Kornimate/medical-research-clean huggingface dataset:
treatment of acute pseudophakic cystoid macular edema: bromfenac 0.09% versus diclofenac sodium 0.1% versus ketorolac tromethamine 0.5%

Conditions: Acute Pseudophakic Cystoid Macular Edema

Summary: to compare bromfenac 0.09%, diclofenac sodium 0.1%, and ketorolac tromethamine 0.5% ophthalmic solutions for the treatment of acute pseudophakic cme after cataract surgery.


Eligibility criteria:
inclusion criteria: * patients must be diagnosed with acute pseudophakic cme within 12 months of cataract surgery * males and females 18 years and older * able to provide written informed consent exclusion criteria: * complicated cataract surgery, particularly posterior capsule rupture and vitreous loss * pre-existing macular pathology, including macular edema, macular scar, macular hole, or macular pucker * history of uveitis * ipsilateral intraocular surgery prior to cataract surgery * cme greater than one year duration
assessment of the effect of gluten free toothpaste on the ulcerative events in children with celiac disease

Conditions: Gluten Sensitivity

Summary: celiac disease (cd) is the most common genetically based food intolerance in the world, with a prevalence among approximately 1% of the general population (guandalini \& assiri, 2014). cd is a frequent disorder among egyptian children, both in the general population and in at-risk groups(abu-zekry et al., 2008). it is estimated that the incidence of cd is 3 to13 cases per1000, with a higher prevalence among first-degree relatives of patients with cd.lifelong adherence to a strict gluten free diet (gfd) remains the only available treatment for patients with cd and typically results in a complete return to health. nevertheless, gluten is not found only in diet, gluten is commonly used as a binder in products like medication, cosmetics, oral and skin care, and even children's toys. gluten is found also in toothpastes and other oral health products and it can be swallowed by mistake and initiate immune response(anon, n.d.). unfortunately, there is no gluten free toothpaste available in the egyptian market and it is very expensive if we bought it from europe or usa. the tube will cost nearly 10 dolars .as a result, the production and availability of gluten free toothpaste in egypt has become mandatory.

production of an experimental gluten free toothpaste and providing it for children with celiac disease

Eligibility criteria:
inclusion criteria: 1. age above 6 yeas. 2. erupting lower 6. 3. can spit the toothpaste. 4. diagnosed as a celiac patient(pathology\&serology) exclusion criteria: 1. with a history of allergy to any ingredient present in the toothpaste to be used for treatment 2. the presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, aids etc. 3. children whose parents had no home or mobile phone to enable post-operative contact. 4. parent that will not sign the consent.

Keywords: gluten-free toothpaste,celiac disease, gfd, children
effect of microbial exposure on health, particularly immune system

Conditions: Immune System Disorders

Summary: the effect of microbial exposure on healthy human subjects will be investigated. changes in cytokine and ige and vaccine response will be measured. the hypothesis is that microbial exposure increases the measured responses.

the effect of microbial exposure on healthy human subjects will be investigated. the volunteers will either receive material containing a microbial inoculum, or they will receive nothing. changes in cytokine and ige and vaccine response will be measured. subjective well-being will be recorded. changes in microbial community will be followed. the hypothesis is that microbial exposure increases the measured responses.

Eligibility criteria:
inclusion criteria: * healthy adults that live in urban conditions; that do not own a furry pet; that do not have hiv or other condition that weakens immune system; that do not use drugs chilling immune system; that do not have a history of five active infections that caused hospitalization within 2 years; that do not have a condition affecting immune response (e.g. rheumatoid, colitis ulcerosa, crohn disease); that do not have dementia, acute depression or psychosis; that do not have cancer within 2 years; that do not have sore skin in arms or hands; that do not have diabetes; that do not have incompetency; that have not received earlier vaccine against pneumococcus sp.; that do not have unwillingness to receive the vaccine; that do not live in countryside.

Keywords: vaccine response immune system activity
efficacy of toct and (tdcs) for gait improvement in patients with chronic stroke

Conditions: Stroke

Summary: stroke is one of the major causes of disability in the western world. initially gait is the most affected function, 80% of patients lose this ability. rehabilitation in stroke patients improves walking abilities in terms of gait and related gait activities, though six months after stroke many patients are significantly disabled. recently, a prospective study of 205 stroke patients showed that approximately 21% of patients have a significant decrease of mobility between the first and the third year after stroke. the main finding showed that inactivity was the most important factor for the mobility decline. evidence about effects of direct current brain stimulation on motor recovery function of lower limb are still little, some show that quadriceps strength after stimulation of damaged m1 area increased. another study where tdcs was associated with robotic gait training did not report any effect compared to treatment alone. it is necessary to define if a different dosage of stimulation or the association of tdcs with gait training can improve walking and if further studies are required to investigate their effectiveness. the aim of this clinical trial is to test the possibility of gait improvement through the association of tdcs with a specific task-oriented circuit training for walking abilities, balance and mobility.

inclusion criteria: * males and females subjects. age \> 18 years, \<75 years. * diagnosis of first ischemic stroke \> 6 months. * mini mental state examination (mmse) \>24; * functional ambulation classification (fac) higher or equal to 4

Eligibility criteria:
inclusion criteria: * males and females subjects. age \> 18 years, \<75 years. * diagnosis of first ischemic stroke \> 6 months. * mmse\>24; * fac higher or equal to 4 exclusion criteria: * contraindications to tdcs: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current, presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants). * neurological or psychiatric pathology. * severe cardio-pulmonary, renal, hepatic diseases. * pregnancy.

Keywords: chronic stroke tdcs transcranial direct current stimulation task oriented circuit training toct gait training
safety and pharmacokinetic study of lyc-30937 in subjects with active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study to assess the pharmacokinetic profile in patients with active ulcerative colitis and compare it to the experience in healthy volunteers.


Eligibility criteria:
inclusion criteria: * active ulcerative colitis defined as a mayo endoscopy score of ≥ 2 despite therapy. * male or female age 18 to 75 * may be receiving a therapeutic dose of an oral 5-amino salicylic acid compound or oral corticosteroid therapy exclusion criteria: * current anti-tumor necrosis factor use * current immunosuppressant use (note: this does not include corticosteroid use) * subjects with only distal active disease (i.e. proctitis) * clinically significant active infection * known bleeding disorder, a risk of bleeding or hypercoagulable disorders in which an anticoagulant is required * history of malignancy within the last 5 years except non-melanoma skin cancer or cervical carcinoma in situ * clinically significant lab abnormalities (i.e. liver function abnormalities, renal insufficiency, abnormal absolute neutrophil count or hemoglobin) * history of colon resection * any other investigational therapy or investigational biologics use within 8 weeks of investigational medicinal product administration
study to evaluate safety, tolerance and efficacy of asc22 combined with art in subjects with hiv

Conditions: HIV-1-infection; HIV Infections; PD-L1 Gene Mutation

Summary: this study is a phase ii, multicenter, randomized, blind, placebo-controlled to evaluate the safety, tolerance, efficacy of asc22 injection in combination with anti-retroviral therapy to treat subjects living with human immunodeficiency virus type 1.


Eligibility criteria:
inclusion criteria: * age ≥18 and ≤ 60 years old at screening. * treated with anti-retroviral medicine continuously for at least 12 months within 6 months of diagnosis of hiv-1 infection. * treated with anti-retroviral medicine continuously, contain integrase inhibitor, for at least months before screening. * cd4+ cell count ≥300 cells/μl and cd4+/ cd8+ratio ≤ 0.9 at screening. * weight ≥ 50 kg at screening. exclusion criteria: * known allergy to the drug or excipients used in this trial. * hiv-associated opportunistic infections in the past 5 years. * co-sensors of hbv, hcv, syphilis, etc. * with bleeding disorders or on anticoagulant therapy.

Keywords: asc22 hiv pd-l1
does in vivo culture of pre-cleavage stage embryo reduce the incidence of aneuploidy?

Conditions: Infertility; Reproductive Sterility

Summary: this clinical study has been designed to assess and compare the impact of in vitro or in vivo culture conditions on the euploidy of sibling blastocysts.

as soon as the very first minute of the fertilization process, very important biological events, critical for the future developmental competency of the embryo are taking place. these biological events, after the sperm cell entry in the oocyte cytoplasm and prior to the first cleavage, include: the completion of the meiosis, the exclusion of the second polar body, the pronuclei formation, the replication of the male and female dna and the chromosome segregation on the newly formed mitotic spindle. if any of these events is aberrant, one or both of the two daughter cells and their descendants may carry chromosomal anomalies. in other words an uneven first cleavage in size or in content is associated with chromosomal abnormality and aneuploidy. in vivo all these events occur in a natural environment where the presence of specific molecules and of a dynamic and physiological environment might be an advantage over in vitro culture conditions to ensure optimal cellular functions. preliminary data from the pilot study have shown a higher proportion of euploid embryos for sibling oocytes cultured in vivo vs. in vitro. moreover, in animal models, in vivo cultured embryos have been described with significant reduction of aneuploidies and with differences in the gene expression levels patterns when compared to in vitro cultured embryos. there is also growing evidence that the culture conditions of human pre-implantation embryos can affect the gene expression regulation with measurable effects on embryos and on newborn children. the investigators hypothesis is that in vivo produced embryos might have a higher percentage of euploidy when compared to their siblings cultured in vitro.

Eligibility criteria:
inclusion criteria: * signed informed consent by the subject and her partner * women, aged between 18 and 38 years (up to 38th birthday) * ≤ 2 previous stimulation cycles * routinely measured hormonal levels within normal range (i.e. fsh, lh, e2, prl) * no uterine or ovarian anatomical abnormalities and/or alterations that would compromise device delivery or function in the uterus as demonstrated by ultrasound and trial insertion * 19 ≤ bmi ≤ 29 kg/m2 exclusion criteria: * history of previous moderate or severe ovarian hyperstimulation syndrome (ohss) * severe endometriosis * any active infection that would contraindicate art, at the discretion of the investigator * severe male factor in the partner (cryptozoospermia or non-obstructive azoospermia)

Keywords: in vivo culture
observation of cough variant asthma treated in combination of chanqin granules.

Conditions: Cough Variant Asthma

Summary: this single-center, randomized, double-blind, placebo-controlled trial was undertaken at an outpatient clinic in shuguang hospital. newly diagnosed cough variant asthma adult patients with the t.c.m. pattern of pathogenic-wind are randomly divided into treatment and control group, with 60 patients in each group. clinical observation of the respiratory impedance and inflammation in cough variant asthma adults reated in combination of chanqin granules.

this single-center, randomized, double-blind, placebo-controlled trial was undertaken at an outpatient clinic in shuguang hospital. newly diagnosed cough variant asthma adult patients with the t.c.m. pattern of pathogenic-wind are randomly divided into treatment and control group, with 60 patients in each group. all patients enrolled are treated with budesonide + formoterol fumarate dry power (160/4.5ug bid) for inhalation. the treatment group are given additional chanqin granulate (10g bid) and placebo granulate for controlled group. investigators hypothesis that chanqin granules may reduce day \& night cough score as well as the respiratory impedance, inflammation statues, and improve t.c.m. syndrome after 8 weeks of treatment.

Eligibility criteria:
inclusion criteria: 1. diagnosis of cough variant asthma according to western medicine 2. diagnosis of cough with pathogenic wind syndrome according to tcm 3. aged between 18 to 70 years, regardless of gender, race or educational and economic status 4. the cough symptom should last for at least 8 weeks 4. willingness to participate and to sign the informed consent form exclusion criteria: 1. patients with history of smoking (or quite smoking for less than 6 months) 2. systemic use of corticosteroids in the past 4 weeks 3. upper or lower respiratory tract infection in the past 4 weeks 4. incapable of corporation with spirometry and feno test 5. other chronic respiratory disease eg: copd, pulmonary cirrhosis 6. women who are pregnant or preparing to become pregnant or breast feeding women

Keywords: cough variant asthma impedance inflammation chanqin granules
non interventional study of levofloxacin in chronic prostatitis

Conditions: Chronic Prostatitis

Summary: chronic prostatitis is a common disease in men with the following typical symptoms decreasing the ability to work and quality of life: pain, urination disorders, copulatory dysfunction. following study is conducted to study levofloxacin in chronic prostatitis.

chronic prostatitis is a common disease in men with the following typical symptoms decreasing the ability to work and quality of life: pain, urination disorders, copulatory dysfunction. professional societies recommend diagnosing and treating patients with chronic prostatitis on the basis of determination of belonging to classification categories proposed by the national institute of diabetes and digestive and kidney diseases and the national institutes of health in the usa . according to the recommendations of european association of urologists, in chronic bacterial inflammation of the prostate and in nonbacterial (inflammatory syndrome of chronic pelvis pain), the performance of antibacterial therapy during four - six weeks is efficient. the first-line drugs are fluoroquinolones (ciprofloxacin and levofloxacin) as along with good tolerance they easily penetrate into the zones of the prostate inflammation and are highly efficient in respect of prostatitis pathogens . although the treatment with levofloxacin promotes more evident decrease in clinical symptoms and demonstrates better parameters of eradication of pathogen in comparison with ciprofloxacin administration, it is used less common, possibly due to insufficient awareness of physicians of its high efficacy in chronic prostatitis .

Eligibility criteria:
inclusion criteria: * male patients aged from 18 to 60 years, inclusive, with a diagnosis of the chronic prostatitis, which appointed the drug levolet® p as a causal treatment. * demonstrated sensitivity to levofloxacin abjection of chronic bacterial prostatitis. * the presence of a written informed consent to participate in research exclusion criteria: * participation in another clinical study during the period of this study.
39946-i laser and bevacizumab treatment for retinopathy of prematurity

Conditions: ROP Threshold

Summary: retinopathy of prematurity (rop) is a leading cause of childhood blindness. vascular endothelium growth factor (vegf) is an important component of this disease. the goal of treatment is to reduce the production of vegf in the immature retina and to eliminate the abnormal growth of new vessels. currently, laser photocoagulation of the peripheral avascular retina is the treatment standard. intravitreal injection of anti-vegf antibody bevacizumab (ivb) has been used clinically off-label as an alternative therapy. however, vegf is important for the development of neurons and vessels in the systemic organs in premature infants. pharmaceutical study showed that ivb was absorbed into the bloodstream. it is unclear if the systemic absorption of bevacizumab is dose related, and the short and longterm effects on ocular and systemic systems, especially neurological development. in this study, our goals are to establish the pharmacokinetics of bevacizumab in the premature infant and to compare the short and long-term vision and neurodevelopmental outcomes of infants treated with ivb compared to laser rop.

this study will enroll preterm infants who were scheduled to receive treatment for rop by laser or bevacizumab. we will observe the patients in the hospital for the cure of rop until 54 weeks' postmenstrual age. we will check the changes of chemicals in the blood and observe short-term and long-term effects on visual system, brain and other body organs. descriptive statistics from a two sample t-test or fisher's exact test will be used to compare the short and long-term vision and neurological development outcomes. we predefined a statistical significance level p=0.05.

Eligibility criteria:
inclusion criteria: premature infants who were scheduled to receive laser or bevacizumab treatment for type i rop . exclusion criteria: 1. have unilateral or bilateral rop stage 4 or 5 rop; 2. lack of signed consent by the parent or legal guardian.

Keywords: rop bevacizumab laser development
effectiveness study of the guardian rt in type 1 diabetics

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to determine whether type 1 diabetic patients using the guardian rt glucose sensor can improve glycemic control over a 12-week period, compared to patients using self-monitoring blood glucose testing (smbg) alone.

the long-term benefit of tight glycemic control in diabetics is well documented. hba1c generally assesses the average/long term quality of glycemic control. on a daily basis, patients assess their glycemic control through finger stick measurements (smbg), which allows them to adjust their therapy. a device which would provide a patient with a real-time glucose value, as well as high and low alerts, could aid the patient in knowing when to perform confirmatory smbg tests and intervene so that dangerous glycemic excursions may occur less frequently.

Eligibility criteria:
inclusion criteria: * type 1 diabetes for at least 12 months * hba1c must be 8.1% or above at study entry * intensive insulin therapy 3 months prior to study entry exclusion criteria: * impaired hearing or vision (must see screens and hear alarms) * unable to comply with protocol * chronic debilitating or psychiatric disturbances

Keywords: diabetes glycemic control continuous glucose monitoring
effect of food on bioavailability of modified release formulations of imatinib

Conditions: Healthy

Summary: this study will evaluate the effect of food on the relative bioavailability of a single dose of imatinib given as a 800 mg modified release tablet, compared to twice-daily doses of 400 mg film-coated tablets. there will be a 8 day wash out phase between treatments and a 1 week safety period at the end of the study. each participant will receive all four treatments.


Eligibility criteria:
inclusion criteria * healthy male or female subjects (postmenopausal women), 18-65 years of age * able to communicate well with the investigator and comply with the requirements of the study. exclusion criteria * smokers within 3 months * subjects using any prescription drug or over-the-counter (otc) medication (including herbal and alternative medication) within 3 weeks prior to dosing. * participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation. * a past medical history or presence of clinically significant ecg abnormalities * history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated). * history of medications pre-disposing the subjects for gi bleedings/cerebral hemorrhage. * women taking any biphosphonates (fosomax like drugs) * history of being immunocompromised, including a positive hiv test result. * a positive hepatitis b surface antigen (hbsag) or hepatitis c test result. * females nursing infants. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: food effect bioavailability pharmacokinetic sti571 modified release formulation of sti571 cml chronic myeloid leukemia philadelphia chromosome imatinib
effect of high-calcium intake on appetite, insulinemia and incretins

Conditions: Nutritional and Metabolic Diseases

Summary: the purpose of this study is to investigate the appetite, insulin and incretin hormone responses to a high-calcium meal.

participants will be provided with control and high-calcium meals. insulin, appetite, glucagon-like peptide-1 and glucose-dependent insulinotropic peptide responses will be assessed, along with rates of substrate oxidation.

Eligibility criteria:
inclusion criteria: * recreationally active * male exclusion criteria: * food intolerances/allergies
the real world study of apatinib for gastric cancer treatment in henan province

Conditions: Gastric Cancer

Summary: the investigators conduct the real world study to explore the efficacy and safety of apatinib in gastric cancer .


Eligibility criteria:
inclusion criteria: 1. male or female patients . 2. confirmed by pathology or histology of gastric cancer. 3. patients should be voluntary to the trial and provide with signed informed consent. 4. the researchers believe patients can benefit from the study. exclusion criteria: 1. patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories. 2. pregnant or lactating women. 3. patients with apatinib contraindications. 4. patients of doctors considered unsuitable for the trial.