cyrilzakka/clinical-trials huggingface dataset:
Aesthetic Reconstruction of Onco-surgical Maxillary Defects Using FSF With and Without CAD/CAM Customized Cutting Guide

The aim of the study is to compare aesthetic results and operation time of Free Scapular flap with and without CAD/CAM customized osteotomy guide for reconstruction of maxillary Defects.

Maxillofacial defects create unique challenges for the reconstructive surgeon, often involving bony and soft tissue components of the midface. Surgical reconstruction following maxillectomy is currently a topic of interest for reconstructive head and neck surgeons. maxillary defects were reconstructed with maxillofacial prosthetics including obturation. While the latter is an effective reconstruction. Over the past two decades, there has been increasing interest in the use of free tissue transfers of bone to reconstruct the maxilla.

Scapular flap It is an excellent candidate for maxillectomy defects because of its unique feature, which is characterized by additional skin paddles or muscles. and can be harvested along with a part of the scapular bone for bony reconstruction

Traditional reconstructive techniques often lead to suboptimal reconstructions due to inexact planning, poor communication between the resective and reconstructive teams or surgical difficulties in adjusting a free flap and osteosynthesis plates into a three-dimensional (3D) defect without the help of any templates or surgical guides The advent of 3D modeling in head and neck reconstruction has allowed surgeons to improve upon functional and aesthetic outcomes, which are crucial to patient satisfaction and can be difficult to achieve in maxillectomy defects The cutting guides used or not used, however debate still present for its benefits and worth for patient and surgeon. current study to evaluate how such virtual planning with using of customized cutting guide is effective and worth for patient aesthetic and operation time.

our priori-hypothesis is that utilization CAD/CAM assisted with customized osteotomy guide is not related to an altered result regarding aesthetic outcome and operation time in patient undergoing maxillary reconstruction using free scapular flap.

In order to test this hypothesis, we will compare aesthetic outcome and operation time in group of patients receive FSF by CAD/CAM-assisted with customized osteotomy guide to results of another group of patients receive FSF but without customized osteotomy guide. only model will be performed as conventional method aiding in reshaping of reconstruction plate which is another well-established concept of management of maxillary defect.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by tumor involving Maxillary bone.

Exclusion Criteria:

* Patients having poor oncological prognosis
* Patients with poor performance status together with other relative or absolute vascular contraindication.
Clinical Study of Methylene Blue - Mediated Photodynamic Therapy for Diabetic Lower Limb Ulcer

The investigators designed this prospective, randomized control study to confirm the efficacy and safety of methylene blue - mediated photodynamic therapy for diabetic lower limb ulcer and to explore its mechanism.

OBJECTIVE- Infection is associated with poor healing of diabetic lower limb ulcer. Diabetic lower limb ulcer are often lower extremity vascular stenosis or occlusion, poor blood supply, making local ulcer local antibacterial drugs difficult to effectively reach and distribution, resulting in systemic antibacterial efficacy is limited, and easy to induce bacterial resistance at the same time . In recent years, the incidence of clinical multidrug-resistant bacteria increased, increasing the difficulty and cost of treatment.

The current study attempts to identify whether the photodynamic therapy (PDT) would kill the surface of ulcer bacteria and promote ulcer healing, and explore the mechanism of methylene blue-mediated photodynamic therapy for diabetic lower limb ulcer RESEARCH DESIGN AND METHODS-This study evaluated six clinical indicators： diabetic foot ulcer area reduction rate, inflammation control rate, Local bacterial load, the dose and use time of antibiotics, adverse reaction rate, bacterial biofilm,local neutrophil extracellular traps. The efficacy and safety of PDT could be confirmed if the clinical indicators of PDT group is better than the control group. In this study, three methods were used to investigate the mechanism of -methylene blue mediated photodynamic therapy for diabetic lower limb ulcer: a comparison of the bacterial load, bacterial biofilm,local neutrophil extracellular traps of the ulcer immediately pre-treatment and immediately,1-week ,2 week,1 momth post-treatment ; EXPECTED RESULTS-The investigators will expect that methylene blue-mediated photodynamic therapy could kill bacteria on the surface of diabetic lower limb ulcer and accelerate wound healing.

Eligibility Criteria:
Inclusion Criteria:

* 1. Understand the whole test process, voluntary and signed informed consent form.
* 2. Men and women aged 18 to 80 years old.
* 3. Diagnosed with diabetic lower limb ulcer.
* 4. Ulcer duration\> 1 month of wagner grade Ⅱ, Ⅲ subjects.
* 5. An ulcer area ≤100 cm² or of linear dimension ≤ 10 cm.

Exclusion Criteria:

* 1. Diagnosis of systemic infection or any concomitant infection that would require treatment with an additional antimicrobial agent.
* 2. Pregnant or lactating women.
* 3. Wagner grade Ⅰ, Ⅳ, Ⅴ subjects.
* 4. Patients with a peripheral vascular disease require immediate revascularization, and/or an ankle brachial systolic blood pressure (SBP) index\<0.5 in the infected limb.
* 5. Patients with inappropriate health to participate as determined by the principal investigators.
* 6. Patients in the hepatitis A, hepatitis B, AIDS, tuberculosis and other infectious diseases of the active period.
Parkinstep: Automated PD Gait and Balance Assessment for Optimizing DBS

Changes in deep brain stimulation (DBS) settings can have a delayed effect on gait function, which makes it impractical to optimize DBS for gait parameters in the clinic. Wearable movement sensors could be used to assess gait impairment in the patient's home hours after treatment adjustments are made in the clinic. This study aims to quantitatively evaluate the effects of turning off deep brain stimulation on lower extremity and gait function over three hours. This study will provide vital information about our patient worn system's ability to detect changes in lower impairment over time, which could be used to assist with DBS tuning for the lower extremities and gait in the future.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease
* Age \> 21
* Underwent DBS surgery targeting the subthalamic nucleus (STN)
* Bilateral or midline involvement when "off" DBS/medication state
* Clinical history of gait impairment or freezing of gait

Exclusion Criteria:

* "Parkinson's plus" syndrome, secondary, or atypical Parkinson's disease
* Underwent DBS surgery targeting the ventral intermediate (VIM)
* Unable to walk independent of a wheelchair (use of assistive devices, like a cane, is okay for this study)
* Dementia (determined by a neuropsychological assessment).
Intravitreal Aflibercept InjectiOn in Vitrectomized Eyes for Treatment of Diabetic Macular Edema

This a non-interventional retrospective study on the efficiency and the tolerance of intravitreal injections of Aflibercept on vitrectomized eyes in the diabetic macular oedema

Diabetic macular edema (DME) is the leading cause of blindness among people of working age. Treatment of DME included blood pressure and glycemic control, grid laser, intravitreal injection of steroids (acetonide of triamcinolone, dexamethasone implant, fluocinolone implant) or anti-Vascular endothelial growth factor (VEGF) therapy (Bevacizumab, Ranibizumab, Aflibercept) (2015). The advent of anti-VEGF therapy has revolutionized the management of DME. Aflibercept, one of the drugs in this group has recently been approved in France. However, there is no report in the efficacy and tolerance of Aflibercept in vitrectomized eyes in the diabetic macular oedema . In this study, in order to prove the efficiency and tolerance of Aflibercept, data will be collected in a anonymous way in medical records of patients having received a treatment by Aflibercept in the past.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients aged between 19 and 90 years old
* Patients with the following characteristics at the beginning of the Aflibercept therapy :

HbA1c \< 9% Diabetic macular oedema with the central affected Visual acuity between 1/20 and 5/40 (between 20 and 70 letters ETRS) Patients who had a vitrectomy over 3 months ago

* Patients who did not received an anti-VEGF treatment or any other treatment for their diabetic macular edema 3 months before the beginning of the injections

Exclusion Criteria:

* Patients who refused the collection of their data in medical records
* Patients with a macular ischemia of more than 1500µm diagnosed via an avascular central fluorescein angiography before the inclusion
* Patients with a recent cardiovascular incident (heart attack, stroke dating for less than 3 months before the inclusion)
* Pregnancy at the moment of inclusion
Efficacy of 3D-Printed Mouth Splints

The study will investigate the effectiveness of a 3D-printed mouth splint designed to increase dimensions of oral aperture and reduce disability associated with mouth contractures. The validated Mouth Impairment and Disability Assessment (MIDA) survey will be used to objectively measure patient progress in functionality and quality of life.

Microstomia, or reduced oral aperture, is a debilitating condition that can arise after burn injuries, particularly to the face. This condition severely impacts oral hygiene, nutrition, speech, and overall quality of life. Current management strategies often rely on therapy, surgical intervention, and splinting to improve mouth opening and functionality. However, there is a lack of accessibility to good mouth splinting devices. 3D-printed, dynamic splints offer may offer a superior and cost-effective solution that can be tailored to the patient's anatomy while allowing for at-home treatment. Sizing can also be adjusted to fit essentially any aperture since, including pediatrics. This device is intended for use at home, supported by teaching and follow-up provided by occupational therapists (OTs).

Eligibility Criteria:
Inclusion Criteria:

* Patients 2 years to 99 years of age with documented microstomia following burn injuries.
* Ability to comply with prescribed home exercises and follow-up visits.

Exclusion Criteria:

* Cognitive or physical inability to perform the prescribed exercises.
* Inability of a caretaker to be able to deliver therapy daily.
* Concomitant conditions that may significantly affect oral aperture (e.g., temporomandibular joint (TMJ) disorders).
Prevalence, Impact and Reversibility of Acute Diaprhagmatic Dysfunction in Acute Respiratory Detresse

The diaphragm is a fine striated muscle with both extra respiratory and respiratory functions. It does most of the breathing work in interaction with the accessory respiratory muscles, the rib cage and the abdomen. Its activity can be measured by the transdiaphragmatic pressure generated by the magnetic stimulation of phrenic nerves (gold standard). It has been shown in the literature that diaphragmatic ultrasound, via the measurement of diaphragmatic excursion and especially the thickening fraction, is an easily accessible, non-invasive, reproducible and relevant technique for evaluating acute diaphragmatic dysfunction in resuscitation patients.

The objective of this project is to evaluate the prevalence of diaphragmatic dysfunction at admission in patients hospitalized in intensive care / respiratory intensive care unit for hypercapnic and/or hypoxic acute respiratory distress and requiring ventilatory support by non-invasive ventilation or high flow oxygen therapy. A subgroup analysis will then be carried out on 3 populations:

* Hypercapnic exacerbation of chronic obstructive pulmonary disease
* Hypoxic acute respiratory distress on infectious lung disease
* Acute pulmonary edema


Eligibility Criteria:
Inclusion Criteria:

* Hospitalization for acute respiratory distress management
* Etiological diagnosis either:
* Exacerbation of chronic obstructive pulmonary disease
* Infectious pneumonitis
* Acute pulmonary edema
* Need for a ventilatory support by either:
* Non-invasive ventilation
* High flow oxygen therapy (flow rate \> 40L/min and oxygen inspired fraction \> 40%)
* Mask oxygen therapy with flow rate \> 5L/min

Exclusion Criteria:

* Exacerbation of interstitial pathology / pulmonary fibrosis
* Deformation of the thoracic cage
* Neurodegenerative pathology
* Need for oro-tracheal intubation from the beginning for mechanical ventilation
* Contraindication to Non-invasive Ventilation
* Patients undergoing diaphragmatic rehabilitation
* Immunocompromised patients
* History of known diaphragmatic dysfunction
Comparison of the Effect of Rabeprazole 50 mg DDR Capsules and 20 mg Enteric-coated Tablets

It is planned to compare the efficacy and safety of rabeprazole 50 mg DDR (dual delayed release) capsules versus rabeprazole 20 mg enteric coated tablets administered once daily in patients with Gastroesophageal Reflux Disease (GERD).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of GERD with symptoms (i.e. regurgitation, pyrosis) at least 1 or more episodes a week.
* Age ≥ 18 years and \<65 years
* Helicobacter pylori (an infection) negative
* Have a body mass index (BMI) between 18 and 33 kg/m²
* pH\>4 gastric exposure \<25% on a 24-hour dual pH channel monitoring study performed prior to screening (normal intragastric pH +2SD)
* Pathologic intraesophageal acidity exposure (DeMeester score \>14.75 and/or \>4% of pH\<4 (at least 21 hours measured)

Exclusion Criteria:

* Patiets with Barrett's stricture, gastric outlet obstruction, malignancy, gastrointestinal system bleeding or any other upper gastrointestinal system pathology.
* Patients whose Hiatus hernia is \> 3 cm.
* Patients with uncontrolled or insulin dependent diabetes mellitus, symptomatic gallbladder stone, active or unhealed stomach or duodenum ulcer, Zollinger-Ellison syndrome, primary esophagus motility disorder, pancreatitis, inflammatory bowel disease, severe lung disease, chronic liver disease, uncontrolled kidney impairment, cancer (except skin cancer except melanoma), cerebrovascular disease, epilepsy.
* Patients with history of heart failure, ventricular tachycardia, ventricular fibrillation, cardiac arrest, Torsades de pointes, bradycardia, sinus node dysfunction, heart attack, long QTc (\>450 ms for male, \>470 ms for female patients).
* Patients taken PPIs or H2-blockers within 7 days and prokinetic drugs within 3 days before entering the study.
* Patients with major psychiatric disease.
* Alcoholism and drug use.
* Patients with pathologic laboratory tests; hemogram, sedimentation, CRP, thyroid functions tests, liver enzymes.
* Malabsorbtion.
* Immunosuppressive patients.
* Patients taken cortisone.
* Patients taken other drugs that prolong QT interval.
* Patients taken drugs that need gastric acid for optimal absorption; ketoconazole, iron salts, digoxin, ampicillin esters, anticoagulants, antineoplastic agents, prostaglandin analogues, sukralfat.
* Pregnancy or breast-feeding.
* Patients taken drugs that may affect gastrointestinal system motility or acid release.
* History of abdominal surgery (hysterectomy, abdominal hernia repair, caesarean cases may be included; cholecystectomy have to be excluded).
* Patients taken NSAII drugs (paracetemol may be used up to 2 gr/day).
* Patients taken antidepressants.
* Hypersensitivty to study drugs.
* Known allergy to peanut and soy.
Acceptability, Feasibility, Safety and Efficacy of a Optimized Rehabilitation Program for Treated Patients With Spinal Muscular Atrophy (SMA).

The goal of this study is to investigate the acceptability, feasibility, safety and efficacy of an optimized rehabilitation program for treated patients with spinal muscular atrophy (SMA) compared to the current rehabilitation program in the United Kingdom. The aim is to provide patients with more hands on physiotherapy and access to rehabilitation devices at home to support parents currently providing rehabilitation on their own.

The main study objective is to investigate whether an optimized rehabilitation program would be accepted and is feasible within the SMA patient community.

The optimized program will comprise of goal orientated rehabilitation with more frequent hands on physiotherapy (every 2 weeks) as well as a SMA approved rehabilitation device used at home on a weekly basis, to provide the most appropriate therapy for each individual patient. All study participants will receive the optimized rehabilitation program over 12 months. An external control group will be used to determine the potential efficacy.

Research study visits will take place at baseline, month 6 and month 12. At these visits a general physical exam will be undertaken alongside collecting the participant and carer perception, satisfaction and compliancy of the rehabilitation program. Motor function assessments according to age and ambulatory status will be assessed to help evaluate potential therapeutic benefits.

Eligibility Criteria:
Patient participant Eligibility Criteria:

Inclusion Criteria:

* Genetically confirmed SMA considered as a non-sitter, sitter or walker
* Post-symptomatically treated and on stable dose for 12 months with any disease-modifying market-approved drug
* Patients from 1-10 years of age at baseline
* Parent(s)/legal guardian(s) of patients less than 16 years of age must provide written informed consent prior to the patient's participation in the study
* Willing and able to comply with all protocol requirements and procedures.

Exclusion Criteria:

The participant may not enter the trial if ANY of the following apply:

* Any acute or chronic condition which, as assessed by the investigator, significantly interferes with the rehabilitation of the patient
* Need of diurnal and/or invasive ventilation, naps excluded
* Currently enrolled in a treatment study; or treatment with an experimental therapy
* Any surgical and/or medical intervention, according to the investigator, 3 months before baseline and/or during the study participation.

Carer (considered as participant) Eligibility Criteria:

Inclusion Criteria:

* Willing and able to comply with all protocol requirements and procedures
* Carer's child has been included in study.

Exclusion Criteria:

• No exclusion criteria.
A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia

This Phase 1/1b, open-label study will evaluate the safety and pharmacokinetics of escalating doses of RO5503781 as a single agent or in combination with cytarabine in participants with acute myelogenous leukemia. In Part 1, RO5503781 will be administered in escalating doses as a single agent, and in Part 2, RO5503781 will be administered in combination with cytarabine. An optional Part 3 in which RO5503781 will be administered with cytarabine and anthracycline may be considered . In Part 4, the safety and pharmacokinetic profile of an optimized formulation of RO5503781 in combination with cytarabine will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Documented/confirmed acute myelogenous leukemia (AML), except for acute promyelocytic leukemia
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 in Part 1 and Part 2, participants enrolled in the extension/tail portion, Part 3 and Part 4 must have an ECOG performance status of 0 or 1
* All non-hematological adverse events of any prior chemotherapy, surgery or radiotherapy must have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade less than or equal to (\</=) 2 prior to starting therapy
* Adequate hepatic and renal function
* Willing to submit the blood sampling and bone marrow sampling required by protocol

Additional inclusion criteria for Parts 1-4 may apply.

Exclusion Criteria:

* Participants receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 14 days of first receipt of study drug, with the exception of hydroxyurea as defined in protocol
* History of allergic or toxic reactions attributed to cytarabine (Part 2) or history of allergic reactions to components of the formulated product
* Current evidence of central nervous system (CNS) leukemia
* Participants with severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
* Participants with evidence of electrolyte imbalance greater than or equal to (\>/=) Grade 2 which cannot be corrected prior to study initiation
* Pregnant or breastfeeding women
* Human immunodeficiency virus (HIV) - positive participants receiving anti-retroviral therapy
* Participants who refuse to potentially receive blood products and/or have a hypersensitivity to blood products

Additional exclusion criteria for Parts 1-4 may apply.
Metformin Suspension and Insulin Sensitivity

Metformin is an insulin sensitizing drug routinely used for the treatment of anovulatory patients with polycystic ovary syndrome (PCOS). To date, the metabolic effects of the long-term metformin administration are know but no data are available on the effects after its suspension.

The purpose of this study is to evaluate the effects of metformin suspension on insulin sensitivity in PCOS patients.

Thirty young normal-weight anovulatory PCOS women will be enrolled. The diagnosis of PCOS will be based on the presence of clinical \[Ferriman-Gallwey score ≥ 8\] or biochemical hyperandrogenism (serum testosterone levels (\>2 SD above our reference mean values) and chronic anovulation \[serum luteal progesterone (P) below 2 ng/mL)\].

Patients will be randomly allocated into two groups (metformin and placebo group) using a computer-software. Fifteen PCOS patients will be treated with metformin at a dosage of 1700 mg daily (one tablet of 850 mg twice daily; metformin group), whereas other 15 PCOS will be treated with placebo tables (one tablet twice daily; placebo group). The duration of the treatment will be 12 months. Patients will be instructed to follow their usual diet and physical activity, and to use barrier contraception throughout the study. The length and the frequency of the menstrual cycles, and the adverse experiences (AEs) will be reported on a daily diary.

Each subject will undergo follow-up visits under (at six and 12 months from treatment starting) and after treatment (at six and 12 months from treatment withdrawal). At each follow-up visit, in all subjects the same operator will perform clinical, hormonal, metabolic, and insulin sensitivity assessments by euglycemic hyperinsulinemic clamp.

Eligibility Criteria:
Inclusion Criteria:

* Polycystic ovary syndrome (using NIH criteria).

Exclusion Criteria:

* Age \<20 or \>30 years;
* BMI higher than 25 and lower than 18;
* Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses;
* Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia;
* Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs;
* Intention to start a diet or a specific program of physical activity.