louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03592160: Role of Rehabilitation for the Repair of Pelvic Floor Injuries Associated to Vaginal Delivery Identified by 3/4D Transperineal Ultrasound
Official title: Role of Rehabilitation for the Repair of Pelvic Floor Injuries Associated to Vaginal Delivery Identified by 3/4D Transperineal Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Disorders
Ultrasound Therapy; Complications
Physical Disorder
Obstetric Labor Complications
Lead sponsor: Hospital Universitario de Valme
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2018-07-19
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: SUMMARY: (Objective, design, scope of the study, subjects of study, instrumentation, results, conclusions)

Objectives: To evaluate if the physiotherapy treatment in pelvic floor dysfunctions, identified by transperineal ultrasound 3 / 4D, in postpartum improve the tone and functionality of pelvic floor.

Design: Post-authorization, prospective, longitudinal randomized intervention study

Scope: Full-term deliveries at the University Hospital. Subjects of study: Full-term primiparous and full-term pregnancies with pelvic floor lesion, identified by transperineal ultrasound 3 / 4D, which are randomized between the physiotherapy treatment of pelvic floor and the non-work.

Variables: Primary variable: Assess the improvement in contractility / tone, evaluation by manometry and assess the anatomical improvement of the area of ?? the genital hiatus, stay by transperineal ultrasound 3 / 4D. Secondary variables: Identify the levator ani muscle injury rate, estimate the sonographic changes in the levator ani muscle through rehabilitation. Analyze the improvement of the symptoms associated with the public organic prolapse and evaluate the improvement of the quality of life.

Data analysis: To detect a difference of 10% in the reduction of the size of the index between the study groups (not intervened / intervened) after 6 months of intervention, standard deviation 10%, Error-alpha 5%, Error- beta 10% (P90%) we need 23 women in each group. Assuming a loss of 10% in the follow-up, the final size would be 52 women, 26 per group.


Eligibility criteria: Inclusion Criteria:

* Vaginal delivery
* Cephalic presentation
* Primiparity
* At term gestation (37-42 weeks)
* No prior pelvic floor corrective surgery
* Written informed consent

Exclusion Criteria:

* Pregnancies with severe maternal or fetal pathology

Primary outcomes:
measure: Contractility
timeFrame: 6 months after randomisation
Secondary outcomes:
measure: Changes in the levator ani muscle
timeFrame: 6 months after randomisation
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Nuestra Señora de Valme
Study officials:
affiliation: Hospital Universitario Nuestra Señora de Valme
name: José Antonio García Mejido
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00717860: A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED)
Official title: A Multicenter, Double-Blind, Comparative Study of MK0991 (Caspofungin) Versus Micafungin in Adult Japanese Patients With Deep-seated Candida or Aspergillus Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fungal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-18
Enrollment: 121
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 investigate the safety and efficacy of MK0991 in patients with deep-seated mycoses.


Eligibility criteria: Inclusion Criteria:

* Japanese Patients In Whom A Causative Fungus Is Detected Before Treatment With The Study Drug Or Patients With Strongly Suspected Deep-Seated Fungal Infection Due To Candida species (Spp.) Or Aspergillus Spp.

Exclusion Criteria:

* Patients With Mycoses Other Than Ones Due To Candida Spp. Or Aspergillus Spp.
* Patients Who Will Receive Other Systemic Antifungal Agents For The First Time In Screening Period.

Primary outcomes:
measure: Number of Participants With a Significant Drug-related Adverse Experience
timeFrame: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis
Secondary outcomes:
measure: Number of Participants With a Specific Safety Finding
timeFrame: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis
measure: Number of Participants With Favorable Overall Response at the End of Study Therapy
timeFrame: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kohno S, Izumikawa K, Yoshida M, Takesue Y, Oka S, Kamei K, Miyazaki Y, Yoshinari T, Kartsonis NA, Niki Y. A double-blind comparative study of the safety and efficacy of caspofungin versus micafungin in the treatment of candidiasis and aspergillosis. Eur J Clin Microbiol Infect Dis. 2013 Mar;32(3):387-97. doi: 10.1007/s10096-012-1754-z. Epub 2012 Oct 3.
Clinical trial NCT01818960: Revascularization Strategies for STEMI; The CMR Endpoint Study
Official title: Revascularization Strategies for ST Elevation Myocardial Infarction; The Cardiac Magnetic Resonance Endpoint Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Stent, Myocardial Infarction, Coronary Intervention
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 250
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: Revascularization strategies for ST elevation myocardial infarction (STEMI) study (ASSIST-CMR) will compare the effects of two revascularization strategies \[same sitting multivessel primary PCI (SS-PCI) and culprit vessel only primary PCI (IRA-PCI)\] on myocardial infarct size (MIS) as determined by cardiac magnetic resonance (CMR) imaging in patients presenting with STEMI and multivessel disease (MVD).


Eligibility criteria: Inclusion Criteria:

* High risk ST elevation myocardial infarction evidenced by: ≥2 mm ST elevation in 2 anterior or lateral leads; or ≥2 mm ST elevation in 2 inferior coupled with ST depression in 2 contiguous anterior leads for a total ST deviation of ≥8 mm; or New left bundle branch block with at least 1 mm concordant ST elevation.
* Multivessel CAD as evidenced by ≥1 significant (≥70% by visual assessment or FFR\<0.80 for 50-70% stenosis) stenosis in non-IRA.
* Successful IRA-PCI with \<10% residual angiographic stenosis and TIMI III flow.
* Written informed consent.

Exclusion Criteria:

* Age ≤ 18 years.
* Prior coronary artery bypass graft (CABG) surgery.
* Administration of thrombolytic therapy.
* Non-IRA stenosis is a chronic total occlusion or located in left main artery.
* Hemodynamic instability evidenced by BP\<90 mmHg, Killip class ≥2, need for inotropes/vasopressors.
* Known renal insufficiency (estimated GFR \< 50ml/min).
* Contraindication to CMR.

Primary outcomes:
measure: Infarct size by CMR
timeFrame: 90 days
Secondary outcomes:
measure: MACE rate
timeFrame: One year
Other outcomes:
measure: LV function
timeFrame: 90 days and one year
Locations:
city: London
country: Canada
facility: London Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Regina
country: Canada
facility: Regina Qu'Appelle Health Region
state: Saskatchewan
Study officials:
References:
Clinical trial NCT00204360: Pediatric Epilepsy Database
Official title: Pediatric Epilepsy Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: epilepsy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2005-09-20
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY
Time perspective: OTHER

Brief summary: The purpose of this database is to collect information for clinical purposes on all children being treated for seizure disorders.

Detailed description: At some point this information may be used to retrospectively review trends in seizure types, diagnostic evaluation and treatment (medical or surgical). The potential data recorded will be that of standard of care provided to these patients, including age, gender, seizure type/classification, diagnostic procedures (eg. EEG, MRI Magnetoencephalography {MEG}, Single Photon Emission Computed Tomography {SPECT}, Positron Emission Tomography {PET}, invasive electrocorticography) and various treatments (medications, diet, or neurosurgical interventions for the treatment of epilepsy). Records in the database will have identifiable information (name, date of birth, date of procedure, medical record number), but these identifying data will be removed, and only nonidentifying data will be used in the event of research completed using information from this clinical database.

Eligibility criteria: Inclusion Criteria:

* NONE

Exclusion Criteria:

* NONE

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Pongkiat Kankirawatana, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04802460: Virtual Reality Effects on Pain During Hysteroscopy Hysteroscopy: A Randomized Control Trial
Official title: Virtual Reality Effects on Acute Pain During Office Hysteroscopy: A Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain and Hysteroscopy
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Objective of this study is to compare pain levels in women undergoing office-based hysteroscopies using Virtual Reality versus control in a randomized control prospective trial.

Detailed description: The primary aim of this study is to see if virtual reality can decrease pain intensity during office hysteroscopies using a 100mm Visual Analogue Scale (VAS).

A secondary aim will be to monitor heart rate for patients using virtual reality versus the controls during the procedure. Another secondary aim will be to time the length of the procedure as it is possible if pain perception is reduced, the procedure can be completed faster. Lastly, we would also want to evaluate both patient and surgeon satisfaction of the procedure with or without virtual reality by using a satisfaction questionnaire to assess for patients satisfaction with the procedure, with the VR intervention, perceived realism of VR game, and measure simulator sickness related to the VR game.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria will be women over the age of 18 presenting for office hysteroscopy.

Exclusion Criteria:

Exclusion criteria included patients with visual or auditory impairment that would interfere with their ability to use the virtual reality set, English language non-fluency, history of opioid dependence/abuse, current narcotic use, or desire for narcotic use during the procedure.

Primary outcomes:
measure: pain scale
timeFrame: 10 minutes
Secondary outcomes:
measure: heart rate changes
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Washington
country: United States
facility: MHRI IRB
state: District of Columbia
Study officials:
References:
Clinical trial NCT02726360: Physician Use of Non-English Language Skills in Cancer Care
Official title: Physician Use of Non-English Language Skills in Cancer Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Colon Cancer
Lung Cancer
Keywords: Communication
15-316
Physician
Use
Non-English
Language Skills
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Edward-Elmhurst Health System
name: Johns Hopkins University
name: Lincoln Medical and Mental Health Center
name: Queens Cancer Center of Queens Hospital
First posted: 2016-04-01
Enrollment: 71
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll all treating physicians of participating sites who are likely to treat LEP Spanish-speaking patients. All patient recruitment will be done by bilingual research staff who are consenting professionals with (when necessary) a volunteer affiliation with the collaborating study site.

Brief summary: The purpose of this study is to test a method for analyzing interactions between patients and doctors, the Roter Interaction Analysis System (RIAS). The RIAS measures the quality of communication between patients and their cancer doctors.


Eligibility criteria: Inclusion Criteria:

* is a English or Spanish-speaking patient
* between the ages of 21-80 years old
* has a new diagnosis of any type of cancer (diagnosed within the past 4 months), or has a recurrence of either breast, colon or lung cancer (recurrence diagnosed within the past 4 months)
* scheduled to have surgery or begin chemotherapy and/or radiation therapy within the next 2 months

Oncology clinician Inclusion:

* provides care to LEP patients
* has MD, DO, RN, NP or PA degree
* is between the ages of 21-80

Exclusion Criteria:

* is unable to provide informed consent in either English or Spanish

Primary outcomes:
measure: study-specific coding structure
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Lincoln Medical Center
state: New York
city: Jamaica
country: United States
facility: Queens Cancer Center of Queens Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Ralph Lauren Center for Cancer Care and Prevention
state: New York
city: Queens
country: United States
facility: Elmhurst Hospital Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Lisa Diamond, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00450060: Juvenile Postlumbar Puncture Headache After Puncture With Needles With Quincke Tip or With Sprotte Tip
Official title: Postlumbar Puncture Complaints After Lumbar Punctures in Children and Adolescents: Frequency and Impact by Compariosn of Two Needle Designs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Headache
Keywords: postlumbar puncture headache
atraumatic needle
Sprotte
Quincke
lumbar puncture
headache
backache
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2007-03-21
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare postlumbar puncture complaints as headache or backache after lumbar puncture with needles with Quincke design or with Sprotte design in children and adolescents.

Detailed description: After lumbar puncture patients may develop complaints as position dependent headache, other headache or backache. Several though not all studies in adults showed that the frequency of complaints can be reduced by using non-traumatic Sprotte-design needles instead of cutting Quincke-design needles. In children and adolescents there are no comparable data published. In most pediatric hospitals in Germany Quincke needles are used.

Comparison: Children and adolescents from 4 to 18 years of age who have to undergo a lumbar puncture are randomly attributed to puncture with Quincke needle or with Sprotte needle. During the following days headache (main criterium), position-dependent headache, backache, vomitus, and malaise are noted. Pain is measured with a visual analogue scale/faces scale.

Eligibility criteria: Inclusion Criteria:

* lumbar puncture necessary for diagnostic reasons

Exclusion Criteria:

* intrathecal instillation at lumbar puncture
* patients in whom severity of disease make it impossible to judge endpoint criteria

Primary outcomes:
measure: headache frequency
measure: headache intensity
Secondary outcomes:
measure: position dependent-headache frequency
measure: position dependent-headache intensity
measure: backache frequency
measure: backache intensity
measure: practicability of needle designs (multiple punctures necessary?, longer lasting?
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Pediatric Hospital
city: Heilbronn
country: Germany
facility: Klinik für Kinderheilkunde und Jugendmedizin
Study officials:
affiliation: University Pediatric Hospital Heidelberg
name: Friedrich Ebinger, DM
role: STUDY_CHAIR
References:
citation: Ebinger F, Kosel C, Pietz J, Rating D. Headache and backache after lumbar puncture in children and adolescents: a prospective study. Pediatrics. 2004 Jun;113(6):1588-92. doi: 10.1542/peds.113.6.1588.
citation: Ebinger F, Kosel C, Pietz J, Rating D. Strict bed rest following lumbar puncture in children and adolescents is of no benefit. Neurology. 2004 Mar 23;62(6):1003-5. doi: 10.1212/01.wnl.0000115387.67958.0f.
Clinical trial NCT01244360: The Effects of Resveratrol Supplementation on Measurements of Health and Human Performance
Official title: The Effects of Resveratrol Supplementation on Measurements of Health and Human Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammation
Keywords: resveratrol
insulin
inflammation
cognition
metabolism
Lead sponsor: Marywood University
Sponsor class: OTHER
First posted: 2010-11-19
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of resveratrol on health and human performance. The study will evaluate cognitive function and several indicators of physical health before and after taking a resveratrol supplement or a placebo for three weeks.

Detailed description: Measurements

* blood laboratory parameters
* cognitive assessment changes
* body composition changes
* vascular endothelial response

Eligibility criteria: Inclusion Criteria:

* men and women between 45 and 75 years of age
* Normal heart rate and Blood pressure
* Ability to use personal computer interface
* Successful completion of physical activity readiness questionnaire

Exclusion Criteria:

* Cardiovascular disease, uncontrolled hypertension, lung disease
* inability to tolerate exercise
* have taken grape related supplement in past 12 months
* current use of drugs or dietary supplements to enhance exercise performance
* allergy to wine, grape juice or grape seed supplements

Primary outcomes:
measure: Vascular function
timeFrame: 4 weeks, with option of additional 4 week treatment period
Secondary outcomes:
measure: Body fat percentage
timeFrame: 4 weeks, with optional additional 4 week treatment period
measure: inflammation biomarkers
timeFrame: 4 weeks, with optional additional 4 week treatment period
measure: cognitive function
timeFrame: 4 weeks, with optional additional 4 week treatment period
Other outcomes:
Locations:
city: Scranton
country: United States
facility: Marywood University
state: Pennsylvania
Study officials:
affiliation: Marywood University
name: James Smoliga, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05492760: Evaluation of Recurrence Risk of Atrial Fibrillation After Cryoballoon Ablation
Official title: Evaluation of Recurrence Risk of Atrial Fibrillation After Cryoballoon Ablation： a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with paroxysmal AF and accept cryoballoon ablation.

Brief summary: The recurrence of atrial fibrillation(AF) after pulmonary vein ablation with cryoballoon is conducted by many factors . The previous studies found larger left atrial and longer AF duration are tied to higher risk of AF recurrence. The characters of ablation procedure is also of critical importance to durable clinical success such as temperature features and time-to-isolation (TTI). The aim of our study is to develop an tool of recurrence risk evaluation with both pre-procedure and procedure factors.


Eligibility criteria: Inclusion Criteria:

Patients with paroxysmal AF and accept cryoballoon ablation.

Exclusion Criteria:

* left atrium (LA) diameter (anterior-to-posterior)\>55mm on transthoracic echocardiography (TTE)
* the presence of thrombus in the LA or left atrial appendage (LAA) on transesophageal echocardiography (TEE)
* uncorrected heart failure (NYHA class III or IV),
* concomitant moderate or severe valvular heart disease or bioprosthetic valve,
* malignancy necessitating chemotherapy.

Primary outcomes:
measure: the time to atrial fibrillation recurrent
timeFrame: 1year after the cryoballoon ablation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Yawei Xu, doctor
role: STUDY_DIRECTOR
References: