Kornimate/medical-research-clean huggingface dataset:
a dose-finding study of dalotuzumab in subjects with advanced solid tumors (mk-0646-002)

Conditions: Advanced Solid Tumors

Summary: the study determined the recommended phase 2 loading and maintenance doses and dose schedules for administering dalotuzumab using dose-limiting toxicities (dlts) observed during the entire treatment period (up to 18 months). the primary hypothesis of the study was that administration of dalotuzumab as an every other week infusion in participants with relapsed or refractory locally advanced or metastatic cancers associated with a high frequency of insulin-like growth factor receptor type 1(igf-1r) overexpression will be generally safe and well tolerated to permit further study and achieve a constant clearance and a minimum trough concentration of 3 µg/ml.

the study consisted of 3 parts. in part 1 the loading dose was escalated while the maintenance dose was kept constant. in part 2 the loading dose was kept constant while the maintenance dose was escalated. in part 3 the recommended phase 2 loading and maintenance doses and schedule were administered to an expanded cohort to explore safety and efficacy of dalotuzumab.

Eligibility criteria:
inclusion criteria: * males and females with advanced solid tumors who have failed to respond to standard therapy, ages 18 years and older, with adequate organ function exclusion criteria: * participant is using growth hormones or growth hormone inhibitors * participant is known to be allergic to components of the drug or similar drugs (e.g. monoclonal antibodies such as rituximab or biological therapies such as immunoglobulin g * participant has had chemotherapy, radiotherapy, or biological therapy within 4-6 weeks of entering the study or has not recovered from previous therapy * participant is taking part in or has taken part in a study of an investigational compound or device within 30 days of their first dose of study drug * participant has an active central nervous system metastases and/or carcinomatous meningitis. however, a participant who has completed a course of therapy and is clinically stable may be able to participate * participant is pregnant or breastfeeding * participant is human immunodeficiency virus (hiv) positive * participant has a history of hepatitis b or c * participant has symptomatic ascites or pleural effusion. however, if the participant has received treatment and is stable, they may be able to participate * female participant plans to become pregnant or a male participant who plans to impregnate their partner during the time the study is ongoing
prediction of fluid responsiveness in atrial fibrillation patients who underwent valvular heart surgery: peep-induced increase in central venous pressure vs. passive leg raising

Conditions: Valvular Heart Surgery

Summary: dynamic indices of preload depending on the heart-lung interaction require sinus rhythm and cannot be applied to patients with atrial fibrillation. peep-induced increase in central venous pressure (cvp) was shown to be a valid predictor of fluid responsiveness after cardiac surgery in patients with sinus rhythm, and was speculated to be of value in patients with rhythm other than sinus. the aim of this study is to assess the predictability of peep-induced increase in cvp and passive leg raising (plr)-induced changes in stroke volume index (svi) on fluid responsiveness in patients with atrial fibrillation following valvular heart surgery.


Eligibility criteria:
inclusion criteria: 1. age ≥20 2. atrial fibrillation patients who underwent elective valvular heart surgery exclusion criteria: 1. age \< 20 2. lv ejection fraction \< 40% 3. any pulmonary disease 4. end stage renal disease 5. high intrabdominal pressure patient 6. contraindication of passive leg raising 7. deep vein thrombosis

Keywords: fluid responsiveness atrial fibrillation passive leg raising central venous pressure valvular heart surgery
radio frequency ablation (rfa study )

Conditions: Uterine Myoma

Summary: the aim of this study is to investigate the safety and feasibility of a radiofrequency (rf) system employing rfitt (celonprosurge) probes for the ablative treatment of uterine fibroids.

10 consecutive premenopausal women with symptomatic uterine fibroids not responsive to medical therapies (including progestins, oral contraceptives, and anti-inflammatory drugs) will be recruited at our hospital to be submitted to abdominal myomectomy. all patients will be counseled on the potential risks and benefits of the procedure before giving their own written consent. procedures will be performed at the hospital and patients will be under general anesthesia.all patients will be submitted to abdominal myomectomy. target leiomyomas will be intramural, 5-15 cm in diameter. intra-operative rf ablation will be carried out followed by surgical removal of the treated leiomyoma. after the removing of the fibroid, it will be send to the pathologist. specimens of fibroid will be fixed immediately in 10% neutral formaline solution for approximately 3h, then embedded in paraffin, cut into 4mm section and stained with along the direction of the rfa electrode. pathologic confirmation of ablation will be assessed as follows: the specimens of leiomyoma will be examined grossly for the histologic leiomyoma subtype and for pathologic findings representing treatment, including necrosis, hemorrhage, or fibrosis, using hematoxylin and eosin staining. treated areas will be measured for their largest orthogonal dimensions in the planar cut surface with the third dimension estimated by summing the affected 0.5-cm-thick sagittal planes. rf ablation volumes will be calculated using the prolate ellipsoid formula. the relationship between thermal dose estimates and pathology will be assessed using bland-altman analyses and intra-class correlations. the surgical procedure will be concluded as usual with the same steps of standard approach.

Eligibility criteria:
inclusion criteria: 1. premenopausal women, 25 years of age or older; 2. presence of fibroid-related symptoms (menorrhagia, pelvic pain and/or bulk symptoms) not responsive to medical therapy; 3. uteri \<20-week gestational size on pelvic examination; 4. one myoma 5-15 cm in diameter as measured by transvaginal ultrasound; 5. desire for uterine preservation; 6. normal coagulation profile; 7. normal pap test result in the last year, 8. hemoglobin level of 10.0 g/dl or more at the time of treatment. exclusion criteria: 1. pedunculated subserosal or intracavitary myomas, 2. a history of pelvic malignancy, 3. presence of cervical dysplasia, 4. a prior procedure to treat or remove myomas, 5. contraindications to general anesthesia or abdominal surgery.
discriminating ability of the cirrus high definition (hd) optical coherence tomography (oct) for glaucoma

Conditions: Glaucoma

Summary: the cirrus hd oct, a new spectral domain optical coherence tomography, has better resolution than the previous oct. reproducibility and discriminating ability of the cirrus hd oct for glaucoma detection will be studied.

the cirrus hd oct is a newly developed imaging device of the spectral domain optical coherence tomography. even though its resolution and speed are much better than the previous oct, its reproducibility and diagnostic power for detecting the glaucomatous defect of retinal nerve fiber layer (rnfl) have not known yet. in the present study, we will review the data of rnfl thickness measurement using the cirrus hd oct. after assessing the inter-test variability, the discriminating ability of the cirrus hd oct for glaucoma diagnosis will be determined by the roc curves.

Eligibility criteria:
inclusion criteria: * cooperative patients * repeated oct data exclusion criteria: * intraocular surgeries history * dm * high refractive error ( \ + 4.00 diopters) * media opacity

Keywords: glaucoma retinal nerve fiber layer cirrus oct
the safety and influencing factors of liwen procedure in the treatment of hypertrophic cardiomyopathy

Conditions: Hypertrophic Obstructive Cardiomyopathy

Summary: liwen procedure is generally safe and effective in treating hypertrophic cardiomyopathy, but a small proportion of patients have complications after the operation. the goal of this observational study is to explore the incidence of postoperative complications of the liwen procedure in hypertrophic cardiomyopathy patients underwent liwen procedure in xijing hospital. the main question it aims to answer are: * what is the incidence of complications in hcm patients underwent liwen procedure during postoperative hospitalization and a short-term follow-up period? * what is the relevant factors of complications in hcm patients who underwent liwen procedure during postoperative hospitalization and short-term follow-up period? can the complications of surgical patients during postoperative hospitalization be predicted? participants have been evaluated using a variety of medical examinations before they underwent liwen procedure. variants collected from medical examination and case history were used to analyze the association with each postoperative complication.


Eligibility criteria:
inclusion criteria: 1. subject with symptoms that limit daily activities (new york heart association functional class \>ii, exercise-induced syncope) despite adequate medical treatment or when medical treatment is not tolerated 2. subject with a peak lvot gradient≥50 mm hg 3. subject volunteers for the liwen procedure and received the procedure at the hypertrophic cardiomyopathy center of xijing hospital. exclusion criteria: 1. subject with a peak instantaneous doppler lvot gradient of \<50 mm hg 2. subject with an indication for septal reduction therapy and other lesions requiring surgical intervention (e.g., mitral valve repair/replacement and papillary muscle intervention) 3. subject has end-stage heart failure

Keywords: cardiomyopathy, hypertrophic hypotension postoperative complication
evaluation of hand strength and spasticity in hemiplegic patients

Conditions: Neurological Rehabilitation; Stroke; Upper Extremity Problem

Summary: the aim in this study is to evaluate spasticity and hand grip strength with a finger hand robot in the turkish population.

spasticity has been defined as "irregular sensorimotor control resulting from upper motor neuron lesion manifesting as intermittent or sustained involuntary activation of muscles". the commonly used tools in the evaluation of spasticity are subjective clinical scales, including ashworth scale (as), modified as (mas), tardieu scale (ts), modified ts (mts), and tone assessment scale (tas). current scales are based on the clinician's perception of the patient assessing spasticity through their perceptions, experience, and training over the years. an objective measure of spasticity is required, and the development of robot-based systems for this purpose can help clinicians objectify their assessment. it has been widely shown that robotic systems can be useful in the rehabilitation of adults and children with brain damage. in addition, these systems can be used to assess upper extremity function during treatment. the aim in this study is to evaluate spasticity and hand grip strength with a finger hand robot in the turkish population.

Eligibility criteria:
inclusion criteria: * hemiplegic patients with sufficient cognitive and language skills to follow instructions will be included in the study. exclusion criteria: * uncooperative patient * having a skin ulcer on the hand, * patients with contractures of the hand fingers will be excluded.

Keywords: hemiplegia spasticity hand grip strength finger-hand robot
us selumetinib registry

Conditions: Neurofibromatosis Type 1; Plexiform Neurofibromas

Summary: the purpose of this study is to understand treatment patterns and assess long-term effectiveness and safety outcomes associated with selumetinib treatment as well as to explore clinical and non-clinical factors affecting those outcomes in patients with neurofibromatosis type 1 (nf1) and plexiform neurofibromas (pns) who started selumetinib between the ages of 2 to 18 years inclusive, and initiated selumetinib treatment on or after 10 april 2020 in a real-world setting.

this is a us observational registry of pediatric nf1 pn participants treated with selumetinib.

Eligibility criteria:
inclusion criteria: * participants diagnosed with nf1 and pn * started selumetinib between the ages of 2 to 18 years inclusive, and initiated selumetinib treatment on or after 10 april 2020, including patients who: * discontinued selumetinib before enrollment; or * initiated treatment before enrollment and are currently on selumetinib; or * initiated selumetinib on the day of enrollment or intend to initiate selumetinib within 3 months after enrollment * able to give written informed consent. participant or participant's parent/legal guardian must be willing and able to give written informed consent and the participant (if minor) must be willing to give written informed assent. exclusion criteria: * participants currently participating in any clinical trials at time of enrollment or initiation of selumetinib.

Keywords: neurofibromatosis type 1 plexiform neurofibromas nf1 pns
anterior chamber versus scleral fixated intraocular lens: long-term vision and safety outcomes

Conditions: Corneal Endothelial Cell Loss; Secondary Intraocular Lens

Summary: this is a prospective comparative non-randomized cohort study to understand the long-term vision outcomes, safety, and stability of anterior chamber intraocular lenses (ac iols) vs. scleral-fixated intraocular lenses (sf iols).

on the pre-operative visit, specular microscopy, biometry, applanation tonometry and ocular coherence tomography (oct) will be performed. the patient will then undergo treatment as per surgeon's discussion/ decision with the patient for implantation of an ac-iol or sf-iol. participation in the study will not impact the management plan in any way. specular microscopy will be performed wit the cellchek xl (konan medical, irvine, ca). biometry will be performed with the iolmaster (carl ziess meditec, jena, germany), and anterior segment and macular oct will be performed with the cirrus-hd oct (carl zeiss metidec, jena, germany). ec count, oct (macula and anterior segment) and specular microscopy will be performed at baseline, week 1, month 1, month 6, 12 and 24.

Eligibility criteria:
inclusion criteria: 1. patients who are undergoing ac iol or sf iol implantation for any reason (including but not limited to aphakia, posterior capsular rupture, primary or secondary lens dislocation/ subluxation or iol exchange). 2. patients on whom imaging (specular microscopy, biometry and oct) can be performed without delaying their treatment (i.e. based on availability of operator). 3. decision makers able to provide informed consent. exclusion criteria: 1. inability to obtain adequate imaging, in the form of specular microscopy and oct data at baseline. 2. patients unable to attend follow-up visits. 3. patients who have had a corneal transplant prior to secondary iol implantation.
impact of pre-pregnancy micronutrient supplementation on maternal and child outcomes

Conditions: Anemia; Intrauterine Growth Retardation; Preterm Delivery; Iron Deficiency

Summary: the study evaluates the efficacy of providing weekly iron-folate (ifa) supplements or multiple micronutrient (mm) supplements before pregnancy in increasing birth weight and duration of gestation as well as maternal and infant iron status.

low birth weight and anemia remain intractable problems in many developing countries despite considerable efforts to address them. intervening with just prenatal iron-folate (ifa) supplements may not be the best approach given the substantial demands for iron by maternal and fetal tissues. therefore, there is an urgent need to evaluate the additional contribution of prepregnancy interventions. the study evaluates the efficacy of providing weekly iron-folate (ifa) supplements or multiple micronutrient (mm) supplements before pregnancy in increasing birth weight and duration of gestation as well as maternal and infant iron status.

Eligibility criteria:
inclusion criteria: * 18-35 years old * currently married * currently living in one of the 10 communes and intends to live in the areas for 24 months following recruitment * plans to have children in the next year * agrees to participate with informed consent exclusion criteria: * currently pregnant * delivered in the previous six months * regularly consumed ifa or mm supplements in the past 2 months * severe anemia (hb \< 7 g/l) * history of high risk pregnancy including abruptio placenta, placenta previa, gestational diabetes, pregnancy induced hypertension, coagulation disorders, thrombocytopenia or chronic vascular, renal or systemic disease and drug use * chronic hematological diseases, hereditary defects of red cells or hemoglobin

Keywords: prepregnancy micronutrient supplementation maternal child health
estimating quality of life in people with asthma

Conditions: Asthma

Summary: the aim of this project is to estimate the quality of life for people with asthma and specifically the loss in quality of life associated with an asthma-related crisis event (accident and emergency (a\&e) attendance or admission).

asthma is a serious respiratory condition which causes shortness of breath, chest tightness and wheezing. quality of life can have an impact on asthmatics due to such symptoms. previous studies capture quality of life at specific time points (e.g. baseline, 1 month, 3 months), and the assumption of a steady improvement is made. however, these assumptions and time points could miss an asthma event in between. therefore, the investigators aim to provide a more accurate estimation of the loss in quality of life by following participants over an 8 week period from when the participants have attended a\&e or been admitted to hospital following an asthma attack. this will be done by using different quality of life methods, and analysed by calculating the difference between the quality of life scores from a\&e attendance / hospital admission and follow-ups.

Eligibility criteria:
inclusion criteria: * male or female 18 years old and over * has asthma alone, or asthma with chronic obstructive pulmonary disease (copd) or asthma with a respiratory infection * speaks english * not in need of help from carer / guardian to complete questionnaires * not hypoxemic * not participated in the study before * able to give informed consent exclusion criteria: * younger than 18 years old * does not speak english * has participated in the study before * remains hypoxemic despite oxygen therapy * impaired capacity to consent
effect of dulaglutide on glycemic variability in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: glycemic variability will be assessed using continuous glucose monitor(cgm) in type 2 diabetic patients who receive dulaglutide 1.5 mg/qw injection for 4 weeks.

glycemic fluctuation is a major problem in glucose control in diabetic patients. it is interesting to know that whether weekly glp-1ra can improve glycemic variability in diabetic patients. the present study aims to assess the effect of dulaglutide on glycemic variability using continuous glucose monitor(cgm) (libra, abbott) in type 2 diabetic patients with 4 weeks.

Eligibility criteria:
inclusion criteria: * fully understand the test content and possible adverse reactions and voluntarily participate in the trial and sign the informed consent form; * meet the world health organization(who) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes; * 18 ≤ age ≤ 70 years old, male or female; exclusion criteria: * subjects with type 1 diabetes mellitus or secondary diabetes mellitus (i.e. any type other than t2dm) * personal history or family history of thyroid medullary carcinoma or multiple endocrine neoplasia type 2 (men2). * history of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study (e.g. due to symptomatic gallstones). * history of significant gastrointestinal (gi) surgery that in the opinion of the investigator is likely to significantly affect upper gi or pancreatic function. * fasting triglyceride level more than 750 mg/dl at screening. * estimated glomerular filtration rate (egfr) less than 60 ml/minute/1.73 meter\^2 (calculated using the schwartz equation) at screening. * alt more than 2.5x upper limit of normal (uln) or bilirubin more than 1.5xuln (isolated bilirubin more than 1.5xuln is acceptable if bilirubin is fractionated and direct bilirubin more than 35%) at screening. * use of a glp-1receptor agonist at study entry and during the study.
screening for arteriopathy in general medicine: a preliminary feasibility study

Conditions: Peripheral Obliterative Arteriopathy

Summary: the main objective of this study is to evaluate the inter-observer concordance when measuring the maximum value of the external antero-posterior diameter of the sub-renal aorta (both cross-sectional and longitudinal ultrasound views are measured). the first measure is made by a general practitioner in private practice; second reading are made by an expert in vascular medicine.

the secondary objectives of this study are: a. to assess the prevalence of abdominal aortic aneurysm (aaa) detected by ultrasound measurement of the anterior and posterior longitudinal outer diameter of the sub-renal abdominal aorta in a high cardiovascular risk population consulting with general practitioners (defined according to recommendations stated by the french society of vascular medicine). b. to assess the prevalence of peripheral obliterative arteriopathy of the legs (poal) by measuring the systolic pressure index (spi) at the toe (ratio of arterial pressure in upper limbs versus lower limbs). measures are made by a general practitioner in the same population. c. to assess the quality and interpretability of ultrasound recordings and ultrasound acquistion failure rate. these second measures are made by an expert in vascular medecine. this evaluation with use a 3-level scale: 1. appropriate image was not obtained or not recognized expert - uninterpretable 2. poor image quality - interpretable 3. image of good or very good quality - interpretable d. to calculate the impact of risk cofactors such as hypertension , smoking, age and family history among patients diagnosed with aaa. e. evaluation of general practitioner training from a qualitative and quantitative point of view after 4 h of training organized by dr. bobbià .

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient falls into one of the following 4 groups as defined by the french society of vascular medecin (2006): * (1) men and women 60-75 years of age who are active smokers or ex-smokers * (2) men over 75 years of age * (3) women over 75 years of age who smoke and who have known hypertension * (4) men and women over 50 years of age with a family history of aneurysm of the abdominal aorta exclusion criteria: * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the subject has an allergy to the gel used for ultrasound examination.

Keywords: peripheral obliterative arteriopathy of the legs screening by generalists ultrasound