Kornimate/medical-research-clean huggingface dataset:
clinical safety and efficacy of hydrophilic acrylic intraocular lenses

Conditions: Cataract

Summary: clinical safety and efficacy of ct asphina 409 iols after implantation


Eligibility criteria:
inclusion criteria: * patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent; * patients of any gender * assured follow-up examinations * biometry measurement preferably compatible with the iolmaster evaluation; * iol implanted into the capsular bag with iol model ct asphina 409mp (uve material) in one eye with at least 12 months follow up at the time of the postop visit * patients who had uncomplicated (no peroperative complication) aged-related cataract surgery in a healthy eye (beside clinically significant cataract) exclusion criteria: * bcva not available preoperatively or better than 0.3 logmar pre-op * patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial * patients whose freedom is impaired by administrative or legal order * concurrent participation in another drug or device investigation -
intranasal transmucosal fentanyl pectin for breakthrough cancer pain in radiation-induced oropharyngeal mucositis

Conditions: Breakthrough Pain; Mucositis; Radiotherapy; Chemotherapy; Head and Neck Cancer

Summary: an open-label, non-randomized study to assess the titration, safety and efficacy of intranasal fentanyl pectin nasal spray for the treatment of secondary breakthrough pain secondary to radiation-induced mucositis in patients with confirmed tolerance of opioid therapy for chronic pain. study objectives include assessment of breakthrough pain episodes related with food intake in patients with mucositis secondary to radiotherapy or radio-chemotherapy for head and neck tumors

an open, non-randomized study design was used to assess the titration, safety and efficacy of intranasal fentanyl in pectin for the treatment of secondary breakthrough pain in patients with confirmed tolerance of opioid therapy for chronic pain secondary to radiation-induced mucositis. the study plans to include 30 evaluable patients from multiple centers throughout the country. the trial comprises a screening period, an open titration period, and an open-label treatment period in which at least 12 breakthrough pain episodes are to be treated.

Eligibility criteria:
inclusion criteria: a histologically confirmed diagnosis of head and neck carcinoma treatment in the form of radiotherapy or radio-chemotherapy breakthrough pain related to swallowing (one to four daily episodes) treatment with controlled release opioids at the time of inclusion: at least 60 mg of morphine sulfate daily, at least 25 microg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily exclusion criteria: * patients without controlled release opioid treatment.

Keywords: mucositis breakthrough pain head nad neck cancer intranasal transmucosal fentanyl in pectin
delivery of yamani-15/5 chemical solution for pad

Conditions: Peripheral Arterial Disease

Summary: this is a feasibility pilot study to evaluate the impact of local delivery of yamani-15/5 (combination of l-lactic acid 15% and d-gluconic acid 5%) on vascular calcification of lower extremities in patients with severe peripheral arterial disease (pad) who were deemed to have unreconstructable arterial disease and who have already been scheduled to undergo limb amputation (below knee or above knee amputation).


Eligibility criteria:
subject has severe calcific pad who have been deemed to have unreconstructable arterial disease and who have already been scheduled to undergo limb amputation (below knee or above knee amputation). exclusion: * patients who will be undergoing amputation of the limb because of infection, osteomyelitis or cancer. * patients with chronic kidney disease stage v (unless on dialysis). * patients with liver cirrhosis. * patients with history of deep vein thrombosis or pulmonary embolization in the last 3 months. * patients with history of stroke in the last 3 months. * patients with unstable angina or history of myocardial infarction in the last 3 months. * patients with sepsis, respiratory failure, hypovolemic shock or cardiogenic shock. * women who are pregnant or nursing.
opioids following acl

Conditions: Pain, Postoperative

Summary: the purpose of this study is to evaluate the effectiveness of a post-operative opioid pain 18 management protocol for anterior cruciate ligament reconstruction (aclr).


Eligibility criteria:
inclusion criteria: - all patients undergoing primary aclr for acl tear, including patients with concomitant 76 meniscectomy or meniscal repair. exclusion criteria: * concomitant procedure other than meniscectomy or meniscal repair. * acl revision * history of chronic pre-operative opioid use * history of substance abuse * workmen's compensation claims * pregnancy
lower urinary tract symptoms and school functioning in children

Conditions: Lower Urinary Tract Symptoms; Neurodevelopmental Disorders; Incontinence, Urinary; ADHD; ASD; Developmental Coordination Disorder; Child Development; Quality of Life

Summary: children in primary school often suffer from lower urinary tract symptoms (luts), which may negatively impact their overall well-being. co-occurring neurodevelopmental disorders (ndds) can adversely affect children as well and can cause restrictions in their daily life, especially in their school-environment. the goal of this observational study is to identify the prevalence of luts in flemish primary school children.the main questions it aims to answer are: * how prevalent are luts in regular primary education? * is there a relation with well-being in school environment? * is there an influence of co-occuring ndds? children, parents and teachers will be asked to fill in questionnaires related to this research question.


Eligibility criteria:
inclusion criteria: * children in 4th-6th grade * parents whose children are in grades 1-6 * teachers responsible for teaching children in grades 1-6 * children who attend regular primary education * capable of speaking \& comprehending dutch exclusion criteria: * high school students * home-schooled children * children who attend special needs education * language barrier to understanding dutch

Keywords: lower urinary tract symptoms quality of life pediatrics neurodevelopmental disorders vssdes dcd-q
a study of individualized radiotherapy based on a prediction model of lymph node metastasis in hepatocellular carcinoma

Conditions: Lymph Node Metastasis; Hepatocellular Carcinoma; Radiotherapy

Summary: objectives: 1. to further validate the predictive efficacy of our established microrna prediction model of hcc lymph node metastasis. 2. to establish a precise therapeutic mode of prophylactic radiation therapy in high-risk patients with hcc with lymph node metastasis under the guidance of a microrna prediction model.

first, screening out patients who underwent hepatic tumor resection and pathologically diagnosed as hcc . then，performing the detection of mir-145, mir-31 and mir-92a by using the hcc lymph node metastasis microrna correlation prediction model established in our previous study. the patients are judged as high risk of lymph node metastasis and low risk patients, then high-risk patients under the condition of informed consent into the group, randomized into treatment group and control groups. last, patients enrolled in the treatment group were treated with radiotherapy and followed up.

Eligibility criteria:
inclusion criteria: 1. patients underwent liver tumor resection and pathological diagnosis of hcc in our hospital. 2. the tumor samples of these hcc patients were detected by in situ hybridization with mir-145, mir-31 and mir-92a. we used the previously established hcc lymph node metastasis microrna prediction model to determine the patients with high-risk lymph node metastasis and low-risk patients at high risk patients were randomly assigned into treatment group and control group with informed consent. 3. hcc patients were not receive other anti-cancer treatment. 4. blood routine examination was normal. 5. child-pugh grade a, normal liver and kidney function in the normal range (including alt or asl within 2.5 times the normal), wbc\> 3 × 109 / l, hb\> 90g / l, plt\> 50 × 109 / 6. hcc patients were not receive the history of upper abdominal radiotherapy. 7. sign the informed consent. 8. age 18-75 years old. 9. kps score 80-100 points. exclusion criteria: 1. accepted other anti-cancer treatment. 2. patients was determined to be low-risk lymph node metastasis by the pre-established hcc lymph node metastasis microrna prediction model. 3. blood and liver and kidney dysfunction. 4. can not control the infection. 5. at the same time the merger of other malignant tumors. 6. while using other experimental drugs or to participate in other clinical trials. 7. serious heart, lung, kidney disease. 8. pregnant or lactating women. 9. serious nervous system disease, can not clearly tell the treatment
a study of tirzepatide (ly3298176) versus placebo in participants with type 2 diabetes inadequately controlled on insulin glargine with or without metformin

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. participants will administer tirzepatide or placebo along with their previous glucose lowering medications. the study will last approximately 47 weeks and may include about 23 visits.


Eligibility criteria:
inclusion criteria: * have been diagnosed with type 2 diabetes mellitus (t2dm) and have been treated with insulin glargine (u100), once daily with or without metformin ≥3 months prior to screening visit. * have hba1c between ≥7.0% and ≤10.5%. * have a stable weight (± 5%) for at least 3 months before screening. * have a body mass index (bmi) ≥23 kilograms per meter squared (kg/m²) at screening. exclusion criteria: * have type 1 diabetes mellitus. * have had chronic or acute pancreatitis any time prior to study entry. * have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment. * have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss. * have an estimated glomerular filtration rate \<30 ml/minute/1.73 m² \[for participants on metformin, estimated glomerular filtration rate \<45 ml/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)\] * have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months. * have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2. * have been taking weight loss drugs, including over-the-counter medications during the last 3 months.

Keywords: glucose-dependent insulinotropic polypeptide (gip) glucagon-like peptide-1 (glp-1) gip/glp-1 dual receptor agonist t2dm
gyni™ study with leumit health services

Conditions: Vaginitis

Summary: about one third of the women referring to gynecological clinics present with vulvovaginal inflammation symptoms (vaginitis) possibly caused by seven different conditions or mixed infections. the gyni™ system is intended to provide physicians with the means to obtain an accurate, fast and inexpensive diagnosis which is unavailable today. gyni™ is comprised of a compact tabletop scanner, a disposable sample collector and a cloud based algorithm that provides a suggested diagnosis within 5 minutes. the trial is a prospective evaluation of the cost-effectiveness of using gyni™ by comparing its usage outcomes in a practice setting to the outcomes obtained using the current standard of care.


Eligibility criteria:
inclusion criteria: * female ≥18 years old * able to read, understand and sign an informed consent form * at least one of the following: abnormal vaginal discharge, odor, vulvovaginal itch, burning, irritation, dyspareunia, vaginal dryness or pain. exclusion criteria: * patients under the age of 18 years * patient is unfit to provide an informed consent * patient with vaginal bleeding, including menstruation within past 24 hours21 * patient who used intra vaginal preparations within 72 hours prior to study enrollment (antimicrobials, spermicides, lubricants, diaphragm)22 * uninterpretable sample (e.g. patients who used vaginal creams or lubricants before the visit or insufficient sampling material)

Keywords: gynecology ivd
temozolomide in association with topotecan in refractory or relapsed malignant tumors in children and adolescents

Conditions: Refractory Tumors; Malignant Tumors

Summary: long term survival can now be achieved in 75% of cases of pediatric cancers. however, some types of tumors (ie cns tumors) or advanced stages (metastatic sarcomas/neuroblastomas) cannot be cured by any treatment. thus, evaluation of new drugs or combinations are strongly needed. the recommended doses have been defined in children for tmz (200 mg/m2/d x 5 d) and tpt (1.5 mg/m2/d x 5 d). some preclinical and clinical studies have shown activity of both drugs in some pediatric cancers. nevertheless, the association of the two drugs has never been evaluated. the study aims to determine maximum tolerated dose and dose limiting toxicities of each drug when associated and to assess efficacy of the combination.


Eligibility criteria:
inclusion criteria: * histologically documented malignant tumor * refractory or relapsing after conventional treatments and for which there is no curative treatment available * life expectancy \> 8 weeks * no significant co-morbidity (nci-ctc \< 2) * no organ toxicity * no chemotherapy within the 4 previous weeks, 6 weeks for nitrosurea or radiotherapy exclusion criteria: * hypersensibility to topotecan and/or temozolomide or to one of their compounds * hypersensibility to dacarbazine (dtic) * galactosaemia, glucose and galactose malabsorption syndrom, deficiency in lactase
viral hepatitis and gallstone disease study

Conditions: Gallstone Attack; Viral Hepatitis

Summary: the study aims to investigate possible associations between ongoing viral hepatitis (i.e. hepatitis a, b, c or e virus infection) and ultrasound or computed tomography-verified gallstone disease.

patients seeking care at emergency room at sahlgrenska university hospital, gothenburg, sweden undergoing ultrasound or computed tomography for suspected gallstone disease, will be asked if they wish to participate in the study. if they agree, a serum sample will be draw for analysis of anti-hav igm, hbsag, anti-hcv, hcv core antigen and hev rna. the proportion of patients with vs. without ultrasound or computed tomography-verified gallstone disease will be evaluated regarding possible ongoing viral hepatitis (i.e. hepatitis a, b, c or e virus infection).

Eligibility criteria:
inclusion criteria: * acute abdominal pain entailing an abdominal ultrasound or computed tomography for suspected gallstone disease at the emergency room at sahlgrenska university hospital, gothenburg * written informed consent * ability to obtain 9 ml serum for analysis of anti-hav igm, hbsag, anti-hcv, hcv core antigen and hev rna exclusion criteria: * not willing to give written informed consent * age below 18 years
comparison of diagnostic performance of digital breast tomosynthesis and ultrasound in women with dense breasts

Conditions: Breast Neoplasms

Summary: diagnostic performance of digital breast tomosynthesis (dbt) would be not inferior to the that of breast ultrasound in women with dense breast.

1. patients with dense breast will be examined for the detection of breast cancer by imaging studies. 2. the imaging including digital breast tomosynthesis (dbt), physician-performed bilateral whole breast ultrasonography will be performed according to a standard protocol.interpretation will be conducted independently and classified according to the breast imaging reporting and data system (bi-rads) by experienced radiologists. 3. definitive information about the presence of malignancy will be obtained by biopsy directed by the imaging method best depicting the lesion with 14-g or 11-g needle devices or needle localized excision. the absence of breast cancer was determined by means of biopsy, the absence of positive findings on repeat imaging and clinical examination, or both at follow-up. 4. the diagnostic yield of digital breast tomosynthesis (dbt) compared to ultrasonography will be assessed.

Eligibility criteria:
inclusion criteria: * women aged at 20 years * women who had heterogeneously dense or extremely dense parenchyma, either by prior mammography report or by review of prior mammograms * signed study-specific informed consent prior to registration exclusion criteria: * had breast surgery * had breast core biopsy performed within the prior 6 months on the study

Keywords: breast neoplasms/radiography mammography/methods mass screening tomography, x-ray computed/methods predictive value of tests false positive reactions
study of sperm molecular factors implicated in male fertility

Conditions: Male Infertility

Summary: sperm analysis following world health organization guidelines is unable to explain the molecular causes of male infertility when basic sperm parameters are within a normal range and women do not present gynaecological pathology. subsequently, there is a need for accurate diagnostic tools in this sense and microarray technology applied to sperm analysis emerges as a promising field

sperm analysis based in sperm count and motility has been employed for the diagnosis of male fertility for several decades. it is an easy, inexpensive and useful tool to determine the fertile status of a male but there is still a significant number of infertile males with normal sperm features, as determined by the basic sperm analysis, while they remain unable to reach a full-term pregnancy (1). this fact clearly indicates the need to develop new male infertility tests and accurately diagnose the sperm samples from these individuals. recent investigations about sperm mrna contents have described the relevance of the sperm mrna stock in fertilization and early embryo development in several species. (2) although sperm is a quiescent cell from the translational point of view, several functional mrnas that will be delivered into the oocyte after fertilization, that were synthesized in an earlier phase of the spermatogenesis process can be found (3, 4). the fertile male transcriptome (stock of mrnas within the sperm of a male able to have progeny) has been already described (5, 6), confirming the expression of thousands of sequence tags with different intensity of expression. moreover, several investigations have demonstrated that a differential expression of some key mrnas is found in infertile males in comparison with fertile males (1, 7). nevertheless, there is no information available neither about the characteristics of the stock sperm mrnas on infertile males or the differences between fertile and infertile men, although several authors have hypothesized that sperm microarray analysis will be the future in the male infertility diagnosis (2, 8-11). microarray technology provides information about a wide range of mrnas expression within a single experiment, permitting to analyze complete sperm expression profiles (sep) in cells or tissues. bioinformatics can help in the organization of such amount of results by following logical processes of gene expression grouping, and analyzing statistically these findings. our aim with this work was to compare the sep in spermatozoa obtained from males with idiopathic infertility versus those from sperm donors of proven fertility by employing microarray technology followed by a functional analysis, in order to determine the genes, sequences and biological processes involved in the sperm physiology that are different in infertile vs. fertile males.

Eligibility criteria:
inclusion criteria: * fertile (controls) or infertile males, with sperm parameters above the who criteria values exclusion criteria: * well established infertility causes

Keywords: sperm, male fertility, microarrays
a training software (sj-rs-wl2015) rehabilitating intermittent exotropia binocular functions

Conditions: Intermittent Exotropia

Summary: evaluating the effect of sj-rs-wl2015 visual training program in children with intermittent exotropia after eye surgery, including the improvement of simultaneous perception (i binocular function), fusion (ii binocular function), stereopsis (iii binocular function).

all the patients are after eye surgery for intermittent exotropia. all the participants with 20/20 or better visual acuity.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of intermittent exotropia * must be after eye surgery for intermittent exotropia * baseline deviation range: esotropia\<=5△ or exotropia\<15△ after eye surgery * visual acuity: \>=20/20 exclusion criteria: * a-v patterns deviations * abnormal oblique or vertical rectus * nystagmus * ophthalmoplegia * anisometropia \>2.5d * with other eye surgery history * mental disorder * neural disease * tumor * heart disease * hypertension * epilepsy * severe systemic disease * with vision therapy history within 4 weeks * implanted electronic device * in other researches within 4 weeks

Keywords: intermittent exotropia
phase ⅳ clinical trial of recombinant hepatitis e vaccine（hecolin®）

Conditions: Hepatitis E

Summary: the purpose of this study is to determine the safety and immunogenicity of the recombinant hepatitis e vaccine in people older than 65 years, and evaluate the efficacy of hepatitis e vaccine in this population.


Eligibility criteria:
inclusion criteria: * healthy people aged over 16 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form. * healthy subjects as established by medical history and history-oriented clinical examination before entering into the study. * subjects will reside in the study region in the next 7 months. * free of history of hepatitis e. * can comply with the request of study. * axillary temperature is below 37 degree centigrade. exclusion criteria: for dose 1: * receiving other vaccine or immunoglobulin within two weeks; * having serious allergic history to vaccine and medicine * eclampsia, epilepsy, encephalopathy and history of mental disease or family; * thrombocytopenia or other disturbance of blood coagulation which would lead to muscle injection taboo; * fixed or suspected deficiency of immunologic function, containing immunosuppressant treatment, genetic defect, hiv or other factors; * congenital malformation, eccyliosis or severe chronic disease; * fixed or suspected other disease including fever, active infection, liver and kidney disease, angiocardiopathy, malignancy, acute and chronic disease; * joining other clinical study undergoing; * women pregnant or in lactation. for dose 2 or 3: * severe allergy for dose 1 or 2; * severe adverse reaction associated with last vaccination; * new occurrence of symptoms meet dose 1 exclusion criteria after the first dose.

Keywords: hepatitis e immunogenicity vaccine safety