Kornimate/medical-research-clean huggingface dataset:
a study of pf-06664178 in patients with advanced solid tumors

Conditions: Neoplasms

Summary: to assess the safety and tolerability at increasing dose levels of pf-06664178 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended phase 2 dose.


Eligibility criteria:
inclusion criteria: * diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available * performance status of 0 or 1 * adequate bone marrow, kidney and liver function * part 2 includes target expressing nsclc, ovarian or breast cancer patients exclusion criteria: * brain metastases requiring steroids * major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin c or nitrosoureas) * active and clinically significant bacterial, fungal, or viral infection

Keywords: adc pf-06664178 solid tumors tumors neoplasm metastasis nsclc non small cell lung cancer ovca ovarian cancer phase 1 breast cancer
feasibility of molecular biology in pancreatic cyst tumors

Conditions: Pancreatic Cyst; Pancreas Cyst; Serous Cystadenoma; Mucinous Cystadenoma; IPMN

Summary: the main objective of the study is to compare the diagnostic accuracy of intra-cystic fluid dna molecular analysis to standard diagnostics. the secondary objective of the study is to evaluate the feasibility of intra-cystic fluid dna molecular analysis.

multicenter study to determinate the feasibility of intra-cystic fluid dna molecular analysis in patients with suspected cystic tumours of pancreas in whom eus fna is clinically indicated. morphological criteria obtained by mri and computerised tomography (tumor characterization (size, metastases presence, dilatation of bile ducts), etiologic diagnosis, serious symptoms), biological exams (biomarkers), cytological analysis will lead to a diagnosis and a treatment. the goal of this study is to compare this standard diagnostic modalities to diagnosis obtained by intra-cystic fluid dna molecular analysis. is the dna molecular analysis improve the diagnosis accuracy.

Eligibility criteria:
inclusion criteria: * patient older than 18 years of age, male or female * cystic tumor of the pancreas requiring a puncture under endoscopic control to determine the etiologic diagnosis and gravity. exclusion criteria: * doubts regarding the etiological diagnosis of the pancreatic cyst * contraindications for the realization of a high digestive endoscopy * haemorrhagic disorder, haemostasis and coagulation disorder (tp \ 40 sec and platelets \<60000 / mm3). * avk, aod and aap cannot be stopped
visual acuity outcome differences between the alcon vivity toric iol and rxsight lal+

Conditions: Cataract

Summary: phase 1 will be ambispective, multi-site, single arm study in age-related cataract patients with regular astigmatism, who were bilaterally treated with the lal+ iols phase 2 will be a prospective, randomized, unmasked, comparative, multi-site study with 90 days of follow up. subjects will be randomized in a 1:1 manner to lal+ or clareon vivity toric iols.


Eligibility criteria:
inclusion criteria: * adult (≥45) subjects who are astigmatic and require bilateral, routine small-incision, surgery for age-related cataracts with femtosecond laser; * all subjects will be required to be targeted for refractive emmetropia (plano or first minus closest to plano); * subjects will have an expected monocular bcdva outcomes of 20/25 or better in the opinion of the investigator; * subjects will have regular corneal astigmatism (1.00 to 2.00 d), which can be corrected with a toric power iol of t3-t5; * subjects will be required to have a dilated pupil diameter of 7 mm or greater in both eyes; exclusion criteria: * moderate-severe corneal pathology; * irregular astigmatism; * subject desire monovision correction; * preexisting macular disease or other retinal degenerative diseases that is expected to cause future vision loss; * history of glaucoma; * severe dry eye disease; * history of uveitis; * history of ocular herpes simplex virus; * history of nystagmus; * zonular laxity or dehiscence; * history psueudoexfoliation; * history of corneal refractive and intraocular surgery or requiring any other planned ocular surgical procedures; * currently taking systemic medication that may increase sensitivity to uv light or that may cause toxicity to the retina; * pregnant or breastfeeding.

Keywords: intraocular lens lal+ clareon vivity toric iols
bilaterally innervated sensory dorsal digital flaps for sensory reconstruction of the fingers

Conditions: Soft Tissue Injuries

Summary: sensory coverage in the finger continues to be a challenging problem. this study reports sensory reconstruction of the fingers with the bilaterally innervated dorsal digital flaps and compares the results between the dual- and single-innervated flaps.the main evaluated outcomes are static 2-point discrimination and semmes-weinstein monofilament scores of the flap, fingertip pain and joint motion.

pain was given subjectively by the patient using the visual analogue scale (vas). the vas consists of a 10 cm line that was grouped into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm). tinel's sign was rated as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma.

Eligibility criteria:
inclusion criteria: * a soft-tissue defect in the areas where sensory return was considered important ●a defect with exposed bone or tendon in one finger * the defect associated with the transected digital nerves in both sides * a defect greater than 1.5 cm * a patient aged 15 to 60 years exclusion criteria: * injuries to the dorsum of the finger or to the course of the vascular pedicle that precluded its use as the donor * injuries to the dorsal branches of the digital nerves that precluded its use as donor nerves attached with the flap * a defect less than or equal to 1.5 cm * patient age \ 60 years

Keywords: soft tissue defect dorsal branch of the digital nerve dorsal branch of the digital artery dorsal digital flap
allogeneic valve transplantation

Conditions: Valve Heart Disease; Valve Disease, Heart; Valve Disease, Aortic

Summary: valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.

heart valves in children and young adults may need replacement or repair. in many children the options for heart valve replacement do not grow as the child grows. a transplanted valve may have the option to grow with time and may reduce the need for multiple operations over a lifetime. this trial will study the outcomes of heartfelt transplant in children and young adults undergoing this procedure. the study will look at outcomes of valve transplant and any potential side effects.

Eligibility criteria:
inclusion criteria * patients requiring aortic, pulmonary, mitral or tricuspid valve replacement. * pediatric patients 30 days or older and \< 18 years, and adult patients 18-50 yrs. o particularly patients with significant growth potential * insufficient options are available for valve replacement o patients at risk of immunogenic bio-prosthetic valve failure * discussion with patient /family - option for durable valve rather than traditional prosthesis * abo compatible * patient and family able to travel to bch within 48 hour time frame or within our organ procurement organization * patients that are able to maintain follow-up at bch during the duration of the study * patients that are able to provide medical record authorization for 5 year follow-up exclusion criteria * age \< 30 days * irreversible multisystem organ failure; or additive effects of the multiple systems affected making transplant survival unlikely * progressive systemic disease with early mortality (genetic/metabolic, idiopathic, syndromic) * morbid obesity (bmi\>35) * diabetes mellitus with evidence of end-organ damage * severe chromosomal, neurologic or syndromic abnormalities * immunocompromised condition (digeorge, scid etc.) * active infection * history of endocarditis * hiv or chronic hepatitis b or c infection * malignancy within 5 years prior to transplant * severe renal or liver failure * inadequate social support for post-transplant management * recent history of illicit drug, tobacco or alcohol abuse despite trials/assistance to stop behavior * evidence of large stroke with high risk for hemorrhagic conversion * heart transplant recipient * patients that are unable to follow-up during the initial 6 month window * patients that are unable to provide medical record authorization for 5 years
intraocular lens power calculation for combined phaco-vitrectomy procedures

Conditions: Intraocular Lens Calculation; Combined Phaco-vitrectomy

Summary: the aim of the study is to evaluate the degree of refractive error postoperatively in combined procedures and to calculate a new constant in order to improve current state of the art biometry calculations.

the iol power calculation in combined phaco-vitrectomy has been performed similar to that in cataract surgery alone. in patients who undergo combined phaco-vitrectomy, deviations in refractive outcomes may be observed because of possible errors in measurement of axial length, changes in the properties of the vitreous cavity after removal of the vitreous, or intraocular tamponade. most of the previous studies have reported variable degrees of myopic shift after phaco-vitrectomy for diabetic retinopathy, epiretinal membrane, and macular hole. furthermore, use of intraoperative gas may increase further the risk of anterior displacement of the intraocular lens which may induce a higher myopic shift. however, these publications did not provide any quantification of the spherical deviations nor calculate any specific constant in order to improve currents state of art biometry calculations.

Eligibility criteria:
inclusion criteria: * patients who undergo a combined procedure with phacoemulsification and pars plana vitrectomy exclusion criteria: * sulcus fixation of the iol, sulcus suture of the iol, or intra-scleral iol fixation because of intraoperative posterior capsule rupture * corneal disease, such as keratoconus, that interfered with refractive results * iol implantation with a toric iol or multifocal iol * history of previous vitrectomy or corneal transplantation * other coexisting ocular disease such as proliferative diabetic retinopathy, advanced age-related macular degeneration, uveitis, acute retinal necrosis, coat's disease, proliferative vitreous retinopathy, or trauma * intraocular tamponade using silicon oil

Keywords: vitrectomy phacoemulsification biometry iol calculation cataract
bevacizumab in combination with visudyne photodynamic therapy (pdt)

Conditions: Age Related Macular Degeneration; Choroidal Neovascularization; Macular Edema

Summary: to evaluate safety, visual acuity outcomes, persistence of choroidal neovascular leakage, and the number of treatments of combination intravitreal bevacizumab and verteporfin photodynamic therapy at standard or reduced fluence level in patients with subfoveal cnv due to age-related macular degeneration.


Eligibility criteria:
inclusion criteria: * patients are men or women of age 50 or older. * patients have not received previous treatment for subfoveal choroidal neovascularization (cnv). * patients must have evidence of active or recurrent subfoveal cnv as confirmed by fluorescein angiography. * the total lesion must be less than or equal to 9 disc areas in size, with a greatest linear distance of 5400 microns. * best corrected visual acuity, using etdrs charts, of 20/40 to 20/320 (snellen equivalent) in the study eye. only one eye will assessed in the study. * the cnv lesion must be primarily cnv (i.e. cnv equal to or greater than 50% of the lesion. * the cnv is associated with only macular degeneration. * patient defers other approved treatments of subfoveal cnv associated with amd. exclusion criteria: * prior treatment for subfoveal choroidal neovascularization (cnv). * prior treatment for juxtafoveal or extrafoveal cnv involving previous antiangiogenic agent, photodynamic therapy, or intravitreal triamcinolone acetate. * history of vitrectomy or submacular surgery in the study eye. * subretinal fibrosis accounting for more than 50% of the lesion. * non-cnv lesion components account for more than 50% of the total lesion components. * cnv due to causes other than amd. * retinal pigmented epithelial tear involving the center of the macula. * geographic atrophy involving the central macula. * any concurrent intraocular condition in the study eye that in the opinion of the investigator could require surgical or medical intervention during the course of the study (i.e. cataract). * active intraocular inflammation. * vitreous hemorrhage in the eye. * history of spherical equivalent in the study eye greater than negative 8 diopters. * intraocular surgery within 2 months of study enrollment. * uncontrolled glaucoma in the study eye. defined as intraocular pressure greater than 30mmhg despite treatment with anti-glaucoma medication. * history of other disease, such as recent myocardial infarction, recent cerebral vascular accident, or uncontrolled hypertension that in the opinion of the investigator might render the subject at high risk for complication. * inability to comply with study or follow-up procedures.

Keywords: choroidal neovascularization macular degeneration macular edema intravitreal bevacizumab vegf verteporfin pdt
serratus anterior plane block versus paravertebral block for postmastectomy analgesia

Conditions: Breast Cancer; Acute Pain

Summary: ًًًُُُُthe investigators are testing the efficacy of a new novel technique; serratus anterior plane block, for preventing postoperative pain after breast surgery for cancer. this block will be compared with the well-established paravertebral block.

paravertebral block (pvb) can be considered as a well-established option to provide anesthesia and postoperative analgesia during breast surgery. for patients receiving a pvb alone or in combination with general anesthesia significant lower resting, evoked and worst pain scores compared with other analgesic treatment strategies indicating that a pvb provides improved postoperative pain control in patients undergoing breast surgery. furthermore, there might be a reduced need for postoperative opioid requirements and consecutively a decrease in opioid-induced adverse effects in patients receiving a pvb. anyways there are always fear of pleural injury and pneumothorax in addition to epidural and intrathecal spread of the block. a novel newly introduced field block has been described recently to block the hemithorax under ultrasound guidance that is the serratus anterior muscle plane sam block. still this technique to the investigators knowledge is not tried in randomized clinical studies. the aim of this study is to find out that this new technique is comparable to pvb in patients undergoing breast surgeries with or without axillary node dissection.

Eligibility criteria:
inclusion criteria: * unilateral mastectomy with or without axillary lymph node dissection. * american society of anesthesia (asa) i\&ii exclusion criteria: * morbid obesity (body mass index \> 40 kg/m2); * renal insufficiency (creatinine \> 1.5 mg/dl), * current chronic analgesic therapy (daily use \> 4 weeks), * a history of opioid dependence, pregnancy, * inability to communicate with the investigators or hospital staff, * american society of anesthesia (asa) iii-iv

Keywords: serratus paravertebral breast cancer axilla
fmri study comparing bold activation patterns using gw679769 in subjects with social anxiety disorder

Conditions: Social Anxiety Disorder

Summary: evidence suggests the use of neuroimaging to detect therapeutic effects of anxiolytic treatment when appropriate cognitive-emotional tasks are use to activate the emotional brain neurocircuitry believed to be involved in the core symptoms of the disease.


Eligibility criteria:
inclusion criteria: * primary diagnosis of social anxiety disorder. * willing to restrict alcohol to a limited intake. exclusion criteria: * history of schizophrenia, schizoaffective disorder or a bipolar disorder. * left-handed. * suffer from claustrophobia. * any reason why subject could not go into the fmri, for example have metal implants.

Keywords: fmri placebo gw679769 social anxiety disorder sad
efficacy and safety of fentanyl for pain control in newborn on mechanical ventilation

Conditions: Mechanical Ventilation Complication

Summary: the purpose of the study is to assess the efficacy and safety of fentanyl for pain control in newborns on mechanical ventilator.

this randomized controlled trial will be conducted in the department of neonatology, bsmmu, dhaka after approval by institutional review board (irb). a written informed consent will be obtained before enrollment in the study from the parents or guardians. . the study cohort will comprise all inborn and outborn newborns admitted to the neonatal intensive care unit (nicu) who receive mechanical ventilation administered through an endotracheal tube . the enrolled neonates will be randomly assigned with computer-generated random number tables via software named 'random allocation software', to receive either of the intervention. once the parents will agree to the study and provide signed informed consent, all eligible neonates will be randomized to start treatment within 24 hours from the initiation of mechanical ventilation. randomized infants will be allocated to the fentanyl group to receive a continuous infusion of fentanyl or to the placebo group to receive a continuous infusion of iv fluid. fentanyl will be administered as an intravenous loading dose of 1 microgram/kg in 30 minutes, followed by a continuous intravenous infusion of 1μg/kg/hour. the infusion will be administered through a peripheral line. fentanyl infusion will be initiated within 24 hours after the start of mechanical ventilation and will be continued until the end of mechanical ventilation, and not longer than 5 days .

Eligibility criteria:
inclusion criteria: 1. all inborn and outborn newborns admitted to the neonatal intensive care unit (nicu) who received mechanical ventilation administered through an endotracheal tube. 2. newborn on mechanical ventilator for at least 72 hours. exclusion criteria: 1. known genetic or chromosomal disorders, 2. the need for postoperative analgesic therapy during the study period, 3. major congenital anomaly, 4. those who received drugs like midazolam, paracetamol, morphine, muscle relaxants, phenobarbital, phenytoin, and chloral hydrate during the study period. 5. probable rapid extubation.
the role of sodium chloride and the treg/th17 axis in autoimmune hepatitis

Conditions: Autoimmune Hepatitis

Summary: the purpose of this study is to determine whether a salt restriction diet improves immune parameters in patients with autoimmune hepatitis.

the etiology of autoimmune hepatitis (aih) is unknown although both genetic and environmental factors are thought to be involved. a defect in immune regulation affecting regulatory t cells (tregs) has been demonstrated in aih. tregs function in the maintenance of immune homeostasis by controlling autoreactive immune responses to self-antigens. rationale: the western diet has been postulated as a potential environmental risk factor for the increasing incidence of autoimmune diseases in developed countries. data from the investigators' laboratory also suggests that increased dietary salt intake might represent an environmental risk factor for the development of autoimmune diseases through the induction of pathogenic th17 cells. the dramatic in vitro effects of high salt on the induction of pathogenic th17 cells from naïve human cd4 cells {kleinewietfeld, hafler. nature. 2013 apr 25;496(7446):518-22. doi: 10.1038/nature11868.}, and block of in vitro treg suppression, in line with in vivo effects on worsening murine experimental autoimmune encephalomyelitis (eae), have prompted the investigators to examine the effects of increased dietary sodium chloride in a human in vivo system. the investigators hypothesize that excess dietary salt may function as an environmental trigger that favors induction and expansion of pathogenic th17 cells and leads to functional impairment of tregs, thereby favoring development of autoimmunity. the investigators aim to study their established in vitro model in humans by altering the salt intake in patients over a 20-day period.

Eligibility criteria:
inclusion criteria: * adults 18-50 years of age * children 1-17 years of age * alt and/or alp/ggt level \> 2x upper limit of normal * ana or sma \>/= 1:40 * ana or sma \>/= 1:80 * or lkm \>/= 1:40 * or sla positive * igg \> upper limit of normal exclusion criteria: * chronic hepatitis c * decompensated liver disease

Keywords: autoimmune hepatitis liver dysfunction elevated serum auto antibodies
aflibercept with and without micropulse laser in diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: prospective study evaluating the impact of subthreshold micropulsed laser on the number of aflibercept injections when used as an adjuvant therapy in eyes with diabetic macular edema.


Eligibility criteria:
inclusion criteria: * older than 18 years old * diagnosed with dme with central macular thickness (cmt) more than 250 µm measured by oct * best corrected visual acuity (bcva) between 20/400 and 20/40. exclusion criteria: * patients with intra-ocular surgery as cataract surgery within 6 months * prior intravitreal injection of any drug within the preceding 6 months * panretinal photocoagulation (prp) within the former 4 months. * patients with previous macular laser * patients with vitreo-macular traction (vmt) syndrome * severe glaucoma * other retinal vascular diseases * conditions that impede the oct interpretation

Keywords: aflibercept anti-vegfs micropulsed diode laser subthreshold
low back pain and comorbid posttraumatic stress disorder

Conditions: Low Back Pain; Posttraumatic Stress Disorder

Summary: the aim is to test whether the psychotherapeutic intervention somatic experiencing targeting post traumatic stress disorder (ptsd) symptoms will have an additional positive effect on the outcomes of guided physiotherapy against chronic back pain development.

introduction: patients with low back pain after injuries often demonstrate symptoms of ptsd measured via the harvard trauma questionnaire scale (htq). it has been found that ptsd and pain may maintain each other. methods: thousand consecutive patients with low back pain (lbp) referred to the spine center are screened for ptsd. it is expected that 140 patients will meet the inclusion criteria and be randomized to guided physiotherapy or to guided physiotherapy plus 12 psychotherapeutic sessions, that will include the shock-trauma method 'somatic experiencing'. effect parameters are: pain, daily function, euroqol and (htq), anxiety and depression, fear avoidance (tampa scale for kinesiophobia) and pain catastrophizing (pcs) on entry, and at 6/12 months.

Eligibility criteria:
inclusion criteria: * back pain: from 1/2 y duration or longer * trauma according to htq exclusion criteria: * planned surgery, comorbid psychiatry (except ptsd and mild to moderate depression), personality disorders, drug or medical abuse

Keywords: low back pain pain posttraumatic stress disorder ptsd somatic experiencing se