louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00661167: Phase II Study of ABI-007 for Gastric Cancer
Official title: Phase II Study of ABI-007 by Tri-weekly Schedule for Patients With Unresectable or Recurrent Gastric Cancer Refractory to 5-FU Containing Regimen.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of tri-weekly ABI-007 for recurrence or unresectable gastric cancer patients who have received one prior regimen containing fluoropyrimidine and developed disease progression or recurrence.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed gastric adenocarcinoma
* Received one prior regimen containing fluoropyrimidine analogs and developed disease progression or recurrence
* Age: 20 - 74
* At least one measurable lesion by RECIST criteria

Exclusion Criteria:

* History of Taxans use
* Patients with another active malignancy
* Pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE)
* Chronic treatment with steroids

Primary outcomes:
measure: Overall response rate
timeFrame: During chemotherapy
Secondary outcomes:
measure: Safety
timeFrame: During chemotherapy
measure: Progression-free survival
timeFrame: Until progression
measure: Overall survival
timeFrame: Over a year form randomaization
measure: Disease control rate
timeFrame: Duration chemoterapy
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Matsuyama
country: Japan
facility: Shikoku Cancer Center
state: Ehime
city: Sagamihara
country: Japan
facility: Kitasato University East Hospital
state: Kanagawa
city: Saku
country: Japan
facility: Saku Central Hospital Nagano Prefectural Federation of Agricultural Cooperatives for Health and Welfare
state: Nagano
city: Takatsuki
country: Japan
facility: Osaka Medical College Hospital
state: Osaka
city: Hidaka
country: Japan
facility: Saitama International medical center-comprehensive cancer center, Saitama Medical University
state: Saitama
city: Sunto
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Takaoka
country: Japan
facility: Kouseiren Takaoka Hospital
state: Toyama
city: Fukuoka
country: Japan
facility: National Kyusyu Cancer Center
city: Kochi
country: Japan
facility: Kochi Health Sciences Center
Study officials:
affiliation: Kinki University Hospital
name: Nagahiro Saijo, MD
role: STUDY_CHAIR
References:
citation: Sasaki Y, Nishina T, Yasui H, Goto M, Muro K, Tsuji A, Koizumi W, Toh Y, Hara T, Miyata Y. Phase II trial of nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unresectable or recurrent gastric cancer. Cancer Sci. 2014 Jul;105(7):812-7. doi: 10.1111/cas.12419. Epub 2014 Jul 7.
Clinical trial NCT06815367: Pneumatic Compression Vs Blood Flow Restriction for Muscle Recovery
Official title: Comparing the Effects of Pneumatic Compression and Blood Flow Restriction Therapy on Muscle Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delayed Onset Muscle Soreness
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Both BFR and intermittent pneumatic compression are purported to decrease symptoms associated with exercise induced muscle damage (EIMD) that cause delayed onset muscle soreness (DOMS). Blood flow restriction relies on applying pressurized cuffs to the most proximal portion of the limb. Another form of recovery often relied upon is pneumatic compression. The mechanism by which pneumatic compression works is similar to that of a massage, whereby the device progressively increases the pressure on a portion of the limb before releasing and moving further up the limb.The purpose of this study is determine whether BFR or pneumatic compression can be used to decreased DOMS which may indicate enhanced recovery.


Eligibility criteria: Inclusion Criteria:

* 18-30 years of age
* Recreationally active population
* Women should be on a form of hormonal contraception.
* No current musculoskeletal injuries or pathologies
* Must answer "yes" to all PAR-Q questions.

Exclusion Criteria:

* Individuals that routinely train trail running
* Discomfort when running
* Deep vein thrombosis
* Blood clots
* Cancerous lesions
* Sensory or mental impairment
* Unstable fractures
* Acute pulmonary edema
* Acute thrombophlebitis
* Acute congestive cardiac failure
* Acute infections
* Episodes of pulmonary embolism
* Wounds, lesions, infection, or tumors
* Bone fractures or dislocations
* Increased venous and lymphatic return
* Answers "no" to any of the PAR-Q screening questions

Primary outcomes:
measure: Counter Movement Jump Height
timeFrame: Immediately before and immediately after exercise, immediately after treatment, 24-hours post treatment.
measure: Maximal Voluntary Isometric Contraction
timeFrame: Immediately before and immediately after exercise, immediately after treatment, 24-hours post treatment.
measure: Sedentary delayed onset muscle soreness
timeFrame: Immediately before and immediately after exercise, immediately after treatment, 24-hours post treatment.
measure: Active delayed onset muscle soreness
timeFrame: Using a visual analog scale, participants will be asked to rate their level of soreness while at rest.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References:
Clinical trial NCT06394167: A Phase 1 Dose Escalation Study of Intravenous VX-993 in Healthy Adults
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose Escalation Study Evaluating the Safety and Pharmacokinetics of Intravenous VX-993 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2024-05-01
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of intravenously administered VX-993 at different doses in healthy participants.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2), inclusive
* A total body weight of more than (\>) 50 kg
* Nonsmoker or ex-smoker for at least 3 months before first dose of the study drug

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug.
* Any condition possibly affecting drug distribution, metabolism, or excretion

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 16
measure: Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 43
Secondary outcomes:
measure: Part A: Maximum Observed Plasma Concentration (Cmax) of VX-993
timeFrame: Pre-dose up to Day 16
measure: Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993
timeFrame: Pre-dose up to Day 43
measure: Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-993
timeFrame: Pre-dose up to Day 16
measure: Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993
timeFrame: Pre-dose up to Day 43
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON Lenexa
state: Kansas
Study officials:
References:
Clinical trial NCT03573167: Mobile Phone-Based Motivational Interviewing in Kenya
Official title: Mobile Phone-Based Motivational Interviewing to Reduce Alcohol Use Problems in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Africa Mental Health Foundation
First posted: 2018-06-29
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to test whether motivational interviewing (MI) provided over the mobile phone would reduce alcohol use among adults, including people living with HIV/AIDS, visiting primary care in Kenya. Heavy alcohol users voluntarily consented to being randomized to one of three study arms: standard in-person MI, mobile MI, or waitlist control receiving no intervention for 1 month followed by mobile MI. Alcohol use problems were assessed using validated screeners and changes in alcohol use were assessed at 1 month and 6 months after receiving the intervention. The investigators hypothesized that alcohol use would reduce after MI treatment compared to waitlist control, there would be no difference between standard in-person MI and mobile MI, and these reductions would be sustained out to six months following the intervention.


Eligibility criteria: Inclusion Criteria:

* Adults visiting the primary care clinic and screening positive for potential alcohol use problems.

Exclusion Criteria:

* Persons younger than 18 years old, with severe psychiatric morbidity, or cognitive impairment were not eligible for the study

Primary outcomes:
measure: Reduction in alcohol use score as measured by the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) from baseline to one (1) month.
timeFrame: 1 month
measure: Reduction in alcohol use score as measured by the Alcohol Use Disorders Identification Test (AUDIT) and AUDIT-C from baseline to six (6) months.
timeFrame: 6 months
Secondary outcomes:
measure: Reduction in alcohol use score as measured by the AUDIT and AUDIT-C moderated by HIV co-morbidity from baseline to one (1) month and from baseline to six (6) months.
timeFrame: 1 and 6 months
measure: Reduction in alcohol use score as measured by the AUDIT moderated by mental health co-morbidity, as measured by the Achenbach System of Empirically Based Assessments (ASEBA) Adults Self-Report, from baseline to six (6) months.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Vermont
name: Valerie Harder, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01243567: Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma, Open-Angle
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-11-18
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never been previously treated and are at high risk for progression.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma that has never been treated
* Visual Acuity 20/60 or better in each eye

Exclusion Criteria:

* Eye surgery within 3 months
* Any refractive eye surgery
* Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive pulmonary disease \[COPD\], bronchial asthma, sinus bradycardia, heart block, history of severe myocardial infarction \[heart attack\])
* Eye inflammation or eye infection within 3 months
* Eye trauma within 6 months
* Oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use during study

Primary outcomes:
measure: Change From Baseline in Average Intraocular Pressure (IOP)
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: Change From Baseline IOP
timeFrame: Baseline, Month 3
measure: Percentage of Patients Reaching a Predefined Target Pressure Threshold
timeFrame: Baseline, Month 3
measure: Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
timeFrame: Baseline, Month 3
measure: Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
timeFrame: Baseline, Month 3
Other outcomes:
Locations:
city: Coimbra
country: Portugal
city: Madrid
country: Spain
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Gutierrez-Diaz E, Silva Cotta J, Munoz-Negrete FJ, Gutierrez-Ortiz C, Morgan-Warren RJ, Maltman J. Bimatoprost/timolol fixed combination versus latanoprost in treatment-naive glaucoma patients at high risk of progression: a pilot study. Clin Ophthalmol. 2014 Apr 10;8:725-32. doi: 10.2147/OPTH.S56735. eCollection 2014.
Clinical trial NCT01926067: Monitoring of Cardiac Function With 3-axis Accelerometers
Official title: Monitoring of Cardiac Function With 3-axis Accelerometers During Weaning of Cardiopulmonary by Pass After Heart Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart; Surgery, Heart, Functional Disturbance as Result
Keywords: Accelerometer
Cardiopulmonary by pass
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2013-08-20
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with significant aortic stenosis scheduled for surgical AVR

Brief summary: Aim of the study: To validate accelerometers for continuous monitoring of global cardiac function during weaning from cardiopulmonary bypass (CPB) in cardiac surgery.

Detailed description: Hypothesis:

The following hypothesis will be tested: Accelerometer measures are clinical relevant indices of global left and right myocardial performance during weaning from cardiopulmonary bypass.

Model:

The performance of the accelerometer will be tested in a intraoperative setting, during weaning from cardiopulmonary bypass. Accelerometer measures of ventricular systolic and diastolic function will be compared to corresponding measures and indices of ventricular functions by echocardiography and hemodynamic monitoring during a step wise controlled weaning from cardiopulmonary bypass, ensuring precise control of pre- and afterload.

Eligibility criteria: The hypothesis will be tested in 20 elective patients.

Inclusion Criteria:

* Significant aortic valvular disease scheduled to undergo cardiac surgery with an estimated extracorporeal circulation time \> 40 min.

Exclusion Criteria:

* Evolving myocardial infarction,
* dyskinetic wall motions,
* cardiogenic shock,
* hepatic dysfunction or esophageal disease.

Primary outcomes:
measure: Comparison of global heart function measures between accelerometer, echocardiography and hemodynamics.
timeFrame: The patients will be followed during surgery, approximately 3 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, The Intervention Sentre
Study officials:
affiliation: Oslo University Hospital, The Intervention Sentre
name: Erik Fosse, Professor
role: STUDY_DIRECTOR
References:
citation: Grymyr OH, Beitnes JO, Eidet J, Tollofsrud S, Fiane A, Skulstad H, Fosse E, Halvorsen PS. Detection of intraoperative myocardial dysfunction by accelerometer during aortic valve replacement. Interact Cardiovasc Thorac Surg. 2017 Feb 1;24(2):188-195. doi: 10.1093/icvts/ivw326.
Clinical trial NCT00809367: Collection and Banking of Leukemia Cells MDS/AML
Official title: Collection and Banking of Leukemia Cells for Vaccine Generation and Research in Patients With Advanced MDS or AML
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myelodysplastic Syndrome
Acute Myeloid Leukemia
Keywords: MDS
AML
banking study
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: National Institutes of Health (NIH)
First posted: 2008-12-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The goal of this research study is to determine if it is feasible to collect leukemia cells from patients ahead of time (before they undergo further treatments) so that these cells (after being radiated so they will no longer grow or divide) can be given back to them as a cancer vaccine if/after the participant receives a bone marrow or blood stem cell transplant in the future. The purpose of the research study will be to collect, freeze and store leukemia calls from participants blood or bone marrow. This study is a companion study to a vaccine study.

Detailed description: * Leukemia cells will be collected by one or more of the following methods: 1)Routine blood draw 2)Bone marrow aspirate 3) Leukapheresis. The physician and study staff will determine which of the methods above is best suited for each participant.
* After collection, the leukemia cells will be transported to the Cell Manipulation Core Facility (CMCF) at the Dana-Farber Cancer Institute, where they will be frozen until the time of vaccine administration.

Eligibility criteria: Inclusion Criteria:

* Patients with AML will be eligible for banking at the time of relapse or primary induction failure or at the time of AML diagnosis they are 60 years of age or older, AML arising out of background MDS or MPD or AML known with high risk cytogenetics
* Patients with MDS-RAEB-1 or RAEB-II, CMML-1 or CMML-II
* Patients must have \>5% blast in bone marrow or peripheral blood
* ECOG Performance Status 0-2
* Age greater than or equal to 18 years
* Reasonable likelihood, in the physician's opinion, that the patient will be a candidate for allogeneic stem cell transplant

Primary outcomes:
measure: To determine the feasibility of banking leukemic blood or marrow samples from patients with advanced MDS or AML such that these cells could be used for tumor cell vaccination at a later date.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Vincent Ho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05156567: Validation of a Multitask Deep Learning System at Spine Metastasis CT
Official title: Multicenter Validation of a Multitask Deep Learning System for Spine Metastases Detection Andfeatures Evaluations at Spine Metastasis CT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: To Evaluate Performance of the DLS
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Spine Metastasis

Brief summary: 15 resident oncologists were conducted to evaluate the clinical efficacy of DLS in multicenter. They were 1:1 randomly asked to independently read the test images without the assistance of DLS software or with the assistance. Area under the receiver operating characteristic curve (AUC), sensitivity, and specificity of the DLS were calculated with professional graders as the reference standard.


Eligibility criteria: Inclusion Criteria:

1. pathology-proven diagnosis of solid tumor;
2. spinal CT scan indicating spinal metastasis with at least one lesion;
3. no previous surgery for spinal metastasis

Exclusion Criteria:

1. spinal CT scans with no sagittal reconstruction;
2. the radiologist considered that the quality of CT image was unqualified.

Primary outcomes:
measure: AUC
timeFrame: 1 months
Secondary outcomes:
measure: sensitivity
timeFrame: 1 months
measure: specificity
timeFrame: 1 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
Study officials:
References:
Clinical trial NCT00839267: Clopidogrel Efficacy and Acute Coronary Syndromes
Official title: The Comparison of Clopidogrel Efficacy in Patients With Acute Myocardial Infarction and Severe Hemodynamic Instability to Patients With Hemodynamically Uncomplicated Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: platelet
VASP
clopidogrel
cardiogenic shock
myocardial infarction
percutaneous coronary intervention
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2009-02-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population of 40 consecutive patients is planned, all of them with acute myocardial infarction with ST-segment elevation.

Brief summary: The purpose of this study is to compare clopidogrel effectiveness between severe hemodynamically unstable versus stable patients with acute myocardial infarction.

Detailed description: Clopidogrel exists in oral form only. As a prodrug, it has to be metabolized to the active form by cytochrome system in the liver. Both facts could lead to lower efficacy of the drug in hemodynamically unstable patients, where splanchnic and liver hypoperfusion is present. We hypothesised that clopidogrel efficacy is insufficient in patients with acute myocardial infarction and severe hemodynamic instability. Therefore we would like to compare the effect of clopidogrel in unstable STEMI patients on mechanical ventilation with stable STEMI patients.

Eligibility criteria: Inclusion Criteria for unstable group:

* acute STEMI
* mechanical ventilation
* the need for catecholamine support.

Inclusion Criteria for stable group:

* acute myocardial infarction

Exclusion Criteria for any:

* previous treatment with clopidogrel
* clopidogrel administration during transport by ambulance
* known intolerance to clopidogrel
* history of thrombocytopenia (\<150,000 platelets/ml)
* pre-existing liver disease

Primary outcomes:
measure: Lower efficacy of clopidogrel determined by VASP measurement
timeFrame: 6 months
Secondary outcomes:
measure: Higher frequency of stent thrombosis in the unstable group
timeFrame: 6 months
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Study officials:
affiliation: Charles University Prague
name: Pavel Osmancik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: