Kornimate/medical-research-clean huggingface dataset:
feasibility of lifestyle intervention in brca1/2 mutation carriers

Conditions: Hereditary Breast and Ovarian Cancer

Summary: brca1/2 mutation carriers have a considerably increased risk to develop breast and ovarian cancer during their lifetime. there is evidence from the literature that for sporadic breast cancer disease risk and the course of disease can be significantly influenced by physical activity, nutrition and weight. the hypothesis of this 3 year, prospective randomized multicenter feasibility trial is that a structured life-style intervention program with exercise training and mediterranean diet is feasible and improves the nutritional and fitness status as well as the weight, the quality of life and stress reacting capacity.


Eligibility criteria:
inclusion criteria: * women with proven pathogenic brca1/2 mutation exclusion criteria: * metastatic tumor disease * life expectancy \<3 years * clinically limiting cardiovascular or respiratory disease * significant orthopedic disability which prevents from participating in the exercise training * severe concomitant disease which prevents from participating in the group interventions * karnofsky index \<60 * vo2max \>150% * maximal exercise capacity \< 50 w * food allergies which prevent from mediterranean diet * vegan diet * body mass index \<15 kg/m2 * pregnancy * insufficient knowledge of german language * insufficient compliance * active participation in other interventional trials * no informed consent

Keywords: hereditary breast and ovarian cancer (hboc) brca1/2 mutation carriers mediterranean diet structured exercise training prevention
correlation between non-motor symptoms and malnutrition in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: this study used mini nutrition assessment (mna) , nutrition risk screening 2002(nrs-2002) and non-motor symptom quest (nmsquest) to investigate the nutritional status of patients with parkinson's disease, to analyze the correlation between non-motor symptoms and malnutrition in patients with parkinson's disease (pd) , and to provide evidence for clinical treatment and early nutritional intervention.

data were collected by questionnaire survey.for arkinson patients who were admitted to the facility between june 2020 and july 2021 were targeted. this study used convenience sampling and included criteria: length of stay \> 24 hours; parkinson patients who met chinese diagnostic criteria for parkinson's disease (2016 edition) ; willing participants and able to complete the scale. exclusion criteria: parkinsonism caused by cerebrovascular disease, encephalitis, traumatic brain injury, complete transfusion of blood, plasma, albumin within one month, severe gastrointestinal disease, metabolic disease, and other wasting diseases; patients with critical illness, severe cognitive impairment, and inability to communicate. the study was approved by the medical ethics committee with the informed consent of all selected individuals and their families

Eligibility criteria:
inclusion criteria: * length of stay \> 24 hours; parkinson patients who met chinese diagnostic criteria for parkinson's disease (2016 edition) ; willing to participate in the study and able to complete the scale. exclusion criteria: * parkinson's disease caused by cerebrovascular disease, encephalitis, traumatic brain injury; patients who have received whole blood, plasma, albumin within one month; patients with severe gastrointestinal disease, metabolic disease and other wasting diseases; patients with critical illness, severe cognitive impairment, and inability to communicate.

Keywords: parkinson disease
group therapy for primary breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine whether women with primary breast cancer who were randomly assigned to receive a brief group therapy would show a greater reduction in mood disturbance over time compared to those randomized to the control condition. we also hypothesized that women who were highly distressed at baseline would show the greatest benefit from participating in a support group, and that therapists with more training and experience would be most effective in reducing distress.

breast cancer patients often experience significant psychological distress after diagnosis and during initial treatment. group interventions for cancer patients have been shown to improve psychological adjustment. the tests of efficacy for these interventions have typically taken place in university settings using highly developed models of intervention. our aim was to test our supportive-expressive model in community oncology practices utilizing personnel already working with these populations. to conduct this study of group therapy for primary breast cancer patients, we developed a brief version of the supportive-expressive model (classen et al., 1993). our first aim was to test the efficacy of this intervention for reducing mood disturbance for women who received the intervention compared to a control group. a second aim was to examine who was most likely to benefit from the intervention. a third aim was to see if this method could be taught efficiently and effectively to oncology nurses and mental health professionals.

Eligibility criteria:
inclusion criteria: * : 1) diagnosis of primary, biopsy-proven breast cancer, stages i through iiia; 2) diagnosis occurred no more than 12 months prior to recruitment; 3) completion of initial surgical treatment; and 4) no detectable disease present. exclusion criteria: * 1) evidence of metastases beyond adjacent lymph nodes, including chest wall involvement, bone or viscera; 2) recurrence of the cancer prior to randomization; 3) diagnosis of other cancers (except for basal cell or squamous cell carcinoma of the skin or in situ cervical cancer) within the past 10 years; 4) any other major medical problems likely to limit life expectancy to less than 10 years; 5) a history of major psychiatric illness for which the patient was hospitalized or medicated, except for a diagnosis of depression or anxiety treated for a period of less than one year; and 6) attendance at a cancer support group for more than two months.

Keywords: primary breast cancer support groups mood disturbance
study of ca-008 (vocacapsaicin) in bunionectomy patients

Conditions: Post-surgical Pain

Summary: this is a phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating a single dose of one of three ca-008 dose levels vs. placebo injected during an elective bunionectomy bunionectomy to assess post-surgical pain management and the need for rescue medication (oxycodone).

primary objective: to evaluate the efficacy of a single intraoperative administration of ca- 008 vs placebo in subjects undergoing an elective bunionectomy . secondary objectives * to evaluate the safety and tolerability of a single intraoperative administration of ca-008 vs. placebo in subjects undergoing an elective bunionectomy. * to evaluate the pk profile of a single intraoperative administration of ca-008 vs. placebo in subjects undergoing an elective bunionectomy . * to explore the efficacy of various doses of ca-008 administered intraoperatively in subjects undergoing an elective bunionectomy .

Eligibility criteria:
inclusion criteria: 1. healthy adult aged 18 - 75 years old 2. american society of anesthesiology (asa) physical class 1, 2 or 3 3. planning elective bunionectomy repair 4. for both males and females: using an acceptable method of birth control 5. if a female: not pregnant or breastfeeding 6. have a body mass index ≤ 40 kg/m2. 7. be willing and able to sign the informed consent form (icf) 8. be able to complete study procedures and pain scales and to communicate meaningfully in english 9. be willing to undergo 17 blood draws for pharmacokinetic (pk )assessments over 24 hours exclusion criteria: 1. have another painful condition, other than bunion-related pain, that may require pain treatment during the study period 2. have active skin disease or another abnormality at the anticipated site of surgery that could interfere with the planned surgery. 3. have a known allergy to chili peppers, capsaicin or the components of ca-008, bupivacaine hcl, ketorolac, acetaminophen or oxycodone. 4. have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values 5. be on any medication not allowed per the protocol 6. within the past year have a history of illicit drug use or prescription medicine or alcohol abuse 7. have positive results on the alcohol test (breath or saliva) or urine drug screen 8. have previously participated in a clinical study with ca-008. 9. have participated in another clinical trial or used an investigational product within 30 days or five half-lives (whichever is longer)
the articulated oral airway as an aid to mask ventilation

Conditions: Mask Ventilation; Airway Obstruction Upper; Airway Management

Summary: the articulating oral airway (aoa) is a novel oral airway which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. the investigators hypothesize that, in patients with predictors for difficult mask ventilation, the aoa will be non-inferior to the geudel oral airway in terms of expired tidal volumes.

difficult mask ventilation (mv) is common in the obese population and can result in patient morbidity and mortality. the articulating oral airway (aoa) is a novel oral airway which actively displaces the tongue, allowing for a greater cross-sectional area for mv. the investigators hypothesize that, while using the same ventilatory pressure in neuromuscularly blocked patients with predictors for difficult mask ventilation, mv with an aoa will not result in smaller expired tidal volumes than mv with a similarly sized guedel oral airway (gda). in other words, the aoa will be non-inferior to the gda in terms of expired tidal volumes.

Eligibility criteria:
inclusion criteria: * individuals demonstrating 2 or greater predictors of difficult mask ventilation (as listed below) who are scheduled for elective surgery with general anesthesia and asleep mask ventilation/orotracheal intubation utilizing long-acting neuromuscular blockade. * predictors of difficult mask ventilation i) age \> 55 years ii) bmi \> 30kg/m2 iii) beard iv) lack of teeth v) history of snoring exclusion criteria: * documented history of impossible mask ventilation * planned omission of mask ventilation ('rapid-sequence induction,' etc.) * planned omission of long-acting paralytics * need for awake airway management * need for emergent airway protection * presence of oropharyngeal anatomic abnormalities * distance from the maxillary incisors to the angle of the mandible \<11cm * \<18 years of age * known pregnant state * current incarceration * refusal to be involved in the study

Keywords: morbid obesity obstructive sleep apnea mask ventilation upper airway obstruction
ablation confirmation study

Conditions: Cancer of the Liver; Liver Cancer; Neoplasms, Liver

Summary: prospective, single-arm, multicenter study that will generate clinical data using the neuwave microwave ablation system with ac (ablation confirmation) software in patients undergoing ablation of a soft tissue liver lesion.

prospective, single-arm, multicenter study that will generate clinical data on 100 adult patients using the neuwave microwave ablation system with ac (ablation confirmation) software in patients undergoing ablation of a soft tissue liver lesion. ac software is a computed tomography (ct) image processing software package available as an optional feature for use with the neuwave microwave ablation system. ac imports images from ct scanners for display and processing during ablation procedures to assist physicians in identifying ablation targets, assessing optimal ablation probe placement, and confirming the adequacy of the ablation margin. all ablations will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.

Eligibility criteria:
inclusion criteria: 1. a patient with at least one soft-tissue liver lesion less than or equal to 5cm undergoing microwave ablation using the neuwave microwave ablation system. note: a patient cannot have more than 3 lesions ablated during the procedure. 2. intent to use ablation confirmation software (any ac software version permitted) during the ablation procedure. 3. written informed consent to voluntarily participate in the study, follow ct scan schedule, and authorize the transfer of his/her data to the sponsor 4. patients greater than or equal to 22 years of age 5. performance status 0-2 (eastern cooperative oncology group \[ecog\]) classification 6. class a or b functional hepatic reserve based on the child-pugh score. 7. lesion must be visualized by non-contrast enhanced ct scan or the patient must tolerate contrast and meet institutional guidelines for contrast use based on glomerular filtration rate (gfr). exclusion criteria: 1. active bacterial infection or fungal infection on the day of the ablation. 2. patients with implantable pacemakers or other electronic implants. 3. platelet count less than 50,000/mm cubed. 4. patients with uncorrectable coagulopathy at the time of ablation. 5. currently breastfeeding or pregnant (latter confirmed by serum pregnancy test, per site's soc). 6. physical or psychological condition which would impair study participation. 7. asa (american society of anesthesiologists) score of great or equal to 4. 8. use of hydrodissection. 9. systemic chemotherapy or radiation therapy for the liver, within 30 days prior to the study ablation procedure. 10. inr greater than 1.8. 11. patient has participated in an investigational clinical study within 30 days of the screening visit for this study. 12. patient judged unsuitable for study participation by the performing physician for any other reason.
non-invasive hemodynamic monitoring of mv ild patients with arf

Conditions: Interstitial Lung Disease (ILD)

Summary: non-invasive hemodynamic monitoring of interstitial lung disease (ild) patients admitted to respiratory icu with acute respiratory failure and differentiate according to different modes of mechanical ventilation.


Eligibility criteria:
inclusion criteria: * interstitial lung disease patients with acute respiratory failure admitted to respiratory icu in different modes of mv (niv, invasive mv and hvni). exclusion criteria: -

Keywords: ild mv non-invasive hemodynamic monitoring
vibrotactile coordinated reset for the treatment of post surgery refractory parkinson's disease patients

Conditions: Parkinson Disease

Summary: the purpose of our study is to evaluate vibrotactile coordinated reset stimulation (vcr) and its effects on refractory post-surgery pd. vcr will be administered with a device called the stanford glove. vcr is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. patients will be followed for two years.


Eligibility criteria:
inclusion criteria: 1. age at the time of enrollment: 35 - 92 years 2. diagnosis of idiopathic parkinson's disease 3. surgical treatment for parkinson's disease that does not involve deep brain stimulation 4. fluent in english 5. appropriate social support if required during an off state. 6. comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes. 7. lives in the united states exclusion criteria: 1. any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies 2. any current drug or alcohol abuse. 3. participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. any other trial participation should be approved by the principal investigators. 4. pregnancy, breast-feeding or wanting to become pregnant 5. patient is unable to communicate properly with staff (i.e., severe speech problems) 6. excessive drooling 7. sensory abnormalities of the fingertips 8. deep brain stimulation treatment 9. pd symptoms so severe and that the patient is bed-bound
phase ii study of amithiozone (thiacetazone) for patients with mycobacterium avium complex pulmonary disease

Conditions: Mycobacterium Avium-intracellulare Infection

Summary: objectives: i. determine the bacteriological activity of amithiozone against mycobacterium avium complex (mac) pulmonary disease. ii. define the ability of amithiozone to improve clinical outcomes in patients with mac infection. iii. determine the safety and tolerance of amithiozone with chronic dosing in these patients. iv. assess the contribution of clarithromycin, streptomycin, rifampin, ethambutol, kanamycin, and amithiozone in the treatment of pulmonary mac infection.

protocol outline: the is a randomized, open label study. all patients receive a core regimen of clarithromycin and streptomycin. patients are randomized into two treatment arms. arm i patients receive rifampin and ethambutol. arm ii patients receive amithiozone. patients are followed for one year to detect any relapse or other complications. patients not eligible for this randomized study may be entered on a short open label study with amithiozone. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * progressive pulmonary disease due to mycobacterium avium complex (mac) as defined by: three of more sputum culture(s) positive for mac change in serial chest roentgenograms consistent with active mycobacterial disease over a 12 week period no other obvious cause of pulmonary disease * patients must have organisms that are: susceptible to amithiozone and susceptible or moderately susceptible to the combination of rifampin and ethambutol, and to clarithromycin and streptomycin --prior/concurrent therapy-- * no likelihood of resectional thoracic surgery within 24 weeks of evaluation --patient characteristics-- * age: 18 and over * performance status: not specified * hematopoietic: not specified * hepatic: bilirubin less than 3 times normal sgot/sgpt less than 3 times normal alkaline phosphatase less than 3 times normal * renal: creatinine clearance at least 30 ml/min * cardiovascular: no new york heart association class iii or iv heart failure * other: no optic disease that precludes the use of ethambutol no hypersensitivity to rifampin, ethambutol, clarithromycin, streptomycin, or amithiozone hiv negative not pregnant or nursing

Keywords: bacterial infection immunologic disorders and infectious disorders mycobacterium avium infection mycobacterium infection rare disease
topiramate versus placebo as add-on treatment in patients with bipolar disorder in the outpatient setting

Conditions: Bipolar Disorder

Summary: the purpose of this study is to assess the efficacy and safety of adding topiramate as compared to placebo to the medications a patient with bipolar disorder is already taking (lithium or valproate) to see if adding topiramate will better control the patient's manic symptoms.

many patients with bipolar disorder (manic-depressive illness) require more than one medication to control their symptoms. this is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-groupd study to evalute the efficacy and safety of topiramate versus placebo as add-on therapy to lithium or valproate for the treatment of bipolar 1 disorder as an outpatient setting. these patients must already be taking either lithium or valproate for at least 6 weeks before the first visit and have been on the same dose of the mood stabilizer for at least 2 weeks before the first visit. paitents will be randomized to receive either placebo or topiramate, an anti-seizure medication not approved for the treatment of bipolar disorder, in addition to their lithium or valporate. the study consists of 56-day titration (topiramate will be titrated up to 400mg per day or the maximum tolerated dose), 28-day continuation period, and 7 days of follow-up to taper off the medication. the study hypothesis is that topiramate will be more effective than placebo in the treatment of mania in type 1 bipolar disorder patients as measured by the young mania rating scale (ymrs) and will be well tolerated. ymrs is a questionnaire consisting of 11 items designed to assess severity of mania symptoms. patients will start taking topiramate 25 mg per day or placebo by mouth. over the next 8 weeks, doses will be increased to up to 400 mg per day or to the maximum tolerated dose, whichever is lower. after the first 8 weeks, patients will stay at the established dose for the next 4 weeks.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of bipolar disorder type i * total young mania rating scale (ymrs) score of 18 or higher * currently being treated with a mood stabilizer (lithium or valproate) * having a stable therapeutic dose of the mood stabilizer in their bloodstream * currently not requiring hospitalization exclusion criteria: * patients taking an antidepressant or anti-seizure medication * hospitalized paitents * women who are pregnant or breast-feeding * women who are not using birth control * patients with history of drug or alcohol abuse

Keywords: manic depression mania depression bipolar disorder psychosis
improving bone health among rheumatoid arthritis (ra) patients on chronic glucocorticoids

Conditions: Adverse Effect of Glucocorticoids and Synthetic Analogues; Osteoporosis; Rheumatoid Arthritis

Summary: this quality improvement project is aimed at improving health care by identifying low cost strategies to get rheumatoid arthritis (ra) patients to more effectively communicate with their physicians about osteoporosis prevention and treatment (improving doctor-patient communication). the investigators will implement a direct to patient intervention to the population of interest (patients on chronic glucocorticoids) via story-telling, using an internet based video. the target audience is people on chronic glucocorticoids not already receiving bones-specific osteoporosis medications to determine differences in post-intervention rates of osteoporosis care, and the rates of prescription anti-osteoporosis therapies.


Eligibility criteria:
inclusion criteria: * greater than or equal to 5 milligrams of prednisone or glucocorticoid dose equivalent for greater than or equal to 90 days within the previous 12 months * medco member for entire study period * refill steroid prescription online exclusion criteria: * anti-osteoporosis medication in previous 12 months