louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02186483: Clinical Trial to Investigate the Pharmacokinetics Drug Interaction Between Metformin and Rosuvastatin
Official title: An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Drug-drug Interaction Following Coadministration of Metformin and Rosuvastatin in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperlipidemia
Diabetes
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-07-10
Enrollment: 24
Sex: MALE
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 purpose of this study is to investigate the pharmacokinetic drug interaction between Metformin and Rosuvastatin in healthy male volunteers.

Detailed description: Drug-drug Interaction Following Co-administration of Metformin and Rosuvastatin in Healthy Male Volunteers

Eligibility criteria: Inclusion Criteria:

* 19\~55 years healthy male
* BMI measurement 19.0kg/m\^2\~ 28.0kg/m\^2
* Signed informed consent form from to participate voluntarily and to comply with the trial requirements.

Exclusion Criteria:

* History of clinically significant kidney, liver, gastro-intestinal system, cardiovascular system, respiratory system, tumor or blood disorders, nervous system, immune system, endocrine disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
* SBP\>140mmHg or \<90mmHg, DBP\>90mmHg or \<60mmHg.
* An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
* History of drug abuse
* A alcohol consumer(alcohol\>140g/week) or smoker(cigarette\>10 cigarettes/day) Hypersensitivity reaction in history of investigational drugs or specific drugs(aspirin, antibiotics)
* Administrated investigational product in a previous clinical trial within 60 days of the screening day in this study.
* Administrated drugs which can inhibit or induce OCT2, OATP1B1 transporter within 30 days of the screening day in this study.(ex: proton pump inhibitor, rifampicin)
* Glomerular filtration rate\<60mL/min
* Donated blood within 60 days prior to the screening day or apheresis blood within 30 days prior to the screening day .

Primary outcomes:
measure: Cmax,ss, AUCτ
timeFrame: 32h
Secondary outcomes:
measure: Tmax,ss
timeFrame: 32h
measure: t1/2
timeFrame: 32h
measure: Cmin,ss
timeFrame: 32h
measure: CL/Fss
timeFrame: 32h
measure: Vd/Fss
timeFrame: 32h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center(SMC)
state: Gangnam-Gu
Study officials:
affiliation: Samsung Medical Center(SMC)
name: Jung-ryul Kim, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01504997: Phase II Study for Robot Assisted Distal Gastrectomy
Official title: A Phase II Study of Robot Assisted Distal Gastrectomy With Nodal Dissection for Clinical Stage Ia Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Early Gastric Cancer
Keywords: DaVinci
Robot assisted surgery
Gastrectomy
Safety
Gastric Cancer
Lead sponsor: Shizuoka Cancer Center
Sponsor class: OTHER
First posted: 2012-01-06
Enrollment: 23
Sex: ALL
Minimum age (years): 20
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 aim of this study is to clarify safety of robot assisted distal gastrectomy with lymph node dissection in patients with stage Ia early gastric cancer.


Eligibility criteria: Inclusion Criteria:

1. Biopsy specimen from the primary lesion shows adenocarcinoma
2. Diagnosed as Stage IA early gastric cancer according to the preoperative esophagogastroduodenoscopy and computer tomography
3. Endoscopic submucosal dissection is not indicated
4. Tumor was located within lower two thirds of stomach
5. Not having duodenal invasion
6. Eastern clinical oncology group performance status is 0 or 1
7. Body mass index is lower than 30
8. No prior laparotomy
9. No prior chemotherapy or radiation including those for other cancers
10. Fulfil all following conditions WBC \> 3,000/mm3 Plt \> 100,000/mm3 AST \< 100 IU/L ALT \< 100IU/L T.Bil \< 2.0 g/dl Cre \< 1.5mg/dl

Exclusion Criteria:

1. Having other active cancers
2. Possibly pregnant, or breast feeding woman
3. with psychiatric disorder
4. Receiving steroids
5. With Acute myocardial infarction in 6 months or with unstable angina
6. With uncontrolled hypertension
7. With uncontrolled diabetes mellitus
8. With pulmonary disease which require continuous oxygen therapy

Primary outcomes:
measure: The Incidence of Post-operative Intra-abdominal Infectious Complications
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary outcomes:
measure: Overall Survival
timeFrame: 5 years
measure: Relapse Free Survival
timeFrame: 5 years
measure: Completion Rate of Robot Assisted Surgery
timeFrame: During the surgery, an expected average of 5 hours
measure: Incidence of Adverse Events
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Other outcomes:
Locations:
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
Study officials:
affiliation: Division of Gastric Surgery, Shizuoka Cancer Center
name: Masanori Terashima, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02645097: Ideal Anatomic Location for Saphenous Nerve Blocks: A Prospective Clinical Evaluation
Official title: Ideal Anatomic Location for Saphenous Nerve Blocks: A Prospective Clinical Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Injury
Ankle Injury
Keywords: Adult
nerve blocks in foot and ankle surgery
saphenous
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is being done to compare two different saphenous nerve block locations and will help to determine which site best maintains knee strength and pain control.

Detailed description: This is a prospective, randomized, observer blinded clinical trial comparing motor strength in knee extension between two sets of patients, one receiving a proximal thigh block of the saphenous nerve and one receiving a distal thigh block of the saphenous nerve. The secondary objectives are to compare the pain relief and quality of life of participants in these two groups.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Upcoming elective foot or ankle surgery

Exclusion Criteria:

* Preoperative weakness in knee extension
* Documented neuropathy
* Previous knee surgery
* Inability to provide informed consent

Primary outcomes:
measure: knee extensor strength measured in kilograms
timeFrame: change from baseline preoperatively to 30 minutes after nerve block placement
Secondary outcomes:
measure: pain level
timeFrame: change from baseline preoperatively to two weeks post-operatively
measure: quality of life assessment
timeFrame: change from baseline preoperatively to two weeks post-operatively
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Paul J Juliano, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05385497: Combining Aerobic Exercise and Virtual Reality for Cognitive-motor Rehabilitation in PD
Official title: Combining Aerobic Exercise and Virtual Reality for Cognitive-motor Rehabilitation in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Keywords: Aerobic Exercise
Virtual Reality
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Texas Physical Therapy Association
First posted: 2022-05-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study will utilize a single group, pre-post design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project will provide preliminary data on the feasibility and effects of exercise and VR on motor behavior and neuroplasticity in PD. Results from this work will provide insight into whether combination interventions utilizing AE and VR have parallel effects on cognition, gait, and neuroplasticity in PD.

Detailed description: In this pilot proof-of-concept study, the study team will recruit 25 individuals with Parkinson's disease who will perform aerobic exercise (AE) followed by virtual reality (VR). The study team will measure the effects of the intervention on dual task performance, clinical measures of gait, cognition, TMS measures and questionnaires pertaining to quality of life.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of idiopathic PD (ages 18 - 85) in Hoehn and Yahr stages 1 - 3.
2. Subjects need to demonstrate a score of equal to or greater than 23 on the Mini Mental State Examination.

Exclusion Criteria:

1. Subjects with a history of other neurological diseases (i.e. stroke, multiple sclerosis).
2. Subjects with a history of severe cardiopulmonary disease, uncontrolled hypertension, orthostatic hypotension, uncontrolled diabetes, severe osteoporosis.
3. Subjects with a history of PD-specific surgical procedure such as deep brain stimulation etc.
4. Subjects with a history of head injury.
5. Subjects with a history of seizures or epilepsy,
6. Subjects who are currently pregnant
7. Subjects who use of medications that could alter corticomotor excitability or increase risk of seizure
8. Subjects with skull abnormalities, fractures, unexplained, recurring headaches.
9. Subjects who have cognitive or communication impairment that would affect participation.

Primary outcomes:
measure: Gait speed
timeFrame: Baseline to 3 weeks
measure: Spatiotemporal Parameters
timeFrame: Baseline to 3 weeks
measure: Cognition
timeFrame: Baseline to 3 weeks
measure: Balance
timeFrame: Baseline to 3 weeks
measure: Corticomotor excitability
timeFrame: Baseline to 3 weeks
Secondary outcomes:
measure: Quality of Life Survey
timeFrame: Baseline to 3 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UT Health San Antonio- Dept. of Physical Therapy
state: Texas
Study officials:
References:
Clinical trial NCT04396197: Physical Activity Levels in COVID-19 Patients Admitted to Intensive Care
Official title: Physical Activity Levels in COVID-19 Patients Admitted to Intensive Care Requiring Invasive Ventilation: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Critical Illness
Ards
ICU Acquired Weakness
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 92
Sex: ALL
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: Adults admitted to ICU with a confirmed diagnosis of COVID-19, mechanically ventilated for \>24 hours and surviving to ICU discharge were included.

Brief summary: This is an observational study exploring the levels of mobility and rehabilitation in patients admitted to critical care with a confirmed diagnosis of COVID-19

Detailed description: An admission to an intensive care unit (ICU) often results in significant muscle weakness and physical deconditioning, which can take many months or even years for recovery. Early and progressive programmes of rehabilitation are recommended to limit any muscle loss and support recovery as early as possible. Patients admitted to intensive care with COVID-19 have been found to require prolonged periods of mechanical ventilation, high sedation and neuromuscular blocking use and as a result require prolonged stays in the ICU. As yet no data exists to examine the specific physical impact this may have, or whether it is safe and feasible to commence this earlier rehabilitation within the ICU for patients with a diagnosis of COVID-19. Our study set out to evaluate the levels of rehabilitation which were delivered in a large acute NHS trust.

Eligibility criteria: Inclusion Criteria:

* having a confirmed diagnosis of COVID-19
* being mechanically ventilated for at least 24 hours
* surviving to critical care discharge.

Exclusion Criteria:

* none

Primary outcomes:
measure: Mobility level
timeFrame: At ICU discharge, an average of 3 weeks
measure: Time taken to first mobilise
timeFrame: during ICU admission, up to 3 weeks
Secondary outcomes:
measure: Discharge location
timeFrame: Hospital discharge, up to 2 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: UHB NHS Foundation Trust
Study officials:
References:
citation: McWilliams D, Weblin J, Hodson J, Veenith T, Whitehouse T, Snelson C. Rehabilitation Levels in Patients with COVID-19 Admitted to Intensive Care Requiring Invasive Ventilation. An Observational Study. Ann Am Thorac Soc. 2021 Jan;18(1):122-129. doi: 10.1513/AnnalsATS.202005-560OC.
Clinical trial NCT02411097: Role of Femoral Nerve Block on Prevention of Postoperative Deep Venous Thromboembolism
Official title: Prevention of Deep Venous Thromboembolism: Effect of Preemptive Analgesic of Femoral Nerve Block in Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gonarthrosis
Keywords: Deep venous thromboembolism
Femoral nerve block
Total knee arthroplasty
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To investigate whether preemptive analgesic of femoral nerve block could prevent deep venous thromboembolism due to inhibiting the excessive release of neutrophil elastase and inflammatory cytokines.

Detailed description: Femoral nerve block is an effective analgesic mode in patients after total knee arthroplasty. In recent studies, there has been shown that a large amount of neutrophil elastase release from neutrophils could induce the development of deep venous thromboembolism and femoral nerve block may reduce the incidence of the development of deep venous thromboembolism. In addition, inflammatory cytokines including interleukin-1(IL-1), IL-6, IL-8 and tumor necrosis factor(TNF) were associated with deep venous thromboembolism. Thus, the investigators hypothesised that preemptive analgesic of femoral nerve block could prevent deep venous thromboembolism due to inhibiting the excessive release of neutrophil elastase and inflammatory cytokines.

Eligibility criteria: Inclusion Criteria:

* adult patients scheduled for total knee arthroplasty under general anesthesia

Exclusion Criteria:

* ASA physical status Ⅳ-Ⅴ,
* psychiatric illness,
* chronic opioid consumption,
* patient refusal,
* coagulopathy,
* peripheral neurological injury,
* local anesthesia drug allergy,
* preoperative existing deep venous thromboembolism.

Primary outcomes:
measure: Serum concentration of inflammatory cytokine
timeFrame: change from baseline at 30min, 60min, 90min after using tourniquet and 12h, 24h,48h after operation
Secondary outcomes:
measure: Concentration of related inflammatory factors of deep venous thromboembolism
timeFrame: change from baseline at 30min, 60min, 90min after using tourniquet and 12h, 24h,48h after operation
Other outcomes:
measure: Diagnosis of deep venous thromboembolism by ultrasonography
timeFrame: 2day and 7day after operation
Locations:
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
affiliation: Gereral Hospital of Ningxia Medical University
name: Xu Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06587997: Changes in Renal Perfusion During Hemodialysis in Patients with End-stage Renal Disease
Official title: Changes in Renal Perfusion During Hemodialysis in Patients with End-stage Renal Disease: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: End-stage Renal Disease
Keywords: hemodialysis
renal perfusion
end-stage renal disease
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First Medical Center of Chinese PLA General Hospital

Brief summary: Residual renal function (RRF) characteristically declines after patients with end-stage renal disease (ESRD) initiate dialysis. Although RRF preservation correlates with improved patient\&amp;#39;s quality of life and survival prospects, poor understanding of the pathophysiology underlying RRF decline limits protection strategies.

Detailed description: Hemodialysis (HD) is the primary renal replacement therapy for patients with end-stage renal disease. However, residual renal function (RRF) characteristically declines after these individuals start dialysis. This loss of RRF not only impacts the adequacy of dialysis and control of complications but also affects the patient\&amp;#39;s quality of life and survival prospects. Due to a lack of clear understanding regarding the pathophysiology underlying this decline in RRF, no effective strategies exist for its preservation at present. The objective of this study is to explore the changes in renal perfusion during hemodialysis in patients with end-stage renal disease, and provide a new idea for protection of RRF. This study was an observational study, and no interventions were performed.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Clinical diagnosis of end-stage renal disease requiring long-term hemodialysis treatment, with dialysis duration ≤ 3 months;
* Urine output \&gt; 500ml/day or GFR \&gt; 3ml/min/1.72m2;
* Signed and dated informed consented is obtained.

Exclusion Criteria:

* Presence of vascular access dysfunction (blood flow rate \&lt; 180ml/min);
* Severe heart failure;
* Active infection;
* Infectious disease;
* Patients with severe anemia;
* Patients with polycystic kidney disease;
* Expected dialysis duration \&lt; 6 months;
* Pregnancy or lactation women;
* Patients who are participating in other clinical studies, or who have participated in other clinical studies within 3 months prior to enrollment;
* Unwillingness to be followed up or poor adherence to treatment;
* Other circumstances that the investigator considers unsuitable for enrolment.

Primary outcomes:
measure: renal perfusion
timeFrame: one day
Secondary outcomes:
measure: diastolic blood pressure
timeFrame: one day
measure: systolic blood pressure
timeFrame: one day
measure: urine volume
timeFrame: 10 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01857583: Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs
Official title: Phase III Clinical Study of DU-176b (Venous Thromboembolism): Japanese, Multicenter, Open-label Study of DU-176b in Patients With Severe Renal Impairment (SRI) Undergoing Orthopedic Surgery of the Lower Limbs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: anticoagulant
DU-176b
edoxaban
factor Xa
oral
orthopedic surgery of lower limbs
severe renal impairment
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2013-05-20
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the safety and pharmacokinetics of DU-176b administered to patients with severe renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b administered to patients with mild renal impairment (MiRI) undergoing orthopedic surgery of the lower limbs.

For reference, the safety of DU-176b in patients with SRI undergoing orthopedic surgery of the lower limbs will be compared with that of fondaparinux.


Eligibility criteria: Inclusion Criteria:

* Patients with SRI or MiRI undergoing orthopedic surgery of the lower limbs

Exclusion Criteria:

* Patients who are on hemodialysis or are scheduled to undergo hemodialysis during the study period
* Patients who are at a significantly high risk for bleeding or thromboembolism
* Patients who are receiving another antithrombotic therapy and are unable to suspend the therapy
* Patients who have evidence of hepatic function test abnormalities

Primary outcomes:
measure: Incidence of Any Adjudicated Bleeding Events
timeFrame: 14 days
measure: Incidence of Adverse Events
timeFrame: 1 month
measure: Incidence of Adverse Drug Reactions
timeFrame: 1 month
measure: Plasma Concentration of DU-176b
timeFrame: 14 days
measure: Plasma Concentration of D21-2393
timeFrame: 14 days
Secondary outcomes:
measure: Incidence of Adjudicated Thromboembolic Events
timeFrame: 1 month
Other outcomes:
Locations:
city: Asahikawa
country: Japan
facility: Toyooka Chuo Hospital
state: Hokkaido Prefecture
Study officials:
affiliation: Osaka Koseinenkin Hospital
name: Takeshi Fuji, VP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fuji T, Fujita S, Kawai Y, Abe Y, Kimura T, Fukuzawa M, Abe K, Tachibana S. A randomized, open-label trial of edoxaban in Japanese patients with severe renal impairment undergoing lower-limb orthopedic surgery. Thromb J. 2015 Jan 30;13(1):6. doi: 10.1186/s12959-014-0034-9. eCollection 2015.