Kornimate/medical-research-clean huggingface dataset:
a study to assess the efficacy of intravenous/oral bondronat (ibandronate) in patients with metastatic bone disease experiencing moderate to severe pain

Conditions: Pain; Bone Neoplasm; Neoplasm Metastasis

Summary: this 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. patients will be randomized to receive either bondronat (6mg iv on days 1, 2 and 3 followed by bondronat 5omg po daily from day 22 to week 24) or zoledronic acid (4mg iv on day 1, and then every 3-4 weeks). the anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * patients with malignant bone disease; * patients with moderate to severe pain. exclusion criteria: * patients who have received a bisphosphonate within 3 weeks from the signing of informed consent; * patients receiving concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of dosing; * untreated esophagitis or gastric ulcers; * recent or pre-scheduled radiotherapy to bone; * patients who are pregnant or breast-feeding.
to compare teg (thrombelastography) and conventional tests in ckd patients

Conditions: End Stage Renal Disease; Coagulopathy

Summary: background: coagulopathy in chronic kidney disease is multifactorial. both hypocoagulopathy and hypercoaguability are seen. conventional tests of coagulation (ccts) end at the formation of thrombin, and do not take into account the interaction of coagulation factors, platelets, rbc etc. by overcoming the above deficiencies, thromboelastography provides a holistic picture of blood coagulation. the present study evaluated the teg profile of esrd patients and compared it to ccts and to controls. methods: 50 esrd patients and 50 controls were recruited for the study. venous samples were withdrawn and platelet count, inr and fibrinogen levels were measured. simultaneously a thromboelastography was performed. all samples were drawn prior to initiation of dialysis.


Eligibility criteria:
inclusion criteria: 1. healthy voluntary donors belonging to asa psi or asa psii 2. patients suffering from end stage renal disease i.e. ckd stage 5 (defined by kdigo 2012 ) who never received renal replacement therapy (rrt) exclusion criteria: 1. patients on antiplatelet drugs, erythropoietin, desmopressin 2. patients with known bleeding disorders like haemophilia, aplastic anaemia etc 3. patients having coexisting liver diseases 4. patients on dialysis 5. patients who have received prbc, ffps or platelet transfusions in the past 3 months 6. patients less than 18 years of age 7. pregnant patients 8. malignancy

Keywords: end stage renal disease esrd thromboelastography fibrinogen
effects of gs-3k8 and ginst15 on acute respiratory illness

Conditions: Acute Respiratory Infection

Summary: this study was conducted to investigate the effects of daily supplementation of gs-3k8 or ginst15 on acute respiratory illness (ari) in healthy subjects.

this study was a 8 weeks, randomized, double-blind, placebo-controlled trial. forty five subjects were randomly divided into gs-3k8 (ultrafiltered red ginseng extract) or ginst15 (hydrolyzed ginseng extract) or placebo group. the primary clinical outcome measure was the incidence of ari. the secondary clinical outcome measure was the development and duration of ari symptoms.

Eligibility criteria:
inclusion criteria: * age 39-65 years with healthy adults exclusion criteria: * subjects had been vaccinated against influenza in the previous 6 months * subjects with symptoms of upper respiratory tract infection * subjects with acute/chronic disease * history of alcohol or substance abuse * history of disease that could interfere with the test products or impede their absorption * subjects taking medications such as immune or upper respiratory tract infection related drug or functional foods * abnormal liver or kidney function tests * pregnant or lactating women and heavy smokers * being judged by the responsible physician of the local study center as unfit to participate in the study

Keywords: ultrafiltered red ginseng hydrolyzed ginseng acute respiratory illness clinical trial
mediastinal grey zone lymphoma from the lysa

Conditions: Mediastinal Grey Zone Lymphoma

Summary: mediastinal grey zone lymphoma, b cell lymphomas with intermediate features between classical hodgkin lymphoma and primary mediastinal b cell lymphoma, are not well described in the literature. investigators report the clinical characteristics and outcomes of a large retrospective series of 99 cases centrally reviewed by a panel of hematopathologists, with a consensus established for the diagnosis.


Eligibility criteria:
inclusion criteria: * cases with an intermediate morphology and phenotype between chl and pmbcl were included after central pathological review exclusion criteria: * cases of chl with partial cd20 expression or low expression in tumoral cells were excluded and considered as cd20-positive chl * exclusion of sequential form patients (with a diagnostic biopsy of pmbcl and a relapse biopsy of chl or vise-versa) as they represent a biases for statistical analysis.
plasma exosomes reveal the efficacy of targeted therapy in patients with egfr mutation in lung adenocarcinoma

Conditions: Lung Adenocarcinoma; EGFR Activating Mutation

Summary: the objective of this observational study is to explore the therapeutic trajectory of targeted therapy in lung adenocarcinoma patients with epidermal growth factor receptor (egfr) mutations. the main objective is to identify potential biomarkers that can predict the efficacy of targeted therapy through plasma exosomes and to explore strategies to reverse drug resistance to targeted therapy. biological specimens and medical imaging data will be collected from patients already receiving targeted therapy as a first-line treatment, and followed-up will be conducted to analyze prognosis based on different patterns.

the medical imaging data will be collected retrospectively and prospectively, and the blood samples and tumor tissues will be collected prospectively.

Eligibility criteria:
inclusion criteria: * pathological examination confirmed lung adenocarcinoma * no other type of tumor was present * common sensitive egfr (ex19del l858r or combined with other sites) mutations have been identified * receive targeted therapy with or without chemotherapy as first-line treatment * ≥ 18 years and ≤80 years old exclusion criteria: * history of other malignant tumors * irregular treatment or poor compliance * incomplete clinical information or lost to follow-up
acetazolamide facilitates ventilator weaning

Conditions: Ventilator Weaning; Alkalosis, Metabolic

Summary: metabolic alkalosis(ma) is common metabolic disorder in icu setting. ma could be cause of weaning failure or delay by depression of respiratory center. the purpose of this study is to evaluate that correction of ma by administration of acetazolamide facilitates weaning of mechanical ventilation.


Eligibility criteria:
inclusion criteria: * patients on mechanical ventilation for at least 24 hours with an assisted mode and passed acute resuscitation and considered for weaning. (definition of weaning point: 1. oxygenation * fio2 ≤ 0.4 \& pao2 ≥ 60 mmhg * o2 index (pao2/fio2) ≥ 150 * sao2 \> 90% * peep ≤ 5 cmh2o * mn ≤ 15 l/min 2. vital sign * stable bp: map ≥ 60 mmhg ((i.e., no epinephrine or norepinephrine \<0.2μg/kg/min, or equivalent dose vasopressin or phenylephrine) * hr ≤ 140bpm * 35 ≤ bt ≤ 38 ℃ * rr ≤ 35/min 3. clinical status * resolution of acute disease process * no newly developed pulmonary infiltration * ramsay sedation score 2\~4 * hb \> 7, ph \> 7.30, normal electrolyte * no active bleeding, no iicp, no bronchospasm, no cad * no rescure or specific treatment (no, prone, op plan) * abga : ph ≥ 7.43 and hco3- ≥ 26meq/l exclusion criteria: * permanent ventilator dependency due to brainstem disease, diffuse cerebral disease, severe respiratory or neuromuscular disease * active bleeding, iicp, unstable coronary artery disease, bronchospasm, and rescue treatment (inhaled no, prone), pre-op condition * contraindication to acetazolamide: renal insufficiency (creatinine clearance \<20 ml/min and/or renal replacement therapy), intolerance or allergy to acetazolamide or sulfonamides, hyperchloremic metabolic acidosis, hyponatremia (na\<130), hypokalemia (k\<3.5), adrenal insufficiency. * diaphragm dysfunction : as diagnosed by fluoroscopy, nerve conduction velocity, usg, or overt paradoxical motion of the abdomen

Keywords: mechanical ventilation weaning phase patients with metabolic alkalosis
the clinical effectiveness of static resting splints in early rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study tested the hypothesis that there would be a difference in the 12 month progression of structural hand impairment and hand function between a group of patients with early ra who received static resting splints and those that did not.

this study is a multi centred rct recruiting patients across 8 rheumatology occupational therapy departments in the uk. patients with early ra (\<5 years) were recruited. the study followed patients over a 12 month treatment period. patients were randomised to receive standardised occupational therapy or standardised occupational therapy plus static resting splints over 12 months. the primary outcome measure was dominant hand grip strength and secondary out measures included; dominant hand mcpj ulnar deviation, the button board from the arthritis hand function test and the michigan hand outcomes questionnaire. data were analysed using ancova. baseline outcome values, ritchie scores at baseline and the number of intra articular wrist and hand steroid injections were controlled for as covariates. this study is a multi centred rct recruiting patients across 8 rheuamtology occupational therapy departments in the uk. patients with early ra (\<5 years) were recruited. the study followed patients over a 12 month treamtent period. patients were randomised to receive standardised occupational therapy or standardised occupational therapy plus static resting splints over 12 months. the primary outcome measure was dominant hand grip strength and secondary out measures included; dominant hand mcpj ulnar deviation, the button board from the arthritis hand function test and the michigan hand outcomes questionnaire. data were analysed using ancova. baseline outcome values, ritchie scores at baseline and the number of intra articular wirst and hand steroid injections were controlled for as covariates.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of ra, less than 5 years duration exclusion criteria: * patients with previous wrist and hand surgery, non-addressable fixed hand or wrist deformity, those from vulnerable group

Keywords: clinical splints rheumatoid
study of zg005 combined with gecacitinib in patients with advanced non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this is a multicenter phase i/ii study for patients with advanced non-small cell lung cancer who have failed pd-1/l1 therapy, aiming to evaluate the safety of zg005 in combination with gecacitinib in this population, as well as the preliminary efficacy of this combination regimen.


Eligibility criteria:
inclusion criteria: * fully understand this study and voluntarily sign the icf. * age 18-75 years, no gender restriction. * patients with locally advanced or recurrent/metastatic squamous and/or non-squamous non-small cell lung cancer confirmed by histology/cytology, unsuitable for radical therapy. exclusion criteria: * medical history, ct scan, or mri indicates the presence of cns metastases. * other malignancies within 5 years. * any other reason deeming the participant unsuitable for the study, as judged by the investigator.
virtual rehabilitation and pnf in the recovery of the motor function post stroke

Conditions: Stroke; Cerebrovascular Disorders

Summary: the purpose of this study is to determine the effects of use the nintendo wii® (nw) and therapeutic exercises by the method proprioceptive neuromuscular facilitation (pnf) in the recovery of the motor function of poststroke hemiparesis patients.

randomised clinical trial (rct) will be held in following the recommendations of the consort (consolidated standards of reporting trials). this rct have longitudinal and prospective feature, held at the neurosciences clinic located at the clinic professor francisco magalhães neto the hupes complex / federal university of bahia from june 2015 until june 2016. in the initial evaluation were obtained by a trained examiner and blinded to the allocation of participants, all personal data of all patients, as well as evaluations of balance and quality of life through specific validated scales: 1. fugl meyer scale (fms); the investigators employ an experimental program of therapeutic exercises for the pnf method and virtual rehabilitation with nw, for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years, of both sexes; neurological clinical diagnosis of stroke; * owning grade 2-4 spasticity according to the ashworth scale; * hemiparetic patients after 6 months of onset of stroke; * deficit moderate gait according to functional ambulation classification (values ≥ 2). exclusion criteria: * score \<24 on the mini mental state examination; * other associated neurological diseases, as well as orthopedic and no visual or hearing impairment; * participation in other rehabilitation programs.
cross-cultural adaptation and validation in moroccan arabic dialect "darija" of the qor-15 postoperative recovery quality score"

Conditions: Recovery of Function

Summary: the qor-15 is a post operative recovery score developed in 2013 from the qor-40 with an advantage of simplification. the investigators aim to translate and to validate a such useful score in arabic adapted for morocco by a full psychometric evaluation of the arabic version, by testing its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, thoracic, gynecological surgery, or digestive endoscopy in the national institute of oncology of rabat, affiliated to mohammed v university in rabat, morocco.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * agreement in writing for the use of the data exclusion criteria: * patients who expressed their refusal to participate in the study * patients unable to express their non-opposition to participating in the study * patients operated on for surgery for which it was highly probable that it would not be possible for them to answer the questionnaire postoperatively (first 24 hours) * patients who do not master the arabic language, neither read nor spoken
top-trial safety of not flushing non-used port-a-cath® in cancer patients

Conditions: Adjuvant Chemotherapy; Solid Tumours; Port-A-Cath

Summary: the benefits and risks of flushing or not flushing the non-used port-a-cath® in cancer patients and the time interval of eventual port-a-cath® flushing are currently unknown. the manufacturers of port-a-cath® recommend regular flushings every 4 weeks. in clinical practice, the intervals are usually at least three months. regular flushing might lead to a decreased risk of port-a-cath® thrombosis, but may also lead to an increased infection or thrombosis rate and patients discomfort. therefore, this study investigates the safety of not flushing the port-a-cath® for 6 or 12 months.

currently it is unknown if flushing a non-used port-a-cath® every 4 weeks is a valid strategy to preserve its functioning. even more, decision to keep the port-a-cath® after completion of adjuvant therapy cannot be based on profound patient information as there exist hardly any data regarding port-a-cath® related complications of non-used port-a-cath®. the proposed prospective, two arm trial aims to investigate if no flushing of a non-used port-a-cath® over a period of one year has equal port-a-cath® related complications compared to flushing the port-a-cath® every 4 weeks. the proposed trial also aims to examine the frequencies of port-a-cath® related complications in non-used port-a-cath®. the authors put up the hypothesis that there will be fewer port-a-cath related infections in the experimental arms compared to the infection rate mentioned in the literature up to 27 %, since the puncture of the port-a-cath® and the administration of fluids are the main causes of infection.

Eligibility criteria:
inclusion criteria: * cancer patients in curative setting, with port a cath implantation for systemic chemotherapy, including neo-adjuvant and adjuvant chemo-immunotherapy and supportive therapy (e.g. parenteral nutrition) * completion of curative treatment with port a cath indication, operation included, regardless of a non-intravenous (subcutaneous or oral) given therapy (endocrine therapy, chemo-immunotherapy, radiotherapy) * patients with pectoral port a cath systems * no port a cath associated complications during curative therapy such as investigated events: persistent malfunction, thrombosis, infection of the port-a-cath (to puncture the port a cath under x-ray control is allowed except it results in diangosis of persistent malfunction) * no therapeutic anticoagulant therapy (phenprocoumon/marcoumar®, heparin) * no evidence of metastatic disease * ≥18 years * willing to participate exclusion criteria: * no signed informed consent * patients with port a cath systems other than pectoral port a cath systems (e.g. forearm port a cath system) * unable to attend control timepoints * use of the port-a-cath after the above defined curative treatment (within the investigational period) * willing to explant the port-a-cath * willing to become pregnant within one year after adjuvant treatment * patient with heparin-induced thrombocytopenia (hit)
development and evaluation of a tonic immobility focused psychoeducational intervention

Conditions: Posttraumatic Stress Disorder; Tonic Immobility Response

Summary: a randomized controlled trial is planned to evaluate a brief, web-based intervention intended to educate about tonic immobility (ti) within a sample of those who experienced ti in the context of a traumatic event.

a randomized controlled trial is planned to evaluate a brief, web-based intervention intended to educate about tonic immobility (ti) within a sample of those who experienced ti in the context of a traumatic event. the investigators expect that this intervention will lead to improvement in posttraumatic guilt, shame, and ptsd symptoms as compared to an active control condition.

Eligibility criteria:
inclusion criteria: * 18 years or older * endorsed prior ti experience (tiq items a \& b) * elevated posttraumatic stress symptoms (pcl-5; blevins et al., 2015) exclusion criteria: inability to consent or complete the intervention including: * cognitive impairment * uncorrected visual or auditory impairment * unmedicated severe mental illness * imminent risk of harm to self or others

Keywords: psychoeducation online intervention
nicotinic receptors and schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the investigators hypothesize that sustained-release dmxb-a-sr (3-2,4 dimethoxybenzylidene anabaseine sustained release) will provide clinical improvement in cognition in patients with schizophrenia who are smokers and who are non-smokers. the study drug may also maintain abstinence from cigarette smoking and improve other symptoms in patients with schizophrenia.

patients with schizophrenia will be screened then enrolled for one week placebo trial in addition to their existing antipsychotic medication. if pill compliance is greater than 80%, then they will receive baseline clinical, cognitive, and brain imaging and all clinical laboratory examinations and a physical examination, vital signs, and cardiogram. then patients will receive in a randomized double blind trial either dmxb-a-sr (3-2,4 dimethoxybenzylidene anabaseine sustained release) or placebo comparator in addition to their existing antipsychotic medication. after one month patients will receive repeat clinical, cognitive, and brain imaging testing and all clinical laboratory examinations and a physical examination, vital signs, and cardiogram.

Eligibility criteria:
inclusion criteria: * subjects will be selected to be 18 to 65 years old and in good general health. * subjects who fulfill diagnostic and statistical manual -iv-text revision (dsm-iv-tr) criteria for schizophrenia or schizoaffective disorder. * smokers will smoke at least 20 cigarettes per day. * non-smokers will also be enrolled. * subjects will have normal: * vital signs, * hematology, * serum chemistries, * ekg, and * urinalysis with a negative drug screen before entry into the study. * subjects will be fluent in english. * smoking subjects will be interested in stopping smoking in the near future and not interested in nicotine replacement therapy. exclusion criteria: * subjects with histories of: * neurological illness, * liver disease, * severe hypertension (cut-off blood pressure 160/100) or * cardiac disease, or * renal failure (cut-off creatinine above 1.4). * subjects who currently meet dsm-iv-tr criteria for substance dependence other than nicotine, cannabis, or alcohol will be excluded. * women who are capable of pregnancy and not on acceptable forms of birth control will be excluded. * subjects being treated with clozapine will be excluded.

Keywords: drug trial smoking smoking cessation cognition mental focus
indirect vs. direct decompression for treatment of central stenosis: rct

Conditions: Patients With Spinal Stenosis Indicated for LLIF

Summary: this is a prospective, randomized clinical trial of patients undergoing 1-level lateral lumbar spinal fusion. this study seeks to randomize patients indicated for lateral lumbar interbody fusion (llif) into one of two groups: direct decompression and indirect decompression.

while indirect decompression has been largely accepted as a strategy to treat foraminal stenosis, there is some disagreement regarding its efficacy in treating patients with central and lateral recess stenosis. the current study seeks to randomize patients indicated for lateral lumbar interbody fusion (llif) into one of two groups: direct decompression and indirect decompression. enrolled participants will be evaluated before surgery, during their hospital course and post-operatively at 6 weeks, 3 months, 6 months, 1 and 2 years. operative details, complications, reoperation rates, patient reported outcomes, clinical and radiographic outcome measures will be compared.

Eligibility criteria:
inclusion criteria: * fusion indicated by the treating surgeon. fusion may be indicated for one or more of the following reasons: * mobile degenerative spondylolisthesis * severe vertical foraminal stenosis * adjacent segment degeneration and/or degenerative disc disease with suspected discogenic pain * one-level central canal stenosis * with neurogenic claudication * as measured in preoperative mri * oswestry low back pain disability questionnaire score \> 35% (18/50) * failed 3 months of conservative treatment * willing to give written informed consent and psychosocially, mentally, and physically able to comply fully with protocol, including adhering to follow-up schedule and requirements, and filling out forms exclusion criteria: * multilevel central canal stenosis * patients with vertebral endplate dimensions that are too small to allow for safe placement of an intervertebral cage * known allergy to titanium, polyethylene, cobalt, chromium, or molybdenum * prior surgery at index disc level (discectomy, decompression, or fusion) * history of spinal or vertebral infection of the lumbar spine * history of vertebral fracture of the lumbar spine * current pregnancy or interest in becoming pregnant over the next 1 year * active infection-systemic or local * non-english speakers

Keywords: lateral lumbar interbody fusion (llif) foraminal stenosis spine fusion decompression lumbar