Kornimate/medical-research-clean huggingface dataset:
functional organization of somatosensory responses in the secondary somatosensitive area and insula

Conditions: Healthy

Summary: the implication of the second somatosensory area (sii) and the insular cortex in the processing of somatosensory inputs is now well established. however the functional anatomy of these areas hidden in the depth of the sylvian scissure remain mostly unknown. the aim of this fmri study is to determine the functional cartography of sii and insula. the localization of responses to different somatosensory stimuli (slight touch, warm, cold, heat pain and arthrokinesia) applied on the left hand of 25 healthy volunteers, will be compared.

aims : demonstrate that localization of the several types of somatosensory stimuli is different into sii and into insula. if possible, we'll determine a functional cartography of these areas.

Eligibility criteria:
inclusion criteria: * 25 healthy volunteers will be included ranging in age from 18 to 50 years * contraception needed for women * right handed * all the subjects have to give their written informed consent. exclusion criteria: * pregnancy * neurological or psychiatric disease * drugs taken \<12h before fmri * contra-indications to fmri : pacemaker, clip, metallic device * refusing to be informed of the presence of a cerebral abnormality, detected during mri.

Keywords: healthy volunteers somatosensory stimuli fmri second somatosensory area insular cortex functional anatomy
iguratimod in systemic sclerosis

Conditions: Systemic Sclerosis, Diffuse

Summary: the purpose of this study is to evaluate the safety, tolerability and efficacy of iguratimod in adult subjects with diffuse cutaneous systemic sclerosis.


Eligibility criteria:
inclusion criteria: * diagnosis of systemic sclerosis (ssc), as classified using the 2013 american college of rheumatology/ european union league against rheumatism classification of ssc. * diffuse cutaneous systemic sclerosis (dcssc) as defined by 2001 leroy and medsger disease duration ≤ 3 years (defined as time from the first non-raynaud phenomenon manifestation). * agree to use effective contraception during the study period (women of childbearing age). * smokers agreed to quit smoking during the study. * ability to provide informed consent. exclusion criteria: * the following drugs have been used within one month before screening: including tnf-α inhibitors (continuous use for more than 14 days), il-6 inhibitors, abatacept (continuous use for more than 14 days), jak inhibitors (continuous use for more than 14 days). * used rituximab within 3 months before screening. * ssc with tumor. * people with various lung infections, asthma or other lung diseases such as bronchiectasis. * for patients with severe heart, liver, kidney and other important organ dysfunction, the evaluation criteria are as follows: alt or ast is greater than 2 times the upper limit of normal, or total bilirubin rises twice; cpk\>400; renal crisis, or hypertension of various causes (≥160/100mmhg) is not controlled; creatinine clearance rate \<30ml/min; white blood cell count\<3×109/l; hemoglobin \<80g/l; platelet count\<60×109/l; heart function level iii-iv; pao2\<50mmhg in resting state; fev1/fvc\<0.7. * in the period of acute or chronic infection (not including finger ulcer combined infection). * a history of peptic ulcer or bleeding within 6 months before screening. * people with allergies or multiple drug allergies. * people with mental illness or other reasons who cannot cooperate with treatment.
peer coaching for low-income patients with diabetes in primary care

Conditions: Diabetes Type 2

Summary: patients with diabetes who are counseled by a peer coach (another patient with diabetes) will have improved glycemic control compared with usual care patients.

peer coaches have controlled diabetes, patient study subjects have poorly controlled diabetes.

Eligibility criteria:
inclusion criteria: * diabetes with most recent hba1c 8 or above in past 6 months. exclusion criteria: * dementia, * life expectancy less than 6 months, * inability to speak english or spanish.

Keywords: diabetes
the vital amyloidosis study, a global phase 3, efficacy and safety study of neod001 in patients with al amyloidosis

Conditions: Primary Systemic (AL) Amyloidosis

Summary: this is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with al amyloidosis. subjects will remain on-study until study completion, which will occur when all primary endpoint events (all-cause mortality or cardiac hospitalizations) have been reached.

this is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with al amyloidosis. approximately 236 subjects will be enrolled in \~60 centers, with approximately 118 subjects per arm. this is an event driven trial, therefore subjects will remain on-study until study completion, which will occur when all primary endpoint events (all-cause mortality or cardiac hospitalizations) have been reached. all subjects who discontinue will be followed until the last event is adjudicated. the estimated overall study duration is approximately 42 months, including the enrollment and treatment periods study drug will be administered once every 28 days as a 60-120 minute iv infusion. first-line chemotherapy must be a bortezomib-containing regimen, with bortezomib administered weekly. the number of cycles of first-line chemotherapy that are administered are at the discretion of the investigator, and subsequent chemotherapy regimens may be prescribed as per standard of care at the investigator's discretion. an independent data monitoring committee (dmc) will review data on a regular basis.

Eligibility criteria:
key inclusion criteria: 1. age ≥ 18 years 2. newly diagnosed, al amyloidosis treatment naïve 3. bone marrow consistent with plasma cell dyscrasia 4. confirmed diagnosis of al amyloidosis 5. cardiac involvement 6. planned first-line chemotherapy contains a proteasome-inhibiting agent administered weekly 7. adequate bone marrow reserve, hepatic and renal function key exclusion criteria: 1. non-al amyloidosis 2. meets diagnostic criteria for symptomatic multiple myeloma 3. subject is eligible for and plans to undergo asct 4. history of grade ≥ 3 infusion-associated aes or hypersensitivity to another monoclonal antibody, or known hypersensitivity to diphenhydramine or acetaminophen
intra-bone cord blood transplantation

Conditions: Hematologic Neoplasms

Summary: for the great majority of hematological malignancies, hemopoietic stem cell (hsc) transplant is the only possible cure. the source of hsc is usually bone marrow (bm) or peripheral blood cell (pbsc) mobilized by granulocyte growth factor. transplant needs a hla compatible donor weather related or unrelated. a suitable compatible donor can be found in at least 70% of the patients. thus, at least 30% of patients with indication for allogeneic hsc transplant are not able to undergo the procedure because of the lack of a hla compatible donor. cord blood (cb) cells represent another possible source, that needs a lower degree of hla compatibility. cb transplant, however, offers a lower number of hsc. thus, adult patient rarely may benefit from this source of stem cells, mainly beacuse thie body weight is too high to have ad adequate number of cell per kg. recently, experimental animal models confirmed that an adequate recovery of allogeneic hemopoiesis can be achieved via intrabone injection, using a 1log lower number of cells compared to the intravenous way (yahata 2003, castello 2004). safety and feasibility of intrabone infusion was verified by two clinical studies on humans: the first was conducted by ringden o. et al. in 18 patients using bm as a source of sc. no side effects and complete engraftment of donor hemopoiesis was observed; the second one was conducted by frassoni et al. (frassoni 2008) with cb as the source of hsc. the aim of this study is to evaluate the intrabone infusion of compatible cb in patients with haematological malignancies lacking a hla matched donor. we will perform: evaluation of the engraftment kinetics; evaluation of the chimerism degree at 30, 60, 100 days, 6 months and 1 year after transplant; studies on immunological reconstitution and the role of the nk compartment.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years. * patients affected by hematological malignancies without a hla identical sibling donor or unrelated donor. * informed consent. exclusion criteria: * patients with ecog \< 2. * patients with blood creatine \> 2 mg/dl or with transaminase or cholestase index \> 5 times compared to normality upper limits. * patients with cardiac fraction ejection \< 40%. * patients with dlco \< 60% or diffusing lung capacity of carbon monoxide attesting a severe pulmonary insufficiency. * patients with peripheral blast cell count over 10%. * second neoplasia diagnosed no more than 2 years before. * patients with active or suspected infection by fungi for which a therapeutic treatment is ongoing. * hiv positive patients. * hcv-rna and hbv-dna positive patients * pregnant or lactating women. * severe mental diseases.
intrathecal injection pemetrexed and bevacizumab in patients with leptomeningeal metastases in nsclc

Conditions: Lung Cancer (NSCLC); Leptomeningeal Metastasis

Summary: this is a prospective, single-arm, phase ia clinical study, which was designed to evaluate the efficacy and safety of pemetrexed combined with bevacizumab intrathecal injection in patients with leptomeningeal metastases in nsclc.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * ecog ps score 0-3. ecog ps score 2 or 3 should be due to leptomeningeal metastases. * patients with pathologically diagnosed non-small cell lung cancer with cerebrospinal fluid and/or mri diagnosis of leptomeningeal metastasis(lm); * unsatisfactory efficacy of lm,which defined as disease progression in lm,or lm-related neurological progression, while patients received standard systemic anti-tumor treatment; * expected survival time ≥ 1 month; * the laboratory test results meet the following criteria:hemoglobin ≥ 90 g/l, neutrophil count ≥ 1.5 × 10\^9/l, platelet count ≥ 100 × 10\^9/l; total bilirubin ≤ 1.5 times the upper limit of normal (uln); alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 2.5 × uln ; creatinine≤ 2.0 × uln,or creatinine clearance rate (crcl) ≥ 50 ml/min; * females of child-bearing potential agree to use contraception during the study period and for 6 months after the completion of the study; patients who have had a negative serum or urine pregnancy test within seven days prior to enrollment in the study and who are not breastfeeding; and males agreeing to use contraception during the study period and for 6 months after the completion of the study; * understand and sign the informed consent form. exclusion criteria: * positive for human immunodeficiency virus (hiv) ; * history of allergy to pemetrexed or bevacizumab; * history of pemetrexed and/or bevacizumab intrathecal injection; * presence of contraindication of bevacizumab: 1. uncontrolled hypertension(systolic pressure≥150mmhg，or diastolic pressure≥100mmhg；history of hypertensive crisis or hypertensive encephalopathy; 2. urine protein≥2+,or 24-hour urine protein≥2g； 3. unstable angina pectoris, symptomatic congestive heart failure,myocardial infarction within 6 months before enrollment, severe vascular disease, severe uncontrolled arrhythmia; 4. major hemoptysis within the past 1 month; history of coagulation disorders; 5. presence of serious non-healing wounds, ulcers, or bone fractures 6. presence of abdominal fistula, gastrointestinal perforation, or gastrointestinal tract obstruction; 7. presence of macrovascular invasion； 8. some neurological disorders unrelated to tumors，such as intracranial infection,cerebral hemorrhage,cerebral infarction,encephalitis; * brain/spinal cord radiation therapy within 1 week before enrollment; * pregnant and lactating female; * refuse to use contraception during the study period; * individuals considered by the investigator to be unsuitable for enrollment.

Keywords: leptomeningeal metastases nsclc intrathecal injection
piezosurgery in the treatment of class ii furcation involvement

Conditions: Furcation Defects

Summary: the purpose of this study is to evaluate the effectiveness of piezosurgery in the treatment of class ii furcation involvement using biomaterials and new surgical techniques


Eligibility criteria:
inclusion criteria: * previous subgingival instrumentation with adequate plaque control (fmps \< 20%) and bleeding on probing (fmbs \< 20%). * one or more mandibular molar with buccal class-ii furcation involvement exclusion criteria: * diabetes mellitus * pregnancy and lactation period * subjects smoking \> 10 cigarettes/day were excluded * subjects in chronically treatment with calcium antagonist, immunosuppressive drugs and antiepileptic drugs

Keywords: class ii furcation involvement piezoelectric surgery regeneration biomaterial
paracetamol / ibuprofen for postpartum pain in the early postpartum period

Conditions: Pain

Summary: the investigators will examine the effectiveness of non-opioid analgesia (paracetamol versus ibuprofen) in the early postpartum period

postpartum pain is a common problem that leads to difficulties in basic daily activities, overuse of opioid medications, and even impaired breastfeeding ability. non-opioid analgesia may play an essential role in reducing pain and improving the postpartum period including the ability to breastfeed and caring for the newborn. this study will compare non-opioid treatment - 1000 mg paracetamol versus 400 mg ibuprofen in order to determine the optimal pain relief treatment in the early postpartum period that may decrease the use of opioid analgesia. the investigators will evaluate the pain by the numerical rating scale (nrs) index in the early postpartum period. the evaluation will conduct at 4-time points - while the women taking the pain relief (time 0), an hour later (time 1), 4, and 6 hours later (time 4 and time 6). the investigators will compare the analgetic effect of each drug and evaluate the need for additional analgesia whether opioid or not. furthermore, the investigators will examine when women sought pain relief and whether pain relief contributes to the ability of breastfeeding.

Eligibility criteria:
inclusion criteria: * women between the ages of 18-50, who gave birth in a vaginal birth exclusion criteria: * sensitivity to paracetamol or ibuprofen * after cesarean section * received analgesia prior to study recruitment * perineal tears grade 3 \\ 4 * women with chronic pain, rheumatic disease, fibromyalgia, or trauma * women with a diagnosis or medication for anxiety or depression * dropout for women whose newborns needed respiratory support with intubation, cooling, prolonged hospitalization in nicu exceeding one week

Keywords: post partum pain, pain relief, non-opioids analgesia
efficacy and safety of fixed dose combination (fdc) of olopatadine hydrochloride and mometasone furoate nasal spray (molo; also referred as gsp 301) in the treatment of seasonal allergic rhinitis (sar)

Conditions: Seasonal Allergic Rhinitis

Summary: a single-center, double-blind, placebo-controlled study of fdc olopatadine hydrochloride and mometasone furoate nasal spray (molo; also referred as gsp 301) was conducted in subjects with seasonal allergic rhinitis. in this study, the efficacy and safety of two regimens (bid and qd) of the fdc (i.e. molo 1 and molo 2) were evaluated compared to placebo nasal spray, dymista® and patanase®.


Eligibility criteria:
inclusion criteria: * male and female patients aged 18 to 65 years (inclusive) with a clinical history of seasonal allergic rhinitis (sar) (for at least 2 years) and exhibiting a positive skin prick test exclusion criteria: * pregnant or lactating women * patients with known hypersensitivity to any of the components of the formulation * patients with a history of seasonal asthma during ragweed season. * patient requiring chronic use of inhaled or systemic corticosteroids * patients with perennial rhinitis; non-allergic rhinitis; or ocular infection within 3 weeks before the screening * patients with history of acute or significant chronic sinusitis or chronic purulent post-nasal drip or rhinitis medicamentosa as determined by the investigator. * patients with history of narrow-angle glaucoma, increased intraocular pressure, posterior subcapsular cataract, urinary retention, uncontrolled hypertension, severe coronary artery disease, ischemic heart disease, uncontrolled diabetes mellitus, hyperthyroidism, renal impairment or prostatic hypertrophy, and those receiving mao inhibitor therapy.

Keywords: sar
comparison of fingerstick versus venous sample for troponin i.

Conditions: Chest Pain; Myocardial Infarction; Myocardial Ischemia; Heart Attack

Summary: this study is a prospective, observational, cohort study aiming to compare point-of-care high-sensitive troponin i testing from different sample types with central laboratory (cl) hs ctni plasma samples. a registry of all included patients and their troponin results (poc, cl and hs ctnt) will be made to compare these testing methods.

point-of-care (poc) troponin testing, defined as laboratory testing near a patient location with rapid availability of results, has attracted much interest in the emergency department setting (ed) and seems feasible. these devices might enable earlier decisions, reduce stay at the ed and improve patient flow. while an elevated troponin in patients with suspected acute coronary syndrome (acs) confirms diagnosis and initiates adequate treatment, ruling out acs aids in proper patient dismissal. a next step could be ruling out myocardial infarction by the general practitioner (gp) or fast responder using an on-site poc troponin test. however, drawing venous blood might not be easily available to every gp, especially not during peak hours. the minicare ctni is a bedside system which requires capillary blood, venous whole blood or plasma. the results of the troponin will be given within 10 minutes. it is a very sensitive troponin test, the most clinically sensitive available poc for c-troponin. currently minicare prepares for a high sensitive troponin analysis targeting a reliable result within an hour after onset of chest pain. the objective of this study is to determine if high sensitive troponin testing by minicare (poc hs ctni) has the same analytical performance as standard high sensitivity troponin i testing in our central hospital laboratory ( cl hs ctni architect immunoassay analyzer, abbott).

Eligibility criteria:
inclusion criteria: • patients 18 years or older with chest pain suspected of acs. exclusion criteria: * st elevation myocardial infarction and out of hospital cardiac arrest. * patients with sudden onset tachycardia and a frequency of 110 bpm or higher (supraventricular or ventricular) * patients who are hemodynamically unstable or in which an acute non-coronary diagnosis is suspected, e.g. pulmonary embolism, thoracic aortic dissection etc. * patients recently already admitted for the same set of symptoms at a previous healthcare institution before being transferred to the participating clinical site. * patients not willing or not able to provide informed consent due to their medical condition as judged by the physician.

Keywords: troponin point-of-care minicare
postoperative anemia and functional outcomes after fast-track primary hip arthroplasty

Conditions: Arthroplasty, Hip Replacement; Anemia

Summary: the purpose of this study is to evaluate the possible association between postoperative anaemia and functional outcomes the first 2 weeks after primary hip arthroplasty. the investigators hypothesise that patients with a higher degree of postoperative anaemia have impaired postoperative rehabilitation as measured by standardized functional outcome tests.

postoperative anemia may impair postoperative rehabilitation due to anemia related symptoms such as fatigue or dizziness. although, the impact of postoperative anemia on postoperative rehabilitation and function has previously been examined the results are conflicting. patients undergoing fast-track hip arthroplasty (tha) are mobilized early and participate in physiotherapy during the admission but are discharged early (2-3) days postoperative. however, the ability to rehabilitate early after discharge has not been evaluated in relation to postoperative anemia. the purpose of this observational study is to evaluate the possible association between postoperative anaemia and functional outcomes the first 2 weeks after primary hip arthroplasty. the investigators hypothesise that patients with a higher degree of postoperative anaemia have impaired postoperative rehabilitation as measured by standardized functional outcome tests. hb concentrations and functional outcome measurements will be performed preoperatively, at the day of hospital discharge and during a postoperative visit 12-16 days after surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing primary unilateral tha * age 65 or older exclusion criteria: * not able to give consent * not able to walk prior to surgery * chronic need for rbc transfusion

Keywords: primary hip arthroplasty postoperative anemia functional outcomes
longitudinal multi-omic profiles to reveal mechanisms of obesity-mediated insulin resistance

Conditions: Diabetes Mellitus, Type 2; PreDiabetes; Insulin Resistance; Obesity; Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver; Diet Modification

Summary: this 12-week controlled diet and weight intervention study seeks to define the molecular pathways that link excess body weight to the development of insulin resistance (ir). blood, adipose and stool are sampled at three timepoints; baseline, peak weight (4 weeks) and post weight loss to monitor changes in cellular processes. additionally, direct insulin sensitivity testing, and radiological measurement of visceral fat and intrahepatic fat content is measured at three timepoints to correlate clinical indices with cellular changes.

obesity has become an epidemic worldwide. metabolic/cardiovascular complications of obesity are likely related to the fact that obese individuals tend to be insulin resistant (ir). while insulin- mediated glucose uptake (imgu) correlates with adipose tissue mass, not all obese individuals are ir, and metabolic and cardiovascular profiles of those who are ir vs insulin sensitive (is) differ significantly. why one individual who reaches a bmi of 30 kg/m2 will develop ir and another with similar bmi and activity level remains is is unclear. furthermore, while insulin sensitivity improves with weight loss, this response varies as well. given that fat mass per se does not fully explain the obesity contribution to imgu, itis likely that differential adipocyte function plays a role. with this study, our purpose is to employ an integrated omics strategy to identify analyte/pathway signatures in blood and adipose tissue that characterize ir versus is states and expand our biological knowledge of the mechanisms underlying ir.

Eligibility criteria:
inclusion criteria: * age 35-65 * bmi 25-35 kg/m2 * stable body weight * nondiabetic exclusion criteria: patients with; * diabetes * major organ disease * history of liposuction or bariatric surgery * active eating or psychiatric disorder * pregnancy or lactation, heavy alcohol use * recent change in weight (over the past 12 weeks) * use of weight loss medication, statins, or oral steroids clinical screening exclusions; * hematocrit \< 33% * fasting glucose \>/= 126 mg/dl * blood pressure \>160/100 mmhg

Keywords: metabolomics low fat diet low carbohydrate diet microbiome