Kornimate/medical-research-clean huggingface dataset:
fast-track eligibility and hospital discharge for outpatient lumbar discectomy

Conditions: Lumbar Disc Disease; Post-Op Complication

Summary: 122 asa i-ii patients were enrolled into the study. iv propofol, fentanyl and rocuronium were used for the induction and a total intravenous anesthesia technique for the maintenance of anesthesia. sugammadex was given for neuromuscular blockade reversal. a multi-modal analgesic regimen was utilized. primary outcome measures were pacu bypass rates and hospital discharge times. secondary outcome measure was to compare discharge scoring systems for pacu bypass assessment: modified aldrete scoring system (mass), white's fast-tracking scoring system (wftss), and speeds criteria

after obtaining hospital's ethics committee approval (university of medical sciences, gülhane training and research hospital- date: 06/05/2018; no: 18/148) and written informed consents obtained from patients, 122 asa (american society of anesthesiologists) physical status i-ii patients, aged between 18-65 years, undergoing elective lumbar discectomy under general anesthesia were included into the study . after anesthesia application applied to all groups with the same procedure, patients were extubated after surgery. after extubation, patients were evaluated using mass, wftss and speeds criteria during 15 minutes with 3 min intervals. patients who fulfilled criteria of all scoring systems were defined as eligible for pacu by-pass (fast-tracking) and transferred into phase ii recovery area in the ward without observation in pacu (group ft = fast track;). ineligible patients were taken into pacu where their treatments were continued until discharge criteria were achieved (group pacu). all patients were followed in the ward until hospital discharge. iv tramadol pca (patient -controlled analgesia; infusion rate: 4 mgh-1, bolus dose: 4mg, lock-out time: 30 min., 4 hours-limit: 30 mg), paracetamol (10 mgkg-1 iv with 6 hrs. intervals) and oral diclofenac sodium (75 mg with 8 hrs. intervals) were given in a multimodal analgesic regimen. pain was evaluated using visual analogue scale (vas) with 2 hours intervals and iv pethidine 0.5 mgkg-1 was given as rescue analgesic throughout the study period when vas was \>3. ponv was treated using iv 4 mg ondansetron. discharge from hospital was evaluated using post anesthetic discharge scoring system (padss), . patients with a padss score ≥ 9 were discharged from the hospital by the escort of their relatives.

Eligibility criteria:
inclusion criteria: * asa (american society of anesthesiologists) physical status i-ii patients * elective primary lumbar discectomy performed for one or two vertebra levels under general anesthesia * minimal risks for perioperative bleeding and airway safety exclusion criteria: * patient's refusal * urgent surgery, * regional anesthesia, * history of previous lumbar surgery * difficult ventilation and intubation, * treatment for chronic pain * obstructive sleep apnea, * morbid obesity (bmi≥40 kg/m2) * allergy to drugs

Keywords: pacu-bypass hospital discharge lumbar discectomy
effect of anesthesi̇a techniques on postoperati̇ve cogni̇ti̇ve dysfunction for mmse and nse level

Conditions: Postoperative Cognitive Dysfunction; NEURON SPECIFIC ENOLASE; MINI MENTAL STATE EXAMINATION TEST

Summary: the aim of this study is to compare the effects of total intravenous anesthesia and inhalation anesthesia methods on postoperative cognitive dysfunction according to mini mental state examination scores and neuron specific enolase levels in lumbar disc herniectomy operations.


Eligibility criteria:
inclusion criteria: -lumbal disc herniectomy operation 18-65 age exclusion criteria: * patients before and after the coronary artery bypass graft surgery * patients in the last trimester of pregnancy * patients with severe heart failure * liver failure * kidney failure * malignant hyperthermia * lactating patients * patients with vision or hearing problems * patients having difficulty in understanding and speaking turkish * parkinson's and alzheimer's disease * alcohol and drug addicts * morbidly obese patients * intraoperative hypotension, hypertension and hypoxemia
paricalcitol injection phase ii trial

Conditions: Chronic Kidney Disease

Summary: the pk and tolerability of paricalcitol after repeated intravenous administration for 2 weeks (total 6 doses at every hd session) are studied in subjects with 2°hpt who are receiving hd 3 times a week for stable chronic renal failure.

the purpose of this study is pharmacokinetic \& tolerability.

Eligibility criteria:
inclusion criteria: * subjects with 2°hpt who are receiving hd 3 times a week for stable chronic renal failure exclusion criteria: * subject is considered by investigator, for any reason, to be an unsuitable candidate for the study
effects of noninvasive brain stimulation techniques on bdnf levels

Conditions: Depression; Schizophrenia

Summary: the aim of this study is to investigate the effects of non invasive brain stimulation - nibs - techniques (electroconvulsivotherapy - ect, transcranial direct current stimulation - tdcs, repetitive transcranial magnetic stimulation - rtms) on serum brain derived neurotrophic factor (bdnf) levels in patients with depression and schizophrenia. four blood samples will be collected in each participants, one before the nibs sessions, and 3 after the completion of nibs protocols: one immediately after the end of the nibs sessions, a second one week after and a last one month after. two blood samples separated by one month will also be collected in a a group of healthy volunteers.

the hypothesis is that nibs will modulate bdnf levels and that the modification in serum bdnf levels will be correlated with clinical improvements in the sample of patients.

Eligibility criteria:
inclusion criteria: * in the depression group: dsm iv criteria of mdd; hdrs17\> 22; stage 2 of resistance; received rtms or ect * in the schizophrenia group dsm iv criteria of schizophrenia; pharmaco-resistance of symptoms (either negative symptoms or auditory verbal hallucination); received rtms or tdcs * in the healthy volunteers group : to not have axis i of dsm iv diagnosis; no siblings with axis i dsm iv diagnosis exclusion criteria: * less than 18 years old * pregnancy * received benzodiazepine in the depression and schizophrenia group: * bipolar disorder * other axis i of dsm iv diagnosis (excluding for tobacco use disorder)
quilting sutures after mastectomy

Conditions: Breast Cancer

Summary: the use of wound drains after mastectomy is common practice in belgium. however, placement of suction drainage has several disadvantages. skin bacteria can enter via the drain and cause infection, or the drain itself can cause discomfort and a need for daily nursing. after drain removal, seroma is the most common complication following breast cancer surgery. seromas are collections of serous fluid that frequently develop under the skin or in the axillary space formed after mastectomy and/or axillary lymph node dissection, resulting from surgical trauma to blood/lymphatic vessels and post-traumatic inflammation. seroma formation can cause discomfort and limitations in shoulder function. moreover, it is associated with surgical site infections, often requires treatment and increases healthcare consumption. wound healing problems might be a cause of postponement of adjuvant therapy. the quilting suture technique, in which the skin is sutured to the pectoralis muscle and drain placement is not needed, may lead to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections. in this national multicentric study, we will compare mastectomy with placement of suction drains, a standard technique used in the vast majority of belgian hospitals, with the new quilting suture technique without placement of suction drains. we will focus on 3 distinct primary outcomes: * pain of the mastectomy area 6 months after surgery * upper limb function 6 months after surgery * cosmetic outcome scored by the patient 6 months after surgery. the goal of this study is to demonstrate the absence of long-term negative effects of the quilting suture technique on shoulder function, cosmetic outcome, and pain management.


Eligibility criteria:
inclusion criteria: * capable of giving written informed consent * age ≥ 18 years * scheduled for unilateral mastectomy without immediate breast reconstruction with or without axillary surgery (sentinel lymph node biopsy or axillary lymph node dissection) exclusion criteria: * scheduled for mastectomy with immediate breast reconstruction * scheduled for synchronous bilateral breast and/or axillary surgery

Keywords: mastectomy drain policy pain upper limb function cosmetic outcome quilting
arm exercise capacity, muscle strength and activities of daily living in patients with fibromyalgia syndrome

Conditions: Fibromyalgia Syndrome

Summary: the aim of this study is to compare the upper extremity exercise capacity, muscle strength and activities of daily living of patients with fibromyalgia syndrome and healthy individuals.


Eligibility criteria:
inclusion criteria-fibromyalgia syndrome: * being diagnosed with fibromyalgia syndrome * being aged 18-65 * stable use of medication for at least 3 months or longer * volunteering to participate in the study exclusion criteria-fibromyalgia syndrome: * having comorbidities that may affect physical functions * failure to cooperate with tests to be performed * presence of exercise test contraindication inclusion criteria-healthy control: * being aged 18-65 * volunteering to participate in the study exclusion criteria-healthy control: * having a chronic or systemic disease * failure to cooperate with tests to be performed
cediranib (azd2171, recentin™) in metastatic or recurrent renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.


Eligibility criteria:
inclusion criteria: * confirmation of metastatic or recurrent renal cell carcinoma exclusion criteria: * certain types of previous anti-cancer therapy for renal cell carcinoma * patients with type i insulin-dependent diabetes or poorly-controlled type ii insulin-independent diabetes * patients with a history of poorly controlled high blood pressure

Keywords: cancer tumour advanced cancer metastatic renal cell carcinoma kidney cancer recentin
study assessing immunogenicity and safety of ic43 in intensive care patients

Conditions: Pneumonia, Ventilator-Associated

Summary: randomized, placebo-controlled, partially blinded phase 2 pilot study. multicenter study (approximately 50 centers) in approximately 9 countries. proposed start date is december 2008. the study duration per patient is estimated to be 90 days. overall study duration is estimated to be 12-18 months.

this is a randomized, placebo-controlled, multi-center, partially blinded \[i.e., 100 mcg and 200 mcg ic43 with al(oh)3,, respectively\] and placebo, but unblinded for non-adjuvanted ic43 \[i.e., 100 mcg w/o al(oh)3\] phase 2 pilot study. the study population consists of male or female icu patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.

Eligibility criteria:
inclusion criteria: * male or female patients aged between 18 and 80 years * patients admitted to an icu with a need for mechanical ventilation for more than 48 hours at visit 0 * at high risk for acquiring infection against p. aeruginosa at visit 0. * patients who, as determined by the investigator, have a high probability of survival for at least 48 hours. * in females, either childbearing potential terminated by surgery or 1 year post menopausal, or a negative pregnancy test and the willingness of practicing a reliable methods of contraception * written informed consent or waiver according to the national regulations exclusion criteria: * known use of any other investigational or non-registered drug within 30 days prior to ic43 vaccination at visit 0 * low severity of illness defined by an acute physiology score \< 8 at visit 0 * patients \< 6 months post organ transplantation * severe thrombocytopenia or other coagulopathy which in the opinion of the investigator makes the patient unsuitable for intramuscular injection * pregnancy, lactation * persons who have been committed involuntarily to an institution, e.g. mental health facility or prison, will not participate in the study
brief intervention for substance use and partner abuse among females in the er

Conditions: Substance Related Disorders; Domestic Violence

Summary: the purpose of this study is to target co-occurring problems of substance use and intimate partner violence (ipv) using a computer-based intervention, b-safer (brief intervention for substance use and partner abuse for females in the emergency room). this project will develop and test the computer-based intervention, examining primary outcomes of substance use and utilization of relationship safety resources.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * english or spanish language proficiency sufficient to understand and complete study procedures * moderate drug use in the prior 3 months (by nm-assist) * ipv victimization in the prior 6 months (by wast) * access to a phone exclusion criteria: patients who are: * intoxicated * medically unstable as determined by ed staff * suicidal ideation * psychosis * combative * in police custody
effectiveness of a public campaign to increase stroke awareness in reducing prehospital delay

Conditions: Acute Stroke

Summary: the starting hypothesis is that a multilevel educational campaign, specifically developed for the local community, can increase public stroke awareness and reduce pre-hospital delay. the effectiveness of such intervention will be evaluated according to a cluster randomized, stepped wedged design. the clusters are the four communities of the area vasta emilia nord, aven (parma, piacenza, modena e reggio emilia). as analysis units, we will consider the patients consecutively admitted to the six participating hospitals throughout the study period, for suspected stroke or transitory ischemic attack (tia).

after a baseline 3 month period, the educational campaign will be sequentially launched in the four communities over four 3 month periods, according to a computer-generated list. the comparison will be the"usual care". primary outcome measures: the proportion of patients arriving at the emergency department (ed) with suspected stroke or tia within two hours. secondary outcome measures: the proportion of patients with confirmed stroke or tia diagnosis; the proportion of ischemic stroke patients evaluated for recominanat tissue plasminogen activator (rtpa) therapy; the proportion of patients treated with rtpa; time interval between arrival at the ed and ct scan; for patients treated with rtpa, time interval between arrival at the ed and therapy initiation (door to needle time); death and disability (assessed as modified rankin score 3-5) at 1 and 3 month from stroke onset.

Eligibility criteria:
inclusion criteria: * patients consecutively admitted to the six participating hospitals for suspected stroke or transitory ischemic attack (tia), defined as abrupt onset of focal or generalized neurologic deficit of vascular origin. exclusion criteria: * no information available on the time of stroke onset. * no informed consent from patient or caregiver

Keywords: stroke community education awareness prehospital delay
study of ctdna as prognostic factor on resectable stage iiia nsclc patients treated with neoadjuvant treatment

Conditions: Non Small Cell Lung Cancer Stage III; Neoadjuvant Treatment

Summary: this is an observational, prospective, multicentre and nationwide study. the study enroll resectable stage iiia non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world. the primary objective of this study is evaluating whether there is a significant association between ctdna clearance (no detection of ctdna) after neoadjuvant treatment and before surgery and progression free survival.

this is an observational, multicenter, one-arm, non-comparative, prospective study that will not under any circumstances interfere in the physician's normal clinical practice. being limited to the collection of blood samples at five times and patient data, it does not entail any diagnostic or therapeutic procedure outside of normal clinical practice. approximately 100 resectable stage iiia non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world will be recruited for this study in spain. with this figure, it can be estimated whether ctdna, both baseline and its negativization, has a role as a prognostic marker in the evolution of these patients in real-life conditions. the primary objective of this study is evaluate whether there is a significant association between ctdna clearance (no detection of ctdna) after neoadjuvant treatment and before surgery and progression free survival. the study is planned with the recruitment of patients over a year to a follow-up of 36 months post-surgery.

Eligibility criteria:
inclusion criteria: * 1. previously untreated patients with histologically- or cytologically- documented nsclc who present stage iiia disease (according to 8th version of the international association for the study of lung cancer staging manual in thoracic oncology) and also, potentially resectable locally advanced nsclc patients' stage iiib with t3n2 disease according to 8th edition can be included. * 2. tumor should be considered resectable before study entry by a multidisciplinary team * 3. ecog 0-1 * 4. age ≥ 18 years at time of study entry * 5. patients that are going to be treated with neoadjuvant treatment before surgery * 6. patient capable of proper therapeutic compliance and accessible for correct follow-up * 7. patients must have signed, dated and irb/ec-approved written informed consent form in accordance with regulatory and institutional guidelines. this must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. exclusion criteria: * 1. patients who refuse to sign and date an irb/iec-approved written informed consent form. * 2. no possibility of venipuncture * 3. any medical, mental, or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.

Keywords: resectable stage iiia ctdna
growth hormone treatment for the prevention of short stature in young girls with turner syndrome before the age of 4 years

Conditions: Turner's Syndrome

Summary: the objective of this study is to evaluate the efficacy and safety of recombinant human growth hormone (r-hgh) treatment in girls with turner syndrome under the age of 4 years. after 4 years of treatment, height in these girls will be compared with an historical control group of untreated girls with turner syndrome, matched for age and height at baseline.


Eligibility criteria:
inclusion criteria: * young girls with turner syndrome proved by karyotype * growth hormone secretion confirmed with ornithin stimulation test * normal glucidic metabolism confirmed by assessment of hba1c * none associated severe pathology which could have impact on growth (i.e. renal insufficiency, decompensated heart failure) * no previous or associated treatment with anabolic or sexual steroids * known parental height exclusion criteria: * severe associated pathology with impact on growth * concomitant treatment with impact on growth * previous or associated treatment with anabolic steroids * associated growth hormone deficiency

Keywords: growth hormone turner syndrome r-hgh early treatment
prevention of non-surgical bleeding by management of heartmate ii patients without antiplatelet therapy

Conditions: Heart Failure

Summary: this study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the hm ii lvad as per the current fda approved indications for use.

this is a post-market clinical study of hm ii patient management practices to be conducted in the united states. subjects will be randomized in a 1:1 fashion to the following research drug groups: 1. treatment arm: warfarin (inr target: 2.0-2.5, median: 2.25) + placebo (1 pill/day) 2. control arm: warfarin (inr target: 2.0-2.5, median: 2.25) + asa therapy (81mg/day) the study will investigate if subjects in the treatment arm experience a reduced incidence of non-surgical bleeding, without an increased risk of thromboembolic events.

Eligibility criteria:
inclusion criteria * subject is receiving the hm ii per standard of care (soc) in accordance with the fda approved indications for use * subject is ≥ 50 years of age * subject is receiving the hm ii as their first lvad * subject or legally authorized representative (lar) has signed an informed consent form (icf). exclusion criteria * existence of ongoing mechanical circulatory support (mcs) other than intra-aortic balloon pump or impella® devices * participation in any other clinical investigation(s) involving an mcs device, or an investigation(s) that is likely to confound study results or affect study outcome * antiplatelet therapy is mandated for other conditions, in particular: a) recent coronary artery stenting (≤ 6 months), b) carotid artery disease, and c) other conditions where the investigator is not comfortable leaving subjects off-asa or starting asa post lvad implantation. in situations where the investigator is uncertain, the steering committee can provide recommendation to the investigator as needed. * subjects in whom heart transplantation is expected in ≤ 6 months * subjects with a known asa allergy

Keywords: heartmate ii (hmii) left ventricular assist device (lvad)
propofol versus esketamine for rapid sequence intubation in critically ill patients

Conditions: Acute Respiratory Failure

Summary: rapid-sequence intubation is routinely performed in critically ill patients. it is unclear whether different sedative agents may influence short-term outcomes after intubation, specially hemodynamic stability.


Eligibility criteria:
inclusion criteria: * age above 18 years old * physician indicated intubation exclusion criteria: * pregnancy * intubation during cardiac arrest * known of suspected intracranial hypertension * known allergy to propofol or esketamine * bradycardia (heart rate below 50 beats per minute) or atrioventricular block
monica-sc: a study to evaluate the efficacy, safety and tolerability of blisibimod (a-623) administration in subjects with itp

Conditions: Immune Thrombocytopenic Purpura; Idiopathic Thrombocytopenic Purpura

Summary: the purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when administered on top of standard-of-care to subjects with immune thrombocytopenic purpura (itp).


Eligibility criteria:
inclusion criteria: 1. 18 to 75 years of age(male or female). 2. diagnosis of itp according to the guidelines of the american society of hematology (ash) and british committee for standards in hematology. 3. platelet counts at screening of 30 billion/l or less for subjects not on itp medication, or 50 billion/l or less for subjects receiving stable background itp medication. exclusion criteria: 1. subjects who have had a splenectomy for any reason. 2. currently receiving high-dose itp medications, eltrombopag, romiplostim, rituximab, or investigational therapeutic agents. 3. nursing or pregnant. 4. active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days. 5. any known history of bone marrow stem cell disorder. 6. active hepatitis b, active hepatitis c or a documented history of hiv, hepatitis b, or hepatitis c. 7. liver disease. 8. malignancy within the past 5 years. 9. history of active tuberculosis (tb) or history of tb infection. 10. subject has not yet completed at least 3 months or 5 half-lives (whichever is longer) since ending other investigational study. 11. history of congenital immunodeficiency.

Keywords: immune thrombocytopenic purpura idiopathic thrombocytopenic purpura chronic itp