louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00212732: Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan
Official title: Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Keywords: ONO-8025, KRP-197, overactive bladder, antimuscarinic
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 750
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: The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.


Eligibility criteria: Inclusion Criteria:

1. Patients who are 20 years old or over with overactive bladder
2. Total number of urinary incontinence episodes per week is 5 or over
3. Mean number of micturition per day is 8 or over
4. Mean number of urinary urgency episodes per day is 1 or over
5. Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

1. Patients with genuine stress incontinence
2. Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection
3. Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study
4. Patients suffering from complications for which anticholinergics are contraindicated
5. Other exlcusion criteria as specified in the study protocol

Primary outcomes:
measure: Total number of urinary incontinence episodes per week
Secondary outcomes:
measure: Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL
Other outcomes:
Locations:
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader, Development Planning
role: STUDY_DIRECTOR
References:
Clinical trial NCT05937932: Exploring Clinical Study Experiences of People With Depression
Official title: Inside Depression Clinical Trials: Patient Experiences Shared While Undergoing Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Depression
Keywords: depression
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with depression who are actively considering enrolling in an observational clinical trial, but have not yet completed enrollment and randomization.

Brief summary: The study seeks to delve into the firsthand experiences of patients diagnosed with depression who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.

By joining this clinical trial, individuals have the unique opportunity to contribute to the betterment of future depression patients and play an active role in advancing medical research.


Eligibility criteria: Inclusion Criteria:

* Patient has self-identified as planning to enroll in a clinical trial
* Patient has been diagnosed with depression
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Inability to perform regular electronic reporting
* Patient is pregnant

Primary outcomes:
measure: Number of patients who decide to participate in a depression clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in depression clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Fancourt D, Steptoe A, Bu F. Trajectories of anxiety and depressive symptoms during enforced isolation due to COVID-19 in England: a longitudinal observational study. Lancet Psychiatry. 2021 Feb;8(2):141-149. doi: 10.1016/S2215-0366(20)30482-X. Epub 2020 Dec 9.
citation: Dawson SR, Mallen CD, Gouldstone MB, Yarham R, Mansell G. The prevalence of anxiety and depression in people with age-related macular degeneration: a systematic review of observational study data. BMC Ophthalmol. 2014 Jun 12;14:78. doi: 10.1186/1471-2415-14-78.
citation: Matison AP, Mather KA, Flood VM, Reppermund S. Associations between nutrition and the incidence of depression in middle-aged and older adults: A systematic review and meta-analysis of prospective observational population-based studies. Ageing Res Rev. 2021 Sep;70:101403. doi: 10.1016/j.arr.2021.101403. Epub 2021 Jul 8.
Clinical trial NCT03785132: Performance Measurement in Cardiac Surgery
Official title: Relationship Between Performance Measurement of Intraoperative Mean Arterial Pressure and Mortality in Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: blood pressure
performance measurement
cardiac surgery
mortality
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 1300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing cardiac surgery with cardiopulmonary bypass between 2013 and 2016 at Seoul National University Hospital

Brief summary: This study aimed to evaluate the relationship between the perioperative blood pressure and postoperative mortality after cardiac surgery using performance measurement (PM) of mean arterial pressure (MAP).

Detailed description: The authors conducted a retrospective cohort study of adult patients who underwent cardiac surgery requiring cardiopulmonary bypass (CPB). Median performance error (MDPE), median absolute performance error (MDAPE), and wobble of MAP were calculated using preoperative MAP as the reference value, and MBPs before, during and after the bypass as measured values. Univariable and multivariable logistic regression analyses were performed using PM parameters to predict in-hospital mortality. Survival after cardiac surgery was compared using the Cox proportional hazard model. Predictability of PM was assessed using the area under the receiver-operating characteristic curve (AUROC).

Eligibility criteria: Inclusion Criteria:

* Patients undergoing cardiac surgery with cardiopulmonary bypass between 2013 and 2016 at Seoul National University Hospital.

Exclusion Criteria:

* Patients without information on preoperative blood pressure or mortality.

Primary outcomes:
measure: Mortality
timeFrame: through study completion, average 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Youn Joung Cho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee HC, Ryu HG, Jung CW. Performance measurement of intraoperative systolic arterial pressure to predict in-hospital mortality in adult liver transplantation. Sci Rep. 2017 Aug 1;7(1):7030. doi: 10.1038/s41598-017-07664-0.
citation: Yoon S, Park JB, Lee J, Lee HC, Bahk JH, Cho YJ. Relationship between blood pressure stability and mortality in cardiac surgery patients: retrospective cohort study. J Clin Monit Comput. 2021 Aug;35(4):931-942. doi: 10.1007/s10877-020-00631-7. Epub 2021 Jan 3.
Clinical trial NCT01563432: Clinical Study to Evaluate the Pharmacokinetic Characteristics Between TMX-67 and Feburic® in Healthy Volunteers
Official title: Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Febuxostat Between TMX-67 40mg 2 Tablets and Feburic® 80mg 1 Tablet in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout
Keywords: crossover
pharmacokinetic
hyperuricemia
gout
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-03-27
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was designed to compare and evaluate the pharmacokinetic characteristics of febuxostat after single oral administration of TMX-67 (test drug) and Feburic® tablet in healthy adults; and to evaluate safety and tolerance following a single-dose administration.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males aged between 20 and 45 years
* Subjects whose weight is 50 kg or more and BMI is between 18 and 29 kg/m2
* Subjects who were voluntarily decided to participate in the study and provided written informed consent to observe the directions

Exclusion Criteria:

* Medical history which may influence adsorption, distribution, metabolism, excretion of the drug
* Clinically significant active chronic disease(s)
* Persons who are deemed ineligible for the study by the investigator according to the clinical laboratory test results or for other reasons

Primary outcomes:
measure: Pharmacokinetic characteristics (AUClast and Cmax)
timeFrame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 24 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Ji-Young Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02882932: Comparative Evaluation of Intra-operative Peritoneal Lavage With Super Oxidized Solution and Normal Saline in Peritonitis Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peritonitis
Keywords: peritonitis
solutions
normal saline
infection
peritoneal lavage
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 290
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Super Oxidized Solution (SOS) was used in peritonitis and results were compared by using normal saline solution in two groups. Abdominal fluid was taken to check for bacterial load after giving lavage with SOS solution and in other group normal saline. SOS is a high level disinfectant, non-flammable and no special training is required to handle it.

Detailed description: Aim - To investigate the efficacy of super-oxidized solution (SOS) over normal saline in peritonitis. The investigators objectives are to present the potential clinical impact of intraperitoneal lavage with solutions for early recovery of the patient by reducing the infection rate.

Methods - A double-blind random clinical trial was performed in 240 patients diagnosed as peritonitis at MMIMSR, Mullana, Ambala, India, from December 2014 - November 2015. Subjects were divided into 2 groups, i.e. 120 patients in the study group and 120 cases in the control group. Both the groups underwent peritoneal lavage ; the study group received SOS where as control group underwent normal saline lavage. The effectiveness of both the solutions were compared.

Eligibility criteria: Inclusion criteria:

* gastric, duodenal, ileal perforation, appendicitis
* those patients were willing to participate and the informed consent was taken

Exclusion criteria:

* evidence of enteric encephalopathy
* liver diseases
* renal diseases
* heart disease
* known allergy to any substance
* multiple trauma or organ injury
* any gynaecological etiology

Primary outcomes:
measure: the investigators measured the infection rate by checking the bacterial load during after surgery
timeFrame: average of one year
Secondary outcomes:
measure: The Results Were Measured In the Form of the, Early Recovery, Early Bowel Sounds
timeFrame: With in 10 -20 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00381732: A Study to Evaluate the Efficacy and Safety of 2.5mg and 5mg Tadalafil Given Once a Day to Men With Erectile Dysfunction
Official title: A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5mg and 5mg) Administered Once Daily to Men With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Impotence
erectile dysfunction
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ICOS Corporation
First posted: 2006-09-28
Enrollment: 280
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of 2.5mg and 5mg tadalafil taken once daily in men with erectile dysfunction.


Eligibility criteria: Inclusion Criteria:

* Men with erectile dysfunction
* At least 18 years of age

Exclusion Criteria:

* Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
* A history of certain impotence disorders
* History of specified pelvic surgery
* Any significant genital abnormality identified at the start of the study

Primary outcomes:
measure: Changes in erectile function measured at baseline and after 6 months of treatment with 2.5mg and 5mg tadalafil; assessment of safety after 1 and 2 years of therapy with 5mg tadalafil.
timeFrame: 24-128 weeks
Secondary outcomes:
measure: Changes in additional aspects of erectile function after 3 and 6 months of treatment; assessment of the pharmacokinetics of tadalafil 2.5mg and 5mg.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bothell
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Washington
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:
citation: Porst H, Gacci M, Buttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.
citation: Shabsigh R, Seftel AD, Kim ED, Ni X, Burns PR. Efficacy and safety of once-daily tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline. J Sex Med. 2013 Mar;10(3):844-56. doi: 10.1111/j.1743-6109.2012.02898.x. Epub 2012 Oct 4.
Clinical trial NCT05624632: Cognitive Remote Assessment Using FLAME (CRA-FLAME)
Official title: Cognitive Remote Assessment Using FLAME (CRA-FLAME)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cognitive Impairment
Lead sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 400
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are individuals that have participated/are participating in BBRC-sponsored studies.

Brief summary: We aim to use a multimodal approach comprising conventional neuropsychological cognitive tests, fluid and imaging biomarker data, to explore their association with the FLAME unsupervised cognitive computerized assessment. We believe that this would provide critical information to move forward the current research framework in the field.

Participants will be selected from BBRC-sponsored studies, such as the ALFA project (STUDY 45-65 FPM/2012), the ALFA+ cohort study (ALFA - FPM - 0311), the Beta-AARC study (β-AARC_BBRC2020) or the BarcelonaBeta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018)

Detailed description: We aim to use a multimodal approach comprising conventional neuropsychological cognitive tests, fluid and imaging biomarker data, to explore their association with the FLAME unsupervised cognitive computerized assessment. We believe that this would provide critical information to move forward the current research framework in the field.

Participants will be selected from BBRC-sponsored studies, such as the ALFA project (STUDY 45-65 FPM/2012), the ALFA+ cohort study (ALFA - FPM - 0311), the Beta-AARC study (β-AARC_BBRC2020) or the BarcelonaBeta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018)

Eligibility criteria: Inclusion Criteria:

Participants must meet ALL the following criteria:

1. To sign the study informed consent form approved by the corresponding authorities.
2. Men and women that have participated/are participating in a BBRC-sponsored study.
3. To accept that:

   * The results obtained in this study may be published in scientific journals and at BBRC's communication channels (e.g. web page)
   * The data gathered may be used in combination with those gathered in other BBRC-sponsored studies in which they may (have) participate(d)

Exclusion Criteria:

1. Not having an ICT literacy enough to access and complete the online tests.

Primary outcomes:
measure: FLAME global composite score
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: BarcelonaBeta Brain Research Center
Study officials:
References:
Clinical trial NCT00093132: Satraplatin for Locally Advanced Non-Small Cell Lung Cancer With Simultaneous Radiotherapy
Official title: A Phase 1/2 Study With Satraplatin and Simultaneous Radiation in Locally Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Non-small Cell Lung
Lung Cancer
Keywords: Non-Small Cell Lung Cancer (stage II or III)
NSCLC
Squamous Cell Lung Cancer
adenocarcinoma of the lung
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer
carcinoma, non-small cell lung
Lead sponsor: Agennix
Sponsor class: INDUSTRY
First posted: 2004-10-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: PURPOSE: This trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and radiation therapy for patients with locally advanced Non-Small Cell Lung Cancer (NSCLC) with no prior chemotherapy or radiation therapy treatment. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.

WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

RATIONALE: Intravenously administered platinum-based drugs are currently used in combination with radiation therapy in the treatment of patients with locally advanced NSCLC. The purpose of this Phase I trial is to determine a tolerable dose and schedule for the oral platinum drug (satraplatin) when given to NSCLC patients throughout the course of their radiotherapy treatment.


Eligibility criteria: Inclusion Criteria:

* Locally advanced or medically inoperable NSCLC (stage II or III)
* ECOG performance status score 0-2
* Adequate bone marrow, liver, and pulmonary functions
* Life expectancy \> three months.

Exclusion Criteria:

* Prior malignancy
* Serious concurrent uncontrolled medical disorder.
* Uncontrolled or significant cardiovascular disease
* History of mastectomy
* Pregnant or breast-feeding patients are not eligible
* Prior radiotherapy to the primary tumor site or cytotoxic chemotherapy

Primary outcomes:
measure: Determination of MTD and recommended dose for phase II trials
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Southwestern Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT01660932: Vascular and Metabolic Effects of Omega-3 Fatty Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertriglyceridemia
Keywords: insulin resistance
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 176
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that omega does-dependently improves vascular and insulin resistance.


Eligibility criteria: Inclusion Criteria:

* hypertriglyceridemia

Exclusion Criteria:

* overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (HbA1c \> 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse

Primary outcomes:
measure: flow-mediated dilation
timeFrame: 8 weeks of treatment
Secondary outcomes:
measure: insulin resistance
timeFrame: 8 weeks of treatment
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gil Medical Center
Study officials:
References: