cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Over-glasses Patch Treatment for Amblyopia in Children : OPTA Study

This is a study to investigate efficacy of over-glasses patch treatment for amblyopic children using visual function improvement and Amblyopia Treatment Index (ATI) changes.

In a randomized multi-center controlled clinical trial, children younger than 7 years with moderate amblyopia (visual acuity in the range of 20/40 to 20/100) would be included to receive treatment with either a conventional patch or an over-glasses patch. The patients will be prescribed 2 hours of patching per day for the sound eye. Best-corrected visual acuity (BCVA) and stereopsis will be investigated and ATI questionnaires be collected from parents at 5 weeks and 17 weeks after the initiation of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. moderate amblyopia (logMAR visual acuity in the amblyopic eye 0.3 to 0.7 inclusive)
2. logMAR visual acuity in the sound eye of 0.1 or better
3. intereye acuity difference of larger or equal to 0.3 of logMAR visual acuity
4. the presence of or a history of an amblyogenic factor meeting study-specified criteria for strabismus and/or anisometropia.

Exclusion Criteria:

1. presence of an ocular cause for low vision
2. myopia greater than -6.0 diopters (D) spherical equivalent in either eye
3. prior intraocular or refractive surgery
4. treatment for amblyopia (other than spectacle correction) within the 6 months prior to the enrollment
5. Down syndrome
Comparison of Clinical Efficacy Between Dynamic Dip Screw and Cannulated Compression Screw for Fresh Femoral Neck Fracture

For fresh femoral neck fracture internal fixation, both DHS and CCS can make strong fixation of hip and have good recovery. There is no statistical difference in complications after surgery between the two procedures. Patients with DHS internal fixation have earlier postoperative weight bearing, which is conducive to functional exercise of the injured limb. DHS internal fixation system is recommended for patients with unstable fractures and severe osteoporosis.

Objective: To compare the clinical effect of dynamic hip screw (DHS) and cannulated compression screw (CCS) in the treatment of fresh femoral neck fracture. Methods: A retrospective study was conducted to analyze the data of 91 patients with fresh femoral neck fracture treated with DHS or CCS in our hospital from January 2012 to June 2016.The cases were divided into two groups according to internal fixation: 44 cases in the DHS group and 47 cases in the CCS group. By comparing operative time, intraoperative bleeding, postoperative load, Harris scoring and the complications such as postoperative necrosis of femoral head and shortening of femoral neck appearance, we evaluated the clinical curative effect of two kinds of fixation.

Eligibility Criteria:
Inclusion Criteria:

* fresh femoral neck fracture
* can walk before fracture
* less than 65 years old

Exclusion Criteria:

* Patients combined with other bone fractures.
* Pathological fracture (e.g., primary or metastatic tumor)
* Serious soft tissue injury, judged by the investigator, will impact the union of the fracture, combined open fractures, vascular injury, and combined osteofascial compartment syndrome.
* Multiple systemic injuries judged by researchers not suitable for enrollment. Revision surgeries (for example, due to malunion, nonunion or infection)
* Concurrent medical conditions judged by researchers not suitable for enrollment, such as: metabolic bone disease, post-polio syndrome, poor bone quality, prior history of poor fracture healing, etc
* Patients known to be allergic to implant components
* Patients who are currently using chemotherapeutics or accepting radiotherapy, use systematically corticosteroid hormone or growth factor, or long-term use sedative hypnotics (continuous use over 3 months) or non-steroidal anti-inflammatory drugs (continuous use over 3 months)
* Subjects have significant neurological or musculoskeletal disorders or may have adverse effects on gait or weight-bearing (e.g., muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot arthropathy, avascular necrosis of the femoral head).
Sorafenib and Bevacizumab in Combination With Paclitaxel in Patients With Solid Tumors

The purpose of this study is to evaluate the safety and tolerability and describe the maximum tolerated dose (MTD) of treatment with escalating doses of sorafenib in combination with bevacizumab and paclitaxel for patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of a solid tumor with evidence of residual, recurrent, or metastatic disease. Patients must be incurable by surgical or other standard available therapy
* Measurable or evaluable disease; tumor size of ≥ 2 cm on CT scan
* Patients may have received prior standard taxane therapy or anti-VEGF therapy, but may not have progressed on both therapies. Progression on one type therapy (either taxane or anti-VEGF) is allowed

Exclusion Criteria:

* History or presence of central nervous system (CNS) disease (i.e., primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis).
* Prior chemotherapy ≤ 3 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
* Prior biologic or immunotherapy ≤ 3 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
* Prior full pelvic field radiotherapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to randomization. Patients must have recovered to less than or equal to grade 1 from all therapy-related toxicities except alopecia. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of evaluable disease
* Major surgery (i.e., laparotomy) ≤ 4 weeks prior to randomization or anticipation of need for major surgical procedure during the course of the study
* Minor surgery ≤ 2 weeks prior to randomization. Insertion of a vascular access device is not considered major or minor surgery in this regard. Patients must have recovered from all surgery-related toxicities
* Peripheral neuropathy with functional impairment ≥ Common Terminology Criteria (CTC) grade 2 neuropathy, regardless of causality
* Pleural effusion or ascites that causes respiratory compromise (≥ CTC grade 2 dyspnea)
* Concurrent severe and/or uncontrolled cardiac, vascular or infectious conditions (as described in the protocol) which could compromise participation in the study
* Patients at risk of QT prolongation such as patients with congenital long QT syndrome or with long corrected QT (QTc) at baseline (i.e. QTc greater than 450 msec in males, and greater than 470 msec in females) will be excluded
* Lung carcinoma of squamous cell histology (mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is not acceptable).
Phase Angle as a Marker of Muscle Damage, Muscle Fatigue and Inflammation, After Eccentric Exercise

The purpose of this study will be to assess the effectiveness of bioimpedance device (BIA) as a safe, rapid, and non-invasive method of analyzing muscle damage induced by high intensity induced eccentric exercise as an alternative measurement tool against traditional assessment methods.

A sample of 28 sedentary subjects will be recruited, all participants will perform an eccentric exercise protocol.

Measurements will be done before performing the exercise protocol, immediately after finishing the protocol, 3h after the end of the exercise protocol, 24h after the end of the exercise protocol and 48h after the end of the exercise protocol.

The variables analyzed in all subjects will be phase angle, creatinkinase, jumping strength, VAS scale, white blood count cell, quadriceps muscle thickness, Borg scale and anxiety and depression questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjets
* Sedentary subjects

Exclusion Criteria:

* Trained subjects
* Subjects with musculoskeletal pathology
* Previous Surgeries in the last 6 months
* Subjects under pharmacological treatment
Pilates Effect on Women with and Without Obesity

Obesity, a health problem, is caused by insufficient physical activity and unhealthy nutrition. For individuals with obesity, non-weight-bearing and enjoyable exercises, such as Pilates, should be implemented as physical activity due to potential pain. This study aims to examine the effects of an 8-week Pilates exercise program on body composition, posture, and psychosocial parameters in individuals with and without obesity. Methods: The study included 58 female participants: 30 individuals with obesity (nPilates = 15; nControl = 15) and 28 individuals without obesity (nPilates = 14; nControl = 14). Participants performed Pilates exercises twice a week for 8 weeks. Body Mass Index (BMI), body fat percentage (BFP), and posture scores were calculated, and from a psychosocial perspective Emotional Eating Scale (EE), Social Physique Anxiety Inventory (SPA), and Self-Esteem Scales (SE) were administered before and after the eight weeks.

There are no studies in the literature examining the effects of Pilates exercises on emotional eating and posture. Additionally, there are no studies examining the effects of Pilates on posture in individuals with obesity. Most studies in the literature have focused on sedentary women; however, no study has specifically examined the effects of Pilates-based exercises on individuals with and without obesity. This study aims to investigate the effects of an 8-week Pilates intervention on postural alignment, BMI, fat percentage, and psychosocial parameters (emotional eating, social physical anxiety, and self-esteem) in individuals with and without obesity. Thus, this study will provide valuable insights into the role of Pilates in weight management, posture correction, and psychosocial well-being among individuals with and without obesity. The study included 58 female participants: 30 individuals with obesity (nPilates = 15; nControl = 15) and 28 individuals without obesity (nPilates = 14; nControl = 14). Participants performed Pilates exercises twice a week for 8 weeks. Body Mass Index (BMI), body fat percentage (BFP), and posture scores were calculated, and from a psychosocial perspective Emotional Eating Scale (EE), Social Physique Anxiety Inventory (SPA), and Self-Esteem Scales (SE) were administered before and after the eight weeks.

Eligibility Criteria:
Inclusion Criteria:

* Being a sedentary individual and not not doing regular physical activity
* Being 20 years old or older
* Having a BMI of 30 kg/m² or above for inclusion in the group of women with obesity.
* Having a BMI below 30 kg/m² for inclusion in the group of women without obesity.
* Not having any health problems that would prevent participation in exercise.
* Not having undergone surgery affecting the musculoskeletal system within the last year.

Exclusion Criteria:

* Voluntary withdrawal from the study.
* Failure to comply with the required procedures of the study.
* Arbitrary disruption of the exercise schedule more than twice.
Feasibility of 123I-IBZM Scintigraphy (a D2 Agonist) in Patients With Pheochromocytoma (PHEO) and/or Paraganglioma (PGL) : Study Pilot

Context. Nuclear imaging plays a central role in management of chromaffin-tissue derived tumors because tumor cells exhibit peptide receptors and proteins involved in metabolism that can be targeted with specific radiopharmaceutics. Recently, over expression dopamine-receptor D2 isoforms has been found in endocrine tumors.

Objective. The aim of the present study is to evaluate the feasibility of 123I-IBZM (a D2 agonist radiolabelled with 123I) in patients with PHEO and/or PGL. Diagnostic accuracy will be also compared to traditional SPECT imaging procedures.


Eligibility Criteria:
Inclusion Criteria:

* Age + 18 years. The women in ages to procreate have to have an effective contraception or a negative pregnancy test (in the absence of effective contraception) Having a radiological and functional imaging (balance sheet(assessment) pré--IBZM) considered adapted and complete for the pathology.
* Having a phéochromocytome or a paragangliome proving a surgical operation in view of the data of the balance sheet(assessment) pré--IBZM.
* With or without allergy in the iodine.

Exclusion Criteria:

* NEM2A or 2B.
* Malignant Forms which do not recover from an even partial, surgical gesture(movement).
* Pregnant Women or in the course of feeding.
* Women in age to procreate without effective contraception, with positive pregnancy test.
* Renal insufficiency
Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori

Comparison Efficacy of 14-day Concomitant therapy between levofloxacin and Clarithromycin on the Eradication of Helicobacter Pylori in Syrian population


Eligibility Criteria:
Inclusion Criteria:

-Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods: I-Positive rapid urease test (CLOtest). II-Histologic evidence of H. pylori by modified Giemsa staining. III-Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.

Exclusion Criteria:

* Children and teenagers aged less than 18 years.
* Previous eradication treatment for H. pylori.
* Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
* History of gastrectomy.
* Gastric malignancy, including adenocarcinoma and lymphoma,
* Previous allergic reaction to antibiotics (Amoxicillin, Tinidazole , Levofloxacin) and prompt pump inhibitors (Es-omeprazole).
* Contraindication to treatment drugs.
* Pregnant or lactating women.
* Severe concurrent disease. Liver cirrhosis. Chronic kidney disease.
* Patients who cannot give informed consent by himself or herself.
VisAR Augmented Reality Navigation of Ventriculostomy

This study is intended to evaluate the feasibility of using VisAR augmented reality surgical navigation during placement of an external ventricular drain (EVD). The investigators are interested in confirming the design of the VisAR headset is compatible with this bedside procedure.

A secondary objective of this study is to compare the accuracy of freehand EVD navigation, the current standard of care, with VisAR augmented reality surgical navigation. The intent is to demonstrate the advantages to the patient by the use/application of this next generation navigation technology.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18 years and older, determined to need an external ventricular drain (EVD) or ventriculostomy catheter by the attending neurosurgeon secondary to a variety of pathologies, including obstructive hydrocephalus, trauma and subarachnoid hemorrhage.

Exclusion Criteria:

* Patients less than 18 years of age.
* Pregnant women.
* Prisoners.
Performance Measurement in Cardiac Surgery

This study aimed to evaluate the relationship between the perioperative blood pressure and postoperative mortality after cardiac surgery using performance measurement (PM) of mean arterial pressure (MAP).

The authors conducted a retrospective cohort study of adult patients who underwent cardiac surgery requiring cardiopulmonary bypass (CPB). Median performance error (MDPE), median absolute performance error (MDAPE), and wobble of MAP were calculated using preoperative MAP as the reference value, and MBPs before, during and after the bypass as measured values. Univariable and multivariable logistic regression analyses were performed using PM parameters to predict in-hospital mortality. Survival after cardiac surgery was compared using the Cox proportional hazard model. Predictability of PM was assessed using the area under the receiver-operating characteristic curve (AUROC).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery with cardiopulmonary bypass between 2013 and 2016 at Seoul National University Hospital.

Exclusion Criteria:

* Patients without information on preoperative blood pressure or mortality.
Evaluation of Multiple Subgingival Irrigations.

The study will be conducted at the Department of Periodontology, Cliniques universitaires Saint Luc. Patients diagnosed with Generalized Chronic Periodontitis (GChP) based on the current classification of the American Academy of Periodontology will be included. Detailed medical, periodontal and dental history will be obtained. Those who will fulfill the inclusion/exclusion criteria will be invited to participate in the study.

The study will be conducted at the Department of Periodontology, Cliniques universitaires Saint Luc. The patients will be informed in detail of the nature and course of study, and will sign informed consent prior to engagement in the study. Patients diagnosed with GChP based on the current classification of the American Academy of Periodontology will be included. Detailed medical, periodontal and dental history will be obtained. Those who will fulfill the inclusion/exclusion criteria will be invited to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 30 years of age
* At least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction)
* Any history of periodontal treatment in the previous 6 months
* No removable prosthesis
* A minimum of 6 teeth with at least one site each with periodontal probing depth (PPD) and clinical attachment level (CAL) ≥5 mm
* At least 30% of the sites with PPD and CAL ≥4 mm and bleeding on probing (BOP)

Exclusion Criteria:

* Any sensitivity or allergy to any of the products that will be used in the study
* Thyroid dysfunction
* Systemic disease (ASA II or more)
* Need for antibiotic pre-medication for routine dental therapy
* Antibiotic therapy in the previous 3 months
* Pregnancy and breastfeeding
* Current smokers (more than 5 cigarettes a day)
Interest of Treatment of Obstructive Sleep Apnea Syndrome by Constant CPAP and Auto CPAP

The investigators propose a multicentric controlled randomized trial whose goal is to evaluate the possibility of a prediction of the efficiency of APAP (automatic continuous positive airway pressure) and constant CPAP (constant positive airway pressure) in 800 severe obstructive sleep apnea syndrome (OSAS) patients according to their profile of pressure variability.

Multicenter open randomized clinical trial involving 800 patients with severe OSAS. After inclusion in the study, the patients will be proposed to initiate CPAP at home (ResMed S9 or PHILIPS PR1) using systematically an APAP mode between wide range of pressure variations (4 to 20 cm H2O) during the first 7day-period of time. After this first period of treatment, an analysis of the report will be released from the APAP in order evaluate the residual AHI, the duration of CPAP use and the amount of leaks in order to confirm CPAP efficiency and observance. Pressure parameters (efficient pressure and variability) will be collected. After randomization according to the further mode of ventilation to use (APAP vs constant CPAP), the patients will be treated at home for 3 months. In the constant CPAP group, efficient pressure will be determined as the P95 (ResMed) or the P90 (PHILIPS) as recommended by the manufacturers, while in the APAP group, the patients will be treated within the same range of pressure variations than during the first 7 day-period. Clinical and polygraphic evaluation will be done after 3 months of treatment, using the combined criteria previously described. In each group, results will be considered according to the efficient pressure value and its variability that were evaluated at the end of the first 7 day-period of treatment

Eligibility Criteria:
Inclusion Criteria:

* Adult patients \> 18 with severe OSAS (AHI \> 30/h)
* Patients naive of any previous OSAS treatment
* Written informed consent

Exclusion Criteria:

Patients

* with more than 20% of central events at the initial polygraphic recording
* previously treated by CPAP
* previously treated for OSAS by any surgical procedure involving upper airways
* \< 18
* with cardiac insufficiency
* with Chronic Obstructive Pulmonary Disease or obesity-hypoventilation syndrome
* without health insurance
* pregnant or lactating
* presumed uncooperativeness or legal incapacity
Comparison of Infraclavicular Brachial Plexus Block and Local Anesthesia in Arteriovenous Fistula Surgeries and Their Effects on Tissue Oxygen Saturation

In arteriovenous fistula surgery, the effect of infraclavicular brachial plexus block and local anesthesia on tissue oxygenation and the effect of primary patency of the AV fistula is intended to research.

It is planned to include patients who are American Society of Anesthesiologists (ASA) III and between the ages of 18-80 who will undergo arteriovenous fistula surgery in the research population.In our study, patients who come to the operating room for arteriovenous fistula operation will be randomly divided into two groups.Patients who undergo simple randomization with coin toss method will be assigned to one of two groups: group Local infiltrative anesthesia (Local) and group infraclavicular brachial plexus block with 0.25% bupivacaine (Block). Local infiltrative anesthesia will be applied with 15 ml 2% prilocaine for group Local patients.For Group Block patients, 30 ml 0.25% bupivacaine will be applied with Infraclavicular approach around brachial plexus with inplane technique.Before the start of surgery, NIRS probes will be placed on the thenar ,antecubital regions of both hands and arms .The preoperative observed values and data of every 5 minutes during the operation will be recorded .

Eligibility Criteria:
Inclusion Criteria:

* ASA III
* 18-80 years old
* arteriovenous fistula operation

Exclusion Criteria:

* disabled patients
* mentally retarded
* patients with coagulopathy
* hemoglobinopathy
* patients with infection in the infraclavicular area
* local anesthetic history
* peripheral neuropathy
* peripheral arterial occlusion
* failed peripheral nerve block
Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life

Evaluation of Long-Term Implanted Sensor in Patients on Quality of life

Assess satisfaction and acceptance of long-term implanted single sensor use (eversense XL) for up to 6 months in type 1 insulin-using patients

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female diagnosed with type 1 diabetes mellitus
2. Age \> 18
3. Insulin treatment for at least 1 year (Either MDI of CSII)
4. HbA1c \< 11%
5. Signing informed consent and willing to apply with study procedure

Exclusion Criteria:

1. History of severe hypoglycaemia in the last 3 months
2. History of DKA in the last 3 months
3. Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition
4. Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study
5. Any condition that require MRI imaging or planned MRI during the trial period
6. Known topical or local anaesthetic allergy
7. Known allergy to glucocorticoids
8. History of hepatitis B, hepatitis C or HIV
9. Any Bleeding disorder or taking anticoagulant medication
10. Participation in other clinical trial
11. Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.