Kornimate/medical-research-clean huggingface dataset:
changes in bone mineral density and fracture risk in patients receiving androgen deprivation therapy for prostate cancer

Conditions: Osteoporosis

Summary: the aim of this study is to determine the long term effects of two types of hormonal treatment for advanced prostate cancer (lhrh agonists and the antiandrogen bicalutamide)on the bone mineral density of patients.

androgen ablation is the mainstay of treatment for advanced prostate cancer. however,luteinizing hormone-releasing (lhrh) agonists are associated with accelerated bone loss, osteoporosis and fractures. an alternative is the non steroidal antiandrogen, bicalutamide, which acts at the androgen receptor and maintains serum testosterone levels. our aim was to assess the effects of these two treatments on bone mineral density (bmd) of selected groups of patients, based on their bmd at presentation. all patients will undergo peripheral bone densitometry of the forearm, using dual energy x-ray absorptiometry. osteoporotic patients, at high risk of fractures, will be commenced on bicalutamide. osteopenic and normal bmd patients will be commenced on lhrh agonists. all osteopenic and osteoporotic patients will be given calcium and vitamin d supplementation.patients will undergo annual bone densitometry scans, and will be seen in the clinic every 3 months to monitor well-being and psa levels. any patient who fails to respond or escapes treatment with hormone monotherapy will be managed according to the clinical situation by either being switched to a combination of lhrh and bicalutamide or additional oestrogen therapy.

Eligibility criteria:
inclusion criteria: * patients will locally advanced prostate cancer for whom immediate androgen deprivation was indicated exclusion criteria: * previous systemic therapy for prostate cancer * patients with any illness or medication that would affect bone and mineral metabolism * severe hepatic or renal insufficiency

Keywords: prostate cancer bone density osteoporosis androgen antagonists
depakote monotherapy, olanzapine monotherapy, and combination therapy of depakote plus olanzapine in stable subjects during the maintenance phase of bipolar illness

Conditions: Bipolar Disorder

Summary: the purpose of this study is to assess the efficacy and safety of continued combination therapy using depakote plus olanzapine, vs. depakote monotherapy and olanzapine monotherapy in stable subjects during the maintenance phase of bipolar illness.


Eligibility criteria:
inclusion criteria: * dsm-iv-tr primary diagnosis of bipolar i disorder as confirmed by the scid * outpatient receiving treatment with a combination of depakote plus olanzapine for their bipolar illness and considered clinically stable (e.g., no more than minimal symptoms, no psychiatric hospitalizations, no increase in intensity of clinical interventions) for the preceding 4 months * identified at screening a most bothersome side effect listed in the uku which makes switching to monotherapy desirable * mrs total score \< 12 on two consecutive ratings, separated by at least 5 days (screening and day 1) * dss score \< 13 on two consecutive ratings, separated by at least five days (screening and day 1) * cgi-s score \< 3 on two consecutive ratings, separated by at least five days (screening and day 1) * serum valproate level \> 45 mcg/ml, and a maximum allowable dose of depakote of 3000 mg/day at screening * olanzapine dose between 5 and 20 mg/day at screening exclusion criteria: * history of schizophrenia or schizoaffective disorder * axis i (e.g., anxiety disorder) or axis ii (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results * has taken antipsychotics, mood stabilizers, or anticonvulsants (unless specifically for seizure control) other than depakote or olanzapine in the four months prior to randomization. other psychotropics (e.g., antidepressants, anxiolytics) with the exception of stimulants, that have been used routinely to maintain stability in the preceding four months may be continued, but not increased or decreased * has first manic episode after age 60 * has ever taken clozapine * has received depot neuroleptic medication within six months of randomization * urine toxicology screen is positive for phencyclidine (pcp), opiates, cocaine or amphetamines * history of active alcohol or substance abuse/dependence within 90 days prior to screening * known history of non-response to either depakote or olanzapine monotherapy for the treatment of bipolar disorder

Keywords: bipolar disorder - mania
feasibility of online mr-guided radiotherapy on a 1.5t mr-linac

Conditions: Rectal Cancer; Head and Neck Cancer; Liver Cancer; Breast Cancer; Prostate Cancer; Oligometastasis; Esophageal Cancer

Summary: this study investigates the feasibility of imaging and treatment on a novel 1.5 t mr-linac radiotherapy hybrid device.

novel hybrid devices combine magnetic resonance imaging (mri) and a linear accelerator in a single device. the superior soft tissue contrast compared with cone-beam computed tomography based treatment and the possibility for daily plan adaptation promise a higher precision of treatment, better target volume coverage and normal tissue sparing. in a first step the present study will test the feasibility of imaging and treatment on the 1.5 t mr-linac.

Eligibility criteria:
inclusion criteria: * existing indication for radiation therapy * minimum age 18 years, no upper age limit * capacity for consent * informed consent exclusion criteria: * contraindication for mri (claustrophobia, metallic implants not applicable for mri * pregnancy

Keywords: radiotherapy adaptive radiotherapy
childhood b-acute lymphoblastic leukaemia and role of cd9 gene regulation in relapse

Conditions: Leukemia, Lymphoblastic, Acute, Pediatric

Summary: b-acute lymphoblastic leukaemia (b-all) is the most common cancer in children, with 20% of patients relapsing. cd9, a transmembrane protein, is linked to the migratory and adhesion capacities of leukaemia cells and could be associated with relapses. the aim of this project is to understand how cd9 regulation can be a marker of potential relapses, using bone and blood sampling of newly diagnosed patients at 3 crucial moments of therapy.

b-acute lymphoblastic leukaemia (b-all) is the most common cancer in children, with 20% of patients relapsing despite major therapeutic advances. a research team of the development and genetic institute in rennes has identified that the expression of cd9, a transmembrane protein, is linked to the migratory and adhesion capacities of leukaemia cells, enabling them to persist in niches such as the testis. cd9-associated relapses often arise from these niches. understanding the regulation of cd9 expression is therefore essential. the hypothesis on which this project is based is that cd9 expression could be orchestrated by ncrnas. due to the complexity of deciphering circrna-mirna-mrna networks, an exploration of patient blasts is envisaged in order to delineate a specific non-coding rna network regulating cd9 expression from bone marrow and blood samples of paediatric-aged patients with b-all. if this hypothesis is confirmed, the ncrnas identified could constitute new specific diagnostic and prognostic markers, or even therapeutic targets. to confirm this hypothesis, bone and blood sampling of newly diagnosed patients will be collected at the diagnosis, after first phase of treatment and at the relapse, if it occurs.

Eligibility criteria:
inclusion criteria: * under 18 years * with established diagnosis of b-all * initial diagnosis made in the investigating centre * having received oral and written information about the protocol, or oral only if the patient is unable to read. * having signed a consent form if the patient is capable of giving informed written consent. * whose legal guardians have received oral and written information about the protocol, and have signed a free, informed and written consent. * beneficiary of a social security scheme exclusion criteria: * isolated extramedullary involvement at inclusion * patient of childbearing age without effective contraception. * adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty.

Keywords: cd9 mirna gene regulation
music and sounds for ecv

Conditions: Breech Presentation; Vertex Presentation

Summary: this international study is looking to see if the addition of music and sound on the maternal abdomen encourages fetal position change from breech to vertex in near term women.


Eligibility criteria:
inclusion criteria: * pregnant women near term with breech presentation. exclusion criteria: * women with a contraindication for vaginal birth

Keywords: breech presentation vertex presentation
the effect of cold application on the development of phlebitis in patients receiving intravenous amiodarone treatment.

Conditions: Phlebitis

Summary: this study, which has a quasi-experimental, prospective, and open-label randomized controlled design, was conducted to examine the effect of cold application on the development of phlebitis in patients receiving iv amiodarone infusion treatment. study hypotheses h0-1: there is no difference in the rate of development of phlebitis between the patients who received and who did not receive cold application during amiodarone iv infusion. h0-2: there is no difference in the grade of phlebitis between the patients who received and who did not receive cold application during amiodarone iv infusion. h0-3: there is no difference in the time of development of phlebitis between the patients who received and who did not receive cold application during amiodarone iv infusion.


Eligibility criteria:
inclusion criteria: * patients aged over 18, who were planned to receive 300 mg amiodarone in 150 ccs of 5% dextrose + 900 mg amiodarone (maintenance) in 50 ccs of 5% dextrose in 30 minutes (24 hour-infusion), * patients to whom pvc was placed in the upper extremity, and who did not develop phlebitis on the pvc site exclusion criteria: * cold allergy/sensitivity or circulatory disorders * during the study, patients who had a change in the iv amiodarone treatment protocol, whose iv amiodarone treatment was terminated before 24 hours, whose iv amiodarone treatment protocol was started, but pvc had to be replaced for any reason during the 24-hour period
spi-1005 for prevention and treatment of chemotherapy induced hearing loss

Conditions: Lung Cancer; Head and Neck Cancer; Hearing Loss; Ototoxicity; Tinnitus; Neuropathy

Summary: chemotherapy treatment with platinum based agents is well noted to cause ototoxicity. it is the objective of this study to determine the safety and efficacy of spi-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy in head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.

chemotherapy treatment with the platinum containing chemotherapies (e.g. cisplatin, carboplatin) are well noted and studied for their ability to cause ototoxicity which includes hearing loss, tinnitus, vertigo, or dizziness. it is the objective of this study to determine the safety and efficacy of spi-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy for head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus. spi-1005, a proprietary oral formulation of ebselen is a small molecule mimic and inducer of the enzyme glutathione peroxidase. gpx reduces reactive oxygen species (ros) by reacting with glutathione. spi-1005 has been shown to reduce cisplatin induced hearing threshold shift in animal studies.

Eligibility criteria:
inclusion criteria: * adult male and female subjects, 19-80 years of age; * confirmed diagnosis of advanced head and neck cancer or advanced lung cancer * voluntarily consent to participate in the study * females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study or be using one of the following acceptable birth control methods: * iud in place for at least 3 months prior to study; * barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; * stable hormonal contraceptive for at least 3 months prior to study through completion of study; * surgical sterilization (vasectomy) of partner at least 6 months prior to study. * females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study). exclusion criteria: * subjects previously treated with chemotherapy, antibiotics, or diuretics known to cause hearing loss in the last 90 days * history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, otologic, or psychiatric disease * presence of alcoholism or drug abuse * participation in another investigational drug or device clinical trial within 30 days prior to the study * female subjects who are pregnant or lactating

Keywords: lung cancer head and neck cancer hearing loss ototoxicity tinnitus deafness spi-1005 cisplatin carboplatin ebselen
a phase i study of recombinant hgm-csf herpes simplex virus to treat cancer

Conditions: Melanoma; Liver Cancer; Pancreatic Cancer; Lung Cancer

Summary: the main purpose of this study is to study the safety of orienx010 in the treatment of kinds of solid tumors such as melanoma,liver cancer,pancreatic cancer and lung cancer.


Eligibility criteria:
inclusion criteria: * patients in advanced stage of malignant tumor diagnosticated by pathologic and cytological analysis. * lack of routine effective treatment,failure of routine treatment or relapse * age of 18-70,ecog 0-2 and estimated survival is above 3 months * had an interval of above 4 weeks since exposure to chemotherapy or radiotherapy and above 6 weeks since exposure to nitrosoureas or mitomycin c. exclusion criteria: * serious internal diseases * uncontrolled primary and metastatic brain tumor * sizes of tumor does not meet the requirement of injection
predictive effect of tgf-β and ins-pi3k-akt related proteins for pod in diabetes patients

Conditions: Diabetes; Postoperative Delirium

Summary: to investigate the relationship between pod, tgf-β and ins-pi3k-akt signaling pathway related proteins (adnp, map6, pgc-1α) in diabetic patients

the study was a two-center, prospective，single blind (blinded to subjects and evaluators)，control, observational clinical study. participants will collect 3 milliliters of blood from enrolled patients before surgery begins. the collected blood samples were processed and stored in -80℃ refrigerator. all samples were tested tgf-β and ins-pi3k-akt signaling pathway related proteins (adnp, map6, pgc-1α) by elisa.

Eligibility criteria:
inclusion criteria: 1. age ≥65 years 2. history of diabetes ≥2 years and glycated hemoglobin ≥6.5% or no history of diabetes and normal blood glucose 3. the asa rating is class i to iii 4. the elderly patients of limited thoracic and abdominal tumor surgery exclusion criteria: 1. refused to participate 2. previous history of schizophrenia, epilepsy, parkinson's disease 3. history of alcohol abuse or drug dependence 4. patients with asa grade iv and above 5. severe visual or hearing impairment, can not cooperate with the completion of cognitive function tests 6. participants in other clinical trials within the last two months 7. patients with severe arrhythmia or cardiac dysfunction(ef\<40%) 8. there was a clear history of neurological and psychiatric problems or long-term use of sedatives or antidepressants 9. history of cerebrovascular disease or brain surgery or trauma 10. severe liver dysfunction (child-pugh class c) or severe renal dysfunction (requiring dialysis)
assessing costs & cost-variability among enrollees of health insurance programs utilizing charlson's comorbidity index and administrative databases

Conditions: Multiple Chronic Illnesses

Summary: this study will involve the evaluation of the cost profile of about approximately 241,000 patients (15,000 who are members of the generations plus/ northern manhattan health network and 226,000 members of a large self insured union trust fund). we will test the hypothesis that as comorbidity scores exceed three-four, patients will have an exponential increase in average yearly cost with a parallel exponential increase in cost variability. we will examine the relationship between comorbidity and health insurance costs and variability in costs among patients enrolled in health plans.


Eligibility criteria:
inclusion criteria: * patients with different burdens of comorbidity who have at least two continuous years of enrollment in the generations plus/ northern manhattan health network between june 2007 to july 2009 and members of a large self insured union trust fund from 2007-2010

Keywords: comorbidity, multiple chronic conditions, medicaid, prediction of cost predictive models, cost containment, managed care
long-term outcomes of ablation, liver resection, and liver transplant as first-line treatment for solitary hcc of 3 cm or less

Conditions: Hepatocellular Carcinoma

Summary: curative-intent therapies for hepatocellular carcinoma (hcc) include radiofrequency ablation (rfa), liver resection (lr), and liver transplantation (lt). controversy exists in treatment selection for early-stage tumors. we sought to evaluate the oncologic outcomes of patients who received either rfa, lr, or lt as first-line treatment for solitary hcc ≤ 3cm in an intention-to-treat analysis.


Eligibility criteria:
inclusion criteria: * adult (≥18 years) patients * solitary hcc ≤ 3cm * receipt of either radiofrequency ablation, liver resection, or listing for a liver transplant * treatment received between feb-2000 and nov-2018 exclusion criteria: * pathology other than hepatocellular carcinoma (hcc) * receipt of prior treatment (i.e., not treatment naive) * not eligible for all of the three treatments (ablation, liver resection, or liver transplant listing) * platelet count \<100,000 before treatment * alpha-1 fetoprotein (afp) level \> 1000 before treatment * age \> 70 years * child-pugh score c * esophageal varices grade greater than 2 * model for end-stage liver disease (meld) score before treatment exceeding 15 * presence of ascites pretreatment * presence of encephalopathy pretreatment * spleen size greater than 12 cm

Keywords: liver transplant liver resection radiofrequency ablation hepatocellular carcinoma
study of lipid control in hyperlipidemic participants (mk-0653-179)

Conditions: Dyslipidemia

Summary: this study is being done to see whether dietary and medicinal measures compliant with hyperlipidemia treatment guidelines will result in achieving target lipid values and to evaluate the total risk of cardiovascular disease in study participants who have not reached satisfactory lipid levels with their current hypolipemic therapy.


Eligibility criteria:
inclusion criteria: * hyperlipidemic * on therapy for hyperlipidemia for \>=3 months without achieving target lipid values exclusion criteria: * hypersensitivity or intolerance to hypolipemics * significant myopathy or rhabdomiolysis probably caused by hypolipemics * uncontrolled endocrine or metabolic disease which is known to affect lipid or lipoprotein values (for example, hypothyroidism and hyperthyroidism)
remote exercise to improve physical activity levels and markers of heart health in cystic fibrosis (rhh-cf)

Conditions: Cystic Fibrosis (CF); Cardiovascular Disease Risk Factors

Summary: with advances in genetic therapies, many people with cystic fibrosis (cf) are living longer. with the improvement in life expectancy has emerged an increased risk of cardiovascular disease (cvd). factors such as insulin resistance, reduced physical activity, rising blood pressure from newer medications, and changes in body mass index have made cardiovascular health a growing concern in cf care. this study aims to assess whether a remotely delivered, monitored exercise programme can increase physical activity levels in adults with cf. secondary outcomes will explore whether the intervention improves key cvd risk factors. participants will be randomly assigned to either a control group or an intervention group, which will complete an 8-week home-based aerobic and resistance exercise programme. exercise intensity will be tailored using the rate of perceived exertion scale. key outcomes include weekly physical activity levels, body mass index, waist circumference, lung function (spirometry) and blood biomarkers. home-based capillary blood tests, analysed pre- and post-intervention, will measure cholesterol, lipid profiles, inflammation and other relevant hormones.


Eligibility criteria:
inclusion criteria: * past diagnosis of cystic fibrosis confirmed via two copies of a faulty cftr gene, or; previous sweat chloride test with a result \>60mmol/l chloride, or; prescribed modulator therapy (orkambi, symkevi, kaftrio); exclusion criteria: * any reported condition, behaviour or reported use of substances which may pose undue personal risk to the participant or introduce bias into the study, except for any which are ubiquitous in society and so would be equally distributed between groups and/or therefore relevant to generalisation (e.g. caffeine) * medications which increase risk of harm to a participant exercising remotely such as fluoroquinolone antibiotics, beta blockers, or blood pressure medication * individuals with unstable or poorly controlled diabetes * individuals on statins * females who are pregnant or lactating * individuals with a previous self-reported history of an eating disorder * individuals unable to provide informed consent e.g. inability to read or speak english * individuals who are not weight stable (i.e. \>3kg change in body mass in the past 3 months) * individuals awaiting a solid organ transplant, have a diagnosis of pulmonary hypertension or require long term oxygen therapy to exercise at home * individuals with chest pain, dizziness or loss of consciousness during exercise, who have been instructed by a doctor to only do certain types/quantity of physical activity * individuals on any current ongoing medication or treatment for injuries or illness which impact on their ability to do physical tasks or exercises * individuals who are par-q positive response during screening

Keywords: exercise physical activity cystic fibrosis cardiovascular disease risk mobile health interventions