Kornimate/medical-research-clean huggingface dataset:
fixed dose heparin study

Conditions: Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism

Summary: fido was a multicentred randomized, open-label trial that compared fixed-dose ufh with fixed-dose lmwh for initial treatment of vte. patients were followed for 3 months during which they received warfarin (target inr 2.0-3.0).

the general objective was to simplify and reduce the cost of treatment of acute venous thromboembolism (vte).specific objectives were to compare the efficacy, safety and cost effectiveness of unfractionated heparin (ufh) and low molecular weight heparin (lmwh) when each is administered subcutaneously (sc), twice daily, in weight -adjusted, fixed doses; and to determine if the anticoagulant response (anti-factor xa heparin levels, aptt results) influence efficacy and safety of ufh and lmwh, independently of dose.

Eligibility criteria:
inclusion criteria: * a diagnosis of acute venous thromboembolism (vte,dvt and /or pe) exclusion criteria: * contraindication to subcutaneous (sc) route of administration (eg:shock (evidence of poor peripheral perfusion), major surgery within 48 hours) * active bleeding process * comorbid condition limiting expected survival to less than 3 months * current treatment with therapeutic dose of ufh, lmwh, danaparoid sodium, or a direct thrombin inhibitor for more than 48 hours * currently on long term warfarin or heparin therapy * allergy to heparin or history of heparin induced thrombocytopenia * currently pregnant * contraindication to contrast media (eg: allergy or creatinine \>200 umol/l). * currently enrolled or will be enrolled in a competing study * geographically inaccessible for follow-up assessment

Keywords: unfractionated heparin low molecular weight heparin venous thromboembolism aptt treatment
once-daily investigational nasal spray in adults and adolescents with vasomotor rhinitis

Conditions: Vasomotor Rhinitis; Rhinitis, Vasomotor

Summary: the primary objective of this study is to compare the efficacy and safety of gw685698x 100mcg once daily (qd) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (vmr).


Eligibility criteria:
inclusion criteria: * must be outpatients. * diagnosis of vmr (vasomotor rhinitis). * literate in english or native language. exclusion criteria: * significant concomitant medical condition. * use corticosteroids or other allergy medications during the study. * used tobacco products within the past year.

Keywords: nonallergic rhinitis gw685698x vmr vasomotor rhinitis
study to learn if 200mg test drug (fostamatinib) helps people with large b-cell lymphoma,a type of blood cancer

Conditions: Diffuse Large B-Cell Lymphoma

Summary: this study will evaluate the effectiveness of fostamatinib (200 mg twice a day) in patients with worsening or unmanageable lymphoma with a specific type of lymphoma called diffuse large b-cell lymphoma (abbreviated as dlbcl)

phase ii trial to evaluate the efficacy of fostamatinib in patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl)

Eligibility criteria:
inclusion criteria: * aged at least 18 years of age. * patients with relapsed or refractory diffuse large b-cell lymphoma who have previously received r-chop (or equivalent) chemo-immunotherapy and high dose chemotherapy with stem cell rescue, or who are ineligible for high dose therapy with stem cell rescue. * measurable disease as defined by cheson et al 2007 criteria. * one fresh pre-treatment excisional or core needle biopsy from suitable and accessible site. * world health organization (who) performance status 0 to 1. exclusion criteria: * treatment with nitrosurea, mitomycin c, investigational agents or study drugs w/in28 days of first dose of study treatment, any other chemotherapy, immunotherapy or anticancer agents w/in 3 weeks of first dose of study treatment, previous fostamatinib. * with the exception of alopecia, any unresolved toxicities from prior therapy or surgery greater than common terminology criteria for adverse events (ctcae) grade 1. * uncontrolled hypertension (defined as \>140mmhg systolic and/or \> 90 mmhg diastolic at baseline with or without antihypertensive therapy. * evidence of tuberculosis (tb). * inadequate boen marrow reserve.

Keywords: lymphoma dlbcl fostamatinib diffuse large b-cell lymphoma (dlbcl)
robotic-assisted surgery in treating patients with spine tumors

Conditions: Adult Spinal Cord Neoplasm; Spinal Bone Metastases; Spinal Cord Metastases

Summary: this pilot clinical trial studies robotic-assisted surgery in treating patients with spine tumors. robotic-assisted surgery is a less invasive type of surgery for spine tumors and may have fewer side effects and improve recovery

primary objectives: i. to perform a small pilot study that will demonstrate the feasibility of neurosurgical spinal procedures using the da vinci surgical robot. secondary objectives: i. to compare complication rates, operative time and estimated blood loss with historical controls. ii. to observe wound healing, cerebrospinal fluid (csf) leaks, neurological injury and hardware failure. ii. routine imaging of the spinal segment. outline: patients undergo robotic-assisted surgery using the da vinci robot. after completion of study treatment, patients are followed up for 100 days.

Eligibility criteria:
inclusion criteria: * patient has primary or secondary spine tumor based on computed tomography (ct) or magnetic resonance imaging (mri) * karnofsky performance status (ps) of \>= 80 or eastern cooperative oncology group (ecog) ps 0-1 * expected survival greater than 3 months * patient must be able to understand and sign a study-specific informed consent form exclusion criteria: * previous surgery at that specific segment * radiation at that specific spinal segment within the last 2 months * karnofsky ps \ 1 * pregnancy (due to risk of anesthesia) * the presence of medical conditions which contraindicate general anesthesia * unexplained fever or untreated, active infection * inability to obtain exposure to allow performance of the planned spine surgical procedure * history of psychiatric condition or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance
the influence of tdcs on the arm and hand function in stroke patients

Conditions: Transcranial Direct Current Stimulation; Cerebrovascular Accident (CVA)

Summary: the purpose of this study is to determine whether tdcs in combination with motor training can improve hand and arm function in stroke patients.


Eligibility criteria:
inclusion criteria: * stroke patients onset \> 6 months * first ever stroke * decreased hand and arm function * mini mental state examination (\>24) exclusion criteria: * depression * pregnancy * alcohol abuse * aneurysm clips * pacemaker * neurostimulator * implemented defibrillator * magnetically activated implant or device * implemented pump * spinal cord simulator * implemented hearing aid * artificial or prosthetic limb * metal parts in the body * any external or internal metal * artificial heart valve * other implants * history of brain surgery * migraine * family history of epilepsy
a proof of concept study to evaluate the safety of afamelanotide in patients with acute arterial ischaemic stroke (ais)

Conditions: Arterial Ischemic Stroke

Summary: the primary study objective is to assess the safety of afamelanotide while the secondary objective is to assess whether the therapy affects the size of the penumbra, by increasing blood flow, restoring oxygen supply to the brain, and reducing the amount of cerebral oedema (fluid) which is seen as a result of the stroke. positive findings would indicate that the drug is able to support brain tissue-at-risk and provide overall neuroprotection and benefit to stroke patients.


Eligibility criteria:
inclusion criteria: * male or female subjects with a diagnosis of first ais due to distal \[m2 segment and beyond\] occlusion or perforator occlusion * perfusion abnormalities observed on computed tomography perfusion (ctp) * mild to moderate stroke severity * pre-stroke mrs \<4 * written informed consent obtained from patient and/or medical treatment decision maker prior to study-start (upon admission). exclusion criteria: * administration of intravenous thrombolytic therapy in distal occlusion as etiology of ais * intervention by endovascular thrombectomy (evt) * known allergy or anaphylaxis to adrenocorticotropic hormone (acth) or melanocortins or any of the excipients listed in the investigator's brochure * any evidence of hepatic (defined as three times standard range) or renal impairment (defined as estimated glomerular filtration rate (egfr) \<50 ml/min/1.73 m²) * any other medical condition which may interfere with the study protocol * female who is pregnant (confirmed by positive serum beta human chorionic gonadotropin (β-hcg) pregnancy test prior to baseline) or lactating * females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device) or a lifestyle excluding pregnancy * unable to undergo mri brain evaluation * not suitable for trial participation according to judgment of the principal investigator (pi) * patients starting afamelanotide 24 hours or more from ictus.
clinical study of shr-a1921 combined with adebrelimab and shr-8068 with or without carboplatin in the treatment of advanced nsclc

Conditions: Advanced Non-small Cell Lung Cancer

Summary: a trial to evaluate the tolerability and efficacy of shr-a1921 in combination with adbelizumab and shr-8068 with or without carboplatin in patients with advanced non-small cell lung cancer


Eligibility criteria:
inclusion criteria: 1. volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up; 2. aged 18-75 at the time of signing the informed consent; 3. histologically or cytologically confirmed patients with locally advanced or metastatic non-cellular lung cancer who are not eligible for surgical resection or radical concurrent chemoradiotherapy; 4. at least one measurable lesion consistent with recist v1.1; 5. ecog ps score: 0-1; 6. the organ function level is good; exclusion criteria: 1. untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.; 2. uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms; 3. previous or co-existing malignant neoplasms; 4. the presence of any active or known autoimmune disease; 5. have clinical symptoms or diseases of the heart that are not well controlled; 6. people with past or current interstitial pneumonia/interstitial lung disease; 7. known allergic reactions to any component of shr-a1921, adebrelimab, or severe allergic reactions to other monoclonal antibodies; 8. have previously received topoisomerase i inhibitors (including but not limited to irinotecan, topotecan), trop-2adc, or adc drugs containing topoisomerase i inhibitors; previously received anti-pd-1 /pd-l1 antibody or anti-ctla-4 antibody treatment;
computer-assisted quantification of the synovial perfusion in patients with arthritis using two-dimensional and three-dimensional power doppler ultrasonography

Conditions: Synovitis

Summary: the purpose of this study is to compare the data obtained by computer-aided quantification of the synovial perfusion in patients with arthritis using two-dimensional and three-dimensional power doppler ultrasonography and the clinical data used to represent the degree of joint inflammation. intra- and inter-observer reliability of this method will also be determined.


Eligibility criteria:
inclusion criteria: * patients with at least one painful swollen peripheral joint observed by a rheumatologist, including: * shoulder joints * elbow joints * wrist joints * metacarpophalangeal (mcp) and * proximal interphalangeal (pip) joints of hands, ankle joints, subtalar joints, mid-tarsal joints, mtp and pip joints of feet exclusion criteria: * patients with active infection * patients with concurrent malignant disease * patients with a history of traumatic, septic, or cystal arthritis * previous joint surgery, or isotopic synovectomy within the past 12 months before the study

Keywords: active synovitis
autograft versus calcium phosphate macroporous bioceramics as bone substitute for tibial valgus osteotomy

Conditions: Osteoarthritis of the Knee

Summary: the aim of the study is to compare radiological behavior of blocks of macroporous phosphocalcium as bone substitute in comparison with iliac crest autograft in tibial valgus osteotomy.


Eligibility criteria:
inclusion criteria: * knee osteoarthritis eligible for tibial valgus osteotomy * \> 18 y.o exclusion criteria: * prior tibial osteotomy * history of local infection * rheumatoid and other inflammatory arthritis

Keywords: calcium phosphate ceramic tibial osteotomy osteoarthritis
antimicrobial resistant organism decolonization after microbiome perturbation

Conditions: Gram-negative Bacteremia; Microbial Colonization; Antibiotic Resistant Infection

Summary: aro-decamp is a multi-centre, placebo-controlled, pilot and feasibility randomized controlled trial for the microbial consortium microbial ecosystem therapeutic-2. non-intensive care unit patients ≥ 18 years old diagnosed with a bloodstream infection and receiving treatment for an antibiotic resistant organism will be included. participants will be randomized to receive either met-2 or placebo for 10 days. recruitment rate and study intervention adherence will be evaluated for feasibility. participants will be followed for 180 days, and biological samples will be collected periodically for clinical, ecological, and biomarker outcomes.

reconstituting the perturbed microbiome is a novel therapeutic modality with the potential to decrease aro colonization and infection and combat amr without additional pressure for selection of further antimicrobial resistance. no trial has yet assessed the potential of a therapeutic microbial consortium for aro decolonization and infection prevention after antibiotic treatment. the investigational product, microbial ecosystem therapeutic-2 (met-2), is a defined microbial community derived from healthy donor stool. met capsules are orally administered mixtures of bacterial strains cultured from the stool of a healthy donor. this study is designed to determine if a trial of administration of met-2 after antibiotic treatment for bloodstream infections is feasible. stool and plasma biomarkers to assess the effects of the intervention will also be evaluated.

Eligibility criteria:
inclusion criteria: 1. adult (≥18 years old) inpatient not admitted to the icu or equivalent (step-up and step-down units are eligible) 2. positive blood culture with an aro: * ampc beta-lactamase producing species: enterobacter cloacae, citrobacter spp., klebsiella aerogenes, serratia spp., morganella morganii, hafnia alvei or * esbl-producing gram-negative bacilli 3. currently receiving treatment for the bloodstream infection exclusion criteria: 1. inability to swallow oral met-2 or placebo capsule 2. recipient of small bowel transplant 3. inflammatory bowel disease, short bowel syndrome, diverting/non-diverting ileo/colostomy 4. use of \>3 days over-the-counter or prescription probiotics (not including food additives) within 10 days of enrolment 5. receipt of fecal microbiota transplant (fmt) within 3 months of enrolment 6. absolute neutrophil count \<0.5x109/l 7. death expected within 72 hours of enrolment 8. planned continuation of non-prophylaxis antimicrobial therapy active against the bloodstream isolate for \>42 days 9. known pregnancy, planning to become pregnant during the study period, or breastfeeding 10. any other reason in view of the site investigator or treating team

Keywords: microbial consortia microbiome decolonization infection bacteremia antibiotic microbiota antibiotic resistance
evaluation of computer-assisted, non-cathartic ct colonography

Conditions: Colonic Polyps

Summary: the purpose of this study is to evaluate the performance of a non-cathartic, computer-assisted form of ct colonography (virtual colonoscopy) for detection of pre-cancerous colon polyps in a group of asymptomatic screening patients.

examinations to completely assess the colonic anatomy for the purposes of polyp detection and cancer prevention all require an unpleasant, pre-exam cathartic bowel preparation. the discomfort and embarrassment associated with this bowel prep has been identified as a barrier to adherence of at-risk subjects with recommended colon screening guidelines. ct colonography (ctc) is an imaging based test that evaluates the entire colon anatomy and requires cathartic bowel prep; its performance is considered comparable to optical colonoscopy (oc) for adenomatous polyp detection. in addition, ctc generates a large amount of data to be read by a human, and this data interpretation task can be aided by computer-assisted-detection (cad) software to identify potential polyp lesions for the human reviewer. this trial studies the performance of a form of ctc that uses fecal tagging and electronic image cleansing to obviate the need for cathartic prep. in addition, readings prospectively employ cad to potentially buffer human interpretation performance. the investigators are prospectively testing this augmented (non-cathartic, cad-assisted) form of ctc in asymptomatic (screening) cohort. the trial is a prospective test comparison, using segmentally unblinded optical colonoscopy in combination with pathology specimens as a reference standard for presence of target lesions, adenomatous polyps 6 mm or greater in size.

Eligibility criteria:
inclusion criteria: * age 50-80, eligible for colon screening exclusion criteria: * prior anatomic colon screening exam (optical colonoscopy, sigmoidoscopy, barium enema, ct colonography) within last 5 years * personal history of inflammatory bowel disease, polyposis syndrome, colo-rectal cancer, colon surgery * documented passage of blood per rectum within last 12 months

Keywords: colon cancer adenomatous colonic polyps colon screening ct colonography (virtual colonoscopy) computer aided detection electronic cleansing
use of tranexamic acid in facial fillers

Conditions: Injection Site Bruising

Summary: the overall purpose of this study is to evaluate the safety and efficacy of co-administration of tranexamic acid (txa) with hyaluronic acid (ha) in reducing swelling, bruising and pain after facial injection. this will be done by comparing ha to ha+txa in participants undergoing facial filler injections. patients undergoing facial filler injections almost always have the same type of injection performed bilaterally in order to maintain symmetry. this provides a unique opportunity where participants can serve as their own controls. participants will be injected with ha on half of their face and the other half of the face will be injected with ha+txa. swelling, bruising, pain, and overall satisfaction will be assessed using participant self-reported surveys, physician surveys, and review of medical records.


Eligibility criteria:
inclusion criteria: * age equal to or greater than 18 but less than or equal to 89 years. * medically appropriate to undergo elective facial filler injection at uw health by principal investigator * english speaking exclusion criteria: * minors or under the age of 18 * patient over the age of 89 * pregnant or breast-feeding women * individuals unable to give consent due to another condition such as impaired decision-making capacity. * participants with a history of a thrombotic event (dvt, pe, stroke, mi) or genetic disorder that increases risk of thrombosis * concurrent use of estrogen * participant undergoing unilateral facial filler injections * participants with history of hypersensitivity to txa or any of the other ingredients * participants that are on current therapeutic anticoagulation therapy * participants with stage 2 or greater renal failure * participants on hemo- or peritoneal dialysis

Keywords: patient satisfaction plastic surgery
contribution of pet/mri in locally advanced cervical cancer (aticc)

Conditions: Cervical Cancer

Summary: \[18 f\]fluorodeoxyglucose (18f-fdg) positron emission tomography-magnetic resonance imaging (pet/mri) is a new hybrid imaging tool that has recently arrived in oncology, and is particularly promising. its usefulness seems obvious in certain tumor types, but its place in the staging of cervical cancers has never been explored in a prospective trial to our knowledge. previously, a comparative retrospective study from 2009 found a better sensitivity of pet fused to diagnostic mri images compared to pet/ct (positron emission tomography/computed tomography) in the detection of metastatic lymph nodes (54 and 44% respectively). it was an a posteriori fusion of images, from images acquired by pet-ct.

this monocentric, prospective trial aims at comparing performances of 18f-fdg pet/mri versus standard pet/ct in the detection of lymph node metastases in cervical cancer patients. specificity and sensitivity of both exams will be compared at one timepoint, during the pet/ct prescribed in routine care for assessment of extension. pet/mri will be conducted directly after pet/ct and a unique dose of 18f-fdg radiotracer will be used for both exams.

Eligibility criteria:
inclusion criteria: * patients aged from 18 years old and over * patients with presumed cervical cancer of stages ib2 to iva based on clinical data and pelvic mri, undergoing pre-treatment assessment. * for women of childbearing potential : adequate contraception throughout study participation. note : enrollment in a concomitant clinical trial is authorized exclusion criteria: * oncological history that could possibly interfere with imaging results interpretation, apart from cervical cancer * extra-nodal metastasis clinically or radiologically proven before study participation * contraindication to mri or injection of contrast agents containing gadolinium * contraindication to lumbo-aortic lymphadenectomy * persons deprived of liberty * minor or patients placed under guardianship or supervision * patient under judicial protection * patient unable to consent
genetic autopsy and sudden death

Conditions: Sudden Death

Summary: the purpose of the study is to better identify hereditary cardiac causes of sudden unexpected death in young subjects through next-generation sequencing of autopsy tissue

monitoring : for index cases group, all the data will be monitored. for the relatives group, only the informed consent will be monitored statistical analysis : * evaluate the additional elucidation rate of unexpected sudden death * evaluate causes obtained by next generation sequencing (ngs) ( in comparison with conventional autopsy (macroscopic and / or microscopic) * descriptive study of the causes of sudden unexpected death, identified hereditary cardiac causes percentages compared via various diagnostic approaches * cost-effectiveness analysis data management : a database is created for the agemos study with control of the discrepancies. all the index cases' data entered in the data base will be double checked

Eligibility criteria:
index cases : inclusion criteria: * subjects of more than 2 years old and less than 41 years old * sudden unexpected death from natural and nontraumatic causes * macroscopic autopsy performed within 72 hours after death and without signs of body decomposition * no extracardiac obvious causes, including toxicological analysis when available * no significant coronary cause after autopsy (such as tight coronary stenosis, congenital abnormality of the arteries, coronary vasculitis) * informed consent of the close relation (family/reliable person) and / or legal representative relatives : inclusion criteria: * to be a first degree relative (parents, sister, brother, child) of a deceased subject included in the agemos study and accept to perform medical examination and transmit results of examination

Keywords: sudden unexpected death young subjects molecular genetic autopsy sequencing