Kornimate/medical-research-clean huggingface dataset:
the benefit of repairing the deltoid ligament in unstable ankle fractures

Conditions: Ankle Fractures; Deltoid Ligament; Sprain (Strain) (Ankle)

Summary: ankle fractures occur in 1 out of 800 persons a year and is a common injury. the deltoid ligament is necessary for the stability of the joint and guides choice of treatment. cadaveric studies have shown that deltoid ligament repair gives more stability than the osteosynthesis of the lateral malleolus itself. the investigators want to show if suture of the deltoid ligament in unstable ankle fractures contribute to a better functional result and/or prevent long term osteoarthritis for our participants. patients sustaining severe ankle fractures have shown a considerable loss of function that might affect their long term activities of daily living (adl) function. improving outcome for this group may preserve some patients' ability to work and reduce community expenses.

during the last two decades less severe ankle fractures have been shown not to need operative treatment in general. the total number of ankle fracture surgeries has gone down. therefore, surgically treated ankle fractures nowadays are on average more complex. the understanding of these injuries implies a recognition of the role of the deep deltoid ligament as a main stabilizer of the ankle joint. deltoid ligament repair is documented to be a good option to regain ankle joint anatomy from smaller studies. this repair also compensates for syndesmotic injury to some extent. the effect of deep deltoid ligament repair in weber b ankle fractures and its effect on long term function and arthritis is not yet known from clinical studies. the investigators aim to show whether deltoid ligament suture gives a clinically significant superior result than solely osteosynthesis of the lateral malleolus in unstable ankle fractures. this will be performed as a multicentre randomized controlled study.

Eligibility criteria:
inclusion criteria; fluent in oral and written norwegian language * isolated weber type b fractures and weber b+ posterior malleolar mason molloy class i. * initial medial clear space (mcs)\>=7mm or weightbearing x-ray evaluated as unstable or primary reposition after fracture dislocation. * pre-injury walking ability without aids. exclusion criteria * assumed not compliant (drug use, cognitive- and/or psychiatric disorders). * previous history of ipsilateral ankle fracture or ipsilateral major ankle-/foot surgery. * open fx gustilo anderson ii or more, multi-trauma and pathologic fracture. * neuropathies and generalized joint disease such as rheumatoid arthritis or other more severe condition in same extremity * fixation of tibial fragment or syndesmotic screw or suture button
a prospective study to evaluate clinical outcomes in anti-lgi1 encephalitis

Conditions: Autoimmune Encephalitis; Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

Summary: anti-leucine-rich glioma-inactivated 1 (lgi1) encephalitis has been increasingly identified as the second most common type of autoimmune encephalitis after anti-n-methyl-d-aspartate receptor (nmdar) encephalitis. it presents with acute or subacute onset of epileptic seizures, anterograde amnesia, behavior disturbances, sleep disorders and hyponatremia. in most patients with anti-lgi1 encephalitis, immunotherapy is successful in treating the encephalitis. however, relapses, chronic epilepsy, cognitive declines and psychiatric problems have been reported in some cases. so far, prospective studies to evaluate its clinical outcomes still remain limited. in this project, the investigators will use clinical features and advanced paraclinical examinations to prospectively investigate the clinical outcomes and the associated factors in patients with anti-lgi1 encephalitis.

in this prospective study, the investigators are aiming to recruit newly diagnosed patients with anti-lgi1 encephalitis. at the acute stage and during the follow-up, some routine and advanced paraclinical examinations will be conducted, including dynamic blood and/or cerebrospinal fluid (csf) test, multimodal brain magnetic resonance imaging (mri) including functional mri, diffusion tensor imaging, arterial spin labeling, et al), electroencephalography (eeg) or continuous video-eeg (veeg), positron emission tomography (pet), neuropsychological tests and some other paraclinical examinations. through the comprehensive analysis, the clinical outcomes and associated factors are further explored in anti-lgi1 encephalitis.

Eligibility criteria:
inclusion criteria: 1. meet the 2016 consensus diagnostic criteria for anti-lgi1 encephalitis. 2. newly diagnosed, and during the acute stage before study enrollment. 3. sign the informed consent form. exclusion criteria: 1. with the diagnosis of epilepsy, stroke, cerebral trauma, and/or other nervous system disease prior to the onset of encephalitis. 2. with coexisting antibodies, such as anti-contactin-associated protein 2 (caspr2) antibody. 3. lost to follow-up.
evaluation of polyflex stenting in esophageal cancer patients

Conditions: Esophageal Cancer

Summary: to evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment.


Eligibility criteria:
inclusion criteria: * 18 years of age and older * willing and able to provide informed consent * willing to comply with follow-up requirements * biopsy-confirmed esophageal cancer (adenocarcinoma or squamous cell carcinoma) in mid or distal esophagus (clinical stage 3 or less) * indicated for chemotherapy and/or radiation therapy * ability to dilate stricture to 15mm diameter at extent of disease evaluation * placement of at least 18 x 23mm diameter and 120mm length polyflex stent exclusion criteria: * patients contraindicated for endoscopy * patients with prior esophageal stent placements * advance stage of disease, greater than t3 tumor or m1 disease

Keywords: esophageal stenting
eating disorder prevention program for women with t1d

Conditions: Eating Disorders; Type 1 Diabetes

Summary: this study aims to test the effectiveness of an evidence-based eating- disorder prevention program specifically targeted for individuals with type 1 diabetes (t1d) compared to an educational control group. the diabetes body project (dbp), is an adaptation of the body project which is the only eating disorder prevention program to have repeatedly produced effects when evaluated by independent researchers, produced stronger effects than credible alternative interventions, and affected objective outcomes. dbp has been adapted slightly for individuals with t1d who are at ultra-high risk for eating disorders. the study aims to test the effectiveness of the dbp of reducing body image concerns and reducing eating pathology and improving glycemic control.


Eligibility criteria:
inclusion criteria: i)female-identifying ii) aged 15-30 years old iii) diagnosis of t1d for at least a 6-month duration per american diabetes association(ada) criteria who are taking insulin iv) have visited their diabetes care provider in the past year v) body image concerns exclusion criteria: i) not female identifying ii) not in age range iii) does not have a diagnosis of t1d for at least 6 months per ada criteria who are taking insulin iv) have not visited their diabetes care provider in the past year v) do not report some level of body dissatisfaction
effectiveness of a robot assisted tenodeis-grip neurorehabilitation

Conditions: Rehabilitation, Tenodesis, Stroke

Summary: in the proposed study, the investigators assumed that using robot assisted tenodesis-grip training providing high does assisted grip movement may do the effects on motor shaping and greater brain priming for hand paresis of the stroke patients. the specific aim of this study is to examine the difference in the treatment effects between the combination of robot assisted tenodesis-grip training with task-oriented training and combination of traditional occupational therapy with task-oriented training on the motor, sensation, hand performance of the stroke patients. the expected outcomes of this research are to help the clinicians understand the training mechanism and effects of robot assisted tenodesis-grip training on functional performance of upper extremity for unilateral stroke patients.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of stroke with unilateral side involved; 2. stroke at least 7 days before the start of the first assessment session; 3. a score of mini-mental state examination greater than 24 for proving higher mental function; 4. premorbid right-handedness. exclusion criteria: 1. uncontrolled hypertension; 2. major cognitive-perceptual deficit; 3. other brain disease.
longitudinal imaging in patients with large vessel vasculitis to predict further disease course

Conditions: Giant Cell Arteritis; Large Vessel Giant Cell Arteriitis

Summary: longitudinal imaging in patients with large vessel vasculitis to predict further disease course

this explorative longitudinal prospective observational study is to explore different aspects of vessel wall characteristics as detected by magnet resonance imaging (mri) techniques and positron emission tomography/computer tomography (pet/ct) in patients with large vessel giant cell arteriitis (lv-gca) for their usefulness as predictive factor for future giant cell arteritis (gca) relapse. it analyses parameters in pet/ct and mri in patients with gca at treatment stop which correlate with gca relapse within the first 6 months after treatment stop. patients included in the established local gca database (bark) will be screened for eligibility. aortal imaging is performed during routine care according to established guidelines at diagnosis and during follow up at least every two years and before treatment stop.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of gca and having a diagnosis of lv-gca confirmed by imaging (pet/ct) * informed consent to the local gca cohort bark * followed for gca treatment in the outpatient department. exclusion criteria: * known hypersensitivity or allergy to gadolinium (gd)-based mri contrast agents. * patients with cardiac pacemakers, intra cranial clips, metallic foreign bodies or other not mr-compatible implants (e.g. pumps etc.). * renal failure or severely impaired kidney function (egfr \< 30 ml/min /1,73 m2) * epilepsy.

Keywords: magnet resonance imaging (mri) positron emission tomography/computer tomography (pet/ct) gca relapse
polypharmacy-related adverse events in critically ill children

Conditions: Delirium

Summary: the purpose of this study is to learn how 2 medications (fentanyl and dexmedetomidine) affect how sick children think and interact with their environments.


Eligibility criteria:
inclusion criteria: * ages 2-\<18 at the time of enrollment * admitted to the duke picu or pcicu * planned or anticipated mechanically ventilation for ≥2 days * require sedation to maintain mechanical ventilation * no contraindication to receipt of fentanyl or dexmedetomidine per clinician judgment * availability and willingness of the parent/legal guardian to provide written informed consent exclusion criteria: * any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study. * previous participation in this study * planned receipt of sedatives other than fentanyl or dexmedetomidine * participants with any of the following diagnoses: traumatic brain injury, intracranial hemorrhage, baseline neurodevelopmental delay, status epilepticus, or requiring inotropic support for hemodynamic stability. * renal failure requiring renal replacement therapy * hepatic failure * support with extracorporeal membrane oxygenation

Keywords: children, mechanically ventilated, fentanyl, dexmedetomidine, delirium, polypharmacy
whole brain radiotherapy following local treatment of intracranial metastases of melanoma

Conditions: Metastatic Melanoma

Summary: people with brain metastases from melanoma are offered different treatment options after local treatment of their brain metastases via surgery or stereotactic irradiation. depending on the treating institution and the clinician involved a patient may or may not be offered whole brain radiotherapy (wbrt) after their brain metastases are excised or treated with stereotactic irradiation. this trial seeks to determine if wbrt reduces the spread of brain metastases and lengthens the time to recurrence. the trial also examines the effect of wbrt on quality of life and brain functions such as memory, speech and concentration. participants will be randomised after local treatment of their brain metastases to either wbrt or observation. 220 people will be recruited from sites in australia, norway, the uk, the us and other international sites.


Eligibility criteria:
inclusion criteria: * 1-3 intracranial metastases on mri from melanoma, locally treated with either surgical excision and/or stereotactic irradiation. * life expectancy of at least 6 months * aged 18 years or older * wbrt must begin within 8 weeks of completion of localised treatment and within 4 weeks of randomisation * able to have an mri brain scan with contrast. estimated glomerular filtrate rate (egfr) is adequate at the discretion of the radiologist and capable of having gadolinium-containing contrast medium for mri as per practice guidelines * complete localised treatment of all these metastases no more than 6 weeks prior to randomisation * an eastern cooperative oncology group (ecog) performance status of 2 or less at randomisation * ct scan of chest, abdomen and pelvis as a minimum prior to randomisation. scans must be within 12 weeks of randomisation * serum lactate dehydrogenase (ldh) must be = or \< 2 x upper limit of normal * able to provide written informed consent exclusion criteria: * any untreated intracranial disease * any previous intracranial treatment (surgical excision and/or stereotactic irradiation treatment and/or wbrt) prior to this diagnosis of intracranial melanoma * evidence of leptomeningeal disease on pre-local treatment mri scan * patients with prior cancers, except: * those diagnosed more than five years ago with no evidence of disease recurrence within this time; * successfully treated basal cell and squamous cell skin carcinoma; * carcinoma in-situ of the cervix * a medical or psychiatric condition that compromises ability to give informed consent or complete the protocol * positive urine pregnancy test for women of childbearing potential within a week of registration onto the trial

Keywords: whole brain radiotherapy brain metastases melanoma stage iv metastatic melanoma neurocognitive function quality of life
outcomes of total arterial coronary artery bypass grafting

Conditions: Coronary Artery Disease; Surgical Wound Infection

Summary: "real-life" retrospective multicentric database for the analysis of the long term outcomes of total arterial cabg in comparison to saphenous vein based cabg

this aim of this registry is to create a multi centric database for the analysis of basic long term outcomes and immediate postoperative outcomes of total arterial cabg in comparison to saphenous vein based cabg. the registry will include both on pump and off pump surgery. the registry is intended to capture the "real-life" picture of the cabg scenario among centers worldwide

Eligibility criteria:
inclusion criteria: * elective cabg patients (on pump or off pump surgery; pedicles of skletonized internal mammary artery harvesting technique; open or endoscopic vein harvesting technique) exclusion criteria: * urgent or emergent cabg * concomitant procedures * redo cases
ventilator-associated events: prevalence, outcome and preventability

Conditions: Ventilator-Associated Lung Injury

Summary: the aim of this study is to determine the prevalence of ventilator-associated events (vae). to analyze the patients profile, morbidity and mortality compared to patients who did not develope vae. the preventability of vae will be assessed by comparing the percentage of adherence to the bundle of preventive measures among patients who developed and did not develope vae.

this is a retrospective analysis of prospectively collected data, approved by the research ethics committee of hospital sao domingos. the need for informed consent was waived. included were all patients admitted to a surgical (13 beds) and medical (32 beds) of a tertiary hospital over a 3-year period (february 2013 to january 2016), aged above 18 years and submitted to mechanical ventilation for at least 4 days. at admission and daily the following data were collected: head of bed elevation, daily interruption of sedation, gastric ulcer prevention, thromboembolism prophylaxis, aspiration of subglottic secretions, oral care with chlorhexidine gluconate and monitoring of endotracheal tube cuff pressure. identification of vae, ventilator-associated condition (vac), infectious condition associated to mechanical ventilation (ivac) and ventilator-associated pneumonia possible and probable followed definition criteria of the national healthcare safety network / center for disease control and prevention. the percentage of adherence to the bundle of preventive measures of vae prevention was registered.

Eligibility criteria:
inclusion criteria: * patients admitted to a medical and a surgical icus over a 3-year period aged above 18 years and submitted to mechanical ventilation for at least 4 days. exclusion criteria: * patients aged bellow 18 years and those that remained under mechanical ventilation less than 4 days.
long-term study to evaluate safety and persistence of gf-cart01

Conditions: DLBCL - Diffuse Large B Cell Lymphoma; Follicular Lymphoma (FL); Primary Mediastinal Large B-Cell Lymphoma; High Grade B Cell Lymphoma

Summary: the goal of this observational study is to learn about the long-term safety of gf-cart01 after cell infusion up to 15 years.

this comprehensive long-term follow-up study is meticulously designed to assess the safety and persistence of gf-cart01. subjects who participated in the initial study of gf-01-01 and received treatment with gf-cart01, irrespective of their completion status, are eligible to participate in this follow-up study. the study may allow for a maximum enrollment of 18 subjects.

Eligibility criteria:
inclusion criteria: 1. subjects previously enrolled in the study of gf-cart01 (protocol no.: gf-01-01) and received gf-cart01 infusion 2. subjects or their legal guardians must volunteer to participate in the study and sign the informed consent 3. willingness and ability to comply with protocol-stated requirements, instructions, and restrictions in the investigator's judgement exclusion criteria: none
effect of cannabis consumption on sperm nuclear quality in infertile men

Conditions: Teratozoospermia

Summary: lifestyle and environmental factors can disrupt development and testicular function. in france, cannabis is the most widely used illicit substance and about 8% of adults between 18 and 64 years smoke cannabis at least once a year, and mostly men under 45 years. endocannabinoids are lipid mediators that share some effects with the active ingredients of cannabis. cannabis and endocannabinoids act via two types of endogenous receptors which were detected at different levels of the reproductive system and are involved in the central and local regulation of the gonad. cannabis use may alter the normal regulation of the endocannabinoid system. in males, the regulation of the endocannabinoid system is critical for sertoli and leydig cells functions, germ cell differentiation, maturation of sperm nucleus and sperm quality. the cannabis can have a negative impact on sperm parameters, capacitation and acrosome reaction. cannabinoids may decrease testosterone synthesis and induce apoptosis of sertoli cells. studies on the effect of cannabinoids on male fertility are scarce or nonexistent in infertile men because of ethical considerations and bias due to consumption often underreported. investigators hypothesized that cannabis use may alter sperm nuclear quality. investigators want to explore this hypothesis conducting a multicentric prospective study exposed/non-exposed in infertile men who are consulting for medically assisted reproductive technologies (art). to reach this study, it is planned to include a total of 200 subjects taking into account any exclusions.


Eligibility criteria:
inclusion criteria: * male patient, * patient age ≥ 18 years, * infertile patient with isolated teratozoospermia or associated with asthenozoospermia and / or oligozoospermia and / or necrozoospermia, defined according to who recommendations (who guidelines, 2010) and the david amended classification (auger et al, 2001) for teratozoospermia * patient with normal constitutional karyotype (46, xy). * smoking tobacco, * drinking ≤ 20 g (2 units) / day, * patient exposed : cannabis user for over 3 months and consuming at least weekly (≥ 1 / week) \[questionnaire and positive blood detection of delta-9-tetrahydrocannabinol (thc) and / or its derivatives (11-hydroxy-thc and 11-nor-9-carboxy-thc)\]. * unexposed : no cannabis user (questionnaire and negative blood detection of delta-9-thc and its derivatives) matched for age (+/- 2.5 years) with exposed patients included, exclusion criteria: * patient age \> 60 years * patient with azoospermia * patient previously exposed to gonadotoxic treatment (chemotherapy, radiotherapy, androgen therapy and other gonadotoxic treatments), * patient with professional toxic exposure, * patient consuming other recreational drugs, * patient with severely impaired sperm parameters and sperm counts \<1 million,

Keywords: cannabis
azacytidine plus caold regimen in relapsed/refractory peripheral t-cell lymphomas

Conditions: Relapsed Peripheral T-Cell Lymphomas; Refractory Peripheral T-Cell Lymphomas

Summary: this is a multicenter prospective single arm phase ii study. the purpose of this study is to evaluate the safety and efficiency of azacytidine combined with caold regimen in the treatment of relapsed/refractory peripheral t-cell lymphomas.

the investigators will evaluate response rate, progression free survival (pfs), overall survival (os), and toxicity of azacytidine combined with caold regimen in relapsed/refractory peripheral t-cell lymphomas.

Eligibility criteria:
inclusion criteria: patients must satisfy all following criteria to be enrolled in the study: * pathologically confirmed angioimmunoblastic t-cell lymphoma according world health organization (who) classification; * patient is ≥ 18 years of age at the time of signing the informed consent form (icf). * patient must understand and voluntarily sign an icf prior to any study-specific assessments/procedures being conducted; * patient is willing and able to adhere to the study visit schedule and other protocol requirements; * relapsed (after partial or complete response) or refractory aitl after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below.) * meet the following lab criteria: * absolute neutrophil count (anc) ≥ 1,5 x 10\^9/l (≥ 1 x 10\^9/l if bone marrow (bm) involvement by lymphoma) * platelet ≥ 75 x 10\^9/l (≥ 50 x 10\^9/l if bm involvement by lymphoma) * hemoglobin ≥ 8 g/dl. * anticipated life expectancy at least 3 months exclusion criteria: * active or uncontrolled infections requiring systemic treatment within 14 days before enrollment; * any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy; * pregnant or lactating women