Kornimate/medical-research-clean huggingface dataset:
intelligent electric bicycle for health (velis) to optimize the return to physical activity for oncology patients

Conditions: Cancer; Oncology

Summary: the purpose of this pilot study is to encourage oncology patients to continue effort retraining after their release from rehabilitation and recuperative care facilities with physical activity sessions and therapeutic education using an intelligent electric bicycle (velis)

the benefit of physical activity in oncology is now clearly established. physical activity has its place at all stages of the fight against cancer in primary, secondary and tertiary prevention. rehabilitation and recuperative care facilities may be a first step for patients with significant deconditioning, but long-term benefits are essential. nevertheless, the post rehabilitation and recuperative care facilities transition period is for these patients a temporary period during which they may loose part of the benefit of effort retraining and physical reconditioning. the investigators believe that it is necessary to go beyond the "physiological" efficiency to identify and overcome the patient's stereotypes regarding physical activity, to customize and adapt the programs to each patient, and to bring quickly the notion of pleasure and success in the practice of physical activity. electrically assisted bicycles can reach most of these goals provided that they are adapted. the objective of this project is to set up and evaluate, thanks to a monocentric pilot study, a process of continuation of exercise retraining through physical activity and therapeutic education sessions for the promotion of physical activity, focusing on the use of electrically assisted bicycles, in continuation of an exercise retraining in rehabilitation and recuperative care facilities.

Eligibility criteria:
inclusion criteria: * patient aged 18 and over * patient who has followed a post-cancer effort retraining program in a rehabilitation facility at rocheplane medical center * patient with the ability to pedal on an outdoor bicycle * patient with no restriction to moderate physical activity or bicycling (acute coronary disease of less than 2 years, locomotor problem of the spine or lower limbs incompatible with the practice of cycling) * weight less than 125 kg (maximum load for velis) * patient available for a 4 months follow-up exclusion criteria: * patient with a restriction to the practice of moderate physical activity or bicycle (acute coronary disease of less than 2 years, locomotor problem) * persons referred to in articles l1121-5 to l1121-8 of the csp (corresponds to all protected persons), pregnant, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, a legal protection measure

Keywords: post-cancer retraining physical activity intelligent electric bicycle
a phase ii study of ccx282-b in patients with celiac disease

Conditions: Celiac Disease

Summary: the purpose of this study is to determine whether ccx282-b is effective in mitigating the effects of gluten ingestion in patients with celiac disease

study acquired by amgen and all disclosures were done by previous sponsor chemocentryx.

Eligibility criteria:
key inclusion criteria: * male or female, between 18 and 75 years of age * established diagnosis of celiac disease * subject has been following a strict gluten-free diet for at least 24 months key exclusion criteria: * history of any infection requiring intravenous antibiotics, a serious local infection, systemic infection, or gastrointestinal infection within 12 weeks of randomization * use of any immunosuppressants, tnf inhibitors, or natalizumab during the 12 weeks prior to study randomization * use of steroids during the 4 weeks prior to study randomization * receipt of an experimental treatment for any disease within 4 weeks prior to randomization * known ige-mediated atopy or allergy or anaphylactic reactions to gluten * the subject suffers from a condition that carries a risk at endoscopy or is on anticoagulant treatment
reducing infection at the surgical site with antibiotic irrigation during ventral hernia repair (rinse trial)

Conditions: Ventral Hernia Repair

Summary: this is a study to determine if the incidence of infection at the surgical site is impacted if with antibiotic irrigation is used during ventral hernia repair (rinse trial)

surgical site infection (ssi) is common after open ventral hernia repair. numerous factors contribute, including patient comorbidities, operative technique, and degree of contamination of the case. ssi often requires prolonged hospital length of stay (los), readmission, or other procedural intervention. one potential intervention to reduce ssi is the use of antibiotic irrigation, which has been shown to reduce ssi in colorectal surgery in a recent randomized control trial. we retrospectively evaluated our use of dual antibiotic irrigation at the time of mesh placement during open ventral hernia repair (ovhr), demonstrating a significant reduction in ssi (16.5 vs 5.4%) using a combination of gentamicin and clindamycin irrigation when compared to saline alone. we plan to complete a registry-based, randomized clinical trial (rct) through the americas hernia society quality collaborative (ahsqc) to further assess the impact of dual antibiotic irrigation on ssi after ovhr with mesh. this will include patients undergoing open retromuscular (rm) repair with or without transversus abdominis myofascial advancement flap (tar) with placement of permanent synthetic mesh (mid-weight, large-pore polypropylene). power analysis based on only this subset of patients from our initial study indicates a total of 210 patients are needed to demonstrate a significant reduction in ssi using antibiotic irrigation vs saline irrigation alone.

Eligibility criteria:
inclusion criteria: * age \>18 y/o. * elective, open ventral hernia repair in a retromuscular fashion, with or without tar. * clean, clean-contaminated, or contaminated wounds. exclusion criteria: * age \<18 y/o. * pregnancy. * emergency hernia repair. * laparoscopic, robotic, or hybrid approach. * dirty wounds. * use of biologic or absorbable synthetic mesh. * onlay, intraperitoneal or preperitoneal mesh placement.

Keywords: infection hernia repair
application of platelet function test in prevention of ischemic events after stent placement in intracranial aneurysms

Conditions: Unruptured Intracranial Aneurysm; Stents; Antiplatelet Drugs

Summary: this study was designed to identify high platelet reactivity (hpr) who might have in-stent thrombosis in unruptured aneurysm with intracranial stent placement with light transmittance platelet aggregometry (lta). for hpr patients, higher ischemic stroke rate maybe occurred, and we hypothesis that dose adjustment of aspirin and clopidogrel based on lta monitoring maybe reduces the rate of ischemic stroke compared to a standard strategy after intracranial stent implantation at early periprocedural period and 1 month follow-up period.

for the patients of unruptured intracranial aneurysms with stent placement, standard antiplatelet therapy (100mg aspirin + 75mg clopidogrel) is considered to be the most effective antiplatelet regimen in reducing ischemic complications. however, despite the use of standard antiplatelet therapy, a number of patients continue to have ischemic events. a hypothesis is that high platelet reactivity (hpr) patients identified by platelet function test have higher ratio of the ischemic events, and dose adjustment of hpr patients reduces the rate of the ischemic complications at early periprocedural period and follow-up period. objectives: the study aim to evaluated the superiority of the strategy of platelet function test(monitoring arm) with the modified strategy in hpr patients compared to the standard strategy (conventional arm) whether reduce the primary endpoint after intracranial stent implantation at early periprocedural period (7 days) and 1 months follow-up period.

Eligibility criteria:
inclusion criteria: 1. age 18 - 80, male or non-pregnant female; 2. patients have unruptured aneurysm who plan to undergo intracranial stent placement; 3. patients with less than 2 of modified rankin scale score at the day of enrollment; 4. patients who is able to understand the objective of the trial, agrees and signs the written informed consent form. exclusion criteria: 1. the complications related to operation or material quality, such as guidewire pierces out blood vessel, coil herniation, incompletely opened stent, etc; 2. simultaneous treatment of other cerebrovascular diseases, such as intracranial arteriovenous malformation, intracranial arteriovenous fistula, etc; 3. patient with history of hypersensitivity of aspirin, clopidogrel, or ticagrelor; 4. patients with preoperative prophylactic use of tirofiban; 5. patients with a high possibility of active bleeding, such as symptomatic intracranial hemorrhage or active gastric ulcer; or patients with coagulopathy; 6. patients with thrombocytopenia (platelet count \<100,000/mm3 within three months before enrollment); 7. patient using anticoagulant; 8. pregnant or lactating women; 9. patients with malignant diseases, such as liver disease, kidney disease, congestive heart failure, malignant tumors, etc; 10. poor compliance patients.

Keywords: platelet function test high platelet reactivity light transmittance platelet aggregometry
huaier granule in treating women with triple negative breast cancer

Conditions: Triple Negative Breast Cancer

Summary: rationale: huaier (trametes robiniophila murr) is a traditional chinese medicine, which has been widely used in china for many years. the investigators previous study has reported that huaier could exert great inhibitory effects on breast cancer cells both in vitro and in vivo. purpose: to evaluate the efficacy and safety of huaier granule in treating women who have triple negative breast cancer that has been surgically removed.

objectives: compare the disease-free survival (dfs) and overall survival (os) of patients with triple negative breast cancer who are randomized to adjuvant huaier granule group vs. those randomized to blank-control group. outline: patients are randomized to the following one of two treatment groups and are followed annually. arm i: patients taking huaier granule for adjuvant treatment after the triple negative breast cancer has been surgically removed. arm ii: patients not taking huaier granule after the triple negative breast cancer has been surgically removed.

Eligibility criteria:
inclusion criteria: * age: ≥ 18 and ≤ 75 years, female; * triple negative breast cancer has been surgically removed; * the triple negative breast cancer has been confirmed by pathological examination and immunohistochemistry (ihc); * not receiving any preoperative anticancer drugs; * the liver and kidney function satisfies the following conditions within 3 days after surgery (excluding day 3): aspartate aminotransferase (ast), glutamic-oxalacetic transaminase (alt) \< 2 upper limit of normal (uln), total bilirubin ≤ 1.5 uln, serum creatinine \< 1.5 uln; * other laboratory tests meet the following requirements within 3 days after surgery (excluding day 3): hb ≥ 90g/l, platelet count ≥ 100×109/l, absolute neutrophil count \> 1.5×109/l; * the expected survival time ≥ 6 months; * the subjects volunteer to sign the informed consent. exclusion criteria: * patients with stage iv breast cancer; * triple negative breast cancer was not surgically removed; * non-triple negative breast cancer patients confirmed by pathological examination and immunohistochemistry (ihc); * pregnant or lactating women; * those with active bleeding due to various reasons; * those with hiv infection or aids-associated diseases; * those with severe acute and chronic diseases; * those with severe diabetes; * those with serious infectious diseases; * those who can not take drugs by oral route; * drug abusers or those with psychological or mental diseases that may interfere with study compliance; * conditions that are considered not suitable for this study investigators
phase iii randomized, placebo-controlled study of acyclovir oral suspension for neonatal herpes simplex virus infection limited to the skin, eyes, and mouth

Conditions: Herpes Simplex

Summary: objectives: i. determine whether acyclovir (acv) oral suspension suppresses recurrent skin lesions and improves neurologic outcome in neonates with localized herpes simplex virus type 2 infection when administered for 6 months in a placebo-controlled study. ii. determine whether the prevention of recurrent skin lesions reduces long-term neurologic morbidity. iii. determine whether resistant disease develops after oral acv therapy. iv. evaluate the natural history of recurrent skin lesions. v. measure any adverse effects and laboratory abnormalities associated with long-term oral acv therapy in infants and young children.

protocol outline: this is a randomized, double-blind study. patients are stratified by participating institution. all patients are treated with intravenous acyclovir for 14 days. patients are then randomly assigned to 1 of 2 treatment groups if the following criteria are met: no systemic disease involvement, documented by negative cerebrospinal fluid exam, brain computerized tomography, and magnetic resonance imaging; and entry criteria continue to be met. randomized treatment begins 8 hours after the final dose of intravenous acyclovir. one group is treated with oral acyclovir, while the control group receives an oral placebo. treatment continues for 6 months in the absence of unacceptable toxicity, systemic disease, and 2 or more recurrences of skin lesions. patients are followed at 6 months, then yearly for at least 4 years. the study duration is estimated to be 4 years.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * virologically confirmed herpes simplex virus type 2 (hsv-2) with skin lesions localized to the skin, eyes, and mouth * no central nervous system or disseminated disease normal cerebrospinal fluid wbc less than 20 protein less than 90 mg/dl * normal brain computerized tomography or magnetic resonance imaging (mri) mri if feasible * no hsv-1 --patient characteristics-- * age: under 29 days * renal: creatinine no greater than 1.5 mg/dl * other: birth weight at least 1200 g * gestational age greater than 32 weeks * no breast feeding if mother on acyclovir

Keywords: herpes simplex virus infection herpesvirus infection immunologic disorders and infectious disorders rare disease viral infection
study of gemtuzumab ozogamicin therapy in dna samples from patients with acute myeloid leukemia treated on cog-aaml0531

Conditions: Leukemia

Summary: rationale: dna analysis of blood and tissue samples may help doctors predict how well patients will respond to treatment. it may also help doctors learn more about how gemtuzumab ozogamicin works in the body. purpose: this research study is looking at gemtuzumab ozogamicin in dna samples from patients with acute myeloid leukemia treated on cog-aaml0531.

objectives: * to genotype the genomic dna from acute myeloid leukemia (aml) patients treated on cog-aaml0531 clinical trial for cd33 (and pgp and soc3) single nucleotide polymorphisms (snps). outline: archived dna samples are analyzed for single nucleotide polymorphisms in cd33, pgp, and soc3 genes by sequenome platform. results are then compared with patients clinical outcomes, including minimal-residual disease levels post induction i (chemotherapy and gemtuzumab ozogamicin), complete remission rates, refractory disease with various levels of bone marrow blasts, development of cns/persistent disease, event-free survival, overall survival, and toxicity.

Eligibility criteria:
disease characteristics: * diagnosed with acute myeloid leukemia * dna samples from patients treated on cog-aaml0531 patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: adult acute myeloid leukemia with 11q23 (mll) abnormalities adult acute myeloid leukemia with del(5q) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) untreated adult acute myeloid leukemia untreated childhood acute myeloid leukemia and other myeloid malignancies adult acute basophilic leukemia childhood acute basophilic leukemia adult acute eosinophilic leukemia childhood acute eosinophilic leukemia adult acute myeloblastic leukemia without maturation (m1) childhood acute myeloblastic leukemia without maturation (m1) adult acute minimally differentiated myeloid leukemia (m0) childhood acute minimally differentiated myeloid leukemia (m0) adult acute myeloblastic leukemia with maturation (m2) childhood acute myeloblastic leukemia with maturation (m2) adult acute myelomonocytic leukemia (m4) childhood acute myelomonocytic leukemia (m4) adult acute monoblastic leukemia (m5a) adult acute monocytic leukemia (m5b) childhood acute monoblastic leukemia (m5a) childhood acute monocytic leukemia (m5b) adult erythroleukemia (m6a) adult pure erythroid leukemia (m6b) childhood acute erythroleukemia (m6) adult acute megakaryoblastic leukemia (m7) childhood acute megakaryocytic leukemia (m7) recurrent adult acute myeloid leukemia recurrent childhood acute myeloid leukemia
dose ranging study of alfuzosin in patients with lower urinary tract symptoms related to benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: the primary objective is to assess the dose-response relationship of sl77.0499 10 (alfuzosin hydrochloride) 5 mg, 10 mg, 15 mg, and placebo once daily during a 12-week oral administration period for the efficacy in patients with lower urinary tract symptoms (luts) related to bph. secondary objectives are to assess the efficacy of each dose of alfuzosin as compared with placebo and to assess the safety of each dose of alfuzosin.


Eligibility criteria:
inclusion criteria: * suffering from luts related to bph for at least 6 months; * having an ipss \>13; * having a urinary peak flow rate 5.0 to 12.0 ml/s for a voided volume of at least 150 ml; * having a residual urine volume \< or = 200 ml.

Keywords: urinary tract
fdg pet/ct in monitoring very early therapy response in patients with glioblastoma

Conditions: Glioblastoma

Summary: this pilot clinical trial studies fluordeoxyglucose (fludeoxyglucose) f-18 (fdg) positron emission tomography (pet)/computed tomography (ct) in monitoring very early therapy response in patients with glioblastoma. diagnostic procedures, such as fdg pet/ct, may help measure a patient's response to earlier treatment. chemotherapy can induce very rapid changes to the tumor's glucose consumption which can be measured with imaging. fdg pet/ct shortly after the start of therapy may help identify very early therapy response in patients with glioblastoma.

primary objectives: i. to assess very early response to therapy in glioblastoma patients using 18f-fdg pet/ct. ii. evaluate very early changes in fdg uptake within 48 hours of start of therapy and correlate them with objective response parameters such as response assessment in neuro-oncology (rano) and survival. outline: patients undergo standard fdg pet/ct scan 6-8 weeks before start of chemotherapy and one additional fdg pet/ct scan within 48 hours of the start of chemotherapy.

Eligibility criteria:
inclusion criteria: * patients with histologically proven high grade glioma * intention to start therapy exclusion criteria: * severe psychiatric illness * inability to give written consent * breast feeding / pregnancy

Keywords: fdg pet/ct very early response (48 hrs)
the use of low dose prophylactic naloxone infusion to prevent respiratory depression with intrathecal morphine.

Conditions: Respiratory Depression

Summary: this is an investigator led, randomised, double blind, placebo controlled, double arm comparator study.

delayed respiratory depression is a well-documented side effect associated with the use of intrathecal morphine. this respiratory depression has implications for patient safety and necessitates either the observation of the patient in a high dependency setting for at least 24 hours or the use of an alternative analgesic technique. other associated side effects include pruritus, nausea and vomiting and sedation. naloxone is the most effective treatment for these side effects. however, it is usually given as a reactive treatment when the side effect presents. the hypothesis is that patients who are commenced on a naloxone infusion at low dose early after injection of intrathecal morphine will have a clinically significant reduction in incidence of these side effects. the primary endpoint is a reduction in respiratory depression.

Eligibility criteria:
inclusion criteria: * subjects must be aged 18 years or above at baseline * diagnosed with any hepatobiliary condition requiring an elective major surgical resection under general anaesthetic. * subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol exclusion criteria: * allergy/sensitivity to naloxone * female subjects who are pregnant or breast-feeding. * subjects who have received any other investigational agent within 2 months * subjects taking anticonvulsant medications for epilepsy * subjects who have a cardiac arrhythmia with an uncontrolled rate * subjects who have a history of chronic opioid use / chronic pain * any contraindication to intrathecal injection eg coagulopathy * documented history of obstructive sleep apnoea * treating clinician feels not in the patients best interests to be randomised
a trial investigating the nn1250 concentration-time curve in subjects with various degrees of renal impairment and in subjects with normal renal function

Conditions: Diabetes; Healthy

Summary: this trial was conducted in europe. the aim of this clinical trial was to evaluate if the nn1250 (insulin degludec/insulin 454) concentration-time curve is altered to such an extent that the dose should be adjusted in subjects with impaired renal function compared to the dose for subjects with normal renal function.


Eligibility criteria:
inclusion criteria: * subject with normal renal function or renal impairment (mild, moderate, severe or end stage renal disease (esrd) requiring haemodialysis) * body mass index maximum 40.0 kg/m\^2 exclusion criteria: * subject with any disease or condition which the investigator feels would interfere with the trial except for conditions associated with renal impairment in the group of subjects with compromised renal function. diabetes mellitus can be accepted in the group of patients with renal impairment, but not in subjects with normal renal function * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * significant history of alcoholism or drug/chemical abuse * not able or willing to refrain from smoking during the inpatient period