Kornimate/medical-research-clean huggingface dataset:
comparison between implanted functional electrical stimulation and foot orthosis

Conditions: Hysterical Simulation of Disease

Summary: the implantable feet stimulator proposes to correct the feet's steppage observed after central nervous system's injury such as hemiplegia secondary to stroke. it aims to improve the patient's walking floor by removing the steppage, reducing the effort of walking, facilitating the flow and removing anomalies compensatory (such as the mowing of the hip). its objective is to improve the patient's autonomy locomotor. the aim of this study is to compare the results of the implementation of an implanted stimulator in the levator muscles of the foot to the results obtained by wearing a splint-type reliever, which is considered standard treatment, in order to determine if the implanted stimulation may be proposed in the treatment of foot drop off a neurological center.

the implantable feet stimulator proposes to correct the feet's steppage observed after central nervous system's injury such as hemiplegia secondary to stroke. it aims to improve the patient's walking floor by removing the steppage, reducing the effort of walking, facilitating the flow and removing anomalies compensatory (such as the mowing of the hip). its objective is to improve the patient's autonomy locomotor.

Eligibility criteria:
inclusion criteria: * steppage foot walking in a patient with a central neurological disease * can walk for 50 meters with or without technical assistance * stable disease for at least 1 year * possible walk with a brace-type reliever * verification of possible nerve stimulation * age greater than or equal to 18 years and under 75 years * no toxin for 4 months * no alcohol for 6 months * no neurotomy for 1 year * patient who agreed to sign an informed consent to participate in the study exclusion criteria: * cons-indication to general anesthesia * wearing a stimulator implanted for other reasons * patients taking neuroleptics, benzodiazepines, or antidepressants or other drugs that interfere with the quality of walking * advanced peripheral neuropathy * excessive restriction of passive range of ankle * poorly controlled epilepsy * pregnant or lactating * non-membership of a social security scheme * wearing orthopaedic shoes including the malleolus

Keywords: feet steppage of central neurological origin implanted functional electrical stimulation feet orthosis
evaluating mitochondrial dysfunction in patients with neurofibromatosis type 1

Conditions: Neurofibromatosis 1

Summary: neurofibromatosis type 1 is a common genetic disease with a broad spectrum of clinical manifestations in multiple organs of the body. this project will study the (dys)function of mitochondria in patients with neurofibromatosis through multiple collections of blood samples from patients and people not afflicted by neurofibromatosis (control group). this study will evaluate how the function of mitochondria changes with time and if medications and supplements can influence the function of the mitochondria. patients will also answer questions regarding symptoms like fatigue and pain.

neurofibromatosis type 1 is a common genetic disease with a broad spectrum of clinical manifestations in multiple organs of the body. some of those symptoms are skin lesions, tumors and cancers, as also pain, and fatigue. in animal models of this disease, dysfunction of mitochondria, a part of the cell which is responsible for energy production, is often described. this project will study the (dys)function of mitochondria in patients with neurofibromatosis through multiple collections of blood samples from patients and people not afflicted by neurofibromatosis (control group). those blood samples will be used to run tests that analyses the function of the mitochondria and compare the results from the neurofibromatosis group with the control group. as multiple samples from the same patient will be tested in different times, this study will evaluate how the function of mitochondria changes with time and if medications and supplements can influence the function of the mitochondria. patients will also answer questions regarding symptoms like fatigue and pain. doing so, the investigator plan to confirm mitochondrial dysfunction in patients, if the degree of dysfunction correlates with symptoms like pain and fatigue, and if supplements and medication like mek inhibitors that patients with neurofibromatosis type 1 use in a daily basis modulates (for better or worse) a pre-existing mitochondrial dysfunction.

Eligibility criteria:
nf1 group: inclusion criteria: * diagnosed with nf1 inclusion criteria: * not the first degree relative (biological parent, sibling, or child) of the nf1 patient who is in the nf1 group
effects of exenatide and insulin glargine in subjects with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: this phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes, but otherwise healthy * hba1c between 6.6% and 9.5%, inclusive. * body mass index (bmi) of 25 kg/m2 to 40 kg/m2, inclusive. * treated with a stable dose of metformin for at least 2 months prior to screening. exclusion criteria: * patients previously in a study using exenatide. * treated with oral anti-diabetic medications other than metformin within 2 months of screening (thiazolidinediones within 5 months of screening). * treated with insulin within 3 months of screening.

Keywords: diabetes exenatide exendin-4 amylin lilly
a study to test the sense device in military-age patients with traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the study population will consist of 3 mutually-exclusive sets of patients and subjects: * tbi patients with intracranial bleeding * tbi patients without intracranial bleeding * control subjects with normal brain health. research subjects between the ages of 22 to 50 will be enrolled. all tbi patients must have a diagnostic head ct scan within 24 hours of the injury. tbi patients without intracranial bleeding based on the ct scan must have a glasgow coma scale (gcs) score at enrollment of ≤ 14. total maximum duration of active monitoring with the device in this study is 48 hours with a clinical follow-up at day 7 after enrollment.


Eligibility criteria:
inclusion criteria: * patients who meet all of the following inclusion criteria will be considered candidates for study enrollment: * male or female subjects age 22 to 50 * patients with tbi who have a diagnostic head ct scan within 24 hours of the injury. * for patients with tbi without intracranial hemorrhage, glasgow coma scale score at enrollment of ≤ 14. * for patients with tbi, intended clinical monitoring in the hospital setting for at least 6 hours from study enrollment. * signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legal guardian. * willingness and ability to comply with schedule for study procedures. * control subjects with normal brain health. exclusion criteria: * all subjects meeting any of the following criteria will be excluded from this study: * female patients who are pregnant or lactating. * known history of seizure or clinical seizure prior to initiating sense monitoring. * open skull fracture. * metallic intracranial clip, coil, or device (such as metallic icp monitor). * presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for the sense device monitoring or study participation or may confound the outcome of the study. * planned placement of an intraventricular catheter after the diagnostic (pre-enrollment) ct. * planned withdrawal of care within 24 hours of enrollment. * planned intracranial surgery within 24 hours of enrollment. * current participation in a medical or surgical interventional clinical trial. * planned or current use of continuous eeg monitoring. * control subjects with normal brain health will have no known history of seizure, stroke, brain tumor, tbi
thymoglobulin® pharmacokinetics in patients undergoing hematopoietic stem cell transplantation

Conditions: Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy

Summary: thymoglobulin is widely applied as serotherapy in order to prevent acute graft-versus-host disease (gvhd) and graft rejection in patients undergoing non-human leukocyte antigen (hla)-identical hematopoietic stem cell transplantations (hsct), with a delicate balance between prevention of gvhd and the promotion of immune reconstitution. thymoglobulin is known as a drug with high pharmacokinetic (pk) variability. this variability influences drug exposure, which in turn determines the drug response of pharmacodynamics (pd). in order to maintain efficacy while reducing adverse effects of drugs across the entire age range, identification of the pk/pd relationships and the effect of growth and maturation on the different pk and pd parameters involved are crucial. the investigators hypothesise that a better knowledge of thymoglobulin pk and its covariates would help to individualise dosage regimen and would improve clinical outcomes, such as gvhd and immune reconstitution. the investigators aim to build a population pk model of thymoglobulin in order to study pk variability and its covariates. this model will help in optimizing dosage regimen in an individually way.


Eligibility criteria:
inclusion criteria: * patient receiving thymoglobulin therapy as part of a first hsct * age ≥ 2 years * lansky or karnofsky score ≥ 50%. * enrolled in a social security plan * patient 18 years of age or older who is informed and has consented to participate in the study or minor patient whose parents/guardians have been informed and have given consent for the minor patient to participate in the study * female patients of childbearing potential must have an effective method of contraception (a pregnancy test will also be performed at inclusion). exclusion criteria: * patient having received serotherapy (thymoglobulin® or other) within 3 months before this hsct * patient receiving another serotherapy during conditioning (campath®) * patients with uncontrolled acute or chronic infections for which any form of immunosuppression would be contraindicated * known hypersensitivity to thymoglobulin®. * pregnant or lactating women * patient participating simultaneously in another study of an investigational drug (no exclusion period) * patient under legal protection or deprived of liberty

Keywords: hematopoietic stem cell transplantation pharmacokinetics hsct anti-thymocyte globulin graft versus host disease
glioblastoma imaging using a strong iron-like bloodpool contrast medium?

Conditions: Glioblastoma

Summary: rationale: visualization of tumor spread is of crucial importance when treating patients suffering from glioblastoma (gbm) as the success of tumor resection depends strongly on the extent of tumor infiltration. current mri protocols, however, cannot visualize the extent the tumor infiltration. the use of non-toxic, non-dangerous ultrasmall superparamagnetic biodegradable iron oxide (uspio) particles as a very strong blood pool contrast agent could help visualizing this invisible infiltration objective: to what extent, do gbms infiltrate healthy brain tissue and can we use ultrasmall superparamagnetic iron oxide particles to visualize co-opting infiltrating tumor cells in an attempt to predict regions of tumor recurrence? study design: this study concerns a single arm prospective observational study. study population: patients diagnosed with suspected glioblastoma. intervention (if applicable): uspio neuroimaging main study parameters/endpoints: the main parameter of this study concerns the feasibility of using of uspio particles in healthy controls (n=6) and glioblastoma patients (n=15). nature and extent of the burden and risks associated with participation, benefit and group relatedness: during this study patients will be intravenously injected with low doses of uspios. risks involved with this procedure include: bruising of the skin after venapunction and allergic reaction to uspio particles. the application of uspio neuroimaging can improve diagnosis of patients with suspected glioblastoma, provide more information on the pathophysiology of growth of glioblastoma lesiosn, the role of neuro-inflammation in these lesions and maybe predict regions of tumor recurrence after treatment.


Eligibility criteria:
inclusion criteria: * aged between 18 and 75 years * diagnosed with suspected glioblastoma * eligible for neurosurgical resection and/or chemoradiation therapy. exclusion criteria: * younger than 18 years old * patients unfit for surgery or lesions unsuitable for neurosurgical treatment
human papilloma virus (hpv) knowledge and attitudes and the role of (ses) socioeconomic status and ethnicity

Conditions: HPV

Summary: this is a survey study to assess the vaccination knowledge and attitudes of women in an inner city gynecology clinic. results of this study will help determine which factors influence vaccination knowledge and attitudes. this may help improve future vaccination tools.


Eligibility criteria:
inclusion criteria: * all women attending gynecology clinic exclusion criteria: * none

Keywords: hpv hpv vaccine
comparison of automatic and manual endotracheal tube cuff pressure monitoring in pediatric intensive care patients

Conditions: Cuff Pressure; Mechanical Ventilation; Pediatric Intensive Care

Summary: this prospective, randomized controlled cross-over study compares automatic (intellicuff®) and manual methods of endotracheal tube cuff pressure (cp) monitoring in pediatric intensive care patients. the study evaluates the frequency and duration of cuff pressure deviations outside the recommended range (15-25 cmh₂o) and assesses the impact on nursing workload.

optimal cuff pressure management in pediatric patients undergoing mechanical ventilation is critical to prevent complications such as aspiration pneumonia or tracheal injuries. this study was designed to compare the effectiveness and safety of continuous automatic cuff pressure monitoring using the intellicuff® system versus standard manual cuff pressure monitoring performed by nurses every 2 hours. patients aged between 1 month and 18 years requiring invasive mechanical ventilation for at least 48 hours participated in a cross-over study at two tertiary pediatric intensive care units. each patient underwent two consecutive 24-hour monitoring periods: one with automatic cuff pressure monitoring and another with manual monitoring. data collected included the frequency and total duration of low (\ 25 cmh₂o) pressure episodes, number of manual corrections required, and total nursing intervention time. this study aims to determine whether automatic monitoring provides better control of cuff pressure, reduces the frequency of cuff-related complications, and decreases nursing workload compared to manual monitoring.

Eligibility criteria:
inclusion criteria: * patients aged between 1 month and 18 years who were intubated with a cuffed endotracheal tube and expected to require invasive mechanical ventilation for at least 48 hours were eligible for inclusion exclusion criteria: * patients with tracheostomy, known tracheal pathology, extubated within 48 hours, or those requiring frequent ventilator adjustments due to clinical instability were excluded.

Keywords: cuff pressure automatic monitoring mechanical ventilation
a patient navigation program for addressing disparities in breast cancer care

Conditions: Breast Carcinoma; Breast Ductal Carcinoma in Situ

Summary: this clinical trial evaluates a patient navigation program for addressing disparities in breast cancer care. the navigation program is designed to help improve patient knowledge about clinical and supportive care services, navigate to existing services, help manage barriers to care, and enhance patient skills related to management of cancer treatment. offering a patient navigation program may increase health equity and improve social needs and quality of life over time for newly diagnosed breast cancer patients.

primary objective: i. implement a patient navigation program in the roswell park breast clinic focused on underserved women with a first cancer diagnosis of breast cancer or ductal carcinoma in situ (dcis) (n=126). secondary objective: i. systematically address barriers to care by connecting women with multiple barriers of care with a first diagnosis of breast cancer or dcis to supportive services and culturally appropriate resources.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age * have a confirmed diagnosis of breast cancer or dcis * have not had a previous diagnosis of cancer * currently identify their gender as woman or female * was assigned female sex at birth (afab) * participant must understand the investigational nature of this study and verbally consent to participate prior to receiving any study related intervention exclusion criteria: * participants under the age of 18 * participants who are not suspected of or diagnosed with breast cancer or dcis * participants who have had a previous diagnosis of any cancer * participants who identify their gender as other than woman or female * participants who were assigned male sex or intersex at birth * unwilling or unable to follow protocol requirements
bone microcirculation after remote ischemic preconditioning

Conditions: Intact Scaphoid Bone; Intact Metacarpal Bone; Fractured Scaphoid Bone; Fractured Metacarpal Bone

Summary: in trauma surgery and hand surgery treatment strategies of none healing bone fractures aim at replacing pseudarthrosis by well vascularized bone and improving microcirculation. although previous studies indicate that remote ischemic preconditioning (ripc) can accelerate bone healing in case of non-union, only a few studies focused on the elucidation of its mechanisms of action. therefore, the aim of this study is to evaluate the microcirculatory effects of remote ischemic preconditioning (ripc) on scaphoid bones and metacarpal bones and metatarsal bones in a human in-vivo setting for the first time.


Eligibility criteria:
inclusion criteria: * group a (n=20): consent-capable male and female patients ≥18 years of age who have an intact scaphoid bone. * group b (n=20): consent-capable male and female patients ≥18 years of age who have an intact metacarpal bone. * group c (n=20): consent-capable male and female patients ≥18 years of age who have a fractured scaphoid bone. * group d (n=20): consent-capable male and female patients ≥18 years of age who have a fractured metacarpal bone. exclusion criteria: * below 18 years of age * scar tissue above measuring focus * osteoporosis or comparable bone disease * medication that influences bones
buzzy versus vapocoolant spray: pediatric needle pain relief

Conditions: Pain

Summary: a vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of cannulation when compared to vapocoolant spray.

needle pain is the most common and the most feared source of childhood pain, resulting in needle phobia for 10% of adults. current pain relief options include numbing creams, vapocoolant spray, or injected lidocaine. 17 million pediatric iv access procedures are done yearly with no pain intervention. an inexpensive, immediately acting form of needle pain control could reduce needle phobia in the long term if demonstrated to be effective for needle pain. this study will evaluate pain self report and parent report using the faces pain scale revised, and video-coded osbd-r scores for patients undergoing emergency department venous access or cannulation procedures. demographic information, pre-procedural anxiety, and success data from the attempts at placement will be included.

Eligibility criteria:
inclusion criteria: * patients requiring venipuncture in a pediatric emergency department * informed consent * patient assent exclusion criteria: * patients with sickle cell or other sensitivity to cold * nerve damage in the area * abrasion or break in skin where device would be placed * critically ill

Keywords: pediatric venipuncture pain vibration vapocoolant
reconstruction of maxillary and midfacial defects using latissimus dorsi scapular free flaps

Conditions: Maxillary Neoplasms

Summary: bony reconstruction of the midface with free tissue transfer is complex and challenging due to structural considerations such as the need for orbital support, patency of the nasal cavity, restoration of the palate and alveolus and skull base support when needed. as a result, bony reconstruction is important especially for patients who experience diplopia, hypoglobus and enophthalmos postoperatively. orocutaneous and nasocutaneous fistulae and infection due to communication with the oral cavity or sinuses are also common complication . finally, cosmetic deformities from inadequate projection are also a concern. cosmetic and functional outcomes are improved with bony reconstruction as it is able to provide rigid support of key structures, restoration of contour, affords the possibility of dental rehabilitation and is less likely to contract significantly following radiation treatment. subscapular system free flaps (sf) are uniquely suited to address the needs of midface reconstruction. a substantial amount of bone can be harvested from the lateral scapular border and scapular tip, each with different shapes and thicknesses. chimeric flaps can be harvested in various combinations, adding para scapular and scapular skin paddles, latissimus muscle (with or without skin), serratus muscle and rib. additionally, due to the vascular organization of this network, these components can be harvested off separate pedicles, offering great flexibility and freedom of movement relative to each other .

reconstruction of defects post maxiilectomy by scapular free flaps

Eligibility criteria:
inclusion criteria: 1. all patients post maxillectomy due to benign maxillary lesions. 2. all patients post maxillectomy with malignant maxillary swelling with no distant metastases. 3. all patients which implants are needed after surgery for head and neck neoplasia . exclusion criteria: 1. oropharyngeal, nasopharyngeal, and hypopharyngeal cancers, and lip cancers;. 2. recurrent tumors resulting in implant loss. 3. previous free flap harvest from scapula.
effects of pepper gas exposure in non-combatant bystanders.

Conditions: Cough; Irritation in Throat; Irritation in Skin; Lacrimation

Summary: pepper sprays and pepper gas grenades are used by riot police at various places in the world for crowd control. data about the acute effects based on human studies is extremely scarce. kashmir valley in the northern indian state of jammu \& kashmir has witnessed political turmoil for the past 22 years and incidents of stone pelting are common wherein groups of youth indulge in stone pelting at the security personnel. while there have been previous episodes of fatalities associated with incidents of firing by the security personnel; non lethal methods are adopted routinely now. these include lathis, water cannons, tear gas and more recently the pepper gas grenades. the pepper grenades explode in the area and the adverse effects are perceived by the population in the area too who are even sitting in their homes. the study proposes to observe the health effects of the pepper gas exposure in non-combatant civilians.

eligibility: history of exposure to a pepper grenade explosion. exclusion: participation in combat operation/ stone pelting/ demonstration.

Eligibility criteria:
inclusion criteria: all participants with a history of exposure to pepper gas grenade explosion exclusion criteria: combatant role while exposure

Keywords: pepper spray bronchospasm lacrimation