Kornimate/medical-research-clean huggingface dataset:
assessment of efficacy of vardenafil in the treatment of subjects with symptomatic benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: assessment of efficacy of vardenafil in the treatment of subjects with symptomatic benign prostatic hyperplasia.the purpose of this study is to find out whether vardenafil can improve the lower urinary tract symptoms of benign prostatic hyperplasia after 8 weeks of daily administration of 10 mg bid.


Eligibility criteria:
inclusion criteria: * males 45 to 64 years of age * lower urinary tract symptoms \> 6 months * international prostate symptom score \> 12 exclusion criteria: * prostate specific antigen \> 3 ng/ml * residual urine volume \> 150 m * history of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months * nitrate use * other exclusion criteria apply acc. to summary of product characteristics

Keywords: benign prostate hyperplasia vardenafil genital disease male: signs and symptoms of benign prostate hyperplasia
phase i study of olaparib with cisplatin based chemoradiotherapy in squamous cell carcinoma of the head and neck

Conditions: Carcinoma, Squamous Cell

Summary: the aim of this study is to find the safe dose and best dosing schedule of olaparib to give in combination with cisplatin based chemoradiotherapy (crt) in patients with locally advanced head and neck cancer. the dose decided on in this part of the study will become the recommended dose for the randomised phase ii trial.

this is a dose escalating phase i/ii trial evaluating the safety and tolerability of the addition of olaparib to crt in high risk locally advanced human papillomavirus (hpv) negative squamous cell carcinoma of the head and neck (hnscc). a fixed dose of weekly cisplatin and intensity-modulated radiation therapy (imrt) will be used, with doses of olaparib escalating for consecutive days and both dose level and duration will be increased through each cohort. this phase i trial will assess how olaparib, a poly adp ribose polymerase (parp) inhibitor is tolerated when added to standard chemoradiotherapy treatment. patients will be recruited from sites in the uk only. a placebo controlled, randomised phase ii trial will follow once the recommended dose and schedule of olaparib has been established.

Eligibility criteria:
inclusion criteria: * histologically confirmed high risk, locally advanced hnscc patients (tnm staging: t-any n2/3 m0, bulky t3 or t4 n-any m0) who would normally be offered cisplatin-based radical chemoradiotherapy * estimated life expectancy of at least 12 weeks * who performance status of 0 or 1 * aged ≥18 years of age * adequate major organ function * willing to use contraception for the duration of the trial treatment and for six months after completion of treatment * able to give informed consent * willing and able to comply with the protocol for the duration of the study exclusion criteria: * head \& neck cancers of the following types: * nasopharyngeal and paranasal sinus tumours, * oral squamous cell carcinomas (tumours of the oral cavity), * human papilloma virus positive oropharyngeal tumours (tonsillar and tongue base tumours) * confirmed distant metastatic disease * previous chemotherapy or radiotherapy for the treatment of hnscc tumour * previous therapy with a parp inhibitor * pre-existing gastrointestinal disorders that may interfere with the delivery or absorption of olaparib * grade 3 or 4 peripheral neuropathy * significant hearing difficulties or tinnitus (deaf patients can be included) * the current use of drugs which are known to inhibit or induce cyp3a4

Keywords: radiotherapy biomarkers, pharmacological pharmacokinetics genetic markers cisplatin poly(adp-ribose) polymerases azd 2281 radiotherapy, intensity-modulated head and neck chemoradiotherapy scc
prospective, longitudinal, observational registry of adult patients with hypophosphatasia (reg-hypo)

Conditions: Hypophosphatasia

Summary: the purpose of this study is to assess medical events during follow-up of adult patients having hypophosphatasia and consulting rheumatologists.

hypophosphatasia (hpp) is a rare inherited disease caused by mutations of the alpl gene. in adult hpp, patients may suffer from fractures, pseudofractures, fracture healing complications, osteoarthritis, chondrocalcinosis, dental diseases, muscle pain and disability, but also headache, muscle weakness, ocular disease, and other symptoms. in some cases the diagnosis is severely delayed. moreover a number of patients having such symptoms and a low level of serum alkaline phosphatase, without gene mutation can be followed by rheumatologists with difficulties in management of bone fragility and pain. the aim of this register is to describe prospectively the medical events in adult patients having hypophosphatasia, whether or not there is a proven genetic abnormality.

Eligibility criteria:
inclusion criteria: * men and women, * aged 18 and over, with no upper age limit, who have had a total alkaline phosphatase value of less than 40 iu/l on at least 3 occasions, * with at least one rheumatological symptom. exclusion criteria: * transient hypophosphatasia: absence of confirmation of a value below 40 iu/l on at least 3 samples, * secondary hypophosphatasia according to the expert rheumatologist (drugs, endocrine disease, other genetic disease...).

Keywords: cohort hypophosphatasia bone fragility enthesopathy asfotase
specificity study of diagnostic for chagas disease

Conditions: Infectious Diseases

Summary: this study assesses the specificity of chagas detect™ plus (cdp) rapid test versus standard reference tests (e.g. ripa or ifa) for chagas diagnosis in the us. the chagas detect™ plus rapid test is a rapid immunochromotagraphic strip assay for the qualitative detection of antibodies to trypanosoma cruzi (t. cruzi) in human serum or whole blood samples. reactive assay results are presumptive evidence of chagas infection. this study will enroll males and females 18-70 years of age from areas non-endemic for chagas infection. a fingerprick blood sample and a venous blood sample (for processing to serum) will be collected from each subject. subject age, gender, and symptoms will be recorded. for this study, samples will have no personally identifiable information. cdp and reference tests will be performed by different operators who are laboratory staff members. these staff members, blinded to each other's results, will evaluate the samples from each method independently.


Eligibility criteria:
inclusion criteria: 1. male and female subjects 18 to 70 years of age 2. subjects must be able to answer questions concerning: 1. clinical symptoms 2. blood transfusions 3. organ transplants 4. travel or residence in chagas endemic areas exclusion criteria: 1. any subject who knows that they have positive serology for chagas disease 2. subjects who are unable to understand verbal of written or oral language of the consent, or require a legal authorized representative for consent.
a study of s5g4t-1 in the treatment of papulopustular rosacea

Conditions: Papulopustular Rosacea

Summary: to assess the efficacy and safety of s5g4t-1 compared to its vehicle when applied once daily for 12 weeks in participants with papulopustular rosacea.

in this phase 3, double-blind, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. male and female participants at least 18 years of age with moderate or severe papulopustular rosacea will be eligible for enrollment for daily treatment with s5g4t-1 or its vehicle for 12 weeks.

Eligibility criteria:
inclusion criteria: 1. participants must sign an institutional review board (irb) approved written informed consent for this study. 2. male and female 18 years of age and older. 3. participants must have clinical diagnosis of moderate to severe rosacea. 4. have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose. 5. have 2 nodules or less. exclusion criteria: 1. females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation or were found to have positive pregnancy test at baseline or screening visits. 2. presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm). 3. current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

Keywords: papulopustular rosacea
phase ii study to evaluate the efficacy and safety of gc6101a in subjects with gastritis

Conditions: Gastritis

Summary: the purpose of this study is to evaluate the efficacy and safety of the investigational products in the patients with gastritis during their participation in the study.

gc6101a is botanical drug products made from the lonicerae flos. two hundred volunteers will participate in the study, receive 2-week treatment with gc6101a or placebo.

Eligibility criteria:
inclusion criteria: * age is over 19 years old, men or women * patients diagnosed with acute or chronic gastritis by gastroscopy * patients with one or more erosions found by gastroscopy * signed the informed consent forms exclusion criteria: * patients who is impossible to receive gastroscopy * patients with peptic ulcer and gastroesophageal reflux disease * patients with gastroesophageal surgery and surgery to reduce the secretion of gastric acid (except for surgery for perforated peptic ulcer and cecectomy) * patients with esophageal varix * patients with malignant neoplasm of gastrointestinal tract * patients with thrombosis or administered with anti-thrombotic drugs * patients with consumption coagulopathy * patients administered with h2 receptor antagonists, muscarinic receptor antagonists, gastrin receptor antagonist, proton pump inhibitors, prostaglandins or mucosal protective agents prior to study in 2 weeks * patient who cannot interrupt steroid, non-steroid anti-inflammatory drugs or aspirin during treatment * allergic or hypersensitive to any of the ingredients in the test products * pregnant or lactating female * patients who have abnormal baseline laboratory test result * patients taking other investigational drugs within 30 days prior to the study. * patients with zollinger-ellison syndrome * patients that investigators consider ineligible for this study
pre-emptive scalp infiltration with methylprednisolone plus ropivacaine for postoperative pain after craniotomy

Conditions: Pain, Postoperative

Summary: pain is common for the first 2 days after major craniotomy. a majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. inadequate analgesia induced sympathetically mediated hypertension may lead to an increased risk for post-operative complications. adequate pain control is essential for patients' prognosis and their postoperative life quality. pain after craniotomy derives from the scalp and pericranial muscles. local anesthetics administered around the incision have been performed clinically. however, some studies revealed that the analgesic effect of local anesthetics was not unsatisfactory due to its short pain relief duration. pain is common for the first 2 days after major elective intracranial surgery, and the relatively short analgesic time of scalp infiltration does not seem to meet the requirements of craniotomy. steroid such as methylprednisolone as an adjuvant to local anesthetics intra-articular injected locally reduced pain intensity after total knee arthroplasty or lumbar discectomy. however, there has not been reported about local application of methylprednisolone on scalp infiltration. thus, the investigators suppose that pre-emptive scalp infiltration with steroid (methylprednisolone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective craniotomy for resection of tumour under general anaesthesia; * american society of anesthesiologists (asa) physical status of i , ii or iii; * participates with an anticipated fully recovery within 2 hours postoperatively. exclusion criteria: * history of craniotomy; * expected delayed extubation or no plan to extubate; * participants who cannot use a patient-controlled analgesia (pca) device; * • participants who cannot understand the instructions of a numeral rating scale (nrs) 35 before surgery; * extreme body mass index (bmi) (\ 35); * allergy to opioids, methylprednisolone or ropivacaine; * history of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects; * history of psychiatric disorders, uncontrolled epilepsy or chronic headache; * pregnant or at breastfeeding; * symptomatic cardiopulmonary, renal, or liver dysfunction or history of diabetes; * preoperative glasgow coma scale\< 15; * suspicion of intracranial hypertension; * peri-incisional infection; * participants who have received radiation therapy and chemotherapy preoperatively or with a high probability to require a postoperative radiation therapy and chemotherapy according to the preoperative imaging.

Keywords: postoperative pain; post-craniotomy; methylprednisolone ropivacaine scalp infiltration
isthmic spondylolisthesis treated with combined approach: clinical and radiological outcomes

Conditions: Isthmic Spondylolisthesis; Surgical Procedure, Unspecified

Summary: this study aims to evaluate clinical and radiological outcomes of isthmic spondylolisthesis surgically treated with combined approach. the goal is to demonstrate that it is a safe and efficient technique to treat isthmic spondylolisthesis. there is very little literature concerning this procedure.

isthmic spondylolisthesis can cause back and leg pain. if pain persists after well conducted medical management, a surgical treatment can be proposed. even though the goal is consensual, there are plenty of ways to reach vertebral fusion: alif, plif, tlif, posterior fusion only, etc... this study aims to evaluate clinical and radiological outcomes of isthmic spondylolisthesis surgically treated with combined approach. the goal is to demonstrate that it is a safe and efficient technique to treat isthmic spondylolisthesis using standard xrays, ct scan and patient reported outcome measurements. there is very little literature concerning this procedure.

Eligibility criteria:
inclusion criteria: * all patients aged over 18 years * with isthmic spondylolisthesis at l4-l5 or l5-s1 * operated in our center with a double approach: anterior lumbar interbody fusion then postero-lateral fusion * consent for participation exclusion criteria: * pseudarthrosis l5-s1

Keywords: isthmic spondylolisthesis vertebral fusion combined approach circumferential fusion alif posterior fusion
plant-based dietary intervention in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current american diabetes association (ada) guidelines. the principal measure is hemoglobin a1c. cardiovascular risk factors and dietary acceptability are also assessed. the study duration is 22 weeks with a one-year follow-up.

preliminary evidence suggests that low-fat, vegetarian regimens similar to those used to reverse coronary artery blockages may have a significant beneficial effect on type 2 diabetes, as demonstrated by reductions in fasting serum glucose concentrations and medication use. we therefore randomly assigned 99 individuals with type 2 diabetes to either a low-fat, vegan diet or a diet based on current american diabetes association guidelines for 22 weeks with a one-year follow-up period. the principal dependent measure is hemoglobin a1c. cardiovascular risk factors are also being tracked, as is dietary acceptance.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus exclusion criteria: * hemoglobin a1c values \ 10.5% * use of insulin for \> 5 years * tobacco use within the preceding 6 months * consumption of more than 2 alcoholic beverages per day * current drug abuse * pregnancy * unstable medical status * current use of a low-fat, vegetarian diet.

Keywords: diabetes mellitus, type 2 diet, vegetarian diet, fat-restricted glycemic index
a study to compare multiple doses intravitreal microplasmin for treatment of patients with vitreomacular traction (mivi-iit)

Conditions: Vitreomacular Traction

Summary: a multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical pvd induction for treatment of patients with vitreomacular traction.


Eligibility criteria:
inclusion criteria: * patients \>_ 18 years of age with vitreomacular traction exclusion criteria: * pvd present at baseline * certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (pvr) * vitreous hemorrhage * patients who have had a vitrectomy in the study eye at any time

Keywords: vitreomacular traction maculopathy vmt pvd
circulating micrornas for discriminating obese preschoolers at risk of diabetes

Conditions: Discriminate Obese Children at Risk for Diabetes.

Summary: childhood obesity certainly increases susceptibility to type 2 diabetes (t2d) in adulthood. recently, micrornas (mirnas) are closely related to various diseases and have been suggested as valuable biomarkers. here, we sought to identify potential mirnas to discriminate obese children at risk for diabetes in future.

this study was designed to screen the circulating mirnas in association with progression from children obesity to type 2 diabetes (t2d) in adulthood. serum samples were evaluated in a 3 step procedure: 1) discovery study, in which samples from obese children and healthy controls were pooled for mirna sequecing experiment; 2) cross-sectional validation study, in which mirnas of interest were validated in all individuals (obese children, overweight children and normal controls); 3) longitudinal validation study, in which the candidate mirnas were estimated in newly diagnosed diabetes patients and normal glucose tolerance controls (ngt). the final determined mirnas were further confirmed though primary function studies.

Eligibility criteria:
inclusion criteria: obese preschoolers; adults with type 2 diabetes; age-matched healthy controls. exclusion criteria: -

Keywords: circulating microrna childhood obesity adulthood diabetes
belgian real life non-interventional study (nis) on xarelto in non-valvular atrial fibrillation (af) patients treated for the prevention of stroke and systemic embolism

Conditions: Atrial Fibrillation

Summary: the objective of this nis is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with non-valvular af treated with xarelto, in accordance with the terms of the european marketing authorization and the belgian reimbursement criteria.


Eligibility criteria:
inclusion criteria: * adult patients ≥ 18 years old with a confirmed diagnosis of non-valvular atrial fibrillation * patients must in addition present with at least one of following risk factors: * prior stroke, tia (transient ischemic attack) or non-cns (central nervous system) systemic embolism * left ventricular ejection fraction of \< 40% * symptomatic heart failure, new york heart association class 2 or higher * age ≥75 years * age ≥65 years in combination with either diabetes, coronary disease or arterial hypertension exclusion criteria: * patients who do not fulfil the belgian reimbursement criteria

Keywords: non-valvular atrial fibrillation stroke systemic embolism oral anticoagulation real-life setting preventive measure
type 2 diabetes glucose biomarker study with a continuous glucose monitoring system

Conditions: Healthy; Type 2 Diabetes Mellitus

Summary: current gold standard methodologies for diagnosing type 2 diabetes (t2d) or prediabetes can be unreliable and inaccurate, and require the need for multiple different tests for comparison. it is possible that a simpler and more refined method of diagnosing t2d or prediabetes involves examining the proportional-integral (pi) control system of the body's glycemic function (i.e., a model of the glucose curve). the purpose of this research is to examine how well a pi model can diagnose nondiabetic, prediabetic, or diabetic patients based on glucose data gathered from a wearable glucose monitoring device.


Eligibility criteria:
inclusion criteria: * either male or non-pregnant, non-lactating female aged \> 18-60 \<years (both inclusive) * subjects willing to give written informed consent * healthy volunteers * subjects able to comply with the study protocol * women of child bearing potential must have a negative urine pregnancy test prior to study entry * minimum 4 subjects in each interval of approx 7 years (18-25/26-32/32-38/39-45/46-52/53-59) * minimum 40% subjects of one gender to mark relative distribution exclusion criteria: * any person below the age of 18 years * suspected or confirmed pregnancy * currently breastfeeding * diagnosis of any known chronic or acute medical disease of any kind (e.g., cardiovascular disease, respiratory disease, influenza, pneumonia, etc.) * diagnosis of any known neurological disease or psychological disorder of any kind (e.g., brain lesion, epilepsy, anxiety, eating disorder, mood disorder, sleep disorder, etc.) * any implanted electrical medical device (e.g., pacemaker, insulin pump, deep brain stimulator, etc.) * any form of prescription medication * use of antibiotics in the three months prior to enrollment * any person planning to undergo a magnetic resonance imaging (mri), computed tomography (ct) scan, or high-frequency electrical heat (diathermy) treatment during the duration of the study (as per restrictions of the freestyle libre pro device)
the effectiveness of smartphone application on the serevity of obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: a two-year study design is formulated. the overall aim of this study is to examine the effectiveness of the care model combing smartphone application on improve obstructive apnea in obesity adults.

this study was the second year.the purpose of this study is to evaluate the effectiveness of the lifestyle modification intervention for overweight employees with obstructive sleep apnea. a randomized control trial with single blind will be used. stratified with proportional randomized sampling will be employed and 160 suitable participants will be recruited from 4 electronics industries in northern of taiwan. the subjects will be randomly divided into three groups. the total duration of intervention program is 6 months. only the intervention group received the combining smartphone application with lifestyle modification intervention. the home portable sleep monitor will be used to collect the change of ahi at baseline, 3, and 6 months after intervention.

Eligibility criteria:
inclusion criteria: a) \>21 years old; b) )bmi greater than24 kg/m2; (c) the absence of any mental disorder, alcohol and drug addiction, and serious disease, such as cancer or cardiorespiratory failure; and d) screening for osa , ahi\>5 and voluntary participation. - exclusion criteria: * a) diagnosis of osa and currently under treatment and；b) diagnosis of severe depression (c) have cardiopulmonary diseases and are not suitable for activities; and d) plan to become pregnant during or within 6 months

Keywords: obstructive sleep apnea home portable sleep monitor smartphone application lifestyle modification intervention