Kornimate/medical-research-clean huggingface dataset:
aflibercept injection for proliferative diabetic retinopathy

Conditions: Vitreous Hemorrhage

Summary: to evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients undergoing pars plana vitrectomy for proliferative diabetic retinopathy.

patients who need pars plana vitrectomy surgery, and agree to participate in this study will receive an injection of 2.0mg aflibercept 4 to 6 days before vitrectomy surgery. half of these patients will be randomized to receive another injection of 2.0mg aflibercept immediately after their surgery. postoperative patient visits in this study will be at 1 day, and at weeks 1, 4, 16 and 24, and at any other times as deemed necessary by the investigator.

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study * age \> 18 years * diagnosed with proliferative diabetic retinopathy (pdr) requiring pars plana vitrectomy (ppv) * best corrected visual acuity in the study eye between 20/40 to light perception (lp) using an early treatment diabetic retinopathy study (etdrs) chart exclusion criteria: * pregnancy (positive urine pregnancy test) or lactation * premenopausal women not using adequate contraception. the following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device (iud), or contraceptive hormone implant or patch. * participation in a study of an investigational drug or device within the past 30 days prior to enrolling in the study * for previously treated subjects - * prior treatment with anti-vascular endothelial growth factor (anti-vegf) therapy in the study eye within 28 days of screening * prior treatment with triamcinolone in the study eye within 6 months of screening. * prior treatment with dexamethasone in the study eye within 30 days of screening * intraocular surgery (including cataract surgery) in the study eye within 2 months preceding baseline * history of vitrectomy surgery, submacular surgery, or other surgical intervention for pdr in the study eye * active intraocular inflammation (grade trace or above) in the study eye * history of rhegmatogenous retinal detachment or macular hole (stage 3 or 4) in the study eye * active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye * uncontrolled glaucoma in the study eye (defined as intraocular pressure (iop) ≥ 30 mmhg despite treatment with anti-glaucoma medication) * history of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 6 months of study enrollment. * history of allergy to fluorescein, indocyanine green (icg) or iodine, not amenable to treatment * presence of macular traction * uncontrolled hypertension (e.g., 120/200 mmhg) prior to surgery (ppv) * concomitant use of any systemic anti-vegf therapy

Keywords: proliferative diabetic retinopathy
this randomized controlled study aims to investigate the effect of botox injection in abdominal wall muscle post major abdominal surgery in terms of postoperative pain, incidence of incisional hernia.

Conditions: Hernia, Abdominal

Summary: aim of the work this randomized controlled study aims to investigate the effect of botox injection in abdominal wall muscle post major abdominal surgery in terms of postoperative pain, incidence of incisional hernia study design and setting this is a double-blind prospective randomized controlled trial that will be conducted in the general surgery department and colorectal surgery unit of mansoura university hospital in the period from june 2019 to june2020. the patient's recruitment process will be started and continued for one year after getting the approval from the local institutional review board in mansoura university in concordance with the helsinki declaration principals. the data will be collected and analyzed prospectively. a signed informed consent will be obtained from every patient before enrollment highlighting the possible future publication. on request, patients can be excluded from the study at any time if they do not want to continue.


Eligibility criteria:
inclusion criteria: -patients with major abdominal surgery including trauma and elective exploration surgery, damage control surgery. exclusion criteria: * pregnancy * patients with myopathies * motor polyneuropathies, impaired neuromuscular transmission (myasthenia gravis) * complicated chronic obstructive pulmonary disease (copd), * necrotizing fasciitis of the trunk * unfit for general anesthesia * patients with psychiatric disorders * patients with drug abuse or history of opioid intake * chronic pain disorder * coagulopathy
evaluating the efficacy of pku synergy in patients expressing phenylketonuria or hyperphenylalaninemia

Conditions: Phenylketonurias; Hyperphenylalaninaemia, Type I

Summary: this study centres around a new one-a-day phenylalanine-free protein substitute for phenylketonuria patients. fifty eligible adults (≥ 16 years) with proven phenylketonuria or hyperphenylalaninemia will be recruited and randomly allocated to one of two intervention arms (n = 25 per arm). following a 3-day baseline period, and in addition to routine nutritional management, patients will receive either one sachet of the new protein substitute daily (intervention) or continue their usual dietary and/or protein substitute regimen (maximum of 1 protein substitute per day (equal to 20g protein equivalent) control) for 28 days.

this study centres around a new one-a-day phenylalanine-free protein substitute for phenylketonuria patients. in particular, this randomised controlled trial aims to evaluate the efficacy (changes relating to nutritional status and metabolic control) of this new protein substitute, while also capturing data pertaining to tolerance, compliance, safety and acceptability. designed for poorly compliant adult patients with proven phenylketonuria or hyperphenylalaninemia, this new protein substitute is composed of an adapted mixture of other essential and non-essential amino acids, carbohydrates, vitamins and selected minerals and trace elements and enriched with docosahexaenoic acid (dha). fifty eligible adults (≥ 16 years) will be recruited and randomly allocated to one of two intervention arms (n = 25 per arm). following a 3-day baseline period, and in addition to routine nutritional management, patients will receive either one sachet of the new protein substitute daily (intervention) or continue their usual dietary and/or protein substitute regimen (maximum of 1 protein substitute per day (equal to 20g protein equivalent) control) for 28 days.

Eligibility criteria:
inclusion criteria: * male or female * over 16 years of age * diagnosed with proven pku or hyperphenylalaninemia with an increased phenylalanine-tolerance/intake * currently taking a maximum of 1 protein substitute per day (equal to 20g protein equivalent) * have a minimum blood phenylalanine level of ≥ 600 umol/l (for pku patients) * have relaxed (if not stopped) their dietary and protein substitute regimen for at least 1 month prior to trial commencement * have written informed consent from patient exclusion criteria: * pregnant or lactating * requiring nutritional support (including enteral and parenteral nutrition) * major hepatic or renal dysfunction * participation in other studies within 1 month prior to entry of this study * allergy to any of the study product ingredients, including milk protein or soya * investigator concern around willingness/ability of patient to comply with protocol requirements

Keywords: phenylketonuria hyperphenylalaninaemia inherited metabolic disorders
metacognition in neurological injury

Conditions: Brain Injuries

Summary: the purpose of this study is to investigate the trajectory of metacognitive functioning throughout phases of recovery from neurological insult, and to determine its relationship to rehabilitation compliance and functional outcome. it is hypothesized that metacognitive accuracy improves over time, and is a significant predictor of engagement in rehabilitation activities.

this study will examine the trajectory of metacognitive functioning through different phases of recovery from neurological insult, and document its relationship to rehabilitation compliance. individuals currently completing rehabilitation programs and individuals from the community who meet study criteria are invited to participate. after consenting and enrolling in the study, participants complete 2 study sessions: a baseline session, and a follow-up session either at time of completion of rehabilitation program or 3 months later if not in a rehabilitation program. during the study sessions, participants will complete paper-and-pencil and computerized tests of cognition (including metacognitive tasks).

Eligibility criteria:
inclusion criteria: * history of brain and/or spinal cord injury * no history of brain or neurological injury/insult (for healthy control group) * fluent in spoken and written english * adequate gross motor abilities to provide a button push on a keyboard exclusion criteria: * exclusion criteria for healthy controls include: * current/past history of psychiatric illness * learning disorder * developmental disorder * diagnosis of attention deficit disorder/attention deficit hyperactive disorder

Keywords: metacognition self-assessment
evaluation of anti-inflammatories in the reduction of bite reactions

Conditions: Mosquito Bite

Summary: the purpose of this study is to evaluate two separate antiinflammatory products for the relief of symptoms through suppression of the immunological and inflammatory response following a mosquito bite. the investigators have selected ibuprofen gel as a nsai formulation and 0.05% clobetasone butyrate as a steroid cream with their appropriate physical matched placebo products.


Eligibility criteria:
inclusion criteria: 18 to 65 years of age (inclusive). caucasian (white or pale skin) good health as determined by medical history and physical examination females of child bearing potential must confirm they are not pregnant at the study start and agree not to become pregnant throughout the duration of the study. history of the following triad of symptoms following a previous mosquito bite: weal, flare, and pruritus as immediate reaction to mosquito bites at least once in the past (= mosquito bite sensitive stages iii or iv). willingness to attend for all study procedures at designated intervals. willingness to provide full consent to the study exclusion criteria: abnormalities of the skin on the forearms (including sunburn) that might interfere with the study results, as determined by the investigator/clinician during physical inspection. history of clinically significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, or other disease deemed clinically significant by investigator / clinician use of prohibited therapies (including cosmetics on either forearm) as specified in section 6.3.3 of the clinical trial protocol (use of systemic or local antihistamines, steroids, or nsaids during or within 2 weeks prior to planned date of first study procedure); use of any medication considered to have an influence on the outcome of the study. any acute illness within the 7 days prior to planned date of first study procedure which might interfere with the study results (as determined by the investigator/clinician from medical history). history of malignancy within 5 years of the planned date of the first study procedure neurological or psychiatric disease, or drug or alcohol abuse which would interfere with the subject's completion of the protocol assignments. participated in research involving an investigational drug within 3 months of the planned date of first study procedure. history of known anaphylactic hypersensitivity to mosquitoes bites, bee or wasp stings. history of allergic reaction to any of the topical agents used in the study or any of their components. history of allergy to latex or other rubber material women who are pregnant or breastfeeding

Keywords: mosquito allergy bite ant-inflammatory aedes aegypti mosquito bite
blood endothelium progenitor cells and dendritic cells as predictive biomarkers of in-stent restenosis

Conditions: Atherosclerosis; Restenosis

Summary: clinically relevant in stent restenosis occurs in 5-10% of the non-diabetic patients treated with a coronary bare metal stent. recent research has identified endothelial progenitor cells as well as dendritic cells as components of neointima. numerical and functional evaluation of endothelial progenitor and dendritic cells at the time of coronary stent implantation is assessed and the relation with clinical and/or angiographic restenosis at 6 months post-stent implantation is evaluated.


Eligibility criteria:
inclusion criteria: * age\>18 years old * scheduled for pci * candidate for cabg if necessary * clinical evidence of ischemic heart disease and/or abnormal functional study * new native coronary artery lesion \>50%-\<100% stenosis * lesion length\<30 mm, treatment with a single bare metal stent planned * reference diameter 2.5-3.5 mm * informed consent explained, red, understood and signed by the patient exclusion criteria: * pregnancy, birth or lactation period \<6 months ago * women of childbearing age who do not intend to use accepted anticonceptive measures or who wish to get pregnant * left ventricular ejection fraction \<30% * acute myocardial infarction (st-elevation, q-wave evolution or ck-mb \>2x upper limit of normal)in the past month * contra-indication to pci * diabetes mellitus * planned drug eluting stent implantation * total occlusion (timi 0 or 1) * ostial localisation (\<3.0 mm of the coronary ostium) of the lesion * bifurcational lesion with side branch \>2.0 mm or side branch which will be recanalised at occlusion due to pci * lesion in arterial or venous bypass or anastomosis with coronary * angiographic contra-indication to ivus * severe renal insufficiency (creatinine clearance \<30 ml/') * severe hepatic insufficiency * systemic inflammatory pathology of any kind * uncorrected hyperthyreosis * hematologic or other malignancy, prior radio- or chemotherapy * severe peripheral artery disease (accesproblem via groin) * use of corticosteroïds or immune suppression therapy * contrastallergy * life expectancy \<1 year * participation in other clinical study which has not ended yet

Keywords: atherosclerosis restenosis epc dc
clinical study investigating safety and performance of a new urinary intermittent catheters in healthy volunteers

Conditions: Incontinence, Urinary

Summary: the aim of the study is to test the performance and safety of a newly developed intermittent catheter


Eligibility criteria:
inclusion criteria: * 1. have given written informed consent and signed letter of authority 2. be at least 18 years of age and have full legal capacity 3. be a male 4. willing to refrain from using analgetics up to 24 hours prior to catheterization visits 5. have a negative urine multistix - erythrocytes (microscopic haematuria) 6. have a negative urine multistix: * leukocytes * nitrite or if positive, subsequent negative for bacterial growth in urine culture exclusion criteria: 1. abnormalities, diseases or surgical procedures performed in the lower urinary tract 2. symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination) 3. participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation 4. known hypersensitivity toward any of the test products -
survey study on barrett's esophagus screening

Conditions: Gastroesophageal Reflux Disease; Barrett's Esophagus; Esophagus Adenocarcinoma

Summary: the goal of this study is to optimize barrett's esophagus (be) screening to reduce the incidence, morbidity, and mortality of esophageal adenocarcinoma (eac).

the initial step to achieve this goal is to study shortcomings of the current be screening referral processes in the united states. these shortcomings will be identified through completion of two synergistic aims that assess:, (1) provider knowledge, attitudes, and barriers to be screening referral and (2) patient knowledge, attitudes, and barriers to completion of be screening. the central hypothesis is that there are patient- and provider-level factors that can be modified to improve be screening adherence. this hypothesis was formulated based on strong preliminary data demonstrating significant single-mindedness among gastroenterologists regarding be screening criteria.

Eligibility criteria:
1. patient eligibility criteria inclusion criteria: * patients identified by icd-10 codes for gerd (k21.0 and k21.9) and * have had at least one outpatient clinic visit at a participating site exclusion criteria: * prior diagnosis of be/eac * non-english speaking 2. provider eligibility criteria inclusion criteria: * provider must be a pcp and/or gastroenterologist and * must be at a participating site

Keywords: barrett's esophagus upper endoscopy barrett's esophagus screening gerd gastroesophageal reflux disease be eac esophageal adenocarcinoma
methylene blue mouthwash for the treatment of oral mucositis pain in patients with cancer

Conditions: Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm; Stomatitis

Summary: this phase iii trial compares the effect of methylene blue mouthwash to standard of care mouthwash for the treatment of oral mucositis pain in patients with cancer. using methlylene blue mouthwash may improve oral pain in patients with oral mucositis related to cancer and/or cancer treatments compared to usual standard of care.


Eligibility criteria:
inclusion criteria: * active cancer diagnosis * admitted to the inpatient setting * pain related to oral mucositis * experiencing oropharyngeal pain * able to provide informed consent exclusion criteria: * pediatric age (under 18 years old) * pregnant or nursing women * any contraindication to methylene blue including severe hypersensitivity to methylene blue and patients with glucose-6-phosphate dehydrogenase deficiency (g6pd) due to the risk of hemolytic anemia
sitagliptin cardiovascular outcomes study (mk-0431-082)

Conditions: Type 2 Diabetes Mellitus

Summary: this is a clinical trial designed to assess the cardiovascular outcome of long-term treatment with sitagliptin used as part of usual care compared to usual care without sitagliptin in participants with type 2 diabetes mellitus (t2dm) having a history of cardiovascular (cv) disease and a hemoglobin a1c (hba1c) of 6.5% to 8.0%. primary hypothesis a is that sitagliptin, when used as part of usual care, is non-inferior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary cv composite endpoint of major adverse cardiovascular event (mace) plus. if hypothesis a is satisfied: hypothesis b is that sitagliptin, when used as part of usual care, is superior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary cv composite endpoint.


Eligibility criteria:
inclusion criteria: * has t2dm * has hba1c between 6.5% (48 mmol/mol) and 8.0% (64 mmol/mol) on stable dose(s) of antihyperglycemic agent(s), including insulin * has pre-existing cardiovascular disease exclusion criteria: * has a history of type 1 diabetes mellitus or ketoacidosis. * is not able to take sitagliptin
a study of hc-7366 in combination with belzutifan (welireg™) in patients with renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: this is a phase 1b, open-label, multicenter, safety, tolerability and efficacy study of hc-7366 in combination with belzutifan (welireg™). this is a multipart study that consists of a hc-7366 monotherapy cohort, a combination dose escalation, and a combination dose expansion. approximately 80 patients will be enrolled in this study (up to 20 patients will be enrolled into the hc-7366 monotherapy cohort, up to 30 patients into the combination dose escalation, and up to 30 patients into the combination dose expansion). the primary purpose of this study is to determine the maximum tolerated dose of hc-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic rcc with predominantly clear cell histology, irrespective of vhl gene mutation status.


Eligibility criteria:
inclusion criteria: * has diagnosis of locally advanced (inoperable) or metastatic rcc with a predominant clear cell component * be age 18 years or older (male or female) at the time of consent

Keywords: ccrcc belzutifan kidney cancer metastatic locally advanced hc-7366 welireg™
exploring patient and staff experience of using ipads for ppi activity

Conditions: Asthma

Summary: patients' and healthcare professionals' experience of using apple ipads to conduct patient and public involvement activity

there is a long overdue push to get patients engaged at the earliest stage possible of the research cycle so there is earlier collaboration between the public/patients and the researcher rather than much later on in the research process. for this reason there are successful patient and public meetings that occur in various specialities within the nhs. however, attending these meetings can be difficult as timings for multiple people to attend at the same physical location can be logistically difficult. it can be further compounded if potential members are unable to attend due to their illness. for example, patients may be on home oxygen and therefore may not be selected by the facilitator or perhaps they themselves may decide to exclude themselves. previous research has had an online forum to engage the public/patients with the research process. however, the findings were that there was room to improve from an engagement perspective and furthermore, the real-time communication was limited due to how forums functions. for this reason, the investigators have suggested using ipads so the investigators can have virtual meetings which negates the need to attend meetings physically. the investigators have used ipads instead of other tablets due to their higher encryption standards and because the in-built facetime is easier to use than other systems that install a separate application. virtual meetings where a group of people are not in the same physical location and are communicating via telephone or the internet. many patients who may not have been considered/been approached about being part of ppi can now participate virtually. in addition, the time commitment is significantly reduced as it would only involve the time the meeting would be held and not the travel time, which can be extensive.

Eligibility criteria:
inclusion criteria: * adults aged 18 and over * part of a respiratory medicine ppi group or a ppi group that will be started prior to consent into the study at nottingham university hospital trust exclusion criteria: * adults lacking mental capacity