louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00858715: Resistance to Antithrombotic Therapy
Official title: Resistance to Antithrombotic Therapy in Patients Undergoing Angioplasty and Stenting for Cardiovascular Disease - Vienna REACT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Angioplasty
Keywords: Clopidogrel
Aspirin
Antithrombotic therapy
Platelet function testing
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-03-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clopidogrel plays a pivotal role in the antithrombotic regimen after percutaneous intervention with stent implantation. However, response to clopidogrel shows a wide interindividual variability and a high on-treatment residual ADP-inducible platelet reactivity has already been associated with an increased risk for adverse events after coronary stenting. In the present study, platelet reactivity will be determined by 6 different platelet function tests in patients on dual antiplatelet therapy after angioplasty and stenting for peripheral, coronary and carotid artery disease. One hundred patients showing high on-treatment residual ADP-inducible platelet reactivity in 2 or more tests will be randomized to receive either 75mg or 150mg of daily clopidogrel in addition to aspirin for 3 months. The aim of the present study is to investigate the effects of intensified antithrombotic therapy (150mg clopidogrel + 100mg aspirin daily) versus standard antithrombotic therapy (75mg clopidogrel + 100mg aspirin daily) in patients with decreased clopidogrel-mediated platelet inhibition after percutaneous intervention with stent implantation.


Eligibility criteria: Inclusion Criteria:

* written informed consent
* angioplasty and stenting for peripheral, coronary or carotid artery disease

Exclusion Criteria:

* known aspirin or clopidogrel intolerance
* therapy with vitamin K antagonists (warfarin, phenprocoumon, acenocoumarol)
* treatment with ticlopidine, dipyridamol or nonsteroidal antiinflammatory drugs
* family or personal history of bleeding disorders
* malignant paraproteinemias
* myeloproliferative disorders
* heparin-induced thrombocytopenia
* severe hepatic failure
* known qualitative defects in thrombocyte function
* major surgical procedure within one week before enrollment
* platelet count \< 100.000 or \> 450.000/µl
* hemoglobin \< 8 g/dl

Primary outcomes:
measure: Occurence of major adverse cardiovascular events (MACE)
timeFrame: 3 months
measure: Occurence of major adverse cardiovascular events (MACE)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Division of Angiology, Department of Internal Medicine II, Medical University of Vienna
Study officials:
affiliation: Division of Angiology/ Department of Internal Medicine II/ Medical University of Vienna
name: Christoph W. Kopp, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04259515: Buckberg vs Del Nido in Isolated Aortic Valve Replacement
Official title: Randomized Multicentric Trial to Compare Efficacy and Security of Bucberg vs Del Nido Cardioplegic Solutions in Isolated Aortic Valve Replacement.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiac Surgical Procedures
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study compares safety and efficacy of the Del Nido cardioplegic solution, comparing it with the Buckberg cardioplegic solution in single aortic valve replacement procedures. Half the patients will receive the Del Nido solutions while the other half will receive the Buckberg solution.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old
* Patients listed for elective aortic valve replacement
* Patients that have signed informed consent

Exclusion Criteria:

* Emergent surgery
* Patients that do not accept blood transfusion

Primary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Troponin T
timeFrame: 5 days
measure: CK
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Manel Tauron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07010315: Development and Testing of a Patient-facing Educational Tool About Liver Cancer Prevention
Official title: Development and Testing of a Patient-facing Educational Tool About Liver Cancer Prevention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cancer
Keywords: Liver cancer
Liver disease
Fibrosis
Cirrhosis
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Cancer Prevention Research Institute of Texas
First posted: 2025-06-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants at HOPE Clinic

Brief summary: To develop and test liver cancer prevention educational material.

Detailed description: Primary Objectives:

* To ensure the text for the site is understood by participants, participant comprehension will be measured qualitatively through cognitive testing. Adjustments will be made to the content, messages, and layout iteratively until interviewer notes show no large discrepancies between participant understanding and the meaning of the text.
* To ensure the site is easy to use, usability will be measured qualitatively through usability testing. Adjustments will be made to the functionality of the patient-facing portions of the web-based tool iteratively until interviewer notes indicate that participants are able to input their risk factors and download the personal summary on their own.

Secondary Objectives:

* To describe whether the site is acceptable to users, acceptability will be measured (as part of usability testing) with the Ottawa Acceptability Measures.
* To describe participants' knowledge of liver cancer risk factors, knowledge will be measured (as part of usability testing) with Knowledge Questions developed for this study.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Participants at the HOPE Clinic
* Able to speak and read either English or Spanish
* For usability testing: Able to use and navigate websites on own smart phone or study computer

Exclusion Criteria:

* Has been diagnosed with liver cancer
* Cannot provide consent or otherwise participate in research activities (e.g. vision or hearing impairment)

Primary outcomes:
measure: Cognitive Testing
timeFrame: Up to 1.5 hours
measure: Usability Testing
timeFrame: Up to 1.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jessica Hwang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01594515: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers
Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers (a Partially Randomised, Partially Single-blind, Placebo-controlled Phase I Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-05-09
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.


Eligibility criteria: Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Number (%) of Subjects With Drug Related Adverse Events
timeFrame: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
measure: Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests
timeFrame: Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).
measure: Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs
timeFrame: Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).
measure: Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs
timeFrame: Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).
measure: Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability
timeFrame: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
measure: Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations
timeFrame: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
Secondary outcomes:
measure: Cmax of BI 1015550
timeFrame: -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing
measure: AUC0-infinity of BI 1015550
timeFrame: -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing
Other outcomes:
Locations:
city: Ingelheim
country: Germany
facility: 1305.1.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT02858115: Use of Mini-fluid Challenge for Fluid Responsiveness Prediction During One-lung Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Circulatory Failure During One-lung Ventilation Surgery
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients requiring one lung ventilation lung resection.

Brief summary: During thoracic surgery, an excessive use of fluid results in pulmonary complications. Dynamic fluid responsiveness predictors are not easily usable during one lung ventilation. The investigators hypothesized that the assessment by transesophageal echocardiography (TEE) of subaortic velocity time index (VTI) variation after 100 ml of crystalloid would predict fluid responsiveness in patients receiving one-lung ventilation.

This retrospective, observational, single center study was from January 2014 to December 2015. The investigators included 105 patients requiring one lung ventilation lung resection. The investigators analysed 39 patients presenting an acute circulatory failure. 100 ml of crystalloid was infused over 1-min. After an echocardiographic assessment at 1-min, remaining 400 ml were administered over 14-min Fluid responsiveness was defined as an increase in the VTI above 15% after infusion of 500 ml of crystalloid.


Eligibility criteria: Inclusion Criteria:

* Lung resection
* Acute circulatory failure
* One-lung ventilation

Exclusion Criteria:

* Sinusal rhythm

Primary outcomes:
measure: Fluid responsiveness
timeFrame: one day
measure: Velocity time index
timeFrame: one day
Secondary outcomes:
measure: Pulsed pressure variation
timeFrame: one day
Other outcomes:
Locations:
city: Marseille
country: France
facility: hôpital Nord Assistance Publique Hôpitaux de Marseille
Study officials:
References:
Clinical trial NCT02400515: Influence of Regular Exercise and Detraining on Metabolic and Emotional Parameters in Diabetic Individuals
Official title: Influence of Regular Exercise and Detraining on Metabolic and Emotional Parameters in Diabetic and Hypertensive Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Exercise
Exercise Therapy
Diabetes Mellitus, Type 2
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 12
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This quasi-experimental study aim to evaluate the effect of moderate aerobic exercise on glucose and lipid metabolism as well as the scales of anxiety and depression and levels of salivary cortisol in women with type 2 diabetes.

Detailed description: This quasi-experimental study aim to performed a 12-week training program (3 times/week, 60 minutes per session) which consisted of a supervised moderate aerobic exercise previously determined (50% to 70% of maximal Heart Rate) in women with type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

* having normal physical examinations,
* no participation in regular, moderate or intensive exercise for at least 6 months before the study and
* not be following a diet

Exclusion Criteria:

* the use of insulin and beta-blocker medications and
* the functional inability to perform exercise

Primary outcomes:
measure: Glucose levels
timeFrame: 3 months
Secondary outcomes:
measure: Systolic and Diastolic blood pressure
timeFrame: 3 months
measure: Heart Rate measurement
timeFrame: 3 months
measure: Glycated hemoglobin levels
timeFrame: 3 months
measure: Proteinuria levels
timeFrame: 3 months
measure: Triglycerides levels
timeFrame: 3 months
measure: High Density Level (HDL) Cholesterol levels
timeFrame: 3 months
measure: Low Density Level (LDL) Cholesterol levels
timeFrame: 3 months
Other outcomes:
measure: Salivary cortisol
timeFrame: 3 months
measure: Hospital Anxiety and Depression scale (HADS)
timeFrame: 3 months
Locations:
Study officials:
References:
Clinical trial NCT06052215: Effect of Online Information Cards Education on Women's Perception of Family Planning Behaviors in the Postpartum Period
Official title: Effect of Online Information Cards Education on Women's Perception of Family Planning Disability, Attitudes and Behaviors in the Postpartum Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Care of the Giving Birth
Keywords: Family Planning
Health Education
Postpartum Period
Women
Nursing
Lead sponsor: Ankara Medipol University
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is emphasized that the contraception knowledge of women in Turkey is insufficient and the rate of use of modern family planning methods should be increased. In this study, it is aimed to evaluate the effect of family planning education given via online information canrds on women's perception of disability, attitudes and behaviors in the postpartum period. The study is planned to be conducted in a randomized controlled experimental type using the Solomon four-group design. In the study, it is planned to make up a total of 150 women determined by using the G\*Power program. The research will be carried out online with the women followed in Ankara Etlik City Hospital-Gynecology Hospital Obstetrics Clinics.

The data of the research will be collected with Introductory Information Form, Family Planning Method Usage History Form, Perception of Obstacles in Using Contraceptive Methods Scale and Family Planning Attitude Scale. The data will be analyzed using the SPSS 25.0 program. In the evaluation of the data; descriptive statistics, independent sample t-test, paired samples t-test, anova will be used.


Eligibility criteria: Inclusion Criteria:

* Hospitalization in Turkey Ankara Etlik City Hospital-Gynecology Hospital Obstetrics Clinics on the dates of the research
* Having had a cesarean or normal birth
* Being sexually active
* Being a woman aged 18 or over who has given birth
* Volunteering to participate in research
* Having the ability to read and understand Turkish
* Having a smart phone and internet access to access online information cards

Exclusion Criteria:

* Women with tubal ligation after cesarean section
* Women whose partner has had a vasectomy
* Women who received an Intrauterine Device at the time of delivery

Primary outcomes:
measure: Perception Scale of Barriers to Contraceptive Use
timeFrame: 1-3 mounth
measure: Family Planning Attitude Scale
timeFrame: 1-3 mounth
measure: The rate of use of family planning methods by women
timeFrame: 3. mounth
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Medipol University
Study officials:
References:
Clinical trial NCT05863715: Working Memory Quality of Attentional Templates
Official title: Working Memory Quality of Attentional Templates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: attention
visual search
working memory
Lead sponsor: Lehigh University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants receive each level of visual cue type.
Primary purpose: BASIC_SCIENCE

Brief summary: In this line of research, the researchers are examining a basic science question regarding the working memory representations underlying visual search using a positive template (looking for a target) or a negative template (avoiding a distractor).

Detailed description: When finding a search target, receiving a target cue or distractor cue can increase search efficiency. Critically, in order to use these cues to help search performance, they must be maintained in working memory. The researchers are examining whether the working memory representations are of similar quality for a target cue (positive template) or distractor cue (negative template).

Eligibility criteria: Inclusion Criteria:

* normal or corrected to normal visual acuity, normal color vision

Exclusion Criteria:

-

Primary outcomes:
measure: Button Press Reaction Time
timeFrame: Day 1 (single day of testing)
measure: Button Press Accuracy
timeFrame: Day 1 (single day of testing)
measure: Working Memory Report Quality
timeFrame: Day 1 (single day of testing)
Secondary outcomes:
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: Lehigh University
state: Pennsylvania
Study officials:
affiliation: Lehigh University
name: Nancy Carlisle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01690715: Prognostic Value Related to the Presence of Thrombosis or Portal Vein Invasion in Patients With Hepatocellular Carcinoma Submitted to Surgery
Official title: Prognostic Value Related to the Presence of Thrombosis or Portal Vein Invasion in Patients With Hepatocellular Carcinoma Submitted to Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatocellular Carcinoma
Portal Vein Thrombosis
Hepatic Portal Vein Tumor Invasion
Keywords: Hepatocellular Carcinoma
Thrombosis
Portal Vein Invasion
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with hepatocellular carcinoma confirmed by imaging or histological specimen underwent surgical resection with curative intent with the presence of venous outflow obstruction, either by direct tumor invasion or thrombosis, on portal vein or one of its main vessels.

Brief summary: A retrospective study based on analysis of medical records of patients with hepatocellular carcinoma treated at the Hospital Sírio-Libanês (Sao Paulo-Brazil) between 2001 and 2011 with diagnosis confirmed by imaging or histological specimen underwent surgical resection with curative intent. The study aims to determine the prognostic value of vascular complications related to cancer and to evaluate the survival rate of these patients, comparing the data with those reported in the literature.


Eligibility criteria: Inclusion Criteria:

* hepatocellular carcinoma confirmed by imaging or histological specimen underwent surgical resection, with or without hepatic cirrhosis association;
* presence of venous outflow obstruction, either by direct tumor invasion or thrombosis, on portal vein or one of its main vessels;

Exclusion Criteria:

* Patients undergoing prior systemic treatment;
* Patients presenting incomplete data that do not allow their classification according to the stratification models;
* Patients whose information of progression or death can not be recovered;

Primary outcomes:
measure: Prognosis (disease graduation)
timeFrame: 1 to 3 years
Secondary outcomes:
measure: Survival rate in years
timeFrame: 1 to 3 years
measure: Relation established between survival and degree of underlying liver dysfunction
timeFrame: 1 to 3 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Sírio-Libanês
Study officials:
References: