Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and effectiveness of a new non-nucleoside reverse transcriptase inhibitor (nnrti), (+)-calanolide a, in hiv-positive patients who have never received anti-hiv treatment

Conditions: HIV Infections

Summary: the purpose of this study is to test the safety and effectiveness of a new non-nucleoside reverse transcriptase inhibitor (nnrti), (+)-calanolide a, in hiv-positive patients who have never received anti-hiv treatment.

patients are randomized into 2 cohorts, with cohort 2 receiving a higher dosage than cohort 1. patients in each cohort receive either (+)-calanolide a or a placebo for 14 days, followed by a 14-day follow-up period. following study treatment, patients may elect to receive an open-label, 6-month course of anti-hiv drugs to be selected by and administered under the care of the patient's physician.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are hiv-positive. * have a cd4 count of at least 250 cells/mm3. * have an hiv count (viral load) of at least 5,000 copies/ml. * are at least 18 years old. exclusion criteria you will not be eligible for this study if you: * have received prescription or nonprescription medications within 14 days of study entry, or if you will need to take any of these medications during the study. * have ever received anti-hiv medications. * test positive for hepatitis b. * have received a blood (or red blood cell) transfusion within 3 months prior to study entry. * have severe diarrhea. * have severe heart, liver, kidney, or neurological (brain and spinal cord) disease. * have hemophilia or another blood disorder. * have received certain medications or vaccines within 30 days prior to study entry. * have received chemotherapy or radiation within 16 days prior to study entry, or if you will need either of these during the study.

Keywords: anti-hiv agents
lumbar proprioception in lower back pain patients versus healthy subjects : a comparative study on the effects of low- and high-frequency muscle vibrations

Conditions: Back Pain

Summary: the primary objective of this study is to compare the lumbar proprioception of patients with chronic back pain to that of healthy volunteers during low- and high-frequency muscle vibration. the order of measures (low frequency of vibration, high frequency vibration and no vibration) is randomized in a cross-over design. patients and volunteers are matched by age and body mass index.

the secondary objectives of this study are: a-measure the effect of low- and high-frequency vibrations on lumbar repositioning in patients with chronic lower back pain. b-measure the effect of low- and high-frequency vibrations on lumbar repositioning in healthy volunteers. our working hypothesis is that low frequency vibrations induce an illusion of shortening, and high frequency vibrations induce an illusion of elongation. the variability of the error should not increase.

Eligibility criteria:
inclusion criteria for patients: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient has had chronic low back pain (which did not originate in a postoperative setting) for at least 6 months inclusion criteria for healthy volunteers: * the subject must have given his/her informed and signed consent * the subject must be insured or beneficiary of a health insurance plan exclusion criteria for patients: * the patient is under judicial protection, or any kind of guardianship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant, parturient, or breastfeeding * the patient has a history of spinal surgery * the patient has a history of preexisting postural disorder preceding low back pain * the patient has been treated in the last month (e.g. back pain injections) * the patient has a balance disorder, blindness, inability to perform the experimental protocol exclusion criteria for healthy volunteers: * the subject is under judicial protection, or any kind of guardianship * the subject refuses to sign the consent * it is impossible to correctly inform the subject * the subject is pregnant, parturient, or breastfeeding * the subject has a history of spinal surgery * the subject has a history of preexisting postural disorder preceding low back pain * the subject has been treated in the last month (e.g. back pain injections) * the subject has a balance disorder, blindness, inability to perform the experimental protocol * the subject has a history of acute low back pain \> 15 days or which has resulted in leave from work for more than 7 days in the 5 years preceding the study

Keywords: vibration proprioception
secondary prevention of osteoporotic fractures in residents of long-term care facilities

Conditions: Hip Fractures; Osteoporosis

Summary: osteoporotic fractures of the hip are a major cause of admission to long-term care facilities. such fractures put patients at high risk for further fractures, pain and disability. current data show that many patients in long-term care facilities do not receive fda medications for their osteoporosis. this trial will test whether a multi-model intervention (which provides feedback about provider use of osteoporosis medications, information about osteoporosis, and currently approved osteoporosis medications)directed at physicians, other health care providers, and nurses will improve the number of prescriptions written for fda approved medications for osteoporosis treatment.


Eligibility criteria:
inclusion criteria: any north carolina long-term care facility with ten residents who had had a hip fracture or osteoporosis diagnosis

Keywords: all nc ltc facilities having ten residents with a hip fracture or osteoporosis on the mds will be invited to participate in the trial
quality of life intermittent catheter study

Conditions: Neurogenic Bladder Dysfunction Nos

Summary: the purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the intermittent self-catheterisation quality of life measure.


Eligibility criteria:
inclusion criteria: * is at least 18 years of age * has given written informed consent * has neurogenic bladder dysfunction * has used coated intermittent catheter as primarily bladder emptying method for at least 6 months * is able to self-catheterise * is able to use speedicath® compact catheters * if spinal cord injury subject, injury must have occurred more than 12 months ago * covered by social security system exclusion criteria: * has used speedicath® compact catheters (not including screening for this investigation) * is admitted to rehabilitation centre * subjects using primarily catheter sets * is pregnant or breast-feeding
breathing control in patients with chronic obstructive pulmonary disease (copd)

Conditions: COPD

Summary: there is a demand for explorative and comparative studies on various non-pharmaceutical efforts in treating and helping chronic obstructive pulmonary disease patients. this study has been developed in light of this need. the main purpose of the project is to test whether a device guided breathing control system can decreasing the feeling of breathlessness in patients with moderate stage and severe stage of copd. in addition the study could shed light on whether a reduced feeling of breathlessness can lead to improved physical function, and less experience of other symptoms (i.e., depression, anxiety, sleeping difficulties, fatigue, pain) and provide a better quality of life for patients with copd.


Eligibility criteria:
inclusion criteria: * dyspnoea symptoms in daily life * spirometry values showing a copd moderate stage ii (fev1/fvc\<70%, fev1\<80%) and severity grade at a severe stage iii (fev1/fvc\<70%, fev1\<50% and fev1 = 30% of a predicted) * be able to read, write and speak norwegian * be at a stable phase of the disease exclusion criteria: * changes in pulmonary medication during the last 4 weeks * diagnosis of cancer * presently attending a pulmonary rehabilitation course or other similar copd education courses (due to the fact that these courses often have instructions on breathing control), or having attended similar courses during the last six months * ongoing exacerbation * attending other competitive studies * diagnosis of neuromuscular disease * diagnosis of dementia * attending help from a pulmonary physiotherapist

Keywords: breathlessness symptoms quality of life
effect of obesity on ozone-induced airway inflammation

Conditions: Obesity

Summary: the purpose of this study is to compare the effect of ozone exposure on airway reactivity and inflammation in obese vs. non-obese adults.

obesity has been shown to be associated with initial onset of asthma in children and increased airway hyperresponsiveness in adults (1,2). an important aspect of these epidemiologic data is that the impact of obesity on asthma is much stronger in females than males. for example, the incidence of asthma after the age of 11 years is five- to sevenfold higher in female children who become obese versus those who remain lean, whereas no such relationship exists for males (3). recent mouse models of obesity suggest that this condition enhances airway responses to ozone air pollution (4). these mice eat excessively due to a defect in the gene encoding leptin, a satiety hormone produced in adipocytes. shore et al (4) showed that these leptin-deficient obese mice had greater airway hyperreactivity to i.v. methacholine following ozone exposure compared to lean, wild-type mice. furthermore, administration of exogenous leptin (which is actually increased in the serum of obese individuals (4)) was shown to enhance ozone-induced cytokine and protein release into bal fluid of lean, wild type mice (4). reduced lung volumes and altered breathing patterns in the obese may also contribute to enhanced airway reactivity in these patients (5). stretch of airway smooth muscle during tidal breathing and especially during deep breaths, i.e. sighs, acts as a potent bronchodilator that might ameliorate ozone-induced bronchoconstriction. the increased chest load associated with obesity may also diminish tidal breathing volumes and frequency of sighs during ozone exposure.

Eligibility criteria:
inclusion criteria: * twenty (20) non-obese, non-overweight (body mass index, 18 kg/m2 \> bmi \ bmi \ = 35 inches) volunteer females between 18-35 yrs of age exclusion criteria: * are female and pregnant or have any reason to believe you might be pregnant. * are not between 18 and 35 years old. * have a history of asthma or have current hay fever. * have ever smoked more than 10 cigarettes (one half pack) a month or smoked during the past 30 days. * have a history of acute or chronic cardiovascular disease, chronic respiratory disease, and acute respiratory illness within 4 weeks. * have contraindications for performing sustained light exercise. * you've been in a recent or recurring exposure to a dusty environment at work * if you are unwilling to refrain from strenuous physical activity for 24 hours before and after each exposure.

Keywords: ozone clean air
glumetinib combined with osimertinib in the treatment of relapsed and metastatic non-small cell lung cancer patients who failed to receive egfr inhibitors

Conditions: Negative T790M Mutation and Met Amplification

Summary: to explore the safety and efficacy of glumetinib combined with osimertinib in the treatment of relapsed and metastatic non-small cell lung cancer (nsclc) with failed first-generation or second-generation egfr inhibitors, negative t790m mutation and met amplification.

to explore the safety and efficacy of glumetinib combined with osimertinib in the treatment of relapsed and metastatic non-small cell lung cancer (nsclc) with failed first-generation or second-generation egfr inhibitors, negative t790m mutation and met amplification.

Eligibility criteria:
inclusion criteria: * can fully understand and sign informed consent form(icf) voluntarily male and female patients 18-80 (inclusive) years of age * stage: iiib/iiic/iv (ajcc version 8) * ecog performance status (ps): 0-1 * at least one measurable lesion as per recist 1.1 exclusion criteria: * subjects with characterizedalk or ros1 activating mutations that predict sensitivity to anti-alk-therapy or anti-ros1-therapy; t790 mutations is uknown or positive * patients who have symptomatic cns metastasis which is neurologically unstable or those who have cns disease requiring increase in the dose of steroid. (note: patients with controlled cns metastasis can participate in the trial. before entering the study, patients should have finished radiotherapy, or have received operation for cns tumor metastasis at least two weeks before. patients' neurological function must be in a stable state; no new neurological deficit is found during clinical examination and no new problem is found during cns imaging examinations. if patients need to use steroids to treat cns metastasis, the therapeutic dose of steroid should be stable for ≥3 months at least two weeks prior to entering the study.) * prior exposure to met-directed or third generation egfr inhibitors therapy anticancer therapy (including chemotherapy, targeted therapy, biotherapy, hormone therapy or other investigational agents) within 4 weeks or 5 times of half-lives (whichever is shorter) prior to the first dose of the study drug or who have not recovered from the side effect of such therapy * major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product

Keywords: met amplification， t790
efficacy and safety of alisporivir alone or combined with rbv or peg in chronic hepatitis c genotype 2 and 3 treatment-naïve participants

Conditions: Hepatitis C; Chronic Pain

Summary: the study is to investigate whether alisporivir (alv; deb025) alone or in combination with either ribavirin (rbv) or peginterferon alfa-2a (peg) is more efficient compared to standard of care (peg+rbv) in treatment-naïve participants with hepatitis c virus (hcv) genotype 2 and 3. in addition, triple therapy with deb025 plus standard of care will be applied to participants not achieving rapid viral response (rvr) in the different arms.


Eligibility criteria:
inclusion criteria: * chronic hepatitis c viral infection * plasma hcv rna level lower limit ≥ 10,000 iu/ml assessed by quantitative polymerase chain reaction (qpcr) or equivalent at screening (no upper limit) * hcv genotype 2 or 3 * no previous treatment for hepatitis c infection exclusion criteria: * evidence of cirrhosis at the time of screening * evidence of hepatocellular carcinoma at the time of screening * any other cause of relevant liver disease other than hcv * alanine aminotransferase (alt) ≥ 10 times upper limit of normal (uln) * other protocol-defined inclusion/exclusion criteria may apply

Keywords: chronic hepatitis c genotype 2 chronic hepatitis c genotype 3 cyclophilin inhibitor
identifying early lung cancer cells in malignant pleural effusion samples from patients with primary lung cancer

Conditions: Lung Cancer; Metastatic Cancer

Summary: rationale: studying samples of pleural fluid in the laboratory from patients with lung cancer may help doctors identify early lung cancer cells. it may also help the study of lung cancer in the future. purpose: this laboratory study is looking at malignant pleural effusion samples from patients with primary lung cancer to see if early lung cancer cells can be identified.

objectives: * isolate and identify lung cancer precursor cells in discarded pleural fluid specimens obtained during routine thoracentesis procedures for the diagnosis and treatment of malignant pleural effusions. outline: malignant pleural effusion specimens obtained from the pathology department at the university hospitals of cleveland are analyzed using an immunomagnetic bead enrichment assay to isolate cells of epithelial origin. the isolated cells are then stained with fluorescent dna binding dye, hoechst 33342, and other markers (i.e., cd133, cd24/cd44) and sorted by flow cytometry into progenitor and nonprogenitor subpopulations. the sorted subpopulations are separated and examined functionally by in vitro and in vivo studies. sphere culture studies are also performed on the sorted subpopulations. the specimens may also be utilized for transcriptional profiling studies, rnai studies, and for the establishment of long-term cultures and cell lines. dna is also isolated and stored from tumor and nonepithelial normal cell compartments for future genetic studies on known and unidentified genetic abnormalities contributing to the development of lung cancer, such as egfr, erbb2, k-ras, and p53 mutational status.

Eligibility criteria:
disease characteristics: * cytologically positive malignant pleural effusion secondary to primary small cell or non-small cell lung cancer * recruited from the division of hematology/oncology, the multidisciplinary thoracic oncology group of ireland cancer center, or the inpatient or outpatient units of case medical center-university hospitals patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: non-small cell lung cancer malignant pleural effusion small cell lung cancer
ms-553 in diabetic retinopathy patients with central involved macular edema

Conditions: Diabetic Macular Edema; Macular Edema; Type 2 Diabetes With Diabetic Macular Edema; Type 1 Diabetes With Diabetic Macular Edema; Diabetic Retinopathy

Summary: this is an open label dose-escalation study to evaluate the safety and treatment benefits of ms-553 in treatment-naive diabetic retinopathy patients with central involved macular edema. fifteen subjects with diabetic macular edema will be enrolled into each of three dose cohorts and will receive oral administration of ms-553 for 8 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of diabetes mellitus (type 1 or type 2) according to ada or who diabetic diagnosis criteria * subject has the ability to follow the study instructions and is likely to complete all required study procedures and visits; * all males and females must consent to pregnancy prevention during the study and qualified measures of birth control. all females of childbearing potential must consent to a pregnancy test before entering the study. * presence of central involved macular edema associated with diabetic retinopathy, i.e. diabetic macular edema (dme), as assessed by spectral domain optical coherence tomography (sd-oct) of the central retina subfield thickness (crt) at the screening visit (centration must be confirmed by investigators with signatures); * best corrected visual acuity (bcva) score ≥ 34 letters (approximately 20/200 to 20/20 snellen equivalent or better) using the early treatment diabetic retinopathy study (etdrs) visual acuity protocol, and assessed at the screening visit visual acuity (va); * confirmation by the investigator that laser photocoagulation and anti-vegf treatments are either declined by the patients or not needed and can be withheld for at least 3 months after the screening visit; * ocular media and pupil dilation adequate to permit good quality retinal imaging as assessed at screening visit. exclusion criteria: * subjects with unstable metabolic or blood pressure control * subject with emaciation or obesity at screening visit: body mass index (bmi) \ 28kg/m2 * current use or likely need for medications know to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine / hydroxychloroquine (plaquenil), tamoxifen, phenothiazines and ethambutol - * history of myocardial infarction or other cardiac event requiring hospitalization (unstable angina pectoris, etc.), cerebrovascular accident, transient ischemic attack, treatment for acute congestive heart failure or any arrhythmia within 4-months prior to screening visit; * any situation that may in the opinion of the investigator preclude the safe administration of the study medication, adherence to the scheduled study visits, safe participation in the study or affect the results of the study as assessed at screening visit;

Keywords: diabetic macular edema macular edema center-involved diabetic macular edema center-involved dme dme diabetic retinopathy
aneufix for endoleaks type ii

Conditions: Abdominal Aortic Aneurysm

Summary: the study is a non-randomized, multi-center safety and feasibility trial of aneufix acp-t5 to treat patients with isolated type ii endoleak in the presence of a non-shrinking aaa sac following an evar procedure.

the investigational device is called aneufix, more specifically the model acp-t5, which is a product treating the endoleak by blockage of backflowing blood vessels, i.e. by filling the 'endoleak void and nidus of feeding artery and exit of existing draining arteries'.

Eligibility criteria:
inclusion criteria: 1. persistent type iia or iib endoleak (more than 6 months post-evar or post-embolization procedure); and 2. volume of the 'endoleak void' can be determined upfront; and 3. an evar without circulatory complications; and 4. an endoleak confirmed by ct scan in preceding 6 weeks demonstrating the high likelihood of the isolated nature of the endoleak; and 5. an aneurysm sac growing in contours after evar (per european guidelines) as documented in the preceding 6 weeks by means of echo (or alternative visualization technique); and 6. an aneurysm sac that can be punctured in translumbar approach ; and 7. possibility to withhold anti-thrombogenic medication temporarily; and 8. ability and willingness to undergo the translumbar procedure under local anesthesia in a ct scan; and 9. be older than 18 years. exclusion criteria: 1. patient not able or willing to give written informed consent; or 2. patient undergoing emergency procedures; or 3. patient with traumatic vascular injury; or 4. patient with hemostatic disorder or who is clinically unstable; or 5. patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; or 6. patient who is allergic to contrast media or anticoagulants; or 7. patient with renal impairment (serum creatinine \> 2 mg/dl or \> 176 mmol/l); or 8. patient who is participating in another trial with an investigational drug or medical device; or 9. women of child-bearing potential; or 10. patient with a life expectancy of less than 12 months.

Keywords: aaa endoleak