louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02246790: Surgical Ablation of Long-standing Persistent AF During CABG
Official title: Surgical Ablation of Long-standing Persistent Atrial Fibrillation During CABG Through Continuous Subcutaneous Monitoring
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: ablation, CABG
Long-standing persistent Atrial Fibrillation
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2014-09-23
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose. Comparison of outcomes in patients underwent CABG combined with left atrial and biatrial radiofrequency ablation of long-standing persistent atrial fibrillation.

Hypothesis of the study - patients with long-standing persistent atrial fibrillation and coronary artery disease after CABG in combination with biatrial RFA have a better outcomes for the freedom of AF compared with patients undergoing left atrial RFA during CABG.

Detailed description: This is a single blinded prospective randomized study involving 116 patients with long-standing persistent AF and coronary artery disease. 116 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome (freedom fro AF) measure by 12% in the biatrial group over left atrial group. Patients are divided into two groups, group I - biatrial + CABG (58 patients), and group II - left atrial + CABG (58 patients). Randomization is conducted by using accidental sampling before operation. The blinding process is applied to a patient, who is informed about received coronary artery bypass grafting, but don't know about kind of surgical ablation. Subcutaneous cardiac monitor is implanted to all patients for cardiac rhythm monitoring.

Eligibility criteria: Inclusion criteria:

* American College of Cardiology (ACC)/ American Heart Association (AHA) Indications for CABG
* At least 2 ECG-verified (12-channel ECG, Holter telemetry) long-term persistent AF within last 12 months
* The patient's consent to participate in the study

Exclusion Criteria:

* Intolerance of antiarrhythmic drugs
* Heart valve disease requiring invasive treatment
* Left atria more than 6.5 cm
* Prior cardiac surgery
* Active pacemaker treatment
* Active anti-arrhythmic treatment (AAD) class I and III
* Contraindication to oral anticoagulant/heparin treatment
* Ejection fraction less than 30 % (EF \< 30 %) assessed by transthoracic echocardiography

Primary outcomes:
measure: Freedom from atrial fibrillation
timeFrame: up to 36 months
Secondary outcomes:
measure: Cardiovascular events
timeFrame: Within three years after surgery
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Meshalkin State Research Institute of Circulation Pathology
Study officials:
References:
Clinical trial NCT01231438: Treatment of Early Stage Renal Failure With Active Vitamin D or a Phosphate Binder.
Official title: An Open, Randomized, Crossover Phase 2 Pilot Study of Treatment of Stage 3B Renal Failure With Active Vitamin D or a Phosphate Binder to Evaluate the Effect on the FGF23 and PTH Levels.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Failure
Keywords: Renal failure stage 3B
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Rikshospitalet University Hospital
First posted: 2010-11-01
Enrollment: 21
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: Patients with reduced renal function normally develop hyperparathyroidism, which in turn is associated with increased cardiovascular risk and de-calcification. Hyperparathyroidism may be enhanced by an increased level of FGF23 which is often seen in the early stage of renal failure. This pilot study will investigate the FGF23-lowering effect of early initiation of treatment with a phosphate binder versus active vitamin D in an open crossover design.


Eligibility criteria: Inclusion Criteria:

* Renal failure stage 3B
* 25(OH)vitamin D level above 50 nmol/l
* Age over 18 years
* Written consent

Exclusion Criteria:

* Major surgery during the previous 6 months
* Myocardial infarct during the previous 6 months
* Unstable heart failure
* Ongoing treatment for any malignancy
* History of frequent infections
* Pregnancy
* Ongoing treatment with steroids, lithium or biphosphonates

Primary outcomes:
measure: FGF23 serum level
timeFrame: Change over 2 weeks of treatment
Secondary outcomes:
measure: Calcium serum level
timeFrame: Change over 2 weeks of therapy
measure: Phosphate serum level
timeFrame: Change over 2 weeks of therapy
measure: CTX-1 serum level
timeFrame: Change over 2 weeks of therapy
measure: PINP serum level
timeFrame: Change over 2 weeks of therapy
measure: PTH serum level
timeFrame: Change over 2 weeks of therapy
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Rikshospitalet
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Lasse Göransson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bleskestad IH, Bergrem H, Hartmann A, Godang K, Goransson LG. Fibroblast growth factor 23 and parathyroid hormone after treatment with active vitamin D and sevelamer carbonate in patients with chronic kidney disease stage 3b, a randomized crossover trial. BMC Nephrol. 2012 Jun 28;13:49. doi: 10.1186/1471-2369-13-49.
Clinical trial NCT03353038: A 3D Printed Assistive Technology Intervention
Official title: A 3D Printed Assistive Technology Intervention: A Phase I Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Disease
Keywords: assistive technology
3 Dimensional Printing
Self-Management
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to understand the feasibility of using a 3D printer to create tailored assistive technology rehabilitation devices. Specifically, we are investigating if a tailored 3D printed pillbox is safe, acceptable, and effective compared to an off-the-shelf generic pillbox. In this study, approximately 20 people with chronic health conditions who use pillboxes will describe their satisfaction and medication adherence with their current pillbox using a series of surveys and interviews. Then they will partake in an interview about their pillbox, medications, and routines. Based on the interview, the research team will 3D print a new pillbox tailored to the participant's preferences, abilities, and medication regimen. Then the participant will use the pillbox for 2-8 weeks. At the end, the participant will answer the same questions describing their satisfaction and medication adherence with the new pillbox using a series of surveys and interviews. This research will reveal important knowledge about the potential of 3D printing in the clinic and effectiveness of customized assistive technology.


Eligibility criteria: Inclusion Criteria:

* English-speaking
* Adults (ages 18+ years)
* Use a pillbox at least weekly
* Prescribed 2+ medications
* Willing to try a new 3D printed pillbox

Exclusion Criteria:

* Have significant cognitive impairment evidenced by a score of 10+ on the short blessed test
* Unable to meet with the research team in person and by phone

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 1 week and again at 2-8 Weeks
measure: Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST2.0)
timeFrame: 2-8 Weeks
measure: Adherence to Refills and Medications Scale (ARMS)
timeFrame: 2-8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03840538: Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's Syndrome
Official title: Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sjogren's Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sjogren's syndrome is an autoimmune chronic disease. It has two forms Primary Sjogren's syndrome charactrized by dry eyes and dry mouth. Secondary Sjogren's syndrome characterized by rheumatoid diseases as rheumatoid arthritis, scleroderma and lupus erythematosus. SS patients are most liable to oral candidiasis , so they need prophylaxis aganist oral candidiasis. Probiotic bacteria are live microorganisms that when administered in adequate amounts confer benefits to health.Probiotics are commonly used as a prophylaxis aganist oral candidosis.


Eligibility criteria: Inclusion Criteria:

* primary or scondary Sjogren's syndrome

Exclusion Criteria:

* allergy to milk derivatives previous intake of antifungals

Primary outcomes:
measure: Pain assessment
timeFrame: 5 WEEKS
Secondary outcomes:
measure: Candidal load
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
citation: Kamal Y, Kandil M, Eissa M, Yousef R, Elsaadany B. Probiotics as a prophylaxis to prevent oral candidiasis in patients with Sjogren's syndrome: a double-blinded, placebo-controlled, randomized trial. Rheumatol Int. 2020 Jun;40(6):873-879. doi: 10.1007/s00296-020-04558-9. Epub 2020 Mar 26.
Clinical trial NCT02530138: The Effect of Synbiotics Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Lean and Normal Weight Patients With Nonalcoholic Fatty Liver
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Non Alcoholic Steatohepatitis
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Currently, Nonalcoholic Fatty Liver Disease (NAFLD) is the most common liver disease in the world. The only approved treatment for it is lifestyle modification and weight loss; however, there is no evidence for patients with normal or low body mass index (BMI).

The aim of this study is to evaluate the efficacy of symbiotic supplementation in NAFLD patients with normal or low BMI.

Methods and analysis: In this randomized, double-blind, placebo-controlled clinical trial protocol, 21 cases and 21 controls will be individually matched based on age and sex. This 42 patients with NAFLD will be supplemented twice daily for 28 wk with either a synbiotic or a placebo capsule. Both groups will be advised to follow an energy balanced diet and physical activity recommendations.


Eligibility criteria: Inclusion Criteria:

* Age of 18 to 70 years
* Body Mass Index (BMI) below 25
* Serum alaninaminotransferase more than 1.5 fold of upper limit of normal range
* Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion Criteria:

* Diabetes
* Taking any kind of antibiotics two weeks before recruitment
* History of alcohol consumption
* pregnancy or lactation
* Professional athletes
* Other liver disease (viral/etc)
* Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E
* A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
* History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty
* Following program to lose weight in recent 3 mo
* A history of hypothyroidism or Cushing's syndrome

Primary outcomes:
measure: Alaninaminotransferase (ALT) (UL)
timeFrame: 28 weeks
measure: hepatic steatosis (cap score)
timeFrame: 28 weeks
Secondary outcomes:
measure: Body Mass Index (BMI) (kg/m2)
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: NNFTRI clinic
Study officials:
References:
Clinical trial NCT04027738: a Single Intraarticular Injection of PRP for Early Knee OA
Official title: Efficacy of a Single Intraarticular Injection of Platelet-Rich Plasma for the Treatment of Early Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee
Osteoarthritis
Platelet rich plasma
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical trials with a single arm
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the efficacy of a single intraarticular injection of PRP for the treatment of early knee OA.

Detailed description: Platelet-rich plasma (PRP) has been reported to be effective for the treatment of knee osteoarthritis (OA). This study aimed to investigate the efficacy of a single intraarticular injection of PRP for the treatment of early knee OA.

In a prospective trial with 6-month follow-up, patients with early knee OA were recruited and received a single intraarticular PRP injection. Several outcomes were measured.

Eligibility criteria: Inclusion Criteria:

* aged 20-70 years
* symptomatic knee OA with pain for at least 6 months despite conservative treatment such as analgesics, NSAIDs and/or physical therapy
* average knee pain of at least 30 mm on a 100-mm visual analog (VAS) scale
* grade 1 or 2 knee OA according to the Kellgren-Lawrence grading system based on -radiographs taken within the previous 6 months
* Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee was less than 30 mm.

Exclusion Criteria:

* previous orthopedic surgery on the spine or lower limbs
* disabling OA of either hip or foot
* knee instability or marked valgus/varus deformity
* history of severe knee trauma; intraarticular injections into the knee in the past 6 months
* infections or skin diseases around the target knee
* women ascertained or suspected pregnancy or lactating
* presence of malignancy, hematological disease, collagen vascular diseases, or autoimmune diseases;
* therapy with anticoagulants or anti-aggregating agent
* serious medical conditions that would interfere with the assessments during the study.

Primary outcomes:
measure: VAS pain
timeFrame: 6 months
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 6 months
measure: Lequesne index
timeFrame: 6 months
measure: Single-leg stance test (SLS)
timeFrame: 6 months
measure: Patients satisfaction
timeFrame: 6 months
measure: safety assessment
timeFrame: during the study, for 6 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, Veterans General Hospital,
Study officials:
affiliation: Kaohsiung Veterans General Hospital, Taiwan
name: Shu Fen Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01322438: Effect of Rifampin on the Pharmacokinetics of BAY73-4506
Official title: A Phase 1, Non-Randomized, Open Label Study to Determine the Effect of Rifampin on the Pharmacokinetics of a Single Oral Dose of 160 mg Regorafenib (BAY73-4506) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: healthy volunteers
rifampin
pharmacokinetics
single dose
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-03-24
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to see if giving rifampin, a marketed antibiotic, changes how your body absorbs and distributes BAY73-4506.


Eligibility criteria: Inclusion Criteria:

* Healthy male subject
* Age: 18 to 45 years (inclusive) at the first screening examination / visit
* Body mass index (BMI): 18 to 32 kg/m² (inclusive)
* Ability to understand and follow study-related instructions
* Subjects enrolled in this study must use adequate barrier birth control measures prior to, during the course of the study, and 3 months after the last administration of regorafenib. An adequate contraception includes the use of condoms or a vasectomy. In addition, adequate birth control measures for the subject's partner is required, such as a hormonal contraception with implants or combined oral contraceptives, certain intrauterine devices, bilateral tubal ligation, or hysterectomy.

Exclusion Criteria:

* Clinically significant disease or condition
* Recent serious infection

Primary outcomes:
measure: Pharmacokinetic profile
timeFrame: after 1 month
measure: Proportion of subjects with adverse event collection
timeFrame: after 35 days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04438343: Impairment-Specific and Augmented Intervention on Turning
Official title: Effects of Impairment-Specific and Augmented Intervention on Turning Performance in Individuals With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2020-06-18
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: TREATMENT

Brief summary: The objective of this study is to investigate the effects of the impairment-specific and augmented intervention based balance and strength training on turning performance in individuals with chronic stroke.


Eligibility criteria: Inclusion Criteria:

* ≧ 6 months post first-ever stroke with unilateral motor deficits
* ≧20 years of age
* The ability to walk independently for at least 7 m with or without using walking aids
* Score ≧ 24 of 30 on the Mini-Mental State Examination

Exclusion Criteria:

* Unstable medical conditions (e.g., deep vein thrombosis, aspiration pneumonia, or superimposed sepsis)
* History of other diseases known to interfere with participation in the study (e.g., heart failure, hemineglect, or diabetic neuropathy)

Primary outcomes:
measure: Turning performance
timeFrame: Change from baseline at 4 week
Secondary outcomes:
measure: Balance
timeFrame: Change from baseline at 4 week
measure: Strength
timeFrame: Change from baseline at 4 week
measure: Straight walking performance
timeFrame: Change from baseline at 4 week
measure: Timed up and go test
timeFrame: Change from baseline at 4 week
measure: Falls Efficacy Scale International (Chinese)
timeFrame: Change from baseline at 4 week
measure: Stroke Impact Scale (SIS) Taiwan version
timeFrame: Change from baseline at 4 week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Yea-Ru Yang
state: Beitou
Study officials:
References:
Clinical trial NCT06754943: To Evaluate the Safety and PK Characteristics After Co-administration of JW0104 and C2402 and Administration of JW0105
Official title: A Randomized, Open-label, Single Dose, 2x4 Replicate Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of JW0104 and C2402 and Administration of JW0105 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2025-01-01
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0104 and C2402 and administration of JW0105 in healthy volunteers under fasting conditions.

Detailed description: Pharmacokinetic characteristics: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Subjects does not meet the inclusion Criteria

Primary outcomes:
measure: AUCt
timeFrame: Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4
measure: Cmax
timeFrame: Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4
Secondary outcomes:
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Metro Hospital
state: Gyeonni-do
Study officials:
affiliation: Metro Hospital
name: Sung-Dae Kwon
role: PRINCIPAL_INVESTIGATOR
References: