronic acid filling under the same area
* those who withhold consent
* Use of following medications:
* Histamine receptor-blockers \<7 days before study initiation
* Topical corticosteroids in test area \<7 days before study initiation
* Topical calsineurin inhibitors \<7days before study initiation
* Longterm (\>10days before study initiation) systemic prednisolon \>10mg/d
* Omalitsumabi \< 4weeks before study initiation
* Doksepin \< 7 days before study initiation

Primary outcomes:
measure: SAFETY
timeFrame: Follow up 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Terveystalo, Ruoholahti
Study officials:
References:
Clinical trial NCT00995384: Cardiac Computed Tomography (CT) Scan Compared to Transesophageal Echocardiogram (TEE) in Endocarditis
Official title: A Novel Modality of Cardiac CT in Characterization of Acute Infective Endocarditis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Endocarditis
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2009-10-15
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 98
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the effectiveness of cardiac CT versus TEE in endocarditis patients.


Eligibility criteria: Inclusion Criteria:

* Acute endocarditis with positive TEE

Exclusion Criteria:

* Renal failure
* Contrast dye allergy
* Beta-blocker allergy

Primary outcomes:
measure: Visual Difference in CT versus TEE images in Endocarditis
timeFrame: Upon CT Scan
Secondary outcomes:
measure: Morbidity
timeFrame: 4 weeks & 6 months post CT scan
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hosptial
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Phillip Kadaj, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01724684: Feasibility and Effectiveness of Telehealth in Patients With Chronic Obstructive Pulmonary Disease in Taiwan
Official title: Feasibility and Effectiveness of Telehealth in Patients With Chronic Obstructive Pulmonary Disease in Taiwan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-11-12
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Recent studies have demonstrated the promising potential that telehealth has in management of chronic disease. For COPD patients, implementation of telehealth reduced readmissions, emergency room visits, and exacerbations and was cost-effective. Telehealth as a method of delivering healthcare to remote, resource-deprived areas is not lacking in evidence of benefit; however, the situation about its more widespread use for monitoring purposes is much less clear. To date, most of the studies dealing with telehealth in COPD were conducted in countries covering vast territories. Therefore, it needs to be investigated whether telehealth conveys similar advantages for COPD patients in a small island country.


Eligibility criteria: Inclusion Criteria:

* Admissions for chronic obstructive pulmonary disease
* Age 20 or more

Exclusion Criteria:

* Discharge against medical advice
* Enrolled in other trials
* Not being discharged to home
* Unconsciousness

Primary outcomes:
measure: Number of Participants with Hospital Readmission at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chun-Ta Huang, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
Clinical trial NCT06611384: Arrhythmias in Hemorrhagic Myocardial Infarction During the Acute Post-PCI Phase
Official title: Prevalence of Arrhythmias in Hemorrhagic Myocardial Infarction During the Acute Post-PCI Phase
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Hemorrhagic Myocardial Infarction
CCS-AMI Reperfusion Injury
Arrhythmia
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute MI with Primary PCI

Brief summary: Prevalence of Arrhythmias in Hemorrhagic Myocardial Infarction During the Acute Post-PCI Phase


Eligibility criteria: 1. Age 18-85 years
2. Index STEMI
3. Coronary angiogram with Primary coronary intervention
4. No contraindications for Cardiac MRI

Primary outcomes:
measure: Prevalence of Ventricular Arrhytmia
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU School of Medicine/ IUHealth, Krannert Cardiovascular Research Center
state: Indiana
city: Rājkot
country: India
facility: Synergy Cardiovascular Research Center
Study officials:
affiliation: Indiana University School of Medicine
name: Rohan Dharmakumar, PhD
role: STUDY_DIRECTOR
affiliation: Indiana University School of Medicine
name: Keyur P Vora, MD MS FACC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03014284: Novel Listeria Vectors Secreting Gut Flora-Altering Agents to Prevent Colon Cancer and Treat Colitis
Official title: Novel Listeria Vectors Secreting Gut Flora-Altering Agents to Prevent Colon Cancer and Treat Colitis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Colon Cancer
Colitis
Keywords: Tissue collection
colonoscopic surgical procedures
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 50% of patients are expected to be Caucasian, about 40% Hispanic and the remainder African American and other minorities. The investigators anticipate that subjects will range in age from 18 years old and older.

Brief summary: This is a simple tissue collection study with no therapeutic intent. Colon tissues will be taken from standard of care procedures. Tissues will be tested for their functions, expression of immune co-signaling molecules and reactions to transduction with recombinant Listeria vectors to assess effects on expression of B7-H1 and cytokines.


Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent (or have consent provided through a guardian)
* No immune-modulating drug use during study or within 30 days prior to enrollment
* Having colon material collected as part of standard of care

Exclusion Criteria:

* Unable to provide informed consent (or have consent provided through a guardian)
* Not having colon material collected as part of standard of care

Primary outcomes:
measure: Expression of B7-H1
timeFrame: Baseline tissue collection
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Cancer Therapy & Research Center at UTHSCSA
state: Texas
Study officials:
affiliation: University of Texas Health Science Center at the Cancer Therapy and Research Center
name: Tyler Curiel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05219084: Hip Denervation and Intra-articular Hydration in Damaged Hip in Axial Spondyloarthritis Patients
Official title: Hip Denervation and Intra-articular Hydration in Damaged Hip in Axial Spondyloarthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Patients With Axial SpA According to ASAS Criteria
Patients With Unilateral or Bilater Hip Damage According to BASRI Score
Age > 18
Lead sponsor: Sohag University
Sponsor class: OTHER
Collaborators: name: Suez Canal University
First posted: 2022-02-01
Enrollment: 60
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: Background: The hip joint is frequently affected in axial spondyloarthritis (SpA) of adults with destructive effects in untreated patients. About 35% of axial SpA patients had either unilateral or bilateral hip arthritis. Destruction is more common with early-onset, active disease, or enthesitis.

Objectives: The aim of this study is to evaluate the effect of hip denervation (HD) and intra-articular hydration (IAH) on pain, function score, hip mobility scores in a cohort of axial SpA patients with grade 3 and 4 hip BASRI scores.


Eligibility criteria: Inclusion Criteria:

* age 18 or more
* Axial; SpA fulfilled ASA criteria
* BASRI score grade 3 or 4 for one hip at least

Exclusion Criteria:

* patients younger than 18
* Axial; SpA with normal hip or hip involvement less than 3 on BASRI score

Primary outcomes:
measure: Change in visual analogue scale
timeFrame: Baseline , after 4 weeks and after 12 weeks
measure: Change in Harris functional hip score
timeFrame: Baseline, after 4 weeks and after 12 weeks
measure: Change in range of motion of the hip
timeFrame: Baseline, after 4 weeks and after 12 weeks
measure: Change in semiquantitative tenderness score
timeFrame: Baseline, after 4 weeks and after 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Ahmed Elsaman
Study officials:
References:
Clinical trial NCT01828684: Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine
Official title: Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Disorders
Photophobia
Keywords: Migraine with Aura
Migraine without Aura
Photophobia
Chronic Daily Headache
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Approximately 9% of men and 18% of women suffer from migraine headaches. Almost all migraine sufferers report light sensitivity during a headache. Some people with migraine report that light can trigger their migraines and some people with migraine are light sensitive all of the time. The investigators have recently determined that certain colors of light are more likely to trigger migraines than other colors. In this study the investigators want to know if people who wear glasses that block these colors of light will have fewer migraine headaches.


Eligibility criteria: Inclusion Criteria:

1. Must be diagnosed with migraine with aura or migraine without aura
2. Must have chronic daily migraine (at least 15 headache days per month)
3. Age 18 or older

Exclusion Criteria:

1. Currently wearing a spectacle tint specifically prescribed for migraine or light sensitivity
2. Pregnant
3. Unwilling or unable in the judgment of the investigator to complete the study
4. Unavailable for any of the study visits
5. Light sensitive conditions: meningitis, iritis, blepharospasm
6. Degenerative diseases of the retina or optic nerve: diabetic retinopathy, ischemic optic neuropathy
7. Medications known to affect retinal or optic nerve function: hydroxychloroquine, chloroquine, ethambutol, amiodarone, erectile dysfunction drugs
8. Best corrected visual acuity less than 20/40 in either eye

Primary outcomes:
measure: HIT-6
timeFrame: 10 weeks
Secondary outcomes:
measure: Headache frequency and severity
timeFrame: 10 weeks
Other outcomes:
measure: Photophobia
timeFrame: 10 weeks
Locations:
city: Salt Lake City
country: United States
facility: John A Moran Eye Center; University of Utah Hospitals and Clinics
state: Utah
Study officials:
affiliation: University of Utah
name: Bradley J Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01520584: Supplement Intake in Infertile Men;the Effect on Sperm Parameters,Fertilization Rate and Embryo Quality
Official title: Vitamins ,Minerals and Amino Acids Supplement Intake in Infertile Men;the Effect on Sperm Parameters,Fertilization Rate and Embryo Quality. A Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oligospermia
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-01-30
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The vitamin,minerals and amino acid supplementation for 3 months will improve the semen parameters,fertilization rate and embryo quality in subfertile men undergoing IVF treatment

Detailed description: With the supplement intake containing amino acids, vitamins and minerals designed to improve sperm parameters, the couples undergoing IVF treatment will benefit as the change and improvement of sperm parameters will increase the fertilization rate and improve the embryo quality thus allowing shorter time for pregnancy achievement and less frustration with long duration of treatments

Eligibility criteria: Inclusion Criteria:

* healthy male age 20-50
* at least one IVF cycle without pregnancy
* sperm parameters:
* Oligospermia 5-20\*106
* Teratospermia 6-14% normal forms
* Asthenospermia \<30% motility

Exclusion Criteria:

* female factor infertility
* age \> 50 or under 20
* testicular problem on physical examination
* history of malignancy and /or chemotherapy
* usage of antiandrogen/testosterone
* history of drug abuse/alcohol
* a known endocrinological problem
* current STD or genitourinary infection
* Retrograde Ejaculation
* Y chromosome microdeletion
* Karyotype abnormalities

Primary outcomes:
measure: Sperm parameters
timeFrame: 3 months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Dana Irge, DR
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, Fleischer K, de Bruin JP, Showell MG. Antioxidants for male subfertility. Cochrane Database Syst Rev. 2022 May 4;5(5):CD007411. doi: 10.1002/14651858.CD007411.pub5.