Kornimate/medical-research-clean huggingface dataset:
assessment of the safety and performance of ankle ligament supports in the context of a return to sport after sprain

Conditions: Ankle Sprain 1St Degree; Ankle Sprain 2Nd Degree; Ankle Sprain 3Rd Degree

Summary: decathlon has developed ankle strong products which are medical devices that must be positioned around the ankle to limit ankle sprain occurrence. the ankle strong devices cover a range of 3 products (ankle strong 100/500/900). the differences between the devices is based on the strength of compression and the ankle maintain. the objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved decathlon ankle strong products to demonstrate safety and performance of these devices in a real-world setting.


Eligibility criteria:
inclusion criteria: * subject is aged ≥ 18 years old * subject has a recent mild or moderate or serious ankle sprain * the current condition of his/her ankle allows the subject to resume usual physical activity * subject has been informed and is willing to sign an informed consent form * subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (12 weeks) * subject is affiliated to the french social security regime non-inclusion criteria: * subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent * subject has worn a support (ankle brace or articulated orthosis) since his/her recent injury * subject has resumed regular physical activity since his/her recent injury * subject has any medical condition that could impact the study at investigator's discretion * subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastane, polyester, cotton) * adult subject to legal protection measure
special survey for long term application

Conditions: Genetic Disorder; Achondroplasia

Summary: this study is conducted in japan. the aim of this study is to assess the incidence rate of adverse drug reactions (adrs) when using somatropin (norditropin®) for treatment of for achondroplasia without epiphyseal line closure under normal clinical practice conditions.


Eligibility criteria:
inclusion criteria: * achondroplasia without epiphyseal line closure
comparing laparoscopic and open pancreaticoduodenectomy for nonpancreatic periampullary adenocarcinomas

Conditions: Periampullary Adenocarcinoma

Summary: the aim of this study was to evaluate the outcomes of lpd versus opd in non-pancreatic periampullary adenocarcinoma

the aim of this study was to evaluate the outcomes of lpd versus opd in non-pancreatic periampullary adenocarcinoma

Eligibility criteria:
inclusion criteria: 1. age between 18 years and 75 years. 2. histologically confirmed nppc or clinically diagnosed nppc by an mdt without histopathologic evidence. 3. patients feasible to undergo both lpd and opd ac- cording to mdt evaluations. 4. patients understanding and willing to comply with this trial. 5. provision of written informed consent before patient registration. 6. patients meeting the curative treatment intent in ac- cordance with clinical guidelines. exclusion criteria: 1. patients with distant metastases, including peritone- al, liver, distant lymph node metastases and involve- ment of other organs. 2. patients requiring left, central or total pancreatecto- my or other palliative surgery. 3. preoperative american society of anaesthesiologists (asa) score ≥4. 4. history of other malignant disease 5. pregnant or breastfeeding women. 6. patients with serious mental disorders 7. patients treated with neoadjuvant therapy. 8. patients with vascular invasion and requiring vascular resection as evaluated by the mdt team according to abdominal imaging data. 9. body mass index \>35 kg/m 2 . 10. patients participating in any other clinical trials with- in 3 months.

Keywords: non-pancreatic periampullary adenocarcinoma laparoscopic pancreaticoduodenectomy
defining volume status in sepsis with extracellular water measurement

Conditions: Sepsis

Summary: the goal of this observational study is to learn about the influence of extracellular water on volume status in adult sepsis patients presenting with hemodynamic instability. the main question it aims to answer is: • can measurement of extracellular water (moisturemeterd, delfin technologies ltd, kuopio, finland) contribute to the description of hemodynamic instability in adult sepsis patients. patients with sepsis admitted to intensive care will receive standard care with the addition of measurement of extracellular water.

adult patients with sepsis admitted to any of our icus will be recruited. during the first three days after inclusion blood samples and extended non-invasive monitoring, including monitoring of the microcirculation (cytocam) and measurement of extracellular water (dielectronic constant), will be added to routine care and monitoring.

Eligibility criteria:
inclusion criteria: * adults with sepsis. exclusion criteria: * pregnancy, palliative care, other than sepsis known cause of shock.
a study of the effect of r1507 in combination with tarceva (erlotinib) on progression-free survival in patients with stage iiib/iv non-small cell lung cancer (nsclc).

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this 4 arm study in patients with advanced stage iiib/iv non-small cell cancer (nsclc) who failed at least one standard chemotherapy regimen will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with r1507 and tarceva or placebo and tarceva. patients will be randomized to one of four treatment arms to receive r1507 (9mg/kg iv) or placebo weekly or r1507 (16mg/kg iv) or placebo every 3 weeks. tarceva (150mg oral daily) will be administered in all treatment arms. other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. the anticipated time on study treatment is 1-2 years, and the target sample size is \<500 individuals.


Eligibility criteria:
inclusion criteria: * male or female patients \>=18 years with histologically documented inoperable, locally advanced or metastatic (stage iiib or iv) nsclc; * patients must have failed at least one but no more than two standard chemotherapy regimens; * measurable disease according to the recist criteria; * eastern cooperative oncology group (ecog) performance status; * life expectancy \>12 weeks. exclusion criteria: * patients with active central nervous system (cns) lesions; * prior treatment with agents acting via insulin-like growth factor 1 receptor (igf-1r) inhibition or epidermal growth factor receptor (egfr) targeting; * administration with high doses of systemic corticosteroids; * radiotherapy in the 4 weeks prior to study start; * surgery or significant traumatic injury with in the last 2 weeks prior to study start.
an epidemiological study on antimicrobial treatment of nosocomial infections in clinical practice

Conditions: Nosocomial Infection

Summary: the present study is a retrospective cohort study on patients who suffered a nosocomial infection in major hospitals in vietnam. data relating to patient demography include age, gender; medical history; apache ii score; background conditions, infection details and antimicrobial therapy; and all-caused mortality, time of hospitalization and intensive care. the investigators hypothesis is that antimicrobial treatment inappropriate is highly dependent on incidence of antibiotic resistant pathogens, nonfermentative gram-negative bacilli and esbl-producing enterobacteriaceae spp. variables are demographic characteristics, background conditions, immunosuppressive therapy, antimicrobial susceptibility and inappropriate treatment is explored as possible predictors of mortality.


Eligibility criteria:
inclusion criteria: * patient was diagnosed as nosocomial infection defined according to criteria established by the us cdc. the diagnosis criteria for ventilator-associated pneumonia are modified from those established by the american college of chest physicians. * patient received empiric antimicrobial therapy within 24 hour from onset of infection and had antimicrobial susceptibility. exclusion criteria: * a patient was in part of a controlled clinical trial for the current infection episode. * patients with suspected infections by virus or fungus or tuberculosis will be excluded.

Keywords: non-interventional study vietnam inappropriate treatment nosocomial infection
using game-based exercise to improve balance in cancer patients

Conditions: Chemotherapy Induced Peripheral Neuropathy; Cancer

Summary: cancer patients with chemotherapy-induced peripheral neuropathy (cipn) have deficits in sensory and motor skills leading to inappropriate proprioceptive feedback, impaired postural control and high fall risk. this study will investigate the acceptability and effect of an interactive motor adaptation balance training program based on wearable sensors for improving balance in older cancer patients with cipn. cancer patients with confirmed cipn will be recruited and will be randomized to either intervention (ig) or control (cg) group and followed for 6 months. the intervention group will take part in a 6-week balance training program twice per week in either their home or in clinic (based on subject preference) under the supervision of a qualified research staff member. this intervention includes interactive game-based balance training including repetitive weight shifting and virtual obstacle crossing tasks. wearable sensors will provide real-time visual/auditory feedback from foot and ankle position and allowed perception of motor-errors during each motor-action. the control group will be instructed to complete a supervised foot and ankle exercise without using sensor technology. changes in balance, gait, and physical activity, and number of falls will be compared pre- and post-intervention, as well as 3 and 6 month post intervention. investigators hypothesize that patients receiving sensor-based exercise training will benefit more compared to group receiving conventional non-technology home-based training in terms of improving functional performance and reducing falls.


Eligibility criteria:
inclusion criteria: * cancer patients * men or women aged 55 years or older * patients undergoing neurotoxic chemotherapy (agents including platinums, vinca alkaloids, taxanes, proteasome inhibitors and interferons) * confirmed peripheral neuropathy (vpt\>25) will be eligible to participate exclusion criteria: * subjects will be excluded if they have undergone surgery in the last 6-8 weeks * have parkinson's disease * stroke patients * dementia patients * have an active foot ulcer * have an active infection * lower extremity major amputation * patient is taking medications unrelated to cancer treatment that may affect balance and gait * patient has other medical conditions that may affect their balance and gait * patient is unable to ambulate without assistance.

Keywords: chemotherapy induced peripheral neuropathy cancer game-based exercise exercise wearable sensors balance falls virtual reality
new technological pathway for gait rehabilitation

Conditions: Neurological Diseases or Conditions; Cardiovascular Diseases; Neuromuscular Disease

Summary: \*\*brief summary\*\* the study aims to explore how the integration of visual and motor systems can be trained and enhanced to improve gait rehabilitation in patients with various neurological and cardiovascular conditions. scientific evidence highlights that physical activity requires coordination and precise processing of visual, auditory, and sensory information from the external environment, which is then integrated at the brain level. this process establishes synaptic connections that direct the movement of arms, hands, legs, and the trunk through bottom-up and top-down mechanisms. however, inaccurate or incomplete perceptual information can impair performance, even when accurate visual stimuli are provided, emphasizing the importance of assessing and enhancing visuo-motor integration. the research investigates the central mechanisms controlling peripheral muscle activation patterns during gait. while over-ground walking in healthy individuals generally does not activate the prefrontal cortex except in dual-task scenarios, evidence suggests that post-stroke patients exhibit increased prefrontal cortex metabolism during walking. recent studies have shown that gait training with exoskeletal systems improves walking patterns in post-stroke patients by altering muscle activation patterns and increasing fronto-parietal connectivity. this study seeks to answer the following question: how do central and peripheral mechanisms interact to influence gait rehabilitation outcomes, and what role do visuo-motor integration and neuroplasticity play in this process? to address this, advanced neuroimaging technologies such as fmri, dtmri, and nirs will be employed to investigate these mechanisms in vivo.


Eligibility criteria:
inclusion criteria: * patients with a montreal cognitive assessment (moca) score, corrected for age and education, equal to or greater than 20. * subjects capable of walking independently (functional ambulation categories - fac \> 2). exclusion criteria: * cognitive impairments that compromise the understanding and/or execution of the proposed exercises. * associated comorbidities that prevent maintaining an upright position or walking (e.g., hypotension). * refusal or inability to provide informed consent. * patients with contraindications to the use of the technological equipment required for the dynamic movement pathway.

Keywords: neurorehabilitation gait rehabilitation analysis of movement neuroplasticity
a late phase ii clinical trial of kdt-3594 in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: this trial is a late phase ii, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy, safety, and pharmacokinetics of kdt-3594 administered at escalating doses ranging from 0.25 to 2 mg per day for 17 weeks in patients with advanced pd with levodopa.

this trial is a late phase ii, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy, safety, and pharmacokinetics of kdt-3594 administered once daily in patients with advanced pd with levodopa.

Eligibility criteria:
inclusion criteria: * patients diagnosed with pd according to the parkinson's disease society brain bank clinical diagnostic criteria of the uk parkinson's disease society * patients who are being treated with levodopa or levodopa combination drugs and have any of the following troublesome symptoms or conditions: * patients with wearing-off phenomenon * patients with on-/off-phenomenon * patients with no-on/delayed on phenomenon * patients with inadequate response to levodopa exclusion criteria: * patients suspected of having parkinsonism other than pd based on medical history, physical findings, laboratory test values, dopamine transporter-single photon emission computed tomography (dat-spect), etc. * patients who have undergone neurosurgical therapy for pd (e.g., stereotactic thalamotomy and pallidotomy and deep brain stimulation) or who are scheduled to undergo surgical therapy during the trial period * patients complicated with overt dementia or a mini-mental state examination (mmse) score of \< 24 at the start of the screening period
sglt-2i and arb combination therapy in patients with t2dm and nocturnal hypertension (sacra study)

Conditions: Nocturnal Hypertension; T2DM (Type 2 Diabetes Mellitus)

Summary: to explore the beneficial effects of 'empagliflozin + arb' in comparison with 'placebo + arb' on the reduction of nocturnal blood pressure in t2dm with hypertension

the study consists of a 8-week run-in period and a 12-week treatment period.

Eligibility criteria:
inclusion criteria: patients who meet the following criteria at the start of treatment are eligible for the study: * receiving stable treatment with anti-hypertensive including arb for at least 8 weeks at baseline (0w). * receiving stable anti-diabetic treatment with/without anti-diabetics for at least 8 weeks at baseline (0w). * hba1c\>=6.0%, \<10% * seated office sbp 130-159mmhg or dbp 80-99mmhg * nocturnal hypertension (sbp\>=115 mmhg) as measured by home bp during 5days before baseline (0w). * age\>=20 exclusion criteria: patients who meet any of the following criteria are not eligible for the study: * history of hypersensitivity to empagliflozin * breast-feeding, pregnant, possibly pregnant, or plan to become pregnant * treated with insulin or su * with renal dysfunction (egfr\<45ml/min/1.73m2) * with liver dysfunction (ast or alt is 3 times higher than reference value) * hypotension (systolic blood pressure \< 90 mmhg) * with pituitary gland dysfunction or adrenal gland dysfunction * heart failure patients whose nyha class is iv * deemed ineligible for the study due to another reason by investigator * history of diabetic ketoacidosis or diabetic come within 3 months before enrollment * history of acute myocardial infarction, unstable angina, cerebrovascular disease, or transient ischemic attack within 3 months before enrollment * patients who have undergone percutaneous transluminal coronary angioplasty (pci) or coronary artery bypass graftin (cabg) within 3 months before enrollment * patients received sglt2 inhibitor within 8 weeks before enrollment
real-world evaluation of patient characteristics and treatment patterns among patients with cml-cp treated with asciminib

Conditions: Chronic Myeloid Leukemia, Chronic Phase

Summary: a retrospective, non-interventional cohort study design using data obtained from the flatiron health oncology electronic health record (ehr)-derived de-identified database, was used to address the study objectives. the overall asciminib cohort included adult patients with philadelphia positive (ph+) chronic myeloid leukemia (cml) in chronic phase (cml-cp), with or without the t3151 mutation, who initiated asciminib in any line of therapy. the third-line or later (3l+) asciminib cohort included adult patients with ph+ cml-cp who did not have t315i mutation and initiated asciminib after prior use of at least 2 different tyrosine kinase inhibitors (tkis) or omacetaxine. the 3l asciminib cohort included the subgroup of the 3l+ asciminib cohort who initiated asciminib after prior use of 2 different tkis or omacetaxine. the fourth-line or later (4l+) asciminib cohort included the subgroup of the 3l+ asciminib cohort who initiated asciminib after prior use of at least 3 different tkis or omacetaxine.


Eligibility criteria:
inclusion criteria: * patients who initiated asciminib as identified by flatiron through the flatiron health-novartis scemblix cml spotlight database study. * patients had at least one diagnosis for cml (international classification of diseases, 9th edition, clinical modification \[icd-9-cm\]: 205.1x; international classification of diseases, 10th edition, clinical modification \[icd-10-cm\]: c92.1x). * diagnosed with cp as identified by flatiron through chart abstraction. * had 2 or more documented clinical visits, on different days in the flatiron data on or after 1 january 2011. * had evidence of treatment with asciminib on or after food and drug administration (fda) approval date (29 october 2021), with data granularity availability at least at the month level for dates of asciminib use. * had cml initial diagnosis date on or after 1 january 2011. * had 1 or more clinical activity within 6 months prior to asciminib initiation (e.g., medical visit, medication order, lab test, etc.). exclusion criteria: * patients who did not meet inclusion criteria listed above. * had stem-cell transplant (sct) on or prior to asciminib initiation or unknown sct date. * diagnosed with cml in accelerated phase (ap) or blast crisis (bc) before asciminib initiation, as identified by flatiron through chart abstraction, or had blast greater than 15% or unknown blast result within 60 days prior to asciminib initiation. * patients had received a clinical study drug between 15 november 2017 and 4 december 2019 (randomization dates for the ascembl trial).
personality change study for borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: participants with borderline personality disorder will undergo an a 2 - 4 week baseline assessment to determine level of outcomes of interest in the absence of treatment. after the baseline period, participants will receive six weekly 50-60-minute treatment sessions. after the 6 treatment sessions, participants will complete a 4-week follow-up period to determine the sustainability of the treatment module.


Eligibility criteria:
inclusion criteria: * speak english fluently * diagnosis of borderline personality disorder exclusion criteria: * diagnosed psychological conditions that would be better addressed by alternative treatments * concurrent psychotherapy * medication instability * substance use disorder
gluten-free diet in irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: to evaluate the effects of a gluten-free diet in irritable bowel syndrome.

irritable bowel syndrome with diarrhoea (ibs-d) is commonly encountered in primary and secondary-care practice. there are various triggers including diet. there is a growing number of people taking a gluten-free diet (gfd) of their own volition even in the absence of coeliac disease (cd). the investigators aim to assess whether a gfd could be of benefit to patients with ibs-d, previously naive to the effects of gluten and in whom cd has been excluded as per normal duodenal biopsies. the investigators will also assess whether certain factors may predict a clinical responder such as the presence or absence of at-risk coeliac serology.

Eligibility criteria:
inclusion criteria: 1. patients aged 16 years or over 2. patients fulfilling rome iii symptom based criteria for ibs-d but do not have coeliac disease exclusion criteria: 1. patients diagnosed with coeliac disease 2. patients already on a gluten-free diet 3. patients initially referred with self-reported gluten sensitivity 4. patients with organic conditions that can mimic ibs-d such as idiopathic bile acid diarrhoea, pancreatic insufficiency, microscopic colitis, and inflammatory bowel disease
oral paracetamol as preemptive analgesia for labor pain

Conditions: Labor Pain

Summary: it is a double blinded randomized control trial assessing the use of oral paracetamol in managing the intrapartum pain.

it is a double blinded randomized control trial comparing the use of oral paracetamol to placebo in managing the intrapartum pain.

Eligibility criteria:
inclusion criteria: * primigravida * the gestational age between 37- 42 weeks * not seeking analgesia * singleton pregnancy * vertex * spontaneous onset of labour * 1st stage of labour (less than 5 cm) exclusion criteria: * extreme of age (below18-above 40) * multiparous * multiple gestation * malpresentation * congenital or acquired pelvic abnormalities(eg. poliomyelitis) * any medical disorder with pregnancy * induction of labour * advanced 1st stage \> 5 cm * use of any other kind of analgesia before recruitment in the study * scared uterus * fetal distress