louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02899520: Evaluation of Programs of Reeducation for Urinary Incontinence in Woman
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare two methods of pelvic floor muscle training: reference method versus CMP ® method ( (Connaissance et Maîtrise de Périnée : Knowledge and Control of Perineum)


Eligibility criteria: Inclusion Criteria:

* Patients more than 18 years old and less than 75 years
* Patients presenting an urinary incontinence of effort or mixed symptomatic associated with a pelvic statics disorder
* Patients with a perineale reeducation prescription
* Patients affiliated to a national insurance scheme or benefiting from such a program
* Patients having given her written consent form

Exclusion Criteria:

* Nulliparous woman
* Patients already operated for their incontinence
* Patients with a prolapse of higher level at the stage II of the classification POP-Q (Pelvic Organ Prolapse Quantification)
* Pregnant women
* Patients presenting an associated anal incontinence,
* Patients presenting a cancellation (section of marrow, syringomyelia for example) or an inversion of perineum control
* Patients having given birth less than 6 months before the care
* Patients having benefited from a pelvi-périnéale reeducation in the previous 12 months,
* Patients presenting psychiatric disease
* Patients presenting a vaginismus,
* Patients presenting a contraindication to the practice of the electrostimulation.

Primary outcomes:
measure: USP (Urinary Symptoms Profile) score
timeFrame: 38 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Sophie FLANDIN-CRETINON
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02989220: Feasibility Study of a Coping Intervention for Recurrent Miscarriage
Official title: A Feasibility and Acceptability Study and a Qualitative Process Evaluation of a Coping Intervention for Women With Recurrent Miscarriage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Miscarriage
Keywords: Miscarriage
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-12-12
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Some women experience the pain of miscarriage on numerous occasions. Studies show that these women experience feelings of anxiety and distress during the early stages of a new pregnancy as they worry another miscarriage will occur. This study will investigate whether a coping strategy, developed for a similar group of women, would be acceptable and useful to women suffering recurrent miscarriage, and reduce the anxiety and worry they experience. A secondary aim of the study is to develop a deeper understanding of the experiences and feelings of women in the early stages of a new pregnancy, following multiple miscarriages.


Eligibility criteria: Inclusion Criteria:

* Women with three or more miscarriages
* Women aged \>18 years
* Willing and able to give written consent

Exclusion Criteria:

* Women will be excluded from this study if they do not speak English well enough to understand and complete study materials. This criterion is in place because the study materials (including PRCI) are not currently available in translation.

Primary outcomes:
measure: Number of patients finding the proposed methods of recruitment, randomisation, intervention and follow-up acceptable
timeFrame: Through Study Completion - Average of 1 year
measure: Number of patients recruited into the study using current inclusion/exclusion criteria
timeFrame: Through Study Completion - Average of 1 year
measure: Number of completed questionnaires
timeFrame: Through Study Completion - Average of 1 year
measure: Data collected from questionnaires
timeFrame: Through Study Completion - Average of 1 year
Secondary outcomes:
measure: Data Collected from questionnaires
timeFrame: Through Study Completion - Average of 1 year
measure: Data Collected from questionnaires
timeFrame: Through Study Completion - Average of 1 year
measure: Data Collected from questionnaires
timeFrame: Through Study Completion - Average of 1 year
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Princess Anne Hospital
Study officials:
References:
Clinical trial NCT02202720: Evaluation of Richmond Agitation Sedation Scale According to Alveolar Concentration of Sevoflurane During a Sedation With Sevoflurane in ICU Patients
Official title: Evaluation of Richmond Agitation Sedation Scale According to Alveolar Concentration of Sevoflurane During a Sedation With Sevoflurane in ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Requiring Sedation by Sevoflurane in ICU
Adult Patients
Patients Covered by French Health Care System
Patients Who Have Given Their Consent
Keywords: Sevoflurane
RASS score
Sedation
Minimal alveolar concentration (MAC)
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Describe the Richmond Agitation Sedation Scale (RASS) values corresponding to the values of Minimum alveolar concentration of sevoflurane during sedation of patients in ICU

Detailed description: Prospective clinical study in ICU with sedated ventilated patients with sevoflurane using the Mirus® system. Pharmacological study of the concentration-effect relationship by administration at increasing and decreasing concentrations.

Eligibility criteria: Inclusion Criteria:

* Requiring sedation by sevoflurane in ICU
* Adult patients
* Patients covered by french health care system
* Patients who have given their consent or his family

Exclusion Criteria:

* Pregnant or lactating women
* Sevoflurane anaphylaxia
* Known or suspected risk of malignant hyperthermia
* Refusal Protocol
* Brain-damaged patients
* Hemodynamic conditions not compatible with the use of sevoflurane
* ARDS patients
* Minor patients

Primary outcomes:
measure: Description of the RASS score
timeFrame: at day 1
Secondary outcomes:
measure: determination of the associated hemodynamic and respiratory parameters
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sébastien PERBET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05892120: A Smartphone App on Medication Adherence
Official title: The Effectiveness of a Smartphone App on Medication Adherence and Psychotic Symptoms and Cognitive Functions in Patients With Schizophrenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Medication Adherence
Keywords: schizophrenia
medication adherence
smartphone app
psychiatric symptoms
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Schizophrenia is a brain disorder that is possibly related to the reduction of neural connections in the prefrontal cortex or imbalances in dopaminergic neurons in brain. It can be induced by genetic, social, physiological, psychological, and other factors, resulting in cognitive, emotional, behavioural, and perception dysfunction.

At present, new generations of anti-psychotic drugs have become available, allow patients to stabilise their condition with less side effect by receiving regular drug treatment. However, medication non-adherence can cause disorder progression, compromise the patient's quality of life, and increase medical expenses

Brief summary: This is an experimental study which aims to explore the effectiveness of a smartphone app for medication adherence (MedAdhere app) among schizophrenic patients for eight weeks.

Detailed description: Schizophrenia is a mental disorder that causes severe functional disabilities and imposes a heavy economic burden. Poor medication adherence is one of the major causes of relapse of psychiatric symptoms in schizophrenic patients. This is an experimental study which aims to explore the effectiveness of a smartphone app for medication adherence (MedAdhere app) among schizophrenic patients for eight weeks.

Eligibility criteria: Inclusion Criteria:

* schizophrenia
* aged 20 to 65 years
* able to read traditional Chinese
* owning a smartphone
* currently admitted at a psychiatric day-care center

Exclusion Criteria:

* Intellectually disabled or severe cognitive function impairment (Dementia)

Primary outcomes:
measure: psychiatric symptoms
timeFrame: Change from Baseline psychiatric symptoms at 8 weeks
measure: cognitive functions
timeFrame: Change from Baseline cognitive functions at 8 weeks
measure: Medication adherence rate
timeFrame: Change from Baseline Medication adherence' rate at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
References:
Clinical trial NCT01672320: Outcomes of Robotic Total Hip Arthroplasty
Official title: Outcomes of Robotic Total Hip Arthroplasty: A Prospective Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Osteoarthritis
Keywords: Robotic
Arthroplasty
Total Hip Arthroplasty
Cup Positioning
Outcomes
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: MAKO Surgical Corp.
First posted: 2012-08-24
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults requiring a total hip arthroplasty procedure.

Brief summary: The objectives of this study are to evaluate the clinical value of robotic-assisted total hip arthroplasty with respect to acetabular cup implantation, and to document the long-term clinical outcome of patients with Total Hip Arthroplasty (THA). IRB approval will be obtained at every study site to evaluate the basic clinical outcomes and post-operative component placement accuracy of each MAKO® THA patient.

The hypothesis is that robotic preparation of the acetabulum will significantly reduce the variability and inaccuracy in the component alignment parameters that lead to post-operative complications, including implant failure.


Eligibility criteria: Inclusion Criteria:

* Male or female
* 20 to 75 years of age
* Subjects requiring primary total hip replacement
* Contralateral hip should be relatively free from arthritis for comparison purposes, specifically with less than a grade of 2 on the Kellgren-Lawrence Scale.
* Subjects diagnosed with osteoarthritis or traumatic arthritis
* Subjects with avascular necrosis
* Subjects who demonstrate the ability to return for follow-up for the next 10 years

Exclusion Criteria:

* Subjects with difficulty understanding protocol for any reason
* Subjects with a limited life span
* Subjects with inflammatory hip disease, previous joint infection, or those requiring hip revision surgery
* Female subjects who are pregnant, or who plan to get pregnant while enrolled in the study

Primary outcomes:
measure: Survivorship of Components
timeFrame: 10 Years
measure: Adverse Events
timeFrame: 10 Years
Secondary outcomes:
measure: Retrieval Analysis of implants from revision surgery
timeFrame: Up to 10 Years
Other outcomes:
measure: Assessment/questionaire HOOS
timeFrame: Pre-op, 1, 3, 5, 7, 10 years after surgery
measure: Assessment/Questionaire UCLA Activty Score
timeFrame: Pre-op, 1, 3, 5, 7, 10 years after surgery
measure: Assessment/Questionaire EQ-5D
timeFrame: Pre-op, 1, 3, 5, 7, 10 years after surgery
measure: Assessment/questionaire
timeFrame: Pre-op, 1, 3, 5, 7, 10 years after surgery
measure: Assessment/Questionaire Case Mix Indicator
timeFrame: Pre-op, 1, 3, 5, 7, 10 years after surgery
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT03628820: Canine Assisted Therapy to Reduce Emergency Care Provider Stress
Official title: Canine Assisted Therapy to Reduce Emergency Care Provider Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Anxiety
Keywords: Stress
Anxiety
Cortisol
Therapy
Dog
Coloring
Mandala
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main study hypothesis is that emergency healthcare workers on shift who interact for 5 min with a therapy dog and handler will have lower perceived and manifested stress response compared with use of a time out that includes voluntary use of a coloring mandalas. The work will also address two exploratory hypotheses: The first is that salivary cortisol will correlate significantly with perceived stress and will increase from beginning to end of shift, and that exposure to a therapy dog will blunt this increase. The second exploratory hypothesis states that participants who interact with a therapy dog will display more empathic behaviors.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria require that participants work full time as either a nurse or physician in the Eskenazi emergency department and are willing to consent to participation.
* Participants will include residents, faculty and nurses who work in the emergency department

Exclusion Criteria:

* Exclusions include any reported prior fear or adverse reaction to dogs

Primary outcomes:
measure: Cortisol change
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
References:
Clinical trial NCT00992420: Genotype Information and Functional Testing Study
Official title: GIFT: Genotype Information and Functional Testing Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: thienopyridine
platelets
CYP2C19
clopidogrel
platelet function tests
platelet
genes
cytochrome P450
single nucleotide polymorphisms
Platelet Aggregation Inhibitors
Lead sponsor: Scripps Health
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Sanofi
name: Accumetrics, Inc.
First posted: 2009-10-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients meeting inclusion criteria for GRAVITAS who undergo VerifyNow blood sampling for VerifyNow P2Y12 platelet function testing and IVRS entry for GRAVITAS randomization/selection determination.

Brief summary: This study is a sub-study of GRAVITAS (clinicaltrials.gov identifier NCT00645918). The purpose of this study is to assess which genes influence residual platelet reactivity on standard dose clopidogrel therapy, and also to determine whether certain genes influence the incremental change in platelet reactivity with high-dose clopidogrel maintenance dosing in patients who have high residual platelet reactivity on standard dosing.

Detailed description: AS DESCRIBED BY THE PI: This study is a sub-study of GRAVITAS (clinicaltrials.gov identifier NCT00645918). The purpose of this study is to assess which genes influence residual platelet reactivity on standard dose clopidogrel therapy, and also to determine whether certain genes influence the incremental change in platelet reactivity with high-dose clopidogrel maintenance dosing in patients who have high residual platelet reactivity on standard dosing.

Eligibility criteria: Inclusion Criteria:

* Patients meeting inclusion criteria for GRAVITAS who undergo VerifyNow blood sampling for VerifyNow P2Y12 platelet function testing and IVRS entry for GRAVITAS randomization/selection determination

Exclusion Criteria:

* See GRAVITAS trial (ClinicalTrials.gov identifier: NCT00645918)

Primary outcomes:
measure: residual platelet reactivity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Genomic Medicine
state: California
Study officials:
affiliation: Scripps Clinic, La Jolla, CA
name: Matthew J Price, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Price MJ, Murray SS, Angiolillo DJ, Lillie E, Smith EN, Tisch RL, Schork NJ, Teirstein PS, Topol EJ; GIFT Investigators. Influence of genetic polymorphisms on the effect of high- and standard-dose clopidogrel after percutaneous coronary intervention: the GIFT (Genotype Information and Functional Testing) study. J Am Coll Cardiol. 2012 May 29;59(22):1928-37. doi: 10.1016/j.jacc.2011.11.068.
Clinical trial NCT02175420: Role of BCG as Booster Vaccination
Official title: Role of BCG Vaccination as Booster on Salmonella Typhi Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BCG Vaccination
Keywords: BCG
Salmonella
Trained immunity
Non-specific effect vaccines
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The BCG (bacillus Calmette-Guerin) vaccine is used for the protection against tuberculosis.

Apart from it's protective effect against tuberculosis BCG vaccine has been shown to have non-specific effects on the innate immune system and is in epidemiological studies associated with reduced mortality due to infectious diseases.

Several studies have shown that BCG can boost the effect of other vaccines. The present study aims to investigate the boosting effect of BCG on the response to typhoid fever vaccine (TFV) and to assess the non-specific effects of BCG on the innate immune system at early timepoints by vaccinating volunteers with either TFV alone or BCG followed by TFV 14 days later.

The study hypothesis is that when BCG is given 14 days before typhoid fever vaccine a better vaccination result in terms of antibody production will be accomplished against typhoid fever due to the effects of BCG on the innate immune system.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Born in Salmonella typhi endemic country
* Pregnancy
* Oral medication except anticonceptive drugs
* Previous vaccination with BCG and/or TFV

Primary outcomes:
measure: anti-salmonella typhi Vi antigen antibody titer 2 weeks post TFV
timeFrame: 2 weeks
measure: anti-salmonella typhi Vi antigen antibody titer 3 months post TFV
timeFrame: 3 months
Secondary outcomes:
measure: Change in ex vivo cytokine responses
timeFrame: 0, 1 and 4 days; 2 weeks, 3 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
affiliation: Radboud University Medical Center
name: Mihai Netea, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blok BA, Arts RJW, van Crevel R, Aaby P, Joosten LAB, Benn CS, Netea MG. Differential effects of BCG vaccine on immune responses induced by vi polysaccharide typhoid fever vaccination: an explorative randomized trial. Eur J Clin Microbiol Infect Dis. 2020 Jun;39(6):1177-1184. doi: 10.1007/s10096-020-03813-y. Epub 2020 Feb 17.
Clinical trial NCT00913120: Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery
Official title: Phase II/III Study of YM150 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients Undergoing Elective Total Hip Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Venous Thromboembolism
Keywords: YM150
FXa inhibitor
Thrombosis
Anticoagulant
Venous thromboembolism
Arthroplasty, replacement, hip
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 610
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total hip replacement surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects is scheduled for elective primary total hip replacement surgery
* Written informed consent obtained before screening

Exclusion Criteria:

* Subject has history of deep vein thrombosis and/or pulmonary embolism
* Subject has a hemorrhagic disorder and/or coagulation disorder
* Subject has had clinically important bleeding occurred within 90 days prior to the screening visit
* Subject has an acute bacterial endocarditis, retinopathy, hypertension, or thrombocytopenia
* Subject is receiving anticoagulants/antiplatelet agents

Primary outcomes:
measure: Overall incidence of venous thromboembolism
timeFrame: For 2 weeks
Secondary outcomes:
measure: Incidence of individual venous thromboembolism
timeFrame: For 2 weeks
measure: Incidence of bleeding events
timeFrame: For 2 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyusyu
country: Japan
city: Shikoku
country: Japan
city: Touhoku
country: Japan
city: Daegu
country: Korea, Republic of
city: Jeonnam
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Changhua
country: Taiwan
city: Chiayi
country: Taiwan
city: Taichung
country: Taiwan
city: Bangkok
country: Thailand
city: Chiangmai
country: Thailand
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References: