louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03113539: Low-dose Gated CT Validity for the Evaluation of Ascendant Aortic Aneurysm.
Official title: Low-dose, EKG-gated CT Validity for the Evaluation of Ascendant Aortic Aneurysm.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ascendant Aortic Aneurysm
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 66
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: We will demonstrate the validity of measurements with a low-dose, EKG-gated CT without contrast in the ascending aorta evaluation, compared with the current Angio-CT measurements.

Detailed description: The actual protocol used in aorta evaluation consist of two CT-scans on the same study. The first scan that detects calcifications is using parameters with low-dose current, non EKG-gated and without contrast. The second scan uses iodine-contrast, EKG-gating and higher current dose to obtain higher image quality of diagnostic value.

The study will optimize the first scan parameters and compare the measures of the aorta diameters from the standard protocol.

By modifying the first scan parameters, we would demonstrate that the follow-up of an aortic aneurysm can safely be made with lower radiation exposure.

Eligibility criteria: Inclusion Criteria:

* 60 years old and more
* 85 bpm or less

Exclusion Criteria:

* aortic material
* EKG gating not possible
* aorta pathology (thrombus, dissection)

Primary outcomes:
measure: Measures validity (aorta diameter in mm from scan images)
timeFrame: 12 months
Secondary outcomes:
measure: Radiation (in msev from scanner report)
timeFrame: 12 months
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Sherbrooke University Hospital
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Paul Farand
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00809939: 17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pregnancy
Keywords: preterm delivery
short cervical length
progesterone
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2008-12-17
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous studies showed that administration of progesterone to pregnant women at high risk, decrease spontaneous preterm deliveries.

The purpose of this study is to compare between two different modes of treatment with progesterone for the prevention of preterm delivery: weekly injection of 17 alfa hydroxyprogesterone caproate versus daily vaginal administration of progesterone in terms of efficacy, comfort and compliance, safety and cost of treatments.


Eligibility criteria: Inclusion Criteria:

* The subject has a history of spontaneous preterm delivery defined as earlier than 37 gestational week.
* The subject has a short cervical length defined as 25 mm before 24 weeks gestation.
* A singleton gestation.

Exclusion Criteria:

* Multifetal pregnancy.
* The subject has or will have a cervical cerclage in place.

Primary outcomes:
measure: efficacy
timeFrame: 3 years
Secondary outcomes:
measure: comfort of use and consequently of that compliance
timeFrame: 3 years
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center, Israel, Affiliated to Tel Aviv University
name: Tal Biron-Shental, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05410639: Effect of Online Education Given to Parent on Motor Social Development for The Premature Babies in The Neonatal Intensive Care Unites
Official title: Effect of Online Education Given to Parent on Motor Social Development for The Premature Babies in The Neonatal Intensive Care Unites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infant
Keywords: Premature Infant,Motor Development,Social-Communication Development,Parental Stress,Online Education
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 73
Sex: ALL
Minimum age (years): 0
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Our study aim to evaluate the effect of online program that provides education to parents of premature infants in which stayed in the neonatal intensive care units (NICU),in their motor,socail-communişcation development and the parents stress level.

Detailed description: Our study aim to increase the level f knowledge of the parents of premature infants that stayed in the NICU,to better manage their stress and to provide them with informations to support the motor and social-communication development of their infants.

Eligibility criteria: Inclusion Criteria:

* infants Stayed in the neonatal intensive care unit for some time after premature birth for the purpose of care and treatment.
* Being a premature baby born at or under 32 weeks
* infant corrected age between 0-8 months
* To agree to participate in the study.

Exclusion Criteria:

* Having a concomitant major anomaly and genetic disease
* The fact that the family did not accept the evaluation of their baby in motor and social-communication area at sixth month of the study.

Primary outcomes:
measure: Alberta Infant Motor Scale (AIMS)
timeFrame: Premature infant motor development was assessed one time by AIMS at their 6 month corrected age
measure: The Social-Communication Area Screening Test of İnfant (SCASI)
timeFrame: Premature infant social-communication development was assessed one time by SCASI at their 6 month corrected age.
Secondary outcomes:
measure: Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF)
timeFrame: Parents stress level was assessed one time by PSI-4-SF at their infant 6 month corrected age.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Bachelor study principal invistigator Marmara University
name: Khaoula Ben Kilani
role: PRINCIPAL_INVESTIGATOR
affiliation: Assoc.Prof.
name: Gönül Acar
role: STUDY_CHAIR
References:
Clinical trial NCT00949039: Study Comparing Isolated Pelvic Perfusion With TNF-α 0.3 mg and Melphalan 1.5 mg/kg Versus Standard Treatment in Patients With Non Resectable, Recurrent Gynaecologic or Digestive Pelvic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gynaecologic or Digestive Pelvic Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2009-07-30
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomised phase 3 trial comparing 2 arms: an experimental treatment (Isolated pelvis perfusion) and a standard treatment (systemic chemotherapy +/- radiotherapy +/- surgery).

Patients included have a non resectable, recurrent gynaecologic or digestive pelvic cancer.

The aim of the study is to show a 25% increase in 1 year overall survival rate with isolated pelvic perfusion.


Eligibility criteria: Inclusion Criteria:

* Histologically proved locally advanced gynaecologic or digestive tumours (epidermoid carcinomas, adenocarcinomas, neuroendocrine tumours, sarcomas or melanomas), (cervix, vagina, rectal, anal).
* Locally recurrent tumours for which surgical treatment will be mutilating or marginal (R1 or R2) and/or for cervix cancer, primary tumours non accessible for standard treatment (radiotherapy- chemotherapy - brachytherapy and surgery).
* Surgically resectable tumour (R0 type) but for which patient does not agree with surgery.
* Patients aged over 18 and under 76 ans
* Performance OMS Index ≤ 2
* Normal biologic parameters
* Good general and cardiac state (ASA I or II and NYHA I or II)

Exclusion Criteria:

* Surgically resectable tumour (RO) or peritoneal tumour extension or distant metastasis.
* Cardiac or vascular pathology
* Pulmonary disease
* Uncontrolled Sepsis disease
* Pregnancy

Primary outcomes:
measure: Survival rate
timeFrame: From randomization to death
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References:
Clinical trial NCT03693339: Capmatinib in Patients With Non-small Cell Lung Cancer Harboring cMET exon14 Skipping Mutation
Official title: An Open-label, Multicenter, Phase II Study of Capmatinib in Patients With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cancer
Lung Cancer Metastatic
MET Gene Mutation
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 27
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: This study is a phase II, single-arm, open label study under an umbrella trial for NSCLC. This clinical study is targeted for the patients who harbor exon 14 skipping mutation of MET and all patients will be treated with Capmatinib. The treatment period begins on Day 1 of Cycle 1 and 1 cycle consists of 28 days.


Eligibility criteria: Inclusion Criteria:

* Subjects with histologically or cytologically confirmed, unresectable stage IIIB/IV NSCLC that carries MET exon 14 skipping alteration by molecular testing, as per NGS and RT PCR.
* ECOG performance status of 0 to 2
* Male or female; ≥ 18
* Subjects with measurable lesion (using RECIST 1.1 criteria)
* Subjects must have archival tissue sample available, collected either at the time of diagnosis of NSCLC or any time since
* Patients who have progressed during or after 1st line or 2nd line therapy prior to the first dose of capmatinib. For patient who have received prior platinum containing adjuvant, neoadjuvant, or definitive chemoradiation for locally advanced disease, those treatments are regarded as 1st line if the progression has occurred \< 12 months from last therapy.

Exclusion Criteria:

* Any major operation or irradiation within 4 weeks of baseline disease assessment
* Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
* Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
* Patients who have received more than 2 lines of prior systemic therapy, which include chemo, immune and targeted therapy

Primary outcomes:
measure: Objective response rate
timeFrame: At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months]
Secondary outcomes:
measure: Duration of response
timeFrame: At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months
measure: Progression-free survival
timeFrame: At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months
measure: Overall survival
timeFrame: At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT01680939: Investigating the Safety of Post-surgical Analgesics in Children With Obstructive Sleep Apnea
Official title: Investigating the Safety of Morphine and Ibuprofen in Children Post-adenotonsillectomy for Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pediatric Obstructive Sleep Apnea Syndrome
Keywords: Pediatrics
Obstructive Sleep Apnea
Adenotonsillectomy
Analgesia
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: University of Western Ontario, Canada
First posted: 2012-09-07
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Every year thousands of young children with obstructive sleep apnea undergo surgery which requires them to be prescribed pain medication. The current standard in North America is administration of opioids, mainly codeine or morphine; however in many areas of the world including Canada, nonsteroidal anti-inflammatory medications such as ibuprofen are used. Some North American surgeons are uncertain regarding the potential of ibuprofen to increase bleeding following surgery. The results of research studies have been inconclusive overall. Due to recent codeine fatalities in children following adenotonsillectomy, codeine has been removed from the formulary at many Pediatric institutions. Some surgeons have begun to use oral morphine as an alternate to codeine, which necessitates the need to find safe alternative analgesics in this treatment group.

The primary objectives of this study is to assess the safety(1) and efficacy (2) of morphine and ibuprofen in children with sleep apnea.

An interim analysis will be conducted after recruitment of 70 patients, to monitor both safety and efficacy


Eligibility criteria: Inclusion Criteria:

* diagnosed with OSAS,
* scheduled for tonsillectomy plus/minus adenoid removal at MUMC,
* between the ages of 1-10years

Exclusion Criteria:

* contraindications to analgesia,
* asthma,
* has had previous adenotonsillectomy, or
* any craniofacial,
* neuromuscular or cardiac conditions

Primary outcomes:
measure: Safety
timeFrame: 1.5 years
Secondary outcomes:
measure: Effectiveness
timeFrame: 1.5 years
measure: Risk Factors
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
Study officials:
References:
citation: Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906.
Clinical trial NCT01857622: Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment
Official title: Phase III Clinical Study of DU-176b (Non-valvular Atrial Fibrillation): Japanese, Multicenter, Open-label Study of DU-176b in Patients With Non-valvular Atrial Fibrillation and Severe Renal Impairment (SRI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-valvular Atrial Fibrillation
Keywords: anticoagulant
DU-176b
edoxaban
factor Xa
oral
atrial fibrillation
severe renal impairment
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2013-05-20
Enrollment: 93
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: To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial fibrillation (NVAF) patients with normal renal function or mild renal impairment (Normal/MiRI).


Eligibility criteria: Inclusion Criteria:

* Patients with NVAF and SRI, or patients with NVAF and Normal/MiRI.

Exclusion Criteria:

* Patients who are on hemodialysis or patients who may start hemodialysis before the follow-up assessment
* Patients who are at a significantly high risk for bleeding
* Patients who are receiving treatment with any anticoagulant drugs excluding warfarin, rivaroxaban, and dabigatran
* Patients who have evidence of hepatic function test abnormalities

Primary outcomes:
measure: Incidence of Any Adjudicated Bleeding Events
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Hospital
Study officials:
affiliation: Osaka National Hospital
name: Yukihiro Koretsune, Dir
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06156722: The Combination of Sperm Selection by IMSI and Hyaluronic Acid Binding Assay May Improve ICSI Outcome.
Official title: The Combination of Sperm Selection by IMSI and Hyaluronic Acid Binding Assay Improves ICSI Outcomes: A Randomized Prospective Sibling-oocytes Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fertility Issues
Keywords: IMSI
SpermSlow
Sperm selection
ICSI outcome
Sibling-oocytes study
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Assuta Medical Center
name: Tel Aviv University
First posted: 2023-12-05
Enrollment: 189
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: In this prospective randomized sibling-oocytes blinded study, investigators examine the combination of two sperm selection methods that logically seem to complete each other, and potentially may improve ICSI outcomes.

The methods include the selection of the optimal spermatozoa based on its morphology by IMSI, together with its physiological function of binding to HA by Spermslow (SS).

The current study compared a group of ET after sperm selection by IMSI with SS to a group of ET after sperm selection by IMSI-only without SS, and to a mixed ET group where two embryos were transferred, one after IMSI-only and the other one after IMSI with SS.


Eligibility criteria: Inclusion Criteria:

females ages 38 or younger retrieval of at least 5 mature oocytes and fresh ejaculate samples

Exclusion Criteria:

frozen embryos surgically extracted sperm preparations embryo-biopsy cycles

Primary outcomes:
measure: Pregnancy and delivery rates
timeFrame: Within up to 10 month from treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT00610922: Docosaexahenoic Acid and Gross Motor Milestones in Infants
Official title: RCT of Supplemented Docosahexaenoic Acid and Gross Motor Development Milestones in Healthy Infants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Performance of motor skills
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 1160
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To examine whether daily supplement of docosahexaenoic acid throughout the first year of life may speed up the achievement of gross motor development milestones in healthy infants, a total of 1160 healthy infants randomly allocated to receive throughout the first year of life daily oral supplement of vitamin D3 (400 IU) plus docosahexaenoic acid (20 mg) or vitamin D3 (400 IU) alone. Primary outcome measure: time of achieving gross motor development milestones. Secondary outcome measure: time of achieving early fine motor development milestones and language.


Eligibility criteria: Inclusion Criteria:

* weight at birth equal or above 2500 g;
* gestational age between 37 and 42 completed weeks;
* single birth;
* absence of neonatal or birth abnormalities;
* Apgar score greater than or equal to 7 at 5 m;
* white parents.

Exclusion Criteria:

* presence of neonatal diseases requiring hospitalisation for longer than 7 days;
* unknown father;
* parents unable to understand the protocol requirements and to fill out the infants diary;
* infant already enrolled or selected for another clinical study.

Primary outcomes:
measure: time of achieving the four gross motor development milestones
timeFrame: 4, 8 and 12 months of age
Secondary outcomes:
measure: time of achieving early fine motor milestones and language
timeFrame: 4, 8 and 12 months of age
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Pediatrics, San Paolo Hospital, University of MIlan, Italy
name: Carlo Agostoni, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agostoni C, Zuccotti GV, Radaelli G, Besana R, Podesta A, Sterpa A, Rottoli A, Riva E, Giovannini M. Docosahexaenoic acid supplementation and time at achievement of gross motor milestones in healthy infants: a randomized, prospective, double-blind, placebo-controlled trial. Am J Clin Nutr. 2009 Jan;89(1):64-70. doi: 10.3945/ajcn.2008.26590. Epub 2008 Dec 3.
Clinical trial NCT04842422: Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream
Official title: Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Actinic Keratoses
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 48
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Earliest Stage Treatment of Actinic Keratosis with Imiquimod 3.75% Cream:

The study is to demonstrate that Aktinic Keratosis are present before they are clinically visible, i.e. in a subclinical stage. Since on the basis of the research situation, also subclinical AK can proliferate into the dermis, it is possible that with the application of Imiquimod on chronically light-exposed skin, undetected squamous cell carcinoma can be recognized and treated at the same time.


Eligibility criteria: Inclusion

* Male and female supposed-healthy volunteer outpatients, age: \> 50 years.
* Diagnosis: patients with chronically UV-exposed photodamaged facial skin.
* Consent by signing the ICF (Informed Consent Form)

Exclusion

* Current participation in another clinical trial
* Patients who are using topical glucocorticoids on the face.
* Known intolerance/hypersensitivity to imiquimod
* Pregnant/breastfeeding women
* Systemic disease, immunodeficiency

Primary outcomes:
measure: immunomodulatory-induced inflammatory reaction
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitätsklinik für Dermatologie und Venerologie
Study officials:
References: