louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00967772: The Safety/Tolerability and Pharmacokinetics (PKs) of Naftopidil in Korean Healthy Male Volunteers
Official title: A Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of Naftopidil After Oral Administration in Korean Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Safety
tolerability
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-08-28
Enrollment: 16
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The safety/tolerability and pharmacokinetics (PK) of Naftopidil (commercial name: Flivas) after oral administration will be investigated in Korean healthy male volunteers. All volunteers will be assigned to 2 groups and administered a lower single dose tablet (Period 1). After one week's wash-over period, the volunteers take higher dosages (Period 2).


Eligibility criteria: Inclusion Criteria:

* Healthy males subjects, 20-45 years inclusive
* Weight over 55 kg inclusive and Ideal Body Weight (IBW) between -20% and +20% inclusive
* Written informed consent given

Exclusion Criteria:

* Hypersensitivity to drugs(aspirin, antibiotics and so on) including naftopidil
* History or presence of any clinically significant liver or kidney disease, gastrointestinal, cardiovascular, respiratory, endocrinal, musculoskeletal, neurologic/psychiatric, urinary, hematological, oncological pathology
* Have a history of drug abuse, or show positive for drug abuse at urine screening
* Have participated in another clinical study within 2 months prior to entering inth the study
* Are considered ineligible by the investigator due to clinical laboratory results or any other relevant reasons

Primary outcomes:
measure: Pharmacokinetics of naftopidil
timeFrame: Dec. 2009 (anticipated)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trial center, Clinical Research institute, Seoul National University Hospital
Study officials:
affiliation: Assistant Professor of Clinical Pharmacology, Seoul Nat'l Univ. Hospital
name: Kyung-Sang Yu, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04404972: Incidence of Complications of Brain Death
Official title: Incidence of Complications in Brain Death Organ Donors. Retrospective Observational Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Death
Keywords: Brain Death
Organ Donation
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult critically ill patinets with confirmed brain death admitted to university hospital who become brain death organ donor.

Brief summary: The purpose of the study is to describe the incidence of complications in brain death adult organ donors.

Detailed description: Pathophysiological changes following brain death may complicate the care of brain death donors. These complications negatively affects function of donated organs. Understanding these complications and its incidence is crucial for their appropriate management. The aim of this retrospective observational study is to evaluate the incidence of complications in adult brain death organ donors. Date will be collected from medical records of eligible patients admitted to intensive care unit for suspected brain death in whom brain death was confirmed and who become organ donors.

Eligibility criteria: Inclusion Criteria:

* age ≥18 years
* confirmed brain death
* organ donor

Exclusion Criteria:

- age under 18 years

Primary outcomes:
measure: Hypotension
timeFrame: 48hours prior confirmation of brain death to ICU discharge
measure: Serum lactate level
timeFrame: 48hours prior confirmation of brain death to ICU discharge
measure: Catecholamine storm
timeFrame: 48hours prior confirmation of brain death to ICU discharge
measure: Myocardial dysfunction
timeFrame: 48hours prior confirmation of brain death to ICU discharge
measure: ARDS
timeFrame: 48hours prior confirmation of brain death to ICU discharge
measure: Oxygenation index
timeFrame: 48hours prior confirmation of brain death to ICU discharge
measure: Diabetes insipidus
timeFrame: 48hours prior confirmation of brain death to ICU discharge
measure: Renal dysfunction
timeFrame: 48hours prior confirmation of brain death to ICU discharge
measure: Coagulopathy
timeFrame: 48hours prior confirmation of brain death to ICU discharge
measure: Hypothermia
timeFrame: 48hours prior confirmation of brain death to ICU discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
Study officials:
affiliation: University Hospital Brno
name: Roman Gal, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00555672: Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
Official title: A Phase I Study Of Sunitinib Malate In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stomach Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safe and tolerable dose of sunitinib when given together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of stomach cancer
* advanced stomach cancer stage IV
* adequate blood chemistry, blood counts and kidney function
* willing to participate to study requirements and to sign an informed consent document

Exclusion Criteria:

* prior chemotherapy for stomach cancer in its advanced stage
* excessive toxicities related to prior therapies
* pregnant or breastfeeding patients

Primary outcomes:
measure: Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)
timeFrame: Cycle 1 (Baseline to Day 21)
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)
measure: Area Under the Curve From Time 0 to 24 Hours Postdose [AUC (0-24)]
timeFrame: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose)
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)
measure: Steady State Concentration (Css) of 5-Fluorouracil (5-FU)
timeFrame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
measure: Infusion Rate (Zero Order) (R0) of 5-FU
timeFrame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
measure: Clearance (CLss) of 5-FU
timeFrame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
measure: Area Under the Curve From Time 2 to 6 Hours Postdose [AUC (2-6)] of 5-FU
timeFrame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
measure: Number of Participants With Objective Response
timeFrame: Baseline, Day 21 of every even-numbered cycle up to 15 Months
measure: Duration of Response (DR)
timeFrame: Baseline up to Month 15
measure: Progression-Free Survival (PFS)
timeFrame: Baseline up to Month 15
Other outcomes:
Locations:
city: L'hospitalet de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06523972: A Study of Cardiovascular Disease Awareness and Cardiovascular Health
Official title: Promoting Cardiovascular Disease Awareness and Cardiovascular Health Among Minnesota State Fair Attendees: The Great Minnesota Heart Health Check
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Cardiovascular Health
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 387
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (≥18 years of age)

Brief summary: The objective is to increase awareness of various cardiovascular diseases (CVDs) through an interactive, educational experience to promote cardiovascular health (CVH) via an inflatable heart model exhibit and assess community CVD knowledge and whether this experience is an acceptable tool to promote and provide education on CVH.


Eligibility criteria: Inclusion Criteria:

* MN resident
* Active email address
* ≥18 years of age

Exclusion Criteria:

- Inability to speak, read or understand English

Primary outcomes:
measure: Cardiovascular Health (CVH)
timeFrame: Baseline
Secondary outcomes:
measure: Social Determinants of Health (SDoH)
timeFrame: Baseline
measure: Individual LE8 component scores (Life's Essential 8)
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: LaPrincess Brewer, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01118572: A Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients
Official title: A Phase III Study of YM177 (Postoperative Pain) -- An Etodolac- and Placebo-controlled, Multicenter, Double-blind, Group Comparison Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients --
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Operative Pain
Keywords: Celecoxib
Celecox
Pain
Surgery
NSAIDs
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-05-06
Enrollment: 616
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study is to compare efficacy and safety of YM177 with placebo and etodolac in patients with postoperative pain.

Detailed description: To verify the superiority to placebo and the noninferiority to etodolac of YM177 in terms of efficacy assessment in patients with postoperative pain. Also, to compare them in terms of safety assessment.

Eligibility criteria: Inclusion Criteria:

* Patients with spontaneous pain within 24 hours postoperatively
* The intensity of the pain:

  * 4-categorical assessment: "Moderate pain" or "Severe pain"
  * VAS assessment: 45.0 mm or higher
* Patients whose postoperative pain can be managed using an oral NSAID

Exclusion Criteria:

* A past history of aspirin-induced asthma
* A past of ischemic heart disease, serious arrhythmia, congestive heart failure or cerebrovascular disease
* Patients who undergoes the surgical procedure under general anesthesia
* Patients taking excluded medications

Primary outcomes:
measure: Patient impressions (4-categorical assessments)
timeFrame: For 2 days
Secondary outcomes:
measure: Pain intensity
timeFrame: For 2 days
measure: Pain intensity difference
timeFrame: For 2 days
measure: Discontinuation due to insufficient efficacy
timeFrame: For 2 days
measure: Safety assessed by AE, clinical lab tests and vital signs
timeFrame: For 2 days
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyusyu
country: Japan
city: Shikoku
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT06672172: A Study of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Diet and Exercise
Official title: A Phase 3, Randomized, Double-blinded Study to Evaluate the Efficacy and Safety of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise (OUTSTAND-1)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 284
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: The aim of this trial is to evaluate the efficacy and safety of HRS-7535 compared with placebo in subjects with type 2 diabetes mellitus with inadequate glycemic control with diet and exercise


Eligibility criteria: Inclusion Criteria:

1. Male or female, 18-75 age years, both inclusive;
2. Type 2 diabetes mellitus diagnosed for at least 2 months before the screening visit;
3. HbA1c 7.0-10.0% (both inclusive) at screening;
4. Treated with diet and exercise, and without any antidiabetic drugs at least 8 weeks prior to screening.

Exclusion Criteria:

1. Known or suspected allergy to the investigational drug or its components or excipients.
2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
3. Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
4. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
5. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.

Primary outcomes:
measure: Change from baseline in HbA1c at 32 weeks of treatment
timeFrame: at 32 weeks
Secondary outcomes:
measure: Percentage of Participants Who Achieved HbA1c <7.0% at Week 32
timeFrame: at 32 weeks
measure: Percentage of Participants Who Achieved HbA1c ≤6.5% at Week 32
timeFrame: at 32 weeks
measure: Change from Baseline in Fasting Serum Glucose, from Baseline to Week 32
timeFrame: at 32 weeks
measure: Percentage Change from Baseline in Body Weight, from Baseline to Week 32
timeFrame: at 32 weeks
measure: Change from Baseline in Body Weight, from Baseline to Week 32
timeFrame: at 32 weeks
measure: Change from Baseline in Waist Circumference, from Baseline to Week 32
timeFrame: at 32 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04455672: A Comparative Study Using Two 3D Printed Occlusal Splints for Patients With Tempromandibular Disorder
Official title: A Comparative Study Using Two 3D Printed Occlusal Splints for Patients With Tempromandibular Disorder (A Randomized Cross Over Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Disorder
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: • to compare the relief of pain for patients with anterior disc displacement with reduction between two groups; in the first group a digitally formed stabilizing splint followed by an anterior repositioning splint (ARS) and the second group a digitally fabricated (ARS) splints followed by a stabilizing splints


Eligibility criteria: Inclusion Criteria:

* • TMDs according to the research diagnostic criteria (RDC)8 which include: i. Painful TMJ audible and palpable click unilateral or bilateral ii. Presence of clicking during opening. iii. TMJ tenderness.

  * Fully dentate patients without any malocclusion (natural or restored by fixed prothesis) and good oral hygiene.
  * Co-operative patient that should show motivation to follow up.

Exclusion Criteria:

* • Patients with systemic diseases which could affect TMJ, e.g., rheumatoid arthritis, osteoarthrosis, Myasthenia Gravis and fibromyalgia.

  * Patients taking analgesic, muscle relaxant, or anti-inflammatory drugs were excluded because such drugs could influence the results.
  * Patients with removable dental prosthesis

Primary outcomes:
measure: pain relief
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03492372: Molecular Characterization of Spinal Tissue
Official title: Molecular Characterization of Spinal Tissue
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Spinal Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing spinal surgery where spinal tissues (disc, cartilage, ligament, etc.) is removed as discarded tissue, waste, or surgical debris.

Brief summary: The researchers are trying to identify molecular mechanisms that control spine deformity and degenerative changes that can be used for therapeutic strategies.

Detailed description: Discarded surgical material from spinal procedures is collected. RNA analysis and other tests on the tissue is performed to determine markers of pathologic disease and to develop pharmacologic treatment strategies for pediatric spinal disorders.

Eligibility criteria: Inclusion Criteria:

* Children and adults undergoing surgical procedures where spinal tissues are removed as a normal part of their procedure. Material from adults may be collected as a control group.

Exclusion Criteria:

* Surgeries where spinal tissues are not being removed.

Primary outcomes:
measure: RNA expression
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: A.Noelle Larson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06958172: The Effects of Core Stabilization on Desk Workers With Postural Disorders
Official title: Investigation of The Effects of Core Stabilization, Hip and Thoracic Mobility Exercises on Desk Workers With Postural Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postural Imbalance
Worker Health
Keywords: Balance
Core Stabilization
Mobility Exercise
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Istinye University
First posted: 2025-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled study
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the effects of core, thoracic and hip mobility exercises on trunk stabilization and postural improvement in desk workers with postural disorders.

Detailed description: A randomized controlled study was conducted with 40 desk workers aged 25-45. Participants were divided into two groups: Study Group (n=21) and Control Group (n=20). Participants in the Study Group received core stabilization, thoracic Participants in the Control Group performed mobility and hip mobility exercises, while participants in the Control Group only performed the same home exercise program. Before and after treatment, trunk stabilization of the participants was evaluated with the Plank test and Sorenson test, and their balance was evaluated with the Y balance test .

Eligibility criteria: Inclusion Criteria:

* Having a desk job
* Being between the ages of 25-45,
* Written approval of participation in the study by himself/herself or his/her legal representative

Exclusion Criteria:

* Having had surgery within the last six months,
* Having a previously identified and diagnosed cardiovascular or pulmonary disease

Primary outcomes:
measure: Assessment Methods
timeFrame: 2 months
measure: Plank test and Sorenson test
timeFrame: 2 months
measure: Y balance test
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: İstinye University
name: Mertcan Kızılpınar
role: STUDY_CHAIR
References:
Clinical trial NCT03467672: Interest of Eosinopia in the Diagnosis of Infection in the Emergency Department
Official title: Interest of Eosinopia in the Diagnosis of Infection in the Emergency Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eosinopenia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any adult emergency counseling subjects who benefit from the routine practice of NFS for any indication.

Brief summary: Several studies have described the interest of eosinopenia as a marker of infection in internal medicine or in intensive care units. Eosinopenia is an inexpensive and easily accessible biological marker of sepsis. Retrospective work in the adult emergency departments of Strasbourg University Hospitals has shown the good specificity of this biological sign for the diagnosis of infection. Our work aims to confirm the results by a more meaningful study.

Main objective: Evaluation of the interest of eosinopenia in the diagnosis of bacterial infection in ED.

Methodology: inclusion of all patients with criteria for bacterial infection in ED, inclusion of an equivalent number of uninfected control patients.

Duration : 12 months Multicentric prospective study 6 centers : Strasbourg, Hôpital Nord Franche comté, Sélestat, Wissembourg, Colmar, Mulhouse


Eligibility criteria: Inclusion Criteria:

* major patient
* patient suspected of infection and benefiting from the routine practice of NFS, whatever the indication during his / her visit to the emergency room.
* patient with or without criteria for bacterial infection
* patient affiliated to a social security scheme
* patient (or legal representative) who has agreed to participate in the study

Exclusion Criteria:

* anti tumor chemotherapy
* immunosuppressive treatment
* corticotherapy
* antibiotherapy in progress
* malignant hemopathy
* evolutionary cancer
* refusal to participate in the study
* subjects under safeguard of justice
* subject under guardianship or curatorship

Primary outcomes:
measure: eosinopenia as a sepsis marker
timeFrame: 102 month
Secondary outcomes:
Other outcomes:
Locations:
city: Colmar
country: France
facility: CH de COLMAR
city: Mulhouse
country: France
facility: CH de MULHOUSE
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
city: Sélestat
country: France
facility: Ch Selestat
city: Trévenans
country: France
facility: CH Nord Franche comte
city: Wissembourg
country: France
facility: Ch Wissembourg
Study officials:
References: