louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01267201: A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form
Official title: A Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, Crossover Bioavailability Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/Ml to Methylprednisolone 32 Mg Tablet Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Biological Availability
Keywords: Single dose bioavailability study of methylprednisolone powder for oral suspension (4mg/mL) versus methylprednisolone tablet (32 mg)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-28
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A new formulation of methylprednisolone is being developed. A study is needed to determine the drug availability using the new formulation, a powder for reconstitution into a suspension, versus the current commercially available tablet formulation in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2;
* a total body weight \>45 kg (99 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
* Any condition possibly affecting drug absorption (eg, gastrectomy).

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose
Secondary outcomes:
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose
measure: Plasma Decay Half-life (t1/2)
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01197001: A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan
Official title: A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study of Amlodipine and Losartan Versus Two Co-administration of Amlodipine and Losartan in Healthy Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Amlodipine, Losartan
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2010-09-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Study Design :

* A single center, open, randomized, single dose, two-period, two-treatment, two-sequence, crossover study

Primary Objective:

* To assess the bioequivalence of combination oral formulation of amlodipine/losartan versus two co-administered products containing amlodipine and losartan

Detailed description: Secondary Objective:

* To evaluate the safety and tolerability of these formulations.

Eligibility criteria: Inclusion Criteria:

* Age 18-55 years
* Healthy Caucasian volunteers
* Non smokers or mild smokers

Exclusion criteria:

* Pregnancy and/or breast-feeding
* Participation in another clinical trial within 60 days prior to Period 1.

Primary outcomes:
measure: AUC, Cmax
timeFrame: 0-144hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Pilsen
country: Czech Republic
facility: CEPHA s.r.o.
Study officials:
References:
Clinical trial NCT02676401: An Extended Treatment Study of MT-3995 in Patients With Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Nephropathy
Keywords: Diabetic Nephropathy
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2016-02-08
Enrollment: 241
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the safety and efficacy of MT-3995 administered over the longer term, following MT-3995-J05 study.


Eligibility criteria: Inclusion Criteria:

* Written informed consent for participation before the completion of MT-3995-J05 Study
* Completion of MT-3995-J05 study

Exclusion Criteria:

* UACR of ≥300 mg/g Cr with an increase of ≥30% in MT-3995-J05 Study
* Symptomatic and clinically significant hypotension
* QT prolongation or torsades de pointes
* New York Heart Association (NYHA) Class III or IV heart failure
* Patients who are judged to be unsuitable for participation based on their safety profile in MT-3995-J05 Study

Primary outcomes:
measure: Adverse events
timeFrame: From baseline to 28 weeks
Secondary outcomes:
measure: Change from baseline in Urine Albumin to Creatinine Ratio (UACR)
timeFrame: baseline and Week 28
Other outcomes:
Locations:
city: Hokkaido
country: Japan
facility: Touei Hospital
Study officials:
References:
citation: Wada T, Inagaki M, Yoshinari T, Terata R, Totsuka N, Gotou M, Hashimoto G. Apararenone in patients with diabetic nephropathy: results of a randomized, double-blind, placebo-controlled phase 2 dose-response study and open-label extension study. Clin Exp Nephrol. 2021 Feb;25(2):120-130. doi: 10.1007/s10157-020-01963-z. Epub 2020 Sep 24.
Clinical trial NCT04144101: Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis
Official title: Comparison of Lower Dosage of Etoricoxib Versus Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis: A Single-center, Parallel-group, Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: etoricoxib aceclofenac efficacy safety Taiwanese
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Comparison of lower dosage etoricoxib (60 mg daily) with aceclofenac (100 mg bid) for their efficacy and safety in the treatment of rheumatoid arthritis (RA).

Detailed description: This was a single medical center, parallel-group, randomized controlled trial, which conducted for eight weeks. In this study, 40 patients of RA were randomly assigned to two different treatment groups (etoricoxib and aceclofenac), and 20 patients were enrolled for each group. In addition to baseline data collection, objective assessment tools were used to evaluate for efficacy and safety. The primary endpoint was American College of Rheumatology 20% improvement criteria (ACR20) , secondary endpoints were the ACR 50,70, disease activity score 28 (DAS 28), European League Against Rheumatism (EULAR) response criteria, the number of tender and swollen joints, physician's global assessment, patient's global assessment, pain scores, the short form health survey (SF-36) health Questionnaire and etc. In addition, all adverse reactions were recorded and all the results were analyzed in the intention to treat (ITT) manner.

Eligibility criteria: Inclusion Criteria:

* Diagnosis as Rheumatoid Arthritis

Exclusion Criteria:

* 1. Pregnant or breast-feeding women. 2. Chemotherapy or radiation therapy in cancer patients

Primary outcomes:
measure: American College of Rheumatology 20% improvement criteria (ACR20)
timeFrame: week 0, week 8
Secondary outcomes:
measure: American College of Rheumatology 50% improvement criteria (ACR50)
timeFrame: week 0, week 8
measure: American College of Rheumatology 70% improvement criteria (ACR70)
timeFrame: week 0, week 8
measure: Disease activity score 28 (DAS28)
timeFrame: week 0, week 8
measure: European League Against Rheumatism (EULAR) response criteria
timeFrame: week 0, week 8
measure: The number of tender and swollen joints
timeFrame: week 0, week 8
measure: Physician's global assessment (PhGA)
timeFrame: week 0, week 8
measure: Patient's global assessment (PGA)
timeFrame: week 0, week 8
measure: Visual Analog Scale for pain (VAS)
timeFrame: week 0, week 8
measure: Quality of life by SF-36
timeFrame: week 0, week 8
Other outcomes:
Locations:
Study officials:
affiliation: Chung Shan Medical University
name: Cheng Ching Wei, Ph. D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03045601: Diagnostic Accuracy of CT-FFR Compared to Invasive Coronar Angiography With Fractional Flow Reserve
Official title: Diagnostic Accuracy of Coronary Computed Tomographic Angiography Derived Fractional Flow Reserve Compared to Invasive Coronar Angiography With Fractional Flow Reserve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Keywords: Diagnostic Techniques, Cardiovascular
Coronary Angiography
Fractional Flow Reserve, Myocardial
Echocardiography, Stress
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2017-02-07
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Invasive coronary angiography is currently considered gold standard in the assessment of coronary artery disease although the method has limitations. Most importantly invasive angiography only depicts coronary anatomy without determining its physiological significance i.e the likelihood that the stenosis impedes oxygen delivery to the heart muscle. Fractional flow reserve (FFR) is a catheterization technique for assessing the physiological significance of a coronary artery lesion during invasive coronary angiography. Coronary computed tomographic angiography (CCTA) is a noninvasive imaging test that has become an alternative route to diagnosis for patients with suspected coronary artery disease. Computational fluid dynamics combined with anatomical models based on CCTA scans allows determination of coronary flow and pressure, and has emerged as a promising diagnostic modality called CT-FFR. In this Project New Mathematical algorithms are developed for computation of CT-FFR. The main objective of this study is to determine the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve and state-of-the-art dobutamin stress echocardiography.


Eligibility criteria: Inclusion criteria

* Proven stenosis by CCTA that require further investigation with invasive coronary angiography i.e. patients with estimated stenosis ≥30- 50%.
* Informed consent

Exclusion Criteria:

* Patients with unstable coronary artery disease.
* Previously treated with PCI or coronary surgery.
* Severe renal impairment i.e. GFR \<30ml / min
* Contrast allergy
* Contraindication to adenosine / nitroglycerin / beta-blocker
* BMI\> 40
* Patients referred on the basis of technically unsuccessful CTA, motion artifact or similar

Primary outcomes:
measure: CT- FFR values by New Method as a dichotomous variable
timeFrame: 4 weeks
measure: Worsening regional wall motion abnormality
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital, Klinikk for hjertemedisin
Study officials:
affiliation: Norwegian University of Science and Technology
name: Petter Aadahl, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00205101: Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
Official title: Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Stenosis
Spondylolisthesis
Keywords: Transforaminal lumbar interbody fusion
Posterior lumbar interbody fusion
Isthmic spondylolisthesis, degenerative spondylolisthesis
Pseudoarthritis
Severe Foraminal Stenosis
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: NuVasive
First posted: 2005-09-20
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 70 consecutive patients treated by lumbar fusion using the Triad allograft

Brief summary: The purpose of the study is to prospectively measure pain, function, and patient satisfaction in 70 consecutive patients treated by lumbar fusion using the Triad allograft. Results of the Triad allograft will be compared to those of other anterior lumbar interbody fusion (ALIF), transforaminal lumbar interbody fusion (TLIF), and posterior lumbar interbody fusion (PLIF) surgeries. Patient participation is based on the physician determination that the patient requires one of these surgeries. Participants will be evaluated pre-operatively and post-operatively at 3, 6, 12,and 24 month intervals. Clinic procedures will be related to standard of care except for the completion of several study questionnaires:

1. Back Pain Questionnaire;
2. Oswestry Disability Index Questionnaire;
3. Short Form-36 (SF-36) Survey;
4. Visual Analog Pain Scale (VAS); and
5. The Modems Patient Satisfaction Survey.

Outcome Measurements:

1. The patient's pain is scored by a VAS normalized to 100;
2. Patient function is based on Oswestry scores;
3. General health is assessed by SF-36 completion; and
4. Overall patient satisfaction will be determined by the completion of the Modems.


Eligibility criteria: Inclusion Criteria:

1. Voluntary consent for an observational study
2. One of the following diagnoses:

   * isthmic spondylolisthesis,
   * degenerative spondylolisthesis,
   * pseudoarthritis,
   * severe foraminal stenosis, and
   * prior failed discectomies
3. Single, two, or three level fusions
4. Patients require treatment by TLIF or PLIF posterior fusion as determined by surgeon. Pedicle screw instrumentation will be placed in all cases.

Exclusion Criteria:

1. Infection at operative site
2. Severe osteoporosis
3. Inability to return for follow-up.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Health Spine Clinic
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Paul Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06750601: Rehablines: a Further Use Databank to (re)Use Routine Clinical Data for Scientific Research in Rehabilitation of People With Physical Disabilities and/or Chronic Diseases
Official title: Rehablines: a Further Use Databank to (re)Use Routine Clinical Data for Scientific Research in Rehabilitation of People With Physical Disabilities and/or Chronic Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rehabilitation
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the UMCG-CvR rehabilitation care is provided to patients with a variety of physical disabilities and/or chronic diseases. Provided types of rehabilitation include for instance neurorehabilitation, orthopedic rehabilitation, oncology rehabilitation, pain rehabilitation, pediatric rehabilitation and rehabilitation in chronic illnesses, e.g. heart, lung, diabetes, thoracic and transplant rehabilitation. All patients who are starting their treatment in our facility are invited to participate in Rehablines.

Brief summary: Within the Center of Rehabilitation multidisciplinary treatment is provided to people with various physical disabilities and/or chronic diseases. During and in the context of this treatment, a lot of data is routinely collected. Rehablines is initiated to re-use this routine clinical data in a database for future scientific research. Rehablines aims to: - Efficiently conduct high quality scientific research aimed at patient characteristics, underlying disease processes, and treatment effects; - Provide insight into (short and long-term) treatment effects and efficiency of these rehabilitation treatments; - Personalize treatment by comparing data from the individual patient with data from a large number of patients with similar characteristics from Rehablines.


Eligibility criteria: Inclusion Criteria:

* all participants receiving care at the Center for Rehabilitation of the University Medical Center Groningen

Exclusion Criteria:

* n.a.

Primary outcomes:
measure: Clinical data
timeFrame: Timepoint 1: pre-treatment. Timepoint 2: throughout study completion (on average 12 weeks). Timepoint 3: up to 1 year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Center for Rehabilitation of the University Medical Center Groningen
Study officials:
References:
Clinical trial NCT02646501: Prospective Randomized Clinical Trial for Effect of Stellate Ganglion Block in Medically Refractory Ventricular Tachycardia
Official title: Prospective Randomized Clinical Trial for Effect of Stellate Ganglion Block in Medically Refractory Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Refractory Ventricular Tachycardia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will compare the effects of PSGB(percutaneous stellate ganglion block) in patients with recurrent sustained VT/VF in spite of appropriate medical therapy and cardio-version/ defibrillation after correction of underlying correctable factors with those without PSGB by prospective randomized trail. PSGB will be performed every 3 days by anesthesiology specialist after cardiologist's request, until the stabilization of VT/VF. We will compare the frequency and episode number of VT/VF, procedure related complication, acute and long-term mortality.

Detailed description: Recurrent ventricular tachycardia(VT)/ fibrillation(VF) increases mortality, especially in patients with structural heart disease. It has been reported that cardiac sympathectomy reduces VT/VF episodes in patients with complex VT, long QT syndrome, catecholaminergic polymorphic VT, or myocarditis. However, cardiac sympathectomy operation is hard to conduct in patients with hemodynamically unstable recurrent VT/VF or electrical storm. Therefore, we hypothesized that bed-side percutaneous stellate ganglion block (PSGB) reduces VT/VF episodes and mortality in patients with repetitive VT/VF who are properly managed with optimal medical therapies.

Eligibility criteria: Inclusion Criteria:

* Patients agreement of consent
* AF patient age 20-85
* Patient are diagnosed Refractory Ventricular tachycardia
* Patients who have generated Refractory Ventricular tachycardia despite of defibrillation and drug therapy
* Patients with ICD have generated ICD shock or anti-tachycardia pacing despite of defibrillation and drug therapy

Exclusion Criteria:

* Patients who do not agree with study inclusion
* Patients who do not taken stellate ganglion block due to unstable hemodynamic status
* Patients have experienced major hemorrhagic complication
* Patients of the DNR status
* Patients with malignancy tumor, major neurogenic disease or gastrointestinal disease

Primary outcomes:
measure: Number of VT/VF episodes after randomization
timeFrame: 5 days after randomization
measure: Duration of VT/VF episodes after randomization
timeFrame: 5 days after randomization
Secondary outcomes:
measure: mortality
timeFrame: 1 month after the enrollment
measure: procedure related complication
timeFrame: 1 month after the enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital, Yonsei University Health System
Study officials:
References:
Clinical trial NCT05375201: Clinical Decision-Making and Virtual Reality Exercise
Official title: Optimizing Clinical Decision-Making and Virtual Reality Exercise Training in Degenerative Lumbar Spine Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Degenerative Lumbar Spinal Stenosis
Degenerative Disc Disease
Degenerative Spondylolisthesis
Degenerative Intervertebral Discs
Keywords: virtual reality
degenerative lumbar spine disease
rehabilitation
biomechanic
balance
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Degenerative lumbar spine disease (DLSD) is common in elderly individuals and can result in pain, muscle weakness, and paresthesia. Numerous studies have reported that patients with DLSD usually have postural balance instability, which may affect the patient's gait, functional activities, and quality of life. The investigators propose to achieve the following aims: (1) to develop a clinical balance diagnostic tool to identify patients with DLSD who may require lumbar surgery (2) to investigate the effects of virtual reality skateboard exercise training on gait and balance in patients with DLSD, as well as to compare them with asymptomatic participants.


Eligibility criteria: Inclusion Criteria:

* 1) able to stand and walk for 5 minutes independently
* 2) aged between 50 and 80 years
* 3) received a diagnosis of DLSD based on imaging

Exclusion Criteria:

* 1) previous lumbar surgery
* 2) neurological disorder such as stroke or spinal cord injury
* 3) metabolic disease such as diabetes mellitus
* 4) vestibular disease such as Meniere's disease.

Primary outcomes:
measure: Postural balance
timeFrame: 1 year
measure: Functional assessment
timeFrame: 1 year
measure: Muscle activities
timeFrame: 1 year
measure: Kinematic variables
timeFrame: 1 year
measure: Lumbar Cobb angle
timeFrame: 1 year
measure: Body composition
timeFrame: 1 year
measure: Pain by Visual Analog Scale (VAS)
timeFrame: 1 year
measure: Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei, Taiwan, 100
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan Unversity
name: Wei-Li Hsu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: