Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of extracorporeal shockwave therapy in the treatment of patients with resistant hypertension

Conditions: Hypertension, Resistant to Conventional Therapy

Summary: low intensity shockwaves have been proven in animal and human studies to increase tissue perfusion, promote angiogenesis and tissue regeneration and improve neural function. the hypothesis of this study is that shockwave therapy could improve the symptoms of patients with resistant hypertension.


Eligibility criteria:
inclusion criteria: * subjects who have provided written informed consent. * age ≥18 and ≤80 years old. * office systolic blood pressure that remains ≥160 mmhg (≥150 mmhg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic (unless there is a tolerance or a contraindication for a diuretics). * able and willing to comply with the required follow-up schedule. exclusion criteria: * subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to screening. * have hypertension secondary to an identifiable and treatable cause or take medication that can raise the bp. * prior renal artery intervention (balloon angioplasty or stenting). * pregnancy. * uncompensated heart failure. * chronic liver disease. * patients with skin wound / infection at the treatment area. * subjects who take oral anti-coagulants. * local tumor of treatment area.

Keywords: resistant hypertension rh rht blood pressure kidney shockwave
evaluation effects of nasal nitric oxide measurements are associated with atopy status in chronic nasal inflammation

Conditions: Hypersensitivity; Rhinitis; Respiratory Tract Diseases; Nasal Polyps; Nitric Oxide

Summary: nitric oxide (no) was considered as a mediator of nasal inflammation and the measurement of nasal nitric oxide (nno) may assist in the diagnosis of nasal inflammation. few data exists comparing nno with established, larger accepted reference standard for chronic rhinosinusitis (crs) diagnosis. moreover, the role of atopic status on nno in nasal inflammatory diseases has not been reported. the aim of our study was to determine the value of nno in patients with chronic nasal inflammation, and to assess the relationship between nno and atopic status in these patients. a total of 131 randomized patients suffering form chronic nonallergic nasal inflammation and 20 healthy volunteers were finally recruited. nno was measured by niox devices. sinus computed tomography (ct) scan, nasal endoscope and nasal symptoms evaluation were used in the different diagnosis of chronic rhinitis (cr), crs without nasal polyps (crssnp) and crs with nasal polyps (crswnp). atopic status was confirmed by skin prick test and serum ige levels. blood eosinophils were evaluated simultaneously. relationships among nno, various atopic characteristics and chronic nasal inflammation were evaluated.


Eligibility criteria:
inclusion criteria: * diagnosed as cr, crssnp or crswnp based on the criteria of the european position paper. * had at least two or more symptoms, one of which was either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip), and/or facial pain/pressure, and/or reduction or loss of smell; * either endoscopic signs of polyps and/or mucopurulent discharge primarily from the middle meatus and/or oedema/mucosal obstruction primarily in the middle meatus. exclusion criteria: * pregnancy, lactation, significant psychologic problems, inability to comply with study protocol, children under 18 years of age, systemic diseases affecting the nose (e.g., wegener's granulomatosis, sarcoid, and acute upper or lower respiratory tract infections within 2 weeks before the inclusion visit) * use of systemic corticosteroids within 2 weeks before the inclusion visit, systemic diseases preventing participation in the study, and medical or surgical treatments influencing the study. * patients with diagnosed atopic dermatitis and atopic asthma. * patients with diagnosed allergic rhinitis.

Keywords: chronic nasal inflammation nasal nitric oxide atopy
medication treatment for opioid use disorder in expectant mothers: conceptual model assessments sub-study

Conditions: Opioid-Related Disorders; Drug Addiction; Pregnancy Related; Substance Abuse; Drug Abuse; Neonatal Abstinence Syndrome; Neonatal Opioid Withdrawal Syndrome; Drug Abuse in Pregnancy

Summary: this is a sub-study of nida ctn protocol 0080: medication treatment for opioid use disorder in expectant mothers (moms; unique protocol id: 2019-0429-1). participants in moms will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (bup-xr), may improve mother-infant outcomes, compared to sublingual buprenorphine (bup-sl). the additional data collected in this sub-study will be combined with data from the main moms trial. it is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).


Eligibility criteria:
inclusion criteria: * participating in the moms trial (unique protocol id: 2019-0429-1) exclusion criteria: -

Keywords: ctn-0080 clinical trials network medication assisted treatment pharmacokinetics
temozolomide in elderly patients with kps < 70

Conditions: Primary Brain Tumor; Glioblastoma

Summary: the management of glioblastoma in elderly patients with poor performance status (kps\<70) is unsettled. this single arm phase 2 trial trial was designed to evaluate the efficacy and safety of temozolomide alone in this population

this trial was conducted to evaluate the efficacy, in terms of survival and quality of life, and safety of up-front temozolomide in elderly gbm patients with poor performance status. patients of 70 years of age or older were eligible to participate in this prospective non-randomised multicentric phase ii study if they had newly diagnosed and histologically proven glioblastoma on the basis of the who classification, and a postoperative kps between 30 and 60. treatment consisted of temozolomide 150-200 mg/m2/day for 5 consecutive days every 4 weeks for a maximum of 12 cycles or until disease progression or prohibited toxicity. patients were assessed at least every month by means of physical and neurological examinations, kps, health-related eortc questionnaires (qlq-c30 and qlq-bn20), and mmse. complete blood counts and blood chemistry were drawn before each temozolomide cycle; the earlier were also checked every 10 days during the first 2 cycles and every 2 weeks afterwards. ct or mri studies were repeated every 2 months.

Eligibility criteria:
inclusion criteria: * histologically confirmed supratentorial glioblastoma * baseline contrast-enhanced ct or gadolinium-enhanced mri study performed within the first 4 days from resection or within the first 4 weeks from diagnostic biopsy * patients aged 70 years or older * kps above 30 and below 70 * life expectancy higher than 4 weeks * clinical examination at baseline * affiliation to social security or mandatory beneficiary * patient being informed and obtention of written informed consent exclusion criteria: * prior surgical resection dated more than 1 month before inclusion * prior brain radiotherapy or chemotherapy * severe underlying disease which could interfere with survival * history of hypersensibility reaction on temozolomide components * severe bone marrow hypoplasia * aspartate aminotransferase or alanine aminotransferase more than 3 times the upper limit of normal * absolute neutrophil count \< 1.5x109 cells per liter * platelet count \< 100x109 cells per liter * hemoglobin \< 9 g/dl * neuroimaging baseline examination performed beyond the first 4 days from resection or beyond the first 4 weeks from diagnostic biopsy

Keywords: temozolomide elderly glioblastoma karnofsky performance score (kps)
search for biomarkers of infection and inflammation in patients with acute stroke.

Conditions: Stroke, Acute; Pneumonia, Bacterial

Summary: this study will look for new biomarkers of infection and evaluate current biomarkers of infection in stroke patients. patients with acute stroke will be monitored with daily blood samples for seven days and by clinical examination to detect infections for 10 days.

rationale: stroke is one of the leading causes of death globally, and infections after stroke contribute to a large part of the stroke-related mortality. the current study, which has a prospective, observational design, constitutes the second phase out of four in the inflammatory biomarkers in stroke (ibis) project, of which the overall goal is to enable early treatment of post-stroke infections. aim: to develop a combined clinical and molecular biological signature for early detection of pneumonia in patients with stroke. design: prospective nested case control study methods:patients (n=200) with acute stroke will be monitored with clinical examinations for ten days and by daily blood samples for seven days. when cases of pneumonia have been established, samples and examination results from days preceding overt pneumonia will be compared to samples from similar patients that did not develop pneumonia. outcome: using proteomic and metabolomic methods, novel markers of upcoming pneumonia after stroke will be sought. such laboratory markers will be combined with current biomarkers (such as c-reactive protein and procalcitonin) and data from clinical examinations, with the aim of constructing a biological signature that enables early detection of pneumonia.

Eligibility criteria:
inclusion criteria: * symptoms and radiology consistent with acute cerebral infarction or atraumatic intracerebral hemorrhage. * national institutes of health stroke scale (nihss) ≤5; mild stroke (n=25), nihss ≤10 and ≥ 6; moderate stroke (n=25) or nihss ≥ 11; severe stroke (n=150) * onset of symptoms less than 48 hours before first study blood sampling. exclusion criteria: * symptoms and radiology consistent with acute cerebral infarction but full reversal of symptoms within 24 hours of onset. (i.e. transient ischemic attack, tia) * hemoglobin less than 90 g/l. * ongoing inflammatory disease, such as rheumatoid arthritis or active inflammatory bowel disease. * inability to undergo mri scan (only patients with nihss ≤10 will be excluded by this criteria)

Keywords: stroke pneumonia biomarkers infection
study to evaluate the safety and immunogenicity of mg1109 in healthy adult volunteers

Conditions: Influenza

Summary: this study was designed in two steps with step 1, a single-center, double-blind, randomized clinical pilot study and step 2, a multi-center, single-blind, randomized clinical pivotal study. the investigator evaluate the immunogenicity and safety of the investigational vaccine in the subjects during their participation in the study.

mg1109 is purified, inactivated influenza viral antigen.

Eligibility criteria:
inclusion criteria: * healthy adults who are available for follow-up during the study exclusion criteria: * subjects with history of exposure to the h5n1 subtype or h5n1 subtype vaccine * subjects with immune system disorder including immune deficiency disease

Keywords: avian influenza
breast screening - risk adaptive imaging for density

Conditions: Breast Cancer

Summary: braid is a randomised, multi-centre study assessing the impact of supplementary imaging in the detection of breast cancer in women participating in the uk national breast screening programme who have dense breast tissue.

breast density is a measure of the amount of fibroglandular tissue and is a risk factor for breast cancer. women with extremely dense breasts are at 4-fold increased breast cancer risk compared to women with 'fatty' breasts. high breast density reduces the sensitivity of mammography increasing the probability of the test missing a cancer. women with dense breasts have their cancers found when the cancer is larger as they present with interval cancers or their cancers are not detected until the next screening round at a later stage. the uk national breast screening programme (nhs bsp) offers all women aged 50-70 screening with 3-yearly mammograms. it aims to reduce breast cancer mortality by 20% by detecting small cancers thereby reducing the number of late stage diagnoses. however only 53% of the cancers being detected are small (\<15mm). this is partly due to masking of cancers by dense breast tissue. this trial addresses how best to screen women with dense breasts for breast cancer. braid will randomise women whose recent screening normal mammogram shows that they have dense breasts to either standard of care (no supplementary imaging) or supplementary imaging with abbreviated mri (abb-mri), automated whole breast ultrasound (abus) or contrast enhanced spectral mammography (cem). these imaging techniques have been shown to be more sensitive than mammography at detecting cancers in dense breast tissue. our hypothesis is that more cancers will be detected at an earlier stage with supplemental imaging.

Eligibility criteria:
inclusion criteria: * willing and able to give written informed consent * willing and able to comply with the scheduled study visits, tests and other procedures * female * screening mammogram that is either normal or being recalled for assessment * increased breast density identified on current screening mammogram examination (birads c or d) * if birads c the reporting radiologist should use clinical judgement as to eligibility, there should be a high chance of a cancer being masked in this participant * all birads d will be eligible * aged 50-70 and eligible for 3-yearly nhs breast screening exclusion criteria: * known brca carrier or ≥50% risk of being a carrier * unable to give informed consent * breast implant(s) * unable to be followed-up for the study duration * current participation in another interventional breast screening trial (including but not limited to mypebs) * participated in part a of the braid study * pregnant or breast feeding
effect of bia 9-1067 on the pharmacokinetics of repaglinide

Conditions: Parkinson Disease

Summary: the purpose of this study is to investigate the cyp2c8 inhibition by bia 9-1067.

single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers

Eligibility criteria:
inclusion criteria: * able and willing to give written informed consent. * male or female subjects aged between 18 and 45 years, inclusive. * subjects of body mass index (bmi) between 19 and 30 kg/m2, inclusive. * healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ecg. * negative tests for hbsag, anti-hcvab and hiv-1 and hiv-2 ab at screening. * clinical laboratory test results clinically acceptable at screening and admission to each treatment period. * negative screen for alcohol and drugs of abuse at screening and admission to each treatment period. * non-smokers or ex-smokers for at least 3 months. * (if female) she was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine device. * (if female) she had a negative urine pregnancy test at screening and admission to each treatment period. exclusion criteria: * clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders. * clinically relevant surgical history. * any abnormality in the coagulation tests. * any abnormality in the liver function tests. * a history of relevant atopy or drug hypersensitivity. * history of alcoholism or drug abuse. * consumed more than 14 units of alcohol a week. * significant infection or known inflammatory process at screening or admission to each treatment period. * acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period. * had used medicines within 2 weeks of admission to first period that may have affected the safety or other study assessments, in the investigator's opinion. * had previously received bia 9-1067. * had used any investigational drug or participated in any clinical trial within 6 months prior to screening. * had participated in more than 2 clinical trials within the 12 months prior to screening. * had donated or received any blood or blood products within the 3 months prior to screening. * vegetarians, vegans or had medical dietary restrictions. * cannot communicate reliably with the investigator. * unlikely to co-operate with the requirements of the study. * unwilling or unable to gave written informed consent. * employees at bial - portela \& cª, s.a. * (if female) she was pregnant or breast-feeding. * (if female) she was of childbearing potential and she did not used an approved effective contraceptive method (double-barrier or intra-uterine device) or she used oral contraceptives.

Keywords: parkinson disease bia 9-1067
the effect of blood flow restriction training on muscle atrophy following knee surgery

Conditions: Knee Injuries

Summary: the investigators will compare differences in quadriceps strength, leg girth, and functional outcome scores between two groups of patients after weeks 6 and 12 as well as 6 months following meniscus or articular cartilage repair/restoration requiring 6 weeks of non-weight bearing or limited weight bearing status in a brace at 0° degrees of knee extension. one group will receive bfr with standard post-operative rehabilitation for 12 weeks followed by the standard protocol progression for the remainder of the treatment program. the other group will receive standard post-operative rehabilitation without bfr for the duration of treatment program.

the aim is to compare strength, patient reported outcomes, and functional outcomes of post-operative therapy with and without adjunctive bfr training. to accomplish this task the investigators will compare differences in thigh girth between two groups of patients after the first 6 weeks and 12 weeks as well as 6 months following meniscus or articular cartilage repair requiring 6 weeks of non-weight bearing or limited weight bearing status in a brace at 0˚ degrees of extension. in addition, isokinetic testing of the quadriceps and hamstrings will be performed at 12 weeks and 6 months post-operatively. lower extremity girth measurements after knee surgery can be performed with good to excellent intra- and inter-rater reliability. quadriceps strength measured with isokinetic testing is related to performance measures such as jumping. limb circumference measurement, limb csa measurement, and isokinetic strength testing are commonly utilized in bfr studies as outcome measures.one group will receive bfr for 12 weeks in addition to standard post-operative rehabilitation and the other group will receive standard post-operative rehabilitation without bfr.

Eligibility criteria:
inclusion criteria: * military healthcare beneficiaries between the age of 18 and 50 years. * must intend to remain on station at location of surgery for 6 months from date of surgery. * meniscus repair or cartilage restoration technique to include microfracture, osteochondral autograft transfer system, osteochondral allograft transplantation, and autologous chondrocyte implantation following standard post-operative protocol guidelines requiring a 6 week period of non-weight bearing or limited weight bearing in a brace at 0˚ degrees of extension. exclusion criteria: * concomitant ligamentous repair/reconstruction * known pregnancy * any medical condition for which aerobic exercise is contraindicated * additional back, hip, or knee surgery in the previous 12 months * history of vascular or cardiac impairment

Keywords: blood flow restriction strength muscle atrophy post-operative therapy knee
impact of ct on diagnosis of acute appendicitis

Conditions: Acute Appendicitis

Summary: the purpose of this study is to determine whether computed tomography is reliable investigation in the diagnosis of acute appendicitis.

the aim of this study is to 1. evaluate ct scan validity for the diagnosis of acute appendicitis. 2. compare the difference in evaluation of ct-scan result between radiologist on call and consultant radiologist with ct experience. 3. illustrate difficulties associated with practical implementation of ct-scan in relation to other activities in radiology department and o.r. (logical \& organizational). 4. illustrate patients experiences about the study (pain, discomfort \& other information

Eligibility criteria:
inclusion criteria: * patients who have been admitted and diagnosed as having acute appendicitis exclusion criteria: * patients under the age of 18 years. * pregnancy. * uncooperative patients (senile dementia, mentally ill). * not speaking danish. * does not wish to participate.

Keywords: acute appendicitis diagnosis computed tomography
can testosterone accelerate injury recovery after arthroscopic rotator cuff repair

Conditions: Rotator Cuff Tears

Summary: the objective of this study is to determine if treating patients undergoing arthroscopic rotator cuff repair with testosterone will allow patients to accelerate their recovery time after surgery.

specific aim i: to determine if testosterone treatment would provide superior patient-determined quality-of-life and activity scores in patients undergoing arthroscopic rotator cuff repair compared to a control group at 3 months after surgery. specific aim ii: to determine if testosterone treatment would allow for greater postoperative strength improvements in patients undergoing arthroscopic rotator cuff repair compared to a control group at 3 months after surgery. specific aim iii: to determine if testosterone treatment would allow for greater postoperative range of motion improvements in patients undergoing arthroscopic rotator cuff repair compared to a control group at 3 months after surgery. specific aim iv: to determine if the potentially higher activity levels allowed by the testosterone treatment would affect the success of rotator cuff healing as determined by magnetic resonance imaging at one year after arthroscopic rotator cuff repair. the hypothesis of this study was that testosterone treatment of patients undergoing arthroscopic rotator cuff repair would allow patients to achieve 1) better quality-of-life and higher activity levels as determined by patient-determined outcome scores, 2) greater improvements in strength, and 3) greater improvements in range of motion at three months after surgery as compared to the control group. in addition, the authors hypothesize that there would be equivalent healing rates at one year after rotator cuff repair as determined by magnetic resonance imaging between the testosterone group and the control group.

Eligibility criteria:
inclusion criteria: * males * arthroscopic rotator cuff repair is an indicated treatment exclusion criteria: * female patients * irreparable rotator cuff tears * tears requiring margin convergence repair * atrophy of the rotator cuff greater than stage ii as determined by the modified goutallier staging system * revision rotator cuff repair * inflammatory arthritis * adhesive capsulitis * significant cervical pain or radiculopathy * history of prostate cancer * history of benign prostatic hypertrophy * history of heart failure * history of obstructive sleep apnea * history of polycythemia * history of venous thromboembolism or inherited thrombophilia

Keywords: arthroscopic rotator cuff repair testosterone accelerate recovery from surgery