louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02759198: A Clinical Trial of YH23537 in Patients With Knee Osteoarthritis
Official title: A Randomized, Double-blind, Placebo- and Active-Controlled, Multicenter, Phase 2 Trial to Evaluate the Efficacy and Safety of YH23537 in Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Osteoarthritis
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2016-05-03
Enrollment: 456
Sex: ALL
Minimum age (years): 40
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 evaluate efficacy and safety of YH23537 versus celebrex in patients with knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Men and women ≥ 40 years of age
* Patients with knee osteoarthritis at one or both knee by ACR

Exclusion Criteria:

* Patients with known or suspected secondary knee osteoarthritis
* Other exclusions applied

Primary outcomes:
measure: Change From Baseline in VAS score to assess pain at Week 12
timeFrame: baseline and week 12
Secondary outcomes:
measure: Change From Baseline in VAS score to assess pain at Week 4, 8
timeFrame: baseline, week 4 and week 8
measure: Change From Baseline in Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) score at Week 4, 8, 12
timeFrame: baseline, week 4, week 8 and week 12
measure: Change From Baseline in WOMAC subgroup(pain, stiffness, difficulty performing daily activities) score at Week 4, 8, 12
timeFrame: baseline, week 4, week 8 and week 12
measure: Percentage From Baseline in WOMAC responder at Week 4, 8, 12
timeFrame: baseline, week 4, week 8 and week 12
measure: Percentage of positive response(+1) in Patient Global Impression of Change (PGIC) at Week 12
timeFrame: week 12
measure: Percentage of positive response(excellent, good and fair response) in Physician's Global Assessment of Response to Therapy (PGART) at Week 12
timeFrame: week 12
Other outcomes:
measure: Quality of life measured by SF-12 at Week 12
timeFrame: week 12
measure: Percentage of patients who had taken rescue medication at week 12
timeFrame: week 12
measure: Amount of rescue medication tablets taken following the investigational product
timeFrame: week 12
measure: The number of days taken rescue medication following the investigational product
timeFrame: week 12
measure: Change From Baseline in Kellgren-Lawrence(KL) grading scale to assess the severity of knee osteoarthritis on a plain radiograph at Week 12
timeFrame: week 12
measure: Change From Baseline in International knee documentation committee(IKDC) score at Week 4, 8, 12
timeFrame: week 4, 8, 12
Locations:
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
Study officials:
affiliation: Kyunghee University Medical Center
name: Yoon Je Cho, M.D, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT02033798: The Effect of Daily Tamsulosin 0.2mg Administration on Renal Function in Patients With Benign Prostatic Hyperplasia
Official title: Impact of Medical Treatment for Benign Prostatic Hyperplasia on Chronic Renal Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Failure
Prostatic Hyperplasia
Keywords: Urodynamics
Glomerular Filtration Rate
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2014-01-13
Enrollment: 34
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
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 determine whether medical treatment for bladder outlet obstruction is effective in improvement of glomerular filtration rate and/or proteinuria.

Detailed description: Urodynamic parameters including maximal flow rate, compliance (infused volume gradient divided by bladder pressure gradient during cystometry), maximal detrusor pressure, bladder outlet obstruction index and Schäfer grade will be checked.

Estimated glomerular filtration rate and urinary protein to creatinine ratio will be checked.

International prostate symptom score will be checked.

Eligibility criteria: Inclusion Criteria:

* Men with low urinary tract symptoms aged between 40 and 80
* Estimated glomerular filtration rate \< 60 or evidence of proteinuria
* Bladder outlet obstruction index \> 40, Schäfer grade 2 or more, maximal flow rate lower than 10 cc/s or postvoid residual urine \> 100cc

Exclusion Criteria:

* Bladder outlet obstruction index less than 40, Schäfer grade 0 or 1, maximal flow rate higher than 10 ml/s and postvoid residual urine less than 100cc
* Want surgical procedure
* Evidence of prostate cancer or bladder cancer
* Major depressive disorder, Dementia, Parkinson's disease or neurological deficits
* History of pelvic irradiation
* Uncontrolled diabetes mellitus or hypertension
* Symptomatic orthostatic hypotension

Primary outcomes:
measure: Maximal flow rate
timeFrame: 6 months
measure: Maximal detrusor pressure
timeFrame: 6 months
measure: Bladder outlet obstruction index
timeFrame: 6 months
measure: schäfer grade
timeFrame: 6 months
measure: Compliance
timeFrame: 6 months
Secondary outcomes:
measure: Estimated glomerular filtration rate
timeFrame: 6 months
measure: Urinary protein to creatinine ratio
timeFrame: 6 months
Other outcomes:
measure: International prostate symptom score
timeFrame: 6 months
Locations:
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital
state: Gyeonggi-do
Study officials:
affiliation: The Catholic University of Korea
name: Seung-Ju Lee, MD, PhD
role: STUDY_CHAIR
affiliation: The Catholic University of Korea
name: Dong Sup Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03322098: Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Geriatric Patients Undergoing Total Knee Replacement Under Spinal Anesthesia
Official title: Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Geriatric Patients Undergoing Total Knee Replacement Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anesthesia
Keywords: Atropine
glycopyrrolate
bradycardia
dexmedetomidine
spinal anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 54
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients undergoing total knee arthroplasty with spinal anesthesia are often sedated to reduce patient discomfort due to large noises during surgery and also to reduce anxiety. Most commonly used sedatives include propofol and midazolam, but these agents often cause hypotension or respiratory depression, especially in elderly patients. Dexmedetomidine is a selective alpha 2 adrenergic drug, which acts as a sedative and also has analgesia effects. In contrast to propofol or midazolam, dexmedetomidine rarely causes respiratory depression, and therefore is often used in critically ill patients in the ICU and also in patients undergoing simple procedures. Hemodynamically, dexmedetomidine evokes a biphasic blood pressure response with a short hypertensive phase and subsequent hypotension. Bradycardia is also observed in many patients, which may lead to more serious outcomes in elderly patients who often have multiple comorbidities. Therefore, drugs to prevent bradycardia during dexmedetomidine infusion may help patients maintain a more stable hemodynamic state. The present study aims to compare the ability of atropine and glycopyrrolate to prevent bradycardia during dexmedetomidine infusion in elderly patients undergoing knee surgery with spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

1. Patients 65 years or older undergoing total knee replacement surgery under spinal anesthesia.
2. ASA class 1-3

Exclusion Criteria:

1. Patients with coagulation abnormalities
2. End organ diseases of liver, lung or kidney
3. Severe aortic stenosis
4. High degree AV block
5. Heart failure
6. Patients on MAO inhibitors
7. History of seizures or epilepsy
8. Glaucoma

Primary outcomes:
measure: Pulse rate
timeFrame: From 5 minutes before spinal anesthesia~end of surgery (Intraoperatively)
measure: blood pressure
timeFrame: From 5 minutes before spinal anesthesia~end of surgery (Intraoperatively)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04924998: Clinical Study for AL-CM
Official title: Clinical Study Protocol for the Treatment of Immunoglobulin Light Chain Amyloidosis Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immunoglobulin Light Amyloidosis Cardiomyopathy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 400
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 with AL-CM

Brief summary: In this study, patients diagnosed with Al-CM were selected to observe the effect of treatment and conduct long-term follow-up.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-90 years, regardless of gender, diagnosed with Al-CM at the Second Affiliated Hospital of Zhejiang University School of Medicine;
* Patients have the ability to understand the test, can cooperate with investigators.

Exclusion Criteria:

* Unable to understand or unwilling to fill in informed consent forms or follow visitors

Primary outcomes:
measure: Primary Outcome
timeFrame: 10 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
References:
Clinical trial NCT01760798: Weekly vs Daily Teriparatide Therapy in Severe Postmenopausal Osteoporosis
Official title: To Compare Efficacy of Weekly Versus Daily Teriparatide in the Management of Postmenopausal Osteoporosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis
Keywords: osteoporosis
Teriparatide
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2013-01-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Osteoporosis is characterized by decreased bone strength and it is prevalent among postmenopausal women but also occurs in men and women with underlying conditions or major risk factors associated with bone demineralization. Its chief clinical manifestations are vertebral and hip fractures, although fractures can occur at any skeletal site.The World Health Organization (WHO) operationally defines osteoporosis as a bone density that falls 2.5 standard deviations (SD) below the mean for young healthy adults of the same gender-also referred to as T-score of -2.5. Postmenopausal women who fall at the lower end of the young normal range (a T-score of \>1 SD below the mean) are defined as having low bone density (osteopenia) and are also at increased risk of osteoporosis. More than 50% of the fractures, including hip fractures, among postmenopausal women occur in this group.

Teriparatide is one of the most effective treatment options for osteoporosis. But the cost of teriparatide is prohibitively expensive and in countries like India with limited personal resources of the individuals, its not a feasible option in the majority of the patients with severe osteoporosis. The investigators aim to compare weekly versus daily teriparatide therapy in an open label non inferiority trial and if successful, the investigators anticipate, the cost of treatment could be reduced considerably so that treatment becomes more affordable to a larger number of patients. Also with weekly therapy, number of multiple injections could be brought down.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women of age group 50-70 having T score less than -2.5 SD or lower at lumbar spine or proximal femur.

Exclusion Criteria:

* Patients with renal dysfunction (serum creatinine \>1.5)
* Primary and secondary hyperparathyroidism
* Secondary osteoporosis
* Unexplained elevated ALP (alkaline phosphatase)
* History of therapeutic radiation
* Active malignancy and patients having implant
* Patients who have received i.v. or oral bisphosphonates in their disease course

Primary outcomes:
measure: BMD at Hip and lumber spine
timeFrame: 1 year
measure: Reduction in fracture risk
timeFrame: 6 week, 6 month and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
state: UT
Study officials:
affiliation: Associate Professor, Department of Endocrinology, PGIMER Chandigarh India
name: Sanjay Kr Bhadada, DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05322798: High-frequency SCS in Treatment of Chronic Limb-Threatening Ischemia
Official title: High-frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia (HEAL-SCS): a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Limb-Threatening Ischemia
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2022-04-12
Enrollment: 25
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: The study of high-frequency spinal cord stimulation (SCS) efficacy in the treatment of chronic limb-threatening ischemia (CLTI)

Detailed description: Open-label, parallel-group, randomized study with a 1:1 allocation ratio to check the hypothesis of whether high-frequency-SCS (HF-SCS) is better than conventional low-frequency (LF-SCS) for pain relief in patients with chronic limb-threatening ischemia (CLTI).

Eligibility criteria: Inclusion Criteria:

* non-reconstructable critical limb-threatening ischemia (CLTI)
* Fontaine stage IIB-IV
* VAS score 5/10 or more
* succesful SCS trial

Exclusion Criteria:

* intractable acute infection
* allergy to SCS component
* ulcerations larger than 3 cm2
* inadequate patient compliance
* life expectancy less than 12 months
* patient refuse to participate in any stage of the study

Primary outcomes:
measure: Visual analog scale (VAS) score
timeFrame: 12 months
Secondary outcomes:
measure: Visual analog scale (VAS) score
timeFrame: 3 months
measure: Walking Impairment Questionnaire (WIQ) - calf pain severity
timeFrame: 3 months
measure: Walking Impairment Questionnaire (WIQ) - calf pain severity
timeFrame: 12 months
measure: Walking Impairment Questionnaire (WIQ) - walking distance
timeFrame: 3 months
measure: Walking Impairment Questionnaire (WIQ) - walking distance
timeFrame: 12 months
measure: Walking Impairment Questionnaire (WIQ) - walking speed
timeFrame: 3 months
measure: Walking Impairment Questionnaire (WIQ) - walking speed
timeFrame: 12 months
measure: Walking Impairment Questionnaire (WIQ) - stair climbing
timeFrame: 3 months
measure: Walking Impairment Questionnaire (WIQ) - stair climbing
timeFrame: 12 months
measure: Short form 36 health survey (SF-36) - physical component summary
timeFrame: 3 months
measure: Short form 36 health survey (SF-36) - physical component summary
timeFrame: 12 months
measure: SF-36 - mental component summary
timeFrame: 3 months
measure: SF-36 - mental component summary
timeFrame: 12 months
measure: TcPO2 (rest)
timeFrame: 12 months
measure: TcPO2 (orthostatic probe)
timeFrame: 12 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Meshalkin National Medical Research Center
Study officials:
affiliation: Meshalkin National Medical Research Centre
name: Kiril Orlov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04442698: Tailored Bilio-Pancreatic Limb and HbA1c 10 Years Post Mini-Gastric Bypass
Official title: Tailored Bilio-Pancreatic Limb Length and Hemoglobin A1c Levels 10 Years Following Mini-Gastric Bypass Original Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Surgery
Lead sponsor: Kular Hospital
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having undergone Mini-Gastric Bypass -Original Technique post operative patients

Brief summary: Diabetes is now or soon will be a worldwide epidemic. Diabetes has impact on both healthcare costs in addition to the costs in human lives, suffering and disability. Treatment that lowers Hemoglobin A1c (HbA1c) improved outcomes. Studies have demonstrated that both general surgery and bariatric procedures may improve or reverse diabetes. In several studies the Billroth II reconstruction following gastrectomy was the most effective surgical technique in improving or reversing Diabetes. The purpose of this study is to analyze the outcomes of the Mini-Gastric Bypass-Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB) to investigate the association of a "Tailored" Bilio-pancreatic Limb Length (BPLL) with the HbA1c changes.

Detailed description: There is general agreement that Diabetes is now or soon will be a worldwide epidemic. Studies also make clear the devastating impact of diabetes on both healthcare costs in addition to the costs in human lives, suffering and disability. It is also clear that treatment that lowers Hemoglobin A1c (HbA1c) will result in improved outcomes proportional to the decrease, saving both lives and costs. Unfortunately medical and lifestyle therapy routinely result in less than ideal resolution of elevated HbA1c levels. Studies have demonstrated that both general surgery and bariatric procedures may improve or reverse diabetes. In several studies the Billroth II reconstruction following gastrectomy is the most effective surgical technique in improving or reversing Diabetes. The purpose of this study is to analyze the outcomes of the Mini-Gastric Bypass-Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB) to investigate the association of a "Tailored" Bilio-pancreatic Limb Length (BPLL) with the HbA1c changes.

Eligibility criteria: Inclusion Criteria:

* Mini-Gastric Bypass -Original Technique post operative patients

Exclusion Criteria:

-

Primary outcomes:
measure: Hemoglobin A1c Levels (HbA1c)
timeFrame: 10 years
measure: Delta Hemoglobin A1c Levels (HbA1c)
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Khanna
country: India
facility: Kular Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT03695198: A Study of LY3361237 in Healthy Participants
Official title: A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3361237 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-10-04
Enrollment: 64
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 purposes of this study are to determine:

* The safety of LY3361237 and any side effects that might be associated with it.
* How much LY3361237 gets into the blood stream and how long it takes the body to remove it in healthy participants.

Participants will be admitted to the clinical research unit (CRU) for 4 overnight stays. The study will last about 12 weeks for each participant, not including screening.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females, as determined by medical history and physical examination.
* To qualify as Japanese for this study, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
* Between 18 (20 for Japanese participants) and 65 years of age.
* Have a body mass index of 18.0 to 32.0 kilograms per meter squared, inclusive, and a minimum body weight of 45.0 kilograms.

Exclusion Criteria:

* Show evidence of active or latent tuberculosis (TB), as documented by medical history and examination, chest x-ray and TB testing
* Are immunocompromised
* Have evidence of chronic viral infection have received live vaccine(s) (including attenuated live vaccines) within 28 days of screening or intend to receive during the study (non-live or inactivated vaccinations are allowed). Bacillus Calmette-Guérin (BCG) vaccine must not have been administered within 12 months of screening
* Have had lymphoma, leukemia, or any malignancy or pre-malignant condition within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Week 12
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237
timeFrame: Predose through Week 12
measure: PK: Area Under the Plasma Concentration Time Curve (AUC) of LY3361237
timeFrame: Predose through Week 12
Other outcomes:
Locations:
city: Glendale
country: United States
facility: California Clinical Trials Medical Group
state: California
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: