Kornimate/medical-research-clean huggingface dataset:
valory study of valsartan/hydrochlorizide for patients who do not respond adequately to olmesartan medoxomil

Conditions: Hypertension

Summary: to evaluate the efficacy of valsartan 160 mg/hctz 25 mg in patients not adequately responding to monotherapy with olmesartan medoxomil 40 mg or combination therapy with olmesartan medoxomil 20 mg plus hctz 12.5 mg by testing the hypothesis that valsartan 160 mg/hctz 25 mg significantly reduces the trough mean sitting diastolic blood pressure (msdbp) after a 4-week treatment in the nonresponder population.


Eligibility criteria:
inclusion criteria: * females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives). * patients with essential hypertension: * at visit 1, untreated patients should have a msdbp \>100 mmhg and \< 110 mmhg and treated patients need to have a msdbp \< 110 mmhg. untreated patients can be included as soon as the safety laboratory parameters are available, but not at the day of visit 1. this inclusion visit will be recorded as visit 3 in the crf. * at visit 2, patients previously treated for hypertension need to have a msdbp ≥ 100 mmhg and \< 110 mmhg for entrance into the first treatment phase. patients previously treated for hypertension who have a msdbp \< 100 mmhg at visit 2 will continue the wash-out phase and will be again evaluated with regard to bp criteria at visit 3. untreated patients do not perform visit 2. * at visit 3, which is not performed for patients who entered the first treatment phase already at visit 2, patients need to have a msdbp \>100 mmhg and \< 110 mmhg for entrance into the first treatment phase. * at visit 4, all patients need to have a msdbp \>90 mmhg for entrance into the second treatment phase. exclusion criteria: * msdbp \>110 mmhg or mssbp \>180 mmhg * pregnant or nursing women * inability to completely discontinue all antihypertensive medications safely for a period of up to 2 weeks, as required by the protocol other protocol-defined exclusion criteria may apply.

Keywords: valsartan hydrochlorothiazide olmesartan hypertension
outcomes of three ports versus four ports laparoscopic cholecystectomy, sohag general surgery department experience

Conditions: Cholecystitis, Chronic

Summary: to compare the outcomes of three ports and four ports laparoscopic cholecystectomy

to compare the outcomes of three ports and four ports laparoscopic cholecystectomy randomized clinical trial comparative study will be carried out on 50 patients underwent laparoscopic cholecystectomy in general surgical department, sohag university. an informed written consent will be obtained from the patients. every patient will receive an explanation of the purpose of the study and will have a secret code number. research results will be only used for scientific purposes. any unexpected risks appearing during the course of research will be clarified to the participants and to the ethical committee on time. patients will be randomly classified into two equal groups; 25 patients will be enrolled in each group using computer generated random number in closed sealed envelope. group i (3-ports): 25 patients undergo a three-port lc. group ii (4-ports): 25 patients undergo a four-port lc. all patients will be subjected to thorough history taking (age, sex, symptoms, and duration of symptoms) and full clinical evaluation. abdominal ultrasound will be done in all patients. baseline laboratory (complete blood count and coagulation profile) will be ordered in all patients.

Eligibility criteria:
inclusion criteria: * age 18 to 75 years. * both sexes. * patient with clinical, laboratory and/or radiological evidence that is a candidate for cholecystectomy operation. exclusion criteria: * patient's refusal. * bile duct stones. * history of obstructive jaundice. * severe acute calculus pancreatitis. * severe co-morbid diseases (uncontrolled diabetes, hypertension, and severe direct hyperbilirubinemia). * prior surgery or adhesion. * radical cholecystectomy. * pregnancy. * malignancy.
study of etanercept in subjects with rheumatoid arthritis who have had an inadequate response to adalimumab or infliximab plus methotrexate

Conditions: Rheumatoid Arthritis

Summary: the first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or adalimumab plus methotrexate. this comparison will be performed for all subjects and separately for subjects who are anti-drug antibody positive for one of these medications. from week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. the effect of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of etanercept in these subjects will also be evaluated throughout the study.

this study was prematurely terminated on june 25, 2014 due to significant and continuing delays in achieving the study b1801355 enrolment target. the decision to stop the study was not driven by any safety concerns.

Eligibility criteria:
inclusion criteria: 1. met the 1987 acr revised criteria for ra 2. a history of inadequate response to infliximab or adalimumab in combination with methotrexate. 3. a stable dose of oral methotrexate for at least 6 weeks before the baseline visit. exclusion criteria: 1. acr functional class iv 2. prior treatment with etanercept; both infliximab and adalimumab; or any immunosuppressive biologic agent other than infliximab or adalimumab. 3. discontinuation of infliximab or adalimumab for a primary reason other than inadequate efficacy response.

Keywords: rheumatoid arthritis etanercept methotrexate infliximab adalimumab anti-drug antibody
intraoperative analysis of the central retina in erf

Conditions: Epiretinal Membrane; Macular Pucker

Summary: changes in the retinal anatomy that occur in epiretinal fibrosis have not been sufficiently studied. it is possible that epiretinal fibrosis leads not only to traction dislocation of the macula, but also to ilm anatomical disorders.

purpose: to study anatomical changes in the central retina in epiretinal fibrosis. surgical treatment: standard vitrectomy 25-27g; erm amd ilm stainig by membrane blue dual; epiretinal membrane removal, ilm peeling if the divulsion of ilm was detected. expected results: improving the quality of epiretinal fibrosis surgery by obtaining a more detailed picture of the pathological process

Eligibility criteria:
inclusion criteria: * bcva \< 0,6; exclusion criteria:. * secondary erm, glaucoma, diabetic retinopathy, high myopia, bcva\>0,6

Keywords: epiretinal membrane internal limiting membrane epiretinal fibrosis macular pucker central retina
correlative study on cancer patients and healthcare professionals exposed to infection by severe acute respiratory syndrome-corona virus-2 (sars-cov-2), covid-19 causative agent.

Conditions: COVID-19; SARS-CoV-2

Summary: translational, prospective / retrospective, non-profit, non-pharmacological study, with cohort characteristics. the study consists of two parts: the first to study epidemiological aspects of the spread of the disease and the second one to identify infection-related genetic factors.

the outbreak of covid-19 infections is spreading in italy with unprecedented severity characteristics. in this context, it is essential to collect data relating to the epidemiology of the disease, to outline further useful tools for diagnosis and to define the correct use of rapid molecular and / or serological tests in the surveillance of high-risk subjects (cancer patients and healthcare operators), in order to identify any new disease control strategies, crucial to reduce the transmission and to outline specific guidelines for cancer patients healthcare management. it is also necessary to identify the factors that determine the evolution of the viral genome over time in the various geographical areas and also the potential susceptibility markers in the different types of affected subjects (symptomatic, mildly symptomatic and asymptomatic).

Eligibility criteria:
for epidemiologic analysis: inclusion criteria: * age \> 18 years * asymptomatic * one of the following three conditions: • healthy subjects who have had contact with covid-19 positive patients • healthcare workers • oncological patients candidates for cytotoxic chemotherapy at myeloablative doses (such as transplants) or treated with immune-check point inhibitors. * informed consent to the study and processing of data exclusion criteria: * presence of symptoms for coronavirus disease 19 (covid-19) (fever \> 37.5 °, cough, shortness of breath) for analysis of viral/host genetic factors involved in susceptibility/resistance to infection, samples from patients with confirmed diagnosis of covid-19, residual from diagnostic procedures will be analyzed. all samples for genetic analysis will be anonymized.

Keywords: sars-cov-2 covid-19 cancer igm-igg seroprevalence
can needle size improve cancer detection rate of transperineal mri target prostate biopsy without affecting side effects?

Conditions: Prostate Cancer Diagnosis

Summary: differences in terms of diagnostic capability and side effects related to the needle caliber used for prostate biopsy sampling in patients with suspected prostate cancer

to assess whether a larger caliber (16g) prostate biopsy needle increases the diagnostic capability of prostate neoplasia compared to a smaller caliber (18g) needle, while keeping perioperative complications constant.

Eligibility criteria:
inclusion criteria: * clinical suspicion of prostate cancer (presence of elevated prostatic specific antigen and/or suspicious digital rectal examination); * presence of at least one suspicious prostate lesion on mri (prostate imaging-reporting and data system ≥ 3) according to the prostate imaging-reporting and data system v2.1 performed before magnetic resonance imaging/transrectal ultrasound fusion biopsy. exclusion criteria: * patients under active surveillance or with a previous diagnosis of prostate neoplasia prior to biopsy. * previous radiotherapy to the prostate for neoplasia.

Keywords: pca needle 16 gauge 18 gauge
major allergen in wheat anaphylaxis in thai population

Conditions: Wheat Allergy; Anaphylaxis Food; Anaphylaxis Exercise

Summary: * to study major allergen in wheat anaphylaxis in thai population * to study and compare demographic data between group of wheat anaphylaxis

wheat is one of the most common causes in food-induced anaphylaxis and food dependent, exercised induced anaphylaxis. gold standard for diagnose food allergy is double blind placebo control food challenge, but it is a high risk procedure. the accuracy of skin prick test and specific ige assay showed unsatisfactory results. it might be explained by these tests may not detect all of the major allergens in wheat allergic patients. previous studies showed that the major allergens of wheat dependent, exercised induced anaphylaxis are omega5 gliadin, followed by high molecular weight glutenin. for ige-mediated wheat allergy, the major allergens varied among studies, including omega5 gliadin, glutenin, alpha/beta/gamma gliadin, and the water-soluble part of wheat allergens. there is no study to direct compare the major allergen between patients who have low wheat specific ige and very high wheat specific ige. also, there is no data about the major allergens of wheat anaphylaxis in thai population.

Eligibility criteria:
inclusion criteria: * wheat anaphylaxis patient aged 1-60 years, who received treatment at division of allergy, department of pediatrics and medicine, siriraj hospital from 2001 to 2016 exclusion criteria: * loss follow up * no consent form * celiac disease, autoimmune disease was diagnosed
lidocaine-prilocaine (emla) cream as analgesia in hysteroscopy practice

Conditions: Pain

Summary: the purpose of this study is to demonstrate that lidocaine-prilocaine cream decrease pain during hysteroscopy diagnostic practice.


Eligibility criteria:
inclusion criteria: * patients that he must perform a diagnostic hysteroscopy * acceptance to participate in the study signed informed consent exclusion criteria prerandomization: * hypersensitivity or allergy to anesthetics * refusal of the patient * patients under age 18 and pregnant exclusion criteria postrandomization: * dropout * unbearable pain that involves other analgesic measures * allergic reactions to topical anesthetics

Keywords: hysteroscopy local anaesthetic pain relief gynecological pathology
expanded access study of rad001 in metastatic renal cell cancer patients who are intolerant of or who have failed despite prior vascular endothelial growth factor therapy

Conditions: Metastatic Renal Cell Cancer

Summary: this expanded access study is designed to provide rad001 to patients with mrcc who are without satisfactory treatment alternatives, until rad001 becomes commercially available.


Eligibility criteria:
inclusion criteria: * ≥ 18 years old; metastatic renal cancer, intolerant of or failed sunitinib and/or sorafenib * adequate bone marrow function, liver function, renal function * adequate birth control exclusion criteria: * previously received rad001 or other mtor inhibitors, known hypersensitivity to rapamycin, chronic systemic treatment with corticosteroids or immunosuppressive agents (prednisone ≤ 20 mg/day for adrenal insufficiency ok * topical or inhaled steroids ok) * active bleeding * uncontrolled angina, chf, heart attack ≤ 6 months, uncontrolled diabetes other protocol-defined inclusion/exclusion criteria may apply

Keywords: expanded access metastatic renal cell cancer progression despite vegf receptors
a prospective longitudinal study of health-related quality of life in men with clinically localized prostate cancer

Conditions: Prostate Cancer

Summary: to prospectively assess the health-related quality of life (hrqol) changes during the first year after different treatment modalities for localized prostate cancer.

quality of life is of great concern to patients considering treatment options for prostate cancer. patients with clinically localized prostate cancer treated with active surveillance, radical prostatectomy, external radiotherapy and high intensity focused ultrasound were included. all men completed the questionnaires of functional assessment of cancer therapy-prostate (fact-p) (version 4), international prostate symptom score (ipss) and international index of erectile function (iief) before treatment and 1, 3, 6, 12 months after treatment.

Eligibility criteria:
inclusion criteria: * patients diagnosed with clinically localized prostate cancer exclusion criteria: * patients with another malignancies

Keywords: quality of life localized prostate cancer fact-p
a study to learn about a repeat 5-day treatment with the study medicines (called nirmatrelvir/ritonavir) in people 12 years old or older with return of covid-19 symptoms and sars-cov-2 positivity after finishing treatment with nirmatrelvir/ritonavir

Conditions: COVID-19

Summary: the purpose of this study is to learn about the safety and effects of nirmatrelvir/ritonavir for the potential treatment of covid-19 rebound. the study is seeking participants who: * have completed treatment with nirmatrelvir/ritonavir * have a rebound in covid-19 symptoms * are sars-cov-2 (covid-19) positive all study medications will be taken 2 times a day by mouth for 5 days. the first dose of study medication is taken at the study clinic and the rest at home. we will examine the experiences of people receiving the study medicines to those who do not. this will help us determine if the study medicines are safe and effective. people taking part will be in this study for about 24 weeks. enrolled participants will need to visit the study clinic at least 8 times during the study.


Eligibility criteria:
inclusion criteria: * documentation of nirmatrelvir/ritonavir treatment with patient-reported 100% compliance. symptom alleviation or resolution in covid-19 signs/symptoms followed by a worsening (rebound) of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir * onset of rebound in covid-19 symptoms within 2 weeks (14 days) after the completion of the initial 5-day course of nirmatrelvir/ritonavir. * onset of rebound in signs/symptoms attributable to covid-19 within 48 hours prior to randomization and ≥1 sign/symptom attributable to covid-19 present on the day of randomization. * sars-cov-2 infection as determined by rapid antigen testing within 24 hours prior to randomization * at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from covid-19. exclusion criteria: * current need for hospitalization, hospitalized for the covid-19 infection or anticipated need for hospitalization within 24 hours after randomization * history of severe chronic liver disease * receiving dialysis or have known age-specific estimated glomerular filtration rate (egfr) or estimated creatinine clearance (ecrcl) \<30 ml/min/1.73 m2 at screening as measured by a serum creatinine point of care device * oxygen saturation of \<92% on room air obtained at rest within 24 hours prior to randomization * immunocompromised. * current use of any prohibited concomitant medication(s) * females who are pregnant and \<14 weeks gestation

Keywords: severe acute respiratory syndrome coronavirus 2 (sars-cov-2) coronavirus disease 2019 (covid-19) covid-19 rebound paxlovid nirmatrelvir
placebo controlled clinical trial of the postoperative opioid sparing effects of intraoperative dexmedetomidine infusion for thoracic surgery

Conditions: Pain

Summary: the purpose of this study is to see if the drug, dexmedetomidine (also known as precedex), can reduce pain for patients having thoracic surgery and therefore reduce the amount of opioid drug needed after surgery. it is a drug that is already approved by the fda (food \& drug administration) for use as a sedative in hospitals and is currently used in the investigators intensive care unit for this purpose. the investigators want to investigate if it also has pain relieving properties.

the study involves the use of dexmedetomidine infusion intraoperatively during thoracic surgical procedures (not using an epidural) with discontinuation in the immediate postoperative period. a key feature in this study is to employ the drug infusion intraoperatively only.

Eligibility criteria:
inclusion criteria: * adult patients ( ≥ 21 years old) scheduled for thoracic surgery exclusion criteria: * 2nd or 3rd degree heart block as assessed by preoperative ekg * use of dexmedetomidine within 28 days prior to day of surgery * use of long acting opioids pre-operatively 28 days prior to day of surgery * current or past diagnosis of a major psychiatric disorder precluding adequate outcome responses such as schizophrenia, dementia, delirium etc. as recorded in the pre-operative record. * documentation of congestive heart failure and ejection fraction \< 30% if recorded in the pre-operative record. * planned use of an epidural for surgery or post-operative pain relief * contraindication to use of nsaid, acetaminophen or iv opioids. * any known hypersensitivity to dexmedetomidine * pregnant or breastfeeding * abnormal liver function tests as related to the msk guidelines for use of iv acetaminophen yes or no?; is alt greater than 2 x upper limit of normal (\> 75 u/l)? * abnormal renal function tests as related to contraindications to use of iv ketorolac yes or no?; is serum creatinine \< 1.5 mg/dl?

Keywords: dexmedetomidine opioid thoracic surgery
effect of very low carbohydrate diet on glycemic, metabolic, glycated and inflammatory markers in gestational diabetes mellitus

Conditions: Gestational Diabetes; Inflammation; Metabolic Syndrome; Glucose Intolerance During Pregnancy; Glucose Intolerance; Insulin Resistance

Summary: uncontrolled gestational diabetes mellitus may leads to maternal and fetal complications. these complications can be avoided by adopting the dietary modifications along with medications. previous studies suggested that consumption of low carbohydrate diet improves gestational diabetes and related complications. therefore, this study aims to investigate the effect of very low carbohydrate dietary intervention on glycemic, glycemic, metabolic, glycated and inflammatory markers.

this will be randomized controlled trial of 80-100 gestational diabetic women of second trimester to investigate the effect of very low carbohydrate dietary intervention on glycemic, metabolic, glycated and inflammatory markers. subjects will be recruited from ob/gyn outpatient of different hospitals. eligible subjects will be enrolled in the study and will be allocated into two groups. one will be intervention and other will be control group. at baseline fasting blood samples from both group will be taken and will be analyzed for different biomarkers. thereafter, the experimental group will be counseled about their modified diet (very low carbohydrate diet \<10%,40-50% protein and lipid in diet). control group will be allowed to continue their routine diet counselled as part of their antenatal care.

Eligibility criteria:
inclusion criteria: * 2nd trimester women with gdm * either taking or not taking oral hypoglycemic agent or insulin exclusion criteria: * previously known type 1 or type 2 diabetic patients * age less than 18 and above 40 years * any other chronic disease

Keywords: gestational diabetes insulin resistance carbohydrate inflammation glucose intolerance
effects of topical cream for pain relief

Conditions: Chronic Pain

Summary: to perform a clinical proof-of-concept study on a novel topical formula for pain relief.

an open-label study where each participant will be involved in the study for 4 weeks. during the study participants will use the topical cream 1-2 times daily on the anatomical area(s) causing the most pain.

Eligibility criteria:
inclusion criteria: * bmi between 18.5 and 34.9 kg/m2 (inclusive) * chronic joint/muscle related pain for at least past 6 months * experiencing chronic pain in at least one specific anatomical area for more than 6 months. exclusion criteria: * cancer during past 12 months * chemotherapy during past 12 months * currently taking prescription pain medications * getting regular joint injections (such as cortisone shots); * immunization during last month * participation in another clinical trial study during this trial, involving an investigational product or lifestyle change * regularly experiencing headaches, including migraines * serious active illness within past 6 months * significant active uncontrolled illness (such as lymphoma, liver disease, kidney failure, heart failure). * skin allergies related to ingredients in test product.