Kornimate/medical-research-clean huggingface dataset:
intrapleural minocycline after aspiration of spontaneous pneumothorax

Conditions: Pneumothorax

Summary: the estimated recurrence rate of primary spontaneous pneumothorax is 23-50% after the first episode, and the optimal treatment remains unknown. in the recently published british thoracic society (bts) guidelines, simple aspiration is recommended as first line treatment for all primary pneumothoraces requiring intervention. however, the 1 year recurrence rate of this procedure was as high as 25-30%, making it inappropriate as a standard of care. intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way to shorten the duration of air leaks and reduce the rates of recurrent spontaneous pneumothorax in surgical and non-surgical patients. many chemical irritants (tetracycline, talc, and minocycline) have been used to decrease the rate of recurrence in spontaneous pneumothorax. tetracycline, which was the most commonly used irritant, is no longer available. talc insufflation of the pleural cavity is safe and effective for primary spontaneous pneumothorax. however, it should be applied either with surgical or medical thoracoscopy. minocycline, a derivative of tetracycline, is as effective as tetracycline in inducing pleural fibrosis in rabbits. in the previous studies, we have shown that additional minocycline pleurodesis is a safe and convenient procedure to decrease the rates of ipsilateral recurrence after thoracoscopic treatment of primary spontaneous pneumothorax. in the present study, additional minocycline pleurodesis will be randomly administered in patients with first episode of primary spontaneous pneumothorax after simple aspiration. the primary goal is to test if intrapleural minocycline can reduce the rate of recurrence. the secondary goals are to evaluate the safety profile, short-term results, and long-term effects of minocycline pleurodesis after simple aspiration. the sites of study include national taiwan university hospital and far eastern memorial hospital. a total of 300 patients (150 patients in each arm) will be included for this study.


Eligibility criteria:
inclusion criteria: 1. 15-50years old 2. primary pneumothorax first attack 3. viceral pleura to chest wall more then 2 cm on cxr exclusion criteria: 1. the lungs unable to expad fully after aspiration 2. continuous leakage of air through chest tubes 3. status complicated with hemothorax 4. status post previous chest surgery or pleurodesis 5. patient unwilling to accept the trial
safety and efficacy of the external synchronized vein valve (esvv) in treatment of chronic venous insufficiency (cvi)

Conditions: Venous Insufficiency

Summary: the external synchronized vein valve (esvv), is intended for the treatment of chronic venous insufficiency (cvi), incorporates an external apparatus that is aimed to replace the one-way venous valve and a sensor that identifies the movement of the calf muscles pump. the external device is located above the failed deep vein and exerts synchronized intermittent regulated pressure on it. alteration in the vein structure is occurred and the blood flows in the cephalad direction, preventing the return toward the feet. the device is synchronized with the calf muscles pump to function as a one-way venous valve. this study was design in order to assess safety and efficacy of using the esvv for treatment of consequences of deep chronic venous insufficiency.


Eligibility criteria:
inclusion criteria: * males and females age 18 and up. * patient is diagnosed to have deep chronic venous insufficiency (cvi) proved by recent duplex examination. * patient able to comprehend and give informed consent for participation in this study. * patient must commit to both screening and treatment visits. * patient must sign the informed consent form. exclusion criteria: * acute deep vein thrombosis. * chronic deep vein obstruction. * peripheral arterial occlusive disease. * ankle edema that is not caused by chronic venous insufficiency * partial or complete immobility. * pregnancy. * known cognitive disorder. * drug abuse. * patient objects to the study protocol. * concurrent participation in any other clinical study.

Keywords: chronic venous insufficiency (cvi)
a phase i/ii dose-escalating study of the safety, tolerability and efficacy of kio-301 administered intravitreally to patients with retinitis pigmentosa and choroideremia (abacus)

Conditions: Retinitis Pigmentosa; Choroideremia

Summary: a phase i/ii dose-escalating study of the safety, tolerability and efficacy of kio-301 administered intravitreally to patients with retinitis pigmentosa and choroideremia (abacus). open label.


Eligibility criteria:
inclusion criteria: 1. have a clinical diagnosis of retinitis pigmentosa (cohorts 1 - 3) or choroideremia (cohort 3 only). 2. have a visual acuity of: 1. no light perception for cohort 3 or 2. no light perception or bare light perception for cohort 1 confirmed with a logmar \>2.9 using the berkeley rudimentary vision test (brvt), or 3. count fingers or hand motion for cohort 2 as confirmed by a logmar ≤ 2.9 and \> 1.6 using the brvt. 3. have similar visual acuity in both eyes as defined as a logmar difference between eyes of \< 0.05 using the brvt. exclusion criteria: 1. have evidence of material/substantial optic nerve disease. 2. have a history of retinal detachments. 3. have clinically significant ocular disease (e.g., corneal oedema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study or clinically significant opacities of the media. 4. have high intraocular pressure (iop) \>22 mm hg. 5. have had a previous intraocular surgery (excluding phakocataract surgery). 6. have aphakia.
the impact of arousal threshold in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the investigators hypothesis is that obstructive sleep apnea (osa) patients with a low arousal threshold may wake up too early during a respiratory event, before upper airway muscles can be activated to achieve stable ventilation. thus, strategies to manipulate the respiratory arousal threshold could potentially improve the quality of sleep and sleep disordered breathing. agents that raise arousal threshold are therefore likely to benefit some patients with osa. the overall goal of this project is to determine the importance of the arousal threshold in osa, determine which patients might benefit from a raised arousal threshold, and test this hypothesis by using pharmacological manipulation of the arousal threshold to achieve this goal.

this study is a pilot study. the investigators will test whether donepezil has important effects on the arousal threshold and on the apnea hypopnea index. donepezil is a cholinesterase inhibitor approved by the u.s. food and drug administration (fda) for the treatment of symptoms of alzheimer's disease. eligible participants will undergo overnight polysomonography as described below and will receive either donepezil (10 mg immediately prior to sleep) or placebo (in random order) followed roughly 14 days later with placebo or donepezil. this aim will allow us to test the impact of donepezil on the apnea hypopnea index. the study plans to enroll approximately 30 subjects. the change in apnea hypopnea index as well as arousal thresholds/upper airway mechanics will be compared in the donepezil groups with the placebo group.

Eligibility criteria:
inclusion criteria: * ages 18-70 years * sleep study (with apnea hypopnea index\>5) * diagnosis of obstructive sleep apnea exclusion criteria: * any known unstable cardiac (apart from treated hypertension), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, or hepatic disease. * susceptible to stomach ulcers. * pregnant women or nursing mothers * using positive airway pressure (pap) therapy over one week or longer * body weight \<55kg * history of hypersensitivity to afrin, lidocaine and/or donepezil * history of bleeding diathesis and/or gastrointestinal bleeding. * use of any medications that may affect sleep or breathing. * a psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders. * substantial cigarette (\>5/day), alcohol (\>3oz/day) or use of illicit drugs. * more than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day. * deprived from sleep in the recent one week * desaturations to below 70% lasting greater than 10 seconds in duration per event in the sleep study (without oxygen).

Keywords: obstructive sleep apnea arousal threshold donepezil
a study to assess safety and effectiveness of injections of noa volume injectable gel in adult participants compared to juvéderm voluma xc for change of mid-face volume

Conditions: Mid Face Volume Deficit

Summary: facial fullness is often regarded as a characteristic feature of a youthful face. chronic reduction of collagen, elastin, and glycosaminoglycans contribute to the facial volume loss that characterizes the aging face. volume restoration by replacing or augmenting soft tissue is critical to successful facial rejuvenation. noa volume is a crosslinked hyaluronic acid (ha) gel implant formulated with lidocaine that was developed to provide a safe, minimally invasive method of improving mid-face volume deficit. the purpose of this study is to assess safety and effectiveness of noa volume in adult participants seeking improvement of mid-face volume compared to juvéderm voluma xc (voluma xc). noa volume is an investigational device being developed for the improvement of mid-face volume. there will be 2 cohorts in this study. in cohort 1, participants will receive either noa volume or voluma xc with a fixed follow-up period. in cohort 2, participants will receive either noa volume or voluma xc with a variable follow-up period. around 231 adult participants seeking improvement of mid-face volume will be enrolled in the study at approximately 15 sites in the united states. participants will receive either noa volume or voluma xc as subcutaneous and/or supraperiosteal plane injections in the cheek on day 1. participants will receive optional touch-up treatment at day 31 and optional repeat treatment at month 18 for cohort 1 and at month 12, 15, or 18 for cohort 2 and will be followed up for up to 22 months.


Eligibility criteria:
inclusion criteria: * has moderate (3), significant (4), or severe (5) mid-face volume deficit on the 5-point photonumeric mfvds based on evaluating investigator's (ei) live assessment. * mid-face is amenable to achieving at least a 1-point improvement in mfvds score with the allowed injection volume in the treating investigator's (ti) judgement. exclusion criteria: * significant skin laxity in the midface in the opinion of the ti. * significant skin pigmentation disorders or discoloration in the mid-face area that would interfere with the visual assessment of the mid-face area. * current cutaneous inflammatory or infectious processes (e.g., acne, herpes), abscess, unhealed wound, or cancerous or precancerous lesion on the face.

Keywords: mid face volume deficit noa volume juvéderm® voluma® xc
pharmacokinetic, safety, and efficacy effects of oral lbh589 on dextromethorphan in patients with advanced or metastatic non-small cell lung cancer or malignant pleural mesothelioma

Conditions: Carcinoma, Non-Small-Cell Lung; Mesothelioma

Summary: this study will investigate the effect of oral lbh589 on dextromethorphan, a cyp2d6 substrate, and to assess safety and efficacy of oral lbh589 when used with this co-medication in advanced stage nsclc or malignant pleural mesothelioma patients


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. must have histologically or cytologically confirmed advanced or metastatic incurable solid tumor as documented by ct or mri that has progressed on or following standard therapies 3. must have failed prior standard systemic therapy 4. must have at least one measurable and/or non-measurable lesion as defined by recist criteria 5. baseline muga or echo must demonstrate lvef ≥ the lower limit of the institutional normal. 6. written informed consent obtained prior to any screening procedures 7. willingness to have multiple blood draws 8. ability to swallow capsules or tablets exclusion criteria: 1. uncontrolled brain metastases 2. prior treatment with an hdac inhibitor 3. presence of clinically detectable third-space fluid collections (e.g., ascites or pleural effusions) that can not be controlled by drainage or other procedures prior to study entry 4. concomitant use of any anti-cancer therapy, including radiation therapy 5. significant cardiac disease 6. concomitant use of drugs with a risk of causing torsades de pointes 7. impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of oral lbh589 8. previous use of monoamine oxidase inhibitors (e.g. clorgyline, iproniazid, isocarboxazid, moclobemide, sibutramine, phenelzine, tranylcypromine) within 14 days prior to the first dose of dextromethorphan

Keywords: non-small cell lung cancer nsclc lung cancer pleural mesothelioma malignant advanced stage mesothelioma phase i lbh589 dextromethorphan cyp2d6 oral
generation of anti-hcv antibodies from bone marrow: defining the repertoire of immune response to hcv quasispecies

Conditions: Hepatitis C

Summary: to generate a library of genes that reflect the entirety of antibody responses to hepatitis c virus (hcv) made during the 20-year course of hcv infection in a single patient (wh) whose viral quasispecies has been extensively characterized. in addition to characterizing the sequential events in antibody formation and their relationship to the changing pattern of viral quasispecies, we hope to identify neutralizing antibodies and the epitopes to which they are directed. ultimately we seek to gain insight into the host mechanisms that suppress viral replication and to translate this to therapeutic and preventive modalities.

to generate a library of genes that reflect the entirety of antibody responses to hepatitis c virus (hcv) made during the 20-year course of hcv infection in a single patient (wh) whose viral quasispecies has been extensively characterized. in addition to characterizing the sequential events in antibody formation and their relationship to the changing pattern of viral quasispecies, we hope to identify neutralizing antibodies and the epitopes to which they are directed. ultimately we seek to gain insight into the host mechanisms that suppress viral replication and to translate this to therapeutic and preventive modalities.

Eligibility criteria:
persistent infection with mild hepatitis that is non-progressive.

Keywords: hcv antibody library
radiosurgery of ganglion stellatum in patients with refractory angina pectoris

Conditions: Coronary Artery Disease; Angina Pectoris; Myocardial Ischemia

Summary: the core hypothesis to be tested is that the radiosurgery of stellate ganglion (left one or both if left-sided without full relief of symptoms) is an effective therapy of refractory angina pectoris in patients with no other therapeutic options - proof of concept study.

design: prospective, interventional trial (university hospital ostrava, cardiocentre agel podlesi hospital trinec) * radiosurgery of left gs after confirmation of responding to anesthetic blockade * in case of remaining ap after three months, radiosurgery of right gs in case of response confirmation to anesthetic blockade (patients must be responders of anesthetic blockade of left stellate ganglion) * seattle angina questionary (saq) and amount of nitrate usage for responding confirmation * radiotherapy 40 gy * 2-year follow-up * scheduled follow-up visits: 1, 3, 6, 12, and 24 months (24) preliminary examination: selective coronary angiography, transthoracic echocardiography, stress test, 6 min walk test, saq (19-item) endopoints: primary endpoints: saq, safety of the radiosurgery of gs secondary endpoints:usage decrease of angina relief drugs, 6 min walk test improvement follow-up visits examination, restage: 6 min walk test, saq, amount of nitrate usage, ecg, blood tests incl. nt-probnp, nse

Eligibility criteria:
inclusion criteria: * patients must have coronary artery disease (cad) with refractory angina pectoris (ap). * patients must have a maximum of tolerated medication therapy of angina pectoris available. * patients must have done the maximum possible revascularization of cad. * two certificated independent interventional cardiologists and two cardiac surgeons must conclude that further revascularization (including cabg) is not possible/not effective/ with high risk. * age ≥ 18 years. * patients must have any stress test with proof of myocardial ischemia (dobutamine echocardiography, gated tc-spect of myocardium). * life expectancy at least 24 months (not limited due to severe comorbidities) * patients must be responders of anesthetic blockade of the left stellate ganglion (gs) - clinically significant relief of ap symptoms after blockade at least twice. * patients must provide verbal and written informed consent to participate in the study. exclusion criteria: * life expectancy less than 24 months * non-responders of anesthetic blockade of gs * impossibility to undergo a stress test. * myocardial infarction in last 4 weeks * heart failure - class iv nyha * unwillingness to participate or inability to comply with the protocol for the duration of the study * patients who are pregnant, and patients with reproductive capability will need to use adequate contraception during the time of participation in the study * history of radiotherapy in the head and neck region

Keywords: radiosurgery ganglion stellatum angina pectoris coronary artery disease myocardial ischemia
a trial comparing the pharmacokinetic properties of faster-acting insulin aspart (fiasp) after different injection regions and routes of administration in healthy subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of the trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of faster-acting insulin aspart (fiasp) after different injection regions and routes of administration in healthy subjects.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-64 years both inclusive at the time of signing informed consent * considered generally healthy upon completion of medical history, physical examination,analysis of laboratory safety variables, vital signs and ecg (electrocardiogram), as judged by the investigator * body mass index 20.0-28.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily) * not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
roniciclib (bay 1000394) drug-drug interaction (ddi) study

Conditions: Medical Oncology

Summary: to evaluate the effect of itraconazole, a strong cyp3a4 inhibitor, on the pharmacokinetics of roniciclib in cancer patients. to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole in cancer patients


Eligibility criteria:
inclusion criteria: * male or female patients ≥ 18 years of age with histological or cytological confirmed advanced solid tumors refractory to, or not able to tolerate to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable. * adequate liver, renal and bone-marrow functions as assessed by laboratory values. * ecog performance status of 0 - 2 and life expectancy of at least 12 weeks. * subject with a history of hypertension should be on a stable anti-hypertensive treatment for more than 7 days prior to the first dose of study drug. exclusion criteria: medical and surgical history: * previous deep vein thrombosis (within the last 6 months), arterial thrombotic events (including strokes), or pulmonary embolism. * history of cardiac disease: congestive heart failure, angina (within past 6 months prior to study entry), myocardial infarction, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted). * uncontrolled hypertension (systolic blood pressure \>150 mmhg or diastolic blood pressure \>90 mmhg despite optimal medical management) * moderate or severe hepatic impairment, i.e. child-pugh class b or c. history of human immunodeficiency virus (hiv) infection or chronic hepatitis b or c * active clinically serious infections of common terminology criteria for adverse events (ctcae, v. 4.03) \> grade 2. * symptomatic metastatic brain or meningeal tumors unless the subject is \>3 months from definitive therapy, has no evidence of tumor growth on an imaging study within 4 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry. * seizure disorder requiring therapy (such as steroids or anti-epileptics). * history of organ allograft. * use of strong inhibitors and/or inducers of cyp3a4 in the 14 days before study treatment

Keywords: phase 1 advanced solid tumor pan-cdk inhibitor drug-drug interaction
effects of neighborhood ses on coronary heart disease burden in communities - ancillary to aric

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases

Summary: to investigate the role of racial and socioeconomic disparities in coronary heart disease (chd) mortality in the united states.

background: despite strong decreases in coronary heart disease (chd) mortality over past decades, there is evidence that racial and socioeconomic disparities in chd mortality are increasing. chd surveillance efforts that examine trends within these population subgroups are an important first step in quantifying and reducing disparities. the atherosclerosis risk in communities (aric) study has monitored rates and trends in validated hospitalized myocardial infarction and fatal chd among black and white adults aged 35 to 74 years in four u.s. communities since 1989. design narrative: the study will expand the scope of aric surveillance by examining variations in the rates and temporal trends in chd by socioeconomic status (ses), measured at the level of census tract. for chd events already included in aric surveillance (1992-2002), addresses will be obtained from medical records and death certificates and geocoded so that they can be matched with identifiers for census based geographical areas. the aric study will contribute yearly updates of abstracted chd events and addresses for subsequent years (2003-2005). each event will be linked with census tract level ses indicators available from the 1990 and 2000 censuses. this novel effort will permit an examination of disparities by ses in rates and trends in fatal chd, hospitalized myocardial infarction, case fatality, use of invasive cardiac procedures and prescription of efficacious medication at time of hospital discharge. in addition, the extent to which racial disparities in chd and associated treatments are explained by ses will also be explored.

Eligibility criteria:
hospitalized and fatal coronary heart disease cases eligibility: within 4 defined geographic areas and ages 35 to 74 years of age

Keywords: surveillance coronary heart disease neighborhood ses