louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03061123: Patient Perceptions and Physician Assessment of Benefits and Risks of Oral Anticoagulation Due to Non-valvular AF
Official title: Patient Perceptions and Physician Assessment of Benefits and Risks of Oral Anticoagulation Due to Non-valvular Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Health Literacy
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with atrial fibrillation with new indication for anticoagulation.

Brief summary: The risk of stroke is markedly elevated in patients with atrial fibrillation (AF). Oral anticoagulation (OAC) is indicated in individuals with moderate and high risk of stroke to the disadvantage of an increased burden from bleeding. Adequate knowledge of this disorder and understanding the benefits and hazards of antithrombotic treatment are essential to incorporate patient´s values and preferences in these decisions. This will further improve acceptance of recommended therapy and augment compliance with OAC.

The objective of this investigation is to compare patient´s perceptions and physician´s assessments of benefits and risks of OAC.


Eligibility criteria: Inclusion Criteria:

* Diagnosed and ECG-documented non-valvular atrial fibrillation
* New indication for oral anticoagulation (OAC)
* Ability of informed consent

Exclusion Criteria:

* Existing OAC therapy
* Valvular heart disease
* History of valve surgery

Primary outcomes:
measure: Comparison of subjective stroke risk perception with CHA2DS2-VASc score
timeFrame: Baseline
measure: Comparison of subjective bleeding risk perception with HAS-BLED score
timeFrame: Baseline
Secondary outcomes:
measure: Relationship between accurate perception of stroke and bleeding risks and baseline parameters (highest completed level of education, subjective level of information)
timeFrame: Baseline
Other outcomes:
Locations:
city: Feldbach
country: Austria
facility: LKH Feldbach
city: Furstenfeld
country: Austria
facility: LKH Fürstenfeld
city: Graz
country: Austria
facility: Hospital Barmherzige Brueder Eggenberg
city: Graz
country: Austria
facility: Hospital Barmherzige Brueder Marschallgasse
city: Graz
country: Austria
facility: Hospital Elisabethinen
city: Graz
country: Austria
facility: Medical University of Graz
city: Hartberg
country: Austria
facility: LKH Hartberg
city: Straden
country: Austria
facility: Ordination Dr. Zweiker
Study officials:
References:
citation: Zweiker D, Zweiker R, Winkler E, Roesch K, Schumacher M, Stepan V, Krippl P, Bauer N, Heine M, Reicht G, Zweiker G, Sprenger M, Watzinger N. Association between subjective risk perception and objective risk estimation in patients with atrial fibrillation: a cross-sectional study. BMJ Open. 2017 Sep 25;7(9):e018242. doi: 10.1136/bmjopen-2017-018242.
Clinical trial NCT01846923: B Memory Cell Response to Vaccination With the 13-valent Pneumococcal Conjugate Vaccine in Asplenic Individuals
Official title: Study of the B Memory Cell Response to Vaccination With the 13-valent Pneumococcal Conjugate Vaccine in Asplenic Individuals With Beta-thalassemia Major
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Asplenia
β-thalassemia Major
Lead sponsor: Aghia Sophia Children's Hospital of Athens
Sponsor class: OTHER
First posted: 2013-05-06
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether one dose of the 13-valent pneumococcal conjugate vaccine (PCV13) induces immunological memory in asplenic adults and whether previously administered immunizations with the 23-valent polysaccharide pneumococcal vaccine influence the cellular immune response to PCV13 in this group.


Eligibility criteria: Inclusion Criteria:

* Asplenia
* β-thalassemia major
* older than 18 years

Exclusion Criteria:

* no previously recorded allergy to PCV
* no intravenous immunoglobulin (IVIG) given within the previous 6 months
* no other vaccine given within the previous 6 months

Primary outcomes:
measure: immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by ELISpot)
timeFrame: One month post-PCV13
measure: immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by ELISpot)
timeFrame: one month post PCV13
Secondary outcomes:
measure: Maintenance of B memory cells three years after PCV13 vaccination
timeFrame: three years after study vaccination
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 'Aghia Sophia' Children's Hospital
state: Attiki
Study officials:
References:
citation: Papadatou I, Lagousi T, Kattamis A, Spoulou V. Antibody persistence 5 years after a 13-valent pneumococcal conjugate vaccine in asplenic patients with beta-thalassemia: assessing the need for booster. Ann Hematol. 2019 Mar;98(3):775-779. doi: 10.1007/s00277-019-03615-z. Epub 2019 Jan 25.
citation: Papadatou I, Piperi C, Alexandraki K, Kattamis A, Theodoridou M, Spoulou V. Antigen-specific B-cell response to 13-valent pneumococcal conjugate vaccine in asplenic individuals with beta-thalassemia previously immunized with 23-valent pneumococcal polysaccharide vaccine. Clin Infect Dis. 2014 Sep 15;59(6):862-5. doi: 10.1093/cid/ciu409. Epub 2014 May 30.
Clinical trial NCT03986723: 3D Printed Models in 3D Virtual Treatment Planning of Orthognathic Surgery
Official title: Evaluation of Implementation of 3D Printed Models in 3D Virtual Treatment Planning of Orthognathic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthognathic Surgery
Keywords: traditional plaster model
3D printed model
digital workflow
reliability
time efficiency
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive orthognathic cases planned with 3D virtual planning software

Brief summary: Despite the shift from 2D towards 3D virtual treatment planning of orthognathic surgery, traditional plaster cast are still gold standard. The investigators aimed to compare the overall reliability and time efficiency of an digital workflow using 3D printed models, in comparison to the conventional plaster workflow.

Twenty real-life cases were planned according to both workflows and timed by a single resident.


Eligibility criteria: Inclusion Criteria:

* planned for orthognathic surgery
* planning by a single resident
* planning based on 3D virtual workflow

Exclusion Criteria:

* not eligible according to abovementioned criteria

Primary outcomes:
measure: time efficiency: duration of the complete workflow, measured in seconds with a digital chronometer
timeFrame: preoperative
Secondary outcomes:
measure: reliability of the workflow through registration of problems, difficulties that occur
timeFrame: preoperative
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende AV
Study officials:
affiliation: AZ Sint-Lucas Brugge
name: Gwen Swennen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01245023: Adhesiolysis in Chronic Abdominal Pain
Official title: Laparoscopic Adhesiolysis in Treatment of Chronic Abdominal Pain - a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Abdominal Pain
Lead sponsor: North Karelia Central Hospital
Sponsor class: OTHER
First posted: 2010-11-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laparoscopic adhesiolysis has been used in treatment of chronic abdominal pain. There has been only one previous controlled study, that stated laparoscopy alone had the same benefits than laparoscopic adhesiolysis. The aim of this study is to compare laparoscopic adhesiolysis with a placebo-procedure in chronic abdominal pain.


Eligibility criteria: Inclusion Criteria:

* age 18-65 years
* abdominal pain at least 6 months
* previous abdominal surgery and/or significant abdominal trauma and/or abdominal infection
* ASA class I-II

Exclusion Criteria:

* psychiatric disorder
* significant other somatic diseases (ASA class III-V)
* refusal to participate

Primary outcomes:
measure: pain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kajaani
country: Finland
facility: Kainuu Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Mikkeli
country: Finland
facility: Mikkeli Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Pieksämäki
country: Finland
facility: Pieksämäki district hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
References:
Clinical trial NCT02548923: Dexmedetomidine Versus Propofol for Prolonged Sedation in Critically Ill Trauma and Surgical Patients
Official title: Dexmedetomidine Versus Propofol for Prolonged Sedation in Critically Ill Trauma and Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Delirium
Lead sponsor: University of Tennessee Graduate School of Medicine
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the efficacy of dexmedetomidine versus propofol for prolonged sedation in trauma and surgical patients.

Detailed description: Design: Open-label, single-center prospective study. Setting: Trauma/Surgical Intensive Care Unit (TSICU) at a Level I academic trauma center.

Patients: Patients 18 years of age or older requiring mechanical ventilation and admitted to the TSICU Interventions: Patients were randomly assigned based on unit bed location to receive dexmedetomidine or propofol for sedation.

Eligibility criteria: Inclusion Criteria:

* Patients were included in the study if they were 18 years of age or older,
* mechanically ventilated,
* placed on the institutional sedation protocol,
* expected to require sedation lasting 24 hours after randomization, and
* admitted to the TSICU and followed by the Trauma/Surgical Service.

Exclusion Criteria:

Patients were excluded for any of the following:

* 72 hours or greater since sedation protocol initiation,
* treatment per the institutional traumatic brain injury (TBI) protocol,
* concomitant continuous infusion of a neuromuscular blocking agent,
* heart rate less than 50 beats per minute,
* mean arterial pressure less than 55 mmHg despite fluid resuscitation and vasopressors, and
* use of other alpha-2 agonists within 24 hours of randomization.

Primary outcomes:
measure: Duration of Mechanical Ventilation
timeFrame: ICU stay
Secondary outcomes:
measure: Mortality
timeFrame: Hospital length of stay
measure: proportion of time in target sedation
timeFrame: ICU length of stay
measure: incidence of delirium
timeFrame: ICU length of stay
measure: hypotension
timeFrame: ICU length of stay
measure: bradycardia
timeFrame: ICU length of stay
measure: ICU and hospital length of stay
timeFrame: hospital length of stay
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT02574923: Outcomes of Stem Cells for Cerebral Palsy
Official title: Outcomes of Autologous Bone Marrow Mononuclear Cells for Cerebral Palsy: A Self-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Stem Cells
Lead sponsor: Vinmec Healthcare System
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in patients with cerebral palsy.

Detailed description: The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 30 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.

Eligibility criteria: Inclusion Criteria:

* Cerebral palsy of any types caused by oxygen deprivation.

Exclusion Criteria:

* Epilepsy
* Hydrocephalus with ventricular drain
* Coagulation disorders
* Allergy to anesthetic agents
* Severe health conditions such as cancer, failure of heart, lung, liver or kidney
* Active infections

Primary outcomes:
measure: Change in Total Score of Gross Motor Function Measure (GMFM)-88
timeFrame: 3 months and 6 months after transplantation
measure: Change in Gross Motor Function Measure (GMFM)-66 Percentile
timeFrame: 3 months and 6 months after transplantation
Secondary outcomes:
measure: Change in Muscle tone
timeFrame: 3 months and 6 months after transplantation
measure: Number of adverse events
timeFrame: Through study completion, an average of 6 months
measure: Change in Denver Developmental Score
timeFrame: 3 months and 6 months after transplantation
measure: Change in Quality of Life
timeFrame: 3 months and 6 months after transplantation
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vinmec International Hospital
Study officials:
affiliation: Vinmec Healthcare System
name: Liem T Nguyen, MD., PhD.
role: STUDY_CHAIR
References:
citation: Sharma A, Sane H, Gokulchandran N, Kulkarni P, Gandhi S, Sundaram J, Paranjape A, Shetty A, Bhagwanani K, Biju H, Badhe P. A clinical study of autologous bone marrow mononuclear cells for cerebral palsy patients: a new frontier. Stem Cells Int. 2015;2015:905874. doi: 10.1155/2015/905874. Epub 2015 Feb 18.
citation: Nguyen TL, Nguyen HP, Nguyen TK. The effects of bone marrow mononuclear cell transplantation on the quality of life of children with cerebral palsy. Health Qual Life Outcomes. 2018 Aug 14;16(1):164. doi: 10.1186/s12955-018-0992-x.
Clinical trial NCT02259023: Discretionary Food Sources and Stress Perception
Official title: Discretionary Food Sources and Stress Perception
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stress Perception
Discretionary Calories
Over All Health
Keywords: Stress Perception
Discretionary Calories
Health
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2014-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Purpose:

The objective of this study is to determine the effect different sources and forms of discretionary foods have on stress perception in healthy adults in a free living, real world setting.

Rationale:

The rationale for conducting this study is to test the effects of sugar-sweetened beverages and grain-based desserts have on perceived health and stress perception, since the evidence for this topic is limited.


Eligibility criteria: Inclusion Criteria:

* Adults who consume sugar sweetened beverages and grain based desserts and candy on a regular basis
* Free from major illnesses or chronic disease
* Willing to consume amount of beverages and food provided to supplement usual dietary habits during each period

Exclusion Criteria:

* Recently lost a significant amount or looking to lose weight
* Recently begun a new diet or exercise regimen
* Pregnant or nursing women
* Report restrained eater or having less than 51% control over food preparation

Primary outcomes:
measure: Stress Perception
timeFrame: 12 weeks
Secondary outcomes:
measure: Body Weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota West Bank Office Building
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Andrew Odegaard, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06811623: Omentopexy After Sleeve Gastrectomy in Children and Adolescences.
Official title: Omentopexy After Sleeve Gastrectomy in Children and Adolescences, is it Effective in Reducing Post-operative Complications.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Pediatric Obesity
LAP
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group 1: included 24 patients managed with Laparoscopic Sleeve Gastrectomy with omentopexy and group 2: included 24 patients managed with Laparoscopic Sleeve Gastrectomy without omentopexy.
Primary purpose: TREATMENT

Brief summary: Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric operation, has become one of the most commonly performed bariatric surgeries. Postoperative gastrointestinal complications are agonizing in patients underwent this procedure. Most of these complications can be prevented by omentopexy in association with sleeve gastrectomy. The Primary aim of this study to assess the effectiveness of omentopexy during laparoscopic sleeve gastrectomy in reducing post-operative complication.

Detailed description: This study was a carried out as a prospective study of 48 patients with obesity between January 2015 and October 2024. The patients were divided into 2 groups; group 1: included 24 patients managed with LSG with omentopexy and group 2: included 24 patients managed with LSG without omentopexy. Pre- operation data and post operation outcomes were taken for all patients in each group.

Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) of 40 kg/m2 or
* BMI of 35 kg/m2 due to at least 1 comorbid condition

Exclusion Criteria:

* secondary obesity
* more than 18 years
* previous operation

Primary outcomes:
measure: post-operative complications
timeFrame: 6 months
Secondary outcomes:
measure: operative time and hospital stay
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Al-Azhar University
name: Mohammad Daboos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03000023: Anticipated and Perceived Benefits Following Hepatitis C Treatment
Official title: A Qualitative and Quantitative Evaluation of Patients' Anticipated and Perceived Treatment Benefits Following HCV Viral Eradication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Hepatitis C, Chronic
Keywords: Hepatitis C
Patient-Reported Outcomes
DAA Treatment
Qualitative
Mixed methods
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2016-12-21
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Hepatitis C

Brief summary: The study is both qualitative and quantitative, gathering patient's perceptions of HCV treatment benefits before and after HCV treatment by administering surveys and conducting in-depth qualitative patient interviews. The study seeks to understand all anticipated and actual benefits patients perceive before and after viral eradication.

Detailed description: This study employs a mixed methods (qualitative and quantitative) pre-post study design utilizing in-depth qualitative interviews and patient reported outcome surveys. Pre-treatment surveys and interviews will be conducted before HCV therapy commences to understand all potential psychological, social, physical and medical consequences perceived to be related to HCV and the patients' anticipation (hope for) of improvements in these factors after viral eradication. Post-treatment surveys and interviews will occur 4 to 8 months after treatment ends to examine long-term treatment benefits, i.e., changes in HCV-related factors, such as symptoms, functioning, and health status.

Eligibility criteria: Inclusion Criteria:

* Age 21 or older
* English-speaking
* Any genotype
* Any treatment duration (e.g. 8, 12, or 24 weeks)
* Has been written a prescription for a sofosbuvir (SOF)-containing regimen.

Exclusion Criteria:

* Currently listed for liver transplant; post-liver transplant

Primary outcomes:
measure: Analyze changes in patient perceptions through qualitative interviews before and after HCV treatment.
timeFrame: 1 Year
measure: Evaluate pre-post survey change in patient reported HCV symptoms and other factors.
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Donna Evon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03074123: Cortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon
Official title: Cortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adrenal Insufficiency
Keywords: cosyntropin stimulation test
low-dose
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Previous study showed that afternoon cosyntropin testing was associated with a sevenfold increased likelihood of failing the 1μg test. However, in that study, investigators used a 20.3 cm plastic tube, which might have led to uncompleted cosyntropin delivery. In ther current study investigators will study afternoon 1μg cosyntropin cortisol stimulation using a short 2.5 cm tube.

Detailed description: In earlier studies investigators claimed that subnormal cortisol response using plastic tubes might result from cosyntropin adherence to the tube and loss of the delivered dosage. It was shown that 21.6-58.6% of ACTH dosage had not been recovered when pushed through 20.3 cm plastic tube, and loss of ACTH may be up to 70% when cosyntropin was delivered through a plastic 30 cm scalp vein set.

Moreover, it was previously shown that afternoon cosyntropin testing was associated with a sevenfold increased likelihood of failing the 1μg test. However, in that study, investigators used a 20.3 cm plastic tube, which might have led to uncompleted cosyntropin delivery. In ther current study investigators will study afternoon 1μg cosyntropin cortisol stimulation using a short 2.5 cm tube.

Eligibility criteria: Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

Clinical suspicion of hypoadrenalism Medical condition or treatment that might alter blood cortisol levels Pregnancy

Primary outcomes:
measure: Blood cortisol
timeFrame: one day
Secondary outcomes:
measure: Salivary free cortisol
timeFrame: one day
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Mira Koch
Study officials:
affiliation: Bni-Zion medical center
name: Leonard Saiegh
role: PRINCIPAL_INVESTIGATOR
References: