Kornimate/medical-research-clean huggingface dataset:
switching from oral antipsychotics to long-acting risperidone in participants with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate efficacy, safety and tolerance of long-acting risperidone when switching from oral antipsychotics in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

this is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center) and non-comparative study of long-acting risperidone in participants with schizophrenia who have a previous history (in the last 12 months) of bad adherence to the oral antipsychotic treatment of first or second generation. the duration of this study will be 24 weeks and will include following visits: screening, baseline, week 2, 4, 8, 12, 16, 20, 24, 38 and 50 (end visit or early withdrawal). all the eligible participants (after risperidone intolerance test during screening) will receive a dose of 25 milligram risperidone every two weeks by intramuscular injection (injection of a substance into a muscle). efficacy and safety of the participants will primarily be evaluated by positive and negative syndromes scale and extrapyramidal symptom rating scale, respectively. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * have schizophrenia diagnosis by diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) * be on treatment with oral antipsychotic of first or second generation, for a minimum time of 12 months * previous history of bad adhesion to oral antipsychotic treatment in the last 12 months * total positive and negative syndrome scale score less than or equal to 90, the conceptual disorganization, hallucinatory behavior, suspicion and not usual content of thought must be less than or equal to 4 * be not pregnant as showed on negative pregnancy serum test exclusion criteria: * contraindication or known hypersensitivity to risperidone * previous history of unsatisfactory response to risperidone * previous history of refractivity to the other second generation antipsychotics * use of antipsychotic of intramuscular deposit in the last 12 months * other mental disturbances of dsm-iv axis

Keywords: schizophrenia risperidone risperdal consta
local metabolism of the gastric tube reconstruction after esophagectomy

Conditions: Microdialysis; Ischemia; Anastomotic Leakage

Summary: postoperative surveillance of local metabolism of the surgical reconstruction after esophagectomy by means of microdialysis. dialysate is collected continuously for seven postoperative days. results analysed in a blinded fashion and related to the clinical outcome. primary endpoint: anastomotic leakage

the purpose of the study is to evaluate onzurf probe (microdialysis probe) as a monitoring method for the early diagnosis of complications after surgery in the gastrointestinal tract. samples taken with onzurf probe will be analyzed and then compared with routine clinical data on surgical procedures in gastrointesinala tract. these parameters are: patient general condition, endoscopy, radiology and routine clinical samples (global) as crp (c-reactive protein), white blood cells, blood gases.the patients are their own controls when the purpose is to see if you can detect early complications with onzurf probe and also identify how many people gets complications after surgery in the gastrointestinal tract. the patients' clinical routine tests (blood tests, etc.) will serve as control samples, which then will be compared with results from sampling of onzurf probe. no interventions will be carried out on the patient.

Eligibility criteria:
inclusion criteria: * all patients accepted for esophagectomy with gastric tube reconstruction in the department exclusion criteria: * surgical recontruction other than gastric tube
prediction of the response to neoadjuvant radiation chemotherapy through texture analysis derived from medical imaging

Conditions: Rectal Cancer

Summary: in patient with complete pathological response, surgery could be omitted without compromising progression-free or overall survival. a powerful prediction model is needed to guide management of this population. radiomics features provide complementary information about tumor heterogenity. the aim of the investigators is to develop a model combining clinical and radiomic criteria able to predict complete pathological response.


Eligibility criteria:
inclusion criteria: * locally advanced rectal cancer * patients who received concomitant radio-chemotherapy followed by surgery * pre-therapeutic mri and ct-scan dicom available exclusion criteria: * age under 18 yo * lack of mri or ct-scan

Keywords: locally advanced rectal cancer radiomic
impact of focal muscle vibration on bio-psychosocial outcomes in cerebral palsy

Conditions: Cerebral Palsy

Summary: this study aims to determine the effects of focal muscle vibration on bio-psychosocial outcomes in subjects with cerebral palsy. mixed methods will be used and the study will be conducted in 2 phases; 1st phase is determining the effects of intervention, whereas second step is prediction of outcomes. a qualitative gait analysis will also be done.

the literature suggests the positive effects of focal muscle vibration on various motor components of cerebral palsy. although there is a gap regarding it's effects with perspective of bio-psychosocial model, which will be the main focus of this study. the study will look for the effects of focal muscle vibration on biological, psychological and social aspects of subjects with cerebral palsy (cp). the intervention in form of focal muscle vibration and standard physical therapy will be provided for 12 weeks and the subjects will then be followed for 4 weeks to look for retention effects, and till 24 weeks for prediction of outcomes.

Eligibility criteria:
inclusion criteria: * diagnosed spastic diplegic cerebral palsy cases with following characteristics; * gross motor function classification scale levels ii-iv * receiving standard physical therapy care exclusion criteria: * severe cognitive, visual and hearing impairments. * history of metabolic diseases. * history of recent fractures. * children with severe musculo-skeletal anomalies

Keywords: cerebral palsy focal muscle vibration biopsychosocial functional near-infrared spectroscopy electroencephalography emotional reactivity
adaptive immune response in visceral and subcutaneous fat: role in human insulin resistance

Conditions: Insulin Resistance; Insulin Sensitivity; Obesity; Inflammation

Summary: the proposed study is designed to test the hypothesis that in human obesity, the balance of pro- and anti-inflammatory t cells in fat tissue is in fact related to macrophage phenotype and insulin resistance, and how it is related. this study is needed to confirm whether conclusions based on studies of visceral adipose tissue in mice are indeed applicable to humans. we also want to determine the relationship between insulin resistance/hyperinsulinemia and ability to lose weight in obese individuals.

previous studies have found convincing evidence of the relationship between insulin resistance, t cell profiles, macrophage profiles and inflammation of the fat cells. this study will add human subjects to that body of evidence. overview aim 1: test the hypothesis that the balance of anti- inflammatory vs proinflammatory t cells is protective for systemic insulin resistance. t cell profiles in subcutaneous and visceral tissue and blood will be compared in ir vs is obese humans at baseline and potentially after 12 months following weight loss. tcell profile will be evaluated for relationships with ir and inflammation, with adjustment for total body fat. secondarily, they will be evaluated for relationship to adipose cell size. overview aim 2: test the hypothesis that macrophage phenotype in adipose tissue is associated with t cell profile and ir. frequency of macrophage phenotypes (m1 vs m2) will be analyzed in ir vs is obese humans at baseline and potentially after 12 months following weight loss. overview aim 3: testing the hypothesis insulin resistance is associated with t cell receptor phenotypes in subcutaneous and visceral tissue. ir and is subjects will be evaluated at baseline by sequencing of expressed tcrs in paired sat, vat, and blood. we will determine whether tcr phenotypes are shared between different ir individuals.

Eligibility criteria:
inclusion criteria: * current patients of stanford healthcare, bariatric surgery clinic, scheduled to undergo bariatric surgery (sleeve or rygb) * bmi 30-55kg/m2 * 30-65 years of age * good general health, no major organ disease * non-diabetic by current american diabetes association (ada) criteria (fasting glucose \<126mg/dl) exclusion criteria: * subjects with any clinical or biochemical evidence of significant anemia, gastrointestinal, cardiac, hepatic or renal disease will be excluded. * subjects with other medical problems may participate as long as the problems are stable. * subjects with active psychiatric disorders or past history of bariatric surgery * pregnant or lactating women will also be excluded from the study, due to possible risk to the fetus or infant.
abioscope psp reference range study; extension of ab-psp-003

Conditions: Sepsis

Summary: this is a monocentric, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (psp) performed on abionic's abioscope device with the psp assay on generally healthy adults representative of the us population.


Eligibility criteria:
inclusion criteria: 1. male or female, aged ≥ 18 years. 2. apparently healthy as determined by a subject questionnaire. exclusion criteria: 1. current diagnosis, or history, of any underlying major medical condition determined by the investigator, including but not limited to 1. renal disease 2. stoke 3. liver disease 4. pancreatic disease (including diabetes) 5. hiv aids 6. receiving antibiotic therapy 7. suspected infection 8. immunosuppression 2. underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months. 3. current diagnosis of uncontrolled diabetes. 4. diagnosis of bacterial, fungal, or malaria infection within the last 3 months that required antimicrobial treatment. 5. experienced severe trauma, surgery, cardiac arrest, or severe burn within the previous 3 months requiring medical care. 6. diagnosis and/or treatment of cancer within the last 12 months. 7. received immunosuppressive therapy. 8. hospitalization for more than 24 hours within the last month. 9. reported as currently pregnant or nursing a child 10. unable or unwilling to provide the required blood sample for testing.
the effect of wireless fetal monitoring system on comfort, pain and satisfaction

Conditions: Pregnancy Related

Summary: wireless efm shortens labor duration, increases birth satisfaction, and reduces perceived pain during labor. with wireless efm, comfort in labor increases and higher labor comfort increases birth satisfaction. as perceived pain in labor decreases, birth satisfaction increases. therefore, wireless efm practice is recommended during the antepartum and intrapartum periods.

problem wired electronic fetal monitoring (efm) limits the woman's freedom of movement during labor, causes inability to cope with labor pain, lack of comfort, and a decrease in labor satisfaction. background while efm is performed as wired and wireless in the antepartum and intrapartum periods, wired application is common in the world and in our country. aim this randomized controlled study was conducted to evaluate the effect of the wireless fetal monitoring, which is used during birth, on the woman's comfort, labor pain and birth satisfaction. methods the study population consisted of 88 women, divided into two groups the experimental group (n=44) and the control group (n=44). the data were collected with the personal information form, childbirth comfort questionnaire (ccq), visual pain scale (vas), and birth satisfaction scale-revised (bss-r). during the intrapartum period, the wireless fetal monitoring system was used in the experimental group and the wired fetal monitoring system was used in the control group.

Eligibility criteria:
inclusion criteria: * pregnant women who are willing to participate in the study, * aged 18-40 years, * having a healthy pregnancy, * with a gestational age of \> 37+0 weeks, * with a cervical dilatation of 4-5 cm, * with a singleton pregnancy, * with a live fetus, * can speak turkish, * do not have comprehension, perception, and communication problems participated in the study. exclusion criteria: * pregnant women who did not comply with the study had communication problems, * had complications, * needed urgent cesarean delivery and wanted to withdraw from the study were excluded from the study

Keywords: pain birth chilbirth satisfaction wireless fetal monitoring comfort
ultrasonic perfusion estimation in calf muscle

Conditions: Peripheral Arterial Disease

Summary: the purpose of this study is to evaluate the potential of ultrasound perfusion imaging technique for assessing the progression of peripheral arterial disease (pad) and monitoring its response to therapy by measuring changes in microvessel alterations and perfusion variations.

the clinical manifestations of peripheral arterial disease (pad), regardless of etiology, are due to a lack of blood flow to the musculature relative to its metabolism, which results in pain in the affected muscle groups. pad affecting the lower extremities causes claudication, cramping pain in the calf muscle, thigh or hip muscle induced by exercise. the initial test for evaluation of patients with claudication is ankle brachial index (abi). therefore, a non-invasive and affordable us technique that can quantify blood perfusion and microvasculature density, without using contrast agent, will improve pad detection in early stage and can monitor the disease progress as well as the treatment response. the investigators anticipate that our new cost-effective and non-invasive ultrasound perfusion technique offers a quantitative imaging of perfusion that would help separating pad from non-pad and monitor the disease progression and treatment response.

Eligibility criteria:
inclusion criteria: * male and female volunteers \> 18 years old. * male and female volunteers with symptom of claudication and suspected peripheral arterial disease (pad) who are scheduled for vascular testing. exclusion criteria: * patients with gangrene. * patients with lower leg amputation. * having ulcer and any health condition that does not allow proper use of ultrasound scanning. * people considered in "vulnerable" populations.

Keywords: blood flow blood vessel ischemia calf muscle pain vascular ultrasound intermitant claudication cramp
assessment of the safety and performance of an elbow brace in the prevention of injuries during sports practice

Conditions: Epicondylitis; Tendonitis Elbow; Elbow Injury

Summary: decathlon has developed the elbow soft300 which is a medical device that must be positioned around the elbow to keep a physical activity on a regular basis in case of chronic epicondylitis, pain associated with tendonitis or chronic instability. the objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved decathlon elbow soft 300 product to demonstrate safety and performance of this device in a real-world setting. outcome data collected from this study will provide the basis for post-market surveillance (pms) reporting, clinical study report (csr), clinical evaluation report (cer) on decathlon elbowsoft300 device and support peer-reviewed publications on products performance and safety.


Eligibility criteria:
inclusion criteria: * subject is aged ≥ 18 years old * subject has a chronic epicondylitis (\>3 months) or elbow pain associated with tendonitis or chronic elbow instability (\>3 months) * the current condition of his/her elbow allows the subject to continue 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 (6 weeks) * subject is affiliated to the french social security regime exclusion 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 (elbow brace or articulated orthosis) in the last month during his/her sport practice * 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, elastodiene, polyester, elastane) * adult subject to legal protection measure
prolonged cardiopulmonary bypass time as a predictive factor for agi after heart valve replacement

Conditions: Heart Valve Diseases

Summary: in this retrospective study, the investigators will analyze the correlation between cardiopulmonary bypass (cpb) time and acute gastrointestinal injury (agi), and the outcomes of agi in patients undergoing heart valve replacement.

patients with heart valve diseases often have chronic cardiac insufficiency. patients undergoing heart valve replacement with cpb are always complicated with gastrointestinal tract ischemia-reperfusion injury, which usually leads to agi. agi after cardiovascular surgery, especially in that use cpb, is associated with significant morbidity and an increase in peri-operative mortality. prolonged cpb time could be predictive of agi following heart valve replacement. this study is to analyze the correlation between cpb time and agi, and the outcomes of agi in patients undergoing heart valve replacement. the investigators hope that the benefits will include fewer patients becoming seriously postoperative agi and mortality after cardiac surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing heart valve replacement surgery with cpb * age \> 18 years and ≤ 70 years exclusion criteria: * patients combined with severe hematological disease, respiratory disease, and other critical diseases * patients had severe disorder of multiple systems and organs or severe pulmonary hypertension * have received major gastrointestinal surgery within 5 years * inflammatory bowel disease (ibd), including ulcerative colitis, crohn's disease, or colitis * acute gastroenteritis * clostridium difficile or helicobacter pylori infection * chronic constipation * peptic ulcer * polyps in the stomach or intestines * gastrointestinal neoplasms * abdominal hernia * irritable bowel syndrome * acute or chronic cholecystitis, hepatitis * patients who died during surgery * patients with digestive system tumors

Keywords: heart valve diseases gastrointestinal tract
telemedical vs. conventional prehospital care in acute coronary syndromes

Conditions: Acute Coronary Syndrome

Summary: telemedically supported paramedic care of acute coronary syndromes was compared to a historical control period of solely conventional on-scene physician care. quality outcomes based on current guidelines were researched als well as time requirements in both groups.

telemedically supported paramedic care of acute coronary syndromes was compared to a historical control period of solely conventional on-scene physician care. quality outcomes based on current guidelines were researched als well as time requirements in both groups. all data was collected prospectively for quality management purposes and analyzed retrospectively after ethical approval by the local ethics committee.

Eligibility criteria:
inclusion criteria: symptoms of acute coronary syndrome - exclusion criteria: secondary transfers from hospital to hospital, traumatic chest pain -

Keywords: non-stemi acute coronary syndrome st-segment elevation myocardial infarction telemedicine
sulindac and breast density in women at risk of developing breast cancer

Conditions: Breast Cancer

Summary: the primary objective of this study is to determine if sulindac at a dose of 150 mg twice a day for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control.


Eligibility criteria:
inclusion criteria: 1. age ≤70 years 2. subject must be postmenopausal. 3. must have at least one healthy normal appearing breast (no prior diagnosis of invasive cancer, radiation or prosthetics). prior biopsies are acceptable. 4. must have dense breasts 5. must be at elevated risk for developing breast cancer by abnormal pathological findings, family history, or genetic predisposition 6. a negative fecal occult blood test 7. normal organ function 8. hormonal therapy with aromatase inhibitors is allowed exclusion criteria: 1. daily aspirin or other daily anti inflammatory use. 2. known intolerance to anti inflammatory. 3. use of any selective estrogen receptor modulator therapy (e.g., tamoxifen, raloxifene) within past 12 months 4. gastrointestinal, bleeding or coagulation, cardiovascular disorders. 5. diabetes requiring insulin therapy. 6. current regular smoker. 7. history of claustrophobia or inability to undergo imaging in a closed magnetic resonance imaging. 8. cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses that would preclude mri. 9. uncontrolled hypertension.

Keywords: breast density
cervical spine; movement before and after anterior cervical discectomy, with or without a cervical disc prosthesis

Conditions: Diskectomy; Intervertebral Disk Displacement

Summary: the purpose of this study is to find out if use of a cervical disc prosthesis in the treatment of a cervical disc herniation preserves or restores normal mobility and movement in the cervical spine.

intractable nerve pain to the arm caused by a cervical disc herniation is typically treated by removal of the protruding disc through an operation. fusion of the discs follows in about 70% of cases. adjacent disc disease (add), symptomatic degenerative changes in the levels adjacent to the operated level is regarded as a late complication. fusion at the operated level is thought to contribute to this process due to compensative increased mobility and stress on the adjacent segments. keeping the operated segment mobile through the use of a cervical disc prosthesis possibly prevents add. we hypothesize that use of a cervical disc prosthesis preserves or restores normal mobility to the cervical spine. to test this hypothesis subjects are randomised in a group receiving a standard anterior cervical discectomy, and a group receiving a standard discectomy with placement of a cervical disc prosthesis. digital x-ray cinematographic videos are made of a flexion/extension movement. the videos will be analyzed manually and through a newly designed automated program, to check for mobility and order of movement.

Eligibility criteria:
inclusion criteria: * indication for anterior cervical discectomy * monoradicular syndrome caused by compression at c5-6 or c6-7 * monosegmental disease on mri * able to actively perform flexion/extension movement * segmental mobility on the afflicted level \>2 degrees of rotation * informed consent exclusion criteria: * previous operative interventions on the cervical spine * multiple segments afflicted * positive l'hermittes sing * active infection * immature bone * tumorous processes in the cervical region * previous radiation therapy in the cervical region * pregnancy * cervical myelopathy * not able to speak dutch

Keywords: cervical degenerative disc disease anterior cervical discectomy cervical disc prosthesis activ-c mobility movement