Kornimate/medical-research-clean huggingface dataset:
vinorelbine plus paclitaxel in treating patients with metastatic prostate cancer that is refractory to hormone therapy

Conditions: Prostate Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of vinorelbine plus paclitaxel in treating patients with metastatic prostate cancer that is refractory to hormone therapy.

objectives: i. determine the clinical benefit response (including improvement in quality of life) of vinorelbine and paclitaxel in patients with metastatic hormone-refractory prostate cancer. ii. correlate psa response with clinical benefit response in these patients. iii. determine the objective response rate and duration of remission in patients with measurable disease treated with this regimen. iv. further assess the toxicity of this combination in a cohort of prostate cancer patients. v. examine the survival characteristics of these patients undergoing this regimen. outline: this an open label study. patients receive vinorelbine iv over 6-10 minutes on days 1, 2, and 3 and paclitaxel iv over 3 hours on day 3 following vinorelbine. course repeats every 28 days in the absence of disease progression or unacceptable toxicity. quality of life is assessed before each treatment course. patients are followed until death. projected accrual: a total of 30 patients will be accrued into this study over 15-30 months.

Eligibility criteria:
disease characteristics: histologically proven metastatic adenocarcinoma of the prostate that is hormone refractory hormone-refractory defined as at least 50% increase in psa while continuing hormonal therapy must have received prior hormonal manipulation including either orchiectomy or lhrh agonist must be symptomatic and on a stable dose of pain medication no documented cns involvement patient characteristics: age: 18 and over performance status: zubrod 1-2 life expectancy: at least 16 weeks hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.8 mg/dl renal: creatinine no greater than 1.8 mg/dl other: not hiv positive no concurrent infection no concurrent medical or psychiatric illness that precludes study compliance no prior or concurrent second malignancy in the past 5 years except basal or squamous cell skin cancer prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy no other concurrent chemotherapy endocrine therapy: see disease characteristics at least 4 weeks since prior antiandrogens if patients have received prior antiandrogens, psa levels are reassessed at 4 week intervals until there is no decrease in psa levels before registration into this study radiotherapy: prior radiotherapy allowed must have recovered from prior radiotherapy concurrent radiotherapy for symptomatic bone lesion allowed surgery: not specified other: no other concurrent therapeutic study

Keywords: adenocarcinoma of the prostate stage iv prostate cancer recurrent prostate cancer
a study of ro4607381 in patients with coronary heart disease (chd) or a chd risk equivalent.

Conditions: Coronary Heart Disease

Summary: this 2 arm study will investigate the efficacy and safety of ro4607381 in patients with coronary heart disease, or chd risk equivalent. after a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either ro4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level and lipoprotein metabolism will be measured. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age; * chd or chd risk equivalent; * body weight \<125kg at visit 1. exclusion criteria: * recent (within 3 weeks of screening) clinically significant coronary events; * history of statin-associated myopathy, or intolerance to statin; * history of malignancy (except for curatively treated basal cell or squamous cell cancer of the skin) during the 3 years prior to screening; * exposure to ro4607381 in past 12 months.
response prediction after gks in patients with vestibular schwannoma using dce mr imaging

Conditions: Vestibular Schwannoma

Summary: response prediction after gamma knife surgery (gks) in patients with vestibular schwannoma using dynamic contrast-enhanced (dce) mr imaging

the purpose of this study was to evaluate the response of gamma knife surgery to ktrans, ve, and vp, which are indicators of permeability map obtained from dynamic contrast enhanced (dce) mri in patients with vestibular schwannoma .

Eligibility criteria:
inclusion criteria: * patients with vestibular schwannoma, who underwent gamma knife surgery and pre-op dynamic contrast enhanced (dce) mri * patients with vestibular schwannoma, who received consent exclusion criteria: * in addition to the vestibular schwannoma, if the brain has other underlying or systemic disease * during the observation period, other treatments were performed other than gamma knife surgery * if patients have a contraindication to mri (eg, pacemaker, cochlear implants, hemodynamically unstable) * concomitant use of gadolinium mri contrast agents (eg, renal insufficiency \[glomerular filtration rate \<30 ml / min\]), or if there was a side effect when using a contrast medium. * adults with impaired ability to cope * if the images and medical records required for this study are not available or are not appropriate
using nt-probnp to detect chronic heart failure in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease; Chronic Heart Failure

Summary: the aim of the present study was to evaluate if the analysis of nt-probnp might be used as an initial step for the diagnosis of chronic heart failure in patients with copd in primary health care, and to select patients for a further examination by echocardiography.

patients with a confirmed diagnosis of copd were examined regarding chronic heart failure. 1. an interview regarding symptoms: breathlessness, orthopnoea, night cough, nocturia, walking distance. 2. physical examination: weight and height, heart and lung auscultation, blood pressure measurement after 5 minutes' rest in the sitting position and the presence of peripheral oedema. 3. electrocardiography. 4. natriuretic peptide- nt-probnp (immulite 2500, siemens healthcare diagnostics ab sweden). 5. patients with the nt-probnp level of \> 1200 pg/ml were referred for echocardiography to assess left ventricular function.

Eligibility criteria:
inclusion criteria: * patients aged 65 years and older with the following diagnosis codes according to international statistical classification of diseases and related health problems - tenth revision:j44 (copd) and j41, j42 (chronic bronchitis) registered during the period 1 january 2008-16 april 2008 according to the electronic patient record. exclusion criteria: * impaired cognitive function and/or anticipated difficulties in carrying out spirometry due to immobility, * psychiatric disorders or terminal illness.
maternal and neonatal outcome in severe preeclampsia

Conditions: Pre-Eclampsia

Summary: in normal pregnancy the spiral arteries in the placental bed are invaded by trophoblast, which becomes incorporated into the vessel wall and replaces the endothelium, muscular layer and neural tissue

preeclampsia is considered severe if one or more of the following: 1. blood pressure of 160mmhg systolic or high or 110mmhg diastolic or high on two occasions at least 6 hours a part while the patient on bed rest. 2. proteinuria of 0.3gm. or high in 24 hours urine specimen or +1 or great on two random urine samples collected at least 4 hours apart. 3. oliguria of less than 500ml in 24 hours. 4. cerebral or visual disturbance. 5. pulmonary edema or cyanosis.

Eligibility criteria:
inclusion criteria: * • all women with severe preeclampsia exclusion criteria: * • history of epilepsy. * patients with chronic hypertension. * patients with renal disease.
expanded access protocol for subjects previously treated with gedatolisib in b2151009

Conditions: Breast Neoplasm Malignant Female

Summary: continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.

the primary purpose of this study is to provide continuing access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.

Eligibility criteria:
inclusion criteria: 1. currently enrolled in the b2151009 clinical study and benefiting from treatment with gedatolisib in combination with other therapies as determined by the investigator 2. previously demonstrated compliance and are willing and able to comply with scheduled visits, treatment plans, and other study procedures 3. no evidence of progressive disease, as determined by the investigator 4. provide written informed consent prior to enrolling and receiving treatment exclusion criteria: 1. permanently discontinued from treatment in study b2151009, or discontinued from study b2151009 for any reason 2. women who are pregnant, intend to become pregnant, or nursing
study of quality of life post salpingo-oophorectomy in brca1/2 & palb2 mutation carriers (brca-hrt)

Conditions: Hereditary Breast and Ovarian Cancer

Summary: 1. premenopausal brca1 / 2 or palb2 gene mutation carriers who receive hormone replacement therapy (hrt) after preventive salpingo-oophorectomy (pbso) have a better quality of sexual, psychological, cardiovascular and bone health than carriers who decline hrt. 2. premenopausal mutation carriers treated with pbso who choose hrt have a comparable overall survival and specific survival for breast / gynecological cancer to women who undergo surgery and refuse to receive hrt. 3. premenopausal mutation carriers treated with pbso have better overall and specific breast / gynecological cancer survival than non-sobp carriers.


Eligibility criteria:
inclusion criteria: 1. age between 30 and 49 years 2. being a member of a family with a history of hereditary breast and ovarian cancer, with a cancer risk\> 10% or being a carrier of the brca1 / 2 or palb2 mutation. exclusion criteria: 1. personal history of oophorectomy for benign or malignant ovarian pathology. 2. personal history of breast cancer.
study of the effect of sr57667b in patients with alzheimer's disease

Conditions: Alzheimer Disease

Summary: the primary objective is to demonstrate that sr57667b at the dose of 4 mg/day, in comparison to placebo, decreases the decline in cognitive performance and the global clinical decline over 1 year in patients with mild to moderate ad. secondary objectives are to assess the effect of sr57667b on functional decline and its safety/tolerability in patients with mild to moderate ad, and to document plasma concentrations of sr57667 in patients with mild to moderate ad.

multinational, multicenter, randomized, parallel-group, double-blind, phase ii study

Eligibility criteria:
inclusion criteria: * male / female outpatients. * age \> 50 years at screening. * dementia of alzheimer's type (dsm-iv 290.0) according to dsm-iv criteria, probable ad according to nincds-adrda criteria, mini-mental state examination score \> 12 and \< 26. * untreated or treated for a minimum of 6 months before randomization with a stable dose of the cholinesterase inhibitors * generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane). * presence of a reliable caregiver. * patient, identified caregiver and, if applicable, patient surrogate (primary relative, legal guardian, medical proxy) have given their informed written consent and are capable of following study procedures exclusion criteria: * any cause of dementia not due to alzheimer's disease, delusions, delirium, psychosis, depression, or other significant psychiatric disorder. * treatment with any registered or putative cognitive enhancer or disease modifier other than donepezil, rivastigmine or galantamine. * females who are pregnant or breast-feeding. females of child bearing potential (premenopausal female biologically capable of becoming pregnant) must have a confirmed negative serum b-hcg pregnancy test at the screening visit, and must use an acceptable method of birth control. * severe or unstable cardiovascular, respiratory, renal, hematological, endocrinological, neurological or other somatic disease. * use of cyp3a4 strong inhibitors * evidence (detected by history, physical examination and / or laboratory / ecg tests) of any clinically significant or unstable medical disorder that could interfere with the subject's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug. alterations of laboratory tests or ecg findings of potential clinical significance.

Keywords: alzheimer disease nerve growth factors clinical trial
comparing the secondary stability of dental implants: immediate gradual loading versus early loading protocol in posterior maxilla

Conditions: Dental Implant; Transmucosal Healing; Bone Loss

Summary: the aim of this split mouth study is to compare which method is better in reducing bone loss and healing times following implants. specifically, the two methods investigated will be immediate gradual loading and early loading protocol. research hypothesis immediate gradual loading using gingival formers is superior to early loading protocols in improving bone quality and thus reducing the healing time.

these two methods (gradual loading and early loading) will both be used in implants patients with the aim to compare which protocol leads to a better outcome for the patient. a 'better outcome' is defined as the method, which leads to the least crestal bone loss, and the fastest healing time. immediate gradually loaded side: will include transmucosal healing of dental implants using gingival formers which will be replaced every 2 weeks by consequent larger size gingival former.i.e. at surgery time the implants will receive 2 mm height gingival former which will be swapped by 3 mm, 4 mm, 5 mm and the last is 6 mm early loaded side: implants will be submerged from the surgery time till loading time (2 month).

Eligibility criteria:
inclusion criteria 1. patients with bilateral partial or complete edentulous areas in maxillary premolar/molar region. 2. free medical history. 3. enough bone quantity. 4. enough keratinized mucosa exclusion criteria 1. systemic disease. 2. irradiated bone (radiotherapy). 3. heavy smoking habit. 4. patients undergoing long-term immunosuppressive therapy. 5. atrophic ridges. 6. presence of any local bony lesion. 7. presence of mandibular parafunctional habits

Keywords: immediate gradual loading
reanimation in tetraplegia

Conditions: Spinal Cord Injury (Quadraplegia)

Summary: the purpose of this clinical study is to allow the investigation of the neural bridging system for participants with tetraplegia to assess if the investigational device can reanimate a paralyzed limb under voluntary control by the participant's thoughts.

this study plans to enroll participants who have been diagnosed with c4- c6 asia a spinal cord injuries (motor and sensory complete neurologic injuries), who are more than 1 year post injury, and who are neurologically stable.

Eligibility criteria:
inclusion criteria: * must be 21 years or older. * must be tetraplegic (c4- c6 asia a). * 12 months post injury and neurologically stable. * participant is willing to comply with all follow-up evaluations at the specified times. * participant is able to provide informed consent prior to enrollment in the study. * the participant is fluent in english. * participant must have a caregiver willing to participate in the study who will provide care for the surgical site. exclusion criteria: * no active wound healing or skin breakdown issues. * no history of poorly controlled autonomic dysreflexia. * medical contraindications for general anesthesia, craniotomy, or surgery. * diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months. * participants with any type of destruction and/or damage to the motor cortex region as determined by mri. * history of psychiatric disturbance or dementia * other implantable devices such as heart/brain pacemakers * participants who rely on ventilators * co-morbid conditions that would interfere with study activities or response to treatment. * history of a neurological ablation procedure. * labeled contraindication for mri. * history of hemorrhagic stroke. * history of hiv infection or ongoing chronic infection (such as tuberculosis). * pregnant or of child-bearing potential and are not taking acceptable methods of contraception. * participation in another fda device or medication trial that would interfere with the current study.
intracardiac cryoablation for atrioventricular nodal reentrant tachycardia

Conditions: AtrioVentricular Nodal Reentrant Tachycardia; Supraventricular Tachycardia; Heart Disease

Summary: icy-avnrt (intracardiac cryoablation for atrioventricular nodal reentrant tachycardia) is a prospective multi-center, nonrandomized, single arm, controlled, unblinded, investigational clinical study. the purpose of this clinical study is to demonstrate the safety and effectiveness of the freezor® xtra cardiac cryoablation catheter for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (avnrt) using an endocardial approach.


Eligibility criteria:
pre-electrophysiology study inclusion criteria: * supraventricular tachycardia (svt) compatible with atrioventricular nodal reentrant tachycardia (avnrt), documented by ecg, ttm, holter or event monitor pre-electrophysiology study exclusion criteria: * history of sustained (≥30 seconds) of ventricular tachycardia * atrial tachycardia or other arrhythmia that could be confused with avnrt * reversible cause of svt * history of previous avnrt ablation * therapy with amiodarone within last 90 days * unstable angina/myocardial infarction/open heart surgery in past 60 days * new york heart association (nyha) classification iii or iv currently or within the past 90 days * implantable cardiac rhythm device * atrioventricular block (first degree (pr interval ≥ 220ms), second degree, or third degree) or left bundle branch block * stroke or transient ischemic attack within the past 180 days * life expectancy less than 12 months * female known to be pregnant * unable/unwilling to give informed consent * unable/unwilling to comply with follow-up visits and study requirements * less than 18 years of age * active systemic infection * cryoglobulinemia * other conditions where the manipulation of the catheter would be unsafe (for example, intracardiac mural thrombus) * participating in a concurrent clinical study that may confound the results of this study post-electrophysiology study inclusion criteria: * subject must have one electrophysiology study documented inducible sustained (greater than or equal to 15 seconds) supraventricular tachycardia that is classified as avnrt. post-electrophysiology study exclusion criteria: * presence of a second inducible arrhythmia that could be confused with avnrt during follow-up or will likely result in ablation within the next 6 months * presence of inducible sustained ventricular tachycardia or fibrillation * presence of an accessory pathway * presence of abnormal conduction or refractoriness parameters of the atrioventricular conduction system. * indication for a pacemaker, defibrillator or cardiac resynchronization therapy (crt)

Keywords: cardiac cryoablation avnrt heart disease tachycardia atrioventricular nodal reentrant tachycardia supraventricular tachycardia svt
intravitreal ranibizumab treatment of central serous chorioretinopathy

Conditions: Central Serous Chorioretinopathy

Summary: the purpose of this study is to examine the effects of lucentis for active central serous chorioretinopathy.

this is an open-label, phase i study of intravitreally administered ranibizumab in subjects with unresolving csc and subfoveal fluid. patients will be evaluated at baseline with ophthalmic examination, fluorescein angiography, optical coherence tomography, and color photography. subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered every 28 days (± 2 days) for 3 injections. thereafter they are to be evaluated every month until month 12. treatment will be administered to patients if there is presence of active leakage as determined by fluorescein angiography or persistence presence of sub retinal fluid upon oct examination at that monthly visit.

Eligibility criteria:
inclusion criteria: * a history of persistent central serous chorioretinopathy present for at least 3 months best-corrected visual acuity (bcva) of 20/40 (73 letters on the etdrs chart) to light perception as measured by etdrs protocol refraction. * no signs of choroidal neovascularization * documented subfoveal fluid by oct * active leak associated with the subfoveal fluid * the ability and willingness to provide written informed consent exclusion criteria: * prior treatment with laser or pdt * have uncontrolled hypertension * have a history of thromboembolic events including stroke, transient ischemic attacks, and myocardial infarction * have use of or need for continued anticoagulation therapy, except aspirin 325 mg/day. * are receiving or require chronic concomitant therapy with systemic (\> 5 mg) or topical ocular corticosteroids. chronic concomitant therapy is defined as multiple doses taken daily for 14 or more consecutive days at any time within 6 months prior to screening * previously vitrectomized eyes. * had allergic reactions to fluorescein dye or lack of venous access. * any other additional ocular diseases which could irreversibly compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy (aion), age related macular degeneration (amd), retinal detachment, severe cataracts, etc. * an anticipated need for ocular surgery during the duration of the trial. * within 1 month prior to screening, have had intra ocular surgeries (including cataract surgery) in the study eye. * intravitreal triamcinolone or bevacizumab in the previous 2 months * uncontrolled glaucoma (iop \> 24 mmhg) on greater than 3 medications. * within 1 month prior to screening had yag laser capsulotomy in the study eye * have received any other systemic experimental drug within 12 weeks prior to enrollment. * rubeosis iridis or neovascular glaucoma * any untreated rhegmatogenous retinal detachment. * a visual acuity of worse than 20/400 in the fellow eye. * unwilling or unable to follow or comply with all study related procedures.

Keywords: central serous chorioretinopathy