Kornimate/medical-research-clean huggingface dataset:
roll-over protocol to provide atv and/or truvada for extended access

Conditions: HIV

Summary: the purpose of this study is to provide atazanavir or tenofovir-emtricitabine to hiv-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous bms sponsored clinical trial and to collect long-term safety information on the treated population.

provide study drug for patients rolling off bms atv clinical trials in countries where these medications are not commercially available.

Eligibility criteria:
inclusion criteria: * subjects must provide written informed consent * currently receiving atazanavir (unboosted or boosted with 100 mg ritonavir qd)and/or tenofovir-emtricitabine at time of screening and viral load is ≤ 10,000 copies/ml while on therapy * subjects who are receiving investigational antiretroviral agents through expanded access programs will be allowed to participate following discussion and approval by the bms medical monitor * ≥ 16 years of age (or minimum age as determined by local regulatory or as legal requirements dictate) * both females of child-bearing potential and males must utilize effective barrier contraception to reduce transmission of sexually transmitted diseases, including hiv. other contraception in addition to barrier methods are permitted, however interactions between atazanavir and oral contraceptives have not been studied exclusion criteria: * wocbp who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study * wocbp using a prohibited contraceptive method (no contraceptive methods prohibited in this study. however, caution is warranted with coadministration of oral contraceptives) * women who are pregnant or breastfeeding * women with a positive pregnancy test on enrollment or prior to study drug administration, with the exception of women rolling over from ai424182, who may still have a positive β-hcg test at the time of enrollment * all subjects previously discontinued from an atazanavir study for any reason * active alcohol or substance abuse sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis * any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study, or unable to comply with the dosing requirements * any of the following laboratory values: * a) serum creatinine ≥ 1.5 times the upper limit of normal, * b) liver enzymes (ast, alt) ≥ 5 times the upper limit of normal, * hypersensitivity to any component of the formulation of study drug * refer to section 6.4.1 which details all prohibited therapies * prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Keywords: treatment experienced
postoperative anemia after bariatric surgery

Conditions: Anemia; Bariatric Surgery Candidate

Summary: to investigate the real incidence of short and long-term anemia after bariatric surgery, and explore the risk factors.

this study aims to investigate the real incidence of short and long-term anemia after bariatric surgery and explore the risk factors.

Eligibility criteria:
inclusion criteria: * patients who will undergo sleeve gastrectomy or roux-en-y gastric bypass * aged between 16 and 70 years * patients who is not diagnosed as anemia at baseline exclusion criteria: * patients who have anemia at baseline
randomized clinical trial: nasoenteric catheter or jejunostomy

Conditions: Postoperative Complications After Gastrointestinal Operations

Summary: curative treatment of upper gastrointestinal tract neoplasms is complex and associated with high morbidity and mortality. in general, the patients are already malnourished, and early postoperative enteral nutrition is recommended. however, there is no consensus concerning the best enteral access route in these cases.

a prospective randomized trial with patients undergoing esophagectomy, total gastrectomy or pancreaticoduodenectomy to asses the outcomes of either jejunostomy placement or catheter placement

Eligibility criteria:
inclusion criteria: * age over 18, * gastrointestinal resections exclusion criteria: * age under 18, * no gastrointestinal procedure

Keywords: gastrointestinal surgery, complications, length of hospital stay, mortality
early fdg pet/ct imaging as a measure of response in patients with non-hodgkin lymphoma on lenalidomide

Conditions: Non-Hodgkin Lymphoma

Summary: adult patients with non-hodgkin lymphoma who will be treated with lenalidomide will undergo fdg pet/ct scan as an early evaluation of response to therapy. changes in fdg uptake will be correlated response and long term outcomes.


Eligibility criteria:
inclusion criteria: * adult patients, at least 18 years of age * history of histologically confirmed nhl as assessed per medical record review. * at least one site of measurable disease (per recist 1.1) that is seen on ct, mri, or fdg pet/ct. * recommended to start lenalidomide. * participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. exclusion criteria: * females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. female participants of child-bearing potential will have a urine or serum pregnancy test at the time of the screening visit. * inability to tolerate imaging procedures in the opinion of the investigator or treating physician. * serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
effect study of optimized intervention to heroin addicts

Conditions: Heroin Dependence

Summary: the purpose of this study is to explore barriers and determine whether optimizing protocol is effective in the treatment of heroin dependence in community-based mmt clinics.

drug dependence is one of the most serious public health problems worldwide. in china, among more than 100, 0000 registered drug addicts mostly are heroin dependence. drug dependence post great risks to physical condition, their family and society, and can lead to infectious disease transmission. though almost 500 mmt clinics which can offer mmt service to heroin addicts have been set up, there are still some problems, for example, poor compliance, high rate of dropping out and relapse which affect the service delivery to them. the guideline developed by who focused on psychotherapy to opiate addicts with mmt. so delivery of a set of comprehensive, integrated psychotherapy to opiate addicts is very critical in such methadone clinics.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of heroin dependence * must be able to take methadone exclusion criteria: * schizophrenia and mood disorder * physical disabilities who could not come to take part in psychotherapy sessions.

Keywords: heroin dependence community-based mmt
effectiveness of therapy via telemedicine following cochlear implants

Conditions: Congenital Sensorineural Deafness

Summary: this study will assess the effectiveness of post-cochlear implant or hearing aid fitting aural rehabilitative therapy (art) delivered by means of telemedicine technology.

children with congenital sensorineural deafness can acquire relatively normal language if they undergo cochlear implantation surgery or hearing aid fitting followed by aural rehabilitation therapy in the first three to four years of life. high quality therapy, however, may not be available in many areas. this study will assess the effectiveness of post-cochlear implant or hearing aid fitting art delivered by means of telemedicine technology. this will be accomplished primarily by evaluating subjects' language abilities using the 5th edition of the preschool language scales.

Eligibility criteria:
inclusion criteria: * been fitted with bilateral or unilateral cochlear implants, or bilateral hearing aids. * focus on recruiting families who are members of minority groups. * therapy must be provided in english. exclusion criteria: * the presence of one or more significant co-morbidities * blindness, * severe motor impairment, * autism, * significant genetic/chromosomal syndrome.

Keywords: cochlear implant hearing aid telemedicine
sorafenib for prophylaxis of leukemia relapse in allo-hsct recipients with flt3-itd positive aml

Conditions: Acute Myeloid Leukemia; Hematopoietic Stem Cell Transplantation

Summary: the purpose of this study is to evaluate the efficacy of sorafenib for prophylaxis of leukemia relapse in allogeneic stem cell transplant (allo-hsct) recipients with flt3-itd positive acute myeloid leukemia (aml).

internal tandem duplication of fms-like tyrosine kinase 3 (flt3-itd) mutations have been reported in 20%-30% of patients with acute myeloid leukemia (aml). flt3-itd-positive aml patients have an inferior survival, primarily due to lower complete remission (cr) rate and higher relapse rate. although allogeneic hematopoietic stem cell transplantation (allo-hsct) improves the outcomes of some flt3-itd-positive aml, a significant number will suffer disease recurrence after allo-hsct. sorafenib, an inhibitor of multiple kinases including flt3, has shown promising activity in flt3-itd-positive aml. recent studies have shown that sorafenib monotherapy or in combination with chemotherapy are effective in attaining cr, but they do not have significant improvement in relapse. currently, prophylactic use of sorafenib after allo-hsct has been rarely reported, and whether it can improve outcomes of flt3-itd-positive aml remains unclear.

Eligibility criteria:
inclusion criteria: * flt3-itd positive aml * allo-hsct recipients exclusion criteria: * cardiac dysfunction (particularly congestive heart failure) * hepatic abnormalities (bilirubin ≥ 3 mg/dl, aminotransferase\> 2 times the upper limit of normal) * renal dysfunction (creatinine clearance rate \< 30 ml/min) * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * patients with any conditions not suitable for the trial (investigators' decision)

Keywords: acute myeloid leukemia flt3-itd hematopoietic stem cell transplantation
acute effect of mirror therapy on rehabilitation of paretic upper extremity after chronic stroke

Conditions: Stroke

Summary: objective: to investigate the acute effect of mirror therapy (mt) on motor control, manual dexterity and spasticity of the paretic upper extremity (ue) of individuals with chronic hemiparesis after stroke, during reaching task. design: randomized cross-over single-blinded trial. subjects: thirty-three patients post chronic stroke were recruited of the study. intervention: patients who first participated in the mt intervention performed a single session of mt, whereas in the control intervention a single session composed of the same exercises was performed, but without the mirror. after a month washout, the patients switched groups. main measure: the primary outcome measure was motor control. the secondary outcome measure was manual dexterity and ue spasticity. the data will be expressed as mean and 95% confidence interval (continuous variable) and absolute frequency (categorical variables). to compare the outcomes of the different experimental sessions and at the different moments (pre and post session), the generalized estimating equations with post hoc lsd (least significant difference) methods will be used. for all analysis the significance level was set at α = 0.05 and statistical software spss (statistical package for social sciences for mac, version 22.0, ibm, usa) will be used. key words: stroke, mirror therapy, upper extremity, kinematic analysis


Eligibility criteria:
inclusion criteria:1) to have a diagnosis of unilateral, ischemic or hemorrhagic, stroke for at least 6 months and at most 5 years ; 2) age between 30 and 80 years; 3) cognitive ability to follow the instructions of the study (mini-mental score ≥ 18 for schooling and ≥ 13 for illiterate);4) mild or moderate motor sensory impairment (fugl-meyer assessment scale - mild: 58-64 points, moderate: 39-57 points); 5) spasticity ≤ 2 in the flexor elbow and wrist muscles, and horizontal shoulder adductor (modified ashworth scale); 6) muscle strength ≥ 3 in the flexor muscles of the shoulder, elbow and wrist, and elbow and wrist extensors (kendall assessement). - exclusion criteria: * patients with visual impairment; history of severe depression or severe psychiatric disorder; other neurological or musculoskeletal disorders in the ue; visuospatial heminegligence; or pain file ≥ 4 on the compromised ue (visual analog pain scale), were excluded from the study.
families in balance: enhancing household routines and reducing early childhood obesity among families with low-income

Conditions: Health Behavior

Summary: this study will evaluate the effects of two different approaches to support healthy family mealtime, sleep, and screentime routines: a parent leader-guided online program that promotes parent and child self-regulation as a means to improve healthy family routines versus an asynchronous program that provides parents information about healthy family routines. families will be randomly assigned to either of these programs and changes in parent and child outcomes will be evaluated.


Eligibility criteria:
inclusion criteria: * parents must be the legal and custodial guardian of a 2 through 5-year-old child * parents must report that their child is eligible for public health insurance * parents must be able to complete the study activities in english * parents must be able to complete study activities at a study location or at home, and online/via zoom. exclusion criteria: - children must not have serious medical problems that affect weight, sleep, activity, or eating.

Keywords: online program informational material surveys eating activity sleep health behaviors body mass index
stroke wearable operative rehabilitation device impact trial

Conditions: Ischemic Stroke; Upper Extremity Hemiparesis

Summary: the objective of this study is to determine the impact of vibratory feedback on the quality and intensity of a common motor rehabilitation task of the upper-arm (hand-to-mouth) in stroke patients. for that purpose the investigators use the sword system that combines 3d motion quantification wearable sensors and a vibratory module. the investigators hypothesize that vibratory stimuli during a motor rehabilitation task increase significantly the number of correct movements performed per unit of time. the design of the study is a cross-over randomized clinical trial. with the sword system in place each patient will perform the hand-to-mouth task twice (with vibratory feedback and without it), the order being random. the number of correct movements and other motor outcomes will be assessed continuously under both conditions.


Eligibility criteria:
inclusion criteria: * more than 18 years old at stroke onset, with no superior age limit; * medical diagnosis of acute ischemic stroke; * first ever stroke; * previously independent, defined as having a modified rankin scale (mrs) of 0-1; * clinical and ct or mri compatible with a medial cerebral artery ischemic lesion; * confirmed motor deficit on the upper limb but not plegia (able to actively extend wrist, thumb, and at least 2 other digits \>10°), defined as a score between 0 and 2 on items 5a or 5b of the national institute of health stroke scale; * inpatients, within no more than 4 weeks after stroke onset; * medically stable, no intravenous medication and already able to sit for more than one hour comfortably; * favourable opinion of the attending stroke physician; * patient and caregiver understand the purpose of the study and provided written informed consent. exclusion criteria: * no detectable motor deficits at baseline assessment by the neurologist; * severe aphasia; * dementia (any stage); * other cognitive or psychiatric comorbidity that impairs communication or compliance with the tasks; * severe respiratory or cardiac condition incompatible with more than one minute of continuous mild exercise (e.g. combing hair) in a sitting position; * pain that limits upper limb movement either on the normal or affected side; * upper limb amputation or severe deformity either on the normal or affected side; * fixed articular limitations of upper limb either on the normal or affected side; * enrollment in other trial in the previous 3 months.

Keywords: stroke motor deficits motor rehabilitation neurorehabilitation medical devices wearable devices e-health systems
pilot study of warm acupuncture in treatment of cold-sensitive fibromyalgia syndrome

Conditions: Fibromyalgia

Summary: non-pharmaceutical therapies, such as acupuncture, hydrotherapy, and meditative exercises (such as qigong (including tai chi and ba-duan-jin), have been shown to reduce pain and improve physical function. the management recommendations of fibromyalgia issued by the european union, canada, germany and israel have all affirmed the "first-line" role of non-pharmaceutical therapy. because of its good efficacy and safety, acupuncture therapy has been recommended in the management guidelines and has broad application prospects. warm acupuncture is a therapy combining acupuncture and moxibustion, which is widely used in the treatment of various painful diseases in china, especially for cold-sensitive patients . this study aims to observe the safety and effectiveness of warm acupuncture in the treatment of cold-sensitive fibromyalgia patients, in order to provide a more alternative non-drug therapy for this particular type of patients with fibromyalgia .


Eligibility criteria:
inclusion criteria: 1. meet the 1990 american college of rheumatology (acr) research classification criteria for fibromyalgia; 2. be over 18 years of age; 3. the type and dose of drugs used for fibromyalgia should be stable for at least 2 weeks; 4. the vas score of item 10 (sensitivity to cold) in fiqr scale ≧4 points; 5. sign informed consent. exclusion criteria: 1. patients suffering from systemic or local acute infectious diseases; 2. patients with severe visceral diseases or physical weakness who cannot tolerate acupuncture treatment; 3. pregnant women.

Keywords: fibromyalgia cold-sensitive needle warming moxibustion randomized controlled trial warm acupunctrue
roflumilast as add-on therapy in early cases of ards

Conditions: Respiratory Distress Syndrome, Adult

Summary: * mild cases of ards will be included in a two-arm protocol, to receive 500 mcg of roflumilast daily up to 28 days (fda approved dose for copd) plus standard of care versus standard of care alone. * approximately 76 hospitalized patients with ards will be enrolled in this study. * eligible patients will be randomized at ratio of (1:1) to receive either roflumilast plus standard of care or standard of care alone.

• methodology in details: * informed consent will be obtained from included participants. * mild cases of ards will be included in a two-arm protocol, to receive 500 mcg of roflumilast daily up to 28 days (fda approved dose for copd) plus standard of care versus standard of care alone. * approximately 76 hospitalized patients with ards will be enrolled in this study. * eligible patients will be randomized at ratio of (1:1) to receive either roflumilast plus standard of care or standard of care alone. * randomization: randomization will be in 1:1 ratio using permuted blocks of different sizes. random.org website will be used for random selection of a sequence of blocks. the latter will be used to generate a randomized list which will be generated and stored by a third party independent of the study team. for allocation concealment, the list will be used to make sequentially numbered sealed opaque envelopes, each containing the sequential randomization number and allocation of subsequent cases. envelopes will be handed to the study team member responsible for medication preparation. each envelope will be opened only after: 1. screening for eligibility 2. obtaining consent 3. recording baseline characters the treatment allocation dictated in the envelope will be documented in the case record form and will be subject to audit to assure correct randomization according to the original list. * intervention: drug: roflumilast 1. roflumilast 500 mcg daily for up to 28 days 2. total follow up time will be 28 days. 3. proinflammatory parameters will be assessed at baseline, day 7, day 14, and at the end of treatment. 4. roflumilast will be combined with standard of care for ards. 5. during hospitalization, clinical and laboratory data will be recorded daily in the medical history of the patient and in data collection table of the study. 6. during hospitalization, adverse drug reaction will be monitored clinically and by laboratory tests. 7. in case of an adverse effect or a need to discontinue the treatment, roflumilast should be suspended.

Eligibility criteria:
inclusion criteria: * ability to sign informed consent * patients \>18 years old male or female * mild cases of ards according to the berlin criteria (pao/fio 200 to 300 mmhg) exclusion criteria: * pregnancy and breast feeding * history of hypersensitivity to roflumilast * patients with mechanical respiratory assistance (severe ards) * patients under treatment with roflumilast for copd * patients with psychiatric diseases * hepatic cirrhosis (child-pugh score b or c) * refused to sign informed consent
efficacy and safety in patients with acute coronary syndrome without st-segment elevation

Conditions: Platelet Aggregation Inhibitors; NSTEACS

Summary: to evaluate the efficasy and safety of sr25990c(loading dose:300mg, maintenance dose:75mg/day) in comparison with the standard japanese treatment(ticlopidine) in patients with acute coronary syndrome without st-segment elevation and planned for percutaneous coronary intervention(including stenting).


Eligibility criteria:
inclusion criteria: * patients aged above 20, admitted to hospitals with symptoms suspected to represent an acute coronary syndrome defined as unstable angina or acute mi without st segment elevation greater than 1 mm are eligible for the study if they meet the following criteria: * (1)clinical history consistent with new onset or worsening pattern of characteristic ischemic chest pain occurring at rest or with minimal exercise (lasting longer than 5 minutes or requiring sublingual nitroglycerin for the relief of pain within 24 hours before registration). * (2)patients who meet either of following criteria * ecg changes compatible with new ischemia \[e.g. st depression (at least 1 mm), t wave inversion (at least 2 mm), or hyperacute peaked t waves in 2 contiguous leads\]. * already elevated ck at least twice the upper limit of normal or ck-mb or troponin i or t above the upper limit of normal or positive qualitative test for troponin t. * (3)a percutaneous coronary intervention is planned within 96 hours after the first study drug administration exclusion criteria: * a)factors that affect participation in study: * (1)previous disabling stroke * (2)previous intracranial hemorrhage or hemorrhagic stroke * (3)severe co-morbid condition such that the patient is not expected to survive 1 month * (4)nyha class iv heart failure * (5)uncontrolled hypertension * (6)requirement for use of oral anticoagulants, non study antiplatelet agents (including ticlopidine) or nsaids (excluding unum sumatur), during study period, * b)factors related to asa and/or ticlopidine treatment: * (1)use of ticlopidine within 1 week prior to randomization * (2)history of asa or ticlopidine intolerance or allergy * (3)contraindications to asa or ticlopidine

Keywords: sr25990c platelet aggregation inhibitors nsteacs