Kornimate/medical-research-clean huggingface dataset:
a longitudinal investigation of cognitive function in colorectal cancer patients

Conditions: Colorectal Cancer

Summary: this is a prospective, longitudinal, controlled study of cognitive function and fatigue in patients with apparently localized crc treated with adjuvant or neoadjuvant chemotherapy. in addition to following each patient over time (i.e. acting as their own control), a separate control group will consist of patients with early stage crc (stage a or b) who have had surgical resection of their tumour, but who do not require adjuvant chemotherapy, or patients with stage c crc who have declined chemotherapy. also included is a smaller sub-study of patients with limited metastatic crc who are treated with more toxic chemotherapy to compare changes in cognitive function, as compared to baseline assessment, of patients with crc who do, or do not, receive 5fu-based chemotherapy. the primary measures of cognitive function are the high sensitivity cognitive screen (hscs) \& coghealth™.


Eligibility criteria:
inclusion criteria: * aged 18-70 years old * performance status (ps) of 0-1 on the ecog performance scale * life expectancy of at least 12 months * full recovery from any post operative sequelae * adequate hepatic function as documented by a serum bilirubin \< 18umol/l, and lfts within 1.5x normal range * patients with histologically confirmed, stage b or c colorectal cancer (crc), who have undergone surgical resection and are about to commence chemotherapy. * patients due to receive neoadjuvant chemotherapy prior to surgery are also eligible. exclusion criteria: * any major pre-existing psychiatric history or dementia, alcohol abuse, or currently using a psychotropic medication that might lead to cognitive problems, other than short acting benzodiazepines for nausea or sleep * any evidence of metastatic disease. if there is clinical suspicion of cns involvement patients must have brain imaging (mri or ct scan) prior to recruitment. * ongoing sepsis or uncontrolled infection, including hiv infection * pre-existing neurological condition likely to interfere with ability to perform cognitive testing * any other severe co-morbidity which, in the judgement of the investigator, would make the patient inappropriate for entry into this study * active cancer within the last 5 years other than squamous or basal cell carcinoma of the skin or cervical cancer in situ (except for crc) * previous history of chemotherapy * minimal english skills such that subjects would be unable to follow simple, written english instructions and to read questionnaires of a grade 8 standard with the help of a research assistant.
efficacy and safety of metformin in preventing patients with risperidone from weight gain and amenorrhea

Conditions: Weight Gain; Amenorrhea

Summary: some previous studies has demonstrated that metformin can improve the weight gain which caused by antipsychotics. an our study, which will be published, also found that metformin can improve the amenorrhea for patients with antipsychotics, approximately 60% patients recovery period. so the present study was designed to investigate the efficacy and safety of metformin in preventing patients with risperidone from weight gain and amenorrhea.


Eligibility criteria:
inclusion criteria: 1. age 18-40 years. 2. diagnosis of schizophrenia (naive first-episode) as defined in dsm-iv axis i. 3. at screening, patients were required to have total score ≥60 on positive and negative syndrome scale (panss) and ≥4 on the clinical global impression-severity scale (cgi-s). 4. treat with risperidone. 5. never participate in a diet control nor in other weight loss programs, and have a normal period. 6. written informed consents could be obtained from patients(or their legal guardian). exclusion criteria: 1. female patients, those who were in the period of pregnancy and lactation, or plan pregnancy, were excluded. 2. patients with serious physical disease patients, just like epilepsy, liver and kidney dysfunction, diabetes, blood diseases, etc were excluded. 3. at screening, patients with abnormal results in physical examination, laboratory test, or electrocardiogram (ecg) were excluded. 4. patients were also excluded if they met primary dsm-iv axis i psychiatric disorders other than schizophrenia, or ever used psychoactive substance.

Keywords: metformin risperidone prevention weight gain amenorrhea
pharmacokinetics of piperacillin, given as continuous infusion to patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: at the department of infectious diseases, aarhus university hospital, continuous infusion with piperacillin/tazobactam for a period of 2 weeks, has been used for several years in patients with cystic fibrosis, suffering from acute pulmonary exacerbations (ape). it is an outpatient treatment. to assess the efficacy and quality of the treatment, a blood test every 3rd day is taken to determine the concentration of piperacillin in blood-plasma.

patients with cystic fibrosis (cf) are often colonized with multidrug-resistant microorganisms, which increases the risk of suboptimal dosing of antibiotics as the time above the minimum inhibitory concentration (t\>mic) is suboptimal. continuous infusion of beta-lactam antibiotics is more likely to optimize t\>mic than intermittent infusion. at the department of infectious diseases, aarhus university hospital, continuous infusion with piperacillin/tazobactam for a period of 2 weeks, has been used for several years in patients with cf, suffering from acute pulmonary exacerbations (ape). it is an outpatient treatment, and the patients are given 16 g of piperacillin per 24 hours. to assess the efficacy and quality of the treatment, a blood test every 3rd day will be required to monitor the blood-plasma concentration of piperacillin, as well as c-reactive protein (crp) and white blood cell count (wbc).

Eligibility criteria:
inclusion criteria: * patients with cystic fibrosis, suffering from acute pulmonary exacerbations, treated with continuous infusion of piperacillin/tazobactam for a period of two weeks. exclusion criteria: * age under 18

Keywords: cystic fibrosis continuous infusion pharmacokinetics
pediatric kidney transplant

Conditions: End Stage Renal Disease; Pediatric ALL; Kidney Transplant; Complications

Summary: end-stage renal disease (esrd) is a rare disease in children. renal transplantation (rt) is the treatment of choice for esrd in the pediatric population. in france, around 100 pediatric kidney transplants are performed each year. the aim was to evaluate the surgical management of tr and the long-term results.

end-stage renal disease (esrd) is a rare pathology in children, whose gold standard treatment is a kidney transplant. in france, around 100 pediatric kidney transplants are performed every year. although the first adult kidney transplants were performed in 1954, pediatric renal transplantation was considered unsafe compared with dialysis, which was preferred. in the 1980s, improved graft selection, optimized pre-transplant management and a better understanding of the immune system led to the development of pediatric kidney transplantation. despite considerable progress, graft survival in these long-lived patients remains a major challenge. the aim of this study is to evaluate surgical practices in the four french pediatric transplant centers, and to define risk factors for surgical complications.

Eligibility criteria:
inclusion criteria: * all pediatric patients who underwent renal transplantation in one of the 4 centers exclusion criteria: * multi organ transplant
ridaforolimus in patients with hepatic insufficiency (mk-8669-046)

Conditions: Healthy Volunteers; Hepatic Insufficiency

Summary: this study will evaluate the pharmacokinetics of ridaforolimus including the area under the concentration-time curve (auc\[0-infinity\]) and maximum concentration (cmax) after administration of a single dose of ridaforolimus in patients with moderate hepatic insufficiency and healthy matched control subjects.


Eligibility criteria:
inclusion criteria: hepatic patients: * female patient is of non-child bearing potential * apart from hepatic insufficiency with features of cirrhosis, patient is otherwise in good health * patient has a diagnosis of chronic stable hepatic insufficiency with features of cirrhosis healthy subjects: * female subject is of non-childbearing potential * subject is in good health exclusion criteria: hepatic patients and healthy subjects: * works a night shift and is not able to avoid night shift work during the study * has a history of stroke, seizure or major neurological disease * has a history of cancer * is unable to refrain from or anticipates the use of any prescription or non-prescription drugs during the study * consumes excessive amounts of alcohol or caffeine * has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

Keywords: healthy volunteers hepatic insufficiency
wearable technology to reduce sedentary behavior and cvd risk in older adults

Conditions: Cardiovascular Diseases

Summary: this study will evaluate the feasibility and efficacy of combining a traditional, structured exercise intervention with an innovative intervention designed to decrease sedentary behavior and increase non-exercise physical activity (nepa).

a recruitment of 40 sedentary men and women ≥ 60 years of age with elevated cardiovascular risk and follow them for 20 weeks. participants will be randomly assigned (n = 20/group) to 1) an 8-week, twice-weekly, multi-modal, center-based exercise intervention (ex) followed by 12 additional weeks of follow-up assessment, or 2) the same intervention with participants also asked to wear a validated lightweight activity tracker on their hip during waking hours and instructed on how to reduce sedentary behavior increase nepa within their daily routines (ex + nepa). evaluations will be done to 1) the extent to which ex + nepa modifies sedentary behavior, 2) the impact of the interventions on cardiovascular risk factors, including blood pressure, exercise capacity, waist circumference, and circulating biomarkers, and 3) develop and optimize study procedures to guide the future trial.

Eligibility criteria:
inclusion criteria: * sedentary lifestyle, defined as \<150 min/wk of moderate physical activity by champs questionnaire * moderate to high-risk of chd events according to atp-iii risk classification algorithm * willingness to be randomized to either intervention group * willingness to participate in all study procedures exclusion criteria: * failure to provide informed consent; * regular participation in an exercise training program within the last 3 months * absolute contraindication(s) to exercise training (american college of sports medicine guidelines) * office sbp \> 180 mm hg or dbp \> 110 mm hg * severe cardiac disease, i.e. nyha class iii or iv congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina; * myocardial infarction or stroke within past year * significant cognitive impairment, i.e. known dementia or a mini-mental state examination score \< 24 * progressive, degenerative neurologic disease, e.g., parkinson's disease, multiple sclerosis, als; * severe rheumatologic/orthopedic disease, e.g., awaiting joint replacement, active inflammatory disease * severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen; * hip fracture, hip or knee replacement, or spinal surgery within past 4 months; * other significant co-morbid conditions that would impair ability to participate in the intervention * simultaneous participation in another intervention trial
comparing ciprofloxacin (cpfx) with cefepime (cfpm) in febrile neutropenic patients with hematologic diseases

Conditions: Febrile Neutropenia

Summary: the aim of this study is to investigate whether intravenous ciprofloxacin is as effective as cefepime for the initial treatment of febrile neutropenia developed in patients with hematologic diseases.

infectious complications during neutropenic periods are major causes of morbidity and mortality especially for patients with hematological diseases, and prompt initiation of antibiotic therapy is warranted for those who develop febrile neutropenia. as for initial therapeutic agents, beta-lactam antibiotics, i.e., third- or fourth-generation cephalosporins and carbapenems have been used frequently because of their strong and broad-spectrum of action. however, under these conditions, development of resistance mediated by a beta-lactamase is concerned, and there is a need for alternative non-beta-lactam antibiotics for this indication. ciprofloxacin is a potent agent covering against wide range of strains including pseudomonas aeruginosa, and expected as a potential candidate. we have therefore planned a prospective randomized controlled trial designed to compare intravenous ciprofloxacin with cefepime for febrile neutropenic patients.

Eligibility criteria:
inclusion criteria: * hematologic disease * ages between 15 and 79 years * axillary temperature of 38.0 c or greater on one occasion or of 37.5 to 37.9 c lasting for more than 1 hour * absolute neutrophil count of less than 500/microl * t-bil level less than 2.0 times the upper limit of normal * cre level less than 1.5 times the upper limit of normal * written informed consent exclusion criteria: * past history of allergic reaction to the study drug * positive for hiv antibody * pregnant or lactating women * family history of auditory disturbance * having received systemic antibacterial therapy within 14 days * receiving systemic antifungal or antiviral therapy except fluconazole or acyclovir for cases undergoing transplantation * no recovery of neutrophil count of 1,000/microl or higher from the previous febrile episode * on treatment with ketoprofen * on treatment with sodium valproate * septic shock

Keywords: febrile neutropenia hematologic disease
gemcitabine/oxaliplatin and photodynamic therapy in cholangiocarcinoma

Conditions: Cholangiocarcinoma

Summary: in patients with cholangiocarcinoma therapeutic effects have been reported for gemcitabine/oxaliplatin. furthermore, photodynamic therapy (pdt) has significantly improved patients survival in two randomised trials. pdt induces tumor necrosis only in an area of few millimetres, while tumor parts which are located beyond this area remain untreated. an additive effect could result from pdt as a local therapy in combination with systemic chemotherapy.

patients entered in the study receive a sequential therapy consisted of photodynamic therapy followed by systemic chemotherapy (gemcitabine/oxaliplatin) 4 weeks later. systemic chemotherapy every 2 weeks is scheduled 9 times in each cycle. thereafter, another cycle of pdt followed by chemotherapy is intended.

Eligibility criteria:
inclusion criteria: * histologic/cytologic verified cholangiocarcinoma or cholangiocarcinoma-typical findings in \>= 2 diagnostic methods * bile duct stenoses which are technically successful treated with biliary drainage * irresectability/inoperability * karnofsky-index \>= 60% * age \>= 18 * written consent before chemotherapy: * bilirubin \<= 5 mg/dl * got/gpt \< 5x upper standard * creatinine \< 2x upper standard * thrombocytes \> 100 g/l * neutrophils \> 2,00 g/l * haemoglobin \> 9 g/dl * no occurence of complications during endoscopic procedures (abscess, bilioma, cholecystitis, cholangitis, pancreatitis, biliary leakage) exclusion criteria: * implantation of a metal stent in the bile duct * previous pdt or chemotherapy * neoplasia * porphyria * pregnant or breastfeeding women * women of childbearing age and potent men who are not using highly effective contraceptives

Keywords: photodynamic therapy pdt gemcitabine oxaliplatin cholangiocarcinoma
dornase alpha for the treatment of covid-19

Conditions: COVID-19

Summary: in this study, the effectiveness of the dornase alpha treatment, which is known to reduce the viscosity of respiratory secretions, will be investigated in new diagnosed and severe covid-19 patients separately.

recent studies confirmed the role of immune hyperactivation in the pathogenesis of covid-19. immune cells, especially neutrophils, infiltrate pulmonary capillaries that cause acute fibrin deposition and extravasation into the alveolar space. this excessive accumulation of neutrophils constitutes nets which makes the mucus thick and viscous. the highly viscous mucus lowers the patient's respiratory function and impairs ventilation supporting nets may play a major role in the disease. as a mechanism, double-stranded dna constitutes the backbone of nets and dornase alfa promotes the clearance of nets from plasma neutralization. endogenous deoxyribonucleases (dnases), which physiologically break up this extracellular dna, may become overwhelmed by a massive influx of nets. clinically, recombinant human dnase i (rhdnase, dornase alfa) has the identical primary amino acid sequence with the native human enzyme and has been approved for the management of cystic fibrosis. daily administration of dornase alfa is effective in the treatment of cystic fibrosis patients improving pulmonary functions. the similarity of mucus secretions in covid-19 and cystic fibrosis patients by the means of nets makes dornase alfa as a therapeutic option in covid-19. progressive covid-19 pneumonia may be mortal if it is not treated early, causing respiratory failure. the most important factor leading to respiratory failure is hyaline membrane formed by a neutrophil trap that develops in the cavities of the alveoli. dornase alpha is thought to have an important contribution by the lysis of this hyalen membrane. in this study, it is aimed to evaluate the effectiveness of dornase alpha treatment in case of early and late use in covid-19 disease. patients diagnosed with covid-19 pcr and / or radiological-clinical findings is included in the study, and this treatment is carried out in 2 patient groups in comparison with the control groups. the groups are: 1. newly diagnosed patient group i. dornase alpha treated group ii. control group 2. patient group monitored by mechanical ventilation i. dornase alpha treated group ii. control group

Eligibility criteria:
inclusion criteria: * being 18 or older * approving the informed consent form * being diagnosed with covid-19 with pcr and / or radiological clinical findings * hospitalization indication according to ministry of health criteria exclusion criteria: * pregnant and / or breastfeeding women. * any known allergy to dornase alpha * being involved in another drug study * previously diagnosed with chronic lung disease

Keywords: covid-19, dornase alpha
impact of acute decompensation in patients of cirrhosis with or without prior decompensation

Conditions: Acute Decompensation in Liver Cirrhosis

Summary: this a prospective observational study in chronic liver disease patients admitted or seen in opd, department of hepatology, institute of liver and biliary sciences, india. the study will be conducted in a period of three months starting september 2016 in sample size of 80 . a detailed proforma including history and examination and routine blood investigations will be noted. the patients will undergo close follow up at 0, 7, 15, 30, 45, 60, 90 days and similar activities will be repeated at every visit.


Eligibility criteria:
inclusion criteria: 1. cirrhosis with decompensation in a period of 3 months in form of ascites, jaundice, hepatic encephalopathy, acute variceal bleed irrespective of prior decompensation. 2. age 18-70 years 3. valid consent exclusion criteria: 1. hepatocellular carcinoma 2. admitted and survival less than 48 hrs 3. pregnant 4. acute liver failure 5. post transplant
the norwegian vitamin trial (norvit)

Conditions: Acute Myocardial Infarction

Summary: the purpose of this study is to examine whether the lowering of blood homocysteine levels by treatment with b vitamins can prevent cardiovascular disease

observational studies have demonstrated that elevated levels of plasma total homocysteine is a risk factor for cardiovascular disease. the purpose of this trial is to evaluate the efficacy of homocysteine lowering treatment with b vitamins for secondary prevention in patients who have experienced an acute myocardial infarction. this controlled, double-blind, multi-centre trial will include 3750 men and women aged 30-85 who have experienced an acute myocardial infarction within 7 days prior to randomization. participants will be randomized, in a two-by-two factorial design, to receive one of the following four treatments: a, folic acid 0.8 mg plus vitamin b12 0.4 mg and vitamin b6 40 mg per day; b, folic acid 0.8 mg plus vitamin b12 0.4 mg per day; c, vitamin b6 40 mg per day; d, placebo. the primary end point during 3.5 years of follow-up is a composite of recurrent myocardial infarction and stroke and sudden death attributed to coronary artery disease.

Eligibility criteria:
inclusion criteria: * acute myocardial infarction within 7 days prior to randomization * men and women aged 30-85 years * written informed consent exclusion criteria: * coexisting disease that shortens expected survival to less than 4 years * ongoing treatment with b vitamins * expected poor compliance

Keywords: homocysteine b vitamins folic acid randomized trial secondary prevention
cyriax inferior capsule stretching in idiopathic adhesive capsulitis

Conditions: Adhesive Capsulitis

Summary: the objective of study is to find out the effectiveness of cyriax capsular stretching in idiopathic adhesive capsulitis and to find out the combined effect of capsular stretching's, mobilization and conservative treatment on pain and range of motion (rom) in idiopathic adhesive capsulitis.

this randomized study was carried out at pakistan railway hospital rawalpindi. a total of 28 patients were screened out as per inclusion criteria and randomly placed into two groups a and b through lottery method. the visual analogue scale, shoulder pain and disability index, and range of motion of shoulder joint were used as outcome measures. all the patients were assessed at baseline before intervention and at the completion of 3weeks of treatment.

Eligibility criteria:
inclusion criteria: * idiopathic adhesive capsulitis phase 1 and phase 2 * follow capsular pattern ( er \> abduction\> ir) exclusion criteria: * adhesive capsulitis phase 3 * any intrinsic etiology i.e. rheumatoid arthritis, * infection, * gout, * haemarthrosis or * tumor or arthritis in stage iii or in stage ii with a spastic end-feel

Keywords: adhesive capsulitis cyriax manual therapy stretching
analgesic efficacy of paravertebral morphine

Conditions: Acute Pain

Summary: the investigator will test the analgesic efficacy of paravertebral morphine as an adjuvant to local anesthetics for acute postoperative pain following breast surgery and renal surgery


Eligibility criteria:
inclusion criteria * adult patients subjected to mastectomy or renal surgery exclusion criteria * patients complaining of coagulopathies * patients with vertebral anomalies
study of cs-3150 in combination with arb or ace inhibitor in hypertensive patients with moderate renal impairment

Conditions: Hypertension With Moderate Renal Impairment

Summary: to examine antihypertensive effect and safety of administration of cs-3150 in combination with arb or ace inhibitor in hypertensive patients with moderate renal impairment.


Eligibility criteria:
inclusion criteria: * male and female subjects aged 20 or order to 80 or younger years at informed consent * subjects with hypertension (sitting sbp ≥ 140 mmhg, \<180 mmhg and sitting dbp ≥ 80 mmhg, \<110 mmhg * treatment with an arb or ace inhibitor * egfr ≥ 30 ml/min/1.73 m2 and \< 60 ml/min/1.73 m2 exclusion criteria: * secondary hypertension or malignant hypertension * diabetes mellitus with albuminuria * subjects under insulin treatment * subjects under or pre-planned for hemodialysis * serum potassium level \< 3.5 or ≥ 4.8 meq/l

Keywords: mineralocorticoid receptor antagonist moderate renal impairment hypertension