louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01980316: Argatroban for Preventing Occlusion and Restenosis After Extracranial Vertebral Artery Stenting
Official title: Phase 4 Study of Argatroban for Preventing Restenosis After Extracranial Vertebral Artery Stenting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: CVD
Keywords: Argatroban
Extracranial vertebral Artery Stenting
restenosis
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Argatroban is a selective thrombin inhibitor, and previous study had suggested that argatroban use post percutaneous coronary intervention could potentially prevent reocclusion. But there has no study on large sample of argatroban treated restenosis vertebral artery stenting. This study will test the safety and efficacy of the argatroban on prevent Occlusion and Restenosis in patients with Extracranial vertebral Artery Stenting.

Detailed description: The risk of restenosis post intracranial and extracranial artery stenting is 20-40%, therefore, in the past, aspirin and clopidogrel were performed as anticoagulant therapy post stenting.But this treatment had limited effectiveness upon restenosis. Argatroban is a selective thrombin inhibitor, and previous study had suggested that argatroban use post PCI could potentially prevent reocclusion. But there has no study on large sample of argatroban treated Occlusion and Restenosis Extracranial vertebral Artery Stenting. This study will test the safety and efficacy of the argatroban on prevent Occlusion and Restenosis in patients with Extracranial vertebral Artery Stenting.

Eligibility criteria: Inclusion Criteria:

* For Extracranial vertebral Artery lesion, stenting was considered for symptomatic stenosis≥50% or asymptomatic stenosis≥70%;
* Successfully had intracranial or extracranial artery stenting.

Exclusion Criteria:

* Evidence of hemorrhagic brain infarction, intracranial and extracranial hematoma, or intraventricular hemorrhage, or Gastrointestinal ulcers in 3 months
* Hypersensitivity to contrast agent
* Malignant hypertension
* Difficult to perform the vertebral artery stenting
* Severe hepatic or cardiac disorders, infectious disorders, dehydration, etc.
* Difficult to hand follow-up visit

Primary outcomes:
measure: restenosis
timeFrame: at half a year
Secondary outcomes:
measure: NIHSS, mRS
timeFrame: at half a year
Other outcomes:
measure: Various adverse effects
timeFrame: at half a year
Locations:
city: Nanjing
country: China
facility: Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
state: Jiangsu
Study officials:
affiliation: Department of Neurology, Jinling Hospital, Nanjing University School of Medicine
name: Xinfeng Liu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00608816: Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q4
Official title: Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 4
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 1 Diabetes
Keywords: epinephrine
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Epinephrine is one of the important hormones in the defense of hypoglycemia. We will test the hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.

Detailed description: When a person had previously experienced bouts of low blood sugar, or hypoglycemia, his or her counterregulatory responses to hypoglycemia would be weakened. This is especially true and important for a person with Type 1 diabetes, because it will cause him or her to be vulnerable to another bout of hypoglycemia, and cause hypoglycemia unawareness, which can lead to serious or even life-threatening consequences. Epinephrine is one of the important hormones in the defense of hypoglycemia. We will test the hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.

Eligibility criteria: Inclusion Criteria:

* 28 (14 males, 14 females) conventionally treated Type 1 diabetic patients with HA1C \> 8.5%
* 28 (14 males, 14 females) intensively treated Type 1 diabetic patients with HA1C \< 7%
* 28 (14 males, 14 females) non-diabetic controls
* Age 18-45 yr.
* Had diabetes for 2-15 years if diabetic subject
* No clinical evidence of diabetic tissue complications, no cardiovascular disease
* Body mass index 21-27kg · m-2
* Normal bedside autonomic function
* Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities
* Female volunteers of childbearing potential: negative HCG pregnancy test

Exclusion Criteria:

* Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease
* Hemoglobin of less than 12 g/dl
* Abnormal results following screening tests
* Pregnancy
* Subjects unable to give voluntary informed consent
* Subjects with a recent medical illness
* Subjects with known liver or kidney disease
* Subjects taking steroids
* Subjects taking beta blockers
* Subjects on anticoagulant drugs, anemic, or with known bleeding diseases

Primary outcomes:
measure: catecholamine levels
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University
name: Stephen N. Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03238716: Neuromuscular Re-eduaction, Exercise and Electric Dry Needling vs. Neuromuscular Re-education and Exercise for Stress Urinary Incontinence
Official title: Neuromuscular Re-education, Impairment-based Exercise and Electric Dry Needling vs. Neuromuscular Re-education and Impairment-based Exercise for Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Alabama Physical Therapy & Acupuncture
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
First posted: 2017-08-03
Enrollment: 24
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to compare two different approaches for treating patients with stress urinary incontinence: neuromuscular re-education, impairment-based exercise and electric dry needling versus neuromuscular re-education and impairment-based exercise. Physical therapists commonly use all of these techniques to treat stress urinary incontinence. This study is attempting to find out if one treatment strategy is more effective than the other.

Detailed description: Patients with stress urinary incontinence will be randomized to receive 2 treatment sessions per week for up to 6 weeks (8-12 sessions total) of either: (1) neuromuscular re-education, impairment-based exercise and electric dry needling (2) neuromuscular re-education and impairment-based exercise

Eligibility criteria: Inclusion Criteria:

1. Aged 35 - 75 years
2. Female
3. Meet the diagnosis of stress urinary incontinence - urine leakage with increased abdominal pressure from laughing, sneezing, coughing, or other physical stressors on abdominal cavity and bladder

Exclusion Criteria:

1. Urge urinary incontinence or mixed urinary incontinence
2. Greater than second degree prolapse
3. Previous surgical intervention related to female anatomy
4. Urinary tract infection
5. Unable to participate in movement such as walking, stair climbing, or resistance training
6. Taking medication that impacts bladder function
7. Serious cardiovascular, cerebral disease, psychiatric disorder, cognitively impaired, injury of cauda equine, and/or myelopathy
8. Pregnancy
9. Sacral nerve stimulator implanted
10. Cardiac pacemaker, metal allergy, or severe needle phobia

Primary outcomes:
measure: Incontinence Impact Questionnaire - Short Form IIQ-7
timeFrame: baseline, 6 weeks, 3 months
Secondary outcomes:
measure: Global Rating of Change Scale
timeFrame: 6 weeks, 3 months
measure: Urinary pad per day usage
timeFrame: baseline, 6 weeks, 3 months
measure: Urogenital Distress Inventory
timeFrame: baseline, 6 weeks, 3 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Research Physical Therapy Specialists
state: South Carolina
Study officials:
affiliation: American Academy of Manipulative Therapy
name: James Dunning, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05868616: Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy
Official title: Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Pacemaker DDD
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
name: Norwegian Health Association
First posted: 2023-05-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred for CRT implantation according to European Society of Cardiology (ESC) guidelines (2021) or postoperative control at Oslo University Hospital.

Brief summary: Left bundle branch block (LBBB) exists in about 25% of patients with congestive heart failure and is associated with worsened prognosis. Cardiac resynchronization therapy (CRT) has been one of the most important advancements in the past two decades for patients with LBBB heart failure. However, 30-40% of patients receiving a CRT do not benefit from it. In this study, the investigators will test a noninvasive device to evaluate acute effect of CRT during implantation and at follow-up CRT controls. In addition, echocardiography will be performed during CRT turned ON and OFF to visualize the changes in intraventricular flow and functional parameters of the heart.


Eligibility criteria: Inclusion Criteria:

* Patients referred for CRT implantation or postoperative control at Oslo University Hospital based on the European Society of Cardiology (ESC) guidelines (2021), and criteria below:

  1. Sinus rhythm.
  2. New York Heart Association class II / III heart failure on diagnosis and on optimal medical therapy.
  3. Left bundle branch block.
  4. QRS duration ≥ 130 ms.
  5. Left ventricular ejection fraction ≤ 40%.
  6. Patients must have echocardiography examination before implantation
  7. Informed consent obtained from the patient.

Exclusion Criteria:

1. Age \< 18 years and \> 80 years;
2. Ongoing atrial fibrillation;
3. Complete atrioventricular block

Primary outcomes:
measure: Reverse remodelling at 6 months follow-up
timeFrame: 6 months
Secondary outcomes:
measure: Hospitalization
timeFrame: 2 years
measure: Mortality
timeFrame: 2 years
measure: New York Heart Association (NYHA) Functional Classification
timeFrame: 2 years
measure: Minnesota Living with Heart Failure Questionnaire
timeFrame: 2 years
measure: Packer clinical composite score
timeFrame: 2 years
measure: 6 minute walk test
timeFrame: 6 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Espen W. Remme, Dr.ing
role: STUDY_DIRECTOR
affiliation: Oslo University Hospital
name: Marit Witso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Hongxing Luo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00350116: Topical Vitamin B12 in Chronic Plaque Psoriasis
Official title: Topical Vitamin B12 in Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Plaque Psoriasis
Keywords: plaque psoriasis
Vitamin B12
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2006-07-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective: To test the efficacy and tolerability of a vitamin B12 cream for the treatment of chronic plaque psoriasis.

Design: Multicenter, double-blind, randomized, placebo-controlled trial.

Detailed description: Objective: To test the efficacy and tolerability of a vitamin B12 cream for the treatment of chronic plaque psoriasis.

Design: Multicenter, double-blind, randomized, placebo-controlled trial. Setting: ambulatory patients in research or referral centers. Patients: Volunteer sample of 51 patients with chronic plaque psoriasis. Interventions: All Patients applied vitamin B12 cream twice daily for 8 weeks to one side of the body and placebo to the other.

Main outcome measures: Modified Psoriasis Area and Severity Index (PASI) at weeks 0, 2, 4, 6 and 8. Thickness and density of 3 references plaques determined by 20 MHz sonography. Assessment of efficiency and tolerability by patients and investigators.

Eligibility criteria: Inclusion Criteria:

* 18years
* chronic plaque psoriasis

Exclusion Criteria:

* incapability of Vitamin B12
* necessity of systemic therapy
* use of other potentially psoriasis modifying drugs

Primary outcomes:
measure: Main outcome measures: Modified Psoriasis Area and Severity Index (PASI) at weeks 0, 2, 4, 6 and 8. Thickness and density of 3 references plaques determined by 20 MHz sonography. Assessment of efficiency and tolerability by patients and investigators.
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Dep. Dermatology and Allergology, Ruhr-University Bochum
Study officials:
affiliation: Ruhr University Bochum, Dep. Dermatology and Allergology
name: Peter Altmeyer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00581516: Molecular Urine Tests for Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
PCA3
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2007-12-27
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 100 male subjects who have clinically localized prostate cancer and are scheduled to undergo a radical prostatectomy are anticipated in this study

Brief summary: Prostate cancer is the second leading cause of cancer related deaths among men in the United States.1 Although still controversial, there is growing evidence that early detection will reduce prostate cancer mortality. Currently the most useful biomarker to aid in early detection is measurement of serum prostate specific antigen (PSA) levels. Despite the value of PSA it has substantial limitations. To overcome the limitations of total PSA testing, there is emerging evidence demonstrating that relevant cancer biomarker can be detected in urine.

Patients who present to the urology clinic for a radical prostatectomy will be asked to enter this study. After obtaining informed consent, the following exam and specimen collection scheduled will be followed:

Visit 1 (pre-op):

Digital Rectal Exam (DRE) - Voided urine collection \& serum collection

Visit 2 (time of prostatectomy):

Under anesthesia- catheterized urine collection and serum collection

Visit 3 (approximately 8 days post-prostatectomy):

Catheterized urine collection

Visit 4 (approximately 3 months post-prostatectomy):

Voided urine collection and serum collection

Some patients will not have the serum collection at visits 1, 2, and 4. The patients will be notified as to whether or not their blood will be drawn during the visits. Pre-operative Digital Rectal Exam, urinary catheterization and blood draws are part of standard of care in this patient population with localized prostate cancer. The catheter will be inserted during the time of surgery preparation in the operating room and removed during the post operative clinic appointment.


Eligibility criteria: Inclusion Criteria:

* Those scheduled to undergo radical prostatectomy for the treatment of prostate cancer.

Exclusion Criteria:

* minors

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Atreya Dash, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04322916: Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem
Official title: Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthropathy of Hip
Hip Replacement
Keywords: Primary osteoarthritis
Secondary osteoarthritis
Inflammatory arthritis
Congenital dysplasia
Femoral head fracture
Lead sponsor: Mathys Ltd Bettlach
Sponsor class: INDUSTRY
First posted: 2020-03-26
Enrollment: 675
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: according to Eligibility Criteria

Brief summary: The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the RM Pressfit vitamys cup. The data will be used for an ongoing evaluation of the product safety and performance.

Detailed description: Prospective multicenter follow-up study which examines the short- to long-term post-market clinical data on the safety and performance of the RM Pressfit vitamys cup. In total 675 participants in 9 clinics are included in this international multicenter study.

The primary endpoint of the study is the Harris Hip Score (HHS) 2 years after surgery.

The following parameters will be collected during the regular clinical and radiological follow-up: Harris Hip Score, radiographic evaluation and detection of adverse events.

Eligibility criteria: Inclusion Criteria:

* Informed consent form (signed by participant and investigator)
* Primary implantation
* Age at inclusion: Between 18 and 95 years old
* Willing to participate in the follow-up

Exclusion Criteria:

* Missing Informed consent form
* Known or suspected non-compliance (e.g. drug or alcohol abuse)
* Enrollment of the investigator, his/her family, employees and other dependent persons
* Patient younger than 18 years old
* Revision surgery
* Presence of sepsis or malignant tumors
* Pregnancy

Primary outcomes:
measure: Harris Hip Score (modified after Haddad et al, 1990)
timeFrame: 2 years
Secondary outcomes:
measure: Radiographic evaluation
timeFrame: 6-12 weeks - 10 years
measure: Adverse Events
timeFrame: 6-12 weeks - 10 years
Other outcomes:
Locations:
Study officials:
References:
citation: Afghanyar Y, Joser S, Tecle J, Drees P, Dargel J, Rehbein P, Kutzner KP. The concept of a cementless isoelastic monoblock cup made of highly cross-linked polyethylene infused with vitamin E: radiological analyses of migration and wear using EBRA and clinical outcomes at mid-term follow-up. BMC Musculoskelet Disord. 2021 Jan 23;22(1):107. doi: 10.1186/s12891-021-03981-8.
Clinical trial NCT02950116: Lung Clearance Index (LCI) in Pediatric Patients With Obstructive Lung Disease
Official title: Lung Clearance Index in Pediatric Patients With Obstructive Lung Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Asthma
Bronchiectasis
Cystic Fibrosis
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Chronic respiratory diseases (CRDs) affect the airways and other structures of the lungs and thereby lead to ventilation inhomogeneity. The most common CRDs in children are asthma, bronchiectasis and cystic fibrosis (CF). All three are obstructive diseases. However, while asthma is mostly characterized by obstruction due to bronchoconstriction of the airways, obstruction in bronchiectasis and CF originates primarily from mucus retention due to abnormal airway clearance mechanisms.

The Nitrogen Multiple Breath Washout test (N2-MBW-test) is a robust and sensitive detector of early pulmonary changes and ventilation inhomogeneity. The minimal cooperation which is required for this test makes it very convenient for use in any age category.

Research on LCI described it as a reliable indicator of obstructive lung disease in pediatric CF patients as from 6 years of age. Whether LCI is a reliable parameter for early lung disease in asthma children is less clearly demonstrated. No data were found on LCI calculated from the N2-MBW-test in children with bronchiectasis.

Detailed description: Subjects of all the intervention groups will perform three consecutive nitrogen multiple breath washout tests (N2-MBW-tests) when attending the Universitair Ziekenhuis Brussel (UZB) for their scheduled pulmonology consultation. Only the best measurement (based on LCI result) will be taken into account when comparing the groups. Every subject will be positioned in the same seated position.

Eligibility criteria: Inclusion Criteria:

* Patients with stable asthma
* Patients with non-CF bronchiectasis
* Patients with cystic fibrosis
* Aged 6-17 years
* FEV1 (%pred) \>50%
* Written informed consent from the parents or legal guardian

Exclusion Criteria:

* Unstable disease (e.g. pulmonary exacerbation, acute deterioration, acute asthma crisis)
* Patients mentally not capable to participate in the study

Primary outcomes:
measure: LCI
timeFrame: Day 1
Secondary outcomes:
measure: S_cond
timeFrame: Day 1
measure: S_acin
timeFrame: Day 1
measure: Duration of the N2-MBW-test
timeFrame: Day 1
measure: Number of washout breaths
timeFrame: Day 1
measure: FRC
timeFrame: Day 1
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
affiliation: UZ Brussel Laarbeeklaan 101 1090 Brussels Belgium
name: Hanneke Eyns, MSc, PT
role: PRINCIPAL_INVESTIGATOR
References: