louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03403933: Vitamin D Supplementation on in Major Orthopedic Surgery
Official title: Study of the Effect of Calcifediol Supplementation on Left Ventricular Function in Cardiopathic Patients Undergoing Major Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypovitaminosis D
Cardiovascular Diseases
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 74
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, monocentric study in open, aimed at evaluating the effects of supplementation with calcifediol on left ventricular function parameters in cardiopathic subjects undergoing major orthopedic surgery.

Detailed description: Population of the study: 47 cardiopathic patients with hypovitaminosis D supplemented with calcifediol to reach vitamin D levels\> 30 ng / ml within 6 months. The purpose of this study is to evaluate the improvement of the ejection fraction or GLS (global longitudinal strain) calculated by speckle tracking at 6 months in cardiopathic patients with vitamin D deficiency during functional recovery after major orthopedic surgery.

Eligibility criteria: Inclusion Criteria:

* Age: \> or equal to 55 years, \< or equal to 85 years
* cardiopathic patients (including hypertension) who must undergo major orthopedic surgery at our site
* patients with diagnosis: hypovitaminosis d

Exclusion Criteria:

* presence of neoplasm
* endocrinological pathologies excluding diabetes mellitus
* advanced chronic renal failure (GFR \< 35 ml/min)
* pregnant women
* impossibility to participate to the rehabilitation protocol or to perform the established controls

Primary outcomes:
measure: Evaluation of improvement of ejection fraction (FE)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCCS Istituto Ortopedico Galeazzi
name: Maurizio Turiel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00770133: Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.
Official title: A Multi-center, Double-masked, Randomized, Placebo-controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-10-09
Enrollment: 141
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
* Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
* Positive bilateral conjunctival allergen challenge(CAC) reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
* Positive bilateral CAC reaction for at least 2 out of 3 time points at visit 2.

Exclusion Criteria:

* Known contraindications or sensitivities to the study medication or its components.
* Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
* Use of disallowed medications during the period indicated prior to study enrollment or during the study.

Primary outcomes:
measure: Ocular Itching
timeFrame: 3, 5, and 7 minutes post challenge at 14 days
measure: Conjunctival Redness
timeFrame: 7, 15, and 20 minutes post challenge at 14 days
Secondary outcomes:
measure: Ciliary Redness
timeFrame: 7, 15, and 20 minutes post challenge at 14 days
measure: Episcleral Redness
timeFrame: 7, 15, and 20 minutes post challenge at 14 days
measure: Chemosis
timeFrame: 7, 15, and 20 minutes post challenge at 14 days
measure: Eyelid Swelling
timeFrame: 7, 15, and 20 minutes post challenge at 14 days
measure: Percentage of Eyes With hTearing
timeFrame: 7, 15, and 20 minutes post challenge at 14 days
measure: Percentage of Eyes With Ocular Mucus Discharge
timeFrame: 7, 15, and 20 minutes post challenge at 14 days
Other outcomes:
Locations:
city: North Andover
country: United States
facility: Ophthalmic Research Consultants, Inc.
state: Massachusetts
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Laura Trusso
role: STUDY_DIRECTOR
References:
Clinical trial NCT01520233: Gene Expression in Predicting Outcome in Samples From Patients With High-Risk Neuroblastoma
Official title: Genome Based Outcome Prediction in High Risk Neuroblastoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroblastoma
Keywords: disseminated neuroblastoma
localized unresectable neuroblastoma
recurrent neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-01-27
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neuroblastoma patients treated at the University of Chicago, St. Jude Children's Research Hospital, Children's Memorial Hospital, or Texas Children's Hospital.

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in RNA and predict how patients will respond to treatment. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies gene expression in predicting outcomes in samples from patients with high-risk neuroblastoma.

Detailed description: OBJECTIVES:

* To test the correlation of a previously published microarray gene expression signature with the gene expression obtained with the nCounter™ Analysis System using RNA isolated from formalin-fixed, paraffin-embedded (FFPE), high-risk neuroblastoma samples.
* To construct, test, and validate a novel robust classifier that can be readily integrated into the clinic.

OUTLINE: This is a multicenter study.

RNA samples extracted from paraffin-embedded tissue are analyzed for gene signature expression levels by nCounter™ Analysis System and correlated with published microarray expression data. Results are then used to develop a refined gene-expression-profile classifier of ultra high-risk neuroblastoma.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Formalin-fixed paraffin-embedded tumor sections linked to clinical and outcome data collected from high-risk neuroblastoma patients (n=100) treated at the University of Chicago, St. Jude Children's Research Hospital, Children's Memorial Hospital, or Texas Children's Hospital

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Linear correlation between the nCounter™ Analysis System and the expression data obtained in microarray platforms
measure: nCounter™ Analysis System and microarray platforms equally predictive of outcome in the high-risk group of neuroblastoma patients
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Chicago Comer Children's Hospital
name: Susan L. Cohn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03420833: Metabolic Mapping and Cardiac Resynchronization
Official title: Metabolic Mapping and Cardiac Resynchronization (Aim 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Biotronik SE & Co. KG
First posted: 2018-02-05
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-center, randomized cross-over study
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to gather information on the safety and effectiveness of cardiac resynchronization therapy (CRT) in patients who have mild heart failure (HF) and left bundle branch block (LBBB).


Eligibility criteria: Inclusion Criteria:

* Left Ventricular Ejection Fraction (LVEF) 35%-50%
* New York Heart Association (NYHA) class I-II
* QRS duration of ≥120ms
* Left bundle branch block (LBBB)
* Patient is able to receive a transvenous pectoral CRT implant
* Patient is able to sign informed consent
* Two echocardiograms are required to confirm a stable reduced LVEF
* Patient is on optimal and stable medical therapy (ACE inhibitor or angiotensin II type 1 (AT1 )blocker, beta blocker, etc. over the last 6 months)

Exclusion Criteria:

* Advanced comorbid conditions with life expectancy \<1 year
* Patient is \<18 of years of age
* Patient has a CRT device
* Female patients who is pregnant or not on a reliable form of birth control. Women of childbearing potential are required to have negative pregnancy test within the 7 days prior to device implant
* Unwilling or unable to return for required follow-up visits
* Patient decides study participation is cost-prohibited

Primary outcomes:
measure: Change in Left Ventricle End-Systolic Volume Index (LVESVI)
timeFrame: baseline, 12 months
measure: Number of Subjects Experiencing Any System-Related Complications
timeFrame: Approximately 12 months
Secondary outcomes:
measure: Number of Subjects Admitted to the Hospital for Heart Failure
timeFrame: Approximately 12 months
measure: Change in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) by CRT Randomization From 6 Months to 12 Months
timeFrame: 6 months, 12 months
measure: Number of Subjects Who Experience Sustained Ventricular Tachycardia or Fibrillation Greater Than 30 Seconds
timeFrame: Approximately 12 months
measure: Change in Left Ventricular Ejection Fraction (LVEF)
timeFrame: Baseline, 12 months
measure: Number of Subjects Who Die in One Year
timeFrame: Approximately 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Yong-Mei Cha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02924233: Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer
Official title: An Open-label, Randomized, Multicenter, Phase 1b/2b Trial Investigating the Safety and Preliminary Antitumor Effects of Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Squamous Non-Small Cell Lung Cancer
Keywords: Squamous
Non-Small Cell Lung Cancer
NSCLC
Lead sponsor: Symphogen A/S
Sponsor class: INDUSTRY
First posted: 2016-10-05
Enrollment: 0
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: This is a phase 1b/2b study investigating the safety and preliminary antitumor effects of Sym004 in combination with nivolumab versus nivolumab monotherapy when administered every second week.


Eligibility criteria: Main Inclusion Criteria:

* Signed and dated written informed consent
* Male or female ≥18 years of age at the time of informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy \>3 months assessed during Screening
* Histologically or cytologically confirmed, locally advanced or metastatic squamous NSCLC

Main Exclusion Criteria:

* Any antineoplastic agent (standard or investigational) within 2 weeks prior to starting trial treatment
* Radiosurgery or radiotherapy for target lesions within 2 weeks prior to starting trial treatment
* Prophylactic use of hematopoietic growth factors within 1 week prior to starting trial treatment
* Active Central Nervous System (CNS) metastases or carcinomatous meningitis
* Women who are pregnant
* Women who are breastfeeding

Primary outcomes:
measure: Phase 1b: Determination of the Dose-Limiting Toxicities (DLT) and the MTD and/or RP2D of escalating doses of Sym004 in combination with a standard dose of nivolumab
timeFrame: 1 year
measure: Phase 2b: Evaluation of the antitumor effects of the RP2D of Sym004 when administered in combination with a standard dose of nivolumab as measured by Response Rate
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06360133: Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease
Official title: A Phase 3, Randomized, Double-Masked, Vehicle-controlled, Multi-center Study Evaluating the Safety and Efficacy of 5% VVN001 in Chinese Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Dry Eye
Lead sponsor: VivaVision Biotech, Inc
Sponsor class: INDUSTRY
First posted: 2024-04-11
Enrollment: 700
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 3, randomized, double-Masked, vehicle-controlled, multi-center study designed to evaluate the safety and efficacy of 5% VVN001 Ophthalmic Solution versus vehicle in Chinese subjects with dry eye disease.


Eligibility criteria: Inclusion Criteria:

* Provided written informed consent prior to any study-related procedures.
* Are between 30 and 80 years of age.
* Have a history of dry eye disease in both eyes.
* Have been using artificial tears within 30 days of the screening visit
* Have an Eye dryness score ≥50 (0-100 point VAS)
* Have ongoing dry eye disease in the same eye or both eyes, as defined by all of the following criteria in the study eye and the same eye at Visit 1 and Visit 2: 1) total CFS (tCFS) score ≥6; 2) any subregion CS score ≥2.5; 3) Schirmer score (without anesthesia) ≥1 and ≤7 mm/5 min.
* Have a BCVA in the study eye of ≥4.3 (Standard for Logarithmic Visual Acuity Charts, 5-mark record).

Exclusion Criteria:

* Have a known hypersensitivity or contraindication to the IP or components of IP.
* Have history of uncontrolled glaucoma, IOP over 21 mmHg in either eye at the screening visit or are being treated with eye drops for glaucoma in the study eye. Or the subject has had laser or surgery for glaucoma in the study eye within 90 days of the study.
* Woman of childbearing potential (WOCP) who are pregnant, lactating, or preparing for pregnant.

Primary outcomes:
measure: Corneal Fluorescein Staining
timeFrame: Day 84
Secondary outcomes:
measure: Eye Dryness
timeFrame: Day 84
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & Ent Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Eye & ENT Hospital of Fudan University
name: Xinghuai Sun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01758133: Influence of Medical Clown Activity on Milk Production of Mothers of Premature Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Milk
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-01-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mothers of premature infants

Brief summary: The aim of this study is to determine whether medical clown activity enables relaxation of mothers of premature infants, and as a result increases their breast milk production.


Eligibility criteria: Inclusion Criteria:

* Nursing mothers of infants born less than 34th week

Exclusion Criteria:

* Sick mothers
* Take medication forbidden during nursing

Primary outcomes:
measure: Amount of breast milk produced
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT05864833: METabolism After Orthopedic Surgery
Official title: Study of Energy Metabolism Modifications in Patients Undergoing Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopedic Disorder
Metabolism and Nutrition Disorder
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 51
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients undergoing elective major orthopedic surgery, such as hip, knee, or spine surgery.

Brief summary: This prospective observational study evaluates changes in resting basal metabolic rate in 51 adult patients undergoing elective major orthopedic surgery (hip, knee, or spine surgery).


Eligibility criteria: Inclusion Criteria:

* Age ≥55
* Male and female gender
* Major elective orthopedic surgery (hip, knee, spinal)
* Signature of the informed consent

Exclusion Criteria:

* Inability to follow the study protocol
* Neuropsychiatric disease, developmental disorders

Primary outcomes:
measure: Changes in basal energy expenditure
timeFrame: Day before surgery and first day after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCCS Istituto Ortopedico Galeazzi
name: Matteo Briguglio
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01858233: The IBEP Study: an Intervention for Lifestyle Modification in Women With Gestational Diabetes
Official title: The IBEP Study: a Randomized Control Trial of an Educational Intervention for Lifestyle Modification in Women With Gestational Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Weight Gain During Pregnancy
Weight Loss After Pregnancy
Keywords: Gestational diabetes
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The IBEP study is a randomized control trial of a healthy lifestyle intervention program for women with gestational diabetes. The primary aim of the study is to evaluate whether women with gestational diabetes enrolled in an intensive behavioral educational program (IBEP) demonstrate lower mean fasting glucose levels measured by 2 hour 75 gram oral glucose tolerance test (OGTT) at 6 weeks postpartum compared to women with gestational diabetes who undergo routine gestational diabetes education and counseling.


Eligibility criteria: Inclusion Criteria:

* women diagnosed with gestational diabetes between 20 and 34 weeks gestation

Exclusion Criteria:

* women on chronic steroid therapy
* women with a diagnosis of GDM \<20 weeks or \>34 weeks

Primary outcomes:
measure: The IBEP Study
timeFrame: 2 years
Secondary outcomes:
measure: The IBEP Study
timeFrame: 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Celeste Durnwald, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Durnwald CP, Kallan MJ, Allison KC, Sammel MD, Wisch S, Elovitz M, Parry S. A Randomized Clinical Trial of an Intensive Behavior Education Program in Gestational Diabetes Mellitus Women Designed to Improve Glucose Levels on the 2-Hour Oral Glucose Tolerance Test. Am J Perinatol. 2016 Oct;33(12):1145-51. doi: 10.1055/s-0036-1585085. Epub 2016 Jul 11.
Clinical trial NCT01746433: Mobility of Elderly Patients When Using the "l'Ergonome" Mobility Device
Official title: Evaluation of the Mobility of Elderly Patients (> 65 Years) When Using the "l'Ergonome" Mobility Device: a Randomized, Monocentric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supine Position
Elderly
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 37
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective of this study is to compare the percentage of patients that successfully pass from a laying position to a sitting position in less than 10 seconds between study arms:

* experimental arm: these patients will use the ERGONOME device to help them sit up
* standard arm: these patients will use traditional hanging triangle bar to help them sit up

Detailed description: The secondary objectives of this study are to compare the following between study arms:

* The average time (s) required to sit up
* How the patient's center of gravity moves in relation to a fixed axis

Eligibility criteria: Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient must be in stable medical condition (no complications for the last 10 days)
* The patient is incapable of changing from a laying position to a sitting position by his/herself in \<10 secondes, and requires help for such movement
* The patient has a sitting-balance score \> 2/4 (Brun et al 1991: Actual Rééduc Réadaptat: (16):412-7))

Exclusion Criteria:

* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient has fractured vertebrae or pelvis
* The patient has a weak heart
* The patient has joint pain localized to the dorso-lumbar region
* The patient has behavioral disorders (opposition, agitation, dementia)
* The patient has a medical prescription for physical restraint by bed rails.
* The patient is incapable of understanding the utility of the proposed technical aide, and using it for rolling and sitting up (notion of compliance).

Primary outcomes:
measure: Successful transition from a laying position to a sitting position
timeFrame: Baseline (day 0)
Secondary outcomes:
measure: Time needed to sit up
timeFrame: baseline (day 0)
measure: Shift in the patient's center of mass (cm)
timeFrame: baseline (day 0)
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Emilie Viollet, MD
role: PRINCIPAL_INVESTIGATOR
References: