Kornimate/medical-research-clean huggingface dataset:
a study of zl-1310 in participants with selected solid tumors

Conditions: Solid Tumors

Summary: a phase ib/ii, open-label, multi-center study of zl-1310 in participants with selected solid tumors

this is an open-label, multiple-center, phase ib/ii study of zl-1310 in selected solid tumors.

Eligibility criteria:
inclusion criteria: * signed informed consent * adult men and women ≥18 years of age * participants must have histologically confirmed, locally advanced or metastatic necs, and must have experienced disease progression on or after platinum-based therapy * participants must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample * participants must have at least one measurable target lesion as defined by recist v1.1 * eastern cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy ≥ 3 months exclusion criteria: * participants with another known malignancy that is progressing or requires active treatment within the last 2 years * clinically active central nervous system (cns) metastases * participants with leptomeningeal metastasis * participants who have received any adc with a payload of topoisomerase i inhibitor (e.g., exatecan derivative) * treatment with any systemic anti-cancer treatment or other investigational products/device within 3 weeks before the first dose of study treatment * non-palliative radiotherapy within 2 weeks prior to first dose of study treatment or a history of radiation pneumonitis * major surgery within 4 weeks of the first dose of study treatment * hypersensitivity to any ingredient of the study treatment * out of range value (as defined in protocol) within 10 days prior to the first dose of study treatment * impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment * lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue, or inflammatory disorders including but not limited to pneumonitis * has a history of (noninfectious) ild/pneumonitis that required steroids, has current ild/pneumonitis, or where suspected ild/pneumonitis cannot be ruled out by imaging at screening * pregnant or nursing (lactating) women * participants who have been on concomitant strong cyp3a or cyp2d6 inhibitors within 14 days or 5 half-lives before the first dose of study treatment, whichever is longer
correlation between optic nerve sheath diameter and neurological deficit in adult patients with suspected ischemic stroke

Conditions: Ischemic Stroke

Summary: the ultrasound of the optic nerve sheath diameter (onsd) is a non-invasive tool used in the detection of intracranial hypertension and other neurological conditions. the aim of this research is to evaluate the correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus in the physical examination of adult patients evaluated in emergency departments.

ii. hypothesis the ultrasound measurement of the optic nerve sheath diameter correlates with the side of neurological focus in the physical examination of adult patients evaluated in emergency departments. iii. objectives estimate the correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus in the physical examination of adult patients evaluated in emergency departments. determine the sensitivity and specificity of the ultrasound measurement of the optic nerve sheath diameter for predicting the side of neurological focus. iv. methodology study design: a observational study will be conducted in a secondary care hospital. population and sample: adult patients (≥18 years) presenting to the emergency department with neurological symptoms, such as headache, altered level of consciousness, motor or sensory deficit, among others, will be included. patients with contraindications for ocular ultrasound or with a history of previous ocular surgery will be excluded. procedures: 1. informed consent will be obtained from patients who meet the inclusion criteria. 2. a neurological physical examination will be performed to identify the side of neurological focus. 3. the optic nerve sheath diameter will be measured using ultrasound with a high-frequency linear transducer (7.5-12 mhz). 4. demographic, clinical, and ultrasound data will be recorded for the patients. data analysis: the correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus will be calculated using pearson's or spearman's correlation coefficient, depending on the distribution of the data. additionally, sensitivity, specificity, positive and negative predictive values, and 95% confidence intervals will be calculated to determine the diagnostic utility of the ultrasound measurement of the optic nerve sheath diameter in identifying the side of neurological focus. v. ethical considerations the ethical guidelines established by the declaration of helsinki will be followed, and the privacy and confidentiality of patients will be protected. the protocol will be approved by the hospital's research ethics committee before its implementation.

Eligibility criteria:
inclusion criteria: * patients with suspected acute ischemic stroke * ct scan negative to hemorrhagic stroke * informed consent exclusion criteria: * contraindications to perform ocular ultrasound * patients with ocular surgery

Keywords: optic nerve sheath diameter stroke emergency department
efficacy of prado heart failure in occitania

Conditions: Heart Failure

Summary: patients with heart failure (ic), after hospitalization, have a marked fragility: in france, in the first year, 29% die and 45% are readmitted to ic. interventions improving the coordination of care providers at the time of discharge from hospitalization were tested; they showed a reduction in readmissions for ic (relative risk (rr) from 0.51 to 0.74) and all-cause mortality (rr 0.75 to 0.87). the patient return program ic (prado ic), set up by the health insurance, offers assistance in the initiation of outpatient medical monitoring, and a nursing follow-up of 2 to 6 months depending on the patient's severity. the trial of prado began in the second half of 2013, and the first evaluation showed that the time to first treatment was significantly shorter, and that the readmissions rate and the 6-month death rate were unchanged. this study was of epidemiological type, comparative before-elsewhere. the difficulty of controlling for confounders in this type of study limits the scope of these conclusions. the efficacy hypothesis of prado ic is therefore always posed in the french context


Eligibility criteria:
inclusion criteria: * 18 years or older * hospitalization for heart failure * subject living at home * informed consent exclusion criteria: * discharge to a rehabilitation clinic or to medical home for elderly people * subject without health insurance * terminal kidney failure * programmed heart surgery * waiting for heart transplantation * psycho-cognitive impairment * patient not autonomous for mobility at home * supportive care * planned move to medical home for elderly people in the coming 6 months * no fluent french * not able to provide informed consent * participating to other study

Keywords: heart failure care pathway transition program efficiency
the effectiveness of ozone (o2-o3) injections in the treatment of myofascial pain syndrome

Conditions: Myofascial Pain Syndrome; Myofascial Trigger Point Pain

Summary: ozone (o2-o3) has been used as a supportive therapy in various musculoskeletal diseases such as lumbosacral disc herniation, knee osteoarthritis, meniscus injury, shoulder pathologies.the aim of this study is to investigate the effectiveness of ozone (o2-o3) injection applied to the trigger point in the treatment of myofascial pain syndrome.

the study was designed as a prospective, randomized, controlled trial. fourty six people who met the inclusion criteria will randomized into two groups of 23 people. the first group will be designated as ozone therapy group and patients in the second group will be designated as the lidocaine injection group. patients will be evaluated with visuel analog scale (10cm-vas), neck disability index (ndi), pain score (ps) and neck lateral flexion measurement before and after treatment at 4 and 12 weeks.

Eligibility criteria:
inclusion criteria: * diagnosed with myofascial pain syndrome according to the criteria defined by simons et al. * aged between18-65 * having typical myofascial pain symptoms for at least 3 months exclusion criteria: * presence of cervical radiculopathy, cervical myelopathy, severe dyscal or bony degeneration * presence of a history of neck trauma or surgery in the last year * presence of trigger point injection for myofascial pain syndrome treatment in the last 3 months * presence of cognitive impairment, malignant hypertension, g6pdh (glucose 6- phosphate dehydrogenase) deficiency, graves' disease, chronic recurrent pancreatitis attack, severe thrombocytopenia (platelet value \<50,000 / microliter), cerebrovascular disease in which bleeding is active * presence of systemic diseases such as fibromyalgia, inflammatory diseases such as rheumatoid arthritis, polyneuropathy, coagulopathy. * presence of pregnancy and breastfeeding

Keywords: myofascial pain syndrome trigger point pain ozone lidocaine
a bioequivalence study of 8 mg fesoterodine extended-release tablets (toviaz™) in healthy subjects

Conditions: Treatment of Overactive Bladder

Summary: this bioequivalence (be) study is to satisfy fda regulatory requirements for extended releases drug product transfer from zwickau, germany to vega baja, puerto-rico.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects * body mass index (bmi) of 17.5 to 30.5 kg/m2 exclusion criteria: * subjects with evidence or history of clinically significant urologic diseases * a positive urine drug screen * pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method

Keywords: bioequivalence, pharmacokinetics
bioequivalence between two explorative insulin degludec formulations and between two explorative idegasp formulations in healthy subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted i europe. the aim of this trial is to test for bioequivalence between two explorative formulations of insulin degludec (insulin 454) and between two explorative insulin degludec/insulin aspart (idegasp - formerly siac) formulations, all with or without buffer, in healthy male subjects. the investigated formulations are explorative, not similar to the proposed commercial formulation.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. trial related activities are any procedure that would not have been performed during the normal management of the subject * considered generally healthy upon completion of medical history and physical examination as judged by the investigator * body mass index (bmi) between 18.0 and 27.0 kg/m\^2 (inclusive) * fasting plasma glucose below or equal to 6 mmol/l * sexually active and non-sterilised participants must be informed that they and their partner must use a safe method of contraception during sexual intercourse (risk of pregnancy must be lower than 1%), e.g. implants, injections, combined oral contraceptives or hormonal intrauterinedevice or be willing to refrain from having sexual intercourse from the beginning of the study until up to three months after the conclusion of the study. this serves to exclude the possibilityof a pregnancy through sperm that could have been damaged by the study medication exclusion criteria: * a history of any illness that, in the opinion of the investigator, might confound the results of the trial or pose risk in administering the trial product to the subject * known or suspected allergy to trial products or related products * subject who has participated in any other trials involving investigational products within the last 3 months prior to first dosing
study to evaluate safety, efficacy of botulinum toxin type a in patients with cervical dystonia

Conditions: Cervical Dystonia

Summary: study is to investigate the use of the toronto western spasmodic torticollis rating scale (twstrs) scale in a cervical dystonia population treated with botulinum toxin type a, and placebo.


Eligibility criteria:
inclusion criteria: * diagnosis of cervical dystonia exclusion criteria: * current or previous botulinum toxin treatment of any type for any condition
primary tka cruciate retaining vs cruciate substituting with rotating platform knee prostheses

Conditions: Osteoarthritis; Arthritis, Rheumatoid; Avascular Necrosis of Bone; Post-traumatic Arthritis; Rheumatoid Arthritis

Summary: the purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary tkas. outcome scoring and radiographic assessment will be the methods used to evaluate performance.

the study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary tkas. patients will receive either the p.f.c.® sigma™ rotating platform cruciate retaining knee implant or the p.f.c.® sigma™ rotating platform cruciate substituting knee implant and assignment will be randomized.

Eligibility criteria:
inclusion criteria: * osteoarthritis * rheumatoid arthritis * avascular necrosis (avn) of bone * other inflammatory arthritis * post-traumatic arthritis * juvenile rheumatoid arthritis exclusion criteria: * prior ipsilateral tka * metabolic disorders * joint replacement due to autoimmune disorders * history of recent/active joint sepsis * charcot neuropathy * psycho-social disorders that would limit rehabilitation * greater than 75 years of age at the time of surgery * severe diabetes mellitus * skeletal immaturity

Keywords: total knee replacement
extended open challenge in patients with a history of drug eruption following beta-lactam treatment

Conditions: Beta-lactam Allergy

Summary: beta-lactam allergy is the most prevalent drug allergy. drug eruption is the most common symptom whereas life-threatening anaphylaxis is rather rare. a recently published study (journal of allergy and clinical immunology, january 2011, vol. 127, p. 218-222) described the safety of a 2-day oral beta-lactam challenge in penicillin-allergic patients, disregarding their penicillin skin test results. in the proposed study the investigators will similarly challenge beta-lactam allergic patients, both children and adults for an extended (5 days) period of time. the study will include patients with a history of a skin rash following beta-lactam administration as well as patients who cannot provide any data on their presumed allergic reaction, disregarding their penicillin skin test results.


Eligibility criteria:
inclusion criteria: * history of skin rash following the administration of beta-lactam antibiotic * patients with a diagnosis of penicillin allergy who have no data on the nature of the symptoms that have eventually resulted in establishing this diagnosis exclusion criteria: * patients in whom the rash appeared within 1 hour after the last dose of the drug * patients who also developed other anaphylactic symptoms * patients who had a life-threatening rash such as stevens-johnson syndrome, toxic epidermal necrolysis or dress. * pregnancy
blood flow regulation in glaucoma

Conditions: Glaucoma

Summary: glaucoma is one of the leading causes for blindness in industrialized countries. it is characterized by a progressive loss of retinal ganglion cells, morphological changes in the optic nerve head and a characteristic loss of visual field. although increased intraocular pressure has been identified as the major risk factor for the development and the progression of the disease it has been speculated for a long time that impaired ocular blood flow may contribute to the pathogenesis of the disease. this concept has been supported by several epidemiological studies showing that low ocular perfusion pressure and small retinal vessel caliber are associated with the disease. the proposed study tests the hypothesis that patients with glaucoma have reduced total retinal blood flow as compared to healthy subjects. additionally, autoregulation of blood flow will be investigated during an increase in ocular perfusion pressure. this is of importance because it may clarify the degree of vascular involvement in glaucoma.


Eligibility criteria:
inclusion criteria: patients with open angle glaucoma: - diagnosis of manifest open angle glaucoma as defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and/or untreated intraocular pressure ≥ 21 mmhg on at least three measurements in the medical history. mean deviation in the visual field test \< 10 decibel healthy control subjects: * normal ophthalmic findings and intraocular pressure \< 20 mmhg on at least three measurements * no evidence of increased intraocular pressure in the medical history * no signs of glaucomatous damage in the optic disc or the glaucoma hemifield test exclusion criteria: * presence or history of a severe medical condition as judged by the investigator * abuse of alcoholic beverages * participation in a clinical trial in the 3 weeks preceding the study * exfoliation glaucoma * pigmentary glaucoma * secondary glaucoma * ocular hypertension * history of acute angle closure * intraocular surgery within the last 6 months * history of epilepsia * diabetes mellitus * ocular inflammation or infection within the last 3 months * untreated hypertension with systolic blood pressure \>160 mmhg, diastolic blood pressure \>95 mmhg * pregnancy or lactating
fit combining fc for predicting mh and histology remission in uc

Conditions: Ulcerative Colitis; Histology Remission; Fecal Calprotetin; FIT; Mucosal Healing

Summary: investigaters will perform a clinical trial to asess the abilitiy of qfit and fc on predicting uc mh and histology remission.


Eligibility criteria:
inclusion criteria: * ulcerative colitis patients. exclusion criteria: * gi bleeding
a randomised proof-of-principle trial investigating pharmacodynamics, pharmacokinetics, and safety of nnc0143-0406 in subjects with type 1 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this trial is to investigate pharmacodynamics (the effect of the investigated drug on the body) , pharmacokinetics (the exposure of the trial drug in the body), and safety of nnc0143-0406 in subjects with type 1 diabetes mellitus


Eligibility criteria:
inclusion criteria: * male or female aged 18-55 years (both inclusive) at the time of signing informed consent * subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening * treated with continuous subcutaneous insulin infusion at least 90 days prior to the day of screening exclusion criteria: * known or suspected hypersensitivity to trial product(s) or related products * males who are sexually active and not surgically sterilised (vasectomy or otherwise) and their partners that are not using a highly effective contraception method, from randomisation until 90 days after dosing, such as double barrier contraception (e.g. condom and spermicide) or combination of either an oral ontraceptive, a contraceptive patch, a diaphragm or intrauterine device, together with a physical barrier such as condom. male subjects must also agree to refrain from sperm donation from randomisation until 90 days after last dosing * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) (adequate contraceptive measures are defined as sterilisation, hormonal intrauterine device, oral contraceptives, condom with spermicide sexual abstinence or vasectomised partner)
endotracheal intubation using three laryngoscopes in maternal cardiac arrest: a manikin simulation study

Conditions: Cardiac Arrest

Summary: european resuscitation council (erc) guidelines for resuscitation 2010 emphasize high quality chest compressions .they propose minor changes for pregnant women: manual left deviation of the uterus or a left-lateral incline of 15-30to alleviate pressure on the inferior vena cava. we will examine the performance of the glidescope (gvl), the pentax-aws airwayscope(aws) and macintosh laryngoscope (mcl) for airway management during chest compressions on 15 and 30 degree left-lateral tilt (15 \&30 llt) custom-made hard wedges.

materials 1. sim mom manikin (laerdal, stavanger, norway) 2. stryker st104-747(transport stretcher®, 760 x 2110 mm, 228 kg, stryker co., kalamazoo, michigan, us) 3. lucas chest compression system( lucas chest compression system, physio-control/jolife ab) 4. backboard(450 ×600 ×10 mm, 3 kg lifeline plastic, sung shim medical co., bucheon, korea)

Eligibility criteria:
inclusion criteria: * experience of intubation \> 50 times * postgraduates year 1,2,3,4 and emergency physicians in emergency department exclusion criteria: * wrist or low back disease

Keywords: endotracheal intubation left lateral tilt wedge maternal cardiopulmonary resuscitation manikin study
a study of mavacamten in adults with obstructive hypertrophic cardiomyopathy in india (rover)

Conditions: Symptomatic Obstructive Hypertrophic Cardiomyopathy

Summary: the purpose of this study is to evaluate the safety, tolerability and effectiveness of mavacamten in adults with obstructive hypertrophic cardiomyopathy in india.


Eligibility criteria:
inclusion criteria * diagnosed with obstructive hypertrophic cardiomyopathy (hcm) consistent with current american college of cardiology foundation/american heart association and european society of cardiology guidelines. * has unexplained lv hypertrophy with nondilated ventricular chambers in the absence of other cardiac (ie, hypertension, aortic stenosis) or systemic disease and with maximal lv wall thickness ≥ 15 mm (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy). * has lvot (valsalva left ventricular outflow tract) peak gradient ≥ 50 mmhg during screening as assessed by tte at rest, valsalva maneuver, or post exercise lvot peak gradient. * has lvot peak gradient with valsalva at screening tte of ≥ 30 mmhg. * has adequate acoustic windows to enable accurate ttes. * has new york heart association (nyha) class ii or iii symptoms at screening. * body weight is greater than 45 kg at screening. * documentation of lvef ≥ 55% at rest of screening tte. exclusion criteria * known infiltrative or storage disorder causing cardiac hypertrophy that mimics obstructive hypertrophic cardiomyopathy, such as fabry disease, amyloidosis, or noonan syndrome with lv hypertrophy. * has paroxysmal atrial fibrillation present per the investigator's evaluation of the participant's ecg at the time of screening. * has persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to screening and/or not adequately rate controlled within 6 months prior to screening. (note: participants with persistent or permanent atrial fibrillation who are anticoagulated and adequately rate-controlled are allowed). * has a history of syncope with exercise within 6 months prior to screening. * history of sustained ventricular tachyarrhythmia (\> 30 seconds) within 6 months prior to screening. * has documented obstructive coronary artery disease (\> 70% stenosis in one or more epicardial coronary arteries) or history of myocardial infarction. * other protocol-defined inclusion/exclusion criteria apply.