Kornimate/medical-research-clean huggingface dataset:
effects of amps on cardiovascular variables in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: this study evaluates the addition of automated mechanical peripheral stimulation (amps) to physical exercise in the treatment of cardiovascular and motor disabilities in parkinson's patients. half of participants will receive amps and exercise, while the other half will receive a simulated session (sham) and exercise.

cardiovascular abnormalities are frequent in parkinson's disease (pd) even in the early stages. as consequence, patients may experience orthostatic hypotension and/or arterial hypertension in the supine posture, especially at night. thus, the management of dysautonomia in patients with pd is challenging. automated mechanical peripheral stimulation (amps) has been recently proposed as therapy for motor and cardiovascular improvements in patients with pd. on the other hand, physical exercise has been recommended for patients with pd showing to be effective in improving physical conditioning and cognitive function. however, the combined effects of amps and exercise on cardiovascular variables and functional capacity of patients with pd are still unknown. therefore, volunteers will be randomly allocated into two groups: 1) exercise group: will be submitted to a program of 24 exercise sessions, along with 2 weekly sessions of sham amps for 12 weeks. 2) amps groups: will be submitted to the program of 24 exercise sessions, along with 2 weekly sessions of amps during the same period. amps sessions will be held prior to exercise sessions. before and after the 12-week program, all volunteers will be submitted to assessments of cardiac autonomic control, timed up and go, and cardiopulmonary exercise testing to assess aerobic functional capacity. the hypothesis is that the exercise program combined with amps therapy will provide greater improvement on the cardiovascular function and aerobic functional capacity in patients with pd, than the exercise program alone.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of idiopathic parkinson's disease * scoring 1 to 3 on the hoehn and yhar scale * pharmacological treatment unchanged for at least 30 days prior the study exclusion criteria: * signs of cognitive decline, based on the results of the mini mental state examination * cardiorespiratory, neuromuscular and musculoskeletal diseases not related to pd * sensory peripheral neuropathy, diabetes or any other disease known to promote autonomic dysfunction * changes in pharmacological treatment after inclusion in the study
the effects of pancreatic enzyme supplementation in critically ill patients on enteral feeding

Conditions: Critically Ill; Enteral Feeding; Exocrine Pancreatic Insufficiency

Summary: determine the effect of high-dose pancreatic enzyme supplementation on nutritional indicators and clinical course in critically ill patients undergoing enteral nutrition.


Eligibility criteria:
inclusion criteria: * adults 19 years and older * hospitalized in the surgical/medical intensive care unit of the seoul national university hospital * enteral nutrition * patients who consented to this study * patients with risk factors for pancreatic exocrine dysfunction * shock (norepinephrine) * sepsis (3 rd definition of sepsis) * diabetes * cardiac arrest * hyperlactatemia serum lactate \> 2 mmol/l) * mechanical ventilation * continuous renal replacement therapy exclusion criteria: * chronic pancreatitis * unresectable pancreatic cancer * history of pancreatectomy * underlying diseases in which the effect of exocrine pancreatic enzyme administration is difficult to show * inflammatory bowel disease * short bowel syndrome
safety and efficacy of mometasone furoate nasal spray with the addition of loratadine versus placebo in participants with seasonal allergic rhinitis (c94-145)

Conditions: Rhinitis, Allergic

Summary: the purpose of this study is to evaluate the safety and efficacy of mometasone furoate nasal spray (mfns) with the addition of loratadine vs mfns alone, loratadine alone, or placebo, in the treatment of patients with seasonal allergic rhinitis.


Eligibility criteria:
inclusion criteria: * 2-year history of seasonal allergic rhinitis * positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year) * good health and free of any unstable, clinically significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis exclusion criteria: * women who are pregnant or breastfeeding * women of childbearing potential who are not using an acceptable form of birth control * significant history of metabolic, cardiovascular, neurologic, hematologic, hepatic, gastrointestinal, cerebrovascular, respiratory, or renal disease, or any other disorder which, in the judgment of the investigator, could interfere with the study, or require treatment which might interfere with the study * use of any chronic medication which could affect the course of seasonal allergic rhinitis * asthma requiring chronic use of inhaled or systemic corticosteroids (inhaled bronchodilators are permitted for asthma treatment) * current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip * upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks, or a viral upper respiratory infection (uri) within the 7 days prior to screening * dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator * has rhinitis medicamentosa * evidence of clinically significant nasal candidiasis * investigational drug use within the previous 30 days * nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow * immunotherapy (desensitization therapy), unless on a stable maintenance schedule for at least one month prior to the screening visit * history of multiple drug allergies, allergy to antihistamines or corticoids * history of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study
assessment of the effectivity of total-face mask for noninvasive ventilation during acute respiratory failure

Conditions: Respiratory Insufficiency

Summary: total-face mask may improve the efficacy of niv compared to conventional face mask in patients with acute respiratory failure due to enhanced tolerance and the allowance of higher airway pressure without massive leaks.main objective: to assess, in acute respiratory failure patients, whether the total-face mask reduce the intubation rate. methods: 300 patients admitted in the icu for acute respiratory failure needing continuous noninvasive mechanical ventilation. the type of mask (total-face vs. conventional face mask) will be randomized. defined failure criteria and weaning technique will be used.

hypotesis: total-face mask may improve the efficacy of niv compared to conventional face mask in patients with acute respiratory failure due to enhanced tolerance and the allowance of higher airway pressure without massive leaks.objectives: to assess, in acute respiratory failure patients, whether the total-face mask reduce the intubation rate. additionally, whether it may improve mask tolerance, skin pressure damage, number of patients receiving higher pressures, or even a reduction in mortality. methods: 300 patients admitted in the icu for acute respiratory failure needing continuous noninvasive mechanical ventilation. the type of mask (total-face vs. conventional face mask) will be randomized. peep will be titrated to the best oxygenation and ipap up to reduce dyspnea and respiratory frequency, with the limits at clinical tolerance and massive leaks. defined failure criteria and weaning technique will be used. data to record include clinical parameters and mortality risk score (saps ii), and physiologic response to niv (either subjective and objective), technique failures and outcome. expected results: the study has been powered to detect a 30% relative improvement in intubation rate from a 35% baseline incidence of intubation in the conventional group.

Eligibility criteria:
inclusion criteria: * acute hypoxemia:pao2/fio2 lower than 200 mmhg * respiratory rate greater than 30 breaths/min exclusion criteria: * cardiogenic lung edema * copd exacerbation * low level of consciousness (gcs \< 13) * hemodynamic instability * facial damage * do-not-intubate orders * lack of informed consent

Keywords: noninvasive mechanical ventilation acute respiratory failure intubation
an observational study of herceptin sc safety in breast cancer

Conditions: Breast Cancer

Summary: this is a phase iv, prospective, multicenter, observational study (regulatory post-marketing surveillance) in approximately 600 patients who are to receive herceptin sc (trastuzumab, subcutaneous administration) per approved local labeling. patients will be under observation according to standard of care in korea.


Eligibility criteria:
inclusion criteria: - all patients administered herceptin sc for the locally approved indications exclusion criteria: n/a
trial of the safety, transmissibility, and phenotypic and genotypic stability of influenza virus vaccine,(caiv-t), in children who attend day care. (final report version 2.0)

Conditions: Influenza

Summary: to assess whether caiv-t was transmitted from vaccinated children to their unvaccinated contacts in a day care setting; and if so, to estimate the rate of transmission.


Eligibility criteria:
inclusion criteria: * who were at least 8 months and less than 36 months of age (had not reached their 3rd birthday) at the time of enrollment, and in good health as determined by medical history, physical examination, and clinical judgment; * whose parent or legal guardian had provided written informed consent after the nature of the study had been explained; * who, along with their parent or legal guardian, were available for the duration of the study (42 days post-vaccination of first study dose or 42 days post-vaccination of supplemental dose of caiv-t); * whose parent/legal guardian could be reached by telephone by study staff for the postimmunization contacts; * who attended day care at least three days per week and four hours per day; * who was one of at least 4 children in a contact group/playroom (at least 4 children in such a group were required to be randomized in the study). exclusion criteria: * whose parents or legal guardians were perceived to be unreliable or unavailable for evaluation or study visits during the study period; * with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease and asthma; * with down's syndrome or other known cytogenetic disorders; * with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; * who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study; * for whom there was intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study; * with an immunosuppressed or compromised individual in the same playroom or living in the same household; * who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational); * with a documented history of hypersensitivity to egg or egg protein; * with a respiratory illness with wheezing within two weeks prior to enrollment; * who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for whom use was anticipated during the study; * who were administered any live virus vaccine within one month prior to enrollment or expected receipt of another live virus vaccine within one month of vaccination in this study; * who were administered any inactivated vaccine within two weeks prior to enrollment or expected receipt of another inactivated vaccine within three weeks of vaccination in this study; * with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results.
temozolomide & rt followed by dose dense vs temozolomide & retinoic acid in pts w/glioblastoma

Conditions: Glioblastoma; Gliomas

Summary: patients have a newly diagnosed brain tumor called a malignant glioma and participate in the study to see if it is possible to increase the benefit of temozolomide when given after radiation. a recent study showed that patients with newly diagnosed glioblastoma lived longer when treated with both temozolomide and radiotherapy followed by 6 months of temozolomide than patients treated with radiotherapy alone. patients will receive standard low dose temozolomide during radiation. after radiation, they will be randomized to receive either more intense temozolomide or continuous low dose temozolomide.

this is a randomized phase ii study that will test two different adjuvant temozolomide regimens in patients with newly diagnosed glioblastoma multiforme. the goal of this study is to identify a regimen that would be appropriate to bring to a phase iii trial and compare to the standard dosing regimen of temozolomide recently reported by stupp et al. in the new england journal of medicine. secondary goals of this study include: prospective analysis of the prognostic impact of mgmt status and generation of preliminary data regarding this treatment strategy for other types of malignant glioma. the decision regarding which treatment patients receive is made randomly. neither them or their doctor can select which treatment the patient will receive. there is reason to believe that both of these doses may benefit treating your brain tumor. after 6 months of chemotherapy, and assuming the brain tumor has not shown any sign of growth, they will begin receiving cis-retinoic acid. cis retinoic acid has been shown in one study to possibly prevent or delay tumor recurrence.

Eligibility criteria:
inclusion criteria: * pathologic evidence of a malignant glioma. * tissue block or unstained slides must be available for mgmt analysis. * age 18-70 * kps \> 50 * granulocyte count \>1.5 x 109/l * platelet count \>99 x 109/l * sgot \< 2.5x upper limit of normal (uln). * serum creatinine \< 2x uln. * bilirubin \< 2x uln. * all patients must sign written informed consent. exclusion criteria: * any prior chemotherapy, radiotherapy and biologic therapy for glioma. * any prior experimental therapy for glioma. * other concurrent active malignancy (with the exception of cervical carcinoma in situ or basal cell ca of the skin). * serious medical or psychiatric illness that would in the opinion of the investigator would interfere with the prescribed treatment. * pregnant or breast feeding women. * refusal to use effective contraception.
music to reduce use of smoking in patients with schizophrenia

Conditions: Schizophrenia; Nicotine Dependence; Smoking, Tobacco

Summary: the purpose of this study is to explore the impact of self-selected music listening which targets disrupting the reward process maintaining smoking and additionally attenuating the reward processing deficits associated with schizophrenia. five participants with schizophrenia/schizoaffective disorder who smoke/nicotine will participate in an individual session of self-selected music listening for a half an hour.


Eligibility criteria:
inclusion criteria: * clinician verification diagnosis of schizophrenia or schizoaffective disorder * smoked at least 10 cigarettes per day for the past month * score of 4 or more on the fagerstrom test for nicotine dependence73 * psychiatric stability (e.g., no psychiatric hospitalizations within the last year, no expectation for medication change during study participation, no active suicidal ideation, no symptoms that interfere with ability to participate in study activities) * the capacity to participate in the informed consent process exclusion criteria: * being medically unstable (e.g., medical condition that requires frequent medical appointments or hospitalizations and interferes with ability to participate in study activities) * report active substance abuse or testing positive drug or alcohol use * taking bupropion, varenicline, nicotine replacement products and/or involved in any other smoking cessation treatment * participating in any treatment or activity that includes music as a focus * having a seizure disorder, other neurological illnesses, or a family history of seizures

Keywords: schizophrenia
investigation of a smart probe for lung lesion characterization using impedance technology

Conditions: Lung Cancer

Summary: the objective of the study is to evaluate the feasibility of the biospy system sensor to differentiate tissues that are encountered during bronchoscopic biopsy of endobronchial tumors and peripheral lung nodules and masses.

participants in this study require a lung biopsy to confirm if they have a lung tumour. a biopsy is a procedure where a piece of lung tissue is removed for testing. current biopsy techniques cannot guarantee the exact location of lung tumours, so biopsies can be taken from healthy tissue. the biospy system (bss) is a device with a probe, which is placed inside a normal biopsy needle. the tip of the probe contains sensors, that will scan the composition of the tissue which is in contact with the sensors. the inspect study aims at collecting the sensor data, with the goal of being able to differentiate the different tissues. all study participants will have a biopsy with the bss. participants will have a hospital visit for the procedure, and will have to stay up to 16 hours after their procedure as per normal hospital practice.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. subjects with lesions eligible for lung biopsy under general anesthesia. 3. lesion localization: 1. central or proximal lesions ≥ 10 mm in diameter confirmed by imaging (ct scan and/or pet scan) and/or endobronchial visual control; or 2. peripheral lesions ≥ 20 mm in diameter confirmed by imaging (ct scan and/or pet scan) and/or ultrasound analysis (rp ebus with central localization of the ultrasound probe) during the procedure. 4. written informed consent to participate in the study. exclusion criteria: 1. target lesion \<10 mm for central and \<20 mm for peripheral lesions (as determined on previous imaging) 2. contra-indication to bronchoscopy procedures 3. contra-indication to general anesthesia 4. any subject that is, according to the discretion of the investigator, not eligible for study participation 5. known lactating or confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)

Keywords: lung cancer lung masses lung nodes bronchoscopic biopsy
model 4968 capture epi® steriod-eluting bipolar epicardial pacing lead post-approval study

Conditions: Arrhythmia; Heart Failure

Summary: the medtronic capsure epi lead post-approval study will assess long-term safety of the 4968 lead. this study is part of the medtronic system longevity study.

the medtronic capsure epi lead post-approval study is being conducted as part of the requirements to satisfy the pma conditions of approval for the model 4968 lead. 100 subjects (adult and pediatric) with a 4968 lead will be followed for a minimum of five years to assess the long-term safety of the leads.

Eligibility criteria:
inclusion criteria: * provision of written informed consent and/or authorization for access to and use of health information by subjects or appropriate legal guardians as required by an institution's investigational review board, medical ethics board, or research ethics board * availability of implant, follow-up, and product-related event data * implanted with a model 4968 capsure epi lead exclusion criteria: * subjects receiving an implant of a medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant * subjects who are, or will be inaccessible for follow-up at a 4968 post-approval study center * subjects implanted with a medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded * subjects with exclusion criteria required by local law

Keywords: epicardial pacing lead
mk-1006 single dose study in japanese type 2 diabetes patients (mk-1006-005)

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: a single rising dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of mk-1006 in japanese participants with type 2 diabetes mellitus (t2dm). the primary hypothesis of the study is that single doses of mk-1006 will be sufficiently safe and well tolerated, based on the assessment of clinical and laboratory evaluations and adverse experiences, in japanese participants with t2dm.


Eligibility criteria:
inclusion criteria: * japanese male or female between 20 to 64 years of age * diagnosis of type 2 diabetes * patient is being treated with diet and exercise alone or single oral anti-hyperglycemic agent exclusion criteria: * subject has a history of type 1 diabetes mellitus * subject has a clinical diagnosis of glaucoma * subject has donated blood or participated in another clinical study in the past 12 weeks * subject is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months