louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05004532: Transversus Abdominis Plane Block in Acute Appendicitis Pain Managment
Official title: Efficacy of Preoperative Transversus Abdominis Plane Block in Acute Appendicitis Pain and Its Success in Postoperative Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Appendicitis
Acute Abdomen
Postoperative Pain
Keywords: transversus abdominis plane nerve block
acute appendicitis
acute pain
postoperative pain
Lead sponsor: Erol Olcok Corum Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 years and older who underwent open appendectomy with the diagnosis of acute appendicitis, who underwent TAP block, were identified retrospectively. Demographic data of the patients, change of pain scores at rest and with coughing, postoperative pain scores, postoperative analgesic need were evaluated.

Brief summary: In this study, it was aimed to investigate the analgesic efficacy of the preoperatively applied Transversus Abdominis Plane (TAP) Block in the management of acute appendicitis-related abdominal pain and post-appendectomy pain.

Detailed description: TAP block creates an analgesic effect by blocking both sensory skin dermotams and viscerosomatic transmission. TAP block with ultrasound was first performed by Hebbard, and the use of USG made the procedure faster and safer. TAP block has been successfully applied for analgesia in procedures such as laparoscopic colocystectomy, inguinal hernia repair, abdominal hysterectomy, prostatectomy and appendectomy. According to the surgical incision to be applied, TAP block is performed from different anatomical regions. It is also applied for pain palliation in intra-abdominal etiologies or rarely for anesthesia in surgical procedures.

The analgesic efficacy of TAP block on preoperative abdominal pain and postoperative surgical pain in acute appendicitis was investigated.

Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 with a diagnosis of acute appendicitis,
* with abdominal pain,
* tap block applied for perioperative pain management.

Exclusion Criteria:

* The data of patients who underwent laparoscopic appendectomy
* additional surgical procedure other than appendectomy (right hemicolectomy, etc.)
* who were diagnosed other than acute appendicitis after the surgical procedure (diverticulitis, tumor, etc.),

Primary outcomes:
measure: Verbal Numerical Pain Scale
timeFrame: postoperative time 24 hour time
Secondary outcomes:
measure: BMI
timeFrame: preoperative
measure: weight
timeFrame: preoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00938132: A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers
Official title: A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Essential Hypertension
Keywords: fimasartan
drug interaction
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 15
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To evaluate the effect of Fimarsartan on pharmacodynamics, pharmacokinetics, and the safety of warfarin in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* age: 20 - 40 years
* sex: male
* body weight: greater than 55 kg
* written informed consent

Exclusion Criteria:

* known allergy to Fimasartan and warfarin
* existing cardiac or hematological diseases
* existing hepatic and renal diseases
* existing gastrointestinal diseases
* acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder
* positive drug or alcohol screening
* smokers of 10 or more cigarettes per day 3 month ago
* participation in a clinical trial during the last 2 months prior to the start of the study

Primary outcomes:
measure: INR AUC, INRmax, INRtmax
timeFrame: pre-dose, 6, 12, 24, 36, 48, 72, 96, 120, 144 h post-dose on 1 d, 11 d
Secondary outcomes:
measure: AUClast, AUCinf, Cmax ,Tmax, CL/F of S-warfarin and R-warfarin
timeFrame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 h post-dose on 1 d, 11 d
Other outcomes:
Locations:
Study officials:
References:
citation: Choi Y, Han H, Shin D, Lim KS, Yu KS. Comparison of the pharmacokinetics and tolerability of HCP1004 (a fixed-dose combination of naproxen and esomeprazole strontium) and VIMOVO(R) (a marketed fixed-dose combination of naproxen and esomeprazole magnesium) in healthy volunteers. Drug Des Devel Ther. 2015 Jul 31;9:4127-35. doi: 10.2147/DDDT.S86725. eCollection 2015.
Clinical trial NCT04531332: Continuous Infusion of Linezolid Versus Intermittent Dosing in the Treatment of Nosocomial Pneumonia
Official title: Efficacy and Safety of Continuous Infusion of Linezolid Compared With Intermittent Dosing in Critically Ill Pneumonic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumonia
Keywords: linezolid continuous infusion
pneumonia
critically ill patients
Lead sponsor: October 6 University
Sponsor class: OTHER
Collaborators: name: Beni-Suef University
First posted: 2020-08-28
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigator's goal in this study is to determine the clinical efficacy and safety of continuous infusion in comparison with standard intermittent infusion.

Detailed description: Prospective randomized controlled clinical trial on critically ill Pneumonic patients, included two groups, over one year period. The first group will be administered intravenous (IV) linezolid 600mg twice daily. The second group will be prescribed linezolid (IV) 600 mg loading dose followed by 1200 mg by continuous infusion. Both groups will be co-administered intravenous (IV) Meropenem 1g every 8 hours empirically.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to ICUs diagnosed as HAP or VAP
* Chest X-ray/ computed tomography showing new or progressive infiltrate.
* New onset of purulent sputum or change in sputum character.
* Body temperature greater than 38 ℃ or less than 35.5℃.
* White blood cell counts greater than 10000 /mm3 or less than 4000 /mm3.
* Significant quantitative pathogen cultures from respiratory secretions.

Exclusion Criteria:

* Age \<18 years, Pregnancy, Lactation
* Previous known allergic reaction to linezolid
* Creatinine Clearance (CrCl) \<10 mL/min, calculated according to the Cockcroft-Gault formula
* Thrombocytopenia (platelet count less than 80,000/mm3)
* Severe hepatic failure (Child-Pugh C)
* Concomitant treatment with other drugs that can potentially interfere with Linezolid (i.e., macrolides, serotonin modulators, omeprazole)
* Acute DIC score \> 4 points or hematological disorder
* Concurrent drug-associated Thrombocytopenia

Primary outcomes:
measure: Proportion of cured patients in the linezolid continuous infusion group versus the proportion of cured patients in the intermittent group
timeFrame: through study completion, over one year
measure: Percentage of occurrence of anemia and thrombocytopenia
timeFrame: through study completion, over one year
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef University
Study officials:
affiliation: October 6 University
name: Ahmed Essam, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03610932: Vitamin C & Exercise Induced Bronchoconstriction (EIB)
Official title: Vitamin C Supplementation to Improve EIB in College Student-Athletes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Exercise-induced Bronchospasm
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research is to assess the association between diet and pulmonary function during standardized EIB testing. Determine the effect of Vitamin C supplementation on airway inflammatory markers and bronchoconstriction after a standardized EIB test compared to usual diet and placebo control.

Detailed description: This study will use a double-blind, randomized, cross-over design with subjects serving as their own controls. This study will be conducted over a consecutive five-week period.

All subjects will be asked to discontinue taking their short- and long-acting beta-agonist medication 12 and 24 hours respectively prior to data collection. Also, all subjects will be asked to refrain from caffeine, physical activity, and NSAID use 24 hours prior to testing. In addition all subjects will be asked to abstain from taking any vitamin supplement during the course of the study.

Eligibility criteria: Inclusion Criteria:

* Student or student-athlete who has tested positive for EIB
* Able to communicate in English

Exclusion Criteria:

* Forced expiratory volume in 1 second (FEV1) \< 70% of predicted, cardiac history,
* Current respiratory infection
* \> 10 pack year history of smoking
* Pregnancy.

Primary outcomes:
measure: Change in airway inflammatory biomarkers
timeFrame: Change from Baseline to End of Week 5
Secondary outcomes:
measure: Change in quality of life: asthma quality of life questionnaire (AQLQ)
timeFrame: Change from Baseline to End of Week 5
measure: Dietary Intake Questionnaire
timeFrame: Change from Baseline to End of Week 5
measure: Cardiorespiratory Fitness
timeFrame: Baseline
measure: Pulmonary function testing
timeFrame: Change from Baseline to End of Week 5
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Dave Burnett, PhD, RRT, AE-C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00268632: IMPACT Study (Improving Measurements of Persistence on "ACtonel" Treatment)
Official title: A Multicenter Prospective Study to Assess the Impact of Physician's Reinforcement on the Subject's Compliance and Persistence on Treatment Using Feedback on Bone Markers in Previously Undiagnosed Postmenopausal Osteoporotic Women Treated With Risedronate.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Procter and Gamble
First posted: 2005-12-22
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the impact of physician's reinforcement using bone marker data on the subject's compliance (at least 50% drug taken) and persistence on treatment after one year in postmenopausal osteoporotic women.


Eligibility criteria: Inclusion Criteria:

* Ambulatory women,
* Caucasian, Oriental or Multiracial
* not previously diagnosed for osteoporosis.

Exclusion Criteria:

* Females of black descent and for the US african american are excluded because of the very low incidence of postmenopausal osteoporosis
* and having used oral or parenteral glucocorticoids (\>= 5 mg prednisone or equivalent per day) within 3 months of starting study drug or for more than one month within six months prior to study entry.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: To assess the impact of physician's reinforcement using bone marker data on the treatment adherence of women with PMO.
timeFrame: collected at week 10 and 22
Secondary outcomes:
measure: to establish the profile of the unrecognized osteoporotic woman (PVD-, RF-) using a risk factor questionnaire for osteoporosis
timeFrame: During the study conduct
measure: to assess the decrease of type I collagen breakdown products(urinary NTX and serum CTX)
timeFrame: after 10 and 22 weeks of treatment
measure: To assess the change in BMD of both total hip and lumbar spine;
timeFrame: at week 52 compared to baseline
measure: osteoporosis-related genotyping.
timeFrame: During the study conduct
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Lex van de Langerijt
role: STUDY_DIRECTOR
References:
citation: Delmas PD, Vrijens B, Eastell R, Roux C, Pols HA, Ringe JD, Grauer A, Cahall D, Watts NB; Improving Measurements of Persistence on Actonel Treatment (IMPACT) Investigators. Effect of monitoring bone turnover markers on persistence with risedronate treatment of postmenopausal osteoporosis. J Clin Endocrinol Metab. 2007 Apr;92(4):1296-304. doi: 10.1210/jc.2006-1526. Epub 2007 Jan 23.
Clinical trial NCT03058432: Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 122
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Concurrent cisplatin based chemoradiotherapy versus radiotherapy alone
Primary purpose: TREATMENT

Brief summary: Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Detailed description: To evaluate concurrent chemotherapy for elderly patients with locoregionally advanced nasopharyngeal carcinoma treated by intensity-modulated radiotherapy

Eligibility criteria: Inclusion Criteria:

* Previously untreated and histologically confirmed locoregionally advanced nasopharyngeal carcinoma

Exclusion Criteria:

* A history of another invasive cancer, prior RT to the head and neck area, prior cytotoxic chemotherapy or anti-EGFR therapy or the presence of any serious medical conditions,supposed to live less than 6 months.

Primary outcomes:
measure: therapeutic success
timeFrame: From date of treatment until the date of completing treatment 1 month later
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Xiaozhong Chen
state: Zhejiang
Study officials:
References:
Clinical trial NCT02401932: Retrospective Analysis for Patients With Hemophagocytosis in Bone Marrow
Official title: Comparison of Malignant and Non-malignant Disorders Associated Bone Marrow Hemophagocytosis: A Single Center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophagocytosis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators reviewed the electronic data base of medical records at the Samsung Medical Center, and selected 264 patients who had evidence of hemophagocytic histiocytosis in bone marrow aspiration and biopsy between January 2000 and June 2014.

Brief summary: Comparison of malignant and non-malignant disorders associated bone marrow hemophagocytosis.

Detailed description: This is a retrospective study comparing malignant and non-malignant disorders associated bone marrow hemophagocytosis. The medical record of patients who had documented evidences of hemophagocytosis in bone marrow are reviewed. The clinical and biological characteristics are compared according to the underlying disorders of hemophagocytosis.

Eligibility criteria: Inclusion Criteria:

* patients who had evidence of hemophagocytic histiocytosis in bone marrow aspiration and biopsy

Exclusion Criteria:

* patients who did not evidence of hemophagocytic histiocytosis in bone marrow aspiration and biopsy

Primary outcomes:
measure: Overall survival
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Seok Jin Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01254552: Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis
Official title: Assessment With Cardiac Computed Tomography Angiography (CCTA) and Magnetic Resonance Imaging (MRI) in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Coronary Atherosclerosis
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 351
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study aimed to prospectively investigate the prevalence of myocardial scar on Dotarem-enhanced Cardiovascular Magnetic Resonance Imaging (MRI) in asymptomatic patients with type-2 Diabetes Mellitus and to assess its correlation with subclinical coronary artery disease on Cardiac Computed Tomography Angiography (CCTA).

Detailed description: Patients underwent a cardiac MRI examination with Dotarem within 60 days after screening visit. The myocardial CCTA examination with Xenetix 350 was performed within 1 to 30 days (but no sooner than 24 hours) after the MRI examination.

Eligibility criteria: Inclusion Criteria:

* Patient with onset of type 2 diabetes occurred at age 30 years or older
* Patient between the ages of 50 and 75 years at enrolment time
* Patient with at least two identified cardiac risk factors who will undergo a CMR and a CCTA examinations to evaluate his/her coronary and cardiac status

Exclusion Criteria:

* Patient with angina pectoris or chest discomfort
* Patient with stress test or invasive coronary angiography within the prior 3 years
* Patient with history of myocardial infarction, overt non compensated heart failure, or coronary revascularization
* Patient with hemodynamic instability.
* Patient with a contraindication or intolerance to Beta-Blocker administration

Primary outcomes:
measure: Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus
timeFrame: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)
Secondary outcomes:
measure: Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis
timeFrame: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT03695952: A Prospective Cohort Study of Patients with Hepatobiliary Cancer Treated with Immune Checkpoint Inhibitors
Official title: A Prospective Cohort Study of Patients with Hepatobiliary Cancer Treated with Immune Checkpoint Inhibitors
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hepatocellular Carcinoma
Biliary Tract Cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatobiliary cancer patients treated with nivolumab or pembrolizumab

Brief summary: Although immune checkpoint inhibitors including nivolumab and pembrolizumab are now available for the management of hepatobiliary cancers in Korea, there is a lack of data for the efficacy and safety of these agents in the real-world setting. This study aims to prospectively evaluate the efficacy of safety of nivolumab and pembrolizumab against advanced hepatocellular carcinoma and biliary tract cancer.

Detailed description: Nivolumab 3 mg/kg intravenous every 2 weeks has been recently approved by US FDA for the management of patients with sorafenib-failed advanced HCC based on the promising data of Checkmate-040 phase I/II study. Although there is a lack of prospective data for pembrolizumab in biliary tract cancer except for small phase 1 trial, pembrolizumab is now available for use in Korea for the management of advanced biliary tract cancer. Because the approval of these agents was based on the small sample size, further prospective evaluation of nivolumab or pembrolizumab in patients with hepatobiliary cancer is needed.

Eligibility criteria: Inclusion Criteria:

* Biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer) or hepatocellular carcinoma
* Planned immune checkpoint inhibitors including nivolumab or pembrolizumab
* Written informed consent

Exclusion Criteria:

* Not available for the treatment with immune checkpoint inhibitors

Primary outcomes:
measure: Objective response rate
timeFrame: 6 months
Secondary outcomes:
measure: Adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Changhoon Yoo
Study officials:
affiliation: Asan Medical Center
name: Changhoon Yoo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chuah S, Lee J, Song Y, Kim HD, Wasser M, Kaya NA, Bang K, Lee YJ, Jeon SH, Suthen S, A'Azman S, Gien G, Lim CJ, Chua C, Hazirah SN, Lee HK, Lim JQ, Lim TKH, Yeong J, Chen J, Shin EC, Albani S, Zhai W, Yoo C, Liu H, Choo SP, Tai D, Chew V. Uncoupling immune trajectories of response and adverse events from anti-PD-1 immunotherapy in hepatocellular carcinoma. J Hepatol. 2022 Sep;77(3):683-694. doi: 10.1016/j.jhep.2022.03.039. Epub 2022 Apr 15.