Kornimate/medical-research-clean huggingface dataset:
lv endocardial crt for patients with intermediate qrs width

Conditions: Heart Failure，Congestive; Left Ventricular Dysfunction; Left Bundle-Branch Block

Summary: this pilot study is designed as a multi-centre cohort study determining the degree of lv reverse remodeling in patients with intermediate qrs widths (120-149ms) who undergo crt implant with transseptal lv leads, and comparing to the average expected reverse remodeling rate in patients with standard transvenous coronary sinus leads and qrs widths ≥150ms.

this is a multi-centre prospective cohort trial to establish the feasibility of endocardial crt implants.this trial will assess feasibility of a larger scale randomized controlled study. patients consented to the study will receive a crt device with or without icd, placed in the same time frame, and will have ra and rv leads implanted as the standard of care. the device will be implanted in a facility that has the capacity to perform trans-atrial septal puncture with ultrasound guidance (tee or ice) at the time of implantation. the lv lead will be placed using a trans-atrial septal approach, using specially designed puncture tools and lvendo delivery tool kits specifically designed for this study. special care will be taken to avoid the lv apex and transmural scar identified by pre-implant imaging. electrical testing, and programming of the device will be standardized.

Eligibility criteria:
inclusion criteria: * patients with nyha class ii-iv ambulatory hf symptoms * optimal hf medical therapy of at least 3 months (2009 accf/aha, esc 2012) * lvef less than or equal to 35% * sinus rhythm (can have paroxysmal atrial fibrillation) * qrs morphology is non-rbbb * qrs duration 120-149 ms * patients with pacemaker or icd that meet the above criteria may be upgraded to crt-d or crt-p * patients are able to receive oral anticoagulation exclusion criteria: * patients with atrial septal defect closure * planned atrial fibrillation ablation within 12 months * patients with mitral prosthetic valve that precludes the placement of an lv lead trans-septally * patients with rbbb * patients with intra-cardiac thrombi * patients with permanent atrial fibrillation * patients with contraindications to oral anti-coagulation * in-hospital patients with acute cardiac or non-cardiac illness that requires intensive care * acute coronary syndrome (including mi) \< 4 weeks * coronary revascularization (cabg or pci) \< 3 months * uncorrected or uncorrectable primary valvular disease * restrictive, hypertrophic or reversible form of cardiomyopathy * severe primary pulmonary disease such as cor pulmonale * patients with a life expectancy of less than one year from non-cardiac cause. * patients included in other clinical trials that will affect the objectives of this study * those unable or unwilling to provide informed consent * those with a history of noncompliance to medical therapy
bcma-directed car-t cell therapy in adult patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: this was a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous t cells genetically engineered with a novel b-cell maturation antigen (bcma)-specific chimeric antigen receptor (car) and manufactured with a new process. car-t cells were investigated as a single agent in multiple myeloma

this was a phase i, open label study to characterize the safety and tolerability of a novel b-cell maturation antigen (bcma)-specific chimeric antigen receptor (car) manufactured with a new process. in the dose escalation part (part a) of the study, the anti-bcma car-t cell therapy was studied in adult multiple myeloma (mm) subjects who were relapsed and/or refractory. in the dose evaluation part (part b) of the study, the anti-bcma car-t cell therapy was studied in newly diagnosed adult subject with mm.

Eligibility criteria:
inclusion criteria: * part a: subjects with mm who are relapsed and/or refractory to at least 2 prior treatment regimens, including an imid (e.g. lenalidomide or pomalidomide), a proteasome inhibitor (e.g. bortezomib, carfilzomib), and an approved anti-cd38 antibody (e.g. daratumumab), if available, and have documented evidence of disease progression (imwg criteria) * part a: ecog performance status that is either 0 or 1 at screening * part b: subjects with newly diagnosed multiple myeloma (ndmm) who have received a minimum of 4 and up to 6 cycles of standard induction therapy with vrd, d-vrd, or d-rd, and have achieved a response of pr or better. one cycle of cybordex is allowed prior to induction. * part b: ecog performance status that is either 0,1 or 2 at screening * measurable disease as defined by the protocol * adequate hematological values * must have a leukapheresis material of non-mobilized cells accepted for manufacturing exclusion criteria: * prior administration of a genetically modified cellular product including prior bcma car-t therapy. patients who have received prior bcma-directed bi-specific antibodies or antibody-drug conjugates (adc) are not excluded. * autologous hsct within 6 weeks prior to enrollment or any prior history of allogeneic hematopoietic stem cell transplant (hsct) * chemotherapy or any concomitant anti-cancer therapies (other than protocol prescribed lymphodepletion (ld) chemotherapy) within 2 weeks prior to apheresis * treatment with small molecule targeted antineoplastics within 2 weeks of apheresis collection or 5 half-lives whichever is shorter * have received antibodies or immunotherapies (other than daratumumab) within 4 weeks prior to apheresis collection. daratumumab within 3 weeks prior to apheresis collection.

Keywords: multiple myeloma b-cell maturation antigen bcma anti-bcma bcma-directed chimeric antigen receptor car-t phe885
efficacy of ginger in the prevention of abdominal distention in post cesarean section patient

Conditions: Post Cesarean Section Patient

Summary: the purpose of this study is to determine ginger is effective in the prevention of abdominal distention in post cesarean section patient.


Eligibility criteria:
inclusion criteria: * post cesarean section women exclusion criteria: * allergic to ginger * time of cesarean section more than 1 hour * perform another operation such as appendectomy, cystectomy * former use carminative drugs * already have abdominal distention
once a day use of lactobacillus casei shirota on hiv-infected patients infected patients

Conditions: HIV

Summary: in this study, hiv-infected patients with poor recovery of cd4+ t cells and successful viral control after treatment with antiretroviral therapy will be enrolled to receive once a day lactobcillus casei shirota or placebo in a double-blind, randomized fashion. immune parameters will be monitored for 12 weeks in both arms. the main outcome is cd4+ t cell recovery. secondary outcomes will include nk cells and t cells immune parameters.

in this study, hiv-infected patients with poor recovery of cd4+ t cells and successful viral control after treatment with antiretroviral therapy will be enrolled to receive once a day lactobcillus casei shirota or placebo in a double-blind, randomized fashion. the main objective is to investigate whether the continuous, once a day, 12-weeks use of yakult product containing lactobacillus casei shirota could affect immunological parameters in hiv-infected patients on suppressive antiretroviral treatment with poor cd4+ t cell recovery. a total of 48 volunteers will be followed for 12 week after initiation of daily use of lactobcillus casei shirota or placebo, randomized in a 1:1 ratio. we hypothesize that use of the yakult product containing lactobacillus casei shirota after 12 weeks of continuous use will increase the level of cd4+ t-cells, at least, 50 cells/mm³. we also propose to investigate several markers of immune response, including t cellular activation and nk cells function, and changes in the intestinal microbiota.

Eligibility criteria:
inclusion criteria: * male or female hiv-1 infected patients aged between 18 and 60 years. * patient on suppressive antiretroviral treatment with poor cd4+ t-cell recovery. * no change in antiretroviral therapy in the last six months or intended change in the next 12 weeks. * availability for the study procedures during the study period. * giving informed consent to participate in the study exclusion criteria: * diagnosis of any concomitant infections or diseases that might affect immunity or natural history of hiv-1 infection including active hepatitis b infection, hepatitis c infection, diabetes mellitus, neoplasias and autoimmune diseases. * use of treatments that might affect immunity in the last four weeks including immunomodulators, corticosteroids (only systemic use for two weeks or more), or antineoplasic agents. * history of intolerance or allergy to cow milk or any other component of the study product including lactose intolerance, casein allergy, etc. * pregnancy, nursing mother or intention of became pregnant during the study period (only female participants). * unable to safely store the study product at home in the conditions recommended by the manufacturer. * any other condition that might interfere with the study procedure according to the investigators.

Keywords: hiv lactobacillus casei shirota nk cell cd4 lymphocyte cell activation antiretroviral therapy immune discordants
safety of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for pcos

Conditions: Polycystic Ovary Syndrome (PCOS); Polycystic Ovary Syndrome; PCOS

Summary: this trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously for the treatment of polycystic ovary syndrome.

stem cell treatment has shown efficacy for pcos in both human and animal studies. complete resolution was seen of polycystic ovary syndrome (pcos) in a young woman after a single intravenous injection of umbilical cord derived mesenchymal stem cells (ucdsc). it is hypothesized that intravenous infusion of ucdsc can reduce or eliminate pcos. patients will receive roughly 2 million umbilical cord derived mesenchymal stem cells per kg of body weight. hormone levels and ultrasound will be checked 3,6 and 12 months after treatment.

Eligibility criteria:
inclusion criteria: • ultrasound documented poly cystic ovary syndrome exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety * continued drug abuse * previous organ transplant * hypersensitivity to sulfur * inability to supply proper informed consent

Keywords: polycystic ovary syndrome (pcos) polycystic ovary syndrome pcos stem cell stem cells mesenchymal stem cells umbilical cord derived mesenchymal stem cells
disease burden and biology using tumor cell free dna in metastatic kidney cancer

Conditions: Renal Cell Carcinoma

Summary: this study will assess whether dna released by kidney cancer into the blood stream and urine of patients can be used to monitor tumor burden and tumor response to treatment in patients receiving immunotherapy

primary objective: - evaluate tumor cell free (cf)dna as a dynamic marker of response to immuno-oncology (io) therapy exploratory objective: - collect data on somatic mutations in cfdna to gain insight into the biology of io-responders and -non-responders

Eligibility criteria:
inclusion criteria: * renal cell carcinoma with clear cell component * stage iv * receiving io-containing regimen * measurable disease per recist 1.1 exclusion criteria: * active cancer (exclusion criteria only for healthy patient cohort)
apomorphine nasal powder in the treatment of parkinson's disease "off" periods.

Conditions: Parkinson's Disease

Summary: to determine the safety and tolerability of repeated dosing with apomorphine nasal powder in subjects with parkinson's disease.


Eligibility criteria:
inclusion criteria: * 1 year history of parkinson's disease; stable pd medications for 4 weeks; at least one documented "off" period per day exclusion criteria: * hypersensitivity to apomorphine; participation in a clinical trial in the last 12 weeks; pregnant or lactating females
perfect project - part 2 - study 2

Conditions: Diabetes Prevention; Obesity Prevention

Summary: the objectives are to test the acute effects of different cereals containing pulse ingredients on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two hours following the exercise session. the investigators hypothesize that consumption of cereals containing pulse ingredients 60 minutes before exercise will increase aerobic endurance (lower oxygen consumption), decrease carbohydrate oxidation (greater respiratory quotient), and a reduction in lactate production during compared to the same exercise session following the ingestion of a non-pulse food. the investigators also hypothesize that consumption of cereals containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake, suggesting lower calorie compensation, following a 60-minute aerobic exercise session compared to the same exercise session following the ingestion of a non-pulse food.


Eligibility criteria:
inclusion criteria: * normoglycemic (\<5.6 mmol/l) and normotensive (systolic blood pressure \<140 mm hg and diastolic blood pressure below \< 90 mm hg) * body mass index of 18.5-29.9 kg/m2 exclusion criteria: * restrained eaters * regularly skip breakfast * smokers * those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year * those who are active (organized activities or athletic training at a high intensity; ≥ 150 minutes per week of moderate to vigorous physical activity) * those unable to walk for an hour continuously
safety and efficacy of methoxyflurane for treatment of incident pain

Conditions: Pain Measurement

Summary: this study aims to provide further supportive evidence that methoxyflurane, a potent analgesic, administered using the penthrox inhaler is safe and efficacious in adult participants, specifically those who experience incident pain associated with a planned bone marrow biopsy.


Eligibility criteria:
inclusion criteria: * adult participants (18 years of age or older) * able to give written informed consent * anticipated episode(s) of incident pain related to planned bmb lasting no more than 30 minutes on average * anticipated life expectancy of at least 1 month pre-exclusion criteria: * subjects with a clinical condition that may, in the opinion of the investigator, impact on the subject's ability to participate in the study, or on the study results * participants who have had iv sedation/opioid on previous bmb and who wish to receive iv sedation/opioid on this occasion or who in the opinion of the bmb operator would be advised to receive iv sedation/opioid on this occasion * concomitant use of other investigational agents * concomitant use of nephrotoxic agents such as gentamicin * uncontrolled inr (\>4) * personal or familial hypersensitivity to fluorinated anaesthetics * personal or familial malignant hyperthermia * respiratory rate of less than 10 per minute * has previously received methoxyflurane * known pre-existing renal or hepatic impairment * compromised renal function (creatinine ≥ 1.5 x ulnr) * compromised liver function (bilirubin ≥ 2.5 x ulnr) exclusion criteria: * premedication with anxiolytic (e.g. midazolam, diazepam) * dosed with breakthrough dose of analgesic that may contribute to control of pain during the planned procedure

Keywords: incident pain bone marrow biopsy
diaphragm structure and pathobiology in patients being bridged to lung transplant

Conditions: Diaphragm Injury; Respiratory Failure; Mechanical Ventilation Complication

Summary: this study is designed to characterize the changes in diaphragm structure, function and biology during bridging to lung transplant by mechanical ventilation or extracorporeal life support.

mechanical ventilation has been linked to diaphragm injury and dysfunction. during mechanical ventilation, the amount of breathing work done by the diaphragm is unpredictable: the diaphragm could be completely rested, or it could be overworked. either of these possibilities may cause injury to the diaphragm. patients with an injured and dysfunctional diaphragm have greater difficulty weaning from mechanical ventilation - they become too weak to breathe. however, little is known about the relationship between changes in the diaphragm and the histological (structure of cells and tissue) basis of these changes. the investigators have developed a new technique employing beside ultrasound to measure diaphragm thickness. this allows them to observe changes in diaphragm muscle structure and function. the goal of the study is to determine whether different forms of respiratory support (mechanical ventilation vs extracorporeal life support) lead to different degrees of diaphragm injury and to compare changes in the diaphragm seen on ultrasound to changes in the diaphragm tissues under a microscope. this will help the investigators to confirm the best way to avoid diaphragm injury and to understanding the meaning of diaphragm ultrasound images.

Eligibility criteria:
inclusion criteria (cases): * receiving a respiratory support modality as a bridge to lung transplantation * formally listed for transplantation inclusion criteria (control group 1): - undergoing lung transplantation for either obstructive or restrictive lung disease inclusion criteria (control group 2): - undergoing elective thoracic surgery without any prior history of chronic pulmonary parenchymal disease exclusion criteria (cases and controls): * previously diagnosed with neuromuscular disorder * received invasive mechanical ventilation for \>48 hours in the preceding four weeks * thoracic cage deformity

Keywords: diaphragm dysfunction acute respiratory failure mechanical ventilation
epidemiologic follow up study of newly diagnosed epilepsy among seniors

Conditions: Epileptic Seizures

Summary: the purpose of this proposed research is to identify individuals in southeastern arizona aged 65 years and older who have new onset seizures (or newly diagnosed epilepsy) and monitor them for at least two years. in doing so the investigators will be able to describe the public health burden of this condition and to identify factors that predict clinical outcomes and health care needs in this population, using quantitative, administrative, and qualitative data. the aims of this proposed research are 1) to determine the two-year incidence of newly diagnosed epilepsy in the target population, 2) describe health care resource utilization of the target population using medicare data, 3) validate the use of medicare beneficiary data to estimate incidence of epilepsy, and 4) describe the burden of this condition in different ethnic groups.

seniors who have had new onset seizures or newly diagnosed epilepsy will be recruited from emergency departments (eds), neurology clinics, primary care clinics (including geriatric clinics), and other service providers from networks maintained by the area agencies on aging that serve seniors in southeastern arizona. data will be collected in the form of bi-annual surveys,administrative data (from medicare), in-depth interviews, and focus groups. medicare data will be used to describe and evaluate the likelihood of being hospitalized or admitted to a long-term facility within two years of being diagnosed, medication adherence and persistence, and comparing the cost of care between the newly-diagnosed seniors with epilepsy and comparable seniors who do not have epilepsy. the feasibility and validity of using the medicare claims data to estimate newly diagnosed epilepsy will also be assessed. finally, the impact of epilepsy on health related quality of life, mental health, perceived stigma, and family and caregivers will also be evaluated through surveys and qualitative data collection methods, and ethnic differences will also be described.

Eligibility criteria:
inclusion criteria: * aged 65 years or older * new onset seizure or newly diagnosed epilepsy as of october 2010 * is a resident of pima, cochise or santa cruz county exclusion criteria: * seizure dues to hyponatremia, hypoglycemia, alcohol use (with no evidence of other seizures)

Keywords: seniors seizures epilepsy quality of life
cognitive bias modification training on internet gaming disorder

Conditions: Internet Gaming Disorder

Summary: to investigate whether and how the cbm training will alleviate the symptoms of addiction in internet gaming disorders.

the purpose of this study is to use the modification training of cognitive bias to ameliorate the severity and symptoms of internet gaming disorders(igd); the neural mechanisms of cognitive bias modification and its effect during cued-induced craving task in subjects with igd will be investigated as well. this project will be conducted in beijing, china.

Eligibility criteria:
inclusion criteria: 1, dsm-5 recommended diagnosis of internet gaming disorder : 1. the scores of the 9 items of dsm-5 recommended diagnosis for internet gaming disorder ≥ 5. 2. engagement in popular internet games (e.g. arena of valor, league of legends and player unknown's battle grounds) for over 20 hours per week for a minimum of 12 months. 2, the scores of the y-iat(young-internet addiction test) ≥ 50 exclusion criteria: current or history of use of illegal substances and gambling; current or history of psychiatric or neurological illness; current use of psychotropic medications.