Kornimate/medical-research-clean huggingface dataset:
aih-induced walking recovery after subacute sci

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to determine how mild breathing bouts of low oxygen may restore walking and leg strength in persons who have sustained a spinal cord injury.

the goal of the study is to determine whether repeatedly breathing mild bouts of low oxygen for brief periods (termed acute intermittent hypoxia (aih)) improves recovery of walking and strength after spinal cord injury. this idea stems from animal studies on respiration, in which investigators showed that mild aih improves breathing in rats with spinal injuries. these studies showed that aih induces plasticity, strengthening neural connections by increasing the production of key proteins and improving the sensitivity of spinal cord circuitry. the ultimate goal of this research is to assess the potential of mild aih as a therapeutic approach not only in persons with chronic spinal cord injury but also in persons with subacute injury. by applying aih during early stages of recovery, the investigators hope to expand the potential benefits of aih to a broader range of persons with spinal injury, thereby improving functional independence and quality of life for servicemen and civilians.

Eligibility criteria:
inclusion criteria: * 18 to 70 years old * medically stable with medical clearance from physician to participate * spinal cord injury (sci) at or below c3 (phrenic sparing) and above l5 with at least motor function preserved below the neurologic level * non-progressive etiology of spinal injury * american spinal injury association impairment scale (ais) grade a-d * 2-12 months post-injury (subacute) exclusion criteria: * severe concurrent illness or pain, including unhealed decubiti, severe neuropathic or chronic pain syndrome, infection (e.g. bladder), hypertension, cardiovascular disease, pulmonary disease, severe osteoporosis (history of fractures), active heterotopic ossification in the lower extremities, or history of peripheral nerve injury in the legs * score less than 24 on mini-mental exam * severe autonomic dysreflexia * history of cardiovascular/pulmonary complications * pregnancy * severe obstructive sleep apnea (osa), characterized by uncontrolled hypoxia and sleep fractionation specific inclusion/exclusion criteria for recruiting non-ambulatory subjects: participation in this group requires all of the above inclusion/exclusion criteria, as well as being unable to complete any of the below measures: * timed up-and-go (tug) test * 10-meter walk test (10mwt) * 6-minute walk test (6mwt) specific inclusion/exclusion criteria for recruiting ambulatory subjects: participation in this group requires all of the above criteria, as well as successful completion of at least one below measure: * timed up-and-go (tug) test * 10-meter walk test (10mwt) * 6-minute walk test (6mwt)

Keywords: walk rehabilitation strength movement spinal cord trauma spinal cord injury
multipoint pacing™ post market study

Conditions: Heart Failure

Summary: this is a prospective, multicenter, non-randomized registry/observational study. the study will enroll up to 2,000 patients with successful st. jude medical (sjm) cardiac resynchronization therapy (crt) mp device implant from up to 140 centers undergoing crt implantation.

any patient who received a market approved sjm quadra allure mp, quadra assura mp, or newer sjm crt mp device is eligible for enrollment in the study. multipoint pacing (mpp) programming guidance will be specified in the protocol. patients will be followed for 12 months after implant. data will be collected at baseline (within 30 days prior to implant), post-implant (within 30 days following successful crt device implant), 3, 6, 12 months and during any unscheduled follow-up visit.

Eligibility criteria:
inclusion criteria: * are scheduled to receive a new crt implant or an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant (sjm crt mp device and sjm quadripolar lead) with no prior left ventricular lead placement * have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations exclusion criteria: * are expected to receive a heart transplant during the duration of the study * have an epicardial ventricular lead system (active or inactive) * are less than 18 years of age * are currently participating in a clinical investigation including an active treatment arm and belong to the active arm * are not expected to complete the study follow-up schedule or duration due to any health condition other than heart failure, such as malignancy, indication for heart transplant or hospice care

Keywords: multipoint pacing heart failure cardiac resynchronization therapy sjm quadripolar biventricular pacing
b-cell depletion using the monoclonal anti-cd20 antibody rituximab in very severe chronic fatigue syndrome

Conditions: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis

Summary: based on pilot patient observations, and experience from the prior study kts-1-2008, the investigators anticipate that severely affected chronic fatigue syndrome patients may benefit from b-cell depletion therapy using rituximab induction with maintenance treatment. the hypothesis is that at least a subset of chronic fatigue syndrome (cfs) patients have an activated immune system involving b-lymphocytes, and that prolonged b-cell depletion may alleviate symptoms. an approved amendment (april 15th 2011): the study will be extended with up to 5 patients. for up to 5 patients in the study, standard plasma exchange may be performed 2-3 weeks prior to start of b-lymphocyte depletion using rituximab (as in the protocol). approved amendment (december 2011): for patients with gradual improvement in cfs/me symptoms after 12 months follow-up, but not having reached a clear response, up to 6 additional rituximab infusions (500 mg/m2, max 1000 mg) may be given during the following 12 months period.


Eligibility criteria:
inclusion criteria: * patients severely affected by chronic fatigue syndrome, in who performance status iii or iv. * age 18-66 years * informed consent exclusion criteria: * patients with fatigue, not fulfilling criteria for cfs * pregnancy or lactation * previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ * previous major immunological disease, except autoimmune diseases such as diabetes mellitus or thyroiditis * endogenous depression * lack of ability to comply by the protocol * multi-allergy with risk of serious drug reaction * reduced renal function (creatinin \> 1.5 x upper normal limit \[unl\]) * reduced liver function (bilirubin or transaminases \> 1.5 x unl) * hiv positivity * evidence of clinically significant infection

Keywords: chronic fatigue syndrome cfs myalgic encephalomyelitis rituximab b-cell depletion
a study of teclistamab in combination with daratumumab and lenalidomide (tec-dr) and talquetamab in combination with daratumumab and lenalidomide (tal-dr) in participants with newly diagnosed multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (tec-dr) and talquetamab in combination with daratumumab and lenalidomide (tal-dr) versus daratumumab, lenalidomide, dexamethasone (drd).


Eligibility criteria:
inclusion criteria: * have a diagnosis of multiple myeloma according to the international myeloma working group (imwg) diagnostic criteria * be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (asct) due to: ineligible due to advanced age or; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with asct or; deferral of high-dose chemotherapy with asct as initial treatment * have an eastern cooperative oncology group (ecog) performance status score of 0 to 2 * a participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment * a participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment exclusion criteria: * received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams \[mg\] dexamethasone or equivalent). in addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (\>=) 20 mg of dexamethasone within 14 days before randomization * had plasmapheresis within 28 days of randomization * had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization * known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients * known contraindications to the use of daratumumab or lenalidomide per local prescribing information * myeloma frailty index of \>=2 with the exception of participants who have a score of 2 based on age alone
association analysis for chronic diseases based on resident health records by using big data methods

Conditions: Chronic Disease

Summary: this is an observational study to analysis the association factors for common diseases, including chronic obstructive pulmonary disease, coronary artery disease, hypertension, diabetes etc, based on resident healthcare records. more than 10 million resident healthcare records should be collected for the associations study by using big data methods.


Eligibility criteria:
inclusion criteria: * survey chinese residents aged 20 - 100 years, were included in this study. exclusion criteria: * serious hepatic or renal dysfunctions.
efficacy and safety of methylprednisolone administered intravenously for the treatment of patients with active ankylosing spondylitis (metall)

Conditions: Ankylosing Spondylitis

Summary: in this study, efficacy of methylprednisolone in reduction of signs and symptoms (back pain, stiffness, joint pain and swelling) of active ankylosing spondylitis (as) will be investigated. it is expected, that a single dose of methylprednisolone 500 mg given intravenously at baseline will lead to a rapid reduction of symptoms of active as, which can be seen already 2 weeks after drug administration.


Eligibility criteria:
inclusion criteria: * age of ≥18 years. * definite diagnosis of as according to the modified new york criteria. * history of an inadequate response to ≥2 nonsteroidal antiinflammatory drugs (nsaids) taken for at least 2 weeks each or nsaids intolerance. * active disease as defined by the bath ankylosing spondylitis disease activity index (basdai) value of ≥4 at screening despite concomitant treatment with an nsaid or without nsaids in case of intolerance. exclusion criteria: * the female subject is pregnant or lactating. * patients with other chronic inflammatory articular disease or systemic autoimmune disease. * history of inadequate response to previous anti-tumour necrosis factor (tnf) α therapy. * treatment with any other investigational drug within 4 weeks of 5 half-life of the drug (whichever is longer) prior to baseline. * treatments with disease modifying anti-rheumatic drugs (dmards) other than methotrexate within 4 weeks prior to screening (8 weeks for leflunomide or 4 weeks with a standard cholestyramine wash-out). * treatment with intravenous, intramuscular or intraarticular/periarticular steroids within 4 weeks prior to screening. * history of oesophageal, gastric, duodenal or intestinal ulceration, clinically relevant gastrointestinal bleeding. * history of or current signs of coronary heart disease, myocardial infarction, stroke or transient ischemic attack, peripheral arterial thrombotic events. * congestive heart failure (nyha iii-iv) * uncontrolled arterial hypertension. * history of diabetes mellitus. * history of glaucoma. * major surgery within 12 weeks prior to screening. * evidence of any other severe uncontrolled gastrointestinal, hepatic, renal, pulmonary, cardiovascular, nervous or endocrine disorders. * any active current viral, bacterial or fungal infection, a history of recurrent clinically significant infection, infections requiring treatment with antibiotics within 4 weeks prior to baseline. * history of chronic infection with hepatitis b or c, history of hiv infection. * primary or secondary immunodeficiency. * any other conditions making the patient unsuitable in the opinion of the investigator for the participation in the current study.
epicardial mini-maze versus catheter ablation for the management of persistent atrial fibrillation

Conditions: Persistent Atrial Fibrillation

Summary: this study will assess the efficacy of catheter ablation versus the wolf mini-maze surgical ablation for rhythm control in patients with persistent afib.

higher success rates have been achieved after a single surgical ablation when compared to catheter ablation, however contiguous and transmural lesions are not always guaranteed. even though, catheter ablation is now being offered for symptomatic persistent af, recurrence after the index procedure in such a persistent af substrate is not unusual. redo-catheter ablation is routinely offered for such patients; however long term success still remains low. non-pulmonary vein triggers are often targeted in such redo-catheter ablation procedures; though this approach remains controversial. more recently, the wolf mini-maze procedure has been utilized with promising results. this study proposes to randomize a group of persistent af patients to undergo either catheter ablation or the surgical mini-maze procedure with left atrial appendage (laa) ligation

Eligibility criteria:
inclusion criteria: * persistent symptomatic af with failure of at least 1 anti-arrhythmic drug * prior pulmonary vein isolation (pvi) * cha2ds2vasc \> 0 * able to tolerate and compliant with oral anticoagulation with either warfarin, dabigatran, rivoraxaban or apixiban exclusion criteria: * inability to follow-up as per protocol * prior valvular surgery or valve replacement * reversible cause for atrial fibrillation * currently on dialysis or renal replacement therapy * need for concomitant cardiac surgery * history of mi or stroke ≤2 months prior to ablation * intolerance to oral anticoagulants * thrombus in the left atrial appendage
low literacy intervention for colorectal cancer screening

Conditions: Colorectal Cancer

Summary: of 17 performance measures of hospital quality regularly reported for the veterans administration (va) health care system, rates of colorectal cancer screening are the lowest.

background: of 17 performance measures of hospital quality regularly reported for the veterans administration (va) health care system, rates of colorectal cancer screening are the lowest. objectives: the objectives of this study were to 1) test whether a health care provider-directed intervention increased colorectal cancer screening rates in an urban va medical center and 2) evaluate the cost-effectiveness of the intervention. methods: the study was a randomized controlled trial, conducted at two clinic firms at a va medical center in chicago. eligible patients were men, age 50 and older, had no personal or family history of colorectal cancer or polyps, had not received colorectal cancer screening, and had at least one visit to the clinic during the study period. health care providers in the intervention firm attended a workshop on colorectal cancer screening. every 4-6 months they attended quality improvement workshops where they received group screening rates, individualized confidential feedback, and training on improving communication with patients with limited literacy skills. medical records were reviewed for colorectal cancer screening recommendations and completion. literacy level was assessed in a subset of patients. in the cost-effectiveness analysis, resource and cost estimates were derived. status: the project is complete.

Eligibility criteria:
inclusion criteria: patients over 50 with average risk for colorectal cancer. patients with family history and/or personal history excluded, as well as those up to date on colorectal cancer screening. exclusion criteria:
mt2014-25: haplo nk with sq il-15 in adult relapsed or refractory aml patients

Conditions: Acute Myelogenous Leukemia

Summary: a phase ii trial of cd3/cd19 depleted, il-15 activated, donor natural killer (nk) cells in adults and subcutaneous il-15 given after a preparative regimen for the treatment of relapsed or refractory acute myelogenous leukemia (aml). the primary objective is to study the potential efficacy of nk cells and il-15 to achieve complete remission while maintaining safety.


Eligibility criteria:
inclusion criteria (recipient): * meets one of the following disease criteria: 1. primary aml induction failure: no cr after 2 or more induction attempts 2. relapsed aml or secondary aml (from mds or treatment related): not in cr after 1 or more cycles of standard re-induction therapy 3. aml relapsed \> 2 months after transplant: no re-induction required, and no more than 1 re-induction cycle is allowed. 4. relapsed aml for patients \> 60 years of age the 1 cycle of standard chemotherapy is not required if either of the following criteria is met: * relapse within 6 months of last chemotherapy * bm blast count \< 30% within 10 days of starting protocol therapy * available related hla-haploidentical donor (aged 14 to 75 years) by at least class i serologic typing at the a\&b locus * karnofsky performance status ≥ 60% * patients must have adequate organ within 14 days (28 days for pulmonary and cardiac) of study registration * able to be off prednisone or other immunosuppressive medications for at least 3 days prior to nk cell infusion (excluding preparative regimen pre-medications). * agrees to use contraception prior to study entry and for the duration of study participation. exclusion criteria (recipient): * bi-phenotypic acute leukemia. * transplant \< 60 days prior to study enrollment. * active autoimmune disease. * history of severe asthma * uncontrolled intercurrent illness * new or progressive pulmonary infiltrates on screening chest x-ray or chest ct scan that has not been evaluated with bronchoscopy * pleural effusion large enough to be detectable on chest x-ray. * pregnant women * history of hiv, active or chronic hepatitis b, hepatitis c or htlv-i infection * known hypersensitivity to any of the study agents used * received investigational drugs within the 14 days of study registration. * known active cns involvement. criteria for initial donor selection: * related donors (sibling, parent, offspring, parent or offspring of an hla identical sibling). * 14-75 years of age. * at least 40 kilogram body weight. * in general good health as determined by the evaluating medical provider. * hla-haploidentical donor/recipient match by at least class i serologic typing at the a\&b locus. * not pregnant. * able and willing to undergo apheresis.

Keywords: aml relapsed refractory
cannabidiol for inflammatory bowel disease

Conditions: Crohn's Disease; Ulcerative Colitis

Summary: there are many anecdotal reports about improvement of inflammatory bowel diseases (ibd) with cannabis smoking. the most effective anti inflammatory compound known today is cannabidiol. cannabidiol can be extracted from the cannabis plant, it has no central effect and is fat soluble so it can be given as drops in oil. doses of up to 500mg did not cause any side effects. the aim of the proposed study is to examine in a double blind placebo controlled fashion the effect of cannabidiol on disease activity in patients with ibd.

background: inflammatory bowel diseases (ibd) are relatively common disease with a rising incidence. treatment includes various immunocompromising agents including corticosteroids, immunomodulators and biologic agents. current treatment is not always effective and has many side effect. cannabinoids have been known to have anti inflammatory effect, probably via the cb2 receptor. there are many anecdotal reports of cannabinoids in inflammatory disease such as rheumatoid arthritis, and the impression is that cannabinoids do have an ameliorating effect on ibd and that side effects are negligible. however, there are no placebo controled trials in human subjects. the cannabis plant contains about 600 ingredients, and it is not known which are the active ingredients affecting ibd. the most effective anti inflammatory compound known today is cannabidiol. cannabidiol can be extracted from the cannabis plant, it has no central effect and is fat soluble so it can be given as drops in oil. doses of up to 500mg did not cause any side effects. the aim of the proposed study is to examine in a double blind placebo controlled fashion the effect of cannabidiol on disease activity in patients with ibd.

Eligibility criteria:
inclusion criteria: 1. patients with a diagnosis ibd at least 3 months before recruitment will be eligible to the study. 2. patients with active disease who are resistant to either 5 asa, steroids or immunomodulators, or who can not receive those drugs due to adverse reactions will be offered the possibility of receiving cannabidiol at a dose of 10 mg in sub lingual drops or drops of olive oil as placebo. 3. disease activity index of either cdai of more then 200 in crohn's disease or mayo score above 3 in uc. 4. age above 20. exclusion criteria: 1. patients with a known mental disorder 2. patients who are deemed to be at a high risk of abuse or addiction to the study drug. 3. pregnant women 4. patients who are sensitive to any of the ingredients of the study medication. 5. patients who are unable to give informed consent. 6. patients who may need surgery in the near future.

Keywords: crohn's disease ulcerative colitis cannabis cannabidiol
perioperative mechanical ventilation and postoperative monitoring of ipi

Conditions: Mechanical Ventilation Complication; Postoperative Pulmonary Atelectasis

Summary: this study evaluates the influence of alveolar recruitment maneuver, protocolized liberation from respiratory support and monitoring of integrated pulmonary index on the duration of the mechanical ventilation and the number of pulmonary complications in the early postoperative period after cardiac surgery.

the outcome of elective off-pump coronary artery bypass grafting (opcab) can be significantly compromised due to early postoperative pulmonary complications. the risk of pulmonary complications including acute respiratory distress syndrome (ards), atelectases, and early ventilator-associated pneumonia remains inappropriate. therefore, the maneuvers improving pulmonary aeration and the early restoration of spontaneous breathing activity can be of clinical value. protocol-driven liberation from mechanical ventilation (cmv) can decrease the duration of cmv as well as the number of pulmonary complications. intellivent-assisted spontaneous ventilation (intellivent-asv) is a new approach, that may be as effective as conventional protocol-driven liberation from cmv. in parallel, the thorough postoperative monitoring of pulmonary function during both postoperative mechanical ventilation and spontaneous breathing is also of a great value. one of the novel approaches to respiratory monitoring is integrated pulmonary index (ipi). the integrated pulmonary index merges four vital parameters including end-tidal carbon dioxide (etco2), respiratory rate, pulse rate, and oxygen saturation (spo2) measured by capnography and pulse oximetry into a single index value utilizing fuzzy logic model .

Eligibility criteria:
inclusion criteria: * informed consent. * elective opcab. exclusion criteria: * participation in any other study. * morbid obesity (bwi \> 40). * the risk of pneumothorax after alveolar recruitment due to pulmonary emphysema. * constant atrial fibrillation with pulse rate exceeding 100/min. * inability to breathe easily through the nostrils and thus to gain good quality etco2 readings while breathing spontaneously, due to chronic rhinitis.

Keywords: integrated pulmonary index automated protocol-driven weaning pulmonary recruitment maneuver