Kornimate/medical-research-clean huggingface dataset:
bronchodilatory efficacy of a single dose qmf149 (indacaterol maleate/mometasone furoate) via the twisthaler® device in adult patients with asthma

Conditions: Asthma

Summary: this study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500 μg/mometasone furoate 400 μg via the twisthaler® device in adult patients with persistent asthma.


Eligibility criteria:
inclusion criteria: * male and female adult patients aged 18-75 years with persistent asthma * patients with persistent asthma, diagnosed according to the global initiative for asthma guidelines (gina) and who additionally met the following criteria: 1. patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for the month prior to visit 1. 2. patients with a forced expiratory volume in 1 second (fev1) at visit 1 of ≥ 50% of the predicted normal value. this criterion for fev1 had to be demonstrated after a washout period of at least 6 hours during which no short acting β2-agonist had been inhaled, and a minimum of 48 hours for a long acting β2-agonist. 3. patients who demonstrated an increase of ≥12% and ≥200 ml in fev1 over their pre-bronchodilator value 30 minutes after inhaling a total of 200 μg of salbutamol (or albuterol) via metered dose inhaler (mdi) (the reversibility test). reversibility had to be demonstrated after an appropriate washout period of at least 6 hrs prior to the evaluation for a shortacting β2-agonist. the administration of salbutamol (or albuterol) for the reversibility test was to be within 30 minutes after pre-bronchodilator spirometry. reversibility had to be demonstrated at visit 1 or between visits 1 and 2, in order for patients to be included in the trial. 4. for each patient, the smaller value of the visit 1 fev1 or the visit 2 fev1 pre-dose value had to be at least 85% of the larger value. * body mass index (bmi) between 18 and 32 kg/m\^2 and weight \>50 kg. * patients using local contraception exclusion criteria: * pregnant or nursing women * recent use of tobacco or history of smoking \> 10 pack years * patients diagnosed with chronic obstructive pulmonary disease (copd) * patients with recent experience of severe asthma attack/exacerbation within 6-months of study start * patients with frequent rescue medication (\>8 puffs/day for two consecutive days) * clinically relevant laboratory abnormality or a clinically significant condition * active cancer or a history of cancer with less than 5 years disease free survival time * history of long qt syndrome or with long qtc interval prior to dosing * history of hypersensitivity to the study drugs or to drugs with similar chemical structures * use of certain medications * use of other investigational drugs * a positive hepatitis b surface antigen (hbsag) or hepatitis c test result * history of immunodeficiency diseases, including a positive human immumodeficiency virus (hiv) test result. * history of drug or alcohol abuse or evidence of such abuse other protocol-defined inclusion/exclusion criteria may apply.

Keywords: asthma, qmf149, fixed combination of indacaterol and mometasone furoate
simvastatin for the treatment of chronic hepatitis b

Conditions: Hepatitis B

Summary: the investigators have shown robust in vitro anti-hepatitis b activity of simvastatin alone and synergistic activity with all four fda-approved anti-hepatitis b oral drugs tested. the investigators propose phase 1 studies in 48 chronic hepatitis b human carriers who have never been treated before. doses of drugs will remain at or below fda-approved dosage levels for cholesterol lowering (simvastatin) or hepatitis b (tenofovir or entecavir). arm 1 will have simvastatin monotherapy only. arm 2 will combine simvastatin with tenofovir. arm 3 will combine simvastatin with entecavir. for maximum safety, the 3 arms and the dose groups in each arm will be filled consecutively and not concurrently. the definition of efficacy for simvastatin alone will be a 1 log drop of hepatitis b virus in 14 days. efficacy for combination of drugs will require a 2 log drop of hepatitis b virus in 14 days. numerous safety tests and stop rules are noted in the protocol.


Eligibility criteria:
inclusion criteria: 1. hepatitis b positive by hbv dna within 180 days. 2. ages 18-70. 3. men and non-pregnant women eligible. 4. veteran's eligibility or appropriate health insurance. exclusion criteria: 1. use of any anti-hbv medicine within 30 days. 2. decompensated cirrhosis as evidenced by esophageal varices, ascites, or encephalopathy. (grade 1 varices without history of bleeding will be allowed, if patient meets child's-pugh functional classification grade a). 3. a positive urine test for marijuana or alcohol within 2 months of screening.(allowed to repeat tests on different days, if positive first time in order to become eligible for study. 4. severe cardiovascular disease (ejection fraction \<20%)\* or uncontrolled angina. 5. severe pulmonary disease (fev1 \< 1.0). 6. chronic renal insufficiency (creatinine clearance \<50 ml/min. 7. hiv positive patients.

Keywords: hepatitis b simvastatin hbv dna
a rehabilitative approach in patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of the study is to evaluate the effectiveness of a rehabilitative approach using breathing and relaxation techniques, and specifically the elongation of the latissimus dorsi muscle according to the mézières method to improve balance and posture and relief pain in patients with parkinson's disease.


Eligibility criteria:
inclusion criteria: * diagnosis od idiopathic parkinson's disease (according to uk brain bank criteria), hoehn-yahr stage ≤3 (determined during "on phase"), mini mental state examination (mmse) \> or = 27, no rehabilitation treatment carried out within 3 months prior to the study, diagnosis of parkinson's disease by at least 5 years. exclusion criteria: * dyskinesias * severe fluctuations "on-off" * modifications of anti-parkinsonian drug therapy during the three months prior to the start of the study) * sensitivity deficit of the trunk or lower extremities (physical examination) * vestibular disorders or paroxysmal vertigo * previous thoracic or abdominal surgery * other neurological or orthopedic conditions involving the trunk or lower extremities (musculoskeletal diseases, severe osteoarthritis, peripheral neuropathy, prosthetic surgery) * cardiovascular comorbidities (recent myocardial infarction, heart failure, uncontrolled hypertension, orthostatic hypotension)

Keywords: posture pain muscle stretching mézières method camptocormia trunk control
prediction of wmh in migraine using a bold-cvr map

Conditions: Migraine

Summary: brain white matter hyperintensities (wmhs) are prevalent in migraineurs, of which the mechanism is still unclear. the investigators aimed to test the spatial association between areas with reduced cerebrovascular reactivity (cvr) to hypercapnic stimuli and consequent development of wmhs.

a whole-brain map of cvr will be created in patients with migraine and normal controls. hypercapnic stimuli for cvr will be delivered by prospective end-tidal co2 targeting device. hemodynamic responses will be determined by bold signal changes using fmri. wmhs will be determined by high-resolution 3d flair imaging. patients and controls will undergo serial mris with 1 year interval. associations between areas of reduced cvr and consequent wmh development will be tested in both patients and controls.

Eligibility criteria:
inclusion criteria: 1. migraineurs(patients) : * age 18-50 years * migraine with or without aura as defined by the third edition of the international classification of headache disorders (ichd-3 beta) * migraine duration \> 6 months * episodic migraine feature headache (\< 15 attacks/m) * not any preventive medications for migraine 2. control: * age 18-50 years * no headache disorder requiring painkillers within the past year * no more than moderate intensity of headache within the past year * no headache disorder other than infrequent episodic tension-type headache as defined by the ichd-3 beta exclusion criteria: * chronic migraine within last month (≥15 attacks/m) * medication overuse headache as defined by ichd-3 beta * other comorbid disease that may affect vascular function (hypertension, diabetes, hyperlipidemia, cerebral infarction, smoking etc) * can not breath 20 l for 1 minute because of basal cardiopulmonary disease (chronic obstructive pulmonary disease, heart failure etc) * a disease that can be exacerbated by elevated pco2 in blood (interstitial lung disease, amyotrophic lateral sclerosis etc) * predicted to be unable to write the headache diary due to cognitive decline * contraindications to mri * pregnancy * refusal to informed consent

Keywords: white matter hyperintensity cerebrovascular reactivity
management of vaginal fistula by kshar sutra, a minimally invasive treatment

Conditions: Vaginal Fistula

Summary: background:fistula-in-ano is described as bhagandara in the classics of ayurveda, is an ancient surgical problem. it was commonly described even in the vedic period. the description of bhagandara, with the full text of its managements, can be gathered from the sushruta samhita, which is supposed to have been written in the second century b.c. fistula-in-ano is a tubular ulcer formed around the peri-anal region. it may also be found anywhere in the perineal region. its ramifications can extend to the lower back, subscrotal region, vagina etc. hypothesis:in sushruta samhita(2nd bc) acharya sushruta has advocated kshar sutra treatment due to probability of recurrence after surgery. the present treatment modality kshar sutra has been found effective and as adjuvant therapy by avoiding recurrence.

a 42 years old female patient , come to the shalyatantra o.p.d. of government ayurved hospital,nagpur with complaints of recurrent discharging boil at right side of perianal region along with pain and discomfort in october 2010. she gave a surgical history of incision and drainage for gluteal abscess done in year 2008 and after six month. the same complaint recurred after next six month .on local examination patient had discharging sinus at 9 o clock position on right side of perianal region. before planning the treatment other etiologies like tuberculosis, diabetes mellitus , hiv or trauma were ruled out. for the conformation of diagnosis fistulogram was performed suggestive of low anal fistula with posterior internal opening. so under spinal anaesthesia probing was done. but it came to know that the track was directed upward in vagina and it had not any other opening in anal canal. length of the tract was 7cm. after conformation of vaginal fistula the track was cleaned with betadine and hydrogen peroxide. the kshar sutra was tied covering the entire underlying track for simultaneous cutting and healing under all aseptic precaution. the patient was discharged on the next day of procedure. patient was advice for seitz bath with lukewarm water. the kshar sutra was changed weekly. to promote healing and to reduce pain and inflammation oral antibiotics, anti-inflammatory medicine were also prescribed. the total period of kshar sutra treatment was two month. the track cut trough and simultaneously healed. it was observed that healing rate was slow as compare to cutting rate. in this patient. the patient was observed for a period of two year to check for recurrence. the kshar sutra is a standard medicated thread smeared with kshar of apamarga (achyranthus aspera), shnuhi (euphorbia nerrifolia)latex which has quality of cutting and haridra (curcuma longa) which is used as a antiseptic. this combination of drugs on the thread helps in debridement and simultaneously healing.

Eligibility criteria:
inclusion criteria: * without any major illness like diabetes, hypertension, asthma, tuberculosis, and without multiple track. exclusion criteria: * with major illness, multiple fistulas, associated anorectal conditions

Keywords: fistula , bhagandar
lace+ and mrs score readmission rate assessment

Conditions: Hospitalism

Summary: a study to demonstrate that the lace+ score in non-inferior to the medication risk score when predicting 30-day readmission post hospital discharge.

the objective of this study is evaluate a program that provides transition of care services to a local tucson hospital involving activities designed to reduce 30 day post hospital discharge readmission rates. the organization has had a fee for service contract with this hospital since 2017 to provide pharmacist delivered transition of care services. the organization collects internal tracking outcome data as part of the contract deliverable and is required to report it to the hospital once per month. the investigators look to assess lace+ and medication risk scores to learn if there is an association with the 30 day post hospital discharge readmission rate post pharmacist intervention. the outcomes will not be generalizable and will be reported back to the hospital client to demonstrate value added.

Eligibility criteria:
inclusion criteria: * those referred to receive transition of care services between january 2018 to december 2019 and were discharged on 10 or more medications. exclusion criteria: * 89 years or older

Keywords: lace medication risk score
aab-001 in patients with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to assess the safety and tolerability of multiple doses of aab-001 passive immunization in patients with mild to moderate alzheimer's disease (ad).

the humanized monoclonal antibody, aab-001, which binds to and clears beta amyloid peptide, is designed to provide antibodies to beta amyloid directly to the patient, rather than requiring the patient to mount his/her own individual response. it is believed that this approach may eliminate the need for the patient to mount an immune response to beta amyloid. animal studies have shown that this approach is equally effective in clearing beta amyloid from the brain as traditional active immunization methods. this is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple ascending dose study in male and female patients aged 50 to 85 years with mild to moderate ad. approximately 30 study sites will be involved. patients will be randomized to receive either aab-001 or placebo. each patient's participation will last approximately 2 years.

Eligibility criteria:
inclusion criteria: * diagnosis of probable ad * age from 50 to 85 years * rosen modified hachinski ischemic score less than or equal to 4 * magnetic resonance imaging (mri) scan consistent with the diagnosis of ad * fluency in english * stable doses of medications exclusion criteria: * significant neurological disease other than ad * major psychiatric disorder * significant systemic illness * history of stroke or seizure * weight greater than 120 kg (264 lbs.) * history of autoimmune disease * smoking more than 20 cigarettes per day * anticonvulsants, anti-parkinson's, anticoagulant, or narcotic medications * prior treatment with experimental immunotherapeutics or vaccines for ad * presence of pacemakers or foreign metal objects in the eyes, skin, or body

Keywords: alzheimer's disease immunotherapy beta amyloid
advance care planning guidetailored for primary care patients

Conditions: Advance Care Planning; Chronic Disease; Communication Research

Summary: this project seeks to: validate results of acp framework pilot study in a larger randomized controlled trial (rates and quality of acp documentation) prior to using participatory design to develop an electronic health record (ehr)-tethered patient portal delivered acp communication guide, tailored for use in busy primary care settings, incorporating patients, caregivers, and primary care providers


Eligibility criteria:
inclusion criteria: * must have an activated patient portal account over 50 years of age scheduled for a well visit appointment or chronic visit follow up english speaking exclusion criteria: * under 50 * inactive patient portal account
ct-based model for predicting prolonged weaning in patients with abdominal trauma

Conditions: Wounds and Injuries; Ventilation Therapy; Complications

Summary: critically ill patients often require tracheal intubation for mechanical ventilation, and timely weaning is crucial for airway management and reducing complications. however, there is currently a lack of an effective tool to predict weaning time in critically ill patients. this retrospective study established an effective nomogram model for predicting the time of weaning from mechanical ventilation in abdominal trauma patients by considering multiple perspectives. the model has been validated and demonstrated good performance in terms of discrimination, calibration, and clinical utility. moreover, the model can effectively predict the prognosis of critically ill patients. the findings of this study have important implications for guiding respiratory management in clinically critically ill patients, particularly trauma patients.


Eligibility criteria:
inclusion criteria: * (1) with information on survival status and time; * (2) aged 18-80 years; * (3) admitted to icu; * (4) with abdominal ct performed within 1-week post-trauma; * (5) use of mechanical ventilation. exclusion criteria: * (1) low-quality ct images; * (2) history of mental illness.

Keywords: computed tomography prolonged weaning ventilation trauma
furst 2.0 cognitive pre-testing - round 2

Conditions: Huntington Disease

Summary: the study is a single, cross-sectional cognitive interview of furst 2.0, functional rating scale, administered to forty huntington's disease gene expansion carriers (hdgecs) and potentially, their companions (the companion's participation is optional in this study). the scale will be tested as a patient reported outcome (pro) in that the information will come directly from the hdgec participant or the hdgec participant together with his/her companion through self-report. the purpose is to identify real or potential comprehension or usage problems with scale items, response options, instructions and disclaimer statement, which are all components of the furst 2.0 scale. through a structured cognitive interview with the hdgec participants or the hdgec participants together with their companions, followed by qualitative analysis, the final phrasing of the individual scale items, response options, instructions and disclaimer statement for the scale will be generated. depending on the results of this study, an additional round of cognitive pre-testing may be required in a separate study.


Eligibility criteria:
inclusion criteria for premanifest hdgecs: * identified as an active participant in enroll-hd (participants who have completed their last onsite enroll-hd visit within approximately 15 months) * at least 18 years of age * fluent in english and had his/her primary education in english * able and willing to provide critical feedback (per site pi or site pi's designee discretion) * willing and able to provide written informed consent * cytosine, adenine, guanine (cag) length ≥ 40 * disease burden score (dbs) ≥ 250 * diagnostic confidence level (dcl) ≤ 3 inclusion criteria for early-manifest hdgecs: * identified as an active participant in enroll-hd (participants who have completed their last onsite enroll-hd visit within approximately 15 months) * at least 18 years of age * fluent in english and had his/her primary education in english * able and willing to provide critical feedback (per site pi or site pi's designee discretion) * willing and able to provide written informed consent * cag length ≥ 36 * dcl= 4 * total functional capacity (tfc) ≥11 inclusion criteria for a companion of an hdgec * at least 18 years of age * fluent in english and had his/her primary education in english * in his/her opinion, has sufficient interaction and knowledge of the hdgec participant's capabilities and daily activities * is acceptable to the hdgec participant and the site pi or site pi's designee * willing and able to provide written informed consent exclusion criteria for an hdgec/a companion of hdgec: * significant cognitive or any other impairment sufficient to interfere with study associated tasks as judged by the site pi or the site pi's designee
the effects of postoperative physician phone calls for hand and wrist fractures

Conditions: Hand Injuries; Trauma; Hand Injuries and Disorders

Summary: this study seeks to determine if postoperative phone calls by a physician affect outcomes in hand surgery.

this study seeks to determine if postoperative phone calls by a physician affect outcomes in hand surgery. patients who require operative treatment of hand and wrist fractures are randomly assigned to a group that receives a postoperative phone call or the control group that receives the standard postoperative care. patient reported and medical outcomes are observed starting at 1 month postoperatively.

Eligibility criteria:
inclusion criteria: * patients with isolated injuries of the hand who present to a specific level 1 trauma center in the midwestern united states * patients who have planned surgical treatment by a pre-specified group of surgeons exclusion criteria: * patients who have significant trauma to other organ systems proximal to the wrist * patients who have open ("compound") fractures (i.e., bone is exposed) * children

Keywords: hand injuries hand trauma patient reported outcomes
smart boot use to measure offloading adherence

Conditions: Diabetic Foot Ulcer

Summary: the purpose of this study is to help people with diabetes who develop neuropathic diabetic foot ulcers (dfus). these ulcers, or sores, if left untreated can increase the chance of amputation. part of the treatment is to have the person wear a diabetic shoe or boot to help their foot heal. sometimes people don't wear the boot like they are told. the investigators want to compare three different kinds of diabetic boots to see if they can help make it easier for people to wear their boots as instructed. the investigators will look at three groups of participants: the first group will wear a boot that can't be taken off. the second group will wear a boot that can be taken off, and they will get counseling about how important it is to follow instructions as to how often and when to wear the boot. the third group will wear a "smart" boot, which will interact with the person through a smart watch and smart phone, and give them direct feedback about how they are doing with following their boot wearing prescription. the investigators will also be looking at how much physical activity, like walking, the participants do. and they will compare how well participants sleep and rate their quality of life in the three different boots. the investigators think that giving participants information about how much they are wearing their boot using readily available technology will help them to follow the doctor's directions better, and help their wounds heal faster.


Eligibility criteria:
inclusion criteria: * male or female aged 18 or older * diabetic foot ulcer requiring offloading * able to provide written informed consent exclusion criteria: * wound present for more than one year * hba1c \> 12% * ankle brachial index (abi) of index limb is \<0.9 and/or they are being considered for revascularization within the course of the study * ulcer involving bone or tendon * ulcer not caused by diabetes * unable or unwilling to attend prescribed clinic visits * fully confined to a wheelchair