Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of shenfu zhusheye in patients with acute heart failure

Conditions: Acute Heart Failure

Summary: the purpose of this study is to evaluate the efficacy and safety of shenfu zhusheye in patients with acute heart failure.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute heart failure according to guidelines for the diagnosis and treatment of acute heart failure 2010 of chinese medical association(participants whose heart function grade of nyha is ⅲ～ⅳ). * lvef≤40%. * nt-pro-bnp ≥1400 pg/ml or bnp ≥ 350pg/ml. * ages 18-80, male or female. * all participants signed the informed consent. exclusion criteria: * participants with abnormal liver function (alt, ast≥3 times of upper limit of normal) or abnormal kidney function( cr≥1.5 times of upper limit of normal or cr \>3.0 mg/dl (\> 265 µmol/l)). * sbp ≥ 150mmhg. * participants with severe chronic asthmatic bronchitis or acute episode of lung diseases. * participants with acute coronary syndrome, cardiogenic shock, aortic dissection, pulmonary embolism, severe ventricular arrhythmias, complete atrioventricular block without cardiac pacemaker, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy and severe valvular disease without surgery. * participants with advanced cancer. * breastfeeding, pregnant and potentially fertile women participant. * participants with insanity. * known allergies with shenfu zhusheye or its ingredients in the past. * participants who have taken part in other clinical trials in last month. * participants who abuse alcohol or other drugs in last year. * participants who are not suitable for clinical trial under doctors' consideration.
new strategy of improving treatment outcome and larynx-preservation rate in locally advanced hypopharyngeal carcinoma

Conditions: Hypopharyngeal Cancer

Summary: to develope stratification treatment for the patients who have locally advanced hypopharyngeal carcinoma. experimental group patients were treated individually according to the response status after induction chemotherapy, receiving chemoradiotherapy or surgery. thus to achieve a better survival rate and a higher larynx-preservation rate as well as a lower treatment related toxicity rate compared with standard treatment.

eligiblity patient were assign to induction chemotherapy plus concurrent chemotherapy group (ic +ccrt group, arm a)and concurrent chemoradiotherapy group(ccrt group, arm b). for patients in arm a, treatment response were evaluated after 2cycles, if the response reached partial response/complete response, patients received concurrent chemoradiotherapy, otherwise, patients will received surgery and radiotherpay/concurrent chemoradiotherapy after surgery. for patients received concurrent chemoradiotherapy (both in arm a and arm b) , treatment response were evaluated at 50 gy. if response reached complete response or major partial response(\>80% tumor regression), patients will received radical chemoradiotherapy, otherwise, patients will received surgery.

Eligibility criteria:
inclusion criteria: * histologically proven squamous cell carcinoma of hypopharynx * stage iii/iv m0, with t3/4 n0-3 or t1-4 n2-3 * karnofsky performance status\>=70 * have measurable lesions on ct/mri * treatment for the first time * expected lifetime \> 6 months * normal blood test, hepatic and renal functions * normal hearing * can understand and sign the consent * have follow up condition exclusion criteria: * past malignancies history (except for stage i non-melanoma skin cancer or cervical carcinoma in situ) * previously treatment for cancer * pregnant or breeding woman, female without contraception * enrolling in other drug trials * severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes * without follow up * receive target therapy

Keywords: hypopharyngeal carcinoma locally advanced multi-disciplinary treatment functional magnetic resonance imaging prognosis
electrocardiographic autonomic function measures in mechanically ventilated patients

Conditions: Disorders of the Autonomic Nervous System; Cardiovascular Abnormalities; Respiratory Disorders

Summary: this research proposal has two main objectives. the first is to increase understanding of the underlying physiological interactions that occur between the cardiovascular, pulmonary, and ans during transition between positive pressure mechanical ventilation (mv) and spontaneous breathing. the second is to determine if heart rate variability, (hrv) a reflection of autonomic nervous system (ans) activity, and autonomic information flow (aif), a set of nonlinear measures derived from hrv, both measured in the intensive care unit (icu) can predict patient outcomes including successful weaning and in-hospital recovery time after an episode of cardiopulmonary compromise requiring mv. hypothesis 1. transitions between mechanically supported ventilation and spontaneous breathing will disturb cardiovascular synchrony, altering the relationship of hrv, aif, respiratory rate, and blood pressure; hypothesis 2. more normal hrv and aif values, measured during baseline mv and sedation awakening (a period immediately prior to sbt when sedative medications are discontinued) will be associated with easier weaning, and shorter intensive care unit (icu) and hospital lengths of stay; more abnormal measurements will be associated with longer lengths of stay; hypothesis 3. aif is a more sensitive predictor of successful weaning from mv than hrv.


Eligibility criteria:
inclusion criteria: * receiving mechanical ventilation in medical-surgical intensive care unit; * eighteen years of age or older; * expectation of receiving initial spontaneous breathing trial within the next 24 hours. exclusion criteria: * pregnant; * expectation of non-survival when ventilator is discontinued; * cardiac rhythm of atrial fibrillation; * paced cardiac rhythm.

Keywords: heart rate variability, mechanical ventilation, weaning, spontaneous breathing trial
study to evaluate motesanib with or without carboplatin/paclitaxel or panitumumab in the treatment of patients with advanced non-small cell lung cancer (nsclc)

Conditions: Lung Cancer; Non-Small Cell Lung Cancer

Summary: the purpose of this trial is: - to characterize the safety profile of motesanib when used in combination with carboplatin/paclitaxel (cp), with panitumumab or with cp and panitumumab in patients with advanced non-small cell lung cancer (nsclc). - to establish the pharmacokinetic (pk) profile of motesanib when it is used in combination with cp, with panitumumab, or with cp and panitumumab. - to compare the paclitaxel and motesanib pk profiles when the medications are administered 30 minutes (min) or approximately 48 hours (hrs) apart. - to characterize the panitumumab and paclitaxel exposure in the combination regimens of motesanib with cp, motesanib with panitumumab, or motesanib with cp and panitumumab. - to describe the objective response rate (orr) in each dose cohort. - to measure the immunogenicity of panitumumab in patients administered motesanib with panitumumab and motesanib with cp and panitumumab.

this was a multicenter, open-label, dose-finding clinical trial examining the safety and pk of once or twice daily motesanib administered with cp or with cp and panitumumab in chemotherapy naïve patients, and with panitumumab in patients with no more than one prior chemotherapy regimen for nsclc. participants were enrolled into the panitumumab + paclitaxel + carboplatin + motesanib once a safe and tolerable dose of amg 706 was established in the other treatment arms.

Eligibility criteria:
inclusion criteria: * diagnosis of unresectable stage iiib or iv non-small cell lung cancer (nsclc) * no more than one prior chemotherapy * adequate hematologic, renal and hepatic function * measurable disease or evaluable disease on cat scan or mri * eastern cooperative oncology group (ecog) performance status of 0 or 1 * able to fast for 10 hrs twice during the study - able to tolerate oral medications * life expectancy of at least 3 months exclusion criteria: * symptomatic or untreated central nervous system metastases requiring current treatment * history of arterial thrombosis within 1 year prior to enrollment * anticoagulant therapy, except for warfarin of less than 2mg per day * symptomatic peripheral neuropathy * history of pulmonary hemorrhage or hemoptysis * myocardial infarction within 1 year before enrollment * uncontrolled hypertension \[diastolic greater than 85 mmhg; systolic greater than 145 mmhg\] * history of other cancer, unless treated with no known active disease for longer than 3 years * previous treatment with amg 706 or panitumumab, previous treatment with inhibitors of vegf or egf * no antibody treatment for 6 weeks prior to enrollment * known hiv positive, hepatitis c positive or hepatitis b surface antigen positive

Keywords: lung cancer, non-small cell lung cancer, nsclc clinical trial, panitumumab, amg 706 anti-angiogenesis immunex, abgenix, amgen stage iiib, stage iv, unresectable
fulvestrant 500mg with exemestane endocrine therapy for postmenopausal advanced breast cancer patients

Conditions: Breast Cancer

Summary: a randomized, open label, parallel-group, multi-center study. eligible patients will be randomized in a 1:1 ratio to receive fulvestrant 500 mg or exemestane 25mg.

to compare the efficacy and tolerability of fulvestrant 500 mg with exemestane 25 mg as first line endocrine therapy in postmenopausal women with oestrogen receptor positive her2 negative advanced breast cancer who have relapsed on or after adjuvant non-aromatase inhibitor therapy

Eligibility criteria:
inclusion criteria: * signed informed consent document on file; * age over 60 years; * age \< 60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and fsh and oestradiol level in the postmenopausal range; * patients with metastatic or locally advanced disease not amenable to therapy with curative intent * er + and/or pgr +; * duration of adjuvant non-aromatase inhibitors treatment should be at least 2 years or more; * who performance status 0, 1 or 2; * patients with life expectancy of more than 3 months. exclusion criteria: * presence of life-threatening metastatic visceral disease; * previous systemic chemotherapy for advanced breast cancer; * received systemic endocrine therapy for advanced disease; * extensive radiation therapy within the last 4 weeks ; * platelets \< 100\*109 / l,total bilirubin no less than 1.5ulrr, alt or ast no less than 2.5ulrr if no demonstrable liver metastases or no less than 5ulrr in presence of liver metastases; * severe renal impairment, bleeding diathesis, long-term anticoagulant therapy; * history of hypersensitivity to active or inactive excipients of fulvestrant, exemestane and/or castor oil.
normative values for cognitive testing and alzheimer's imaging biomarkers in young adults

Conditions: Alzheimer's Disease

Summary: biomarkers of alzheimer's disease (ad) occupy an essential place in recently formulated diagnostic criteria for ad where their role is to identify the pathophysiological processes underlying cognitive impairment or to predict time to dementia. three of these biomarkers are brain imaging tests (amyloid pet, fludeoxyglucose (fdg) pet, and structural mri). in order to effectively use ad biomarkers for diagnostic and prognostic purposes, continuous values much be divided into normal and abnormal ranges. this requires that a cut point(s) be established in the continuous distribution of values for each biomarker. the investigators objective in this proposal is to obtain imaging biomarker data in a group of individuals who are appropriate for establishing normative values for ad biomarkers. the investigators believe the most valid approach to establishing biomarker cut points is to base them on the upper bound of the range observed in young to early-middle-age subjects in whom the presence of occult ad pathology is extremely unlikely. based on a large volume of community-based autopsy data, that upper age limit would be about 50 years old. the lower age bound for a group of subjects used to establish normative ad biomarker values would have to be based on considerations of brain maturation, which may continue into the middle- to late-20s. thus, taking the above into consideration, the ideal age range for establishing normative ad imaging biomarker data (amyloid pet, fdg pet, and structural mri) may be ages 30-49 years old.


Eligibility criteria:
inclusion criteria: * cognitively normal males or females aged 30 to 49 years old. exclusion criteria: 1. subjects unable to lie down without moving for up to 45 minutes. 2. women who are pregnant or cannot stop breast feeding for 24 hours. 3. claustrophobic patients unable to tolerate the scans (no sedation can be offered). 4. standard safety exclusionary criteria for mri such as metallic foreign bodies, pacemaker, etc.
a pilot of a personalized circadian mhealth to improve sleep in night shift workers

Conditions: Shift Work Sleep Disorder

Summary: the goal of this project is to establish the evidence base for equitable accessibility and implementation of the precision sleep medicine mobile application, shift.


Eligibility criteria:
inclusion criteria: * inadequate sleep duration (habitual sleep less than 7 hours during the day) * willingness to download the shift app and follow the lighting recommendations * ability to follow a set sleep schedule of 7 hours in bed after the night shifts * working at least 4 night shifts a month * shifts that must begin between 18:00 and 02:00 and last 8 to 12 hours * score of 8 or above on the epworth sleepiness scale and/or a score of 8 or above on the insomnia severity index exclusion criteria: * other independent sleep disorders (e.g., obstructive sleep apnea, narcolepsy, etc.) * history of seizures or other significant neurological disorders * bipolar disorder * termination of shift schedule * pregnancy * current use of medications that impact sleep-wake functioning * alcohol and substance use disorder
a phase ii double blind comparative study of kps-0373 in patients with spinocerebellar degeneration (scd)

Conditions: SCD

Summary: the purpose of this study is to evaluate the efficacy and safety of kps-0373 compared to placebo in patients with spinocerebellar degeneration (scd).


Eligibility criteria:
inclusion criteria: * japanese scd patients with mild to moderate ataxia exclusion criteria: * patients with secondary ataxia * patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Keywords: spinocerebellar degeneration (scd) thyrotropin-releasing hormone (trh)
strigolactones and dysplastic colonic lesions or cancer

Conditions: Colonic Neoplasms; Colonic Polyps

Summary: the purpose of this study is to determine the effects of the plant hormones strigolactones, on cell cultures of colonic polyps and colorectal cancer.

strigolactones have been shown to anti-proliferative and pro-apoptotic effects in cell cultures of breast and prostate origin, partially by down-regulation of cyclin b1 and induction of cell cycle arrest. in this study the investigators intend to take biopsies from benign colonic polyps and cancer tissue, culture intestinal explants and generate immortalized primary cells as a platform to assess the effect of this plant hormone on cell viability, cell mobility, apoptosis and cytoskeleton modifications.

Eligibility criteria:
inclusion criteria: * patients with positive findings during colonoscopy exclusion criteria: * patients below 18 years old * patients who cannot sign a consent form
nutritional improvement in chronic heart failure patients

Conditions: Heart Failure

Summary: to assess the effect over the nutritional status in patients who are malnourished with chronic heart failure, of an educational intervention and the provision of nutritional supplements. randomized clinical trial with blind assessors. unicentric. follow up: 12 months

randomized clinical trial with blinded evaluators. (the evaluators will not know the group the patients are assigned. blinded evaluators are no responsible for randomization and intervention once the patients have been randomized). patients will be recruited from the cardiology inpatient unit of tertiary hospital, before discharge. patients will be divided in two groups randomly: in one arm will be held a double intervention: * a structured educational intervention oriented to the patient and primary caregiver, with respect to dietary habits, highly energetic and healthy food, the frequency and manner of eating, exercise and programming breaks. * supplementation with dietary supplements, distinguishing one type of product or another, depending on whether the subject to study: diabetes and or kidney failure. in the other arm of the study was carried out regular interventions

Eligibility criteria:
inclusion criteria: * adult patients with the diagnosis of heart failure: who inadvertently lost at least 5% of their "dry weight" in the last six months and / or moderately or severely malnourished according to the gsa and / or at risk or malnourished according to mini nutritional assessment. * willing to participate by accepting and signing an informed consent. * on treatment with inhibitors of angiotensin converting enzyme (ace) inhibitors and / or antagonists of angiotensin ii receptors (arbs) and / or beta blockers. exclusion criteria: * concurrent active cancer diagnosed. * previous history dementia or severe cognitive impairment. * participation in another clinical trial simultaneously. * social or health condition that makes the patient impossible to follow the treatment.

Keywords: nutritional status mna gsa
study of gonadotropin-releasing hormone pulse frequency in sexual maturation and in the menstrual cycle

Conditions: Hypogonadism; Precocious Puberty

Summary: objectives: i. evaluate the sleep-entrained patterns of gonadotropin-releasing hormone (gnrh) and sex steroid secretion in normal and hypogonadal children. ii. examine the acute effects of sex steroids on the sleep-entrained patterns of gnrh secretion in pubertal children and normal adults, either by stimulation of endogenous production with pulsatile injection or by intravenous infusion of gnrh. iii. examine the role of endogenous opioids by means of opioid receptor blockade in the sex steroid regulation of gnrh secretion in pubertal children and normal adults.

protocol outline: this project involves several clinical protocols that study the regulation and role of pulsatile gonadotropin-releasing hormone (gnrh) secretion. studies include dynamic and repeated stimulation tests of pulsatile gnrh; plasma luteinizing hormone, follicular-stimulating hormone, testosterone (t), estradiol (e2), and gnrh measurements at cyclic and episodic intervals; and evaluation of adrenal androgen patterns. circadian rhythms of gnrh secretion are monitored during sleep and awake hours. growth hormone secretory patterns and responses to provocative stimuli are studied as clinically indicated. selected participants undergo an assessment of pituitary responsiveness following t, e2, and/or naloxone infusions. the suppressive effects of e2 are also studied during the early follicular phase of the menstrual cycle. endocrinologically normal children and normal adult men and women are also studied.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * suspected or proven hypothalamic-pituitary-gonadal dysfunction, i.e.: significant short stature and possible hypopituitarism delayed adolescence precocious puberty isolated growth hormone deficiency (ighd)primary hypogonadism * women are also studied, including those with the following disorders: infertility oligo- or amenorrhea hirsutism --patient characteristics-- * age: 7 to 16 (18 to 35 for women and volunteers) * other: no pregnant or nursing women no prisoners not in neuropsychiatric institute or other facility for mental illness

Keywords: endocrine disorders growth hormone deficiency hypogonadism precocious puberty rare disease
a comparison of neurospan bridge, neuragen nerve guide, and nerve autograft for peripheral nerve repair

Conditions: Peripheral Nerve Injuries

Summary: this is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of auxilium's neurospan bridge.


Eligibility criteria:
inclusion criteria: 1. patients aged 18 to 80 with upper or lower extremity nerve injury with a gap of 0.5 to 3.0 cm. 2. nerve diameter at injury site ≤3mm. 3. nerve injury location is the arm from the shoulder to the wrist, including the hand or the leg from the hip to the ankle including the foot. 4. for motor nerve injuries: distance from site of injury to the nearest innervated muscle: ≤100mm 5. for sensory and mixed nerve injuries: distance from the site of injury to the nearest sensory nerve target: ≤250mm 6. repair must take place within 3 months from injury 7. no contraindications to surgical repair (e.g., risk of concurrent infection, dog bite) exclusion criteria: 1. previous history of nerve repair attempt at the treated nerve. 2. concurrent disease that reduces nerve regeneration: diabetes, previous diagnosis of non-traumatic peripheral neuropathy, chemotherapy treatment, other causes of peripheral neuropathy. 3. allergy to bovine products such as bovine collagen nerve cuff. 4. pregnancy or planning to become pregnant
integrative approaches for cancer survivorship 2: project 1

Conditions: Breast Cancer

Summary: the purpose of this study is to develop and test a 12-month integrative medicine intervention based on ayurvedic medicine in recent breast cancer survivors.

cancer associated symptoms and impaired quality of life remain significant problems for patients despite advances in cancer treatment. few effective treatment options exist for these symptoms. integrative medicine is rising in popularity in the united states; however, few integrative medicine modalities have been rigorously studied. ayurveda, a whole system of medicine that originated in the indian subcontinent, has its own system of diagnostics and therapeutics, and among its strengths are wellness and prevention. the investigators aim to perform a prospective single arm clinical study of a manualized ayurvedic approach in breast cancer survivors with impaired quality of life. specifically, the investigators aim to refine the manualized ayurvedic intervention; to assess feasibility; and to determine whether clinically meaningful effects can be achieved with the intervention.

Eligibility criteria:
inclusion criteria: * female breast cancer survivor who is over 1 month and less than 24 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy) * having received chemotherapy as part of their primary therapy for breast cancer * be in complete remission * aged 18 years or older * able to read, write, and understand english * karnofsky performance status (kps) greater than or equal to 60 * have impaired quality of life * ability to give informed consent exclusion criteria: * having received ayurvedic treatment within 6 months of study enrollment * receiving chemotherapy or radiotherapy at the time of study enrollment. anti-her2 directed therapy is not exclusionary. * being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). smaller surgical procedures such as implant exchange are not exclusionary. * patients on adjuvant hormone therapy for less than 2 months * have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. smaller surgical procedures such as implant exchange are not exclusionary.