Kornimate/medical-research-clean huggingface dataset:
study of hyperbaric oxygen therapy in addition to standard growth factor support for hematopoietic progenitor/stem cell mobilization

Conditions: Multiple Myeloma

Summary: the purpose of this study is to evaluate the safety and efficacy of hyperbaric oxygen therapy (hbot) as a therapeutic option in mobilizing stem cells for autologous stem cell transplant.

subjects will receive hbot daily for 10 days in conjunction with standard growth factor treatment regimens for stem cell mobilization. the role of hbot in stem cell mobilization as well as its role on oxidative stress will be evaluated.

Eligibility criteria:
inclusion criteria: * patients who are being considered for autologous stem cell transplant as part of their routine care who have failed at least one prior attempt at stem cell mobilization with any of currently available standard regimens using growth factors. * patients in who the use of mozobil® is medically justified but is not possible because of insurance or financial reasons * patients scheduled to begin standard growth factor treatment with neupogen® as part of routine care. * patients who have had a bone marrow evaluation performed within one month prior to enrollment as part of routine clinical care or under irb# 02815. * patients who have had a chest x-ray or ct chest within 60 days prior to enrollment. * ecog performance status ≤ 3 performed within 60 days prior to enrollment which will be determined by history. * patients who are at least 18 years of age at the time of registration. * patient must have signed an irb-approved informed consent and understand the investigational nature of the study. exclusion criteria: * clinically significant hepatic dysfunction as noted by direct bilirubin or ast \>3 times the upper normal limit or clinically significant concurrent hepatitis within 60 days prior to enrollment. * history of new york heart association (nyha) class iii or class iv heart failure * recent (\< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias from medical history. * untreated pneumothorax from medical history. * uncontrolled seizure disorder from medical history * uncontrolled insulin dependent diabetes (verified by routine labs in medical record) * history of severe claustrophobia * severe copd (fev1 \< 50% of predicted on pulmonary function test) performed within 60 days prior to enrollment * untreated ear barotraumas from medical history * pregnancy or currently breastfeeding (females of childbearing potential must agree to use adequate contraception during the study). a urine pregnancy test will be performed prior to initiating hbot. * patients currently receiving bleomycin, cisplatin, disulfiram, doxorubicin, and sulfamylon. * any other condition that the pi determines may jeopardize the safety of the subject during the course of the study

Keywords: hyperbaric oxygen mobilize stem cells growth factor
adaptive hip exoskeleton for stroke gait enhancement

Conditions: Stroke

Summary: this work will focus on new algorithms for robotic exoskeletons and testing these in human subject tests. individuals who have previously had a stroke will walk while wearing a robotic exoskeleton on a specialized treadmill as well as during other movement tasks (e.g. over ground, stairs, ramps). the study will compare the performance of the advanced algorithm with not using the device to determine the clinical benefit.

the focus of this work is a proposed novel artificial intelligence (ai) system to self-adapt control policy in powered exoskeletons to aid deployment systems that personalize to individual patient gait. individuals post stroke have a broad range of mobility challenges including asymmetric gait, substantially decreased ssws, and reduced stability, and therefore have greatly impaired overall mobility independence in the community. the investigators expect the proposed novel controller, capable of personalization to such variable and asymmetric gait patterns, will have significant benefits towards increasing community independence and mobility for patients post stroke. patients post stroke will be fit with a hip exoskeleton (in a powered and/or unpowered state) and proceed to walk on a treadmill or perform various movement tasks. the same tasks will be performed by the patients without wearing the hip exoskeleton to serve as a baseline. the investigators expect improved outcomes in the powered hip exoskeleton compared to the unpowered hip exoskeleton and baseline conditions.

Eligibility criteria:
inclusion criteria: * between 18-85 years of age * had a stroke at least 6 months prior to study involvement * are community dwelling, which means the participant does not live in an assisted living facility * are able to provide informed consent to participate in the study activities * can safely participate in the study activities (per self-report) * must have a functional ambulation category (fac) score of 3 or above, which means the participant can walk without the assistance of another person exclusion criteria: * require a walker to walk independently * have a shuffling gait pattern * have a functional ambulation category (fac) score of 2 or lower, which means the participant requires the assistance of another person in order to walk * have a significant secondary deficit beyond stroke (e.g. amputation, legal blindness or other severe impairment or condition) that in the opinion of the principal investigator (pi), would likely affect the study outcome or confound the results

Keywords: stroke
insulin pump vs multiple daily injection on cardiovascular outcomes (italico)

Conditions: Diabetes Mellitus

Summary: the aim of this study was to evaluate if the positive effects recorded on glycemic control with csii were maintained on the long term compared to multi-daily injections (mdi). the secondary objective was to evaluate if there is a reduction of type and number of cardiovascular events (cv) in csii group compared to mdi group after 8 years of observation. this retrospective, observational trial evaluated 104 diabetic patients with prior treatment with mdi initiating csii therapy compared to 109 diabetic patients continuing mdi.


Eligibility criteria:
inclusion criteria: * patients with type 1 or 2 diabetes with prior treatment with mdi initiating csii therapy with tubed insulin pumps * patients type 1 or 2 diabetes with prior treatment with mdi continuing mdi * patients attending the center for at least 8 years exclusion criteria: * patients not taking insulin
renal denervation in patients with uncontrolled hypertension - symplicity htn-4

Conditions: Hypertension; Vascular Diseases; Cardiovascular Diseases

Summary: an international, multi-center, prospective, blinded, randomized, controlled trial. the objective is to demonstrate that catheter-based renal denervation is an effective and safe treatment for uncontrolled hypertension.

after the 6 month follow-up required testing has been completed, control group subjects would be unblinded to their randomization group and would have an option, at the discretion of the investigator and with written concurrence of the medical monitor, to be treated with renal denervation procedure. however, after enrollment closure, subjects previously randomized were no longer allowed to cross-over.

Eligibility criteria:
inclusion criteria: * individual is on maximally tolerated stable medication regimen including 3 or more anti-hypertensive medications of different classes, one of which must be a thiazide or thiazide-like diuretic * individual has office sbp greater than or equal to 140mmhg and less than 160mmhg * individual has abpm average sbp greater than or equal to 135 mmhg exclusion criteria: * individual lacks appropriate renal artery anatomy * individual has egfr of less than 30 * individual has type i diabetes mellitus * individual has had one or more episodes of orthostatic hypotension * individual requires chronic oxygen other than nocturnal respiratory support for sleep apnea * individual has primary pulmonary hypertension * individual has other concomitant conditions that may adversely affect the patient or the study outcomes * individual is pregnant, nursing or planning to be pregnant * individual has had a previous organ transplant

Keywords: uncontrolled hypertension blood pressure renal denervation htn-4 symplicity
study in postmenopausal women with type 2 diabetes looking at approved diabetes drugs and how they affect bone health

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine the effects of rosiglitazone on the bone in postmenopausal women with type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria: * female, \>55 to \<80 years * \>5 years menopausal * type 2 diabetes mellitus (t2dm) diagnosis according to american diabetes association (ada), american association of clinical endocrinologists (aace), canadian diabetes association (cda), world health organization/international diabetes federation (who/idf) * drug-naïve (hba1c \ submaximal doses of metformin (\>1000mg) or sulfonylureas (\>5mg glyburide, \>10mg glipizide or \>8mg glimepiride) (hba1c \< or = 7.0%) * weighs \<300 lbs (136.4 kg) * two or more vertebra (l1-l4) suitable for bmd measurement by dual x-ray absorptiometry (dxa) * absolute bmd value consistent with t-score \>-2.5 at femoral neck, lumbar spine and total hip exclusion criteria: * type 1 diabetes mellitus (t1dm) or history of diabetic ketoacidosis (dka) * renal or hepatic disease (clinically significant) * hepatocellular reaction, severe edema, or medically serious fluid event associated with thiazolidinedione (tzd) * recent (\<6mos) history or clinical intervention for angina or myocardial infarction or is taking nitrates * any stage of heart failure, i.e. new york heart association (nyha) class i-iv * systolic bp \>160mmhg or diastolic bp \>90mmhg while on antihypertensive * hypersensitivity to tzds, biguanides * prior treatment with two or more oral anti-diabetic (oad) agents * bilateral hip replacements * concurrent diseases affecting bone metabolism * active malabsorption syndrome * serum calcium outside the central lab reference range * thyroid replacement therapy, serum thyroid stimulating hormone (tsh) must be within range * vitamin d deficiency * previous treatment with: strontium, intravenous (iv) bisphosphonate, fluoride, hormones, calcineurin inhibitors or methotrexate * chronic systemic corticosteroid \[e.g. glucocorticoid, mineralocorticoid\] treatment of no more than two intra-articular injections within the past year or use of oral parenteral, or long-term, high-dose inhaled corticosteroids

Keywords: type 2 diabetes mellitus bone x-ray absorptiometry bone biomarkers dual-energy bone mineral density
evaluation of safety and effectiveness of the fmwand ferromagnetic surgical system during parotidectomy surgery

Conditions: Parotid Diseases

Summary: the objective of the clinical trial is to determine the suitability of the fmwand ferromagnetic surgical system for parotidectomy and head \& neck surgery.


Eligibility criteria:
inclusion criteria: * patients with an indication for surgical intervention for a parotidectomy. * ecog status ≤ 2. * life expectancy \> 3 months. * age ≥ 18 years old. * able to provide written informed consent and eu data protection directive forms prior to admission to this study. * willingness to meet all of the expected requirements of this clinical protocol. exclusion criteria: * age \< 18 years old. * pregnant or breastfeeding. * vulnerable patient populations (homeless patients, patients with drug or alcohol dependence, etc.). * concomitant treatments that would affect clotting, post-operative healing, increased chances of infection. * previous radiation treatment * previous head or neck surgery
the effectiveness and safety of 4% sodium citrate as a lock solution in central venous hemodialysis catheter

Conditions: Central Venous Catheter Thrombosis; Renal Dialysis

Summary: studies that used a dilute citrate formulation (4%) demonstrated efficacy as an anticoagulant with minimal to no risk of bleeding in hd sessions. this study will compare effectiveness and safety utilizing 4% sodium citrate vs. heparin as a lock solution in central venous hemodialysis catheter among hemodialysis patients.

vascular access is necessary for hemodialysis(hd) procedure. in normal situation, vascular access for hd is created in peripheral vessels. however, vascular catheter may be considered in patients without available peripheral vessels for vascular access. the characteristic of these patients include elderly, diabetes, not tolerant to vascular surgery etc.. commonly, the hd catheter is inserted in the central vein in these population. considering clotting condition, anticoagulant is indicated for catheter locking after hd session. in the past years, heparin is the most common solution to be used as locking solution. nevertheless, heparin has a few disadvantages, such as systemic anticoagulation, thrombocytopenia, and bleeding risk. an alternative for anticoagulation in hd session is 4% sodium citrate. the effectiveness and safety of sodium citrate in hd sessions have been reported in clinical studies. characteristics of sodium citrate and safety profile trisodium citrate acts locally as an anticoagulant by chelating ionized calcium in blood, resulting in the blockage of calcium-dependent clotting pathways. studies that used a dilute citrate formulation (4%) demonstrated efficacy as an anticoagulant with minimal to no risk of bleeding in hd sessions. the advantageous effects of sodium citrate in hd catheter locking solution includes reducing frequency of catheter exchanges, reducing using of thrombolytic drugs, reducing hospitalization rates, and bacteremia. regarding adverse effect of sodium citrate, hypocalcemia and other untoward outcomes are rare reported in the previous clinical studies

Eligibility criteria:
inclusion criteria: 1. age \>=20 years 2. end-stage renal disease patients who received regular hd weekly via central venous catheter for at least 3 months in outpatient clinic in kaohsiung chang gung memorial hospital, taiwan exclusion criteria: 1. bleeding tendency 2. on radiotherapy or chemotherapy for malignancy 3. pregnancy 4. drug allergy history to citrate 5. undefined reasons for refuted participation.
the effect of botox injection on postural stability of cerebral palsy (cp) children

Conditions: Cerebral Palsy

Summary: children suffer from cerebral palsy that willing to participate in the study will be tested with well-established measuring techniques of balance control using force plate before 2 month after botox injection in the movement and rehabilitation laboratory at bgu. an automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the cop data sets collected during quiet standing. these parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (collins \& de luca, 1993). each of the times (before 3 month and 6 month after the tha) in two task conditions (eyes closed and eyes close conditions). participants will be required to stand on the platform 5 times for 30 s for each trial, they will be instructed to sway as little as possible. in addition gait analysis will be also examined.


Eligibility criteria:
inclusion criteria: * cerebral palsy * botox injection exclusion criteria: * not able to stand independently 60 seconds * not able to walk independently

Keywords: cerebral palsy balance gait
development, field testing and evaluation of the efficacy of a hand-held, portable and affordable thermo-coagulator to prevent cervical cancer in low- and middle-income countries

Conditions: Cervical Precancer

Summary: this project develops, tests and produces a lightweight, cordless, battery driven and rechargeable hand-held device for treating cervical precancer (liger thermal coagulator). the study evaluates its effectiveness compared to the current standard treatment (cryocautery) when used as part of a screen and treat programme using visual inspection with acetic acid (via) in sub saharan africa.

this project aims to improve screen and treat programmes for cervical cancers by discovering the best method of treatment. the specific aims are 1. to develop, test and produce 20 novel lightweight hand-held cordless, portable battery driven and rechargeable thermal coagulators (liger medical, utah). 2. to evaluate the success / failure rate of thermal coagulation in a randomised controlled trial comparing thermal coagulation to the existing current standard cryocautery and to large loop excision of the transformation zone (lletz aka leep) as part of a screen and treat programme in zambia. 3. to evaluate the user satisfaction scores of the liger thermal coagulator cryocautery as part of a screen and treat programme in zambia. 4. to determine the rate of over treatment of via positive women as revealed by histopathological examination of the randomly assigned excised treatment cases. 5. to determine the value of z scan to predict normality and abnormality in via positive women randomly assigned to excisional therapy in collaboration with a medical devices company in utah, the engineering performance of the liger thermal coagulator has been developed and tested in vitro and in vivo. 200+ liger units have been produced and a randomised controlled trial of the device has been undertaken, compared to cryocautery and lletz using efficacy and user friendliness as endpoints. the inclusion of a study arm of excisional therapy allows to quantify the rate of overtreatment in via programmes and using the z scan may allow for a non invasive method of accurately predicting normality and abnormality in via positive women.

Eligibility criteria:
inclusion criteria: * positive on via test for cervical cancer screening * eligible for ablative treatment exclusion criteria: * pregnancy * not voluntarily willing to participate

Keywords: cervical precancer screening treatment thermo-coagulation thermal ablation reducing overtreatment
assessment of microrna expression in acute graft-versus-host disease

Conditions: Acute Graft-versus-Host Disease; Allogeneic Stem Cell Transplant

Summary: assessment of microrna expression in acute graft-versus-host disease (gvhd).

the purpose of this study is to examine whether the expression levels of a novel class of molecules, called micrornas, are associated with acute graft-versus-host disease frequency and severity. acute graft-versus-host disease is a acute gvhd is a medical condition that can become very serious. it happens when the donor cells attack and damage your tissues after transplant.

Eligibility criteria:
inclusion criteria: * patients who are receiving allogeneic stem cell transplantation at the ohio state university blood and marrow transplantation program are eligible and will be consented for the study.

Keywords: agvhd acute graft-versus-host disease allogeneic stem cell transplantation hematopoietic stem cell transplantation microrna expression
primary hyperparathyroidism: non-classical manifestations

Conditions: Primary Hyperparathyroidism

Summary: this is a research study to investigate cardiovascular health in people with mild hyperparathyroidism. previous research has suggested that severe hyperparathyroidism may be associated with abnormalities in the heart and blood vessels. it is unclear whether mild hyperparathyroidism affects cardiovascular health. this study involves the investigation of the heart and blood vessels of people with mild hyperparathyroidism. various non-invasive laboratory and radiological test to assess cardiovascular and bone health will be done at set intervals over the course of 2 years. it is our hypothesis that patients with primary hyperparathyroidism will have subtle abnormalities in their cardiovascular system. using state-of-the art techniques that are sufficiently sensitive to detect these subtle abnormalities, we will define cardiovascular features of this disease that have, up to now, eluded clear definition. we expect taht the extent of these findings will be related to the severity of the underlying primary hyperparathyroidism. we further hypothesize that cardiovascular manifestations may regress with successful cure of the hyperparathyroid state.

this study involves a total of 4 visits over a 2-year period. a variety of tests to evaluate your cardiovascular and bone health are performed. the details and timing of the tests are explained below. visit #1 during the first visit, a research doctor or assistant explains the procedures in detail and answers questions. blood is drawn (about 1-2 tablespoons) to confirm the diagnosis of hyperparathyroidism and get baseline blood values. visit #2-4 during the following visits, a variety of procedures are performed to evaluate cardiovascular and bone health. the details of the procedures and when they will be performed are outlined below. 1. blood tests are performed at each visit. approximately 1-2 tablespoons of blood will be drawn at each visit. 2. a 24-hour urine collection is done 3 times during the 2 year study. 3. bone mineral density testing (known as dxa) is performed at baseline, 12 and 24 months after enrollment. 4. carotid ultrasound: at the baseline visit, 12 and 24 months after enrollment, carotid ultrasound is performed. 5. echocardiogram: at the baseline visit, 12 and 24 months after enrollment, an echocardiogram is performed. 6. endothelial function: at baseline, 6 and 12 months after enrollment, flow mediated dilation of the brachial artery is performed.

Eligibility criteria:
inclusion criteria: -primary hyperparathyroidism exclusion criteria: * current use of oral bisphosphonates * addition or change in cholesterol lowering medication * impaired renal function (creatinine \>2.0 mg/dl)

Keywords: primary hyperparathyroidism