Kornimate/medical-research-clean huggingface dataset:
a phase 1, single- and multiple dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of medi4166 in subjects with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: a phase 1, combined single ascending dose (sad) and multiple-ascending dose (mad) study to evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of medi4166 in subjects with type 2 diabetes mellitus (t2d).

this study is a first time in human (ftih), phase 1, randomized, double-blind study to evaluate the safety, tolerability, pk, and pd of medi4166 administered as both single and multiple ascending doses to subjects with t2d.

Eligibility criteria:
inclusion criteria: * type 2 diabetes, ages 18-65 * must provide written informed consent * bmi\>=25 and =\<42 * venous access suitable for multiple cannulations * vital signs within normal specified ranges * females must be non-lactating and non-childbearing potential * males must practice 2 effective contraceptive measures if sexually active exclusion criteria: * any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product * history or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs * history of cancer, with the exception of basal cell carcinoma or carcinoma of the cervix * any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing * positive hepatitis b, hepatitis c or hiv test or use of antiretroviral medications at screening * current or previous use of systemic corticosteroids within the past 28 days prior to screening * use of any medicinal products or herbal preparations licensed for weight loss is prohibited. * positive drug screen * type 1 diabetes

Keywords: medi-4166, diabetes
efficacy of pulsed high intensity laser therapy in psoriatic hand arthritis

Conditions: High Intensity Laser Therapy; Psoriasis; Hand

Summary: the purpose of the study was to evaluate the therapeutic efficacy of pulsed high intensity level laser therapy in improving symptoms of psoriatic hand arthritis.

psoriatic arthritis is a chronic, inflammatory joint disease affecting 20%-30% of patients with psoriasis. it affects peripheral joints and axial skeleton, causing pain, stiffness, swelling, and joint destruction. high-intensity laser therapy can control inflammation and improve pain relief, range of motion, and functional improvement. this study aims to examine high-intensity laser therapy efficacy in managing psoriatic arthritis, aiming to provide a safe, effective, and noninvasive treatment method.

Eligibility criteria:
inclusion criteria: * both sexes of patients their age range between 30-50 years. * bilateral psa following psoriasis * all participants who are diagnosed with psa, and experience clinical symptoms such as pain, swelling, tenderness and stiffness less than 1 year from the beginning of disease. * all patients enrolled to the study will have their informed consent. exclusion criteria: * positive rheumatic factor * circulatory disorders * diabetes * pregnant woman * skin diseases like urticaria.
ad hoc percutaneous coronary intervention study in acute coronary syndrome patients

Conditions: Acute Coronary Syndrome

Summary: the purpose of this study is to assess the pharmacodynamic effect of ticagrelor in acs patients undergoing an ad hoc pci

a randomized, open-label, multiple-center, parallel group study to compare the platelet inhibition with verifynow assay of ticagrelor versus clopidogrel in troponin negative acute coronary syndrome (acs) subjects undergoing ad hoc percutaneous coronary intervention (pci)

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent before initiation of any study-related procedures * male or female patients aged 18 years or older * documented acute coronary syndrome and troponin negative and undergoing ad hoc percutaneous coronary intervention (pci) * females must be post menopausal or surgically sterile * taking aspirin as an anti-platelet medication exclusion criteria: * use of any thienopyridine or ticagrelor within 7 days prior to randomization * any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve) * contraindication that ticagrelor or clopidogrel should not be administered patient requires dialysis * history of intolerance or allergy to aspirin
effectiveness evaluation of the sinopharm vaccine in the dondo district in mozambique

Conditions: Sars-CoV-2 Infection

Summary: three complementary activities will be implemented:1) baseline and repeat census of the catchment population; described in a separate protocol (ivi-ecova-03-ws1); 2) enhanced surveillance for covid-19 disease, and 3) aefi-enhanced surveillance. the mass vaccination campaign will be conducted by the government and is not part of this protocol.


Eligibility criteria:
inclusion criteria: 1. they resided in the study area at the time of mass immunization with the sinopharm vaccine; and 2. they are at least 18 years of age during first round of mass vaccination. 3. their onset of symptoms was \<10 days prior to testing. 4. for each selected pcr test-positive case, we will select up to 3 test-negative controls from generally eligible subjects, matched to each case by age on the date of testing, sex, and calendar date of testing + 3 days. exclusion criteria: 1. we will exclude subjects for selection as controls if they have had a positive test result within the following 21 days 2. any participant not matching the inclusion criteria mentioned above.
does pancreatic stent decrease the risk of pancreatitis after pancreatic sphincterotomy for difficult cannulation?

Conditions: Endoscopic Retrograde Cholangiopancreatography

Summary: the purpose of the study is to compare the risk of pep after pancreatic sphincterotomy performed for difficult cannulation in a group of patients with and in a group of patients without placement of a prophylactic pancreatic stent. the definition of difficult cannulation is defined according to the literature.


Eligibility criteria:
inclusion criteria: * consecutive patients with naïve papilla presenting to ercp with indication of common bile duct (cbd) cannulation will be considered to the study. exclusion criteria: * exclusion criteria are age below 18 years, acute pancreatitis and no consent to the study.
the effect of focused lung ultrasonography on antibiotic prescribing in general practice

Conditions: Lower Respiratory Tract Infection; Community Acquired Pneumonia

Summary: the goal of this randomised controlled trial is to determine if adults presenting with symptoms of an acute lower respiratory tract infection in general practice where the general practitioner suspects cap, who have flus performed as an addition to usual care, have antibiotics prescribed less frequent compared to those given usual care only.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. acute cough (\< 21 days). 3. at least one other symptom of acute lower respiratory tract infection (lrti). 4. the general practitioner suspects a bacterial community-acquired pneumonia. exclusion criteria: 1. previous antibiotic treatment for the current episode of acute lrti. 2. the patient is not listed with the general practitioner (no medical record available). 3. the patient is not capable of understanding and signing informed consent. 4. the patient does not wish to participate in the study.

Keywords: lower respiratory tract infection community acquired pneumonia lung ultrasound point-of-care ultrasound general practice antibiotics
real-world data of paclitaxel and ramucirumab compared to other treatment regimens in advanced gastric cancer

Conditions: Gastric Cancer Stage IV; Second-line Treatment; Ramucirumab Paclitaxel

Summary: our aim was to evaluate whether second-line treatment with paclitaxel and ramucirumab was associated with improved clinical outcomes compared to other available therapies. this study involved real-world data collection, focusing on the safety and efficacy of therapeutic combinations, administered to patients with pretreated advanced gastric cancer in the oncology departments affiliated with the hellenic cooperative oncology group (hecog).


Eligibility criteria:
inclusion criteria: * patients with unresectable or metastatic, locally advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus * treated at departments of medical oncology affiliated with the hellenic cooperative oncology group (hecog) * second-line treatment for advanced disease * treatment for at least two months of second-line treatment. exclusion criteria: * lack of informed consent in case the patient was alive
evaluation of the effectiveness of the safe early intervention program

Conditions: Preterm; Sensory Disorders; Cerebral Palsy

Summary: in this study, it was aimed to examine the effect of safe, which is a sensory-based, activity-oriented early intervention approach applied in an enriched environment with family cooperation, on cognitive, language, motor and sensory development in 3-6 months old risky infants. 46 infants with neurodevelopmental risk, whose corrected age was 3 months, were included in the study. infants were randomly divided into two groups. infants in the treatment group were included in an early intervention program according to the safe approach. infants in the control group were included in the family education program based on the principles of neurodevelopmental therapy (ndt). the intervention was performed for 12 weeks, and all infants were evaluated with bayley developmental scale for infants and young children iii (bayley iii) by a blinded investigator before treatment (3rd months) after treatment (6th months) and 12th months.


Eligibility criteria:
inclusion criteria:• corrected age of 3 months * any neurodevelopmental risk (perinatal stroke, perinatal asphyxia, hie, gmk-ivk, pvl or gestational age of 32 and below) exclusion criteria: • having a congenital anomaly * having a genetic syndrome diagnosis (e.g. down syndrome) * parents do not speak turkish
a clinical trial of decitabine in relapse and refractory diffuse large b cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma

Summary: to explore the safety, tolerability and clinical effects of decitabine combined with r±dhap for patients with replase and refractory diffuse large b cell lymphoma.

this is a randomized,controlled,prospective,open,multi-center clinical trial,amied to evaluate the safety, tolerability,and efficacy of decitabine combined with r±dhap in replase and refractory diffuse large b cell lymphoma.a total of 60 patients are planned to be enrolled into the study.patients with diagnosis of replase and refractory diffuse large b cell lymphoma will be into two groups,and be treated with decitabine pluse r±dhap or only r±dhap,respectively.the primary end points are objective responder rate(orr) and time to progression(ttp) and the secondary end points include overall survival(os) and progression free survival(pfs).

Eligibility criteria:
inclusion criteria: * age:14-65 years;ecog rate≤2;expected survival≥3 months * patients with diffuse large b cell lymphoma diagnoesd by histopathology detection; * patients ever received rchop or chop chemotherapy but did not receive dhap * patients never received radiotherapy * patients with no chemotherapy contraindications:hemoglobin ≥ 90g/l,absoluate neutrophil count ≥1.5x109/l,blood platelet ≥100x109/l,alt and ast ≤ 2-fold upper normal limit,serum bilirubin ≤1.5-fold upper normal limit,serum creatinine ≤1.5-fold upper normal limit,serum albumin ≥ 30g/l,normal serofibrinogen; * at least one measurable nidus; * no other severe diseases conflict with this project,cardiopulmonary function is basically normal * the urine or blood pregnancy test of women in childbearing age must be negative in 7 days before follow-up visit; * applicable for follow-up visit; * no other antitumor adjoint therapy(including antitumor chinese medicine,immunotherapy and biotherapy),but double phosphate anti-bone transfer therapy and other symptomatic treatment are acceptable; * understanding this study and assigning informed consent. exclusion criteria: * rejecting providing blood preparation; * allergic to drug in this study and with metabolic block; * rejecting adopting reliable contraceptive method in pregnancy or lactation period; * uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac,lung,liver and pancreas）； * with severe infection; * with primary or secondary central nervous system tumor invasion; * with immunotherapy or radiotherapy contraindication; * ever suffered with malignant tumor; * having peripheral nervous system disorder or dysphrenia; * with no legal capacity,medical or ethical reasons affecting research proceeding; * participating other clinical trials simultaneously; * adopting other anti-tumor medicine excluding this research; * the researchers considering it inappropriate to participate in the study.

Keywords: decitabine orr ttp os pfs
clinical evaluation of giomer and resin-based fissure sealants

Conditions: Molar Incisor Hypomineralization

Summary: the objective of this research was to evaluate the clinical success of giomer and resin-based sealants applied in the first permanent molars (fpms) affected by mih.

one-hundred fpms with mih which were indicated for non-invasive fissure sealant were selected in 39 children (between 6-12 years). using a split mouth design, the fpms were randomized into two groups; group 1: resin sealant (conceal f); group 2: giomer sealant (beautisealant) and dental isolation device was used during the procedure (mr. thursty). clinical evaluation was performed by two blinded examiners using the united states public health service (usphs) criteria to assess anatomical form, marginal adaptation, surface texture, marginal discoloration, retention and secondary caries at 1, 3, 6 and 12 months. statistical analysis was performed using spss 20.0 software (ibm corp., chicago, il, usa) and the level of significance was set at p\<0.05. the association between independent variable (groups) and dependent variable (usphs scores) was evaluated with fisher's exact test. the crosstabulation of the categorical data regarding the groups were analyzed with chi-square test or fisher's exact test. the log-rank test and kaplan-meier analysis were used to calculate and compare the cumulative survival rates of the sealants.

Eligibility criteria:
inclusion criteria: * healthy children, aged 6-12 years, who attended the pediatric dentistry clinic regular dental examination * cooperative children diagnosed with mih according to european academy of paediatric dentistry (eapd) criteria * presenting at least two fpms that were fully erupted and indicated for non-invasive fissure sealant. * the fpms with white, yellow or brown lesions, indicating mechanical and chemical alteration of the enamel and increased caries risk exclusion criteria: * children having hypomineralized fpms with post-eruptive breakdown, cavitated carious lesions, restorations or fixed orthodontic appliances * enamel defect due to a condition other than mih

Keywords: molar incisor hypomineralization giomer fissure sealants resin sealants adhesion
bone marrow vs liver as site for islet transplantation

Conditions: Type 1 Diabetes

Summary: the goal of this study is to evaluate safety and efficacy of bone marrow (bm) as site for pancreatic islet transplantationin humans. our hypothesis is that bm represents a better site than liver (currently the location of choice for this procedure) thanks to its potential capacity to favor islet engraftment. to address our hypothesis we propose herein a randomized phase ii trial to compare bm and liver as sites for islet transplantation in t1d patients.

the study is a phase ii, single center, open label, pilot study. we will recruit 12 patients with t1d to be randomly (1:1) assigned to receive islet either into the liver through the portal venous circulation (standard procedure; arm a, n=6) or directly into the bm at the level of the iliac crest (arm b, n=6). patients will be selected from those eligible for islet tx based on local practice and guidelines.

Eligibility criteria:
inclusion criteria: * diabetic patients eligible for pancreatic islet transplantation based on local accepted practice and guidelines. this includes at least: a)clinical history compatible with t1d with insulin-dependence for \>5 years; b) undetectable stimulated (arginine or mmtt) c-peptide levels (\<0.3 ng/ml) in the 12 months before transplant c)presence of severe hypoglycaemic events exclusion criteria: * presence of hematologic disease

Keywords: diabetes
ribavirin to enhance hepatitis b virus nucleotide analog antiviral activity

Conditions: Hepatitis B, Chronic

Summary: hepatitis b virus (hbv) leads to life-threatening disease like liver failure and liver cancer. for most, a cure is unattainable as current hbv antiviral therapy (using nucleoside analogues) are not able to clear the virus from their liver. while hbv treatments are typically administered alone (monotherapy), this study will explore the use of ribavirin in combination with standard therapy to enhance current treatment regimens. ribavirin is commonly used to treat hepatitis c virus (hcv) but there is evidence that ribavirin also induces immune effects that are beneficial in hbv treatment. the aim of this study is to determine whether combination of ribavirin and a nucleoside analog is more effective compared to nucleoside analog treatment alone. enrolled patients will be followed for treatment response according to standard clinical and virological tests, as well as immune response to hbv. our ultimate goal is to find a more effective treatment and improve health outcomes for persons living with hbv.


Eligibility criteria:
inclusion criteria: 1. hbv hepatitis b surface antigen (hbsag) positive for a minimum of 24 weeks 2. hbv dna level \>20,000 iu/ml 3. ≥ 18 years of age exclusion criteria: 1. willingness and ability to sign an informed consent 2. hbv nucleos(t)ides and/or interferon exposure within 24 weeks of study medication dosing 3. hiv and other immune compromising condition (e.g. cancer with the exception of non-invasive cutaneous malignancy, autoimmune condition) or therapy (i.e. systemic steroids, chemotherapy) 4. hcv co-infected 5. cirrhosis (defined by biopsy criteria or as \>18.4 kilopascal (kpa) by transient elastography) 6. creatinine clearance \<60 ml/min 7. baseline hemoglobin \<130 g/l in males and \<120 g/l in females 8. unwilling or unable to use contraception (unless confirmed surgical sterilization) 9. pregnancy confirmed by blood test
statin interchange by pharmacist collaborative practice agreement (cpa)

Conditions: Hypercholesterolemia

Summary: a group of \~ 225 patients were switched from atorvastatin to an equivalent statin either by their physicians usual management or by an collaborative pharmacist coordinated process. we will compare the results of pharmacist process to the standard medical practice to find potentially which process is more effective, safer and efficient. we are surveying a total of 35 physicians, 12 using the pharmacist coordinated process and 23 not, comparing their satisfaction of the 2 processes.

this study is a retrospective analysis of patients converted from atorvastatin to another equivalent statin. it is observational because the patients were all on atorvastatin, had been informed by their prescription drug plan that it would not be covered, and that if agreed they would be changed to an equivalent that is covered by their plan. the patients were either converted with the help of pharmacist by collaborative practice agreement (cpa)or upon contacting their physician requesting a different medication. we are comparing the percentage first converted to the equivalent dose in each group and whether patients continued to be at hyperlipidemia treatment goal after the interchange.

Eligibility criteria:
225 insured eligible subjects, 35 pcim physicians

Keywords: low density lipoprotein (ldl) cholesterol statin dose equivalent hypercholesterolemia (defined by ldl guidelines)
comparison of traditional cataract surgery and traditional surgery combined triamcinolone staining

Conditions: Congenital Cataract

Summary: previously, the investigators have developed a surgical technique to reduce inflammatory response after congenital cataract surgery. this prospective, randomized controlled study aims to compare the prognosis of traditional cataract surgery with traditional surgery combined triamcinolone staining of the anterior vitreous in treating congenital cataracts.

surgical technique for congenital cataract is now more and more mature, but many young patients still have obvious postoperative inflammatory response, which might cause visual axial opacification, posterior synechiae and secondary glaucoma. triamcinolone is used in intraocular injection for its anti-inflammatory effect however, the application of triamcinolone was reported to be associated with high intraocular pressure. it is necessary to evaluate the safety and effectiveness of using triamcinolone in congenital cataract surgery. in this randomized clinical trial, children with equal degree of congenital cataract in both eyesare enrolled. patients receive cataract surgery on both eyes on the same day. for each patient, one eye is randomly assigned to undergo traditional surgical procedure, while the fellow eye is undergoing new surgical procedure. the traditional surgical procedure include anterior continuous curvilinear capsulorhexis (accc), irrigation/aspiration (i/a), posterior continuous curvilinear capsulorhexis (pccc), and anterior vitrectomy(a-vit). primary intraocular lens implantation (iol) is performed in children older than age of two. the new surgical procedure is to combine triamcinolone staining of the anterior vitreous on the basis of the traditional surgical procedure. investigators then compare the incidence of high intraocular pressure, visual axis opacification, uveitis, iris/pupil abnormality, and macular edema between two groups

Eligibility criteria:
inclusion criteria: 1. age between 3 months and 13 years 2. uncomplicated bilateral same degree of congenital cataract (≥ 3 mm central dense opacity) 3. informed consent signed by a parent or legal guardian exclusion criteria: 1. intraocular pressure \>21 mmhg 2. preterm birth (\<28 weeks) 3. presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma, microcornea, persistent hyperplastic primary vitreous) or systemic disease (congenital heart disease, ischemic encephalopathy) 4. history of ocular trauma 5. previous intraocular surgery

Keywords: congenital cataract, triamcinolone