Kornimate/medical-research-clean huggingface dataset:
efficacy study of chemotherapy to treat ovarian cancer recurrence by prolonging the platinum free interval

Conditions: Ovarian Cancer

Summary: this study aims to test the hypothesis that the artificial prolongation of the platinum-free interval with a non-platinum treatment will improve the effectiveness of overall therapy in patients with ovarian cancer progression occurring 6-12 months after first-line treatment with a platinum-derivative.

ovarian cancer is the most deadly gynecologic cancer. though many patients respond well initially to chemotherapy, most of them in time will suffer a relapse. patients often receive multiple lines of chemotherapy for their recurrences, and the choice of chemotherapy depends largely on the time interval since the last therapy. patients whose disease recurs longer than 12 months after a platinum containing treatment are considered to be platinum sensitive, and are candidates for retreatment with a platinum regimen. patients in whom disease recurs less than 6 months after a platinum containing treatment are considered platinum resistant or refractory, and are treated with a non platinum chemotherapy. the option of treatment is less clear for patients whose disease recurs between 6 and 12 months after platinum containing therapy. it is hypothesized that prolonging the interval since last platinum treatment by using a non platinum chemotherapy will result in better outcomes for these patients. this study will evaluate if the experimental sequence of a non platinum based chemotherapy, followed at a later progression by a platinum based chemotherapy is superior, in terms of the effect on overall survival, to the standard inverse sequence of treatment.

Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of ovarian cancer * disease recurrence between 6 and 12 months after a first-line platinum based therapy * indication for chemotherapy, but no more than 2 previous lines of previous therapy * life expectancy of more than 3 months exclusion criteria: * previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix) * ecog performance status at least 3 * previous treatment with stealth liposomal doxorubicin * residual peripheral neuropathy grade 3 or higher * heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias) * neutrophils \< 2000 x mm3, platelets \< 100000 x mm3 * inadequate renal function (creatinine no greater than 1.25 x normal values) or liver function (alt or ast no greater than 1.25 x normal values) * present or suspected hemorrhagic syndromes * inability to comply with protocol and follow-up * inability to access study site for clinical visits * refusal of informed consent

Keywords: platinum free interval chemotherapy
abdominal aortic aneurysm sac healing and prevention of endoleaks - netherlands

Conditions: Abdominal Aortic Aneurysm

Summary: to determine the safety and efficacy of impede-fx embolization plug and/or impede-fx rapid fill to fill an abdominal aortic aneurysm (aaa) sac outside of an endovascular aneurysm repair (evar) stent graft.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * a candidate for elective evar of an infrarenal aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women exclusion criteria: * an inability to provide informed consent * enrolled in another clinical study * aortoiliac aneurysm, or concomitant iliac artery ectasia or aneurysm (common iliac artery diameter \>24 mm) close to the bifurcation and/or that cannot be adequately sealed * patent aaa sac feeding vessels (within the sac) \>4 mm in diameter * volume of aaa sac to be filled after stent graft placement \ 135 ml, based on pre-procedure cta (i.e. aortic flow volume exclusive of stent graft volume) * use of aortic stent grafts other than the gore excluder aaa endoprosthesis, cook zenith flex aaa endovascular graft, or medtronic endurant ii stent graft to treat the aaa * planned use of the chosen stent graft outside its instructions for use (ifu) * planned use of fenestrated or chimney stent grafts * study participants in which stent graft placement is abandoned for any reason, and/or in which the investigator decides, during the course of the stent graft placement, that the study procedure may not be appropriate * planned use of embolic devices other than the investigational product to embolize the aaa sac * vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the aaa sac * ruptured, leaking, or mycotic (infected) aneurysm * aneurysmal disease of the descending thoracic aorta * coagulopathy or uncontrolled bleeding disorder * long-term (\>6 months prior to the procedure) use of direct oral anticoagulant or any vitamin k antagonist anticoagulant use * serum creatinine level \>2.5 mg/dl; * cerebrovascular accident within 3 months prior to the procedure * myocardial infarction and/or major heart surgery within 3 months prior to the procedure * atrial fibrillation that is not well rate controlled * unable or unwilling to comply with study follow-up requirements * life expectancy of \<2 years post-procedure * known hypersensitivity or contraindication to platinum, iridium, or polyurethane * a condition that inhibits radiographic visualization during the implantation procedure * history of allergy to contrast medium that cannot be managed medically * uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the study * pregnant or a lactating female. for females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the study * prisoner or member of other vulnerable population.
transperineal laser ablation for focal treatment of prostate cancer

Conditions: Prostate Cancer; Focal Laser Ablation; Transperineal Laser Ablation

Summary: rationale: prostate cancer (pca) is the second cause of cancer-related deaths for men. the standard surgical treatment for localised prostate cancer is radical prostatectomy. possible side effects of this treatment are incontinence and erectile dysfunction and this is related to the whole-gland resection. a focal treatment with fewer side effects is desired for patients with only a small focus of pca. for this purpose, focal laser ablation is feasible. current focal laser ablation techniques use a single fibre setup with the need for fibre replacement revisualisation of the tumour side accordingly. this leads to a long treatment duration. the echolaser® system is a laser ablation system with four simultaneously operating laser sources. this provides a potential larger treatment area, without the need for fibre replacement. this makes the system advantageous for focal laser ablation of prostate cancer, especially since it can be applied under local anaesthesia. this pilot study aims to evaluate histological ablative efficacy on radical prostatectomy specimens following tpla, feasibility and safety using a (multi)fibre setup in men with localized prostate cancer. the investigators hypothesize that tpla will show adequate histological ablative efficacy and will be feasible and safe.


Eligibility criteria:
inclusion criteria: * male * ≥40 years of age * histopathological confirmed organ-confined prostate cancer * indication for a radical prostatectomy * prostate volume ≥40 ml * ability of the patient to stop anticoagulant therapy prior to tpla according to standard hospital pre-operative protocol * signed informed consent exclusion criteria: * refusal of participation or clinically ineligible for treatment under local anaesthesia * prior or concurrent treatment for prostate cancer * other conditions / status

Keywords: prostate cancer transperineal laser ablation prostate neoplasma focal laser ablation
study of mdx-010 in stage iv breast cancer

Conditions: Breast Cancer; Adenocarcinoma

Summary: this phase ii study is designed to treat patients who have been diagnosed with stage iv breast cancer, which has progressed despite treatment with primary therapies, including hormonal therapy, chemotherapy, and antibody therapy. thirty-three patients will be treated with the monoclonal antibody mdx-010. the initial antitumor activity profile of mdx-010 will be determined, as well as identification of the induction of any antitumor immunity following the mdx-010 treatment.


Eligibility criteria:
inclusion criteria: * provide written informed consent * diagnosed with stage iv adenocarcinoma that has progressed despite previous therapy * at least 18 years of age * measurable disease defined by recist * must discontinue any alternative therapy used to treat breast cancer at least 4 weeks prior to enrollment and agree to not use such therapies during the duration of the study (patients may continue to receive tamoxifen, bisphosphate therapy and trastuzumab) * prior radiation must be completed at least 4 weeks prior to enrollment * ecog performance status of 0-2 * negative pregnancy test * screening lab values must be met exclusion criteria: * must be disease free from other cancers for at least 5 years * symptomatic or untreated brain metastases * active or history of autoimmune disease * active hiv, htlv, hbv or hcv infection * concurrent medical condition requiring the use of systemic corticosteroids, must be discontinued at least 4 weeks prior to enrollment * prior therapy with anti-ctla-4 antibody * significant organ compromise, uncontrolled heart, liver, lung, or renal disease or other serious illness * pregnancy or nursing

Keywords: breast cancer stage iv adenocarcinoma of the breast
ghrelin repeated dose study

Conditions: Frailty in Aging

Summary: frailty is a geriatric syndrome leading to physical deterioration including muscle wasting (sarcopenia) and unintentional weight loss. there are currently no approved therapies for frailty. ghrelin is a hormone produced by the stomach that stimulates appetite centers in the brain. the investigators already know that a single dose of ghrelin improves food intake immediately after the dose in frail older people. in this study, the investigators are trying to find out if repeated daily doses of ghrelin will help frail older people improve food intake for multiple days in a row.

the study design is an open label, repeated dose administration study in which we will examine the safety and efficacy of repeated subcutaneous ghrelin administration in frail individuals. there will be a screening visit plus three additional study visits at the ctrc on days 1, 2, and 7. participants will receive an injection of ghrelin subcutaneously once daily on days 1 and 7 and will self-administer the subcutaneous injection before breakfast on days 2-6 at home. a food record will be kept from day -3 to day 6. we will assess the efficacy of repeated ghrelin doses to sustainably increase caloric intake from pre-treatment baseline without hyperglycemia or raising of cortisol levels.

Eligibility criteria:
inclusion criteria: * individuals with three, four or five frailty criteria using the fried frailty criteria exclusion criteria: 1. diabetes mellitus or fasting glucose ≥ 126 mg/dl 2. hospitalization for stroke, myocardial infarction, coronary artery bypass graft surgery, vascular surgery in the past six months. 3. new york heart association class iii or iv congestive heart failure 4. therapy for cancer in the past 12 months, except non-melanoma skin cancer 5. bmi ≥ 30 kg/m2 6. current use of corticosteroids other than topical, ophthalmic, and inhaled preparations 7. therapy with megestrol acetate or dronabinol within the last 6 weeks 8. thyroid stimulating hormone measured as \< 0.4 mu/l or greater than 10mu/l 9. abnormal liver function tests (lfts \> 2x upper limit of normal) 10. hemoglobin \< 11g/dl 11. insulin-like growth factor-i (igf-i) above the age-specific reference range 12. history of surgery within the last 30 days 13. unstable medical or psychological conditions or unstable home or food environment 14. cognitive deficit as defined by a folstein mini mental state exam score \< 24/30 15. depression (defined as a score of \> 11 on the geriatric depression questionnaire)
parkinson's disease evaluated by pet and the effect of memantine

Conditions: Parkinson's Disease

Summary: purpose of study: to investigate whether the nmda antagonist memantine has a substantial effect of brain metabolism in patients with parkinson's disease (pd), using positron emission tomography (pet). background: disturbances in brain metabolism is thought to contribute to degeneration of neurons in brain of pd patients. production of toxic oxygen radicals and presence of too much excitatory neurotransmitter (glutamate) due to over activity is involved. these factors can theoretically be alleviated by memantine. hypothesis: memantine decreases metabolism in areas in pd brain known to be over-active. decreases in cerebral blood flow and oxygen metabolism in these areas will be the consequence and this can be detected by pet.


Eligibility criteria:
inclusion criteria: * parkinson's disease (british brain bank criteria) * age 50-70y exclusion criteria: * tobacco use * any serious medical conditions (heart disease, kidney disease, liver disease, endocrinological disorders etc) * metal implants contraindicating mr scan * drug use affecting the central nervous system * psychiatric disorders * head trauma or any disorders of the head, skull or brain * drug addiction or use of any kind of illegal substance affecting the central nervous system * pregnancy

Keywords: parkinson's disease positron emission tomography memantine nmda antagonists cerebral blood flow cerebral metabolic rate of oxygen
an immuno-therapy study to evaluate the effectiveness, safety and tolerability of nivolumab or nivolumab in combination with other agents in patients with advanced liver cancer

Conditions: Hepatocellular Carcinoma

Summary: the first part of the study is the dose escalation phase designed to establish the safety of nivolumab at different dose levels for each of the three cohorts (uninfected hepatocellular carcinoma (hcc) subjects, hepatitis c virus (hcv)-infected hcc subjects, and hepatitis b virus (hbv)-infected subjects). the second part of the study is the expansion phase designed to generate additional clinical data at specified doses for each of the 3 cohorts. a third cohort has been added in this study to compare the efficacy of nivolumab and sorafenib in the treatment of advanced hcc. a fourth cohort will generate data on the safety and efficacy of the combination nivolumab plus ipilimumab in the treatment of advanced hcc. in the fifth cohort, additional clinical data will be generated for child-pugh b subjects. a cabozantinib combination cohort has been added to evaluate the safety and tolerability of nivolumab in combination with cabozantinib and nivolumab with ipilimumab in combination with cabozantinib.

study classification: pharmacokinetics/pharmacodynamics

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * subjects of 18 years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies * eastern cooperative oncology group (ecog) performance status of 0 to 1 * dose escalation phase: child-pugh score of 7 points or less. cohort 5: child-pugh class b (b7-b8). for all other cohorts child-pugh score of 6 points or less exclusion criteria: * history of autoimmune disease * any prior or current clinically significant ascites * any history of hepatic encephalopathy
effect of a probiotic on the urinary tract microbiota of participants with recurrent urinary tract infection.

Conditions: Recurrent Urinary Tract Infection

Summary: urinary tract infections (utis) are the most common bacterial infections in women. 50% of women experiencing at least one uti in their lifetime with an annual prevalence of 0.5-0.7%. an interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strains on the urinary tract microbiota in participants with recurrent urinary tract infection (ruti). the study duration will be 6 and a half months, including 6 months product intake. participants will be randomly assigned to one of the three study groups: control group with placebo administration, probiotic administration group (1 dose) and probiotic administration group (2 doses).


Eligibility criteria:
inclusion criteria: * adult women with aged between 18 and 55 years old, diagnosed with recurrent uti (defined as at least two episodes during the last six months or three during the last 12 months). * diagnosed, the last 7days, for a new uti episode. * written informed consent signed. exclusion criteria: * menopausal * pregnant, breastfeeding or planning to become pregnant during the study. * congenital abnormalities of the urinary tract. * renal functional alterations, such as neurogenic bladder or vesicoureteral reflux. * relevant renal disorders, such as interstitial cystitis, renal lithiasis, renal failure, kidney transplantation, pyelonephritis, renal nephropathy, etc. * permanent catheter. * immunocompromised (eg: cancer and/or transplant, patients who are taking immunosuppressive drugs, patients with hereditary diseases that affect or may affect the immune system). * type i diabetes. * with a defect in the intestinal epithelium barrier (eg: chronic diarrhea, inflammatory bowel disease). * heart failure and cardiac medical history (eg, artificial heart valve, medical history of infective endocarditis, rheumatic fever, or cardiac malformation). * under antibiotics prophylactic treatment without willingness to leave it at the time of inclusion. * probiotics supplementation during the previous 2 weeks. * to have received urovac, uro-vaxom or equivalent vaccine during the last year. * currently participating in another clinical trial.
measuring omalizumab responses using real-world evidence (morre) study

Conditions: Asthma

Summary: develop new real-world evidence indicators of worsening and improving asthma. scientists will measure (1) steps per day, (2) duration and intensity of exercise per day, (3) sleep duration and the number of awakenings per night using fitbit activity trackers. scientists will measure asthma symptoms using a once-monthly custom survey delivered to participant smartphones via twilio. scientists may measure rescue medication use and adherence to maintenance medications using digital inhaler devices. scientists will correlate the above measures to participant-reported significant asthma exacerbations (saes), lung function (fev1), and standardized surveys (i.e. the asthma control test (act) and global evaluation of treatment effectiveness (gete)(4)) collected in clinic every 3 months. coordinators will record any medication changes or reported medication side effects. determine response to omalizumab therapy. after participants are placed on omalizumab therapy as part of standard medical care, scientists will determine whether and how real-world evidence can be used to gauge responses to omalizumab. then, scientists will determine which features, or combination of features, are the best indicators of disease control in the real world.


Eligibility criteria:
inclusion criteria: * a diagnosis of uncontrolled or difficult-to-treat asthma, defined as 1 course of systemic corticosteroids (e.g. oral prednisone) in the last 12 months or an asthma control test (act) score less than or equal to 19 despite regular use of inhaled corticosteroids (ics) therapy (at least 176 mcg of fluticasone/day or the equivalent) for at least 1 month prior to enrollment. * participants will need access to a smartphone. exclusion criteria: * active smoking and any significant comorbid conditions that could inadvertently interfere with study results as determined by the study investigators (i.e. any terminal illness, cancer, hiv, end-stage renal disease, congestive heart failure, severe autoimmune disease or inflammatory bowel disease) * conditions that require bursts of oral corticosteroids * other significant lung diseases (cystic fibrosis, pulmonary hypertension, interstitial lung disease, pulmonary fibrosis among others) * other disease that may mimic asthma, including vocal cord dysfunction, hypersensitivity pneumonitis, or tracheobronchomalacia.

Keywords: asthma asthma control biologic uncontrolled asthma
a study of indian patients receiving therapy for systemic fungal infections

Conditions: Systemic Fungal Infections

Summary: to collect and summarize information on the diagnosis, management, and clinical and mycological outcomes of patients with systemic fungal infections in order to better understand the effectiveness of antifungals in the treatment of systemic fungal infections (sfi) in india.


Eligibility criteria:
inclusion criteria: * to be eligible for enrollment in the study database, patients must have received (in the intensive care unit \[icu\] at study entry) at least 1 day therapy with systemic antifungal agent for treatment of a proven or suspected fungal infection. exclusion criteria: * none.

Keywords: observational study effectiveness safety tolerability systemic fungal infection