Kornimate/medical-research-clean huggingface dataset:
a study of tak-341 in treatment of multiple system atrophy

Conditions: Multiple System Atrophy

Summary: the main aim is to see how tak-341 works after 52 weeks in participants with multiple system atrophy as measured by the unified multiple system atrophy rating scale part i (umsars). the study will enroll approximately 138 patients. participants will receive a total of 13 intravenous infusions every 4 weeks approximately, these may be either of tak-341 or placebo, after each infusion some blood samplings will be taken and other assessments completed. this trial will be conducted in north america, europe and asia.

the drug being tested in this study is called tak-341. the study will evaluate the efficacy, safety, tolerability, pharmacokinetics (pk), and pharmacodynamics of intravenous (iv) tak-341 in participants with multiple system atrophy (msa). the study will enroll approximately 138 participants. the study comprises a screening period of up to 42 days (6 weeks), a 52-week double-blind treatment period, and a follow-up safety visit. participants will be randomly assigned (by chance, like flipping a coin) to one of the treatment schedules-which will remain undisclosed to the participant, care provider and investigator during the study: * early pk cohort: tak-341 * early pk cohort: placebo * main cohort: tak-341 * main cohort: placebo the change from baseline in umsars will be measured at week 52 post-dose. this multi-center trial will be conducted worldwide. the duration of treatment in this study will be 52 weeks. participants will make a follow-up visit to the site after approximately 90 days after the last dose of study treatment.

Eligibility criteria:
inclusion criteria: diagnostic: 1. the participant has a diagnosis of possible or probable msa using the modified gilman et al, 2008 diagnostic criteria. 2. the participant's onset of first msa symptoms occurred ≤4 years before screening, as assessed by the investigator. 3. evidence of msa specific symptoms and deficits as measured by the umsars scale. exclusion criteria: medical history: 1. the participant has any contraindication to study procedures. diagnostic assessments: 1. presence of confounding diagnosis and/or conditions that could affect participant's safety during the study per investigator judgement. 2. the participant's participation in a previous study of a disease-modifying therapy (with proven receipt of active treatment) will compromise the interpretability of the data from the present study, per consultation with medical monitor or designee. other: 1. the participant has participated in another study investigating active or passive immunization against α-synuclein (αsyn) for progressive disease (pd) or msa, or has had immunoglobulin g therapy, within 6 months before screening.

Keywords: drug therapy
applying the spanish version of the up-a as a universal school-based anxiety and depression prevention program

Conditions: Anxiety; Depression

Summary: the current study proposes to extend transdiagnostic treatment research to adolescents by establishing initial pre to post-treatment and follow-up outcomes associated with the use of the spanish version of the unified protocol for the treatment of emotional disorders in adolescents (up-a; ehrenreich-may, bilek, buzzella, kennedy, mash, \& bennett, 2016) as a universal school-based preventive intervention.

the study has the primary aim to examine whether a transdiagnostic cbt intervention adapted as a school-based universal preventive intervention and delivered by professionals is more effective than the usual school curriculum in: (1) reducing symptoms of anxiety and depression and (2) preventing high levels of anxiety and depression from developing in 13-18 years old adolescents. the study has the following secondary aims: (1) examine the reduction in negative affect, anxiety sensitivity, emotional avoidance and emotional symptoms' interference levels at post-treatment as compared to pre-treatment levels; (3) examine the improvement in positive affect, self-esteem, satisfaction with life, quality of life, school adjustment, and general indiscipline at post-treatment as compared to pre-treatment levels; (4) examine the moderating role of gender, age, social economic status, personality traits, conduct problems, hyperactivity/inattention, and peer problems on the effectiveness of the up-a program; (5) assess the moderating role of home practice, understanding of basic concepts of the program, number of sessions attended, practice of specific strategies and behavior during sessions (6) examine if the effects at post-treatment are maintained at the 3 month follow up; (7) assess the feasibility and acceptability of implementing up-a in a group format and in a school setting.

Eligibility criteria:
inclusion criteria: * providing written, informed consent (both the adolescent and at least one of the parents or legal tutors) * being able to understand, write and read spanish exclusion criteria: * no other exclusion criteria because of being an universal prevention study
flotrac/vigileo in acute circulatory failure

Conditions: Critically Ill; Acute Circulatory Failure; Fluid Loading

Summary: acute circulatory failure may be related to hypovolemia. fluid loading increases stroke volume in approximatively half of challenges. determining fluid responsiveness prevents unnecessary fluid loading. passive leg raising (plr) provides a transient increase of 300 ml in venous return for a short time. the measurement of stroke volume (sv) before and after a plr test allows physician to detect fluid responsiveness, when stroke volume increases is higher than 15 %. beside thermodilution, the use of non invasive device to measure stroke volume becomes largely employed. arterial pressure based cardiac output (apco), provided by the flotrac/vigileo system, does not required specific materials nor repeated calibration. the third generation software is believed to be more accurate and more precise for sv measurement. the aim of this study is to test the performance of the flotrac/vigileo device in a situation of rapid venous return changes induced by plr and then by fluid loading. patients will be classify posteriorly in responders and non responders, according to the magnitude of the fluid loading-induced sv changes measured by transthoracic echocardiography.


Eligibility criteria:
inclusion criteria: * systolic arterial pressure \< 90 mmhg or mean arterial pressure \< 60 mmhg * heart rate \> 100 bpm * norepinephrine infusion * urine output \< 0.5 ml/kg/h during at least two consecutive hours * skin mottling * capillary refill time \> 3 sec exclusion criteria: * acute cor pulmonale * ongoing renal replacement therapy * lack of echogenicity during transthoracic echocardiography

Keywords: critically ill patient
clinical epidemiology of asthma in an hmo

Conditions: Asthma; Lung Diseases

Summary: to provide information on morbidity and health care utilization for asthma for a large, well-defined population over a 20 year period.

background: asthma is the second most common chronic respiratory disorder seen by physicians in outpatients, and in 1988 was estimated to be the primary or secondary cause of 9.3 percent of all physician office visits for ambulatory medical care in the united states. reports citing increased asthma morbidity and mortality in this country and abroad have intensified interest in this disorder. investigations into possible explanations for these increases, however, have been hampered by the lack of good longitudinal data on the incidence, prevalence, and health care utilization associated with asthma, and by the lack of generally accepted diagnostic criteria for defining the disease. design narrative: use of the kaiser-permanente northwest region data base allowed an examination of the secular trends in the prevalence and incidence of physician-diagnosed asthma and asthma-like disorders in inpatient and outpatient populations over a 20 year period, health care utilization and temporal changes in utilization patterns for asthma, and the natural history of asthma in selected subpopulations. demographic factors examined were limited to age and sex. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
3dcrt vs. imrt in early breast cancer

Conditions: Radiation Toxicity

Summary: it has been not clinically determined whether tomodirect was dosimetrically better than 3d-crt for asian patients with early breast cancer. therefore, the objective of this study was to compare dosimetric parameters of tomodirect and 3d-crt in early breast cancer patients of an asian cohort.

in breast cancer patients, helical tomotherapy is not a suitable option since the gantry continuously rotates around the patient, and this technique can deliver low dose radiation to lungs that is associated with an occurrence of radiation pneumonitis. to avoid this inefficiency of beam usage, a tomodirect option using static gantry positions combined with simultaneous couch translation and dynamic collimator modulation has been developed. in a pilot study, tomodirect seemed particularly well suited for postoperative irradiation in breast cancer patients. tomodirect achieved an optimal target volume coverage and coincident adequate normal tissue sparing in a dosimetric study. clinical studies of tomodirect in breast cancer patients are scarce and have been assessed only in small and retrospective series. thus, we undertook a prospective study on the technical feasibility and toxicity of tomodirect in breast cancer patients who received postoperative radiotherapy.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed breast cancer after breast-conserving surgery 2. pt1-2n0 3. no evidence of distant metastasis 4. no previous malignancy 5. patient age, 20 - 80 years 6. karnofsky performance score ≥ 70 7. adequate bone marrow, liver, and renal function (leucocytes \> 4,000/mm3, hemoglobin \> 10 g/dl, platelets \> 100,000/mm3; serum bilirubin \< 1.5 mg/dl, serum transaminase \< 2.5 times the upper normal limit; serum creatinine \< 1.5 mg/dl). 8. completion of scheduled chemotherapy exclusion criteria: 1. carcinoma in situ of breast 2. distant metastasis 3. mastectomy 4. male 5. both breast cancer
study comparing chronic beryllium disease to pulmonary sarcoidosis

Conditions: Pulmonary Sarcoidosis; Chronic Beryllium Disease

Summary: inhalation of beryllium can induce specific sensitization and diffuse pulmonary granulomatosis called chronic beryllium disease (cbd). the clinical, radiographic, and anatomopathological features of cbd are very similar to those of sarcoidosis, another granulomatosis, making its diagnosis difficult. in addition, the progression of cbd is poorly understood. the investigators hypothesis is that there are specific clinical, biological, anatomopathological, and radiological presentation specificities of cbd, as well as a worse prognosis compared to pulmonary sarcoidosis.

inhalation of beryllium can induce specific sensitization and diffuse pulmonary granulomatosis called chronic beryllium disease (cbd). the clinical, radiographic, and anatomopathological features of cbd are very similar to those of sarcoidosis, another granulomatosis, making its diagnosis difficult. in addition, the progression of cbd is poorly understood . the investigators hypothesis is that there are specific clinical, biological, anatomopathological, and radiological presentation specificities of cbd, as well as a worse prognosis compared to pulmonary sarcoidosis.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * sufficiently documented medical record. * informed patients who did not object to participating in the research, or for deceased patients, did not object to the use of their data. * cases: patients followed for confirmed chronic beryllium disease by expert teams based on the ats 2014 criteria, i.e., a history of exposure to beryllium, positivity of two abnormal lymphocyte proliferation tests (lpt) in blood and/or an abnormal lpt in bronchoalveolar lavage, granuloma found in pulmonary biopsy associated by compatible clinical, radiological or spirometric abnormalities. * controls: patients followed for sarcoidosis according to the ats/ers/wasog criteria, i.e., (i) a compatible presentation, (ii) the presence of non-necrotizing granulomatosis in one or more tissues (except löfgren's syndrome or heerfordt syndrome), (iii) and exclusion of alternative causes of granulomatous diseases with pulmonary parenchymal involvement on thoracic ct and/or chest radiography. * controls: without occupational exposure to beryllium. exclusion criteria: * patients under trustee.
reproducibility and accuracy of a portable system for early detection of cardiac dysfunction in childhood cancer survivors

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: the clinical trial compares the reproducibility and accuracy of cardiac tonometry-based portable systems that may detect early cardiac dysfunction (sphygmocor® xcel and oscar 2™ ambulatory blood pressure monitor) at home and in the clinic to currently available screening tests for heart failure including echocardiogram (echo) and cardiovascular magnetic resonance (cmr). the sphygmocor® xcel and oscar 2™ systems may help detect cardiac dysfunction earlier than other available screening tests because it can be self-administered outside of the clinic. this study aims to test the accuracy and practicality of these devices in the clinic setting and at home.

primary objective(s) validate the accuracy of ejection fraction, as measured using a tonometry-based system (sphygmocor® xcel), in the clinic setting, and determine the reproducibility (oscar 2™) at home. secondary objective(s) determine the cost-effectiveness of tonometry-based screening in the clinic setting and at home.

Eligibility criteria:
inclusion criteria: * previously enrolled in irb# 14154. * able to understand and sign the study specific informed consent form (icf). exclusion criteria: * participants cannot be actively receiving cancer-directed therapy. * standard exclusion criteria for cmr imaging will be incorporated, and these include: implanted pacemaker or defibrillator, insulin pump, cochlear implant, central nervous system aneurismal clips, implanted neural stimulator, ocular foreign body (metal), other implanted medical devices (e.g.: drug infusion ports).
effects of tobacco flavoring and liquid composition on vaping topography

Conditions: Tobacco-Related Carcinoma

Summary: this clinical trial tests the effect of tobacco flavor and liquid composition on the way a person puffs on a vape (topography). in general, tobacco products are designed with sensory factors in mind, such as flavor, to increase the appeal. flavors and the composition of nicotine, either made in a lab (synthetic) or from tobacco, may create positive sensory effects, such as look, feel and taste, and influence smoking behavior and willingness to try different types of cigarettes. understanding how nicotine vaping products are used is important in assessing individual and population level health risks. vape flavors and synthetic nicotine may be related to harmful effects on health from vaping and may impact the appeal, risk beliefs and vaping topography.

primary objective: * examine the influence of tobacco flavoring composition on vaping topography. * examine the influence of synthetic versus (vs.) tobacco derived nicotine on vaping topography. secondary objective: * examine the influence of tobacco flavoring composition on vaping topography. * examine the influence of synthetic versus (vs.) tobacco derived nicotine on vaping topography. outline: the order of directed and ad libitum bouts are randomized within participants at each session. session 1: participants puff their own brand liquid on study. sessions 2-5: participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study. sessions 6-7: participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study. participants also undergo collection of saliva samples and optionally undergo collection of oral cell and oral rinse samples throughout study.

Eligibility criteria:
inclusion criteria: * current daily vapers of products containing nicotine * no daily concurrent use of other tobacco products * self-reported general good health * women of child bearing potential must be willing to provide a urine sample and test negative prior to receiving any study-related products/procedures * ability to speak, read, and write in english * participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure exclusion criteria: * allergies - active untreated seasonal allergies that would interfere with smell or taste procedures * self-reported taste or smell deficits * pregnant or nursing female participants * medications known to interfere with taste/smell (i.e., certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc) * unwilling to use open system vaping device in laboratory setting * positive diagnosis of human coronavirus 2019 infection (covid-19) within 10 days prior to start of study intervention * unwilling or unable to follow protocol requirements * any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive the study intervention
diazepam vaginal suppositories for high tone pelvic floor dysfunction.

Conditions: Female Patients With High Tone Pelvic Floor Dysfunction

Summary: the purpose of this study is to determine whether vaginal diazepam suppositories are an effective treatment of high tone pelvic floor dysfunction.

high tone pelvic floor dysfunction is a common cause of pelvic pain in females. it is thought to be initiated by a sentinel event such as trauma, surgery, or vaginal delivery1. currently, treatment options include warm baths, stretching, physical therapy with myofascial therapy or biofeedback, or pharmacologic therapy with oral amitriptyline or tiazadine2. physical therapy can be effective. however, it usually involves frequent visits to a specialized physical therapist to undergo intravaginal treatments consisting of myofascial release, massage, or biofeedback. we would like to find a treatment option for patients that would be effective without the invasive and time consuming nature of physical therapy. it is known that diazepam is a valid treatment option for disorders involving spasticity including spastic cerebral palsy5 and tetanus. a literature search on diazepam and high tone pelvic floor dysfunction revealed one paper. this study has an intrinsic flaw as it is a retrospective chart review, and the results are confounded by concurrent physical therapy. they were, however, able to find that patients treated with diazepam suppositories showed a significant improvement in pelvic floor tone. they also assessed pain and sexual function, but these did not reach statistical significance.

Eligibility criteria:
inclusion criteria: * candidates from the division of urogynecology at good samaritan hospital in cincinnati, oh * aged 18-65 * high tone pelvic floor dysfunction exclusion criteria: * allergy to diazepam or any drug in the class of benzodiazepines * current pelvic floor physical therapy * pelvic surgery within the last 3 months * current pregnancy, planning on pregnancy during the study period, or not sure if pregnant * regular benzodiazepine, muscle relaxant, or daily alcohol use * history of alcohol or drug abuse * contraindications to diazepam: hepatic or renal dysfunction, myasthenia gravis, acute narrow angle glaucoma, severe respiratory insufficiency, sleep apnea

Keywords: high tone pelvic floor dysfunction levator pain dyspareunia
nesiritide infusion for the treatment of decompensated heart failure and renal dysfunction

Conditions: Congestive Heart Failure; Renal Insufficiency

Summary: the researchers hypothesize that the addition of nesiritide to standard therapy will prevent worsening of renal function in patients admitted to the hospital with decompensated heart failure and renal dysfunction relative to standard therapy alone.


Eligibility criteria:
inclusion criteria: * decompensated heart failure hospitalization with at least 1 symptom and 1 sign of elevated filling pressures * admission estimated creatinine clearance =\< 50 cc/min. exclusion criteria: * systolic blood pressure \< 85 mm hg * cardiogenic shock * volume depletion * myocardial infarction, unstable angina within last 30 days * significant valvular stenosis, hypertrophic/restrictive cardiomyopathy, or constrictive pericarditis * chronic hemodialysis * anticipated major procedure during hospitalization i.e. left heart catheterization, surgery, or transplantation * enrolled in another research protocol within last 30 days.
interactive education of patients with coronary heart disease

Conditions: Coronary Disease

Summary: coronary heart diseases are responsible for a high number of deaths in germany. to determine the risk factors secondary prevention is of great importance. after their residence in rehabilitation centers patients often get rid of newly required skills. in addition to that parameters like bmi, blood pressure and cholesterol level return to their initial value. using an audience response system (ars) during oral presentations in rehabilitation centers should improve the learning effect of patients. furthermore patients will receive motivating telephone calls in the follow-up. these methods should lead to a sustainable improvement of learning effects, health care behavior and quality of life.


Eligibility criteria:
inclusion criteria: * cardiovascular disease exclusion criteria: * inability or refusal to give written informed consent

Keywords: coronary disease audience response system
insulin titration system based on deep learning

Conditions: Diabetes Mellitus Type 2 - Insulin-Treated

Summary: this is an open-labeled, one-arm intervention trial to access the effect and safety of the insulin titration system based on deep learning in patients with type 2 diabetes mellitus.

the study enrolls 13 patients with type 2 diabetes in zhongshan hospital who are on treatment with insulin. after screening for the inclusion and exclusion criteria, eligible patients will receive insulin dosage titration set by the insulin titration system based on deep learning in the intervention trial. the goal of insulin therapy was to achieve preprandial capillary blood glucose between 5.6-7.8 mmol/l and postprandial capillary glucose less than 10.0mmol/l. all patients are studied for 5 consecutive days or untill hospital discharge. for each patient, capillary glucose concentration was measured at 7 time points of fasting, after breakfast, before and after lunch, before and after dinner, and before bedtime a day using glucometer (glupad, sinomedisite, china). capillary glucose measurements were performed by the nurse staff according to standard procedures with a point-of-care testing device, which is integrated into the his system. and continuous glucose monitoring (cgm) was performed using flash glucose monitoring (abbott freestyle libre, usa) placed on the upper left arm. this study will be conducted in the department of endocrinology, zhongshan hospital,fudan university.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * age of 18-75 years * hba1c between 7.0% and 11.0%. exclusion criteria: * subjects with acute complications of diabetes, such as ketoacidosis or hyperglycemic hyperosmolar state; * bmi ≥ 45kg/m2; * women who are pregnant or breast-feeding; * subjects with severe cardiac, hepatic, renal diseases; subjects with any psychiatric or psychological diseases; * subjects with severe edema, infections or peripheral circulation disorders, receiving surgery during hospitalization; * subjects who could not comply with the protocol