louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02890225: Comparison Of External Physical Vibration Lithecbole(EPVL) In Different Time After Retrograde Intrarenal Surgery(RIRS)
Official title: Effect Of Renal Residual Stones c Treated By External Physical Vibration Lithecbole(EPVL) In m Different Time n After Retrograde Intrarenal w Surgery(RIRS):At y Multi-center z Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calculi
Keywords: stones
external physical vibration lithecbole
Lead sponsor: Second Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to eliminate stone completely

Detailed description: To evaluate the efficacy and safety of external physical vibration lithecbole for the treatment of residual stone in different time (3 days ,7 days and 14 days) after the operation of RIRS

Eligibility criteria: Inclusion Criteria:

1.Age of 18-75 years;

Exclusion Criteria:

1.Urinary tract anomalies, stricture or obstruction;

Primary outcomes:
measure: Change from stone free rate(SFR) with different follow-up periods
timeFrame: Patients in group A and group B return hospital respectively in 1,2 and 4 weeks after RIRS,patients in group C return hospital respectively in 2 and 4 weeks after RIRS.
Secondary outcomes:
measure: Extracorporeal physical vibration complications
timeFrame: Patients in group A and group B return hospital respectively in 1,2 and 4 weeks after RIRS,patients in group C return hospital respectively in 2 and 4 weeks after RIRS.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: Second Affiliated Hospital of Zhengzhou University
name: EB Wang, PH.D
role: STUDY_CHAIR
References:
Clinical trial NCT02680925: Lung Protective Ventilation During Pulmonary Lobectomy in Children
Official title: The Influence of Lung Protective Ventilation During Pulmonary Lobectomy on Clinical Outcome in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Complication
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 114
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in pediatric patients. The hypothesis is that application of low tidal volume, intermittent alveolar recruitment and adequate positive end-expiratory pressure (PEEP) would be more beneficial than conventional ventilation in children.


Eligibility criteria: Inclusion Criteria:

* Children who are scheduled for lung lobectomy under general anesthesia
* ASA physical status I, II

Exclusion Criteria:

* History of airway or pulmonary interstitial disease
* Active URI
* Systemic inflammatory response disease
* cardiac disease

Primary outcomes:
measure: The number of patients with pulmonary complication
timeFrame: up to postoperative 7 days
Secondary outcomes:
measure: The number of patients with desaturation
timeFrame: During surgery
measure: The number of patients with extrapulmonary complication
timeFrame: through study completion, an average of 1 year
measure: Mean duration of mechanical ventilation
timeFrame: through study completion, an average of 1 year
measure: Mean duration of ICU stay
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JH, Bae JI, Jang YE, Kim EH, Kim HS, Kim JT. Lung protective ventilation during pulmonary resection in children: a prospective, single-centre, randomised controlled trial. Br J Anaesth. 2019 May;122(5):692-701. doi: 10.1016/j.bja.2019.02.013. Epub 2019 Mar 8.
Clinical trial NCT02664025: Simulation in Teaching Vaginal Examination
Official title: The Benefits of Simulation in Teaching Vaginal Examination for Women During Labor: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: teaching vaginal examination
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Teaching technical skills during medical training can lead to some issues, which can concern ethical or medico-legal risks. In this context, the vaginal examination (VE) is specific because it concerns the genital area and it interferes with obstetrical management.


Eligibility criteria: Inclusion Criteria:

* Interns who finished their study in faculty of medicine
* Interns who never performed VE before
* Interns who accept to participate in the study

Exclusion Criteria:

* Interns who refuse to participate in the study

Primary outcomes:
measure: the improvement of vaginal examination accuracy score after practical training on simulators
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT05985525: Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS)
Official title: Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS): Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Shock
Critical Illness
Keywords: Near-Infrared Spectroscopy
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 100
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: Adults admitted to the ICU receiving invasive mechanical ventilation

Brief summary: Investigation of the feasibility of using near-infrared spectroscopy (NIRS) to monitor microvascular function in critically ill patients.

Detailed description: This is a prospective observational study using non-invasive NIRS for microvascular monitoring in the ICU. The study involves no interventions above standard of care other than the application of the NIRS monitors.

NIRS will be applied to skeletal muscle and the brain longitudinally throughout ICU admission. Vital signs are extracted continuously from the ICU monitor and clinical data are recorded from patient records.

The broad goals of the study are:

1. Determine the feasibility of longitudinal NIRS monitoring in ICU patients
2. Determine the ability to derive patient-specific microvascular metrics using NIRS
3. Explore the relationship between microvascular metrics and ICU mortality

Eligibility criteria: Inclusion Criteria:

* Admitted to ICU
* Receiving invasive mechanical ventilation

Exclusion Criteria:

* Body Mass Index \>40
* More than 24 hours has elapsed since ICU admission
* Death is deemed to be imminent and inevitable during the next 24 hours
* Known allergy to the textile components of the device
* Significant clinical jaundice, ecchymosis
* COVID positive microbiological result
* The treating clinician believes that participation in the domain would not be in the best interests of the patient
* Consent declined from patient or authorized third party

Primary outcomes:
measure: Recruitment
timeFrame: 30 days
Secondary outcomes:
measure: protocol adherence
timeFrame: 14 days
measure: NIRS and vital sign data quality
timeFrame: 14 days
measure: Optimal Map (MAPopt) derivation
timeFrame: 14 days
Other outcomes:
measure: ICU mortality
timeFrame: 30 days
measure: Hospital mortality
timeFrame: 100 days
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre Winnipeg
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Asher Mendelson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00814125: ATAC - Endometrial Sub-Protocol
Official title: A Randomised, Double Blind Trial to Assess the Incidence of Endometrial Changes With Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Endometrial
Endometrial histological findings
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-12-24
Enrollment: 285
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To compare the difference between the ARIMIDEX group and the tamoxifen group in the incidence of abnormal endometrial histological findings arising after treatment has commenced.


Eligibility criteria: Inclusion Criteria:

* Patients eligible for entry into the main ATAC trial (1033IL/0029)
* Not received any previous tamoxifen, for whatever reason
* Not undergone a hysterectomy and do not have a hysterectomy planned within the next 6 years
* No previous endometrial ablation

Exclusion Criteria:

* Excluded from entry into the main ATAC trial (1033IL/0029). As detailed in Section 4.4 of the main ATAC trial (1033IL/0029)

Primary outcomes:
measure: Withdrawl
measure: Death
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03067025: Sleep, Physical Activity and Multiple Sclerosis Symptoms in Pediatric Multiple Sclerosis
Official title: Sleep, Physical Activity and Multiple Sclerosis Symptoms in Pediatric Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Multiple Sclerosis
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: Queen's University
First posted: 2017-03-01
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: There will be a total of 60 participants in this study. The study population consists of both patient participants (pediatric multiple sclerosis patients) and non-patient participants (healthy volunteers).

Brief summary: Most youth with MS experience symptoms such as depression and fatigue. In addition, cognitive issues, especially with attention and memory occur frequently. However, little is known about interventions that might work to improve these symptoms. In other work, the investigators have shown that higher levels of physical activity are associated with lower levels of depression and fatigue. Importantly, sleep problems are frequently encountered in youth with MS, and were seen in 60% of surveyed youth with MS in the investigators preliminary work. Modifiable lifestyle factors such as sleep and physical activity (PA) may play a key role in ameliorating common symptoms in pediatric MS. However, sleep has not been objectively described in pediatric MS, and the relationship between PA and sleep is poorly understood. This study aims to address these gaps.


Eligibility criteria: Inclusion Criteria:

1. Children ages 10 to 17 years, 11 months;
2. MS diagnosis following standard definitions (IPMSSG);
3. Healthy controls will include any child without a history of disease or disability

Exclusion Criteria:

1. Inability to communicate or understand English;
2. Those within 30 days of a relapse;
3. Children who exhibit severe respiratory problems at baseline (e.g. use of tracheotomy)

Primary outcomes:
measure: Sleep quality, duration and timing
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
References:
Clinical trial NCT04324125: Chemotherapy Combined With Immunotherapy in HER 2 Insertion or Amplification Advanced NSCLC
Official title: Chemotherapy or Chemotherapy Plus PD-1 Antibody in HER 2 Insertion or Amplification Advanced Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HER 2 Insertion or Amplification Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by NGS

Brief summary: This study aims to explore the efficacy and safety of chemotherapy or chemotherapy plus PD-1 antibody in HER 2 insertion or amplification.

Detailed description: Main enrolled criteria:

Her2 insertion advanced NSCLC Her 2 amplification advanced NSCLC Failed with standard chemotherapy No history of PD-1/ PD-L1 antibody using

Eligibility criteria: Inclusion Criteria:

* ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
* HER 2 Insertion or Amplification
* First Diagnosis and Treatment
* Treatment Plan is Chemotherapy or Chemotherapy plus PD-1 antibody

Exclusion Criteria:

* Patients received antitumor treatment before
* Patients with contraindication of chemotherapy
* Pregnant or breast feeding women

Primary outcomes:
measure: PFS
timeFrame: may 2020- may 2021 (1 year)
Secondary outcomes:
measure: OS
timeFrame: may 2020- may 2021 (1 year)
measure: ORR
timeFrame: may 2020- may 2021 (1 year)
Other outcomes:
Locations:
city: Changsha
country: China
facility: Yongchang Zhang
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Yongchang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04045925: Feasibility Study of the Taïso Practice in Parkinson's Disease
Official title: Feasibility Study of the Taïso Practice in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Taïso
Physical therapy
Exercice therapy
Parkinson disease
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-08-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This is a pilot study of descriptive and analytical, prospective feasibility, monocentric, longitudinal with 6 months of bi-weekly practice of Taïso in patients with Parkinson's disease with mild to moderate postural instability.

The intervention is planned over 6 months (25 consecutive weeks) for the whole project of the patient group. Patients are included in the month before the start of the treatment of the intervention. Four standardized evaluation sessions are conducted: a first evaluation during the first week of Taiso and then every 8 weeks (2 months, 4 months and 6 months). Incident collection and fitness assessment tests are performed by the physical trainer while the balance and are performed by a physiotherapist. The quality of life assessment and the MDS-UPDRS II rating are performed during the inclusion visit and then the final study visit (within 2 weeks) after 6 months of practice) with the coordinating neurologist. An evaluation of incidents is also carried out during this end-of-study visit.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 and \<85 years old,
* Parkinson's disease diagnosed by a neurologist, treated and sensitive to dopaminergic treatment without limitation of the duration of the disease since the date of diagnosis,
* Patient with mild to moderate postural instability (equivalent to grade 2.5 and 3 on the Hoehn and Yahr scale),
* Naive patient of any practice of Taiso,
* Patient available to perform the Taïso program planned in the study,
* Patient with written informed consent

Exclusion Criteria:

* Patient with a contraindication to the practice of sport
* Pregnant woman, parturient and breastfeeding mother
* Patient deprived of liberty by administrative or judicial decision
* Patient admitted to a health or social facility for purposes other than that of research
* Adults under guardianship or trusteeship or unable to express consent
* Patient not affiliated to a social security system
* Patient already participating in a therapeutic research protocol that aims to improve physical or mental abilities

Primary outcomes:
measure: Number of traumatic incident(s) and/or cardiovascular(s)
timeFrame: The collection of traumatic and/or cardiovascular incidents will begin in the first Taiso class and continue until the final visit with the neurologist (6 months of collection
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
Study officials:
References:
Clinical trial NCT04146025: Nurtured in Nature
Official title: Leveraging Urban Nature, Behavioral Economics, and Mobile Platforms to Prevent Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Pregnancy Related
Environmental Exposure
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators pilot test a Nature Coach Intervention in a population of postpartum women, to increase the amount of time people spend outside in local nature, with the goal of preventing postpartum depression.

Detailed description: Postpartum depression (PPD), characterized by feelings of sadness, irritability, and fatigue following the birth of a child, occurs in 10-15% of women. PPD peaks within the first 2-3 months following delivery, but can occur anytime in the first year, representing one of the most common complications of childbearing. The consequences go beyond impaired functioning for the woman, and include harmful effects on the cognitive and emotional development of the woman's infant. Despite this, many women are undiagnosed and do not get adequate treatment.

Living near and spending time in green space is associated with a host of mental health benefits, including reduced depression and improved well-being. Research has shown that women who live near more green space have improved birth outcomes such as higher birthweight infants.

Despite the growing body of evidence linking nature with improved mental health, spending time in green space is not a standard health promoting tool to address mental illness. Behavioral economics concepts have been used successfully in promoting other preventative health behaviors such as physical activity and healthy eating.

Eligibility criteria: Inclusion Criteria:

* 18 years old and older
* Delivery of a living child
* Ambulatory
* Live in West or Southwest Philadelphia
* Have a smart phone
* Able to understand and respond to an oral interview in English

Exclusion Criteria:

* Baby in Neonatal Intensive Care Unit
* Mother has not been in Intensive Care Unit pre/post-delivery
* Gestational age less than 37 weeks
* Department of Human Services involvement

Primary outcomes:
measure: Green space use
timeFrame: 3 months
Secondary outcomes:
measure: Prevention of postpartum depression
timeFrame: 3 months
measure: Improvement in general well-being
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Eugenia South, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04107025: Effects of a Legal Support Program on Women Experiencing Domestic Violence
Official title: Effects of a Legal Support Program on Women Experiencing Domestic Violence: Help Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Domestic Violence
Anxiety
Depression
Stress
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Warwick Research Services
First posted: 2019-09-27
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Intimate partner violence (IPV) is a major public health concern. Worldwide, 1 in 3 women have experienced domestic abuse/ violence in their lifetime. In most cases, family lawyers, advocates are first contact before the police. If the children are involved, finding the legal options become the priority for women before leaving the abuser.

The purpose of this study was to compare the effectiveness of the HELP (Health, Education Legal Support Program) intervention among IPV survivors.


Eligibility criteria: Inclusion Criteria:

* Female survivors of Intimate Partner Violence
* 18 years old or older
* Gives informed consent

Exclusion Criteria:

* Diagnosed mental health condition
* Terminally ill
* Chronic condition
* On psychiatric medication
* Sexual assault

Primary outcomes:
measure: Anxiety
timeFrame: Change from baseline anxiety symptoms at 4 weeks
measure: Depression
timeFrame: Change from baseline depression symptoms at 4 weeks
measure: Stress
timeFrame: Change from baseline stress symptoms at 4 weeks
Secondary outcomes:
measure: Self esteem
timeFrame: Change from baseline self esteem at 4 weeks
Other outcomes:
Locations:
city: Bundi
country: India
facility: Gyansanjeevani
state: Rajasthan
city: Jaipur
country: India
facility: Gyansanjeevani
state: Rajasthan
Study officials:
affiliation: Warwick Research Services
name: Neha Sharma, PhD
role: STUDY_DIRECTOR
affiliation: Patan Girls College
name: Anurag Sharma, MPhil
role: STUDY_CHAIR
affiliation: NMP Medical Research Institute, India
name: Rekha Khandelwal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00633425: Continuous Glucose Monitoring System (CGMS) in Type 2 Diabetic Patients Inadequately Controlled by Metformine Monotherapy; Analyze of Glycemic Profile Before and After Association of Glimepiride
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-03-12
Enrollment: 43
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Analyse the glucose profile, based on continuous glucose monitoring by CGMS, in type 2 diabetics inadequately controlled by metformin, before and after the addition of Glimepiride.


Eligibility criteria: Inclusion Criteria:

* Men or women aged 35 to 70 years
* Having given their consent
* Type 2 diabetics (HBA1c greater than 6.5%
* Fasting glycaemia greater than 1.40 g/l) not controlled by Metformin for at least 6 weeks.

Primary outcomes:
measure: Change in interstitial glucose levels between the observation and maintenance phases.
timeFrame: The mean of 24 variations in average hourly glucose readings recorded by CGMS.
Secondary outcomes:
measure: HbA1c and fasting blood glucose levels.
timeFrame: Measured in the observation and maintenance phases, and change between the two phases.
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Nathalie Billon
role: STUDY_DIRECTOR
References: