louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02470364: Translation, Cross-cultural Adaptation and Validation of the MGQOL-15-F
Official title: Translation, Cross-cultural Adaptation and Validation of the MGQOL-15-F
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myasthenia Gravis
Keywords: Myasthenia gravis
Quality of life
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-06-12
Enrollment: 120
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 with auto-immune myasthenia gravis

Brief summary: The purpose of this study is to translate and culturally adapt the MGQOL-15 (health-related quality of life scale for myasthenia gravis) for use with French-speaking patients in France and to evaluate its psychometric properties to ensure reliability and validity.

Detailed description: It is a translation and validation of a quality of life scale.

Step 1: Translation and cultural adaptation (Forward and back translation, committee review, pre-testing with 10 patients for content and face validity).

Step 2 : Psychometric testing : Test-retest with a 2 day interval, correlation with clinical scores - the Myasthenic Muscle Score and the (MG-ADL) score and with a global quality of life score (WHOQOL-BREF).

Eligibility criteria: Inclusion Criteria:

* Auto-immune myasthenia gravis
* Age ≥ 18 years old
* Clinical Classification (MGFA) I-IV
* French speaking

Exclusion Criteria:

* cognitive or visual impairment which would limit the capacity to fill out the MGQOL-15-F

Primary outcomes:
measure: Perceived quality of life measured via the MGQOL-15-F (French version of the MGQOL-15), a myasthenia-specific quality of life auto-questionnaire
timeFrame: 3 days
Secondary outcomes:
measure: Global quality of life evaluated via the WHOQOL-BREF scale
timeFrame: 1 day
measure: Clinical evaluation : Myasthenic Muscle Score
timeFrame: 1 day
measure: Disease severity assessed via the Myasthenic Muscle Score
timeFrame: 1 day
measure: Impact of symptoms on daily activities and daily life using the MG-ADL score
timeFrame: 1day
Other outcomes:
Locations:
city: Paris
country: France
facility: Institute of Myology, La Pitié-Salpêtrière Hospital
Study officials:
affiliation: Institute of Myology, La Pitié-Salpêtrière Hospital, 75013 Paris, France
name: Simone Birnbaum, Physiotherapist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03740464: Long-acting G-CSF for Febrile Neutropenia
Official title: Long-acting Granulocyte Colony Stimulating Factor for the Prevention Febrile Neutropenia in Epithelial Ovarian Cancer: A Phase 3 Randomized Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Epithelial Ovarian Cancer
Colony Stimulating Factors
Febrile Neutropenia
Myelosuppression Adult
Adverse Event
Cost-effectiveness
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 556
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: This study aims to analyze the effects of long-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in epithelial ovarian cancer. Patients are randomized into study group and control group. In study group, patients accept long-acting G-CSF 48 hours from the chemotherapy. While the control group accept regular treatment rather than long-acting G-CSF. The primary end is the incidence of FN in every course of chemotherapy. The secondary ends include: the incidences of myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency clinics, adverse events related to G-CSF.


Eligibility criteria: Inclusion Criteria:

* Willing to accepted debulking surgeries and adjuvant chemotherapy
* Good performance status
* Aged 18 years or older
* Signed an approved informed consents
* No immunosuppressive disease

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Primary outcomes:
measure: febrile neutropenia
timeFrame: One year
Secondary outcomes:
measure: myelosuppression
timeFrame: One year
measure: doses of granulocyte colony stimulating factor
timeFrame: One year
measure: expenses of granulocyte colony stimulating factor
timeFrame: One year
measure: visits to the hospital
timeFrame: One years
measure: adverse events
timeFrame: One year
measure: progression-free survival
timeFrame: Five years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li L, Ma S, Wu M, Tan X, Zhong S, Lang J. The prophylactic effects of long-acting granulocyte colony-stimulating factor for febrile neutropenia in newly diagnosed patients with epithelial ovarian cancer: a randomised controlled study. BMJ Support Palliat Care. 2019 Dec;9(4):373-380. doi: 10.1136/bmjspcare-2019-001862. Epub 2019 Aug 29.
Clinical trial NCT06950164: Dynamic Changes of Ductus Arteriosus in < 31 Weeks Preterm Infants: an Observational Study
Official title: Dynamic Changes of Ductus Arteriosus in < 31 Weeks Preterm Infants: an Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Preterm
Ductus Arteriosus
Keywords: preterm
patent ductus arteriosus
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Chongqing Medical Center for Women and Children
First posted: 2025-04-30
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: very preterm infants and extremely preterm infants with respiratory distress syndrome (RDS) and without RDS were included.

Brief summary: The ductus arteriosus quickly closes itself. is an important channel connecting the maternal fetal circulation before birth. After birth, this ductus arteriosus generally no longer has a physical function, so ductus arteriosus quickly closes itself. The persistent presence of ductus arteriosus leads to significant pressure changes in the systemic and pulmonary circulation, which have adverse effects on extremely/very premature infants. Therefore, persistent patent ductus arteriosus (PDA) is a systemic disease.

Detailed description: hemodynamic significant PDA(hsPDA) is a risk factor for intraventricular hemorrhage(IVH), bronchopulmonary dysplasia(BPD), necrotizing enterocolitis(NEC). A meta-analysis from Cochrane shows that compared to conservative treatment, drug therapy for PDA within 3 and 7 days after birth does not promote PDA closure and reduce the incidence of BPD. Therefore, there is currently a tendency not to provide medication intervention. Although ductus arteriosus quickly closes itself after birth in normal term infants, however, the dynamic changes detail of ductus arteriosus in preterm infants are unknown.

Eligibility criteria: Inclusion Criteria:

* less than 32 weeks' gestational age
* admission with 1 hours after birth

Exclusion Criteria:

* congenital abnormalities
* parents' refusal

Primary outcomes:
measure: the incidence of patent ductus arteriosus(PDA)
timeFrame: three months after birth
measure: dynamic changes of ductus arteriosus in diameter, velocity and direction of blood flow
timeFrame: after admission, 12 hour, 24 hour, 48 hour, 72 hour, 96 hour, 120 hour, 144 hour, 168 hour, 192 hour, 216 hour, 240 hour and 2 weeks or any time of ductus arteriosus closed
Secondary outcomes:
measure: the incidence of bronchopulmonary dysplasia
timeFrame: 36 weeks' gestational age
measure: the incidence of intraventricular hemorrhage(IVH)
timeFrame: 36 weeks' gestational age
measure: necrotizing enterocolotis(NEC)
timeFrame: 36 weeks' gestational age
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Women and Children's hospital of Chonqing Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT06863064: Brain Tumor Surgery and Postoperative Delirium
Official title: Exploring the Effects of Perioperative Dexmedetomidine on the Incidence of Postoperative Delirium, Acute and Chronic Pain, and Sleep Quality in Patients Undergoing Brain Tumor Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Brain Tumor
Keywords: brain tumor
postoperative delirium
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 1. To explore whether the combined administration of dexmedetomidine during and after surgery in patients undergoing brain tumor resection is an effective and safe modality to prevent postoperative delirium and improve sleep quality than giving it alone after surgery.
2. To explore whether intraoperative and postoperative administration of dexmedetomidine to patients undergoing brain tumor surgery can reduce postoperative acute pain and prevent chronic pain.
3. To explore whether intraoperative and postoperative administration of dexmedetomidine to patients undergoing brain tumor surgery can provide stable anesthesia depth, hemodynamics and reduce the dose of anesthetics, thereby accelerating patient recovery.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old and less than 80 years old
* receive brain tumor surgery with ASA II\~III.

Exclusion Criteria:

* under the age of 18 or over 80
* consciousness unclear
* those who have not signed a consent form
* those with high anesthesia risk ASA IV or higher

Primary outcomes:
measure: Assessment and Documentation of Delirium
timeFrame: Perioperative
measure: Assessment and Documentation of Delirium
timeFrame: Perioperative
measure: Assessment and Documentation of Delirium
timeFrame: Perioperative
measure: Assessment and Documentation of Delirium
timeFrame: 1 to 3 days post-surgery.
measure: Assessment and Documentation of Delirium
timeFrame: 1 to 3 days post-surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
References:
Clinical trial NCT00659464: Multi-Site Near Infrared Spectroscopy (NIRS) Monitoring of Children During Tilt Table Testing
Official title: Use of Multi-site Near Infrared Spectroscopy (NIRS) Monitoring for Hemodynamic Assessment During Tilt Table Testing in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syncope
Keywords: Infrared Spectroscopy
Syncope
Tilt Table Testing
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Health System Foundation, Wisconsin
First posted: 2008-04-16
Enrollment: 22
Sex: ALL
Minimum age (years): 7
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children ages 7 through 21 years who present to exercise stress lab for investigation of syncope.

Brief summary: PURPOSE OF THE STUDY

This study will explore the use of multi-site NIRS monitoring during tilt table testing, combining somatic and cerebral saturations data with hemodynamic data to establish the non-invasive assessment of global cardiac output distribution trends.

HYPOTHESIS / SPECIFIC AIMS

Study Aims: To evaluate the utility of multi-site NIRS monitoring in the cardiovascular hemodynamic assessment of children and adolescents during tilt table testing by establishing a non-invasive method to predict cardiac output maldistribution with the use of two-site NIRS monitoring in children and adolescents with syncope.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 7 and 21 years
* Referred to the exercise stress lab due to syncope

Exclusion Criteria:

* Under 7 or over 21 years of age
* Referred to the exercise stress lab for anything other than syncope

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin/Children's Hospital of Wisconsin
name: Rohit Rao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin/Children's Hospital of Wisconsin
name: John Hambrook, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rao RP, Danduran MJ, Dixon JE, Frommelt PC, Berger S, Zangwill SD. Near infrared spectroscopy: guided tilt table testing for syncope. Pediatr Cardiol. 2010 Jul;31(5):674-9. doi: 10.1007/s00246-010-9683-z. Epub 2010 Mar 4.
Clinical trial NCT02647164: The Value Of Circulating Tumor Cells In Patient With NSCLC In Postoperative Recurrence Monitoring
Official title: The Value Of Circulating Tumor Cells In Patient With NSCLC In Postoperative Recurrence Monitoring
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small-cell Lung Carcinoma
Keywords: Non-small-cell lung carcinoma
Circulating tumor cells
Lead sponsor: GenoSaber
Sponsor class: INDUSTRY
First posted: 2016-01-06
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with NSCLC(stage Ⅰ/Ⅱ/ⅢA), who will receive operation.

Brief summary: The purpose of this study is to assess the value of circulating tumor cells (CTC)for non-small cell lung cancer in the postoperative recurrence monitoring by comparing the CTCs, CT and tumor markers at different time points.The time of CTC and carcinoembryonic antigen(CEA) detection is baseline, 2\~7 days, 3 months, 6 months, 12 months, 24 months, 36 months after the surgery. And the time of CT detection is 6 months, 12 months, 24 months, 36 months after the surgery.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years old
* Patients with histologically documented (stage Ⅰ/Ⅱ/ⅢA ) non-small cell lung cancer.
* Patients will undergo surgery.
* Patients with preoperative CTCs ≥8.5 Units / 3 ml
* Informed consent must be obtained from all patients prior to beginning therapy. Patients should have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients with histologically documented not (stage Ⅰ/Ⅱ/ⅢA ) non-small cell lung cancer.
* After the operation review, patients' result of CTC, CT and tumor markers is incomplete at the same point.
* The blood sample isn't collected in predetermined time.
* The blood samples appear hemolysis.
* The blood sample isn't enough.

Primary outcomes:
measure: Circulating tumor cells will be detected by Immunomagnetic negative screening and targeted PCR method.
timeFrame: 3 years
Secondary outcomes:
measure: carcinoembryonic antigen(CEA) concentration will be detected by electrochemical luminescence.
timeFrame: 3 years
measure: Liconography using conventional CT examination results.
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01425164: Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol
Official title: Ischemia In Hemodialysed Patients And Outcome: Ivabradine Versus Carvedilol. A Randomized, Double Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Heart Disease
Angina
Hemodialysis
Keywords: hemodialysis
coronary heart disease
angina
betablocker
carvedilol
ivabradine
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
Collaborators: name: IRCCS San Raffaele
First posted: 2011-08-29
Enrollment: 220
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In hemodialysed patients, coronary heart disease is the leading cause of mortality and morbidity. Most of the commonly used drug for ischemia are used in this patients, but few prospective data are available. Among anti-ischemic drugs betablocker provided evidence of beneficial effects on outcome and, in dialysis patients, carvedilol was successfully used also in heart failure. Ivabradine is the latest anti-ischemic drug that provided evidence of benefit in general population, but no study is available in dialysis patients. Aim of the present study is to compare in a randomized, double-blind, parallel group trial the effects of ivabradine compared with carvedilol on event-free survival at 18 months in a hemodialysed population of patients with established coronary heart disease.


Eligibility criteria: Inclusion Criteria:

* documented CAD evidenced by either coronary angiography (\>50% diameter stenosis of a major coronary artery) or a previously documented myocardial infarction
* transient ischemia evidenced by abnormalities during an exercise ECG (standard Bruce protocol), myocardial perfusion scintigraphy, or stress regional wall motion study done within 6 months of study entry

Exclusion Criteria:

* unstable angina pectoris
* myocardial infarction or coronary revascularization within 3 months of study entry
* an ECG abnormality interfering with exercise ST-segment interpretation (eg, ST-segment depression \>0.5 mm, QRS duration \>0.1 second, R-wave amplitude \<8 mm,preexcitation,or atrial fibrillation)
* inability to undergo exercise testing
* uncontrolled hypertension
* other serious condition (medical, psychiatric, cognitive, or social)
* symptoms of sufficient severity (Canadian class II or higher) to require antianginal medications other than nitrates
* heart failure
* greater than first-degree atrio-ventricular block, asthma, or other contraindications to betablocker therapy

Primary outcomes:
measure: event-free survival
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Chair of Cardiology Second University of Naples
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Gennaro Cice, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03277664: Electronic Monitoring Combined With Weekly Feedback and Reminders
Official title: The Effect of Electronic Monitoring Combined With Weekly Feedback and Reminders on Adherence to Inhaled Corticosteroids in Infants and Younger Children With Asthma: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: pediatric
asthma adherence
electronic device
Lead sponsor: Shanghai Children's Medical Center
Sponsor class: OTHER
First posted: 2017-09-11
Enrollment: 96
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Study of Asthma Adherence study was a multicentre, single-blind, parallel group randomised controlled trial, with an allocation ratio of 1:1.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A total of 96 recruited children (aged 6 months to 3 years) with mild or moderate persistent asthma who were on regular inhaled corticosteroids (ICS) were randomly allocated to receive electronic monitoring combined with instant messaging software -based weekly feeding back adherence and reminders to keep taking the ICS (intervention group) and to receive electronic monitoring only (control group). The device-monitored adherence rates and caregiver-reported adherence rates were analyzed.


Eligibility criteria: Inclusion Criteria:

1. patients having mild or moderate persistent asthma
2. 6 months-3 years
3. taking regular inhaled steroids, with no change in their medication in the last month.

Exclusion Criteria:

Participants who had severe persistent asthma or another respiratory disease or did not live in Shanghai were excluded.

Primary outcomes:
measure: device monitored adherence rate
timeFrame: up to 6 months
Secondary outcomes:
measure: caregiver-reported adherence rate
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai children's medical center
state: Shanghai
Study officials:
References:
citation: Chen J, Xu J, Zhao L, Zhang J, Yin Y, Zhang F. The effect of electronic monitoring combined with weekly feedback and reminders on adherence to inhaled corticosteroids in infants and younger children with asthma: a randomized controlled trial. Allergy Asthma Clin Immunol. 2020 Jul 29;16:68. doi: 10.1186/s13223-020-00466-6. eCollection 2020.
Clinical trial NCT01890564: Modes of Ventilation During Laparoscopic Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-07-02
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bariatric surgery patients

Brief summary: During minimally invasive surgery, a pneumoperitoneum is created to facilitate surgical visualization. Although effective in facilitating the procedure, there are respiratory consequences of the pneumoperitoneum, which significantly increases intra-abdominal pressure (IAP) up to 20 cmH2O. The increased IAP can decrease functional residual capacity and increase closing capacity resulting in increased resistance, decreased compliance, and increased ventilation-perfusion mismatch. In a randomized, cross-over design, this study will evaluate in sequential order, 3 modes of ventilation during laparoscopic bariatric surgery to determine which is better able to support oxygenation and ventilation while limiting the peak inflating pressure (PIP).


Eligibility criteria: Inclusion Criteria:

* Laparoscopic bariatric surgery requiring intra-arterial blood pressure monitoring, age 14-20 years.

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in heart rate
timeFrame: Baseline to 30 mins.
Secondary outcomes:
measure: Change in blood pressure
timeFrame: Baseline to 30 mins.
measure: Blood gas
timeFrame: 30 mins.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References: