Kornimate/medical-research-clean huggingface dataset:
evaluation of rectal cancer treatment response using pet/mri

Conditions: Rectal Adenocarcinoma

Summary: the investigators will be using the combination of fdg-pet and multiparametric mri in pre- and post-adjuvant chemoradiation therapy in order to attempt to predict pathologic response on surgical resection.


Eligibility criteria:
inclusion criteria: * a diagnosis of histopathologically confirmed rectal adenocarcinoma. * locally advanced disease as determined by erus or pelvic mri. endoscopy reports should clearly state both the t and n stage. * patients with ct2n1-3m0 or ct2-4nxm0 will be considered eligible for participation. * age ≥18. * ability to understand a written informed consent document and the willingness to sign it. * tumor must be determined to be surgically resectable. surgical resection is planned to take place at univeristy of california, san francisco (ucsf). * neoadjuvant chemoradiation prior to resection is planned.. * eastern cooperative oncology group (ecog) performance status of 0, 1 or 2. exclusion criteria: * erus tumor state of t1. * radiographic evidence of metastatic disease * weight in excess of limitations of the scanner or girth that prohibits entry into the bore of the pet/ct scanner due to size. * any medical condition which impairs the ability to lie flat and without movement for 15 minutes (e.g. cough, severe arthritis, etc.) * prior receipt of any therapy, including local excision, radiation or chemotherapy, for the diagnosed rectal adenocarcinoma. * prior history of pelvic radiation. * uncontrolled hyperglycemia (defined as inability to achieve a glucose of \<250 mg/dl at time of fluorodeoxyglucose (fdg) injection). * impaired renal function (ckd 4 or 5: estimated glomerular filtration rate (egfr) \< 30 mls/min), which is a contraindication to gadolinium containing contrast. * known allergy to gadolinium containing contrast agents. * contraindication to use of fluoropyrimidines as a radiosensitizing agent. * pregnancy or nursing. women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of hcg) within 72 hours prior to randomization. this is because of the potential teratogenic effects of the involved imaging modalities, radiation, and chemotherapy.

Keywords: mri pet rectal cancer adjuvant chemotherapy
investigation of a medical device for the immobilisation of radius and ulna fractures in paediatric patients

Conditions: Fractures, Bone

Summary: single-centre, randomised, controlled, non-profit study on a custom-made medical device for immobilisation of radius and ulna fracture in paediatric patients. the aim of the study is to evaluate the benefits in terms of comfort, safety and efficacy resulting from the use of a customised 3d-printed wrist immobilisation device in children aged between 7 and 13 with a fracture of the distal metaphysis of radius or ulna of the 'green stick' type, compared to a control group treated with traditional immobilisation devices. the patients will be randomised between use of customised 3d- printed wrist immobilisisation device and plaster.

the device under investigation has already been the subject of a pilot study (clinical investigation code: t3ddy01) with significant result. these results are also preparatory to the proposed new investigation, which aims to extend its applicability to more complex clinical conditions. compared to the previous one, the new study will be able to take advantage of an improved acquisition process of the anatomy of the child's upper limb, obtained by updating the model of the chambers used. the aim of the study is to evaluate the benefits in terms of comfort, safety and efficacy resulting from the use of a customised 3d-printed wrist immobilisation device in children aged between 7 and 13 with a fracture of the distal metaphysis of radius or ulna of the 'green stick' type, compared to a control group treated with traditional immobilisation devices. the patients will be randomised between use of customised 3d- printed wrist immobilisisation device and plaster.

Eligibility criteria:
inclusion criteria: * patient aged between 7 and 13 years with compound fracture of the distal metaphysis of radius and/or ulna at "green wood" and initial angulation \<20°; * informed consent obtained. exclusion criteria: * complete fracture of radius and ulna; * open fracture of radius and ulna; * polytrauma, polyfracture; * presence of neurovascular deficit at presentation; * presence of underlying bone disease; * presence of acute or chronic skin disorders; * psycho-behavioural disorders; * presence of ≥1 skin lesions according to npuap/epuap classification; * specific allergies related to the materials used in the tested device; * inability to perform follow-up examinations.
intravenous bcaa for he in aclf (bcaa-he-aclf)

Conditions: Hepatic Encephalopathy; Acute-On-Chronic Liver Failure

Summary: this multi-centric study analyses the effect of intravenous branched-chain amino acids (bcaa) on overt he in patients with aclf. the investigators aim to study the efficacy of combining intravenous bcaa with lactulose versus lactulose alone, ammonia measures, endotoxin, metabolomics, and cerebral edema in the medical management of overt he in patients with aclf. the study will also access the impact on overall survival and improvement in the grade of he.

treatment of he in aclf is based on extrapolation of data available from cirrhotic patients with he. the mainstay of treatment remains lactulose. rifaximin is added on to therapy who have a breakthrough episode of he on lactulose. bcaa is used as an add-on therapy if patients have minimal/covert encephalopathy, are protein intolerant or have recurrent he. no studies are available assessing the adjuvant effect of intravenous bcaa on ammonia reduction in he in patients with aclf. so, this study has been designed to analyze the effect of intravenous bcaa on hepatic encephalopathy in patients with aclf. this study will also analyze the systemic and neuronal inflammation, metabolomics, and cerebral edema under the effect of intravenous bcaa in he patients with aclf.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years 2. either gender 3. patients with aclf (canonic definition) of any etiology with he ≥grade 2 as per west-haven criteria exclusion criteria: 1. those who do not consent to participate in the study 2. patients with structural brain lesions or stroke 3. inability to obtain informed consent from patient or relatives 4. severe preexisting cardiopulmonary disease 5. renal dysfunction (s. creatinine ≥ 2mg/dl) 6. pregnancy/lactation 7. post liver transplant patients 8. hiv infection 9. patients who are on psychoactive drugs, like sedatives or antidepressants 10. patients who are too sick to carry out the protocol.

Keywords: hepatic encephalopathy acute-on-chronic liver failure neurological dysfunction metabolomics systemic inflammations branch chain amino acid bispectral index cerebral edema lactulose
study on the clinical performance of steelex® sternum set for sternal closure

Conditions: Coronary Artery Disease; Cardiac Valve Insufficiency; Aortic Valve Stenosis

Summary: the study is designed as a retrospective, international, multi-center cohort study to evaluate steelex® sternum set for sternum closure. the data from 2 clinics located in germany and spain participating in the "opticabg" as well as in the "premivalve" study will be used for assessment. only patients receiving a complete or a partial sternotomy closed with steelex® sternum set will be included in the analysis. "opticabg" patients were followed up 3 months after surgery and "premivalve" patients until 6 months after surgery. adverse events (ae) / serious adverse events (sae)(e.g. surgical site infection, sternum stability, stroke, myocardial infraction, death etc.) reported in both studies will be used for the sterccas analysis.


Eligibility criteria:
inclusion criteria: * opticabg study patients undergoing an elective, primary coronary artery bypass graft surgery (cabg) receiving a sternotomy, by whom the sternum was closed using steelex® sternum set. * premivalve study patients undergoing a cardiac valve replacement or reconstruction receiving a complete or partial sternotomy, by whom the sternum was closed using steelex® sternum set. * eligible patients from the opticabg study and premivalve study who have provided their written informed consent * age ≥18 years exclusion criteria: * opticabg and premivalve patients receiving a sternotomy or partial sternotomy which was not closed with steelex® sternum set.

Keywords: median sternotomy partial sternotomy coronary artery bypass grafting (cabg) cardiac valve replacement cardiac valve reconstruction
pilot study of niacinamide in polycystic kidney disease (niac-pkd2)

Conditions: Polycystic Kidney Disease

Summary: the purpose of this study is to observe the effects of niacinamide on markers of kidney injury, inflammation, kidney cyst growth and kidney function.

polycystic kidney disease (pkd) is a genetic disease that affects about 1 in 500 people worldwide. it can lead to kidney failure which can lead to death. pkd causes the development of kidney cysts (fluid-filled balloons), which cause worsening kidney function. it is common for people with pkd to also have blood in the urine, kidney pain, high blood pressure, kidney stones, kidney infections, and cysts in the brain or other parts of the body. there is currently no treatment known to stop cyst growth or a cure for the disease. participants in this study will be randomly assigned to one of two groups: niacinamide or placebo. participants have an equal chance of being assigned to either of the groups. for people that qualify and decide to participate in this study, they will be asked to make five visits to the study clinic and complete two study related phone calls over the course of 12 months.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of autosomal dominant polycystic kidney disease (adpkd). * estimated glomerular filtration rate (egfr) \> 50 ml/min/1.73m2 as determined from the serum creatinine by the chronic kidney disease epidemiology collaboration (ckd-epi) equation * provide informed consent exclusion criteria: * history of liver disease or abnormal liver function test * heavy alcohol intake * chronic diarrhea or malabsorption syndrome * thrombocytopenia * hypophosphatemia * pregnancy or lactation or plan to become pregnant during the study * treatment with anti-epileptic drugs * treatment with tolvaptan, current or within 2 months prior to screening * participation in another interventional trial currently or within 2 months prior to screening. exclusions specific to magnetic resonance (mr) imaging acquisition and measurement: * partial or total nephrectomy or renal cyst reduction (including aspiration) done \<1 year ago * cardiac pacemaker. * presence of mr incompatible metallic clips (e.g. clipped cerebral aneurysm) * body weight \>159 kg (350 lbs) or untreatable claustrophobia.

Keywords: pkd kidney disease vitamin b3
clinic to home robotics-assisted telerehabilitation for upper limb (chisel)

Conditions: Stroke

Summary: hemiparetic weakness is common after stroke and only a small group of patients achieve useful upper limb function despite best rehabilitation efforts. this is due to the lack of intensive upper limb therapies to drive neuroplasticity either in clinic or at home. in this study, we plan to pilot home-based, robot-aided-therapy using h-man to deliver intensive arm rehabilitation.

it has been assumed that stroke survivors reach a plateau in their recovery within 3-6 months of their stroke. they tend to receive minimal rehabilitation support once they are discharged to the community citing obstacles such as ambulation, transportation, and cost. h-man is a novel telerehabilitation, upper limb training robot, that will deliver robot-aided therapy in patients' homes by clinic-based therapists through remote monitoring and under the supervision of their caregivers. the study aims to refine and evaluate the feasibility, efficacy and safety of home-based training using the h-man robot.

Eligibility criteria:
inclusion criteria: 1) clinical stroke (ischaemic or haemorrhagic) confirmed by admitting doctors and ct, ct angiography or mri brain imaging (2) age 21 to 90 years, both males and females (3) at least \> 28 days (4) upper limb motor impairment of fugl-myer motor assessment (fma) scale 10 to 60 (5) has a stable home abode and a carer/ nok to supervise home based exercise. (6) ability to sit supported continuously for 60 minutes (7) montreal cognitive assessment (moca) score \> 21/30 (8) able to understand purpose of research and give consent exclusion criteria: 1. non-stroke related causes of arm motor impairment 2. medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, ischaemic heart disease, congestive heart failure, bronchial asthma, severe /untreated depression, agitation, end stage renal/liver/heart/lung failure, unresolved cancers. 3. anticipated life expectancy of \< 6 months 4. inability to tolerate sitting continuously for 60 minutes (5 local factors potentially worsened by intensive robot-aided arm therapy and computer-based training: active seizures within 3 months, spasticity of modified ashworth scale grades \>2 skin wounds, shoulder, arm pain vas \>5/10, active upper limb fractures, arthritis, fixed upper limb flexion contractures. (6) hemi anaesthesia of affected limb (7) severe visual impairment or visual neglect affecting ability to use h-man robot (8) history of dementia, severe depression or behavioural problems (9) pregnant or lactating females will not be allowed to participate (10) absence of reliable carer to provide supervision during home training.
electrochemoterapy with bleomycin for the treatment of unresectable pancreatic cancer

Conditions: Pancreatic Cancer

Summary: electrochemotherapy is a type of electroporation that allows the delivery of drugs to the cells through the local creation of pores in the cell membrane. the electric pulses can be applied directly to the neoplastic cells, allowing for the local concentration of a possible chemotherapeutic agent administered through the bloodstream. this technique does not use heat nor other thermal energies and it is performed using special needles/electrodes linked to a generator ("porator"). in this study this technique will be applied on unresectable pancreatic cancer, already submitted to neoadjuvant treatment and still unresectable, through laparotomy. bleomycin will be the chemotherapeutic agent.


Eligibility criteria:
inclusion criteria: * radiologic confirmation of locally advanced pancreatic cancer by at least contrast enhanced ct of chest and abdomen (with the upper abdomen scanned according to a dedicated 3mm slice multiphase pancreatic tumor protocol), performed maximum 4 weeks prior to the procedure * cytohistological diagnosis of pancreatic cancer * age \> 18 and \< 80 * stable disease after chemotherapy (no tumor progression, no oncomarkers (carbohydrate antigen 19-9 \[ca 19-9\] or carcinoembryonic antigen \[cea\]) increase * performance status 0 sec. ecog (eastern cooperative oncology group) * written informed consent exclusion criteria: * resectable pancreatic cancer as assessed by multidisciplinary meeting * stage iv disease * patients receiving fenitoin, phosphofenitoin or living vaccines * pregnancy * progressive disease (either dimensional and not only by stage) * \ 80
evaluation of length and quality of prostate biopsies taken by a new biopsy needle

Conditions: Prostate Cancer (Diagnosis)

Summary: patient-blinded randomized controlled trial evaluating length and quality of prostate biopsies taken by a novel biopsy needle.

prostate biopsy is the golden standard for prostate cancer diagnosis. transrectal prostate biopsy (trusbx) is the most widely used technique. the biopsy chamber of the tru cut needle is in general 19 mm. however, it is on average filled only with 13 mm of tissue. biopsy length is strongly correlated with diagnostic accuracy of prostate cancer. additionally, trusbx has a high risk of infection due to bacteria being brought across the colon wall. the investigators have shown that a new needle design reduces this bacterial transfer in an ex vivo setting and a previous trial (nct049091230) has shown non inferior biopsy length when compared to the standard tru cut needle. a further improvement of the needle has now been designed aiming to increase biopsy length and quality, with the possible potential to improve prostate cancer diagnosis. this is the first human pilot aiming to evaluate if biopsy length of the novel needle is superior to a standard tru cut biopsy needle in prostate biopsy.

Eligibility criteria:
inclusion criteria: * eligible for prostate biopsy * signed informed written consent exclusion criteria: - none (other than general contraindications for prostate biopsy or patient not willing to participate)

Keywords: prostatic neoplasms neoplasms genital neoplasms, male urogenital neoplasms neoplasms by site prostatic diseases
an open-label study of the safety and pharmacokinetics of the tgkp

Conditions: Acute Respiratory Distress Syndrome (ARDS)

Summary: the purpose of the trial is to study the tolerability, safety and pharmacokinetics of the study drug with participation of healthy volunteers after single intravenous administration with dose escalation (0.03 mg/kg, 0.06 mg/kg and 0.12 mg/kg). before administration the study drug will be dosed and diluted in 200 ml of isotonic solution of 0.9% sodium chloride, and then will be administered once intravenously via infusion. during the entire follow-up period, the effect of the study drug on vital signs, instrumental and laboratory data, the development, severity and association of adverse events with the study drug will be monitored, investigated and studied.


Eligibility criteria:
inclusion criteria: 1. written informed consent to participate in the study; 2. men and women aged 18 to 45; 3. healthy volunteers according to the results of a medical examination: no history, as well as according to a screening examination, of pathologies from the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system, musculoskeletal system, genitourinary, immune and endocrine systems, blood, which may affect the safety of the volunteer and the assessment of the results of the study (clinical, instrumental and laboratory studies did not reveal diseases or clinically significant abnormalities); 4. body mass index from 19 to 30; 5. negative test result for hiv, hepatitis, syphilis; 6. negative test for the presence of narcotic and psychostimulant drugs in the urine; 7. negative alcohol test; 8. negative pregnancy test (for women of childbearing age); 9. indicators of general and biochemical blood tests at screening within 1.1 x (upper limit of the reference interval) - 0.9 x (lower limit of the reference interval); 10. consent to the use of barrier contraception methods by the volunteer and his partner during the study period and for 3 months after it. exclusion criteria: a volunteer may terminate his participation in the study at any stage of its implementation. the principal investigator may remove a volunteer from the study at any time in the following cases: 1. the researcher decided that the volunteer must be excluded in the interests of the volunteer himself. 2. the volunteer is uncooperative or undisciplined. 3. the volunteer was included in violation of the rules of the protocol. 4. the volunteer needs additional treatment.
assessment of the utility of the pantheris small vessel (sv) system

Conditions: Peripheral Arterial Disease

Summary: a single-arm study to assess the utility of the pantheris sv catheter in addressing peripheral artery disease in arteries located below the knee. data will be collected on the percent stenosis pre- and post-atherectomy and then symptoms and adverse events noted at 30 days, 6 months, and 1 year after the procedure.

this is a post-market, single-arm study of the optical coherence tomography (oct)-guided directional atherectomy catheter, pantheris sv. patients presenting with reduced blood flow in the lower extremity arteries will under directional atherectomy, followed by adjunctive therapy as deemed necessary by the physician, and then adverse events and symptom resolution will be documented at 30 days, 6 months, and 1 year after the procedure. primary safety endpoints are related to adverse events and will be assessed at the time of the procedure and at 30 days after the procedure. effectiveness endpoints center on restoration of blood flow.

Eligibility criteria:
inclusion criteria: * 18 years or older * target lesion in the infragenicular segment * at least 1 pedal vessel noted in the foot * rutherford classification 3 to 6 * willing to give informed consent exclusion criteria: * if female, is pregnant or breast feeding * has had surgery or endovascular procedure within 30 days prior to the index procedure * has planned surgery within 30 days after the index procedure * had a major bleeding event within 60 days prior to the index procedure * currently in the treatment phase of a drug or device trial * has anticipated life span of less than 1.5 years * is unwilling to present to the investigator at 30 days, 6 moths, or 1 year after the index procedure

Keywords: peripheral artery disease (pad) below-the-knee atherectomy
randomized controlled trials comparing clinical outcomes of 3d versus 2d laparoscopic surgery for gastric cancer

Conditions: Stomach Neoplasms

Summary: the purpose of this study is to explore the feasibility, safety, and efficacy of 3d laparoscopic surgery for gastric cancer. the patients with gastric adenocarcinoma (ct1-4an0-3m0) were studied.

a prospective randomized comparison of 3d and 2d laparoscopic surgery for gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the 3d laparoscopic technique. the evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year/5-year survival and recurrence rates.

Eligibility criteria:
inclusion criteria: * (1)age from over 19 to under 74 years * (2)ct1-4a(clinical stage tumor), n0-3, m0 at preoperative evaluation according to the american joint committee on cancer (ajcc) cancer staging manual seventh edition * (3)heart, lungs, kidneys, and other vital organs function well, with no obvious surgical contraindications * (4)preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around the main abdominal artery, and tumor not a direct violation of the pancreas, spleen, and other surrounding organs * (5)american society of anesthesiology (asa) score class i, ii, or iii * (6)written informed consent exclusion criteria: * (1)women during pregnancy or breast-feeding * (2)severe mental disorder * (3)history of previous upper abdominal surgery (except laparoscopic cholecystectomy) * (4)enlarged splenic hilar lymph nodes with integration into a mass and surrounding the blood vessels * (5)history of unstable angina or myocardial infarction within the past six months * (6)history of cerebrovascular accident within the past six months * (7)history of continuous systematic administration of corticosteroids within one month * (8)history of previous neoadjuvant chemotherapy or radiotherapy * (9)t4b tumors * (10)emergency surgery due to complication (bleeding, obstruction, or perforation) caused by gastric cancer * (11)fev1(forced expiratory volume in one second)\<50% of predicted values

Keywords: stomach neoplasms laparoscopy