Kornimate/medical-research-clean huggingface dataset:
a randomized, open label, comparative, multicenter trial of voriconazole vs. ambisome for empirical antifungal therapy in immunocompromised patients with persistent fever and neutropenia

Conditions: Neutropenia

Summary: the purpose of this study is to evaluate the safety and effectiveness of 2 drugs (ambisome versus voriconazole) in treating fungal infections. immunocompromised patients, especially those with persistent fever and neutropenia, are at a high risk of developing deeply invasive, life-threatening fungal infections with candida, aspergillus, and other opportunistic fungal pathogens. the risk of fungal infection increases in direct proportion with severity of neutropenia and duration of fever. antifungal therapy, therefore, is an important step in the amelioration of fungal disease.

patients are first split into groups to receive either voriconazole or ambisome. both drugs are given through a vein (iv) for at least 3 days. at the conclusion of 3 days, the voriconazole patients are then switched to oral voriconazole. the ambisome patients continue with iv ambisome. both groups continue treatment until blood counts increase and fever subsides.

Eligibility criteria:
inclusion criteria: you may be eligible for this study if you: * are at least 12 years of age. * are hospitalized with low white blood cell counts. * have received at least 96 hours of iv antibiotics. * have an oral temperature (or equivalent) of 38.0 c (100.4 f) or greater within the 24 hours before the study starts. * are not pregnant or breast-feeding. * agree to use a barrier method of contraception (e.g., a condom) during the study exclusion criteria: you will not be eligible for this study if you: * have a serious fungal infection. * have a history of an allergic reaction to antifungal agents. * are taking certain medications which may interfere with the study drug. * are participating in a clinical trial of any investigational drug. * have previously participated in this trial. * have any conditions which could affect your safety, make evaluation of response difficult, or make it unlikely that you can complete the course of therapy.
evaluation of efficacy of mesalamine in the long-term prevention of diverticulitis flares

Conditions: Diverticular Disease

Summary: the purpose of this study is to determine whether mesalamine is effective vs. placebo in the prevention of diverticulitis flares in a 24-months follow-up. the primary end-point of the study is the incidence of diverticulitis flares. will be made a clinical diagnosis of uncomplicated diverticulitis: fever, leukocytosis, abdominal pain and altered intestinal motility.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * both males and females patients * positive history of acute diverticulitis flare during the last year. the patients will be recruited only after the complete clinical remission of diverticulitis flare. * patients who have given their free and informed consent exclusion criteria: * complicated diverticulitis(fistulas, stenosis, abscesses and/or bleeding) * ascertained hypersensitivity to the salicylates * any severe pathology that can interfere with the treatment or the clinical or instrumental test of the trial * clinically significant renal or hepatic impairment * esophageal, gastric or duodenal ulcer within 30 days prior to randomisation * patients with active malignancy of any type, or history of a malignancy (patients with a history of malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable) * treatment with any investigational drug within the previous 30 days * treatment with lactulose or with any compound that lowering the colonic ph can prevent the release of the active moiety from the tablets * recent history or suspicion of alcohol abuse or drug addiction * patients who become unable to conform to protocol * patients with ascertained pregnancy * previous participation in this study
the effectiveness of graston tecnique compared to traditional physiotherapy to improve range of motion after arthroscopic cuff repair.

Conditions: Cuff Tear Arthropathy

Summary: in shoulder rehabilitation after arthroscopic cuff repair, one of first objectives coincides with improving the range of passive movement: this process often requires considerable time of both patients and physiotherapists. this study aims to verify whether it is useful to add instruments assisted soft-tissue mobilization according to graston tecnique to the classic rehabilitation protocol in order to accelerate recovery times of passive range of motion.

there is conflicting evidence about early versus delayed postoperative rehabilitation after arthroscopic cuff repair: early protocol seems to reduce the risk of stiffness but could increase the risk of rupture of the tendon in long time, especially for large tears; delayed protocol impose a period of shoulder immobilization (from 2 weeks to 40-day) that can promote tendons healing but could determine shoulder stiffness. our research question is if after the delayed protocol used in our institute (40 -day immobilization period) it migh be useful to add soft-tissue mobilization assisted by instruments according to graston tecnique to the classic rehabilitation protocol of the shoulder in order to speed up recovery times of the passive movement range.

Eligibility criteria:
inclusion criteria: * arthroscopic rotator cuff repair * partial lesion due to tendon degeneration (1 or 2 anchors reparation) exclusion criteria: * traumatic tendon lesions * associated conditions as arthritis, loss of superficial sensitivity, loss of muscle tone, mental impairment, oncological conditions * shoulder stiffness before surgery due to calcific tendonitis, adhesive capsulitis

Keywords: shoulder rehabilitation range of motion rotator cuff repair instrument assisted soft tissue mobilitation
prevention of chest pain in chemo-treated cancer patients

Conditions: Solid Carcinoma; 5-Fluorouracil Toxicity; Cardiotoxicity; Chemotherapeutic Toxicity; Acute Coronary Syndrome; Coronary Artery Calcification; Chest Pain

Summary: this is a prospective, exploratory, randomised clinical trial. patients with diagnosed cancer that are to be treated with 5-fluorouracil (5-fu) will be randomised into standard oncological treatment or a cardiological assessment prior to the 5-fu treatment. the investigators hypothesize that aggressive management of ischemic risk factors in asymptomatic patients will reduce the number of hospitalisations and investigations for acute coronary syndrome during and after 5-fu treatment and that patients with high coronary artery calcium scores are more likely to experience chest pain during the treatment with 5-fu.


Eligibility criteria:
inclusion criteria: * histologically verified cancer * first-time treatment with 5-fu/capecitabine * expected remaining lifetime \> 6 months * informed consent exclusion criteria: * known ischemic heart disease * ischemia-suspicious symptoms prior to 5-fu treatment * ischemia-suspicious ecg-changes prior to 5-fu treatment
a study of vedolizumab in people with ulcerative colitis and crohn's disease

Conditions: Ulcerative Colitis; Crohn Disease

Summary: vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. in this study, people with ulcerative colitis or crohn's disease will be treated with vedolizumab. the main aim of the study is to check for side effects from vedolizumab. at the first visit, the study doctor will check who can take part. participants will receive vedolizumab slowly through a vein (infusion). participants will regularly visit the clinic for up to 46 weeks for more infusions of vedolizumab. during these visits, the study doctor will check if there are any side effects from this treatment. participants will visit the clinic for a final check-up up to 16 weeks after their final infusion of vedolizumab. clinic staff will arrange a phone call 6 months after their final infusion of vedolizumab for a further check-up.

the drug being tested in this study is called vedolizumab. vedolizumab is being tested to treat people who have active uc or cd. the study will enroll approximately 150 patients. participants will be assigned to the vedolizumab treatment group. •vedolizumab 300 mg vedolizumab 300 mg iv infusion will be administered once in weeks 0, 2, 6 and 10 (cd-participants who have not shown a response can receive a dose at week 10) during induction phase and in weeks 14, 22, 30, 38 and 46 during maintenance phase. this multicentre trial will be conducted in india. the overall time to participate in this study is 74 weeks. participants will make multiple visits to the clinic, and will be contacted by telephone plus a final visit after receiving their last dose of drug for a follow-up assessment.

Eligibility criteria:
inclusion criteria: 1. has a diagnosis of moderately to severely active ulcerative colitis (uc) or crohn's disease (cd) at least 3 months prior to screening, with a full mayo score of 6-12 for uc and a harvey bradshaw index (hbi) score of \>=8 for cd at the time of enrolment. 2. has demonstrated, an inadequate response to, loss of response to, or intolerance to at least 1 of the following agents: 1. conventional therapy 2. tnf-α alpha antagonist exclusion criteria: 1. has undergone an ileostomy, colostomy, or has known fixed symptomatic stenosis of the intestine. 2. has active or latent tuberculosis (tb). 3. has had a prior exposure to vedolizumab or a history of hypersensitivity or allergies to vedolizumab, natalizumab, efalizumab, or rituximab. 4. has a positive progressive multifocal leukoencephalopathy (pml) subjective symptom checklist during screening or prior to the administration of study drug on day 1.

Keywords: drug therapy
non-steroid antiinflammatory drugs to heal colles fracture

Conditions: Colles Fracture

Summary: it is believed that some painkillers (nsaid drugs) slow bone healing but the knowledge is based only on experimental studies with animals whose results are automatically translated for humans. the purpose is to examine whether these drugs slow bone healing and what relationship there is between different bone examinations, scan for osteoporosis, bone marker laboratory tests, radiological controls and histology of newly formed bone under a microscope.

one of the most popular painkillers in the world is known as nsaid (non-steroidal anti-inflammatory drugs). many studies with animals have been made which show a clear tendency for delayed bone healing by taking nsaids. it is known that an early intake of nsaids prevents ectopic ossification in patients, receiving total hip prosthesis. however, cases of prosthetic loosening and instability after 10 years were almost exclusively observed in the group of patients who received nsaids postoperatively. however, very few clinical studies still show this tendency. in this study we include patients with fresh fracture in the wrist; colles fracture. the fracture may seem unstable when there is a lack of bone healing. these fractures are very common in the orthopaedic clinic. although there is no dislocation of the fragments, newly formed bone can be weaker as demonstrated by dexa scanning (bone mineral density measurement). histological examination of the healing bone can give a definitive answer whether the bone was affected or not. thus, the possibilities of studying nsaids affect on bone healing in humans and the clinical significance are very positive.

Eligibility criteria:
inclusion criteria: * patients giving written informed consent and authority * patients with colles fracture who require surgery by means of an external fixation or type bridging with or without suture. * patients who clinically and radiographically are diagnosed for reposition and therefore require external fixation or type bridging with or without suture. exclusion criteria: * patients who have been given adrenal cortex hormone. * patients who have been given non-steroid antiinflammatory drugs (nsaid). * patients who have not been giving written informed consent and authority. * patients who smoke more than 20 cigarettes daily. * patients who consume more than 14 drinks weekly. * lack of mental and physical ability to follow the directions according to the protocol. * medical contraindication to non-steroid antiinflammatory drugs.

Keywords: colles fracture non-steroid antiinflammatory drugs bone healing
near infrared fluorescence cholangiography (nirf-c) during cholecystectomy

Conditions: Cholecystitis

Summary: the purpose of this study is to evaluate an imaging system using indocyanine green (icg) to assist in real-time identification of anatomy during cholecystectomy (gallbladder removal). we propose to define the effectiveness of nirf-c in identifying the cystic duct junction during cholecystectomy.

this study is designed to determine the clinical utility of intravenous indocyanine green (icg) injection pre-operatively for cholecystectomy, followed by visualizuation of the biliary tree with a near-infrared light source and camera. testing will be done during an abdominal surgery which requires gallbladder removal. subjects will be recruited during consult for their surgical procedure. the study itself will take an estimated 5 minutes during the procedure. 2.5mg of icg will be injected intravenously 60-30 minutes before surgery, and following perfusion of the biliary tree, images will be recorded and visibility of the appropriate anatomy will be assessed using a near-infrared light source and camera. if fluorescence has faded prior to adequate visualization, a repeat dose of 2.5mg iv icg may be given. following the completion of imaging, the standard procedure for cholecystectomy will be performed including intraoperative cholangiography (ioc), which is standard of care. subject post-operative recovery will be monitored for the duration of their hospital stay. adverse events will be monitored at the patient's routine follow up visit.

Eligibility criteria:
inclusion criteria: * age 18-89 * planned laparoscopic cholecystectomy exclusion criteria: * inability to provide informed consent * pregnant * allergy to icg, iodine, and/or shellfish * acute cholecystitis, cholangitis, and/or cirrhosis (main study) * lactating

Keywords: cholecystectomy cholecystitis
the impact of pomegranate extract on chronic cardiomyopathy complicated by renal insufficiency (improve): a pilot study

Conditions: Cardiomyopathy; Heart Failure

Summary: this blinded, controlled study will examine the impact of pomegranate polyphenol extract (pomx, from pom wonderful, llc), 1000mg on cardiomyopathy in subjects with chronic renal insufficiency.

heart failure (hf) is a disease of great prevalence in the u.s. with an associated high morbidity and mortality. in individuals with concomitant chronic renal insufficiency (cri), outcomes are even worse due to pharmaceutical under treatment and higher baseline levels of oxidative stress. reactive oxygen species (ros) are generated during mechanoenergetic uncoupling and can cause myocardial protein, lipid, and dna damage, leading to the development of hf. one means of preventing the progression of hf may be through ros reduction or an improvement in systemic or local oxidative stress handling. in this randomized, single blind placebo-controlled pilot study, we hypothesize that 12 weeks of treatment with oral pomegranate extract (pomx) will lead to a reduction in oxidative stress (as assessed by measuring thiobarbituric acid-reactive substances, f8-isoprostanes, and glutathione) in subjects (n=30) with cardiomyopathy (lvef ≤40%) and cri (gfr \<60 ml/hr). secondary aims include assessing the impact of pomx on myocardial remodeling and endothelial dysfunction by measuring serum collagen levels and asymmetric dimethylarginine, respectively. findings from this study will serve as pilot data for a larger randomized trial of longer term pomx therapy in subjects with cardiomyopathy.

Eligibility criteria:
inclusion criteria: * adult subjects (≥21 years of age) with cardiomyopathy (ejection fraction ≤40%) of at least 1 year duration and cri (gfr \<60 cc/hr for at least 3 months) will be eligible for enrollment. * subjects must have new york heart association (nyha) functional class i-iii symptoms and be on stable doses of hf evidence-based therapies (β-blocker, ace inhibitor or arbs, aldosterone inhibitor \[if appropriate\]) for at least 3 months or have a documented contraindication or intolerance to such therapy exclusion criteria: * subjects admitted to a hospital for acute myocardial infarction (defined as positive troponins) or hf exacerbation within the last 6 months will not be eligible for enrollment. * subjects on warfarin or rosuvastatin will also be excluded. * other exclusion criteria are as follows: * hf that is deemed to be congenital or infiltrative in etiology * the presence of a life-threatening illness with a projected survival ≤6 months; ongoing infection * pregnancy * inability to follow-up * end-stage renal disease requiring dialysis * renal transplant listing * recent (within last 6 months) pomx use or intake \>8 ounces daily of pomegranate juice * known hypersensitivity to any fruit in the punicaceae family * connective tissue or collagen vascular disease

Keywords: cardiomyopathy heart failure
acquisition and utilization of skills using innovative smartphone application for regular eating

Conditions: Bulimia Nervosa; Bulimia; Binge Eating; Purging; Eating Disorder

Summary: the study seeks to evaluate the acceptability, feasibility, target engagement, and validity of an innovative smartphone application with ecological momentary interventions to augment cognitive behavioral therapy for bulimia nervosa.


Eligibility criteria:
inclusion criteria: * meets criteria for bulimia nervosa or sub-threshold bulimia nervosa with subjective binge episodes (objective binge episodes or subjective binge episodes and compensatory behaviors at least 1 time per week on average for the past 3 months) * bmi \>17.5 * have a smartphone device * willing and able to use smartphone device to track food intake multiple times per day for 16 weeks exclusion criteria: * pregnant or planning to become pregnant in the next year * currently experiencing severe psychopathology that would limit their ability to engage in study (e.g. suicidality, substance use disorder, psychotic disorder) * have previously received a full trial of cbt for bulimia nervosa * history of bariatric surgery

Keywords: bulimia nervosa eating disorder binge eating bulimia purging
kinematical and muscular fatigue in swimmers

Conditions: Healthy

Summary: during a submaximal task, gradual muscle fatigue occurs, which inevitably results in a decline in performance (mechanical failure). elite athletes are known to employ unconscious compensatory strategies during fatiguing submaximal tasks in an attempt to delay the onset of mechanical failure as long as possible. the purpose of this study was to gain valuable insight into the strategies used by elite swimmers to cope with mechanical failure. twenty-two swimmers were subjected to a swim test consisting of swimming as long as possible at a predetermined and controlled pace. a light strip positioned at the bottom of the pool allows athletes to get feedback on which gait to keep. the kinematics (stroke rate, stroke length, and efficiency index) and electrical activity of 10 muscle groups were analyzed and compared at the beginning of the test (non-fatiguing conditions), just before the athlete lost the ability to maintain the predetermined pace (pre-mechanical failure), and after the athlete lost the ability to maintain the pace (mechanical failure). it is hypothesized that as fatigue becomes more pronounced and the point of inability to maintain a predetermined speed is approached, increased emg activity will occur in key muscles while other muscle groups may show more obvious signs of fatigue. in addition, changes in the rhythm and coordination of upper limb movements may occur.


Eligibility criteria:
inclusion criteria: 1. middle- or long-distance swimmer specializing in front crawl 2. at least 3 years of experience in international competition 3. daily use of flashing light for pace control in aerobic, anaerobic threshold and maximum oxygen consumption training. exclusion criteria: 1) presence of muscle pain or soreness that could prevent the athlete from performing at their best

Keywords: muscle fatigue neuromuscular strategy performance semg swimming
thrombolysis and deferoxamine in middle cerebral artery occlusion

Conditions: Ischemic Stroke, Acute

Summary: iron overload has been associated with greater brain injury in ischemia/reperfusion experimental stroke models and ischemic stroke patients, especially in those treated with thrombolytic treatment. deferoxamine administration, an iron chelator, offers a neuroprotective action in ischemia/reperfusion animal models. primary objective: to evaluate the security and tolerability of deferoxamine endovenous treatment in acute ischemic stroke patients treated with iv. tpa. secondary objectives: to study pharmacokinetics of deferoxamine given by endovenous bolus (10 mg/kg) followed by 72-hour continuous intravenous infusion (20, 40 o 60 mg/kg). to evaluate the deferoxamine effect in clinical outcome, infarct volume and hemorrhagic transformation and brain edema development. methodology: double-blind, randomized, placebo controlled, dose-finding phase ii clinical trial. study stages: 1st: bolus+20 mg/kg/day vs. placebo (n=15:5); 2nd: bolus+40 mg/kg/day vs. placebo (n=15:5); 3rd: bolus+60 mg/kg/day vs placebo (n=15:5). these doses will be increased according to security results of the previous stage. patients will be continuously monitored in stroke units. laboratory parameters will be measured at baseline, 24h, 72h and 30 days to evaluate adverse events related to the drug. serum deferoxamine and feroxamine concentrations will be measured along time after the injection in a subgroup of patients to the pharmacokinetics study. ct scan will be performed at 24-36h to assess hemorrhagic transformation and brain edema. the nih stroke scale will be evaluated during hospitalization, and the rankin score at discharge and 3 months. if deferoxamine demonstrate to be secure and well tolerated treatment in acute stroke patients, it may be a new therapy option to lower the brain injury after ischemia and reperfusion.


Eligibility criteria:
inclusion criteria: * age 18-80 years old * acute ischemic stroke on the middle cerebral artery territory * treatment with iv tpa in the first 3 hours from symptoms onset exclusion criteria: * modified rankin scale more or equal to 2 * infectious, inflammatory, neoplastic or hematologic disease * anemia (hto\<34% or hb\<10g/dl) * previous renal failure * previous treatment with oral iron supplement * minor stroke (nihss less than 4), lacunar or posterior territory * alcohol consumption (more than 40mg/kg) * pregnancy * participation in other clinical trials

Keywords: stroke ischemic stroke thrombolytic treatment middle cerebral artery occlusion deferoxamine iron chelator acute ischemic stroke treated with intravenous thrombolytic