louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04500821: Evaluation of the LipiFlow System With a New Activator
Official title: Evaluation of the LipiFlow System With a New Activator (Model LFD-2100)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meibomian Gland Dysfunction
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-05
Enrollment: 44
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Minimum 50 eyes and up to 100 eyes will be treated in this prospective, open-label clinical study. The investigator or designee will perform LipiFlow treatment with the Activators LFD-2100 on both eyes of a subject. The data from the treatment reports generated by the LipiFlow console and from the questionnaire will be used to assess the clinical utilization of the Activator LFD-2100. This study will be conducted in up to four sites in the USA.


Eligibility criteria: Inclusion Criteria:

To be able to participate in this study, subjects must:

* Be at least 22 years old.
* Has been diagnosed as bilateral MGD prior to the study visit, or has evidence of MGD in both eyes. NOTE: MGD diagnosis can be based on prior medical records, investigator opinion or based on assessment of meibomian glands of the lower eyelid.
* Availability, willingness, ability and sufficient cognitive awareness to comply with study protocol, examination procedures and visit.
* Be willing to provide informed consent and authorization to disclose protected health information or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical procedures.
* Ability to understand and respond in English.

Exclusion Criteria:

Subject will not be able to be in the study, if the subject:

* Has a history of certain medical conditions that have been identified as contraindications and precautions of the LipiFlow System
* Has a history of prior eye surgery or trauma, active eye disease, or other eye abnormality in the study eye(s), which in the opinion of the investigator would confound the study results.
* Is pregnant, or is breast feeding.
* Concurrent participation or expected participation in an interventional (i.e., surgical or pharmaceutical interventional) clinical trial within 14 days prior to study screening.

Primary outcomes:
measure: Successful Completion of LipiFlow Treatment With Activator LFD-2100
timeFrame: 1 day after completion of LipiFlow treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Empire Eye and Laser Center
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Hurst
country: United States
facility: Texas Eye Research Center
state: Texas
Study officials:
affiliation: Johnson & Johnson Surgical vision
name: Johnson & Johnson Surgical Vision Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04333121: Modelling Weight Reference Centiles for Preterm Infants
Official title: Modelling Predictive gender-and Gestation-specific Weight Reference Centiles for Preterm Infants Using a Population-based Cohort Study at Neonatology Unit of Assuit University Children Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre-Term
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is an observational retrospective study achieved by collecting retrospective, longitudinal measurements of weight from preterm infants born at \<34 weeks gestation, starting from birth, and model gender- and gestation specific predictive centile charts till discharge from the neonatal unit by a population-based cohort study.

Brief summary: The aim of this study is to model longitudinal data at NICU of Assuit University Children Hospital to create predictive growth charts for weight in preterm infants from birth till discharge, that take into account the differing growth rates post-birth when compared to in-utero growth ,and to compare it with WHO chart for preterms.

Detailed description: It is an observational retrospective study achieved by collecting retrospective, longitudinal measurements of weight from preterm infants born at \<34 weeks gestation, starting from birth, and model gender- and gestation specific predictive centile charts till discharge from the neonatal unit by a population-based cohort study.

Eligibility criteria: Inclusion Criteria:

* Data will be collected for all infants born at \<34 weeks of gestation who were delivered by vaginal or caesarian section and born at Assuit University Hospital or referred to it.

Exclusion Criteria:

* (1) Any neonate born at 34 weeks of gestation or more, (2) any neonate born at \<34 weeks of gestation who died before a second weight could be recorded.

Primary outcomes:
measure: Modelling predictive gender-and gestation-specific weight reference centiles for preterm infants using a population-based cohort study at neonatology unit of Assuit University Children Hospital
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Dusick AM, Poindexter BB, Ehrenkranz RA, Lemons JA. Growth failure in the preterm infant: can we catch up? Semin Perinatol. 2003 Aug;27(4):302-10. doi: 10.1016/s0146-0005(03)00044-2.
citation: Secher NJ, Kern Hansen P, Thomsen BL, Keiding N. Growth retardation in preterm infants. Br J Obstet Gynaecol. 1987 Feb;94(2):115-20. doi: 10.1111/j.1471-0528.1987.tb02336.x.
Clinical trial NCT03120221: Iodine Status in Pregnant Women in Israel
Official title: Iodine Status in Pregnant Women in Israel
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iodine-Deficiency; Hypothyroidism
Keywords: Pregnancy
Iodine deficiency
Thyroid
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: First trimester pregnant women in Israel

Brief summary: Worldwide Data suggest that Iodine deficiency is a concern among healthy pregnant women. Thus, screening first trimester healthy pregnant women for iodine status is of clinical value for mother and child as iodine deficiency might have implications on thyroid function as well as pregnancy outcomes

Detailed description: New emerging data suggest pregnant women in Israel are iodine deficient in the first trimester of pregnancy. This is of major concern as first trimester iodine sufficiency is critical for the development of the fetal brain. Our aim is to evaluate iodine consumption in first trimester pregnant women in Israel through dietary questioners, Urinary iodine samples and thyroid functions test assessed through blood samples. All data will be analyzed in a central lab.

Eligibility criteria: Inclusion Criteria: First trimester pregnant women with a singleton pregnancy

Exclusion Criteria:

1. Women with a known thyroid disease treated or untreated
2. Women who received contrast material in the year previous to the study
3. women with any chronic disease
4. Women who receive chronic medication not including vitamins

Primary outcomes:
measure: Evaluation of average iodine consumption in food
timeFrame: 1 year
measure: Evaluation of urinary iodine concentration
timeFrame: 1 year
measure: Thyroid function test measurement
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ashdod
country: Israel
facility: Women Health Service
city: Tel Aviv
country: Israel
facility: Women Health Center
Study officials:
affiliation: Clalit Health Services
name: Viviana Ostrovsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02786121: The Role of Kinesiophobia in the Functional Recovery After Hip Replacement
Official title: Is Kinesiophobia a Predictive Factor of the Early Functional Recovery After Total Hip Replacement? - An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Osteoarthritis
Keywords: hip replacement,
rehabilitation,
early ambulation,
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2016-05-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total hip arthroplasties patients following chronic joint disease

Brief summary: Several authors explain as the kinesiophobia plays an important role for the recovery after orthopaedic surgery. The aim of the investigators study is to investigate if the kinesiophobia is able to influence the early recovery after total hip arthroplasty. The early recovery will be measured by the ILOA Score. The Tampa Scale of Kinesiophobia will measure the fear level of movement. All the other variable that could influence the ILOA Score are identified and collected: age, sex, body max index, ability of patient pre-surgery, type of anesthesia, length of stay, pain, haemoglobin, possible complications.


Eligibility criteria: Inclusion Criteria:

* Primary hip joint replacement
* Clinical symptoms from more than 3 months

Exclusion Criteria:

* other orthopaedic surgery on the lower limb In the last year
* Not italian speaking
* Hip arthroplasty following fractures, revision surgery, and partial replacement
* Patients with concomitant neurologic (Parkinson, ictus), rheumatologic (rheumatoid arthritis) diseases,
* cognitive impaired.

Primary outcomes:
measure: Iowa Level of Assistance (ILOA) Score
timeFrame: 5 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Mattia Morri
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morri M, Venturini E, Franchini N, Ruisi R, Culcasi A, Ruggiero A, Govoni C, Benedetti MG. Is kinesiophobia a predictor of early functional performance after total hip replacement? A prospective prognostic cohort study. BMC Musculoskelet Disord. 2020 Nov 7;21(1):724. doi: 10.1186/s12891-020-03748-7.
Clinical trial NCT04961021: Management of Consecutive Exotropia
Official title: Management of Consecutive Exotropia and Its Effect on Ocular Motility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strabismus
Concomitant Squint
Divergent Strabismus
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Patients with consecutive exotropia will be managed by medial rectus muscle advancement +/- resection or medial rectus muscle advancement +/- lateral rectus recession


Eligibility criteria: Inclusion Criteria:

* Patients with consecutive exotropia.
* Eight years old or more.
* Cooperative patients.

Exclusion Criteria:

* Adduction deficit.
* Mental disability.

Primary outcomes:
measure: Percentage of patients with satisfactory postoperative alignment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine
state: Minia
Study officials:
affiliation: Faculty of Medicine, Minia University
name: Sahar TA Abdelaziz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04456621: Proton Beam Therapy for Unresectable Liver Metastasis
Official title: Proton Beam Radiotherapy for Unresectable Liver Metastasis: Prospective Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Local Control Rate
Side Effect
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Proton beam radiotherapy : 5 fractions of 12 GyRBE or 10 fractions of 7 GyRBE
Primary purpose: TREATMENT

Brief summary: The investigators performed the present study to evaluate the role of proton beam therapy for liver metastasis which is unresectable and unsuitable for radiofrequency ablation (RFA) in terms of local control and safety.


Eligibility criteria: Inclusion Criteria:

* pathologically diagnosed cancer patient
* confirmed liver metastasis via computed tomography (CT) or magnetic resonance imaging (MRI) or biopsy
* unresectable or unsuitable for RFA
* solitary liver metastasis or less than 3 metastatic lesions if the distance is less than 3 cm between metastatic lesions
* case discussed by surgeon, radiologist, and radiation oncologist
* Eastern cooperative oncology group performance status 0 to 2
* optimal liver and renal function (Child-Pugh score 10 or less)
* informed consent
* agree to be contraceptive for the duration of the study and for the next 6 months

Exclusion Criteria:

* uncontrolled ascites or hepatorenal syndrome
* status of pregnancy or breast-feeding
* less than 12 weeks of expected survival
* combined disease known to have high radiation side effects
* serious acute illness that is not treated other than liver disease

Primary outcomes:
measure: 6 month local control rate
timeFrame: at the point of 6 month follow-up after proton beam therapy
Secondary outcomes:
measure: Overall survival rate
timeFrame: at the point of 2 year follow-up after proton beam therapy
measure: 6 month side effect
timeFrame: at the point of 6 month follow-up after proton beam therapy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT05360121: Muscle Energy Technique Versus Back Stretching Among Non-specific Low Back Pain-subacute
Official title: Effects of Muscle Energy Technique and General Stretching in the Management of Sub-acute Non-specific Low Back Pain :A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinding will be used in which only the researcher doing the study knows which treatment or intervention the participant is receiving until the trial is over.
Primary purpose: TREATMENT

Brief summary: This study will highlight LBP management using MET and stretching application among subacute type of back pain

Detailed description: This study will explore effects of two approaches , out of two MET has not been used in clinical practice more often, therefore this study will explore its physiological impact among back pain

Eligibility criteria: Inclusion Criteria:

- low back pain (subacute)

* VAS score( more than 3 cm)
* Quadratus lumborum and erector spinae tightness present

Exclusion Criteria:

* back pain (specific)

Primary outcomes:
measure: Change from Visual Analogue scale scores at 3 weeks
timeFrame: at baseline and 3 weeks
measure: Change from Rolland Morris Disability Questionnaire scores at 3 weeks
timeFrame: at baseline and 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Sindh Institute of physical medicine and rehabilitation
state: Sindh
Study officials:
References:
Clinical trial NCT02847221: Cough Peak Flow for Extubation Prediction
Official title: Assessing Cough Peak Flow (CPF) Using Ventilator built-in Flow-meter to Predict Extubation Success: A Single Centre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extubation in ICU Patients
Keywords: cough peak flow
scheduled weaning trial
scheduled extubation
prognosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 92
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 admitted to a 15-bed medical ICU from November 1st 2014 to October 31st 2015

Brief summary: Successful weaning from mechanical ventilation in ICU patients depends on patient ability to breathe spontaneously and on cough efficiency. Previous studies found that cough peak flow (CPF) at 60 L/min threshold predicted extubation failure. These studies measured CPF using a dedicated flow-meter that required patient disconnection from the ventilator, limiting the generalizability of this procedure. This study aimed to predict extubation outcome in a consecutive series of patients by measuring CPF from the ventilator flow-meter. CPF measurements were done by freezing ventilator screen and scrolling the cursor to the maximal value of CPF during expiration and Tidal Volume (TV) in preceding inspiration.

The objective was to assess the performance of CPF to predict early extubation outcome.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Intubation \> 24h
* Eligible for scheduled weaning trial and then scheduled extubation
* Mechanical ventilation from Evita XL ventilator (Dräger, Germany)
* Patient's agreement to participate

Exclusion Criteria:

- Withdrawal decision of life supporting care

Primary outcomes:
measure: Early extubation success rate (EES rate)
timeFrame: 48 hours
Secondary outcomes:
measure: Scheduled weaning trial success rate
timeFrame: 48 hours
Other outcomes:
Locations:
city: Lyon
country: France
facility: Medical Intensive care unit, Croix-Rousse Hospital. 103 Grande Rue de la Croix-Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Florent GOBERT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gobert F, Yonis H, Tapponnier R, Fernandez R, Labaune MA, Burle JF, Barbier J, Vincent B, Cleyet M, Richard JC, Guerin C. Predicting Extubation Outcome by Cough Peak Flow Measured Using a Built-in Ventilator Flow Meter. Respir Care. 2017 Dec;62(12):1505-1519. doi: 10.4187/respcare.05460. Epub 2017 Sep 12.
Clinical trial NCT03174821: Effect Insulin Pump Therapy to Patients With Diabetic Nephropathy
Official title: The Impact of Insulin Pump Therapy to Oxidative Stress in Patients With Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Pump Therapy in Treating Diabetic Nephropathy
Keywords: Diabetic nephropathy
Insulin pump intensive therapy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Normal group (NC) and Type 2 diabetic (DM) group
Primary purpose: TREATMENT

Brief summary: The recent study suggested that oxidative stress resulting from increased production of reactive oxygen species (ROS) plays a crucial role in the development of diabetic complications. The researches aim to monitor the level of oxidative stress of patient in different stage of diabetic nephropathy before and after insulin pump therapy.

Detailed description: Worldwidely, about 30% of Type 1 Diabetes Mellitus (T1DM) and 20%-50% of T2DM patients suffered diabetic nephropathy (DN). Oxidative stress resulting from increased production of reactive oxygen species (ROS) plays a crucial role in the development of diabetic complications. Insulin pump therapy is better than subcutaneous injection in terms of the drug safety and effectiveness. The researches aim to monitor the level of oxidative stress of patient in different stage of diabetic nephropathy before and after insulin pump therapy.

Eligibility criteria: Inclusion Criteria:

Diabetic patients with fasting plasma glucose (FPG) ≥10mmol/l and/or 2 hours' plasma glucose (2hPG) ≥15mmol/l.

Exclusion Criteria:

Diabetic patients who

1. using antioxidant drugs within one month;
2. accompanied with acute and chronic severe complications, fever, malignant tumor, nephritis, congestive heart failure.
3. accompanied with diabetic ketosis, ketoacidosis, severe hypoglycemia, hyperosmolar hyperglycemic state;
4. with other endocrine diseases, autoimmune diseases, or connective tissue diseases;
5. having history of infection within 1 month;
6. having drug or alcohol dependence;
7. severe hypoxia and stress state (e.g., cardiovascular events, trauma, surgery, and consumptive disease, etc.)

Primary outcomes:
measure: The change of 8-hydroxy-deoxyguanosine (8-OHdG)
timeFrame: 2 weeks
Secondary outcomes:
measure: The change of 3-nitrotyrosine (3-NT)
timeFrame: 2 weeks
measure: The change of glutathione (GSH)
timeFrame: 2 weeks
measure: The change of superoxide dismutase (SOD)
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Center for Drug Evaluation, China food and Drug Administration
name: Min Liu
role: STUDY_CHAIR
References:
citation: Zhang XG, Zhang YQ, Cheng QP, Cao Y, Sun JM, Lv XF. The impact of insulin pump therapy to oxidative stress in patients with diabetic nephropathy. Eur J Med Res. 2018 Feb 12;23(1):7. doi: 10.1186/s40001-018-0304-2.