louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03831217: Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery
Official title: Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery Using Urogynecologic Ultrasonographic and Urodynamic Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Keywords: Trans-Obturator Tape
Tension-Free Vaginal Tape
Mid-Urethral Sling surgeries
Stress Urinary Incontinence
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 58
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with underwent mid-urethral surgery in Ankara University Obstetrics and Gynecology Department since 2007 at any age.

Brief summary: The patients who underwent mid-urethral sling surgery for stress urinary incontinence will evaluate. The aim of our study is to assess long term surgical outcomes and post operative clinical findings include physical examinations, quality of life questionnaires, ultrasonographic measurements.

Detailed description: Patients who underwent mid-urethral sling surgery in Ankara University Obstetrics and Gynecology Department since 2007 will be included.

Primary outcome measure is to describe factors effecting long term success in mid-urethral sling surgery.

Eligibility criteria: Inclusion Criteria:

* Undergoing surgery in Ankara University Obstetrics and Gynecology Department since 2007
* Patients come to follow up

Exclusion Criteria:

* inability in verbal and written communication
* impairment in cognitive functions

Primary outcomes:
measure: Objective cure rates
timeFrame: 1-11 years
measure: Subjective cure rates
timeFrame: 1-11 years
Secondary outcomes:
measure: Tape localization
timeFrame: 1-11 years
measure: Quality of life(QoL) after surgery
timeFrame: 1-11 years
measure: Patient satisfaction
timeFrame: 1-11 years
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Kaan Baydemir
state: Çankaya
Study officials:
References:
Clinical trial NCT00249717: Group-Based Contingency Management for Substance Abuse Treatment - 1
Official title: Group-Based Contingency Management for Substance Abuse Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Keywords: Contingency management
Substance abuse treatment
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-11-07
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of prize-based contingency management (CM) when administered exclusively in groups. Substance dependent patients (N=360) at community-based treatment programs are randomly assigned to one of two conditions: (a) standard, non-CM treatment or (b) standard treatment plus prize CM delivered in groups. In the CM condition, patients earn the opportunity to win prizes for attending groups and submitting drug-free biological specimens. Substance use and psychosocial problems are measured at intake, month 1, month 3 (post treatment), and at 6-, 9-, and 12-month follow-up evaluations. We also assess patient characteristics that may be associated with improved outcomes within and across conditions.


Eligibility criteria: Inclusion criteria:

* age \> 18 years
* current DSM-IV diagnosis of cocaine, opioid or alcohol abuse or dependence
* willing to provide breath and urine samples for 12 weeks
* English speaking
* willing to sign informed consent

Exclusion criteria:

* serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk)
* dementia (\<23 on the Mini Mental State Exam; Folstein et al. 1975)
* in recovery from pathological gambling

Primary outcomes:
measure: Drug use
timeFrame: baseline and at each follow-up
measure: Retention
timeFrame: each follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Nancy Petry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03096717: Dysplasia in Inflammatory Chronic Idiopathic Colitis Long-standing
Official title: Incidence of Dysplasia and Colorectal Cancer in Patients With Chronic Idiopathic Inflammatory Colitis Treated With Biologics, Mesalamine, and Immunosuppressive Drug Combinations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dysplasia in IBD
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with long standing idiopathic chronic colitis

Brief summary: Chronic intestinal inflammation produce dysplasia more frequently than the normal population. The therapies protect against these changes, but do not rule out dysplasia. It is not known the effect of different therapies protection.

Detailed description: The literature data show that the inflammatory bowel diseases (rectal ulcerative colitis and Crohn's disease) determine an increased risk of developing dysplasia and cancer of the colon and rectum, for the chronic inflammation that they fee, with the differences that the two diseases arise. The progression from normal mucosa to dysplasia and then to cancer is more rapid than in the adenoma-carcinoma sequence.

In patients with idiopathic chronic inflammatory colitis drug therapies in use reduce the incidence of dysplasia.

A systematic review concluded in favor of a chemo preventive effect of mesalazine. In any case, it has been reported protective association between use of mesalazine and cancer associated with colitis (colitis Associated carcinoma CAC) with an odds ratio of 0.51 per CAC / dysplasia. This data, in subsequent studies, including recent ones, have remained controversial.

The introduction of biological drugs in the treatment of patients with inflammatory bowel disease (IBD) has changed the quality of life and also the natural history of the disease. It is not known what biological drugs have improved the clinical history of these diseases by changing the incidence of dysplasia and colorectal cancer.

The treatment of idiopathic inflammatory bowel diseases (IBD), the last decade has seen profound changes and, now, the use of biological drugs is frequent in the moderate-severe forms, especially if extended. Mesalazine has in the indication of mild to moderate forms of therapy.

Eligibility criteria: Inclusion Criteria:

* long standing colonic inflammatory bowel disease
* clinical, endoscopic and histological remission
* completeness of data

Exclusion Criteria:

* important comorbidities
* family history of colorectal cancer
* insufficient data

Primary outcomes:
measure: incidence of dysplasia in relation to therapy performed
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Castellana Grotte
country: Italy
facility: Alba Panarese
state: Puglia
Study officials:
References:
Clinical trial NCT02779517: Mobile Service Robot for Task-Oriented Stroke Therapy: User Evaluations
Official title: Mobile Service Robot for Task-Oriented Stroke Therapy: User Evaluations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: upper extremity
stroke
rehabilitation
robotics
telepresence
elderly
aged
Housing for the elderly
retirement
homes for the aged
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Therapists with neuro-rehab experience. Patients with neural injury.

Brief summary: By developing an affordable mobile service robot for therapeutic activities in a health center environment, this project addresses the issue of both the high cost and man-power required to provide rehabilitation for stroke survivors and other patients. Our goal is to measure users - clinician and patient - responses to a telepresence robot, VGo, that has been modified with a humanoid torso robot, NAO, to facilitate remote communication between the patient and clinician, and to complete supervisory exercise coaching.

Detailed description: This is a short demonstration and survey study. Clinical staff and patients will be gathered together and our idea for the mobile service robot will discussed. A demonstration of the telepresence feature of the robots and the NAO robot greeting and helping them with simple exercises will follow (e.g., pick up and object that is handy and lift their hands over their heads). The approximately 30-minute demonstration part of the study will start with an introduction and explanation about the project and a short speech about the Rehabilitation and Robotics Lab. After the demonstration the oral consent will be read and surveys will be handed out to those study participants who agree to complete them; if necessary, the research team will assist the study participant with the survey. Surveys will then be collected, and the group will be thanked by the research team.

Eligibility criteria: Inclusion Criteria:

* Certified rehabilitation healthcare professionals
* Participants with upper extremity disabilities
* Participant must be older than 18 years

Exclusion Criteria:

-Less than 18 years of age

Primary outcomes:
measure: Perception of the interaction with the robot
timeFrame: up to 1 week
measure: Usability of the robot
timeFrame: up to 1 week
measure: Sociability with the robot
timeFrame: up to 1 week
Secondary outcomes:
measure: Design requirements
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine Rittenhouse
state: Pennsylvania
Study officials:
affiliation: Penn Medicine Rittenhouse
name: Michelle J Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilk R. and Johnson MJ. 5th IEEE RAS/EMBS International Conference on Biomedical Robotics and Biomechatronics. ; 08/2014. doi:10.1109/BIOROB.2014.6913816
Clinical trial NCT02740517: Usability Evaluation - Reassure Respiration Rate Device: Home User Study
Official title: Reassure Respiration Rate Device: Home User Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ease of Use
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2016-04-15
Enrollment: 48
Sex: ALL
Minimum age (years): 30
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 60 volunteers, all naïve to the device. The majority of the volunteers to be \>65 years old, to represent the likely user profile: person with a set of chronic diseases, and not necessarily technically adept

Brief summary: This is a usability evaluation of the Reassure device. The device is a non-contact device which passively monitors breathing.

The purpose of this usability evaluation is to understand any issues that the intended user population have while using the device unsupervised in the home and to determine if the device can collect data that is of sufficient quality to be successfully analysed for respiration rate.

Detailed description: The aim of the set of Reassure Home User Trials is to understand any usability issues that users have while using the Reassure non contact monitor in their home environment.

Other objectives:

* To gather useful feedback on the user interface and suggestions for its improvement.
* To gather information on the device stability in the more variable conditions of the home user environment.
* To gather data in order to demonstrate compliance with IEC62366, and thus IEC60601-1

The users had the device for a minimum of 10 nights, to confirm if the device could be used for an extended period and the likely compliance rates of users

Eligibility criteria: Inclusion Criteria:

* volunteer, no previous exposure to the device

Exclusion Criteria:

* restless leg syndrome or other conditions giving to uncontrolled movements whilst asleep

Primary outcomes:
measure: Percentage of Nights' Data That Were Successfully Recorded
timeFrame: At least 10 nights
Secondary outcomes:
measure: Percentage of Recordings With Successful First Time Transmission
timeFrame: For at least 10 nights of recordings
Other outcomes:
Locations:
Study officials:
affiliation: ResMed Sensor Technologies Ltd
name: Paul Phillips, MA, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05698017: Study to Evaluate Investigational Allogeneic Cell Therapy Product hOMSC300 for Treatment of Early to Moderate Stage Multiple System Atrophy (MSA)
Official title: Phase 1 Open-Label Study for Treatment of Early to Moderate Stage Multiple System Atrophy Patients With the Investigational Allogeneic Cell Therapy Product, hOMSC300
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Multiple System Atrophy
MSA - Multiple System Atrophy
Keywords: multiple system atrophy
MSA
stem cells
intrathecal
Lead sponsor: Cytora Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-26
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Patients will be allocated to one of the following arms:

1. The first 2 subjects recruited will be treated with the Low dose single Intrathecal (IT) administration of hOMSC300
2. The following 2 subjects recruited will be treated with the High dose single intrathecal (IT) administration of hOMSC300; In the absence of any treatment related SAEs, the remaining patients (6) will be treated with the high dose, without further staggering.
Primary purpose: TREATMENT

Brief summary: Purpose of this phase 1 study is to assess the safety of intrathecal administration of allogeneic human oral mucosa stem cells (hOMSCs) in patients suffering from early to moderate stage Multiple System Atrophy (MSA)


Eligibility criteria: Inclusion Criteria:

* Patient was diagnosed with probable MSA-C (cerebellar) or MSA-P (parkinsonian) variant within 60 months of symptom onset (excluding impotence)
* Subject can ambulate without the assistance of another person, defined as the ability to take at least 10 steps. Use of assistive devices is allowed
* Patient cognitive state permits him to sign informed consent, according to the PI's clinical judgement, and MoCA \>= 24

Exclusion Criteria:

* Pregnant women and women before menopause
* Participants with a clinically significant or unstable medical or surgical condition that, in the opinion of the investigator, might preclude safe completion of the treatment or affect the treatment outcome.
* Patients with thrombocytopenia, other bleeding diathesis or taking anticoagulant therapy (not including Aspirin up to 100mg per day)
* Patients with known hypersensitivities to Plasmalyte, Gadolinium, Penicillin, and with general hypersensitivity to antibiotics
* Patients who fulfill the criteria of Parkinson's Disease
* History of electroconvulsive therapy
* History of brain surgery

Primary outcomes:
measure: Number of participants with treatment related serious adverse events (SAEs)
timeFrame: 18 months
measure: Number of participants with treatment related adverse events (AEs)
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center (Ichilov)
Study officials:
References:
Clinical trial NCT00568217: Antipyretics for Preventing Recurrences of Febrile Seizures
Official title: Antipyretics for Preventing Recurrences of Febrile Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Recurrence of Febrile Seizure
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2007-12-05
Enrollment: 231
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We wanted to find out if the early use of antipyretics is capable in preventing recurrences of febrile seizures. When a child has had his/her first febrile seizure, the parents were instructed to give him/her antipyretic medication every time when the child had a new episode of fever during two years.


Eligibility criteria: Inclusion Criteria:

* First febrile convulsion

Exclusion Criteria:

* Any prior convulsion or antiepileptic medication

Primary outcomes:
measure: recurrence of febrile seizure
timeFrame: two years
Secondary outcomes:
measure: we only had the primary outcome measure
timeFrame: two years
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Heikki Rantala
Study officials:
affiliation: University of Oulu
name: Heikki Rantala, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Strengell T, Uhari M, Tarkka R, Uusimaa J, Alen R, Lautala P, Rantala H. Antipyretic agents for preventing recurrences of febrile seizures: randomized controlled trial. Arch Pediatr Adolesc Med. 2009 Sep;163(9):799-804. doi: 10.1001/archpediatrics.2009.137.
Clinical trial NCT03306017: Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes
Official title: Study on the Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Insufficiency
Keywords: left ventricular assist device
platelet-leukocyte conjugates
lipo-oxygenase products
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To compare in vivo platelet and leukocyte activation and phenotype before and after Left ventricular assist device (LAVD) implantation

Detailed description: The present study plan to investigate platelet activation in vivo using a variety of biomarkers previously identified as sensitive to high shear stress in patients with severe aortic valve stenosis before and after trans arterial valve replacement. As one of the best biomarker is a high degree of platelet-leukocyte interactions, the study will study in parallel leukocytes activation/differentiation. These parameters will be compared at 3 time-points, before and after LAVD implantation in ambulatory patients.

Eligibility criteria: Inclusion Criteria:

* elective implantation of LAVD (Heartmate II),
* written informed consent to the study
* Patients with health insurance

Exclusion Criteria:

* treatment or procedure that could affect platelet functions or turn-over(low-dose aspirin is allowed).
* Pregnancy or breastfeeding
* Juridical Protection

Primary outcomes:
measure: Platelet activation
timeFrame: Month 2 after LAVD implantation
Secondary outcomes:
measure: Level of circulating platelet-leukocyte conjugate
timeFrame: Month 2 after LAVD implantation
measure: Changes in leukocyte phenotype
timeFrame: Month 2 after LAVD implantation
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital of Toulouse, Rangueil, Hematology laboratory
name: Pierre SIE, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04976517: Echocardiographic Assessment of the Impact of Diabetes and Prognostic Analysis of Heart Transplantation
Official title: A Multicenter Clinical Study of Echocardiographic Evaluation of the Impact of Diabetes and Prognostic Analysis of Heart Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Transplant
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Shanghai Zhongshan Hospital
name: Wuhan Asia Heart Hospital
name: Guangdong Provincial People's Hospital
name: Henan Provincial People's Hospital
First posted: 2021-07-26
Enrollment: 1500
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: Adult patients who received a heart transplant after 2015

Brief summary: The aim of this study is to evaluat the impact of diabetes on cardiac function in patients with heart transplantation by multimodal imaging and analyse their prognosis.

Detailed description: This study is planed to enroll 300000 patients after heart transplantation, all the patients will be divided into 3 groups according to whether or not they have diabetes and when did they develop diabete. Echocardiography will be used to evaluat their cardiac function. Comparing their cardiac function and clinical information and analysing their prognosis to evaluat the impact of diabetes.

Eligibility criteria: Inclusion Criteria:

* Adult patients who received a heart transplant after 2015

Exclusion Criteria:

* The image quality is poor

Primary outcomes:
measure: all-cause mortality
timeFrame: up to 2023.12
measure: acute rejection
timeFrame: up to 2023.12
measure: readmission
timeFrame: up to 2023.12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Ultrasound, Union Hospital, Wuhan, China
name: Li Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: