Kornimate/medical-research-clean huggingface dataset:
is video-assisted thoracoscopic lobectomy a clinical alternative for surgically resectable pathologic n2 nsclc patients

Conditions: Non-small Cell Lung Cancer

Summary: the study was designed to compare the safety and effectiveness of vedio-assisted thoracoscopic lobectomy with open lobectomy for patients with surgically resectable pathologic n2 non-small cell lung cancer

the is a multi-center retrospective study. patients with pathologic n2 nsclc who underwent vats or open lobectomy between 2014 and 2017 were included into this study. clinical data on patient demographic, clinical characteristics, treatment and clinical outcomes will be collected to evaluate the safety and effectiveness of video-assisted thoracoscopic lobectomy for pathologic n2 nsclc.

Eligibility criteria:
inclusion criteria: * patients with age \> 18 years old; * patients with pathologically diagnosed non-small cell lung cancer; * patients underwent lobectomy by either vats or thoracotomy between 2014 and 2017; * patients who received lymphadenectomy for all accessible lymph nodes; * patients with n2 lymph nodes (+) after surgeries; exclusion criteria: * patients with second primary tumors or multiple primary tumors; * patients who received chest surgeries before hospitalization; * patients with superior pulmonary sulcus tumor

Keywords: vedio-assisted thoracoscopic lobectomy thoracotomy lobectomy real-world evidences; pn2 nsclc
immunogenicity and safety of nbp607-qiv compared to agrippal in children aged 6 to 35 months

Conditions: Influenza

Summary: this study assesses immunogenicity and safety of nbp607-qiv to agrippal which are indicated for active immunization for the prevention of influenza disease. total of 675 subjects or above (450 subjects for nbp607-qiv arm and 225 subjects for agrippal arm) of 6 to 35 months of age are enrolled, and each subject is administered with single or two doses of vaccines depending on previous vaccination history.

this is a multi-national, multi-center, randomized, double blinded, parallel-group study to assess the immunogenicity and safety of nbp607-qiv compared to agrippal which are indicated for active immunization for the the prevention of influenza disease. total of 675 subjects or above (450 subjects for nbp607-qiv arm and 225 subjects for agrippal arm) of 6 to 35 months of age are enrolled. each subject is administered with single or two doses of vaccines depending on previous vaccination history, and randomly assigned in 2:1 ratio. stratified randomization for trial site and age strata is used to achieve the balance of treatment assignment. total of three or five visits are scheduled depeding on dosing schedule. for subjects assigned to single-dose vaccination schedule, blood sampling is conducted for immunogenicity assessment before and 4 weeks after single vaccination at visit 1 and 3 respectively. safety is monitored 3 days, 4 weeks after vaccination through visit 2\* and 3 (\* telephone contact). for subjects assigned to two-dose vaccination schedule, blood sampling is conducted before first vaccination and 4 weeks after second vaccination at visit 1 and visit 5 respectively. safety is monitored 3 days, 4 weeks after each vaccination through visit 2\*, 3, 4\*, and 5 (\* telephone contact)

Eligibility criteria:
inclusion criteria: * children aged 6 to 35 months * those who were normal gestational age at birth (for children aged 6 months to \<1 year) * those who have provided written informed consent to study participation and compliance with study instructions after being informed of and understand details of the study exclusion criteria: * those with any immunodeficiency disease or malignancy * those with hypersensitivity to vaccination * those who are contraindicated for intramuscular injection due to thrombocytopenia or other coagulopathy * those with history of treatment with any of immunosuppressants or immunoregulators within 12 weeks prior to screening * those with history of receiving blood product or treatment with immunoglobulin within 24 weeks prior to screening * those with history of influenza vaccination within 24 weeks prior to screening * those with any severe chronic conditions that interfere with study participation
a study to examine the effects of a daily supplement on common symptoms of perimenopause and menopause

Conditions: Menopause; Perimenopause

Summary: symptoms of perimenopause and menopause can significantly affect overall quality of life. it is hypothesized that daily supplements can reduce the severity of these symptoms. this 12-week clinical trial will examine the effects of hologram sciences' daily balance gummy supplements on symptoms including hot flashes, night sweats, mood swings, anxiety, fatigue, and brain fog. participants will take the product daily and complete study-specific questionnaires at baseline, week 4, week 8, and week 12. upon conclusion of week 12, participants will be asked to count how many gummies remain in their jar.


Eligibility criteria:
inclusion criteria: women aged 40-65 years old must be experiencing at least two symptoms of menopause, such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, irregular or absent periods, or vaginal changes must experience hot flashes and/or night sweats at least 5 times per day can be either natural or surgical menopause (or perimenopause) willing to adhere to the study protocol for the duration of the study willing to consult with their physician prior to starting the trial if taking any of the following medications: levothyroxine liothyronine calcipotriene (dovonex) digoxin (lanoxin) diltiazem (cardizem) verapamil (calan, others) thiazide diuretics atorvastatin (lipitor) warfarin - might increase the amount of time it takes for blood clotting. minosalicylic acid (paser) colchicine (colcrys, mitigare, gloperba) metformin (glumetza, fortamet, others) proton pump inhibitors (omeprazole (prilosec), lansoprazole (prevacid) or other stomach acid-reducing drugs) phenytoin (dilantin) antihypertensive drugs phenobarbital (luminal) amiodarone (cordarone) levodopa exclusion criteria: not experiencing hot flashes and/or night sweats at least 5 times per day has taken herbal supplements or multivitamins within the last 1 month current use of conventional hormone replacement therapies, or plan to start during the study duration current use of hormonal birth control, or plan to start during the study duration known allergies to any product ingredients including the purified isoflavone genistein history of uterine fibroids, endometriosis, polycystic ovarian syndrome, or history of abnormal pap smear anyone with any known severe allergies requiring the use of an epi-pen unwilling to adhere to the study protocol anyone living with uncontrolled or chronic health disorders, including oncological or psychiatric disorders no planned invasive medical procedures for the duration of the study pregnant or breastfeeding
vns for long-covid-19

Conditions: Post-COVID-19 Syndrome; Postural Tachycardia Syndrome; Dysautonomia

Summary: the goal of this proposed clinical case series is to evaluate the effect of a non-invasive vagus nerve stimulation paradigm on: 1) symptom reporting via validated patient reported outcomes, and 2) objective clinical biomarkers of autonomic nervous system function. this will be a placebo controlled, randomized controlled trial with a crossover design built in. this study will aim to recruit 40 people with long covid to be a part of this research.

participants will be randomized into one of two arms. those in the "active vns" arm will be sent home with a portable vns device and asked to perform a daily vns protocol designed to down regulate sympathetic nervous system activity for six weeks. those in the "sham vns" arm will be asked to use the vns device daily on a sham setting for six weeks. those randomized to the sham group will be given the opportunity to "crossover" into the active vns arm once they have completed the sham arm (week 12). the participant and assessor will be blinded.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * at least 18 years of age * clinical diagnosis of dysautonomia following an acute covid-19 infection at least 3 months prior. see below for criteria: * clinical diagnosis of autonomic dysfunction as evaluated by a qualified healthcare provider * 2 or more if the following clinical assessment findings * symptomatic exacerbation during active stand test * tachycardia on active stand test * tachycardia on orthostatic vitals assessment * hypotension on orthostatic vitals assessment * hypertension in orthostatic vitals assessment * symptom exacerbation on orthostatic vitals assessment * english speaking exclusion criteria: • pregnancy or lactation: * pregnant persons will not be included in this study for the following reasons: * there is not sufficient data surrounding the hormone cycle changes during pregnancy and its effects on the condition being studied (pcd). the results could be skewed due to pregnancy. * of note, there are no risks for pregnant persons to participate. according to the device manufacturer, the following contraindications will be followed during the screening process: * patients with an active implantable medical device, such as a cardiac pacemaker, heading aid implant, or any implanted metallic or electronic device * patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heath failure (chf), known severe coronary artery disease or recent myocardial infarction (within 5 years) * patients with diagnosed bradycardia * patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy) patients diagnosed with narrowing of the arteries (carotid atherosclerosis) * patients whose pain syndromes are undiagnosed * pediatric patients * pregnant women
safety study of once-a-day dosing of udenafil to treat erectile dysfunction

Conditions: Erectile Dysfunction

Summary: phase : phase iii indication : erectile dysfunction study design : open-label, fixed dose, 6-month extension study (parent study : da8159_edd_iii)

completer from parent study(da8159_edd_iii)continued into a 24weeks open-label extension during which they received udenafil once daily. the study concluded with a 4-week ed treatment-free period.

Eligibility criteria:
inclusion criteria: * male patients aged 20 years or more diagnosed with erectile dysfunction(ed) exclusion criteria: * had uncontrolled blood pressure * had hepatic or renal dysfunction * had significant psychiatric disorders or drug abuses * was currently under anticancer chemotherapy * had a treatments for ed using other phosphodiesterase type 5(pde-5) inhibitors
lurasidone extended use study

Conditions: Schizophrenia; Bipolar Disorder

Summary: this is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (nct00868959 and nct01566162) and who may benefit from continued treatment with lurasidone.


Eligibility criteria:
inclusion criteria: * the subject or legal guardian provides written informed consent. for eligible subjects under age 18, verbal assent is also required. * the subject has completed the extension phase of a prior lurasidone clinical study. eligible subjects may enroll into this continuation study directly (or within 10 days) after completing the extension phase of a prior lurasidone clinical study. subjects that have completed an extension study prior to the initiation of this protocol at the study site, may participate in this study up to 3 months after completion of the extension phase of the prior lurasidone study. * the subject is judged by the investigator to be suitable for participation in a clinical study involving open-label lurasidone treatment and is able to comply with the protocol. * the subject, in the investigator's judgment, may benefit from continued treatment with lurasidone exclusion criteria: * the subject is considered by the investigator, to be at imminent risk for homicidal or suicidal behavior. * the subject resides in a country where lurasidone has been approved for any indication. * the subject is currently enrolled in any other investigational study. * the subject answers "yes" to "suicidal ideation" items 4 or 5 on the columbia suicide severity rating scale (c-ssrs).

Keywords: schizophrenia bipolar disorder lurasidone latuda
bronchiectasis effect in copd patients

Conditions: Bronchiectasis; Copd

Summary: the etiology of bronchiectasis, known as permanent, abnormal, and localized development of bronchi, varies. however, most of them are responsible for infections during childhood. the prevalence of bronchiectasis is particularly high in advanced copd patients. this phenomenon, called copd-bronchiectasis overlap syndrome, affects the clinic of copd patients negatively. in this study; bronchiectasis in respiratory function, exercise capacity, dyspnoea and quality of life in copd patients.

the etiology of bronchiectasis, known as permanent, abnormal, and localized development of bronchi, varies. however, most of them are responsible for infections during childhood. the prevalence of bronchiectasis is particularly high in advanced copd patients. this phenomenon, called copd-bronchiectasis overlap syndrome, affects the clinic of copd patients negatively. in this study; bronchiectasis in respiratory function, exercise capacity, dyspnoea and quality of life in copd patients. torax cts of patients with copd who are admitted to the outpatient clinic will be examined. there will be two groups, group 1 in patients with copd accompanied by bronchiectasis and group 2 in copd patients without bronchiectasis. in both groups, respiratory function tests, exercise capacities, dyspnea perceptions and quality of life will be evaluated. the data will be compared between the two groups.

Eligibility criteria:
inclusion criteria: * above 18 years old * clinically stable exclusion criteria: * other respiratory disease
sildenafil in acute pulmonary embolism

Conditions: Pulmonary Embolism

Summary: to investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (pe).

patients with pe randomized to a single oral dose of sildenafil 50mg (n=10) or placebo (n=10) as add-on to conventional therapy. right ventricular function evaluated immediately before and shortly after (0.5-1.5h) randomization by right heart catheterization (rhc), trans-thoracic echocardiography (tte), and cardiac magnetic resonance (cmr). the primary efficacy endpoint was cardiac index measured by cmr.

Eligibility criteria:
inclusion criteria: * patients with acute pulmonary embolism confirmed by contrast enhanced computed tomography (ct) * symptom duration of less than 14 days * older than 18-80 years * right ventricular/left ventricular ratio (rv/lv) \>1 measured by trans-thoracic echocardiography (tte, 1 cm above the atrio-ventricular valves in the four-chamber view at end-diastole). exclusion criteria: * pregnant * cardiac arrest that required cardiopulmonary resuscitation * a life expectancy \<120 days * systolic blood pressure \<90 mmhg * metal implants, obesity or claustrophobia that excluded the patient from cardiac magnetic resonance (cmr) * altered mental status making the patient unable to provide informed consent * recent use of drugs with influence on the nitric oxide-cyclic guanosine monophosphate pathway * known or suspected chronic thromboembolic pulmonary hypertension * inability to perform study protocol \< 72 hours after conventional pe treatment was instituted * active bleeding after thrombolysis.
acetaminophen/naproxen sodium dose ranging study

Conditions: Pain

Summary: study assessing the relative efficacy of five strengths of a fixed combination of acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s) for further development and to evaluate the safety of a fixed combination of naproxen sodium and acetaminophen.

this is a randomized, double-blind, placebo-controlled study to evaluate the analgesic efficacy and safety profile of the following doses of a fixed combination of acetaminophen (apap)/naproxen sodium (npx) administered as a single two-tablet dose:\[acetaminophen/naproxen sodium dose a, acetaminophen/naproxen sodium dose b, acetaminophen/naproxen sodium dose c, acetaminophen/naproxen sodium dose d, acetaminophen/naproxen sodium dose e and placebo\] following surgical extraction of four third molars.

Eligibility criteria:
inclusion criteria: 1. males or females 17-50 years old 2. weigh 100 pounds or greater and have a body mass index (bmi) of 17.5-35.4 (inclusive) at screening 3. surgical removal of three or four third molars, of which, two must be mandibular impactions 4. meets requirements for post-surgical pain level 5. females of childbearing potential and males agree to contraceptive requirements of study 6. have a negative urine drug screen at screening, and on day of surgical procedure exclusion criteria: 1. pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant 2. have a known allergy or hypersensitivity to naproxen or other nsaids, including aspirin, or to acetaminophen, oxycodone or other opioids; 3. not able to swallow whole large tablets or capsules 4. history of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study 5. use analgesics 5 or more times per week 6. history of chronic tranquilizer use, heavy drinking, or substance abuse, as judged by the investigator site staff, in the last 5 years 7. use of any immunosuppressive drugs within 2 weeks of screening 8. history of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years

Keywords: analgesics dental pain acetaminophen naproxen sodium pain fixed-dose
extended duration nicotine replacement therapy and bupropion in smokers with schizophrenia

Conditions: Nicotine Dependence; Schizophrenia

Summary: after successfully quitting smoking, smokers with schizophrenia are vulnerable to relapse shortly after discontinuation of treatment. the purpose of this study was to assess the feasibility and effectiveness of a 12-month relapse prevention intervention in recently abstinent smokers with schizophrenia. subjects participated in a 12-week smoking cessation phase, where they received nicotine replacement therapy, bupropion sr 150mg bid, and cognitive behavioral therapy. if, at the end of the 12 weeks, they were able to demonstrate 1 week of abstinence, they continued in the relapse prevention phase of the study, where they continued to receive nicotine replacement therapy, bupropion sr 150mg bid, and cognitive behavioral therapy.


Eligibility criteria:
inclusion criteria: * diagnosed with schizophrenia or schizoaffective disorder by diagnostic and statistical manual of mental disorders, fourth edition criteria * reported smoking 10 or more cigarettes per day for at least the prior year * expressed a desire to quit smoking and a willingness to set a smoking cessation date within 4 weeks of enrollment * were psychiatrically stable on a fixed dose of an antipsychotic for the past 30 days or more * reported no active substance use disorder other than nicotine or caffeine within 6 months of enrollment exclusion criteria: * participants with neurologic risk factors for bupropion treatment were excluded from receiving bupropion but were eligible to participate and receive short- and long-acting nrt and cbt only.

Keywords: nicotine dependence smoking cessation relapse prevention cognitive behavioral therapy schizophrenia
ultrasound-guided transmuscular quadratus lumborum block for percutaneous nephrolithotomy

Conditions: Kidney Stone

Summary: patients undergoing percutaneous nephrolithotomy (pnl) suffer from acute postoperative pain, despite a multimodal analgesic regime. we hypothesize that active (ropivacaine) transmuscular quadratus lumborum (tql) block will significantly reduce postoperative opioid consumption and pain following pnl operation compared with placebo (saline) tql block. the aim of this study is to investigate the effect of ultrasound-guided (usg) tql block concurrent with a multimodal analgesic regime compared to the multimodal analgesic regime alone (and placebo tql block) in a randomized and placebo controlled design.

patients undergoing percutaneous nephrolithotomy (pnl) suffer from acute postoperative pain, despite a multimodal analgesic regime, and the patients receive considerable amounts of long lasting opioids. for the patients this greatly increase the risk of experiencing the adverse effects of opioids. the ultrasound-guided (usg) transmuscular quadratus lumborum (tql) block is a single dosage of local anesthetic (la) delivered in the plane between the psoas major muscle and the quadratus lumborum muscle. la spreads cephalad into the thoracic paravertebral space to reach the somatic ventral rami (intercostal nerves) and the thoracic sympathetic trunk. the tql block can reduce visceral pain and pain originating from the abdominal wall and has an expected duration of analgesic efficacy of 24 hours. the aim of this study is to investigate the efficacy of the active usg tql block together with the multimodal analgesic regime to reduce postoperative opioid consumption and pain compared to placebo usg tql block and the multimodal analgesic regime in a randomized and placebo controlled design.

Eligibility criteria:
inclusion criteria: scheduled for elective pnl operation in general anaesthesia with propofol and remifentanil. received oral and written information about the trial signed the informed consent american society of anesthesiologists (asa) classification 1-3 exclusion criteria: cannot cooperate does not speak or understand danish allergy towards drugs used in the trial large daily consumption of opioids known alcohol or drug abuse difficulty or inability to visualize the relevant muscular or fascial structures necessary to perform the usg-tql block pregnancy -

Keywords: postoperative pain transmuscular quadratus lumborum block block ropivacaine tql percutaneous nephrolithotomy pnl ultrasound-guided
controlled trial of abeladrug200 in closed, severe head injury

Conditions: Severe Head Trauma

Summary: this is a randomized, controlled clinical trial at three sites to determine the safety and preliminary efficacy of the study drug to treat severe head trauma (gcs 4-8). it is hypothesized that the drug may lower pressure in the brain, reduce mortality and the patient may have improved neurological function following treatment.


Eligibility criteria:
inclusion criteria: * diagnosis tbi * gcs 4-8 * age 16-70 exclusion criteria: * multiple trauma resulting in shock * bilateral absent pupil response * time from injury \> 6 hours * brain tumor or mass effect secondary to hemorrhage or brain surgery * pregnancy * confounding condition or injury * spinal cord injury * sustained high blood pressure or arterial oxygen saturation

Keywords: tbi closed head injury severe head trauma traumatic brain injury