Kornimate/medical-research-clean huggingface dataset:
bapineuzumab in patients with mild to moderate alzheimer's disease (apoe4 carrier)

Conditions: Alzheimer's Disease

Summary: this is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate ad. approximately 200 study sites in the us and canada will be involved. patients will be randomized to receive either bapineuzumab or placebo. each patient's participation will last approximately 1.5 years. bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.


Eligibility criteria:
inclusion criteria: * diagnosis of probable ad * age from 50 to less than 89 * mini-mental status exam score of 16-26 inclusive * brain magnetic resonance imaging (mri) scan consistent with the diagnosis of ad * stable doses of medications (cholinesterase inhibitors and memantine allowed) * caregiver able to attend all clinic visits with patient exclusion criteria: * significant neurological disease other than ad * major psychiatric disorder * significant systemic illness * history of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years * smoking greater than 20 cigarettes per day * anticonvulsants, anti-parkinson's, anticoagulant, or narcotic medications * prior treatment experimental immunotherapeutics or vaccines for ad * women of childbearing potential * presence of pacemakers, csf shunts, or foreign metal objects in the eyes, skin or body
evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of bgm0504 injection in non-diabetic overweight or obese adult subjects

Conditions: Non-diabetic Overweight or Obese

Summary: this is a phase 1, double-blind, parallel-arm ,placebo-controlled study. the study will evaluate the pharmacokinetics (pk), pharmacodynamic (pd), safety and tolerability of bgm0504 following multiple subcutaneous (sc) administrations in non-diabetic overweight or obese adult subjects.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) meeting one of the following requirements: 1. between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese); or 2. between ≥ 27.0 kg/m2 and \< 30.0 kg/m2 (overweight) with at least 1 of the following: 1) one or more of prediabetes (impaired fasting plasma glucose and/or abnormal glucose tolerance), grade 1 hypertension, simple fatty liver or dyslipidemia; 2) weight-bearing joint pain; 3) obesity causing dyspnea or obstructive sleep apnea syndrome * have a stable body weight (\<5% self-reported change during the previous 8 weeks) before screening * capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study. exclusion criteria: * have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to glucagon-like peptide-1 (glp-1) receptor agonists, or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis). * have received glp-1 receptor agonists or similar drugs containing the same target within 12 weeks before screening. * have received drugs that have an impact on body weight within 12 weeks before screening. * surgical treatment for obesity. * known type i/ii diabetes. * history of acute or chronic pancreatitis or pancreatic injury. * history of drug abuse or alcoholism at screening.
deep brain stimulation of the bilateral nucleus accumbens for patients with methadone maintenance treatment

Conditions: Addiction Opiate

Summary: methadone maintenance treatment (mmt) is one of the main forms of treatments for opioid dependence. despite its effectiveness and widespread use, people will experience withdrawal if daily dose is insufficient or missed, promoting reluctance to attempt detoxification. in addition, methadone is a full opioid agonist which can induce respiratory depression or sedation without ceiling level, so overdose usage can be fatal. hence, an alternative therapy is needed to completely reduce the carving for drugs and to relieve the negative affective sate caused by withdrawal. deep brain stimulation (dbs) is a reasonable treatment approach for addiction. since 2009 the first case report emerged, the nucleus accumbens (nac) is still the only brain target to be investigated in clinical case series of dbs for alcohol and heroin addiction. this research will mainly investigate the effectiveness and safety of nac-dbs for patients with methadone maintenance treatment. the investigators will also explore the influence of nac-dbs on brain activity and cognition.


Eligibility criteria:
inclusion criteria: * mini diagnosis of substance dependence; * proficiency in mandarin language; * failure to detox more than three times; * long-term methadone maintenance treatment; * capacity to provide informed consent (understanding of the study purpose and methods); exclusion criteria: * schizophrenia(mini diagnosis); * antisocial personality disorder(mini diagnosis); * contraindications of a mri-examination, e.g. implanted cardiac pacemaker/heart defibrillator; * severe cognitive impairments(moca ≤ 22); * enrollment in other clinical trials; * stereotactic respectively neurosurgical intervention in the past; * contraindications of stereotactic intervention, e.g. increased bleeding disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases); * serious or instable organic diseases (e.g. instable coronal heart disease); * tested positively for hiv; * pregnancy and/or lactation; * epilepsy or other severe brain trauma or neurological impairments;

Keywords: nucleus accumbens deep brain stimulation methadone
a phase ii randomized trial for early-stage squamous cell carcinoma of the oropharynx: radiotherapy vs trans-oral robotic surgery (orator)

Conditions: Early-Stage Squamous Cell Carcinoma of the Oropharynx

Summary: the historical standard treatment for early-stage squamous cell carcinoma of the oropharynx is radiation therapy. some patients require chemotherapy with the radiation, and some patients require surgery if the tumour or lymph nodes have not responded after radiation. this study will compare radiation therapy with a new surgical treatment called transoral robotic surgery (tors). tors is a new surgical approach using a robot to assist the surgeon in removing the tumour, potentially with fewer side effects than older surgical techniques.


Eligibility criteria:
inclusion criteria: * age 18 or older * willing to provide informed consent * ecog performance status 0-2 * histologically confirmed squamous cell carcinoma primary rumour site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx) * tumour stage:t1 or t2, with likely negative resections at surgery * nodal stage: n0, n1, or n2 (less than or equal to 4 cm in maximum dimension in any plane, on either side of the neck), without extranodal extension on pre-randomization imaging. * patient assessed at head and neck multidisciplinary clinic (with assessment by radiation oncologist and surgeon) and presented at multidisciplinary tumour board prior to randomization. exclusion criteria: * serious medical comorbidities or other contraindications to radiotherapy, chemotherapy or surgery * prior history of head and neck cancer within 5 years * prior head and neck radiation at any time * metastatic disease * inability to attend full course of radiotherapy or follow-up visits * neck disease with unknown primary site * prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer * unable or unwilling to complete qol questionnaires
ambispective study to assess the safety and the performance of sagitta evl r stem

Conditions: Hip Arthropathy

Summary: this clinical study is conducted to collect data on hip arthroplasty with the sagitta evl-r revision femoral stems manufactured by serf. this study will confirm the performance and safety of the sagitta evl r revision femoral stems within the framework of mdr 2017/745 and in relation to the recommendations of the meddev guide 2.7.1. rev 4 (clinical evaluation guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices. the primary objective is to evaluate the long-term survival rate (7 to 10 years post-op +/- 2 years) of sagitta evl r stems. secondary objectives are to : * study long term patient satisfaction with their hip prosthesis, * confirm the long-term safety of these implants by studying the possible complications observed, * evaluate the performance of these implants using clinical scores.


Eligibility criteria:
inclusion criteria: * patient over 18 years old at the time of surgery, * patient implanted with a sagitta evl r revision femoral stem within its indications between 01/01/2010 and 31/12/2015, * affiliated to french health insurance system exclusion criteria: * patient who has rejected to the use of his/her personal data, * patient unable to understand the surgeon's instructions or to carry out the post-operative follow-up.

Keywords: total hip prosthesis revision
change of lifestyle in elderly patients with type 2 diabetes and systemic arterial hypertension

Conditions: Diabetes; Hypertension

Summary: evaluate the effect of lifestyle modification through the adoption of a dash diet, with and without physical activity guidance, on blood pressure and insulin sensitivity in elderly patients with type 2 diabetes and hypertension.

data regarding the effects of physical activity and dash-type diet on blood pressure control in patients with type 2 diabetes and hypertension are scarce in the literature, whether evaluating these isolated interventions or together. in addition, most studies do not measure bp using abpm, which has a special importance in the assessment of pressure homeostasis in dm or are short-term studies. were only two studies have been identified in the literature that evaluated the effect of the dash diet on patients with type 2 dm; however, in both trials, being elderly was not an inclusion criterion. the first was an iranian study that demonstrated in 31 non-hypertensive patients a significant reduction in bp after 8 weeks of following a dash diet. in the second ecr, we demonstrated that in 20 hypertensive type 2 dm patients, all using antihypertensive drugs and with uncontrolled bp, a dash-type diet for 4 weeks associated with physical activity reduced the systolic bp assessed by abpm by 12.5 mmhg. however, the adopted design did not allow to separate the effect of diet from the effect of physical activity. on the other hand, the effect of a single session of walking followed by a 24-hour abpm assessment showed a reduction in bp in hypertensive elderly and non-hypertensive patients, also without dm. so far it is not defined in patients with type 2 dm and hypertension, especially the elderly, whether the dash diet alone is as beneficial for bp as its association with physical activity, particularly, considering the difficulties of performing exercises in this group of patients. this is valuable information, as it would reinforce the role of diet therapy intervention even if in isolation in this age group. furthermore, the role of the dash diet with or without physical activity remains unknown on insulin sensitivity.

Eligibility criteria:
inclusion criteria: * age 60 years or more * diabetes mellitus * hypertension with poor control exclusion criteria: * glucocorticoid use * unstable angina * acute myocardial infarction in the last 6 months * heart failure classes iii and iv * history of cirrhosis, alcoholism or use of illicit drugs * dementia and malignant disease that compromises survival in 5 years * serum creatinine greater than 2, 0mg / dl * bmi\> 40 kg / m² * physical disability that prevents the use of a pedometer * participating in another research project involving any type of intervention.

Keywords: diabetes hypertension elderly dash steps
effect of prophylatic use of enoxaparin in women undergoing in vitro fertilization treatment

Conditions: Infertility, Female; Thrombophilia; Fertilization in Vitro

Summary: retrospective study designed to evaluate outcomes in patients undergoing assisted reproduction. some of them had thrombophilia, and part of them was treated with enoxaparin, started on the day of embryo transfer, and the other part not. women without thrombophilia formed the control group.

a retrospective study was performed to evaluate the results in 104 patients undergoing to assisted reproduction. women without thrombophilia were included as controls (n=20), while women with thrombophilia were either treated with 40 mg daily of enoxaparin (treated group, n=54), initiated on the day of embryo transfer, and continued to the week 36 of gestation, or did not receive this medication (untreated group, n= 30).

Eligibility criteria:
inclusion criteria: * women with female infertility or unexplained infertility * normal sperm analysis exclusion criteria: * women who did not agree with in vitro fertilization techniques

Keywords: female infertility thrombophilia enoxaparin abortion in vitro fertilization low molecular weight heparin
compare the effects of preoperative pulmonary rehabilitation exercises on postoperative anxiety and muscle strength

Conditions: Lung Neoplasm

Summary: lung cancer, tracheal and bronchial cancers have long been the leading cause of cancer mortality in taiwan. according to statistics, about 40% of newly diagnosed lung cancers are treated with surgery as the primary treatment. although early surgery improves survival rates, most patients experience significant decreases in lung function, and physical function after surgery, which affects their quality of life. recent studies have found that preoperative and postoperative lung rehabilitation exercises play an increasingly important role in lung cancer care. in taiwan, postoperative interventions for lung cancer have shown significant benefits, but there is a lack of evidence on the effectiveness of preoperative rehabilitation programs. to understand the effectiveness of the preoperative pulmonary rehabilitation program, a preoperative home rehabilitation program was designed to compare the efficacy of preoperative pulmonary rehabilitation in the current lung cancer care of patients undergoing lung neoplasm surgery.

after confirming that the patient is eligible to participate and the patient signs a consent, basic information and the hospital anxiety and depression scale (hads) will be completed at the preoperative clinic, and lung function tests, 30-second 30 seconds sit-to-stand test, grip strength test, physical status assessment, and activity level assessment will be performed. a healthcare instruction manual will be given at the preoperative clinic. the preoperative exercise group (experimental group) and the control group will be assigned randomly. the preoperative exercise experiment group must complete the related exercises and records. the exercises include upper extremity resistance exercise, lower extremity resistance exercise, aerobic exercise, and respiratory muscle training.

Eligibility criteria:
inclusion criteria: 1. patients undergoing thoracic surgery with pulmonary resection (including wedge resection, segmentectomy, and lobectomy). 2. fev1≦80%. 3. over 20 years old. 4. those who can cooperate with pulmonary rehabilitation and sign the consent form. exclusion criteria: * suspected metastases to other organs. * unsteady gait, limited mobility, unable to cooperate with exercise training * those who cannot communicate in mandarin or taiwanese. * oxygen saturation ≦85% at rest and without oxygen. * new york heart association (nyha) defines heart failure as grade iv. * fev1\<30% and ever diagnosed copd patients. * s/p pneumonectomy patient.
building an optimal hand hygiene bundle

Conditions: Hand Hygiene; Health Care Associated Infection; Compliance

Summary: hand hygiene is the single most effective practice in preventing the spread of hospital-acquired infections. despite the strength of the evidence, hospital staff continue to sanitize their hands less than half of the time required by guidelines. effective interventions are needed to improve hand hygiene compliance rates among hospital staff, but most are of poor quality and do not examine the specific effects of individual interventions. this study will build a "bundle" of three hand hygiene interventions using a research design that allows for the effectiveness of each intervention to be measured individually and combined.

the two specific aims and associated hypotheses of create project 2 include: 1. identify combinations of hand-hygiene intervention strategies that optimize hand-hygiene compliance and that could form an evidence-based hand-hygiene bundle for veterans health administration (vha) implementation. hypothesis 1: combinations of interventions will increase compliance rates more than single interventions. aim 1 will entail a 30-month cluster-randomized controlled trial that will sequentially test three individual hand-hygiene interventions - hand-hygiene point-of-use reminder signs to serve as an environmental cue to action, individual hand sanitizers, and health care worker hand cultures - to identify an optimal combination of interventions to increase hand-hygiene compliance. the trial will be conducted in 59 hospital units in 10 va hospitals in order to test the efficacy of individual and then sequentially added interventions to determine their incremental impact on hand-hygiene compliance. the focus for this clinical trial will be on aim 1--single hand hygiene sign changes. 2. identify institutional, organizational, ward/icu, and individual level facilitators and barriers to implementing hand-hygiene interventions. hypothesis 2: facilitators and barriers will pattern around contextual factors such as level of leadership support and organization of infection control programs. aim 2 will entail a qualitative process evaluation that includes site visits to purposefully selected sites, semi-structured interviews, and observations to examine barriers and facilitators to the interventions and develop contextual insight for implementing and scaling-up the intervention at additional sites as a national initiative.

Eligibility criteria:
inclusion criteria: * wards/units at 10 va medical centers: hand hygiene observations of healthcare works on these wards/units exclusion criteria: none

Keywords: methicillin-resistant staphylococcus aureus (mrsa) infection control (ic) hospital-associated infections (hai) hand hygiene (hh) compliance health care workers (hcws)
tofacitnib for the treatment of alopecia areata and variants

Conditions: Alopecia Areata (AA); Alopecia Totalis (AT); Alopecia Universalis (AU)

Summary: the purpose of this study is to investigate the ability of tofacitinib citrate, a janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants.

this study is an open-label pilot study. participants will be treated with oral tofacitinib for a maximum of 5 months. participants will be evaluated at 3 months after completion of therapy to evaluate for durability of response, late response and/or late adverse effects.

Eligibility criteria:
inclusion criteria: * age \>= 18 years old * diagnosis of alopecia areata with \>50% scalp involvement, alopecia totalis, or alopecia universalis * hair loss present for at least 6 months * no treatment for alopecia areata in past 2 months * no evidence of hair regrowth * females of childbearing potential must use birth control while taking the medication and there must be a negative pregnancy test documented prior to starting the medication exclusion criteria: * age \<18 years old * patients have received treatment known to affect alopecia areata within 2 months of enrolling in the study * patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin) * patients known to be hiv or hepatitis b or c positive * patients with positive tuberculin skin test or positive quantiferon tb test * patients with leukopenia or anemia * patients with renal or hepatic impairment * patients with peptic ulcer disease * patients taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or tnh-alpha inhibitors * women of childbearing potential who are unable or unwilling to use birth control while taking the medication * women who are pregnant or nursing
in vivo imaging of pigmentary disorders by reflectance confocal microscopy

Conditions: Vitiligo; Melasma; Hyperpigmentation; Hypopigmentation

Summary: this is a pilot study to evaluate the findings of the reflectance confocal microscopy when performed in cutaneous pigmentary disorders, such as vitiligo, melasma, post-inflammatory hyper-pigmentation and hypo-pigmentation. confocal microscopy is a recent diagnostic technique that has been used for observation of skin conditions that affect the superficial layers of the skin.


Eligibility criteria:
inclusion criteria: 1. subjects 20-70 years of age. 2. clinical diagnosis of vitiligo, melasma, post-inflammatory hypo or depigmentation or post-inflammatory hyperpigmentation. 3. willing and able to understand and sign informed consent. 4. able to complete study and comply with study procedures. exclusion criteria: 1. use of topical therapies such as corticosteroids, protopic, hydroquinone and azelaic acid within the past 2 months. 2. use of light therapy such as narrow-band-uvb, puva or laser within the past 2 months. 3. intake of medications that can cause pigmentary changes within the past year. examples are: * antimalarials (chloroquine, hydroxychloroquine) * chemotherapeutics (bleomycin, busulfan, doxorubicin, daunorubicin, fluorouracil, cyclophosphamide, and carmustine) * heavy metals (gold, silver, bismuth, and mercury) * tetracyclines (including minocycline, doxycycline) * amiodarone * azidothymidine * clofazimine 4. clinically significant abnormal findings or conditions (other than the pigmentary disorder), which might, in the opinion of the principal investigator, interfere with study evaluations or pose a risk to subject safety during the study. 5. subjects who are known to be pregnant or planning a pregnancy.