cyrilzakka/clinical-trials huggingface dataset:
Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial

The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27 and 31 weeks of gestation.

Participants will be randomized once they reach 120 mL/kg/day. Clinicians will be able to increase feeds each day as they see fit, until the patient reaches the target goal of 140-160 mL/kg/day or 180-200 mL/kg/day. They will then maintain this volume until 34 weeks postmenstrual age. Researchers will compare these two targets to see if higher feeding volumes prevent faltering growth without causing adverse metabolic outcomes.

Participants will:

* Have a feeding volume of 180-200 mL/kg/day or a volume of 140-160 mL/kg/day until 34 weeks corrected age
* Have four body composition assessments with a bioelectrical impedance analyzer throughout study period
* Have four stool samples collected throughout study period
* Have four maternal breastmilk samples collected and analyzed throughout the study period
* Have one blood sample collected at 36 weeks corrected age
* Have the option to participate in a follow-up survey completed by parents at 2-3 years of age

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 27 0/7 and 31 6/7 weeks
* Birthweight of 1500 grams or less
* Human milk feeding during the first 14 days after birth
* Full enteral feeding (120mL/kg/day or more) within the first 14 days after birth

Exclusion Criteria:

* Necrotizing enterocolitis stage 2 or greater
* Spontaneous intestinal perforation
* Major congenital/chromosomal anomalies
* Terminal illness requiring limited or withheld support
* Intention to restrict fluid intake after the first 14 postnatal days due to the presence of a symptomatic patent ductus arteriosus (PDA)
* Any formula feeding within the first 14 days after birth
The Reliability And Validity Of A Smartphone App

The goal of this observational study is to validate a smartphone app called Angulus. The main question it aims to answer is:

• Is an Angulus App valid and reliable system for masuring hand and wrist range of motion?

Participants will be evaluated by goniometers which is a gold standart for range of motion assessment.


Eligibility Criteria:
Inclusion Criteria:

* a history of previous traumatic hand or wrist injury in the upper extremity,
* pain in the hand and wrist during evaluation
* orthopedic, neurologic, or rheumatologic disease

Exclusion Criteria:

* not to understand the command that the therapist give
Health Practice of Hemophilia Patiente Care During Pregnancy, Delivery and Newborn Children

Prenancy and specialy delivery for hemophilia mother and her children possibly hemophilia is risked.

Diagnostical of hemophilia pregnan is the first difficulty but patients with hemorrhagic menstruation without etiology known, hemorrhagic complication during a chirurgical procedure or during previously pregnancy currently are examine in Haemostasis consultation.

None French recommendation specifie for health practice of these hemophilia patients exists. However, Anglo-Saxon recommendations are published in 2011.

The objective of this study is to realize a French investigation of health practice about hemophilia care of these patients and to compare them with the English reference table.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* Hemophilia A or B
* Pregnancy between 2014 and 2016

Exclusion Criteria:

- Opposition
A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413)

The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of seasonal allergic rhinitis caused by pollen. Ciclesonide will be administered once during the exposure to ragweed pollen in a controlled environment. The study duration consists of a baseline period (up to 5 days) and a treatment period (1 day). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent
* General good health
* History of SAR to short ragweed pollen for 2 years immediately preceding the study
* Demonstrated sensitivity to short ragweed known to induce SAR through a standard skin prick test

Main Exclusion Criteria:

* Clinically significant physical finding of nasal anatomical deformities causing greater than 50% obstruction, including but not limited to nasal polyps, septal defects, respiratory tract malformations, nasal trauma or surgery
* Known hypersensitivity to any corticosteroid
* History of a respiratory infection or disorder including but not limited to bronchitis, pneumonia, chronic sinusitis, influenza or SARS (severe acute respiratory syndrome) within 14 days preceding the Screening Visit
* History of alcohol or drug abuse within 2 years preceding the Screening Visit
* Active asthma requiring treatment of inhaled or systemic corticosteroids and/or routine use of beta-agonists or any controller drugs
* Use of antibiotic therapy for acute conditions within 14 days preceding the Screening Visit
* Exposure to systemic corticosteroids for any indication, chronic or intermittent within 60 days preceding the Screening Visit
The Effect of a Shaken Baby Syndrome Prevention Program

Objective: This randomized controlled study aims to examine whether the education program prepared to prevent shaken baby syndrome has an effect on mothers' knowledge and attitudes.

Method: Simple randomization will be used to evaluate the intervention and control groups. The study will be carried out with 90 mothers babies of 2-4 months, who applied to Akdeniz University Hospital Healthy Child Outpatient Clinic (intervention group: 45, control group: 45). After the pre-test, the mothers in the intervention group will be trained and a booklet will be given. Tele-consultancy service will be provided to mothers during the 2-month follow-up period. After 2 months of follow-up, a post-test will be applied to the mothers in the intervention group. The mothers in the control group will not be intervened after the pretest is applied. A post test will be applied 2 months after the pre-test. After the post-test, the mothers in the control group will be trained and a booklet will be given. Ethics committee approval and institutional permission were obtained for the study. Verbal and written consent will be obtained from the mothers during the data collection phase.

Method: The study will be conducted with 90 mothers with 2-4 months old babies who applied to Akdeniz University Hospital Healthy Children Polyclinic (intervention group: 45, control group: 45). Personal Information Form, Shaken baby syndrome assessment survey will be used to collect data. Simple randomization will be used to evaluate the intervention and control groups. In order to identify mothers in intervention groups, sealed-envelope randomization method will used. Mothers and statistician group will be unaware of the evaluation. The researcher will not be blind because of the role he plays in the research.

Following the pretest, the intervention group will be trained to prevent shaken baby syndrome. Expert opinion was obtained from 10 expert faculty members for the content of the training. After the training, the booklet prepared in line with expert opinions will be given to the mother in the intervention group. The booklet will remain with the mother. Tele-consultancy will be given to the mother for 2 months after the pre-test. The control group will also be tested beforehand and will not be intervened afterwards. 2 months after the pre-test, a post-test will be applied to the control group and training will be given to prevent shaken baby syndrome. A training booklet will be given to the mothers in the control group after the final test.

Statistical analysis will be done using SPSS 23.0 and statistical significance will be set at p \<0.05.

Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz University.

Eligibility Criteria:
Inclusion criteria:

Having a baby of 2-4 months, Free from physical or mental disability

Exclusion Criteria:

Unhealthy (mother or baby), Any SBS education in the last 2 years
Practicability of Gliding Aids for Medical Compression Stockings

Medical compression stockings are highly effective in the prevention, treatment, and secondary prevention of chronic venous insufficiency and of post-thrombotic syndrome. Non-adherence to the prescribed compression treatment concerns approximately 40% of patients. Elderly patients are often unable to handle stockings in order to put them on properly in the morning and to undress in the evening. Gliding aids and stocking "butlers" are two types of tools to facilitate the dressing manoeuvre with medical stockings.

The present study evaluates four different gliding aids and two different stocking "butlers" to put on three different types of compression stockings. The study is conducted with forty consenting subjects with advanced chronic venous insufficiency.

Subjects: 40 consenting patients \>65y old, with CEAP C4-6 chronic venous insufficiency

Stockings:

One class 3 (36 - 46 mmHg interface pressure) with closed tip One class 3 with open tip Two superimposed class 1 (18 - 21 mmHg)

Gliding aids and stocking "butlers" Three types of gliding aids for closed tip stockings Three types of gliding aids for open tip stockings Two types of stocking "butlers", one optional with mounted handles

Eligibility Criteria:
Inclusion Criteria:

\> 65 years old Chronic venous insufficiency CEAP C4-6

Exclusion Criteria:

Dementia Blindness Paraplegia
A Comparison of Daily Disposable Contact Lenses.

This study seeks to evaluate the clinical performance of a new CE marked daily disposable contact lens that contains a wetting agent to a recently improved daily disposable contact lens.


Eligibility Criteria:
Inclusion Criteria:

* They are of legal age (18 years) and capacity to volunteer.
* They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
* They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
* They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
* They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria:

* They have an ocular disorder which would normally contra-indicate contact lens wear.
* They have a systemic disorder which would normally contra-indicate contact lens wear.
* They are using any topical medication such as eye drops or ointment.
* They are aphakic.
* They have had corneal refractive surgery.
* They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
* They are pregnant or lactating.
* They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
* They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
* They have diabetes.
* They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Evaluation of Antithrombin Deficiency in Patients of Intensive Care Unit Placed on Extracorporeal Membrane Oxygenation

Prospective, monocentric, non-interventional study in patients placed on extracorporeal membrane oxygenation (ECMO)

Our hypothesis is that ECMO initiation is responsible for a severe decrease of antithrombin level in a high proportion of patients who develop heparin resistance.

Eligibility Criteria:
Inclusion Criteria:

* Any ICU patient of receiving veno-arterial extracorporeal membrane oxygenation
* Patients who have not expressed opposition to participate

Exclusion Criteria:

* Arterial thrombosis or progressive venous thrombosis
* Contraindication to heparin
* Constitutional deficiency in antithrombin
* Patient refusal
* Minor patient
* Protected major (safeguard justice, trusteeship and guardianship) and persons deprived of liberty
To Test Bioequivalence Between Two Tablet Formulations in the Treatment of Allergy

This study is designed to assess bioequivalence between two products used for treatment of allergy.

This study is designed to evaluate if a test formulation of cetirizine 10 mg orodispersible tablet (ODT) taken with and without water is bioequivalent to a marketed reference formulation of cetirizine 10 mg tablet (Benadryl One A Day, McNeil Products Ltd, UK) taken with water. This study will also evaluate the tolerability of test and reference formulations.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects
* Volunteers aged of at least 18 years but not older than 55 years
* Subjects will have a Body Mass Index (BMI) greater than or equal to 18.50 and below 30.00 kg/m2
* Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 12 months before day 1 of this study
* Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis)
* Has signed and dated the informed consent document, indicating that the subject has been informed of all pertinent aspects of the study
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

* Seated pulse rate below 45 bpm or higher than 90 bpm at screening
* Seated blood pressure below 90/60 mmHg or higher than 140/90 mmHg at screening
* Relationship to persons involved directly with the conduct of the study (i.e., principal investigator; sub-investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson \& Johnson subsidiaries; and the families of each)
* Presence of any tongue piercings
* Presence of braces
* Females who are pregnant or are lactating
* Females of childbearing potential or males with a female partner of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study
* Females who are pregnant according to a positive serum pregnancy test
* Any medical history or condition, or use of any drug or medication, that the investigator determines could compromise subject safety or the evaluation of results.
DETErmination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents(EES) Versus Biolimus A9-eluting Stents(BES)

The purpose of the study is 1\> to compare neointimal stent coverage after OCT-guided vs. Angio-guided PCI, 2\> to compare neointimal stent coverage at 3 months after EES vs BES implantation, 3\> to determine the duration of dual antiplatelet therapy by OCT measurement at 3 months


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 20 years old
* Patients with ischemic heart disease who are considered for coronary revascularization with stent implantation.
* Significant coronary de novo lesion (stenosis \> 70% by quantitative angiographic analysis) treated by single DES ≤ 25mm
* Reference vessel diameter of 2.5 to 3.5 mm by operator assessment

Exclusion Criteria:

* Complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
* Reference vessel diameter \< 2.5 mm or \> 4.0mm
* Heavy calcified lesions (definite calcified lesions on angiogram)
* Primary PCI for STEMI
* Contraindication to anti-platelet agents
* Treated with any DES within 3 months at other vessel
* Creatinine level ≥ 2.0 mg/dL or ESRD
* Severe hepatic dysfunction (3 times normal reference values)
* Pregnant women or women with potential childbearing
* Life expectancy \< 1 year
Tolerability of Rebif® (Interferon-beta 1-A) Therapy in Korean Patients With Multiple Sclerosis

This is an observational study to assess the tolerability of Rebif treatment in Korean multiple sclerosis (MS) subjects.

The present observational study is being conducted to assess the safety information from a target of 100 Korean subjects with MS treated with Rebif. Various parameters like subjects' background (age, sex, BMI), MS history, MS status (MS type, Expanded Disability Status Score \[EDSS\] and others), MS Treatment Concern Questionnaire (MSTCQ), Rebif treatment status, concomitant disease modifying agents (DMA) therapy and Rebif related adverse events will be collected. Subjects will be followed for 12 months. Proportion of subjects with moderate to severe (Grade 3-5) injection site reactions after 3, 6, 12 months of Rebif treatment will be determined. Secondary outcomes like annual relapse rate, change in EDSS, changes in MSTCQ, time to first relapse and incidence of side effects associated with Rebif therapy will also be determined and presented descriptively.

OBJECTIVES

Primary objectives

* To assess the tolerability of Rebif treatment in Korean MS subjects in a non-interventional setting Secondary Objectives
* To evaluate subject's satisfaction, clinical data and disease characteristics of the population of MS subjects undergoing Rebif treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects, who are eligible for Rebif treatment according to the indication in the national label of Rebif in Korean subjects with MS. The national labels approved by Korean Regulatory Authority are:

  1. Subjects with relapsing MS with two or more acute exacerbations in the previous two years
  2. Subjects with secondary progressive MS with ongoing relapsing activity
* Subjects who sign the informed consent form.

Exclusion Criteria:

* Initiation of treatment in pregnancy.
* Subjects with a history of hypersensitivity to natural or recombinant interferon-ß, or to any excipients.
* Subjects with current severe depression and/or suicidal ideation.
Recovery From Anesthesia After Robotic Assisted Radical Cystectomy

Robot-assisted radical cystectomy (RARC) requires specific surgical conditions: steep Trendelenburg position, prolonged pneumoperitoneum, effective neuromuscular block until the final stages of surgery. The aim of this study was to evaluate the quality of awakening in two groups of patients undergoing different combinations of curarization/reversal.


Eligibility Criteria:
Inclusion Criteria:

* ASA (american society of anesthesiologists) score ≤ III
* Patients underwent robotic assisted cystectomy

Exclusion Criteria:

* Cerebrovascular disease
* BMI (body mass index) ≥ 30
Adults Habitual Patellar Dislocation:a Multiple-center Clinical Investigation Regarding Diagnosis and Therapeutic Strategy

Adult habitual dislocation of the patella is a common dislocation of the patella. The range of lesions is wide and the severity is high. Clinical diagnosis and treatment are difficult. In clinical work, misdiagnosis and treatment are not targeted at pathological mechanisms. This leads to irregular diagnosis and treatment, high failure rate and revision rate, and patients undergoing multiple operations. The project team developed a "four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement" in the preliminary research, which overcomes the disadvantages of traditional knee extension surgery and is suitable for adults. Early research Shows safe and effective clinical efficacy. The purpose of this application project is to take independent innovation of core surgical technology as the lead, adopt a two-way cohort study method, compare the clinical efficacy of the new "four-in-one" technology and traditional soft tissue surgery in the treatment of adult habitual patellar dislocation, and analyze and formulate adult habituation Comprehensive and systematic solutions for patella dislocation, relying on this scientific research project to conduct multi-center and large-sample clinical case studies, and evaluate the effectiveness and safety of independent innovative technologies through standardized medical research methods to improve the surgical treatment of adult habitual patella dislocation Success rate, reduce recurrence rate and failure rate, improve the level of clinical treatment of the disease, and finally put forward a special clinical diagnosis and treatment system for the disease in the international academic community.


Eligibility Criteria:
Inclusion Criteria:

* Patients with habitual dislocation of the patella over 14 years old
* agree to participate in the study

Exclusion Criteria:

* Combined with other knee ligament injuries
* recurrent patellar dislocation
* Skin and soft tissue conditions do not allow surgery
Subtotal Versus Total Thyroidectomy for Benign Goiter

The extent of thyroid resection in benign goiter is controversial. Potential advantages of TT over BST may include: one-stage removal of incidental thyroid cancer reported in up to 10% of operatively treated benign thyroid diseases, and lower risk for goiter recurrence. However, these potential advantages should outweigh the risk of morbidity associated with more radical thyroid resection.

The aim of this study was to compare outcomes of bilateral subtotal (BST) vs. total thyroidectomy (TT) for benign bilateral thyroid disease.

The extent of thyroid resection in bilateral multinodular non-toxic goiter remains controversial. Surgeons still continue to debate whether the potential benefits of total thyroidectomy outweigh the potential complications. Most low-volume surgeons avoid to perform total thyroidectomy owing to the possible complications such as permanent recurrent laryngeal nerve palsy and permanent hypoparathyroidism. On the other hand, the increasing number of total thyroidectomies are currently performed in high-volume endocrine surgery units, and the indication for this procedure include thyroid cancer, Graves disease and multinodular goiter. Recently there has been increasing acceptance for performing total thyroidectomy for bilateral multinodular non-toxic goiter as it removes the disease process completely, lowers local recurrence rate and avoids the substantial risk of reoperative surgery, and involves only a minimal risk of morbidity. This common perception is based largely on single-institution retrospective data, a few multi-institutional retrospective experiences, and only a few small prospective studies comparing the outcomes of total vs. subtotal thyroidectomy.

Eligibility Criteria:
Inclusion Criteria:

* a benign bilateral thyroid disease with the posterior aspects of both thyroid lobes appearing normal on ultrasound of the neck.

Exclusion Criteria:

* thyroid disease involving the posterior aspect/s of thyroid lobe/s,
* suspicion of thyroid cancer,
* previous thyroid surgery,
* pregnancy or lactation,
* age \< 18 years or \> 65 years,
* ASA 4 grade (American Society of Anesthesiology),
* and inability to comply with the follow-up protocol.