louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02622854: Plasma Exchange vs Conservative Management in Non-severe Acute Hypertriglyceridemic Pancreatitis
Official title: Comparison of Plasma Exchange and Conservative Management in Non-severe Acute Hypertriglyceridemic Pancreatitis With Mildly Elevated Triglycerides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pancreatitis
Keywords: plasma exchange
hypertriglyceridemia
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2015-12-07
Enrollment: 22
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 compare effectiveness in reducing triglycerides between daily plasma exchange and glucose+insulin infusion in patients with non-severe acute hypertriglyceridemic pancreatitis with mildly elevated triglycerides


Eligibility criteria: Inclusion Criteria:

* mild acute hypertriglyceridemic pancreatitis
* triglycerides \>15 but \< 40 mmol/l

Exclusion Criteria:

* pregnancy
* severe course of pancreatitis

Primary outcomes:
measure: decrease in triglycerides
timeFrame: within first 24 h after admission
Secondary outcomes:
measure: time until triglycerides drop to <10 mmol/l
timeFrame: by the end of hospital stay, up to 100 days
measure: highest C-reactive protein (CRP)
timeFrame: by the end of hospital stay, up to 100 days
measure: % of patients with severe pancreatitis
timeFrame: by the end of hospital stay, up to 100 days
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana, Ljubljana, Slovenia
Study officials:
affiliation: University Medical Centre Ljubljana
name: Jakob Gubensek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gubensek J, Andonova M, Jerman A, Persic V, Vajdic-Trampuz B, Zupunski-Cede A, Sever N, Plut S. Comparable Triglyceride Reduction With Plasma Exchange and Insulin in Acute Pancreatitis - A Randomized Trial. Front Med (Lausanne). 2022 Apr 12;9:870067. doi: 10.3389/fmed.2022.870067. eCollection 2022.
Clinical trial NCT02115854: Labial Biopsy in Patients With Tuberculosis Disease
Official title: The Value of Labial Biopsy in 65 Patients With Tuberculosis Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Sarcoidosis
Keywords: usefullness of labial biopsy to distinguish between tuberculosis and sarcoidosis
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: bacteriologically confirmed tuberculosis

Brief summary: The distinction between Tuberculosis disease (TB), a worldwide infective granulomatosis requiring long-term antibiotic treatment, and sarcoïdosis, a rare granulomatous disease successfully treated with high dose steroids is not straightforward and may delay the treatment choice by the physician.

The goal was to evaluate prospectively and consecutively the presence of epithelioid granulomas in salivary glands biopsy of patients with TB.


Eligibility criteria: Inclusion Criteria:

* adults above 18 years,
* bacteriologically confirmed tuberculosis

Exclusion Criteria:

* patient not able to sign written consent

Primary outcomes:
measure: presence of granuloma on labial biopsy
timeFrame: at day zero of treatment of tuberculosis
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Unite de Recherche Thérapeutique
Study officials:
References:
Clinical trial NCT02687854: Real-world Comparative Effectiveness of Apixaban Versus Vitamin K Antagonist
Official title: Real-world Comparative Effectiveness of Apixaban Versus VKA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Non-valvular atrial fibrillation (NVAF)
Prevention
Stroke
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-02-22
Enrollment: 18591
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-valvular atrial fibrillation (NVAF)

Brief summary: To obtain a better understanding on the comparative effectiveness of apixaban versus VKA (Vitamin K antagonist) for stroke prevention in patients with NVAF (Non-valvular atrial fibrillation) in a real-life setting.


Eligibility criteria: Inclusion Criteria:

* NVAF will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD-9 427.31 as the diagnosis code at any time in the patient's data history prior to inclusion
* Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics
* CHA2DS2-Vasc (C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years; D: Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category) score ≥2 during the 180 days prior to index apixaban use baseline period

Exclusion Criteria:

* Patients \<18 years of age
* Patients with valvular AF (Atrial fibrillation)
* Pregnancy
* Malignant cancers
* Transient cause of AF
* Patients with VTE (Venous thromboembolism) (pulmonary embolism or DVT (Deep Vein Thrombosis))
* Patients with major surgery defined as hip or knee replacement
* Prescriptions of OACs (Oral anticoagulants) (apixaban, warfarin, dabigatran, rivaroxaban) before index date
* Prescription of more than one OAC on the index date
* Patient with any of the events defined in the composite endpoint

Primary outcomes:
measure: Incidence of Hospitalization Events (composite endpoint)
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
state: New York
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03028454: Effects of Ginger on Muscle Soreness and Dysfunction Stemming From Downhill Running
Official title: Effects of Ginger on Muscle Soreness and Dysfunction Stemming From Downhill Running
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Soreness
Lead sponsor: Old Dominion University
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of the study is to determine whether five days of ginger (Zingiber officinale) supplementation is effective at reducing muscle soreness and improving muscle function following downhill running. Long-distance running is often associated with acute muscle pain, swelling, and reduced muscle functioning, and consequently, many runners utilize non-steroidal anti-inflammatory drugs (NSAID). NSAID use is associated with gastrointestinal side-effects such as stomach discomfort, nausea, dyspepsia, asymptomatic ulcers, and symptomatic ulcers that, although rare, can be fatal. Ginger is a botanical compound that is Generally Recognized as Safe by the Food and Drug Administration (FDA). Evidence from osteoarthritis, dysmenorrhea, and resistance-training models indicate that ginger is effective at reducing general pain and muscle soreness. Therefore, this study will supplement 60 runners with roughly 1.5 g/day of ginger root or a placebo for 2 days prior to, the day of, and 2 days after downhill running. Participants will be evaluated for muscle soreness and function before and after the downhill run.


Eligibility criteria: Inclusion Criteria:

* Be currently running ≥10 miles per week
* Have completed at least one run \>40 minutes over the past month

Exclusion Criteria:

* Have no allergies to ginger
* Willing to avoid pain-relieving medications for the duration of the study
* Have no history of bleeding disorders nor currently taking blood thinners

Primary outcomes:
measure: Muscle Soreness Change
timeFrame: Two days before a 40-minute downhill run, the day of a 40-minute downhill run, 24 hours after a 40-minute downhill run and the two days after a 40-minute downhill run
Secondary outcomes:
measure: Pain Pressure Threshold Change
timeFrame: Two days before a 40-minute downhill run, the day of a 40-minute downhill run, and two days after a 40-minute downhill run
measure: Vertical Jump Test Change
timeFrame: Two days before a 40-minute downhill run, the day of a 40-minute downhill run, and two days after a 40-minute downhill run
measure: 1.5-mile Run Change
timeFrame: Two days before a 40-minute downhill run and two days after a 40-minute downhill run
measure: Lung Function Change
timeFrame: Two days before a 40-minute downhill run and two days after a 40-minute downhill run
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Human Performance Laboratory
state: Virginia
Study officials:
References:
Clinical trial NCT03209154: An Interventional Multidisciplinary Approach to Individualize Blood Pressure Treatment
Official title: Individualized Blood Pressure Treatment: a Multidisciplinary Approach to Uncontrolled Hypertension in Order to Reduce Morbidity and Mortality
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Uncontrolled Hypertension
Keywords: Adherence
Therapeutic Drug Monitoring
Patient perspective
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Haukeland University Hospital
name: University Hospital of North Norway
name: St. Olavs Hospital
First posted: 2017-07-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to investigate and explore the most important aspects of drug-adherence in the treatment of hypertension in order to improve treatment and blood pressure control, implying that new knowledge will reduce morbidity and mortality.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Uncontrolled hypertension
* A stable medication regimen for at least 4 weeks of ≥ 2 antihypertensive agents
* No planned changes in antihypertensive drugs

Exclusion Criteria:

* Withdrawal of consent
* 24-h systolic ambulatory blood pressure \>/= 170 mmHg
* Patients with inadequate Norwegian language skills
* Positive pregnancy test
* Known alcohol or drug abuse
* estimated glomerular filtration rate \<30 mL/min/1.73m2
* Albumin/creatinin ratio \>300 mg/mmol
* Any reason why, in the opinion of the investigator, the patient should not participate

Primary outcomes:
measure: Blood pressure control
timeFrame: 3 months after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Sverre E Kjeldsen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bergland OU, Halvorsen LV, Soraas CL, Hjornholm U, Kjaer VN, Rognstad S, Brobak KM, Aune A, Olsen E, Fauchald YM, Heimark S, Thorstensen CW, Liestol K, Solbu MD, Gerdts E, Mo R, Rostrup M, Kjeldsen SE, Hoieggen A, Opdal MS, Larstorp ACK, Fadl Elmula FEM. Detection of Nonadherence to Antihypertensive Treatment by Measurements of Serum Drug Concentrations. Hypertension. 2021 Sep;78(3):617-628. doi: 10.1161/HYPERTENSIONAHA.121.17514. Epub 2021 Jul 19.
Clinical trial NCT01601054: Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity
Official title: Supplemental Anterior Lumbar Interbody Fusion in Posterior Instrumented Fusion in Surgical Treatment of Spinal Deformities. A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Deformity
Keywords: spine
deformity
instrumentation
ALIF
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Within the last decade there has been an increase in the number of surgical procedures for deformities of the spine. This is caused by the increase in the elderly population, improved surgical techniques and an increased number of patients who have undergone previous surgical treatment for degenerative conditions of the spine. Surgical treatment of spinal deformities bears a revision rate between 15 and 30% depending on definition, and one of the primary reasons for revision surgery is implant loosening in the lumbosacral region.

The hypothesis of the study is that a procedure resulting in anterior fusion of the lumbar spine in addition to the usual posterior instrumentation can reduce the revision rate with 50%.


Eligibility criteria: Inclusion Criteria:

* 18 years or more of age
* planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium

Exclusion Criteria:

* malignancy
* infection

Primary outcomes:
measure: Revision
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Spine Unit, Rigshospitalet, 9 Blegdamsvej
state: Osterbro
Study officials:
affiliation: University of Copenhagen, Rigshospitalet
name: Benny Dahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04069754: Passport to Freedom (P2F): Adaptation and Implementation of a Wellness Program
Official title: Passport to Freedom: Adaptation and Implementation of a Wellness Program to Educate and Empower Women Living in Transitional Housing Due to Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Trauma
Keywords: trauma
stress
depression
coping
mindfulness
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the intervention. There are no other groups.
Primary purpose: PREVENTION

Brief summary: Women currently residing at an emergency shelter for women and children will participate in group sessions that cover topics that promote physical and emotional well-being through a combination of mindfulness exercises and health promotion activities..

Detailed description: In a group setting, the intervention will cover topics such as Mindfulness, Health (examine impact of trauma and stress on physical and mental well-being), Healthy relationships, Family matters (coping with conflicts) and Reflection session.

Each group session (5) will last approximately 90 minutes, once weekly, and begin and end with mindfulness exercises. The women are also encouraged to download free mindfulness apps to practice the exercises between sessions.

Women enrolled will receive health information that will cover a range of chronic health topics (pain, asthma, hypertension, diabetes, obesity), to complement already existing tools on mental health and post traumatic syndrome.

Women enrolled will complete surveys:

baseline questionnaires, a pre and post survey during each session, and follow-up questionnaires 4 weeks after the intervention.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Able to read and write English
* Currently residing at the House of Ruth Maryland emergency shelter or onsite transitional housing.

Exclusion Criteria:

* Under 18 years of age
* Inability to speak or write English
* Physical or mental health conditions that would prevent meaningful group participation.

Primary outcomes:
measure: Change in Physical Health as assessed by the Perceived Health Competence Scale
timeFrame: Baseline, 9 weeks
measure: Change in Mental Health as assessed by the Patient Health Questionnaire
timeFrame: Baseline, 9 weeks
Secondary outcomes:
measure: Change in Stress as assessed by Everyday Stressor Index
timeFrame: Baseline, 9 weeks
measure: Change in Emotions as assessed by Difficulties in Emotion Regulation Scale-Short Form
timeFrame: Baseline, 9 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: House of Ruth Maryland
state: Maryland
Study officials:
affiliation: Johns Hopkins University School of Nursing
name: Patty Wilson, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00168454: A Research Study for Patients With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Urinary Incontinence
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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 investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.


Eligibility criteria: Inclusion Criteria:

* Must be between 18-85 years old
* Must have been diagnosed by his/her doctor with overactive bladder at least 6 months ago
* Must weigh at least 50 kg (110 lbs)
* Must be willing and able to record information regarding bladder function into a diary (provided)
* Must be willing and able to complete the entire course of the study

Exclusion Criteria:

* Cannot currently be catheterizing as a way to control incontinence
* Must not have used botulinum toxin type A or any other botulinum toxin previously for any condition

Primary outcomes:
measure: Change in Number of Urinary Urge Incontinence Episodes
timeFrame: Baseline, Week 2, Week 6, Week 12
Secondary outcomes:
measure: Change in Number of Micturitions
timeFrame: Baseline, Week 2, Week 6, Week 12
measure: Change in Number of Nocturia Episodes
timeFrame: Baseline, Week 12
measure: Maximum Cystometric Capacity (MCC) by Urodynamic Measurements
timeFrame: Baseline, Week 12
measure: Incontinence Quality of Life Instrument (I-QOL)
timeFrame: Baseline, Week 2, Week 6, Week 12
Other outcomes:
Locations:
city: Pittsburgh
country: United States
state: Pennsylvania
city: Ghent
country: Belgium
city: Victoria
country: Canada
state: British Columbia
city: Berlin
country: Germany
city: Warsaw
country: Poland
city: Sheffield
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Fowler CJ, Auerbach S, Ginsberg D, Hale D, Radziszewski P, Rechberger T, Patel VD, Zhou J, Thompson C, Kowalski JW. OnabotulinumtoxinA improves health-related quality of life in patients with urinary incontinence due to idiopathic overactive bladder: a 36-week, double-blind, placebo-controlled, randomized, dose-ranging trial. Eur Urol. 2012 Jul;62(1):148-57. doi: 10.1016/j.eururo.2012.03.005. Epub 2012 Mar 14.
Clinical trial NCT02786654: β Blocker Use and Mortality in Hospital Survivors of Acute Myocardial Infarction Without Heart Failure
Official title: β Blocker Use and Mortality in Hospital Survivors of Acute Myocardial Infarction Without Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction
mortality
evidence-based care
Myocardial Ischaemia National Audit Project
β blockers
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 179810
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprised of 179,810 in hospital survivors of acute myocardial infarction without heart failure recorded in the Myocardial Ischaemia National Audit Project registry between 2007 and June 2013

Brief summary: The aim of the study is to investigate the association between the use of β blockers and mortality among hospital survivors of acute myocardial infarction without heart failure.


Eligibility criteria: Inclusion Criteria:

* acute myocardial infarction patients only
* aged 18 to 100 years

Exclusion Criteria:

* other final diagnosis besides acute myocardial infarction
* died in-hospital
* patients with missing mortality data
* aged \> 100
* patients with previous acute myocardial infarction or angina
* patients who have received coronary interventions before
* patients with heart failure
* patients with β blocker prior use
* patients contraindicated for β blocker use
* patients with use of a loop diuretic

Primary outcomes:
measure: All cause mortality
timeFrame: 1 year
Secondary outcomes:
measure: All cause mortality
timeFrame: 6 months
measure: All cause mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: University of Leeds
Study officials:
affiliation: University of Leeds
name: Chris P Gale, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dondo TB, Hall M, West RM, Jernberg T, Lindahl B, Bueno H, Danchin N, Deanfield JE, Hemingway H, Fox KAA, Timmis AD, Gale CP. beta-Blockers and Mortality After Acute Myocardial Infarction in Patients Without Heart Failure or Ventricular Dysfunction. J Am Coll Cardiol. 2017 Jun 6;69(22):2710-2720. doi: 10.1016/j.jacc.2017.03.578.