Kornimate/medical-research-clean huggingface dataset:
a dispensing clinical of fanfilcon a lens against lotrafilcon b lens over 1 month wear per lens

Conditions: Myopia

Summary: this is a study to evaluate the performance of fanfilcon a lens when worn on a daily wear modality over approximately 1 month in comparison to the lotrafilcon b lens.

this is a 45 subject, 1-month dispensing, crossover, double-masked, randomized, bilateral study comparing the test lens against the control lens. both test and control lenses will be used in a daily wear modality for 1 month each.

Eligibility criteria:
inclusion criteria: a person is eligible for inclusion in the study if he/she: * is at least 17 years of age and has full legal capacity to volunteer; * has read and signed an information consent letter; * is willing and able to follow instructions and maintain the appointment schedule; * is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses; * is an adapted soft contact lens wearer (for the purpose of this study: current lens wear at least 3 days per week, 8 hours each day); * demonstrates an acceptable fit with the study lenses. exclusion criteria: a person will be excluded from the study if he/she: * is participating in any concurrent clinical or research study; * is a habitual wearer of lotrafilcon b or enfilcon a lenses. * has any known active\* ocular disease and/or infection; * has a systemic condition that in the opinion of the investigator may affect a study outcome variable; * is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; * has known sensitivity to the diagnostic pharmaceuticals to be used in the study; * is pregnant, lactating or planning a pregnancy at the time of enrollment; (by verbal confirmation at the screening visit) * is aphakic; * has undergone refractive error surgery; * for the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
the anti-tumor effect of metformin and atorvastatin in breast cancer

Conditions: Breast Cancer Female

Summary: this study aims at evaluating and comparing the anti-tumor effects of metformin and statins (hydroxyl-methyl-glutaryl-coa reductase inhibitors) in patients with non-metastatic breast cancer (stage i, ii, \& iii).

worldwide, bc is the most frequently diagnosed life-threatening cancer in women. in egypt, breast cancer is the foremost oncologic problem, contributing to 20% of all cancers and 43% of female cancers. metformin and atorvastatin have anti-tumor effects. to date, there are limited data to investigate and compare the anti-tumor effect between metformin and statins in patients with breast cancer.

Eligibility criteria:
inclusion criteria: * patients with radiologically and histologically (biopsy) confirmed diagnosis of breast cancer and with stage i, ii, and stage iii breast cancer according to the american joint committee on cancer (tnm staging system of breast cancer). * patients with no contraindication for chemotherapy, metformin, or statins * females aged ≥ 18 years old * performance status \< 2 according to the eastern cooperative oncology group (ecog) score exclusion criteria: * patients with metastatic breast cancer (stage iv) * pregnant or lactating women. * patients with hepatic or renal impairment. * patients with myopathy. * patients with any condition predispose to acidosis (copd, heart failure, ....) * patients who had dementia, mental retarded, and any psychiatric condition that would prohibit the understanding or signing of informed consent.
the ilet experience study

Conditions: Type 1 Diabetes

Summary: a one-year, prospective single-arm cohort study to collect safety and effectiveness data on the ilet dosing decision software during real-world use in people 6 years of age or older with type 1 diabetes (t1d) with 12 months follow-up.

the study will compare outcomes data during ilet use to efficacy and safety outcomes data derived from epidemiological studies, such as data published by the t1d exchange registry, and to the results of the bionic pancreas pivotal trial (bppt), with a special emphasis on serious adverse effects such as severe hypoglycemia and dka. an analysis will be conducted comparing glycemic outcomes during ilet use to baseline pre-ilet cgm and hba1c data in participants who have provided this data. in addition, the study will determine the frequency and types of anticipated and unanticipated device issues experienced by users during real-world use.

Eligibility criteria:
inclusion criteria: * users must meet the following criteria in order to be enrolled in the study: 1. diagnosed with type 1 diabetes and prescribed the ilet bionic pancreas system 2. at least 6 years of age 3. using or planning to use either u100 novolog (insulin aspart) or u100 humalog (insulin lispro) in ready-to-fill cartridges, or u100 fiasp® pumpcart® (insulin aspart) in pre-filled 1.6ml cartridges 4. willing to provide hba1c results obtained within the 6-month period prior to starting use of the ilet and during the last 6-months of study participation 5. willing to provide cgm data, if available, obtained in the 1-month period prior to starting use of the ilet 6. for females, not pregnant or planning pregnancy in the next 12 months 7. able to respond to alerts and alarms, and to provide basic diabetes self-management 8. reside full-time in the us 9. able to speak and read english 10. willing and able to download the ilet mobile app and keep it active throughout the study and upload device data regularly 11. willing to answer baseline survey, monthly surveys, and share cgm data, and follow-up data, as necessary exclusion criteria: * users with the following characteristics will not be considered candidates for the study: 1. type 2 diabetes, cystic fibrosis-related diabetes, congenital hyperinsulinism, pancreatogenic diabetes, or any form of diabetes mellitus other than type 1 diabetes 2. use or planned use of any insulin in the ilet other than u100 novolog (insulin aspart) or u100 humalog (insulin lispro) in ready-to-fill cartridges, or u100 fiasp® pumpcart® (insulin aspart) in pre-filled 1.6ml cartridges 3. end-stage renal disease on renal replacement therapy (peritoneal dialysis or hemodialysis) 4. use or planned use of hydroxyurea

Keywords: diabetes postmarket registry ilet bionic pancreas beta bionics ilet dosing decision software
mirror box therapy as a treatment option for functional movement disorders

Conditions: Functional Movement Disorder

Summary: the purpose of this study is to investigate the potential of using mirror box therapy as a therapeutic technique amongst patients with functional movement disorders. it is hypothesized that a brief, single, in-office mirror therapy session will lead to a noticeable decrease in fmd-related involuntary movements.

patients diagnosed with functional movement disorder presenting with a unilateral or asymmetrical bilateral hand tremor will be asked to participate in a series of hand exercises with and without a mirror box. the severity of the tremor will be rated subjectively by the subject and objectively by the neurologist after hand exercises with and without the mirror box.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with functional movement disorder by a fellowship trained movement disorders neurologist, presenting predominantly with unilateral or asymmetrical bilateral involuntary movement in the upper extremity 2. in patients with bilateral involuntary movements, the symptoms in one arm must be minimal exclusion criteria: 1. patients with moderate to severe involuntary movement in both arms 2. significant cognitive impairment that prevents proper informed consent 3. severe involuntary movement that interferes with the use of the apparatus 4. patients with hemiparesis or the loss of one arm due to various reasons (e.g. amputations, birth defects, etc.

Keywords: fmd functional movement disorder functional neurological disorder functional tremor psychogenic tremor
short term results of platelet-rich plasma in the treatment of chronic anal fissure

Conditions: Anal Fissure Chronic; PRP

Summary: autologous prp currently has many uses in surgical and medical therapy. compared with other regenerative therapies, prp is easy-to-prepare, low-cost, and does not require complex equipment. the use of autologous prp avoids immunological side effects. data is lacking on the use of prp in the treatment of anal fissure. this study evaluated prp as an alternative medical treatment for chronic anal fissures.

. chronic anal fissures are mucosal ulcers in the anal canal distal to the dentate line and most often present with severe pain and bleeding during defecation. the symptoms of chronic anal fissures persist for more than 8 weeks and do not respond well to medical treatment. this randomized controlled trial investigated the effects of prp on the healing of chronic anal fissures, which can be considered as nonhealing ulcers. high anal sphincter pressure can cause chronic anal fissures by producing mucosal ischemia in the posterior anal canal that delays wound healing, ultimately resulting in a chronic nonhealing ulcer. increased anal sphincter pressure induces constipation and spasms in the arterioles that form the mucosal blood supply.9 botulinum toxin, calcium channel blockers, nitrates, or surgery promote healing by reducing anal sphincter pressure, and increasing blood flow. autologous prp has been shown to speed recovery and improve pain and quality of life scores of patients treated for chronic wounds.prp reduced complaints and accelerated epithelialization and healing in patients with chronic anal fissures. prp, which can be obtained easily and did not have any harmful patient effects may be an alternative to surgery in patients with chronic anal fissures. the duration of symptoms should be considered during the evaluation of treatment options.

Eligibility criteria:
inclusion criteria: * between 18 and 65 years of age with painful defecation of at least 2 months duration and diagnosed with anal fissure between january and october 2019 were included. * the diagnosis of chronic anal fissure required : * the presence of internal sphincter muscle fibers in the base of the fissure * hypertrophic anal papillae on digital rectal examination exclusion criteria: * patients with physical examination findings that did not meet the definition of chronic anal fissure * with painful defecation for less than 2 months, * atypical fissure location or multiple anal fissures away from the midline * inflammatory bowel disease * cancer * history of trauma * tuberculosis * immune suppression * sexually transmitted disease * a disease possibly associated with a fissure * a history of anal surgery * previous treatment for anal fissure * current pregnancy .

Keywords: chronic anal fissure medical treatment platelet rich plasma
phase ii trial of sorafenib combined with concurrent haic for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: to evaluate safety and efficacy of combined hepatic arterial infusion (haic) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in patients with advanced hepatocellular carcinoma (hcc).

in most current guidelines, unresectable hcc with major pvtt are considered not generally suitable for transarterial chemoembolization, and sorafenib is recommended as standard care.3-5 however, for patients with major pvtt, the median overall survival of those treated with sorafenib monotherapy was only 3.1 to 6.0 months. whether combining sorafenib with hepatic arterial infusion (haic) of oxaliplatin, 5-fluorouracil and leucovorin is safe, well tolerated, and efficacious remains unknown, with no prospective clinical data currently available.the investigators therefore conducted a prospective single center, single-arm phase ii trial to evaluate the safety and efficacy of sorafenib combined with haic in patients with unresectable advanced hcc.

Eligibility criteria:
criteria: inclusion criteria: * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * patients must have at least one tumor lesion that can be accurately measured according to easl criteria. * diagnosed with major or main portal vein invasion (vp3 or vp4) * kps≥70； * with no previous treatment * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * the following laboratory parameters: * platelet count ≥ 75,000/µl * hemoglobin ≥ 8.5 g/dl * total bilirubin ≤ 30mmol/l * serum albumin ≥ 30 g/l * asl and ast ≤ 5 x upper limit of normal * serum creatinine ≤ 1.5 x upper limit of normal * inr ≤ 1.5 or pt/aptt within normal limits * absolute neutrophil count (anc) \>1,500/mm3 * ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * any other hemorrhage/bleeding event \> ctcae grade 3 within 4 weeks of first dose of study drug * serious non-healing wound, ulcer, or bone fracture * known central nervous system tumors including metastatic brain disease

Keywords: hepatic arterial infusion chemotherapy sorafenib
evaluation of a 3-d tomosynthesis mammography system used in conjunction with conventional 2-d digital mammography

Conditions: Breast Cancer

Summary: this was a multi-center, prospective clinical trial in which the subject was her own control. approximately 950-1400 female subjects were enrolled at five (5) sites in the united states. subjects were from either a screening population or a biopsy population and were imaged first on a conventional 2d full filed digital mammography system then on a 3d tomosynthesis system. the resulting images from the this portion of the study were then randomized into a reader study. the purpose of this clinical study was to compare the 3-d tomosynthesis system used in conjunction with a conventional 2-d digital imaging system (2-d plus 3-d images) to the conventional 2-d digital imaging system (2-d images), and to determine whether the 2-d plus 3-d images compared to the 2-d images alone would: 1. reduce the recall rate and/or 2. improve roc area due to improved breast cancer detection and/or improved lesion classification.


Eligibility criteria:
inclusion criteria: * female * any ethnic origin * no contraindication for screening mammography exclusion criteria: * significant breast trauma * pregnancy * lactating * breast implants * previous breast cancer * previous surgical biopsy * placement of an internal breast marker * unable to understand and or execute written informed consent

Keywords: breast cancer digital mammography tomosynthesis
drug interaction of vildagliptin (laf237) with voglibose in japanese patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this study will evaluate the effect of voglibose on the pharmacokinetics and pharmacodynamics of vildagliptin in japanese patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * diabetic patients with inadequately controlled on diet therapy and exercise therapy (hba1c in the range 6.5 to 10.0% inclusive by ngsp) exclusion criteria: * fasting plasma glucose ≥ 270 mg/dl a history of type 1 diabetes or secondary forms of diabetes treatment of anti-diabetic agents including glp-1 analogues within 8 weeks or insulin within 6 months prior to screening other protocol-defined inclusion/exclusion criteria may apply

Keywords: drug interaction
lean muscle function

Conditions: Single Muscle Fibers

Summary: this pilot study is designed to determine the relationship between intra-myocellular lipids and muscle contractility in fibers from obese and non-obese older adults. obese participants are being recruited for an on-going weight loss intervention study and this application seeks approval to recruit and enroll a lean comparison group of non-obese older adults. the primary goal of this study is to characterize the contractile properties of single muscle fibers and whole muscle in healthy, non-obese individuals under the same recording conditions the investigators used for the obese population to begin to determine whether fat infiltration accounts for diminished force.


Eligibility criteria:
inclusion criteria: * age=65-75 years * bmi=18-24 kg/m2 * no resistance training for past 6 months * normal cognitive function (mmse \>24) * no contraindications for participation in weight loss or weight lifting exercise including severe arthritis or musculoskeletal disorders, knee or hip replacement or spinal surgery in past year * able to provide own transportation to study visits * not involved in any other research study involving strength training or undergoing physical therapy * not dependent on a cane or walker * willing to provide informed consent exclusion criteria: * weight loss or gain (±5%) in past 6 months * body mass \>136 kg (dxa limit) * current smoker (no nicotine within past year) or evidence of alcohol or drug abuse * insulin dependent or uncontrolled diabetes (fbg \>140 mg/dl) * uncontrolled hypertension (bp\>180/100 mmhg) * abnormal kidney function or liver blood tests * serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new q waves or st-segment depressions (\>2 mm) on ecg * past or current cardiovascular disease, including uncontrolled angina or dysrhythmia, hypertrophic cardiomyopathy, congestive heart failure, pad, stroke, history of myocardial infarction, use of defibrillator or major heart surgery, or deep vein thrombosis or pulmonary embolus. these will be reviewed on a case by case basis. * past or current respiratory disease (requiring steroid treatment or supplemental oxygen) * past or current clinical diagnoses of neurological or hematological disease * use of any medications that could influence study variables (growth/steroid hormones, prescription anti-inflammatory medications, or beta blockers, coumadin or any other blood thinner, including plavix, ticid, and aggrenox) * cancer requiring treatment in past 2 years, except non-melanoma skin cancers * clinically evident edema or anemia
short term follow-up of patent implanted with the b-bop lock plate

Conditions: Hallux Valgus; Hallux Varus; Vicious Callus on M1

Summary: in case of deformities of the forefoot (hallux-valgus, hallux-varus), the basal osteotomy may be more indicated than the distal osteotomy as it allows to achieve a greater degree of correction. however, weight bearing forces on the head of the first metatarsal acting at a distance from the osteotomy site subject the construct to an important dorsiflexion stress. fixation strength being the important consideration led to design the b-bop® lock plate, specifically dedicated to basal osteotomy of the first metatarsal, with the following characteristics: * plantar positioning to obtain the best stability and resistance while reducing the implant bulkiness; * anatomical shape adapted to the plantar curve of the first metatarsal. taking advantages of the most appropriated anatomical site to implant the b-bop® lock plate directly on tension, it offers an innovative and unique basal osteotomy fixation solution. the b-bop® lock osteosynthesis plate benefits now of the surfix locking screws technology. the purpose of this study is to collect and publish data from several centers, several users.


Eligibility criteria:
inclusion criteria: * subject of either gender who needs a fixation of osteotomy of the basis of the first metatarsal for whose surgeon has recommended that a b-bop® lock plate from integra be implanted can be enrolled in this study. * age ≥ 18 years * have willingness to give his/her data transfer authorisation exclusion criteria: * contraindication of the implantation of the b-bop lock plate * history of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol

Keywords: forefoot deformities basal osteotomy
pancreatic juice diagnosis from duodenum

Conditions: Pancreatic Adenocarcinoma

Summary: purpose of this study is to understand the clinical feasibility of duodenal juice diagnosis to screen uicc stage ii pancreatic ductal adenocarcinoma patients.

pancreatic cancer (pc) is the most lethal of all major cancers with a five year survival rate of 5 %. while stage i and ii tumors leads to an improvement in survival, almost all pcs are currently diagnosed at more advanced non-resectable stages since minimally invasive technique which is capable of screening early-stage pc does not exist. serum ca19-9 is not recommended as a screening technique because of its low sensitivity and specificity. imaging modalities such as mri, ct, eus and ercp are more accurate but are not appropriate screening tools due to their high cost, discomfort and complications. therefore, there is a strong demand for a screening tool with high sensitivity and specificity which is highly acceptable for the patient. the investigators would like to standardize the detection method of pancreatic cancer that uses the duodenal juice as an optional endoscopic diagnosis. it's a very useful chance to collect pancreatic juice from duodenum, it is called "duodenal juice" ,if we collect them without additional invasion. the investigators would like to collect duodenal juice during undergoing upper gastrointestinal endoscopy and analyze the pancreatic tumor markers in duodenal juice. a definite diagnosis of the patient is made with histology, cytology or imaging diagnosis and the result of each definite diagnosis is correlated to the each marker analyzing result of duodenal juice. therefore this study can be positioned as a feasibility study to confirm clinical performance.

Eligibility criteria:
inclusion criteria: * common inclusion criterion * age is 18 years or older. * informed consent was obtained. * inclusion criterion for normal cohort * an upper gi endoscopy is scheduled to check upper abdominal symptoms. * no findings of pancreatic disorder as documented by ct or mri or eus * inclusion criterion for pc suspicious cohort * a eus or ercp is scheduled to suspected pancreatic disorder. exclusion criteria: * common exclusion criterion * severe cardiac disease * severe respiratory disease * bleeding disorders * pregnancy

Keywords: pancreatic adenocarcinoma
safety and efficacy of a new formulation of bimatoprost/timolol ophthalmic solution compared with bimatoprost/timolol ophthalmic solution in patients with glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: this study will evaluate the safety and efficacy of bimatoprost/timolol formulation a ophthalmic solution with ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * patient has ocular hypertension or glaucoma in both eyes * requires iop-lowering therapy in each eye exclusion criteria: * active or recurrent eye disease that would interfere with interpretation of study data in either eye * history of any eye surgery or laser in either eye within 6 months * required chronic use of other eye medications during the study * anticipated wearing of contact lenses during the study. * intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days