Kornimate/medical-research-clean huggingface dataset:
warfarin prevents portal vein thrombosis in patients after laparoscopic splenectomy and azygoportal disconnection

Conditions: Cirrhosis; Hypertension; Status;Splenectomy; Venous Thrombosis

Summary: the purpose of this study is to determine whether warfarin anticoagulation are effective and safe in prevention of portal vein thrombosis in liver cirrhotic patients after laparoscopic splenectomy and azygoportal disconnection for portal hypertension

after successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. the baseline doppler parameter will be recorded and the patient will be randomized into either interventional (warfarin) or control (aspirin) group. from postoperative day 3, patients in interventional (warfarin) group will receive oral warfarin 2.5mg qd with titration of dose to maintain a target inr of 2-3 for 1 year, patients in control (aspirin) group will receive oral aspirin enterie ccoated tablets 100mg qd for 1 year, and both groups will be along with five days of subcutaneous injection of low molecular weight heparin and three months of oral dipyridamole. every 3 months the doppler screening for the occurrence of portal vein thrombus (pvt) or spleno-mesenteric thrombosis will be done for all patients. both groups will receive the therapy for one year irrespective of the doppler findings in relation to portal vein thrombus occurrence. then one year monitoring will be done in the both groups as per the primary or secondary outcome.

Eligibility criteria:
inclusion criteria: * a clinical, radiological or histologic diagnosis of cirrhosis of any etiology * splenomegaly with secondary hypersplenism * bleeding portal hypertension * ino evidence of pvt or spleno-mesenteric thrombosis by ultrasound evaluation and angio-ct * informed consent to participate in the study exclusion criteria: * hepatocellular carcinoma or any other malignancy * hypercoagulable state other than the liver disease related * drugs- oral contraceptives, anticoagulation or anti-platelet drugs * base line inr \>2 * child-pugh grade c * recent peptic ulcer disease * history of hemorrhagic stroke * pregnancy * uncontrolled hypertension * age\>75 yrs * human immunodeficiency virus (hiv) infection

Keywords: cirrhosis hypertension venous thrombosis warfarin splenectomy azygoportal disconnection laparoscopy
a behavioral health intervention using digital technology in radiation therapy for prostate cancer patients

Conditions: Prostate Cancer; Prostate Adenocarcinoma; Radiation Toxicity

Summary: the purpose of this study is to determine how to incorporate a smart water bottle to improve bladder filling for prostate cancer patients undergoing radiation therapy.


Eligibility criteria:
inclusion criteria: * age older than 17 but less than 81. * non-metastatic prostate cancer patients undergoing definitive radiation treatment. * patients that self-identify as "smartphone owners". * patients with either iphone (ios 13.0 or higher) or android (version 5.0.1 or higher) based smartphone access. * english or spanish speaking patients. exclusion criteria: * patients with any history of pre-existing urinary retention. * patients with any history of kidney, urothelial tract or bladder cancer. * post-operative prostate patients. * patients that plan to be treated with pelvic lymph node radiation coverage. * patients without a functional bladder. * patients with a history of prior pelvic surgery or penile augmentation (circumcision is okay). * patients who have previously received any form of pelvic radiation. * patients unable to give informed consent. * patients who refuse to drink room-temperature water used for bladder filling. * patients without functional vision. * patients who are colorblind. * patient who refuse to use the smartphone app or who refuse consent.
a study of herceptin (trastuzumab)and biomarkers in patients with her2-positive metastatic breast cancer

Conditions: Breast Cancer

Summary: this single arm study will evaluate alterations in molecular marker expression in her2-positive targeted therapy, and will evaluate the effect of continued treatment with herceptin and xeloda beyond progression following initial herceptin-taxane chemotherapy. patients who develop progressive disease will receive first-line herceptin (8mg/kg iv loading dose and 6mg/kg iv every 3 weeks) + taxane therapy. patients who develop progressive disease within 9 weeks of treatment will continue treatment with herceptin in combination with xeloda (1000mg/m2 po bid on days 1-14 of each 3-week cycle).biopsies of tumor tissue will be taken for biomarker and gene profiling evaluation. the anticipated time on study treatment is until disease progression, intolerable side effects or patient choice, and the target sample size is 100 individuals.


Eligibility criteria:
inclusion criteria: * female patients, \>=18 years of age; * her2-positive breast cancer; * al least one metastatic site amenable for core biopsy; * left ventricular ejection fraction \>50%. exclusion criteria: * prior adjuvant/neoadjuvant herceptin within past 6 months; * prior adjuvant taxane therapy within past 12 months; * use of chemotherapy, immunotherapy or biological anticancer therapy within past 3 weeks; * known bleeding diatheses.
study of camrelizumab (shr-1210) in combination with concurrent chemoradiotherapy in locally advanced esophageal cancer

Conditions: Esophageal Cancer

Summary: this is a randomised, double-blinded, placebo-controlled, multi-center phase iii trial, comparing the efficacy and safety of treatment with camrelizumab (shr-1210) + definitive chemoradiotherapy(dcrt) vs placebo+dcrt for locally advanced esophageal cancer patients in china. camrelizumab (shr-1210) is a humanized anti-pd1 igg4 monoclonal antibody.

in this study, eligible subjects will be randomized into study arm or control arm. participants receive camrelizumab or placebo + chemotherapy + radiation therapy . the chemotherapy regimens are : paclitaxel plus cisplatin progression-free survival (pfs) assessed by the independent review committee (irc) will be the primary outcomes.

Eligibility criteria:
inclusion criteria: 1.18 to 75 years; 2.histologically confirmed diagnosis of localized escc; 3.measurable and/or non-measurable disease defined per recist v1.1; 4.ecog performance status ≤ 1; 5.adequate organ function exclusion criteria: 1. indicators of severe malnutrition; 2. a history of surgery for esophageal cancer; 3. clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention; 4. known to be intolerable or resistant to treatment with the protocol-specified chemotherapy; 5. received prior chemotherapy, radiotherapy, targeted therapy or immune-oncology therapies; 6. active autoimmune diseases or history of autoimmune diseases that may relapse

Keywords: pd-1antibody locally advanced esophageal cancer
multi-center study to investigate the effects of citrasate® on heparin n requirements during hemodialysis treatment

Conditions: Renal Dialysis

Summary: the purpose of this study is to determine whether the use of citrasate®, citric acid dialysate enables the reduction of the heparin n (anticoagulant) dose in patients undergoing hemodialysis.

during hemodialysis, waste products are removed from the blood by diffusion across the dialyzer membrane into an electrolyte solution known as dialysate. dialysate is produced from acid concentrate, bicarbonate solution and water using a three stream proportioning system that mixes the acid concentrate, bicarbonate and water to produce the final dialysate. patients are typically anticoagulated with heparin during dialysis to prevent blood from clotting in the extracorpoeial circuit. heparin use is associated with significant risks including the possibility of bleeding, heparin induced thrombocytopenia (hit) and contamination. for these reasons, the possibility of reducing heparin dose while maintaining hd adequacy is clinically attractive. citrasate® is an fda approved acid concentrate that contains citric acid (citrate) rather than acetic acid (acetate) which is traditionally used in acid concentrate. citrate in higher concentrations is also a known anticoagulant. we are therefore conducting this study to determine whether the use of citrasate, citric acid dialysate enables the reduction of the heparin requirements in patients undergoing hemodialysis.

Eligibility criteria:
inclusion criteria: * subject is capable of giving informed consent, or has an acceptable surrogate capable of giving consent on the subject's behalf. * esrd maintained on thrice weekly hd * stable heparin prescription (heparin dose) for the previous 4 weeks * dialyzed using bolus heparin anticoagulation with dose \>/= 2000 units per treatment * hgb \>/= 9.5 prior to study start * ekt/v \>/= 1.0 (or spkt/v \>/= 1.2) in the monthly lab work prior to study start exclusion criteria: * any laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements * patient is maintained on coumadin therapy or lmw heparin * known history of hit, coagulopathy or any other bleeding and/or thrombotic disorders * patients dialyzed with \< 2000 units of heparin per treatment * dialyzed without heparin * known pregnancy * dialyzed with reuse of hemodialyzers * documented clotted dialyzer or dialysis lines in last 30 days (1 month) requiring changing dialyzer, bloodlines or terminating treatment * randomized in a clinical trial involving anticoagulation in the last 30 days

Keywords: end stage renal disease renal dialysis hemodialysis therapy heparin citrasate anticoagulant
effect of pharmaceutical care in patients with bipolar i disorder (bd i)

Conditions: Bipolar Disorder

Summary: this project aims, through pharmaceutical care in patients with bipolar i disorder, improve compliance and adherence rate, associated with greater effectiveness and safety of drug therapy to help achieve therapeutic goals, and finally to improving the quality of life of patients.

the objective of the present study was to assess the effectiveness of the dader method for pharmaceutical care in the reduction of the use of health care services and the increase in the effectiveness and safety of treatment in patients with bipolar i disorder who are discharged or referred for outpatient clinic st john of god-la ceja. primary objective: to assess the effectiveness of the dader method for pharmaceutical care on achieving in reducing the number of hospital readmissions, in the increase of the effectiveness and safety of treatment in patients discharged from the clinic of saint john of god -la ceja - antioquia with bipolar disorder. a randomized controlled trial. 200 patients will be randomized to group of control or intervention. post-randomisation, patients will be required to attend the clinic routinely every 3 months during one year. every 3 months will be evaluated on the criteria of effectiveness and safety of the treatment. intervention's group will be following through pharmaceutical care. in the development of the study will be a record of the use of health care services (rehospitalizations, care emergency and outpatient, additional to those scheduled).

Eligibility criteria:
inclusion criteria: * patients diagnosed with bipolar i disorder * have been discharged from the clinic of saint john of god -la ceja- * have been resulting from external consultation (outpatient) of the clinic of saint john of god -la ceja- * male and female patients aged between 18 and 65 years * living in medellin or any of the following eastern municipalities in the department of antioquia. exclusion criteria: * patients with first episode of manic type, schizoaffective disorder, bipolar disorder ii, cyclothymia and other bipolar spectrum disorders, personality disorders that seem bipolar disorder, sociopathic disorder. * epilepsy * patients unable to comply with the protocol requirements, including severe alcohol and drug use. * patients with diagnostic uncertainty. * pregnancy or breastfeeding * infection with the human immunodeficiency virus (hiv). * chronic decompensate disease (no significant diseases): blood pressure values above 180/110 mmhg, total cholesterol above 300 mg / dl, low density cholesterol greater than 160 mmhg, hemoglobin a1c greater than 9%, lower oxygen saturation 90%. * mental retardation, presence of any cognitive impairment that prevents understands and signs informed consent. * refusal to sign informed consent (consent must be obtained before any study-related procedures are conducted). * illiteracy. * patients in electroconvulsive therapy.

Keywords: pharmaceutical care pharmacotherapy follow-up bipolar disorder pharmacy services
uncuffed endotracheal tube vs. no endotracheal tube

Conditions: Multiple Pulmonary Diseases

Summary: this is a comparison of uncuffed endotracheal tube (ucett) vs. no endotracheal tube (ett) in endobronchial ultrasound-transbronchial needle aspiration (ebus-tbna) procedure under moderate sedation in terms of procedure tolerance, duration of the procedure, desaturation, amount of sedation medication usage.


Eligibility criteria:
inclusion criteria: * any patient that is scheduled for ebus-tbna procedure exclusion criteria: * those who are not safe to receive moderate sedation or flexible bronchoscopy
induced gingivitis & intra-oral imaging

Conditions: Plaque Induced Gingivitis

Summary: using an experimental, non-invasive intra-oral imaging device, this study evaluates the effects on the gingival tissue when oral hygiene is stopped in a section of the mouth for two weeks and gingivitis develops. the effects on the gingival tissue continues to be evaluated as oral hygiene is resumed and the gingival tissue returns to health.

the study will include the following phases - 1) hygiene phase of 2 weeks; 2) gingivitis induction phase with stent lasting up to 2 weeks; and 3) resolution phase of 2 weeks. the intervention will consist of cessation of oral hygiene versus an active control of oral hygiene with a fluoridated toothpaste. this study is a modification of classical experimental gingivitis model. the study will prospectively enroll subjects and assign a maxillary sextant to the intervention, while the other sextant will serve as control in a split-mouth design of localized experimental gingivitis, utilizing localized stent-induced biofilm overgrowth model (sibo). the intervention, i.e. oral hygiene cessation will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues. the purpose of this study is to evaluate the effects of oral hygiene cessation in the gingival tissues by an innovative non-invasive microimaging technique, i.e. optical coherence tomography (oct).

Eligibility criteria:
inclusion criteria: * in good general health, asa i * no clinical signs of gingival inflammation at \>90% sites observed * probing depth(pd) ≤ 3.0 mm * attachment loss (al) = 0 mm * gingival health at baseline visit (day 0): gingival index (gi) ≤ 0.5, bleeding on probing (bop)(-) * fluent in english exclusion criteria: * • medical condition which requires premedication prior to dental treatments/visits * subjects unable or unwilling to undergo informed consent process. * subjects currently using anti-gingivitis oral rinses (washout period of 1 week) * history of periodontal disease * history of systemic inflammatory or immune conditions * use of antibiotic or anti-inflammatory drugs within 30 days of enrollment * pregnant or breastfeeding at time of screening * concurrent orthodontic treatment * untreated carious lesions and/or inadequate restorations, implants, crowns on maxillary non-molar teeth * participation in any other clinical study or test panel within 1 week prior to enrollment into this study * use of tobacco products * subjects who must receive dental treatment during the study dates * orthodontic bands, appliances, or crowns and bridges, or removable partial dentures affecting the non-molar maxillary teeth * immune compromised individuals (hiv, aids, immuno suppressive drug therapy)
comparison of remimazolam-based mac with inhalation general anesthesia under the guidance of an ani monitor during turb

Conditions: Patients Undergoing Transurethral Resection of Bladder

Summary: in patients undergoing transurethral resection of bladder, the effect of remimazolam-based monitored anesthesia care (mac) and inhalational general anesthesia will be compared under guidance by analgesia nociception index (ani) monitoring. anesthesia time, operation time, anesthesia time excluding operation time and total dose of opioid will be compared.

in remimazolam-based mac group, anesthesia will be induced with remimazolam and spontaneous breathing will be maintained. the dose of remimazolam and remifentanil will be adjusted according to the patient state index (psi) and the analgesia nociception index(ani). in inhalation general anesthesia group, anesthesia will be induced with propofol and rocuronium and maintained with sevoflurane and remifentanil. mechanical ventilation will be maintained by inserting laryngeal mask airway (lma) or endotracheal tube. the doses of sevoflurane and remifentanil will be adjusted according to the patient state index (psi) and the analgesia nociception index(ani). surgery cost, anesthesia cost, patient and surgeon's satisfaction score, pain score, ponv score and the incidence of hypotension and hypoxemia will be compared.

Eligibility criteria:
inclusion criteria: patients undergoing transurethral bladder resection exclusion criteria: * asa class 4 * emergency surgery * history of hypersensitivity to sevoflurane, propofol and remimazolam * galactose intolerance * patient refusal * patients in whom muscular relaxation are needed.
aan robotic therapy in sci

Conditions: Spinal Cord Injuries

Summary: the purpose of this study is to demonstrate that a robot-aided rehabilitation protocol that follows the "assist-as needed" paradigm provide statistically significant improvements in arm and hand motor functions when compared to robot-aided protocols that passively move patients' arms along pre-defined trajectories, in patients with incomplete spinal cord injury (sci).


Eligibility criteria:
twenty adults with chronic incomplete sci (according to american spinal injury association (asia) impairment scale (ais) c-d level) will be recruited from tirr and from the houston area. inclusion criteria: 1. providing written informed consent prior to any study related procedures; 2. age between 18-75 years; 3. diagnosis of chronic complete or incomplete spinal cord injury as defined by the american spinal injury association impairment scale classification and at least for 6 months; 4. not being involved in any specific exercise program (e.g., nmes, fes) within the previous 3 months; 5. no planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study; 6. eligibility for standard rehabilitation at the time of enrollment (i.e., absence medical comorbidities that would prevent standard rehabilitation); 7. no condition (e.g., severe arthritis, extreme shoulder pain) that would interfere with valid administration of the measures or with interpreting motor testing; exclusion criteria: subjects will be excluded if they have: 1. any joint contracture or severe spasticity in the affected upper extremity, as measured by a modified ashworth score \> than 3 out of 4; 2. subject who cannot provide self-transportation to the study location.

Keywords: injuries spinal cord
telemedicine for adolescents with insulin-dependent diabetes

Conditions: Type 1 Diabetes

Summary: investigators hope that providing patients and families with additional ways of communication with the diabetes care team will improve diabetes control.

study group study group will be asked to test blood glucose at least 4 times a day each time the study subject takes a meter reading the meter time-stamps the reading. all meter readings will upload to the cloud via" myglucohealth" website, where they can be accessed by caregivers, including providers and parents. device will be programmed to coax patients when readings are due. parents will be notified by device about the blood glucose testing results. provider will set device to alert patient or patient's family if patient has not yet tested or uploaded a test or send alerts to parent if uploaded numbers are outside an identified range (\ 300 mg/dl). as per the standard of care, parents are trained to administer sugar containing liquids, or inject extra insulin for hyperglycemia correction. parents will be encouraged to contact study personnel if they are concerned about the diabetes control. study personnel will access home blood glucose monitor data, and provide insulin dosing advice. parents will be asked to upload blood glucose readings prior to each visit. control group subjects will continue routine care which requires blood glucose testing at least 4 times a day. parents will use customary ways to communicate (pager, email, fax or phone) with the diabetes team, if they are concerned about glycemic control.. study group will have two virtual visits (months 3 and 6) control group will have all quarterly visits in person. a laptop will be used for virtual visits and will be set up with the help of the ttuhsc information technology security officer.

Eligibility criteria:
inclusion criteria: -- age 10-18 years * multiple daily injections regimen * duration of diabetes \> 12 months * hba1c \> 7% * lives outside of lubbock * committed to visit schedule exclusion criteria: * foster care or residential facility * psychiatric illness * developmental delay * reading at \< 4th grade level * pregnancy * known seizure disorder

Keywords: type 1 diabetes, home glucose monitor, upload, cloud
human umbilical-cord-derived mesenchymal stem cell therapy in acute lung injury

Conditions: Acute Lung Injury; Acute Respiratory Distress Syndrome

Summary: phase i-ii clinical trial - safety and efficacy of umbilical-cord-derived mesenchymal stem cell (uc-msc) in patients with acute lung injury ,open label, controlled prospective study.

phase i-ii clinical trial - safety and efficacy of umbilical-cord-derived mesenchymal stem cell (uc-msc) in patients with acute lung injury,open label, controlled prospective study. every patient will maintain their standard treatment of acute lung injury, with maximum tolerated dosage without side effects. the day of infusion will be considered day zero. from that moment, followup will be divided into 2,7,14 days. clinical results will be analyzed after completion of 14 days of followup.

Eligibility criteria:
inclusion criteria: * signed informed consent * age between 35 and 70 y * acute onset within 7 days. * oxygenation index:200\ 35mmhg * bilateral infiltrates on chest radiography * no cardiac failure exclusion criteria: * declined to sign informed consent * socially and mentally disabilities * malignant diseases * combined with severe infectious diseases * patients with positive blood tests for hepatitis b or hepatitis c or hiv or tuberculosis at the time of screening * pregnant or perinatal women * severe diseases of any major organs

Keywords: cellular therapy acute lung injury acute respiratory distress snydrome human umbilical cord mesenchymal stem cell phase 1/2 clinical study allogeneic stem cell transplantation ali ards