Kornimate/medical-research-clean huggingface dataset:
autologous adipose tissue derived mesenchymal stem cells transplantation in patient with lumbar intervertebral disc degeneration

Conditions: Lumbar Intervertebral Disc Degeneration

Summary: the purpose of this study is to investigate the efficacy and safety of autologous transplantation of adipose tissue derived mesenchymal stem cells (mscs) in patient with lumbar intervertebral disc degeneration.


Eligibility criteria:
inclusion criteria: * subjects who understand and sign the consent form for this study * age :19-70, males and females * have chronic low back pain for at least 1 year * have failed 1 year of non-operative low back pain management * have degenerated intervertebral disc on t2-weighted mr images * confirmed by positive discography * have significant lumbar instability at degenerated intervertebral disc exclusion criteria: * have significant lumbar herniated intervertebral disc * women who are pregnant or breast feeding or planning to become pregnant during the study * history or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications * serious pre-existing medical conditions like cardiovascular diseases, renal diseases, liver diseases, endocrine diseases, cancer and diabetes mellitus * participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study * other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
the advantages and disadvantages between uncut roux-en-y reconstruction and billroth ii reconstruction after laparoscopy-assisted distal gastrectomy for gastric

Conditions: Gastric Cancer

Summary: the advantages and disadvantages between uncut roux-en-y reconstruction and billroth ii reconstruction after laparoscopy-assisted distal gastrectomy for gastric.

to search which is the better reconstructions by comparing and analyzing the advantages and disadvantages between uncut roux-en-y and billroth ii reconstructions after laparoscopy-assisted distal gastrectomy for gastric cancer. method: it's a prospective study including all patients underwent laparoscopy-assisted distal gastrectomy (ladg) in the first hospital of jilin university, from february 2016 to february 2017. all surgical procedures will be performed by the single surgery team, which is leaded by professor wang quan. the reconstruction method will be selected randomly from uncut roux-en-y and billroth ii anastomosis by drawing lots preoperatively without distinct indications. clinical data, operation data and perioperative complications and related physiological indexes of differences.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of distal gastric cancer * underwent laparoscopy-assisted distal gastrectomy exclusion criteria: * have simultaneously other cancer * have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases * have upper gastrointestinal surgery * can't bear the gastric tube * the period is too late or the tumor is too large to carry on a laparoscopy assisted radical distal gastrectomy

Keywords: reflux residue gastric stasis emptying time
study to evaluate the efficacy and safety of andecaliximab combined with nivolumab versus nivolumab alone in adults with unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma

Conditions: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Summary: the primary objective of this study is to evaluate and compare the efficacy of andecaliximab (gs-5745) in combination with nivolumab versus nivolumab alone in adults with recurrent gastric or gastroesophageal junction (gej) adenocarcinoma.


Eligibility criteria:
key inclusion criteria: * histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or gej which have progressed on at least 1 prior systemic therapy or line of treatment for unresectable/metastatic disease * eastern cooperative oncology group (ecog) performance score of ≤ 1 * measurable disease according to response criteria in solid tumors (recist) v1.1 * tumor sites that can be accessed for repeat biopsies * archival tumor tissue, preferably obtained from the most recent available biopsy; there must be adequate tissue for a cochran-mantel haenszel (cmh) test stratified by programmed death ligand 1 (pd-l1) stratification test, as assessed by central pathologist * individuals not receiving anticoagulant medication must have an international normalized ratio (inr) ≤ 1.5 and activated partial thromboplastin (aptt) ≤ 1.5 x upper limit of normal (uln) * required baseline laboratory data as outlined in protocol key exclusion criteria: * individuals who have received only neoadjuvant or adjuvant therapy for gastric adenocarcinoma * radiotherapy within 28 days of randomization * uncontrolled intercurrent illness as outlined in protocol * history of a concurrent or second malignancy except for those outlined in protocol * major surgery, within 28 days of first dose of study drug * known positive status for human immunodeficiency virus (hiv) * known acute or chronic-active infection with hepatitis b virus (hbv) or hepatitis c virus (hcv) * chronic daily treatment with oral corticosteroids (dose of \> 10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days of randomization * known or suspected central nervous system metastases * documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of randomization * serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous antibiotics * current or history of pneumonitis or interstitial lung disease * active known or suspected autoimmune disease with exceptions noted in protocol. * history of bone marrow, stem cell, or allogenic organ transplantation note: other protocol defined inclusion/ exclusion criteria may apply.
investigation of antibody and immune responses to sars-cov-2 proteins in covid-19 patients

Conditions: COVID-19; SARS-CoV-2 Infection

Summary: sars-cov-2, the virus that causes coronavirus disease 2019 (covid-19), has negatively impacted global health and requires more research to develop better tests and to improve disease treatment. the purpose of this research is to aid in the testing effort by collecting samples from people who have been diagnosed with covid-19 or are suspected of having covid-19. samples you provide will be used investigationally by inanobio to develop a test to determine when antibodies against various sars-cov-2 proteins are detectable. up to approximately 80 subjects of all ages with either a suspected or lab-confirmed diagnosis of covid-19 will take part in this research.

a longitudinal, non-randomized study to evaluate the utility of the inanobio's protein arrays in detecting unique antibodies in covid-19 patients. to study the feasibility of utilizing a viral proteome microarray for evaluating exposure status, immunity status, diagnosis, and prognosis of sars-cov-2 infections during and after the course of disease. the sample size is to include 80 subjects: 40 diagnosed with covid-19 and 40 suspected to have covid-19. the goal will be to assess antibodies throughout the subject's disease course compared to controls.

Eligibility criteria:
inclusion criteria: subject must meet all of the following criteria to be eligible for treatment in the study: 1. subject or legal representative understands the nature of the procedure and has signed the subject informed consent form prior to study procedures 2. for the covid-19 cohort * subject has lab-confirmed diagnosis of covid-19 by rt-pcr 3. for the pui cohort * subject has suspected covid-19 according to medical evaluation, but does not yet have lab-confirmed diagnosis of covid-19 (results outstanding, or has tested negative by rt-pcr) exclusion criteria: * subject or legal representative not willing to consent
a phase 3 study to evaluate the long-term safety, tolerability and efficacy of efgartigimod ph20 sc in adult participants with bullous pemphigoid

Conditions: Bullous Pemphigoid

Summary: the purpose of this study is to evaluate the safety of efgartigimod ph20 sc over a longer period of time in adult participants with moderate-to-severe bullous pemphigoid (bp) who have completed argx-113-2009 study. the study will also evaluate the efficacy of efgartigimod ph20 sc. eligible participants can roll over from the main study (argx-113-2009) to this open-label extension study (argx-113-2010). the study consists of a treatment period of up to 48 weeks in which participants receive efgartigimod ph20 sc. after the first 5 visits, the participants will visit the study centers at least once every 4 weeks. the participants who are not receiving efgartigimod ph20 sc (after the main study or currently on the study), will enter an observation period with study visits at least once every 8 weeks. if the participant relapses, they can re-enter the treatment period where they will receive efgartigimod ph20 sc. the treatment and observation period is followed by a follow-up period of 8 weeks. oral or topical corticosterioids can be administered at the investigator's indiscretion


Eligibility criteria:
inclusion criteria: * has completed the week 36 visit of argx-113-2009 * is capable of providing signed informed consent and complying with protocol requirements * agrees to use contraceptive measures consistent with local regulations and the following: women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the study drug and must use one of the contraception methods described in the protocol from signing the icf until the last dose of the study drug exclusion criteria: * clinically significant disease, recent major surgery (within 3 months of baseline), or intends to have surgery during the study; or any other medical condition that, in the investigator's opinion would confound the results of the study or put the participant at undue risk * known hypersensitivity to the study drug or 1 of its excipients * permanently discontinued imp in argx-113-2009 due to an adverse event (ae) considered related to the study drug and for whom the benefit/risk balance is not considered positive
pet/mri for the staging of newly diagnosed prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to gain understanding of how pet-mr (positron emission tomography-magnetic resonance imaging) using the substance 18f-dcfpyl (pyl) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.


Eligibility criteria:
inclusion criteria * patients must have a biopsy-proven diagnosis of high risk, very high risk, or locally advanced prostate cancer * patients must have a diagnosis of high risk, very high risk, or locally advanced prostate cancer per nccn guidelines (t3-t4 disease) * patients are healthy enough to be deemed surgical candidates with an ecog performance status of 0-2 * patients must be age ≥ 18 years * patients must agree to use adequate contraception (e.g. barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of the imaging * patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study exclusion criteria * patients who have contraindications to mri (i.e. pacemakers, aneurysm clips or shaped fragments) * patients who are claustrophobic will be required to take an anti-anxiety medication prescribed by their physician one hour prior to the scan * patients may not be receiving any other treatments or investigational agents * patients with a gfr \<30ml/min are ineligible to receive intravenous contrast per standard mr exclusion criteria * patients not interested in pursuing surgical intervention for their disease (i.e. refusing treatment or requesting radiation oncology referral) * patients who have received androgen deprivation therapy or prior surgery for prostate cancer * patients who report taking multivitamins and/or folate supplements on the day of the scan
local infiltration analgesia after abdominal hysterectomy

Conditions: Pain

Summary: the aim of the study is to evaluate traditional analgesic therapy after abdominal hysterectomy with single infiltration of local anesthetics in the surgical area at the end of surgery.

the study is a controlled, double blind, prospective, randomized and performed at sahlgrenska university hospital in goteborg, sweden. the injectant mixture consists of 300 mg ropivacaine mixed with 30 mg ketorolac and 0.5 mg epinephrine. total volume of the solution is 156 ml. the normal saline injection is used in the control group in the same manner as in the lia group. the parameters which would be evaluated are consumption of morphine, pain intensity and side effects. the primary objective is to evaluate whether local infiltration analgesia (lia) into the operating field will reduce morphine consumption during the first 24 postoperative hours in patients undergoing abdominal hysterectomy (ah). secondary end-points are pain intensity, incidence of nausea and vomiting, sedation intensity.

Eligibility criteria:
inclusion criteria: * patients requiring abdominal hysterectomy exclusion criteria: * body mass index \> 35 * american society of anesthesiologists classification \> 3 * renal dysfunction * allergic to acetylsalicylic acid * unwilling to provide informed consent

Keywords: analgesia local infiltration analgesia pain, relief pain, postoperative ropivacaine ketorolac epinephrine adrenergic agonists sympathomimetics therapeutic uses anti-inflammatory agents, non-steroidal analgesics, non-narcotic analgesics opioids morphine pain postoperative complications physiological effects of drugs anesthetics, local anesthetics
preconception lifestyle interventions to improve future metabolic health (before the beginning)

Conditions: Gestational Diabetes

Summary: the aim of this study is to investigate whether the combination of high intensity exercise and time restricted eating before and during pregnancy can reduce the risk of hyperglycaemia during pregnancy.

women who are planning a pregnancy will be recruited into a parallel groups randomised controlled trial where the intervention will consist of high intensity training and time-restricted eating. the intervention will continue throughout pregnancy. the investigators will assess whether this lifestyle intervention can effect maternal and offspring cardiometabolic health.

Eligibility criteria:
inclusion criteria: * contemplating pregnancy within the next six months * at least one of the following criteria: bmi ≥ 25 \ 4.5 kg, fasting plasma glucose \> 5.3 mmol/l, or non-european ethnicity exclusion criteria: * on-going pregnancy * trying to conceive ≥ 6 cycles at study entry * known diabetes (type 1 or 2) * shift work that includes night shifts \> 2 days per week * previous hyperemesis * known cardiovascular diseases * high intensity exercise ≥ 2 hours/week the last 3 months * habitual eating window ≤ 12 hours

Keywords: diet therapy exercise therapy
controlled map trauma brain injury (comat study)

Conditions: Closed-Loop Communication

Summary: the goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in head trauma injury patients will results in more time spent with a mean arterial pressure (map) within the predefined map compared to patients managed without any automated system (manually management)

in head trauma patients, the maintenance of map within a very narrow range is desired to avoid secondary ischemic diseases. however, the map needed to reach can vary over time based on intracranial pressure. additionally, it is well know that the nurses in the intensive care unit managed multiple patients simultaneously and cannot dedicate 100% of his-her time to adjust vasopressor infusion and/or fluid administration. using a novel automated system can overcome this issue and may lead to more time in map target than the traditional management. all patients will have the same automated system for fluid administration using the ev1000 monitoring using the afm mode ( assisted fluid management). this system will recommend to the clinical when to administer a fluid bolus to optimize sv and svv. so fluid administration will be standardized in both groups. the only difference will be the management of map. the goal will be to compare a treatment period of at least 3 hours during which the patient will be under continuous noradrenaline infusion. this treatment time should be within the first 48 hours of patient admission in the intensive care unit.

Eligibility criteria:
inclusion criteria: * severe head trauma patients ( glasgow score ≤8), intubated, ventilated and sedated exclusion criteria: * glasgow score \>8 * bilateral mydriasis at the initial management
treatment of hypertension in primary care in spain

Conditions: Hypertension

Summary: non-interventional,observational and retrospective study assessing the therapeutic and diagnostic attitude followed in primary care for a hypertensive patient depending on his degree of blood pressure control.


Eligibility criteria:
inclusion criteria: * diagnosis of primary hypertension and/or treated for hypertension for one year or more * clinical data of blood pressure measures for the last 12+/- 2 months before inclusion. exclusion criteria: * secondary hypertension * physical or psychological impairment for the understanding of the information to be given to the patient

Keywords: hypertension therapeutic diagnostic attitude blood pressure
efficacy of intraperitoneal versus intravenous lidocaine for postcesarean pain relief

Conditions: Postcesarean Pain Relief

Summary: objective: to evaluate intraperitoneal (ip) lidocaine administration and intravenous (iv) lidocaine infusion for postoperative pain control after cesarean section. study design: prospective randomized, double-blind, placebo-controlled study. patients and methods: initially, 165 pregnant full-term females, indicated to be underwent elective cesarean delivery for various indications were randomized equally to either group c (control, ip and iv saline), group ip (intraperitoneal lidocaine administration), or group iv (intravenous lidocaine infusion).five patients were excluded from each group for various reasons. the outcome measures were postoperative pain scoring, total pethidine consumption and the need for postoperative analgesia.


Eligibility criteria:
inclusion criteria: * singleton pregnancy, more than or equal completed 37 gestational weeks, indicated to undergo elective cesarean delivery for various indications exclusion criteria: * extreme of age (below 18 or above 40 year), uncooperative patients, women under spinal anesthesia, previous abdominal scars, including previous cesarean or myomectomy, multiple gestation, bmi \>35 kg/m², chorioamnionitis, hypersensitivity or contraindications to lidocaine, bronchial asthma, bleeding diathesis, pregnancy induced-hypertension, liver or kidney diseases, diabetes mellitus, and patients with psychological disturbance, or any form of chronic pain before or during pregnancy.
effect of sarpogrelate on the nephropathy in type 2 diabetes (sonata study)

Conditions: Diabetic Nephropathy

Summary: phase 4 study to evaluate the safety and effect on decreasing subjects' albuminuria who have type 2 diabetes by using sarpogrelate and placebo.


Eligibility criteria:
inclusion criteria: * person who signed on icf * type 2 diabetic patient who have microalbuminuria or overt proteinuria * in case of hypertension patients, who keep the same medication steadily over last 4 weeks exclusion criteria: * patients who have hypersensitivity on sarpogrelate or other salicylic acid * patients who should keep the antiplatelet agent because of acute cardiac disease or peripheral vein disease * patients who took other anticoagulant agent within 1 month * patient who take acei or arb but not controlled(over 150/100mmhg) * type 1 diabetes patients * patient who have cardiac or liver problem * cr: \>1.8mg/dl or gfr: \<40ml/min * malignant tumor patients
comparison of tendon transfer, botox injections and ongoing treatment in hemiplegic cerebral palsy

Conditions: Cerebral Palsy

Summary: doctors use different treatments for people with cerebral palsy. surgery is one option. botulinum toxin injections are another option; these are given directly into spastic muscles to weaken them temporarily. regular ongoing treatment (splinting, stretching and exercises) is another option. the investigators want to find out if surgery works better than botulinum toxin (botox) injections or regular ongoing treatment (therapy), and if the effects of botulinum toxin injections last for longer than six months.

the specific aims of this study and the methodology for achieving them are: 1. to determine if tendon surgery for the forearm, wrist and thumb deformities of uecp is more effective than botulinum toxin injections or regular ongoing treatment at improving function and quality of life for children with uecp. children who are candidates for tendon surgery will be prospectively randomized to one of three treatment groups: standard tendon surgery, a series of three botulinum toxin injections over a period of 12 months, and regular ongoing treatment. validated tests of cognition, function and quality of life with tests of stereognosis and range of motion will be administered before, during and after treatment in order to compare outcomes of the three treatment groups. 2. to determine if serial botulinum toxin injections have long-term beneficial effects on upper extremity function which outlast their paralytic effects. botulinum toxin has been shown to have beneficial effects on ue function while the muscles injected remain weakened by the toxin. clinicians have theorized that improvements in ue function are maintained after the toxin wears off, but this has not been proven. children randomized to the botulinum toxin injection group will receive 3 injections. their function will be tested before the first injection, while the paralytic results of the second injection are still in effect, and after the paralytic effects of the third injection have worn off, and the results compared in order to determine if functional improvements outlast the medicinal effects.

Eligibility criteria:
inclusion criteria: * diagnosis of uecp * aged four to 17 years * candidate for standard surgical management (tendon transfer) exclusion criteria: * subject could benefit from procedures in addition to standard surgical management and releases, and these procedures could be performed at the same anesthetic (for example, elbow flexor release) * previous botulinum toxin injection session in the affected ue in \< 1 year * previous ipsilateral ue surgery * primary language other than english or spanish * subject and/or parent unwilling to attend eight therapy sessions and perform home exercise protocol

Keywords: cerebral palsy tendon transfer botulinum toxin type a occupational therapy child