Kornimate/medical-research-clean huggingface dataset:
the laparotomy study

Conditions: Gastrointestinal Cancer

Summary: the depth of neuromuscular blockade (nmb) during surgery may cause a clinical dilemma between optimal surgical conditions and the risk of postoperative residual blockade. the aim of the study is to investigate if intense nmb improves surgical conditions during operation in patients scheduled for elective open upper abdominal surgery.


Eligibility criteria:
inclusion criteria: * patients \> 18 years old * elective open upper abdominal surgery * can read and understand danish * informed consent exclusion criteria: * known allergy to rocuronium or sugammadex * severe renal disease, defined by s-creatinine\> 0.200 mmol/l, gfr \< 30ml/min or hemodialysis * neuromuscular disease that may interfere with neuromuscular data * abdominal mesh with size larger than 5\*5 cm * lactating or pregnant
cognitive dysfunction in mdd patients

Conditions: Major Depressive Disorder

Summary: major depressive disorder (mdd) is one of the most prevalent mental diagnosis within the worldwide population. although there is evidence about relationship between mdd and cognitive dysfunction, still the correlations between biomarkers and the severity of the disorder or the level of cognitive dysfunction need further research. therefore, the aim of the study is to determine such relationships in ukrainian population.


Eligibility criteria:
inclusion criteria: * outpatient 18 to 65 years of age * meets dsm-5 criteria for mdd * depressive episode duration ≥ 2 months * the participant has mards total score ≥ 7 * free of psychotropic medications for at least 5 half-lives before baseline * fluent in russian/ukrainian exclusion criteria: * current diagnosis or history of manic/hypomanic episode * any other psychiatric diagnosis that is considered the primary diagnosis * any significant personality disorder diagnosis * high suicidal risk, defined by clinician judgment * substance dependence/abuse in the past year * significant neurological disorders, head trauma, or other unstable medical conditions * history of endocrinological diseases * pregnant or breastfeeding * psychosis in the current episode * high risk for hypomanic switch * cognitive or language impairment of such severity as to adversely affect the performance of tests

Keywords: mdd vortioxetine cognitive dysfunction igf-1 bdnf functioning
a study to evaluate methods to evaluate back pain

Conditions: Pain

Summary: the study is designed to assess methods used in clinical research.


Eligibility criteria:
inclusion criteria: * lower back pain * male or female in generally good health, from 18 to 55 years of age (inclusive) exclusion criteria: * pregnant or lactating * subject has evidence or history of radiculopathy, i.e. sciatica extending below the knee (numbness, tingling, or shooting pain), or other neurologic deficits (abnormal straight leg raise test, patellar reflexes, and/or bowel and bladder function); * subject has a history of previous back surgery; * subject has back pain resulting from traumatic injury involving physical evidence of bruising, swelling, or inflammation to the abdomen or low back area which occurred less than 48 hours prior to enrollment * has taken an investigational drug within the past 30 days prior to entering the study, or currently enrolled in another investigational study * is a member or relative of the study site staff, cro or sponsor organization directly involved with the study or had a household member or relative participate concurrently or previously in this study * has previously been enrolled in this study

Keywords: pilot study to assess methodologies
osteoporosis and dental implant

Conditions: Osteoporosis

Summary: the purpose of this study is to evaluate the influence of alendronate therapy on the wound healing after dental implants in patients with osteoporosis.


Eligibility criteria:
inclusion criteria: * postmenopausal women \> 2 years after menopause * age between 60 and 75 years * possibility to insert a dental implant * osteoporosis as defined by who criteria (intervention group), or women without osteoporosis / osteopenia (non-intervention group) exclusion criteria: * pathological findings in the jaw bone * chronic inflammatory rheumatoid disease * bisphosphonate treatments during the last 12 months * inflammatory or metabolic bone disease, excluding osteoporosis * systemic corticosteroid treatments of more than one month within previous 12 months * severe diseases with life expectancy less than one year or expectation of rapid worsening within one year

Keywords: osteoporosis, bisphosphonate therapy dental implant
magnesium sulphate to bupivicaine in serratus anterior plane block in modified radical mastectomy

Conditions: Cancer Breast; Chronic Pain Syndrome

Summary: modified radical mastectomy may be associated with severe post-operative pain, leading to chronic pain syndrome which usually requires optimal perioperative pain management.

patients will be randomly into two equal groups (40 patients each) according to the adjuvant added to the local anesthetic (bupivacaine) in the serratus anterior plane block using a computer-generated random numbers concealed in sealed opaque envelopes. group b: the patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml. group bm: the patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml.

Eligibility criteria:
inclusion criteria: * adult female patients * american society of anesthesiologists (asa) class i or ii * scheduled for elective unilateral modified radical mastectomy exclusion criteria * patient refusal * bilateral breast surgery * coagulation disorders * body mass index\> 35 * allergy to local anaesthetics or magnesium sulphate * severe respiratory or cardiac disorders * pre-existing neurological deficits * liver or renal insufficiency

Keywords: serratus anterior plane block magnesium sulphate
trial of early noninvasive ventilation for amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: the goal of this trial is to determine the feasibility of conducting a randomized, double-blind, placebo-controlled trial of nocturnal noninvasive positive pressure ventilation in persons with amyotrophic lateral sclerosis with an forced vital capacity greater than or equal to 50 percent.

amyotrophic lateral sclerosis (als) is an untreatable neurodegenerative disorder characterized by the progressive loss of motor neuron function. respiratory failure is the most common cause of death in persons with als. treatment of respiratory muscle weakness with nocturnal noninvasive positive pressure ventilation (nippv) when forced vital capacity (fvc) is less than 50 percent-but prior to the development of respiratory failure-has prolonged survival in observational studies. despite the association of nippv use and survival, it is unknown whether earlier nippv treatment will benefit people with als. also, no placebo-controlled studies of nippv treatment and people with als have been conducted. the goals of the this trial are to assess the feasibility of conducting a prospective, randomized, double-blind, clinical trial of nippv versus control (sham) nippv in people with als who have a fvc greater than 50 percent, and to gain preliminary data on outcome effects. in the trial, the investigators will test the following hypotheses: (1) people with als who have a fvc greater than 50 percent can tolerate active nippv and control nippv, and will find control nippv to be a believable treatment; (2) initiation of active nippv in people with als who have a fvc greater than 50 percent will have better clinical outcomes with respect to measures of quality of life, rate of pulmonary function decline, and functional outcome; and (3) people with als who start active nippv early will have improved tolerance later when respiratory weakness has progressed. these aims will enable planning of a subsequent, large-scale and definitive clinical trial of early nippv (fvc greater than 50 percent) in people with als. if the benefits of early nippv can be confirmed, then a new treatment may be established for this progressive, fatal disease.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * probable or possible als by el escorial criteria * if of child-bearing potential, has a negative urine or serum pregnancy test exclusion criteria: * fvc \< 50% predicted for age * previous pneumothorax * bullous emphysema * requirement for oxygen * previous use of any positive pressure ventilation equipment (continuous positive airway pressure, or bilevel positive airway pressure) * current involvement in a clinical treatment trial * any unstable medical condition thought likely to interfere with participation

Keywords: amyotrophic lateral sclerosis als nocturnal noninvasive positive pressure ventilation nippv forced vital capacity fvc
macroscopic and molecular changes in knee muscular - tendon unit in response to acute resistant load

Conditions: Physical Exertion

Summary: the aim of this study is to determine whether individuals differ one from the other in their genetic, cellular, systemic, structural and functional response to acute exercise.


Eligibility criteria:
inclusion criteria: * healthy adults exclusion criteria: * unhealthy adults
effect of vegan diet and lifestyle changes on indolent lymphoma during controlled waiting period

Conditions: Indolent Lymphoma

Summary: the aim of the present trial is to evaluate the effect of lifestyle changes on the natural history of indolent lymphomas, during the period of watchful waiting. the intervention program is comprised of specifically designed vegan nutrition, physical activity, mostly aerobic, and stress reduction by relaxation and meditation. outcome results will be followed and analyzed for 3 years, taking into consideration the following parameters - disease burden, specific disease-related symptoms, relevant blood tests, body weight, indicators of well-being. changes in these parameters will be correlated with the level of compliance and adherence to the intervention program. the results of the trial group of patients will be further compared to the natural history of the disease in a comparable group of patients during their waiting period who were not subject to the above intervention.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * patient sex - male and female * diagnosis with indolent lymphoma in low-grade lymphoma (follicular lymphoma (fl), marginal zone lymphoma mzl), as assessed by groupe d'etude des lymphomes folliculaires (gelf) criteria * lack of need and non treatable patients at the time of diagnosis * existence of detailed medical information about physical activity and dietary habits * patients who have signed an informed consent form to participate in the study. exclusion criteria: * need for therapeutic intervention * administration of chemotherapy and / or monoclonal antibodies or immunomodulatory preparation * chronic inflammatory or infectious disease * another malignant disease * pregnant women, special populations - children and incapacitated of judgment
comparison of preoperative inhaled budesonide with salbutamol on the respiratory adverse effects in children undergoing tonsillectomy

Conditions: Preoperative Inhalation of Budesonide and Salbutamol in Children Undergoing Tonsillectomy

Summary: comparison of preoperative inhaled budesonide with salbutamol on the incidence of respiratory adverse effects in children undergoing tonsillectomy

comparison of preoperative inhaled budesonide with salbutamol on the incidence of respiratory adverse effects in children undergoing tonsillectomy adenotosillectomy is routinely performed for children with sleep disordered breathing or recurrent infectious tonsillitis. although the safety of the pediatric anesthesia is constantly improving, a substantial proportion of children undergoing tonsillectomies experience pre operative respiratory adverse events with a prevalence up to 50% in children with at least one risk factor. both minor adverse effects such as oxygen desaturation airway, obstruction coughing or wheezing and the major events such as laryngospasm and/ or bronchospasm occur more commonly undergoing tonsillectomy compared with other non airway surgery.

Eligibility criteria:
inclusion criteria: 1. children scheduled for elective tonsillectomy with or without adenoidectomy, grommets cautery of inferior turbinates. 2. age more than or equal 5 years and less than or equal to 12 years. 3. both genders 4. no obvious abnormalities in preoperative ecg, blood routine electrolytes and other tests. 5. asa class 1 exclusion criteria: 1. patients with known hypersensitivity to any of the drugs that would be used in the study 2. patients that are immunologically compromised 3. sleep apnea syndrome or difficult airway 4. pre-existing hypoxemia is spo2 \< 90% 5. history of adverse events with prior sedation or patients who had taken any sedative drugs within the last 24 hours. 6. parents refusal
double-blind comparative study of tak-875

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to evaluate the efficacy and safety of treatment with tak-875 in diabetic patients.


Eligibility criteria:
inclusion criteria: 1. the participant is an outpatient. 2. the participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. exclusion criteria: 1. the participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease. 2. the participant is considered ineligible for the study for any other reason by the investigator or sub-investigator.

Keywords: drug therapy
role of l-citrulline in prevention of pregnancy associated hypertension

Conditions: Pregnancy Induced Hypertension; Preeclampsia and Eclampsia; Gestational Hypertension

Summary: the target population for our study is healthy nulliparous pregnant women (first pregnancy) between the 12-16 week of pregnancy. if a subject is eligible, written consent will be obtained by person to person contact. eligible participants will be randomized to receive either daily l-citrulline supplementation or placebo.

healthy nulliparous pregnant women (first pregnancy) between the 12-16 week of pregnancy will be eligible for this study. the purpose of this study will be to determine if daily supplementation of oral l-citrulline can reduce the incidence of pregnancy induced hypertension. this will be a double blind study, subjects will be randomized to receive either l-citrulline (3 gram sachet) or a placebo for a total of 8 weeks. participants will be asked to provide urine and blood samples at time of enrollment, be asked to respond to a phone survey to assess for side effects, and again be asked to provide urine and blood samples at the end of 8 weeks. participants will continue with routine prenatal care throughout the study.

Eligibility criteria:
inclusion criteria: * nulliparous (no previous pregnancy greater than 20 weeks) * gestational age of pregnancy between 12 and 16 weeks exclusion criteria: * known fetal anomaly or chromosomal abnormality * early fetal growth restriction * fetal demise or planned termination * participation in another study that may influence this study * known maternal kidney disease * known maternal electrolyte imbalance * known allergies to study interventions * preexisting hypertension (chronic hypertension) * known gastric ulcer * incarcerated status * planned delivery at non-utmb hospital * known lactose intolerance

Keywords: pregnancy induced hypertension
pulse oximetry measurement and transfusions

Conditions: Hypoxia Neonatal; Premature; Blood Transfusion

Summary: the primary purpose of this observational study was to determine if prbc transfusions decrease the frequency of intermittent hypoxia events in very low birth weight infants (vlbw) during the first six weeks of life. the impact on non-prbc transfusions on the frequency of intermittent hypoxia was also assessed.


Eligibility criteria:
inclusion criteria: * 23+0 to 28+6 weeks gestational age at birth exclusion criteria: * infants with life-limiting diagnoses * cyanotic heart disease * in utero fetal transfusion * twin to twin transfusion syndrome * isoimmune hemolytic disease * severe acute hemorrhage * acute shock * sepsis with coagulopathy * need for perioperative transfusion * parents opposed to transfusion of blood * parents with hemoglobinopathy or congenital anemia

Keywords: transfusion intermittent hypoxia
improving crt outcome with non-invasive cardiac mapping

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: the iconic-m study is a multicenter randomized controlled study to assess patient response to crt comparing ecgi map guided left ventricular lead placement with empirical lead placement. the hypothesis of the investigation is to demonstrate that crt lv lead implantation guided by a map obtained with the amycard 01c system and showing lv latest electrical activated site (leas) in combination with a ct cardiac venogram improves crt outcome. an improved crt outcome is defined as a ≥30% increase in lvesvi reduction compared to empiric crt lv lead implantation. the sample size will be 136 in the control arm and 194 in the active arm. a total of 330 subjects. the study follows an adaptive design, in where one interim analysis at 70% enrollment will be performed. the sponsor may stop enrollment when either one of the following conditions apply: * statistical significant difference between groups in the primary endpoint has been reached confirming a difference in reduction of the lvesvi of ≥30% in the active arm compared to the control arm * there is no trend or reason to believe statistical significance will be reached with a higher sample size. statistical significance (primary endpoint) is reached at interim (70%) or at total (100%) of enrollment with a significance value p lower than 0.025.

the study is conducted at european sites as a post-market clinical follow-up study of a ce marked device (amycard 01c). its aim is to strengthen clinical evidence by assessing whether the use of this device for crt planning improves clinical outcome in a statistically significant number of patients.

Eligibility criteria:
inclusion criteria: 1. appropriately signed and dated informed consent. 2. age ≥18 years at time of consent. 3. received optimal medical therapy for hf for at least 3 months before screening 4. patient in sinus rhythm at the time of screening fulfilling class i or iia criteria per esc crt guidelines 2013 . 5. patient is intended for placement of a crt device with biventricular (biv) pacing. exclusion criteria: 1. previous cardiac pacemaker/crt/icd implantation 2. acute diseases or exacerbations of chronic diseases (as per the investigator's discretion) 3. contraindications to ct scanning 4. contraindications to body surface ecg mapping: (ongoing wound healing on the chest (e.g. recent surgery), skin diseases, allergic reactions to surface mapping electrodes and medical band-aid) 5. pregnant, or subjects planning to become pregnant within 6 months after signing informed consent (a documented negative pregnancy test (serum or blood) is required for women of childbearing potential) 6. incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population

Keywords: cardiac resynchronization therapy left bundle branch block
prognosis of trigeminal neuralgia when enrolled in a multidisciplinary management program

Conditions: Trigeminal Neuralgia

Summary: background: prognosis of medically treated trigeminal neuralgia patients is assumed to be poor, but the evidence is lacking. thus, prospective real-life studies of medical management of trigeminal neuralgia are warranted. methods: observational study. patients were consecutively enrolled in a structured management program at a specialist centre for facial pain. optimisation of medical treatment, physiotherapy, psychotherapy, and advice from trained nurses, were parts of the program. medically intractable patients were referred for neurosurgery. data-collection was prospective using standardised schemes and patient surveys. the aim was to describe the two-year outcome of medical treatment at the specialist centre. the primary outcome was a 50% reduction in the overall burden of pain according to a numerical rating scale (nrs) after two years. this study aimed to provide evidence concerning the real-life efficacy of medical management of trigeminal neuralgia (tn) when directed by specialists. the investigatgors hypothesised that the two-year prognosis in a group of medically managed tn patients enrolled in a structured multidisciplinary management program was favourable, defined as a 50 % reduction of the overall burden of pain over a two-year period


Eligibility criteria:
inclusion criteria: 1. recordings of the intensity of pain at enrolment of the programme (baseline recording), 2. a two-year assessment (end-point recording), 3. recording of effect and side-effects of drug treatment (at baseline and endpoint). the exclusion criteria 1. initiation of medical treatment at the dhc before may 2012, 2. neurosurgical treatment of tn within the two-year follow-up 3. incomplete two-year follow-up

Keywords: multidisciplinary management real-life study
direct laryngoscopy during cervical trauma

Conditions: Trauma

Summary: the aim of this study was to compare time, success rates of different laryngoscope blades for intubation with an immobilized cervical spine in a standardized pediatric manikin model.


Eligibility criteria:
inclusion criteria: * give voluntary consent to participate in the study * minimum 1 year of work experience in emergency medicine * experienced emergency medicine personnel (physicians, nurses, paramedics) exclusion criteria: * not meet the above criteria * wrist or low back diseases

Keywords: intubation
precise, a study to gather more information about bone fractures and survival in castration-resistant prostate cancer (crpc) patients treated with radium-223 in routine clinical practice in sweden

Conditions: Metastatic Castration-Resistant Prostate Cancer

Summary: in this observational study researchers want to gather more information about bone fractures and survival in castration-resistant prostate cancer (crpc) patients treated with radium-223 in routine clinical practice in sweden. the goal is to estimate the proportion of new cases (incidence) of symptomatic bone fractures and to estimate the proportion of death occurred in years of observation time per person (person years). radium-223 (ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mcrpc).


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate, i.e., the patient is registered in the npcr (histology other than adenocarcinomas are not registered in the npcr). * start of ra-223 treatment for mcrpc as an n-th line of treatment, where "n" goes from 1 to 4. * ecog performance status of 0-2 at treatment initiation. we will assume that patients starting any of the systemic therapies under study have a performance status of 0-2. exclusion criteria: * prior use of ra-223 * patients that have participated in a ra-223 rct

Keywords: prostate cancer metastatic prostate cancer bone fractures overall survival