Kornimate/medical-research-clean huggingface dataset:
donor cord blood t-cell infusion after stem cell transplant in treating patients with relapsed hematological malignancies

Conditions: Hematopoietic and Lymphoid Cell Neoplasm

Summary: this phase i trial studies the side effects and best dose of donor cord blood t-cells after stem cell transplant in treating patients with relapsed hematological malignancies. after umbilical cord blood transplant, stem cells are collected from the donor's cord blood and stored. the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by treatment. removing the t cells and treating them in the laboratory before infusing them in the patient may also help boost the patient's immune system.

primary objectives: i. to evaluate the safety and maximum tolerated dose (mtd) of infusion of ex vivo expanded cord blood t cells (cli), in cord blood (cb) transplant recipients with relapsed hematological malignancies. secondary objectives: i. to determine the complete remission rate and overall response as a result of cli infusion. ii. to determine the effect of cli infusion on the chimerism. iii. to evaluate the incidence rate and grade of acute graft-versus-host disease (gvhd) after cli infusion. iv. to determine the disease-free survival, cytopenia rate, relapse incidence after cli infusion. outline: this is a dose-escalation study of ex vivo-expanded t-cells. patients undergo ex vivo-expanded umbilical cord blood progenitor cell donor t cell infusion with aldesleukin 11-14 days after t-cell co-stimulation begins. after completion of study treatment, patients are followed up for 100 days.

Eligibility criteria:
inclusion criteria: * umbilical cord blood (ucb) recipients with underlying hematological malignancies presenting with post-transplant relapse and have available approximately 400 microliter to 1 ml aliquots or cb wash from previous transplant * ucb recipients with t-cell and/or overall chimerism value of less than 80%, in absence of relapse and have available approximately 400 microliter to 1 ml aliquots or cb wash from previous transplant * performance score of at least 80% by karnofsky or performance status (ps) \ = 12 years), or lansky play-performance scale of at least 60% or greater (age \< 12 years) * negative beta human chorionic gonadotropin (hcg) or urine test in females of childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on the study * patient or patient's legal representative, parent(s) or guardian able to sign informed consent exclusion criteria: * human immunodeficiency virus (hiv) positive (due to the extreme immunosuppressive nature of allogeneic stem cell transplant) * patients with active (untreated) central nervous system (cns) disease * any active gvhd * active invasive infections * pregnant or breast-feeding
exercise in health and chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to find out more about the effects of chronic obstructive pulmonary disease (copd) on the function of blood vessels, the heart, and muscle at rest and during exercise.

oxidative stress, defined as an imbalance between pro and antioxidant molecular species in favor of the former, has recently been recognized as a potential mechanism in the peripheral muscle dysfunction associated with copd. a series of studies are proposed to better understand the role and source of oxidative stress in the skeletal muscle of patients with copd. specifically, three main aims will address the following questions regarding copd, skeletal muscle, and oxidative stress: where is oxidative stress most prevalent, why does oxidative stress occur, and what are the consequences of oxidative stress in copd? the overall hypothesis to be tested is that copd results in a shift toward greater intramuscular oxidative stress and this is, at least in part, responsible for the diminished mechanical efficiency and greater peripheral muscle fatiguability during muscular work often associated with this disease. the vascular consequence of this augmented free radical load is altered vascular function and a disruption of the local matching of perfusion and metabolism in skeletal muscle during exercise. these crucial changes result in a cascade of factors such as local hypoxia and elevated vascular shear stress, entering a vicious cycle that leads to the generation of more free radicals, especially during physical work. it is proposed that this imbalance between pro and antioxidant potential, toward oxidative stress, plays a significant role in the attenuated exercise capacity and reduced muscle fatigue resistance associated with copd.

Eligibility criteria:
inclusion criteria: * chronic obstructive pulmonary disease (copd) patients (over 18 years old) and * age-matched healthy controls (over 18 years old) exclusion criteria: * severe chronic obstructive pulmonary disease (volume exhaled at the end of the first section of forced expiration is predicted to be under 30 percent), * severe heart failure
app-technology to improve the level of physical activity after bariatric surgery

Conditions: Obesity; Bariatric Surgery; Exercise; Quality of Life; Eating Behavior; Body Fat Distribution; Body Weight Changes

Summary: the aim of this study is to investigate the effect of using new app-based technology to increase the level of physical activity, compared to conventional postoperative information given to patients undergoing bariatric surgery. the hypothesis is that the intervention, i.e. using the new technology, will have a greater positive effect on levels of physical activity and outcomes of weight loss than conventional postoperative information.


Eligibility criteria:
inclusion criteria: * accepted to bariatric surgery due to national guidelines, bmi\>35 kg/m2 * 18 years of age or older * informed consent * ability to read and understand swedish * own and use a smartphone exclusion criteria: * disability preventing daily walking
safety assessment of one-hour infusions of sns-032 for the treatment of select advanced solid tumors

Conditions: Tumors

Summary: the purpose of this study is to assess the safety and tolerability of one-hour infusions given once daily for 5 consecutive days in a 21-day treatment cycle; to define a recommended phase 2 dose; and to learn more about the clinical activity of sns-032.

other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body), preliminary evaluation of biomarkers to see how the levels of certain proteins change after administration of sns-032; assessment of the effects of sns-032 on qt interval.

Eligibility criteria:
inclusion criteria: * able to provide written informed consent * advanced, progressing solid tumor that has no cure * in stage 1, any advanced solid malignancy * in stage 2, advanced breast cancer, melanoma, or non-small cell lung cancer (nsclc) * eastern cooperative oncology group (ecog) performance status score of 0, 1, or 2 * recovered from radiation therapy that may have been given in the last 21 days * recovered from surgery exclusion criteria: * prior exposure to sns-032 (previously known as bms-387032) * pregnant or breastfeeding * women or male partners of women who are able to have children but are unwilling to use an approved, effective means of birth control * took part in another clinical trial during the last 21 days * abnormal lab values for serum potassium, hemoglobin, neutrophils, platelets, creatinine, ast, alt, or total bilirubin * brain metastases, if patient is not neurologically stable or has needed corticosteroids or anticonvulsants at anytime within the 28 day period before enrollment. * other active malignancies * prior pelvic radiation therapy to ≥ 25% of bone marrow reserve * any other condition that would keep the patient from safely taking part in the clinical trial please note: there are additional inclusion/exclusion criteria for this study. please contact the study center for additional information and to determine if all study criteria are met.

Keywords: cancer carcinoma adenocarcinoma tumor advanced solid tumors
the use of barbed sutures in total hip arthroplasty

Conditions: Osteoarthritis, Hip

Summary: the purpose of this study is to evaluate the role of new barbed suture for closure of wound during total hip arthroplasty in reducing the risk for wound healing problems.


Eligibility criteria:
inclusion criteria: * all patients receiving elective primary tha through the direct anterior approach, treated by the primary investigator (jp) at the thomas jefferson university hospital or rothman specialty hospital. exclusion criteria: * prior surgical incision or scar in close proximity of the proposed incision (\<2 cm). * local skin conditions such as dermatitis, eczema, or psoriasis. * active or previous infection in the skin or the hip. * inflammatory arthritis; connective tissue or vascular disorders or diseases that would adversely affect wound healing including the use of oral or topical cortico-steroid use
derivation and validation of a combination of boston score and des-osa score for selection of osa patients.

Conditions: Obstructive Sleep Apnea

Summary: derivation and validation of a combination of boston score and des-osa score to exclude osa or to confirm osa in patients.

the aim of this study is to derive and to validate a combination of boston score and des-osa score. firstly, the investigators will use a retrospective cohort of 400 patients to determine this combination. it will allow classifying patients in 3 groups: 1) patients for whom osa can be excluded with certitude, 2) patients for whom osa can be diagnosed with certitude, and 3) an intermediate group. secondly, the 100 patients included in this study will serve to validate the cutoff of the abovementioned combination into a new population.

Eligibility criteria:
inclusion criteria: * all patients admitted in the clinique saint-luc of bouge for a polysomnography exclusion criteria: * patient's refusal
cryotherapy combine icotinib for advanced nsclc treatment

Conditions: Lung Neoplasms

Summary: this trial is to designed to assess the efficacy and safety of cryotherapy combine with icotinib for advanced nsclc patients harboring egfr mutation.

in this single arm clinical study, enrolled patients, with advanced stage nsclc and confirmed epidermal growth factor receptor (egfr) mutation, would receive cryotherapy for tumors and begin icotinib, an egfr tyrosine kinase inhibitor administration thereafter. progression free survival, overall survival and safety wil be observed.

Eligibility criteria:
inclusion criteria: * histological or cytological confirmation of non-small cell lung cancer (nsclc) in phase 3b/4; * life expectancy ≥12weeks. * eastern cooperative oncology group (ecog) performance status 0-1. * the number of target lesions in whole body ≤ 8 (and the number of lung lesions ≤ 5, the biggest one's diameter≤ 7 cm, the number of liver lesions ≤ three the biggest one's diameter ≤ 5 cm. * adequate hematological function: hemoglobin ≥90g/l (no blood transfusion in 14 days) absolute neutrophil count (anc) ≥1.5 \* 109/l, and platelet count ≥75 x 10\^9/l. * adequate renal function: serum creatinine ≤1.5 \* upper limit of normal(uln), or serum creatinine≥ 50 ml/min. adequate liver function: total bilirubin ≤ 2 \*uln and alanine aminotransferase (alt) and aspartate aminotransferase (ast)\< 2.5 \* uln in the absence of liver metastases, or \< 5 \* uln in case of liver metastases. * female subjects should not be pregnant. all human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications written informed consent provided. exclusion criteria: * previous usage of egfr-tki or antibody to egfr: gefitinib, erlotinib, herceptin, erbitux. * allergic to icotinib. * lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease. * pregnancy or breast-feeding women. * any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction with in 6 months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).

Keywords: lung neoplasms egfr mutation cryotherapy icotinib
glp-1 inhibits prandial antro-duodeno-jejunal motility in humans

Conditions: Functional Gastrointestinal Disorders

Summary: the inhibitory effect of low dose glp-1 is investigated on prandial motility of the stomach, duodenum and jejunum in vivo in humans. supplementary in vitro studies on the mechanism of action of the glp-1 inhibition of motility as carried out on muscle strips from the upper gastrointestinal tract in man.

twelve healthy volunteers will undergo antroduodenojejunal manometry. baseline recording with infusion of saline for 1 hour is compared with infusion of glp-1 0.7 and 1.2 pmol per kg minute for another 1 hour. plasma glp-1 and glp-2 is measured by ria. responses to glp-1 will be measured after food intake as prandial response to glp-1. the outcome will be evaluated as change in motility index from baseline to meal-stimulated conditions and during influence of glp-1. further in vitro studies of gastrointestinal muscle strips, precontracted with bethanechol or electric field stimulation, are planned to investigate the response to glp-1 or glp-1 analogue rose-010. glp-1 and glp-2 receptor immunoreactivity is localized by immunohistochemistry. receptor mediated mechanisms are studied with glp-1 receptor blocker exendin(9-39)amide, nitro-monomethyl arginine to block nitric oxide synthase and tetrodotoxin to block sodium channels and nerve conduction.

Eligibility criteria:
inclusion criteria: * healthy volunteers over 18 years of age. exclusion criteria: * any medical condition. * any drug treatment.

Keywords: irritable bowel syndrome functional dyspepsia gastric emptying gastrointestinal peptide hormones
effects of a spine navigation system on op-time and radiation exposure

Conditions: Spinal Stenosis; Scoliosis; Spondylolisthesis

Summary: the goal of this study is to prospectively collect information about the operative time and intraoperative radiation experienced by patients undergoing posterior spinal fusion procedures guided by the mvigs spine navigation system.

this is a single-center, prospective case series to assess the use of the machine-vision image guided surgery (mvigs) spine navigation system for treatment of spinal stenosis, scoliosis, and spondylolisthesis that requires fusion. this is a single-arm, open-label study. all participants will undergo their single and multi-level posterior spine fusion surgery using bilateral pedicle screw instrumentation under mvigs intraoperative navigation guidance.

Eligibility criteria:
inclusion criteria: * diagnosis of spinal stenosis of the lumbar spine with degenerative spondylolisthesis, all grades, and planning to undergo surgical fusion; * skeletally mature adults between the ages of 18-85 years at the time of surgery; * has completed at least 6 months of conservative therapy for degenerative diagnosis, if appropriate; and, * personally signed and dated an informed consent document prior to any study-related procedures, indicating that the patient has been informed of all pertinent aspects of the study. exclusion criteria: * history of malignancy, craniocervical junction pathology, cervical and thoracic locations, and/or previous lumbar operation; * significant peripheral neuropathy or acute denervation secondary to radiculopathy, caused by conditions other than spinal stenosis; * significant peripheral vascular disease (defined as diminished dorsalis pedis or tibial pulses); * morbid obesity, defined as bmi \> 40 kg/m2; * active systemic or local infection; * active hepatitis (defined as receiving medical treatment within two years); * immunocompromised, such as but not limited to being diagnosed with acquired immunodeficiency syndrome (aids), hiv infection, severe combined immunodeficiency syndrome, or thymic hypoplasia; * insulin-dependent diabetes mellitus or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing; * immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for \> 1 month within last 12 months; * history of paget's disease, osteomalacia, or any other metabolic bone disease; * involved in study of another investigational product that may affect outcome; * women who are pregnant, lactating or anticipate becoming pregnant within 24 months post-surgery; * non-english speaking; * patients who are incarcerated; * worker's compensation cases; or, * patients involved in active litigation relating to his/her spinal condition.
effect of local anesthesia in patients with marginal periodontitis undergoing scaling and root planning

Conditions: Pain and Discomfort During Scaling and Root Planning of Patients With; Periodontitis

Summary: a randomised cross-over study comparing two methods of local anaesthesia for patients diagnosed with periodontitis undergoing scaling and root planning. 40 patients will be included in the study, which aims to demonstrate that the effect of a bupivacaine lozenge is non-inferior to lidocaine-adrenalin injections.

40 periodontitis patients undergoing scaling and root planning (srp) will be randomised to receive local anaesthesia by either a bupivacaine lozenge or lidocaine-adrenalin injection at their first visit. at the following visit, the patients will receive the opposite treatment. at each visit the patient will evaluate pain before, during and after srp by: * visual analog scale (vas) 0-10 where 0 = no pain, 10 = extreme pain. * mcgills pain questionnaire (mpq), which gives a qualitative pain profile. at each visit the patient will evaluate discomfort before, during and after the srp by: - visual analog scale (vas) 0-10 where 0 = no discomfort, 10 = extreme discomfort. additionally the patient assesses the comfort of administration of the two local anaesthesia as well as the taste of the bupivacaine lozenge. the investigator also evaluates the scaling procedure.

Eligibility criteria:
inclusion criteria: * patients diagnosed as having, respectively periodontitis marginalis adulta progressiva lenta and periodontitis marginalis adulta progressiva rapid in the hygiene phase, where depurations are repeated within a short timeframe * age between 18 and 80 years * ability to speak, read and understand danish * ability to give oral and written consent exclusion criteria: * known allergy to bupivacaine or other local anaesthetics of the amide type * other gingival infections (eg lichen planus) * pregnancy -if in doubt a pregnancy test will be made * breastfeeding

Keywords: pain, discomfort, periodontitis, scaling and root planning, visual analogue scale, mcgills pain questionnaire
postoperative pain control in septum and sinus surgery

Conditions: Post-operative Pain; Sinus Surgery

Summary: this study will evaluate if the use of acetaminophen round the clock (scheduled doses) will lead to less opiate use in the first week post-operative (after surgery) in sinus/septum surgery patients. participants will be randomized like a flip of a coin to either the standard of care pain treatment of acetaminophen 325 mg as needed for pain plus opiates (acetaminophen/hydrocodone) as needed for breakthrough pain; or to the study arm of acetaminophen 650 mg every 6 hours plus opiates (oxycodone)as needed for breakthrough pain.

pain control in the postoperative period following septum and/or sinus surgery is controversial, as there is no consensus statement regarding current guidelines to direct clinical practice. recent legislation limits opioid prescription length to 5 days only, which brings into question whether legislation will affect prescribing practices of physicians and whether or not giving patients an alternative to opiates will be a more efficacious route. current prescribing practices for septum and sinus surgery of the otolaryngology private practice group includes as-needed acetaminophen 325 mg and as-needed acetaminophen/hydrocodone 7.5 mg/325 mg. if it can be demonstrated that use of 650 mg acetaminophen in scheduled doses of every 6 hours can decrease postoperative opiate use in the first week without significantly increase in patient pain, this may be deployed as an effective strategy of pain control as the use of opiates has come under scrutiny and attempts are being made to decrease or limit the use of these medications in the medical setting. this study would look to demonstrate that scheduled doses of acetaminophen as opposed to reactionary as-needed acetaminophen can control post-operative pain to the point where narcotics would not be necessary.

Eligibility criteria:
inclusion criteria: * undergoing primary sinus surgery, primary septum surgery, or primary sinus/septum surgery * 18 years of age or older * male or female * no known allergies to or contraindications to the use of acetaminophen, hydrocodone, or oxycodone * patients discharged to home after surgery exclusion criteria: * undergoing revision sinus, septum, or sinus/septum surgery * younger than 18 years old * allergy or contraindication to acetaminophen, hydrocodone, or oxycodone * patients admitted to the hospital postoperatively for airway monitoring

Keywords: post-operative pain sinus pain sinus surgery septum pain deviated septum
dynamic respiratory muscle function in late-onset pompe disease

Conditions: Pompe Disease

Summary: this study intends to evaluate dynamic respiratory motor performance as a valuable measure of pulmonary function in adults with late-onset pompe disease. the investigators will adopt a strategy that includes comprehensive evaluations of respiratory volume, flow, and timing parameters during resting and loaded breathing. these evaluations will then be associated to the standard clinical measure of maximal inspiratory pressure, the static inspiratory muscle function, as well as magnetic resonance imaging of thoracic expansion and diaphragmatic descent at rest and with exertion. outcomes in participants with late-onset pompe disease will be contrasted to the function of age- and gender-matched control subjects. this approach will enable the investigators to evaluate the relationship between dynamic diaphragmatic function and respiratory motor function.

the following tests will be completed over a two-day period: respiratory pressure tests, breathing test, magnetic resonance imaging and magnetic resonance spectroscopy (mri and mrs).

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of pompe disease or * be an age and gender-matched unaffected control subject exclusion criteria: * pre-existing obstructive lung disease or asthma * forced vital capacity (fvc) \ 80% of age/gender predicted values * inability to travel to the study site * requirement for positive pressure ventilator support when awake and upright * participation in longitudinal studies that may independently alter lung function * presence of any other chronic medical condition that, in the opinion of the investigator, would make the subject unsuitable for the study

Keywords: respiratory test respiratory muscle endurance spirometry