Kornimate/medical-research-clean huggingface dataset:
aeriseal® system for lung volume reduction in patients with advanced emphysema

Conditions: Pulmonary Emphysema; COPD; Lung Diseases

Summary: the purpose of this study is to assess the procedural and post-procedural safety and efficacy of aeriseal therapy at up to 4 subsegments during a single treatment session in patients with gold stage iii/iv homogeneous or heterogeneous emphysema.

emphysema is a progressive, debilitating disease characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. the most common cause of this condition is cigarette smoking, although genetic, occupational, and environmental causes account for up to 10% of cases. despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death worldwide. due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality for years to come. the aeriseal system is a novel device system being developed for the treatment of advanced emphysema. the aeriseal system is administered bronchoscopically, and designed to provide the physiological benefits of lung volume reduction without the risks and cost of major surgery.

Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of advanced emphysema as defined by fev1/fvc\ 100% predicted, and rv \> 135% predicted. * patients must have persistent symptoms despite medical therapy and either not be candidates for lung volume reduction surgery (lvrs) or have elected not to undergo lvrs. * patients must be \> 40 years of age, have symptoms despite medical therapy, and have none of the prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy. exclusion criteria: -

Keywords: plvr blvr aeriseal treatment device breathing copd emphysema polymeric lung volume reduction biologic lung volume reduction heterogeneous homogeneous pathologic processes respiratory tract diseases lung diseases pulmonary disease, chronic obstructive
electromagnetic navigation versus ct guided ttna in the diagnosis of early peripheral lung cancer

Conditions: Lung Cancer

Summary: the purpose of this study is to compare electromagnetic navigation guided with ct-guided transthoracic needle aspiration (ttna) in the diagnosis of pulmonary peripheral nodule. primary endpoints：diagnostic rate secondary endpoints：operating time、adverse events study design: multicenter、randomized、open lebel


Eligibility criteria:
inclusion criteria: 1. patients with 0.8-3 cm, high-risk pulmonary peripheral nodules that need biopsy for pathological diagnosis; 2. patients who are older than 18 year-old; 3. patients voluntarily join the study and give written informed consent for the study. exclusion criteria: 1. chest ct scan shows that the pulmonary nodule is pure ground glass opacity. 2. large blood vessels or important structures on the puncture path of peripheral lung tumors； 3. severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
to evaluate safety & reactogenicity of gsk bio's human rotavirus (hrv) vaccine in filipino infants at least 6 weeks of age at first vaccination

Conditions: Infections, Rotavirus; Rotavirus Vaccines

Summary: gsk has submitted a registration file for its live attenuated oral human rotavirus (hrv) vaccine in several countries. in view of its registration in the philippines, the present study will collect data on the safety of the vaccine in the local target population as per the bureau of food and drugs directive.

the protocol was amended to reflect a change in the prescribing information. the age of the infants was changed from 6 - 14 weeks to at least 6 weeks at the time of the first vaccination. this protocol posting has been amended in order to comply with fda aa.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. * a filipino male or female aged at least 6 weeks at the time of the first vaccination. * written informed consent obtained from the parent or guardian of the subject. exclusion criteria: * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * any history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gi tract. * any contraindications as stated in the prescribing information.

Keywords: safety post-marketing surveillance (pms) rotarix oral filipino rotavirus gastroenteritis human rotavirus (hrv) vaccine
study of secox versus sorafenib as first-line treatment in patients with advanced hepatocellular carcinoma (hcc)

Conditions: Carcinoma, Hepatocellular; Secondary

Summary: the purpose of this study is to determine if sorafenib, capecitabine and oxaliplatin (secox) regimen is more effective than sorafenib alone in the treatment of advanced liver cancer.


Eligibility criteria:
inclusion criteria: * advanced or metastatic hepatocellular carcinoma (hcc) not suitable for surgery or various loco-regional therapies. * diagnosis of hcc confirmed either by cyto-histological confirmation or by non-invasive criteria according to the european association for study of liver disease (easl) criteria. * child-pugh a or b7 cirrhosis. * eastern co-operative group (ecog) performance status ≤ 2. * life expectancy of ≥ 12 weeks. * adequate organ function (blood transfusion or use of biologic response modifiers is not permitted). * measurable disease with at least one lesion, which is at least 1 cm in one dimension on computed tomography (ct) or magnetic resonance imaging (mri). * able and willing to meet all protocol-required treatments, investigations and visits. * signed written informed consent form. exclusion criteria: * prior systemic therapy for advanced hcc. * central nervous system (cns) metastasis. * history of liver transplantation. * peripheral sensory neuropathy with functional impairment before the first cycle of treatment. * history of cardiac disease. * uncontrolled hypertension. * women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception. * substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.

Keywords: sorafenib drug therapy
pharmacokinetics of oral desipramine with and without concomitant administration of crobenetine infusion in healthy male subjects

Conditions: Healthy

Summary: to assess the steady state pharmacokinetics of desipramine with/without concomitant administration of crobenetine.


Eligibility criteria:
inclusion criteria: all participants in the study should be healthy males, range from 21 to 50 years of age and their bodymass index (bmi) be within 18.5 to 29.9 kg/m2. in accordance with good clinical practice and local legislation all volunteers will have given their written informed consent prior to admission to the study. exclusion criteria: * any finding of the medical examination (including blood pressure, pulse rate and ecg) deviating from normal and of clinical relevance * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * history of relevant orthostatic hypotension, fainting spells or blackouts * chronic or relevant acute infections * history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * intake of drugs with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study * use of any drugs which might influence the results of the trial (within one week prior to administration or during the trial) * participation in another trial with an investigational drug (within two months prior to administration or during the trial) * smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) * inability to refrain from smoking on trial days * alcohol abuse (\> 60 g/day) * drug abuse * blood donation (\>= 100 ml within four weeks prior to administration or during the trial) * excessive physical activities (within the last week before the study) * any laboratory value outside the reference range of clinical relevance * cytochrome p450 2d6 poor metaboliser (to be determined by phenotyping or genotyping)
a study assessing circulation around surgical incisions at the time of laparotomy closure

Conditions: Laparotomy

Summary: this study is being done to find out if spectrum near-infrared (nir) imaging with indocyanine green (icg) dye can help measure blood flow around an incision before and after the surgeon closes the incision with staples or sutures. the spectrum nir imaging system uses a handheld camera that produces a special type of light that can help surgeons see things during surgery that are difficult to see with the naked eye, for example, cancer tissue versus healthy tissue. spectrum nir imaging has been approved by the food and drug administration (fda) as a tool that is widely used during surgery. icg dye is a sterile solution that can be seen with spectrum nir imaging. this dye, used with spectrum nir imaging, allows surgeons to see blood flow to parts of the body during and after surgery. making sure that there is enough blood flow to the surgical site helps to promote a less complicated recovery.


Eligibility criteria:
criteria for eligibility prior to surgery inclusion criteria: * woman undergoing a laparotomy procedure via a vertical midline incision for any indication with the gynecology service at msk * age ≥18 years exclusion criteria: * women with hepatic dysfunction as evidenced by elevated transaminases * women with a history of cirrhosis or other chronic liver disease * women with an allergy to iodine * women undergoing laparoscopic or minimally invasive surgery criteria for eligibility post-surgery inclusion criteria: * woman undergoing a laparotomy procedure via a vertical midline incision for any indication with the gynecology service at msk * age ≥18 years subject exclusion criteria: * women with laparotomy incisions unable to be closed primarily due to tissue or fascial damage * women with transverse laparotomy incisions * women with laparotomy incisions left open due to a case classification as "contaminated" or "dirty"

Keywords: laparotomy surgical incisions wound perfusion 17-650
assessment of the influence of cleft repair on microcirculation of the palate

Conditions: Cleft Palate; Cleft Lip and Palate

Summary: investigators aim to evaluate the influence of cleft surgery on the tissue microcirculation of the palate with a non-invasive measurement.


Eligibility criteria:
inclusion criteria: * patients with orofacial clefts, who undergo routine cleft repair exclusion criteria: * missing datasets * no signed consent for research.
the effects of wearing a face mask during exercise in youth hockey players during covid-19

Conditions: Hypoxemia

Summary: there is concern that wearing a face mask during covid will affect oxygen uptake, especially during intense exercise. covid transmission is especially prevalent in sports such as hockey, where there is close contact between players and arena ventilation is poor. this study will assess the effect of wearing a surgical face mask on simulated hockey performance and blood and muscle oxygenation during cycling exercise.

the sport of ice hockey involves close contact between players in poorly ventilated arenas. this increases susceptibility for transmission of viruses, such as covid-19. face masks can reduce the risk of virus transmission; however, there is concern that wearing a face mask during exercise will reduce oxygen uptake or increase carbon dioxide re-breathing, which can result in low blood oxygen levels, reduced oxygen delivery to muscle and reduced exercise capacity. the purpose of the study is to determine the effect of wearing a surgical face mask during exercise that simulates ice hockey play on exercise performance and blood and muscle oxygenation in boys and girls. twelve boys and twelve girls (age 9-14y) who are experienced playing hockey, will take part in this randomized cross-over study that will assess exercise performance, blood oxygenation (i.e. pulse oximetry) and muscle oxygenation (with near infrared spectroscopy) during an exercise test on a cycle ergometer with workloads and work to rest intervals that simulates hockey performance. participants will also be tested for repeated-sprint performance on ice while wearing full hockey equipment. the conditions include no mask (a "sham" mask) and a surgical mask. outcome variables include power output during the cycle ergometer testing, skating distance during the on-ice test, rating of perceived exertion, blood oxygen saturation levels, and oxygenated, deoxygenated, and total hemoglobin at the quadriceps muscle.

Eligibility criteria:
inclusion criteria: * experience playing ice-hockey exclusion criteria: * contra-indications to exercise as identified by a screening questionnaire (the "get active questionnaire")
study of inactivated sars-cov-2 vaccine (vero cells) in healthy population aged 3 to 17 years(covid-19)

Conditions: COVID-19

Summary: this study is a randomized, double-blinded, and placebo controlled phase ⅱ clinical trial of the sars-cov-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy population aged 3 to 17 years.


Eligibility criteria:
inclusion criteria: * healthy residents aged 3 to 17 years at the time of consent * subjects and/or their guardian agree to sign the informed consent forms voluntarily. * be able to comply with study requirements/procedures. * axillary temperature ≤ 37.0℃ exclusion criteria: * within 14 days before vaccination, subjects have been abroad and to villages/communities experienced covid-19 epidemics, and in contact with covid-19 cases or suspected cases. subjects are under isolation observation, or living in the villages/communities with covid-19 cases or suspected cases; * confirmed cases, suspected cases or asymptomatic cases with covid-19 (refer to information system of china disease prevention and control); * subjects with history of sars virus infection by self-reported; * positive in throat swab through rt-pcr; * history of vaccination of various covid-19 vaccines or positive in sars-cov-2 antibody test; * positive urine pregnancy test for females with menarche * history of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated sars-cov-2 vaccine; * history or family history of convulsion, epilepsy, encephalopathy or mental illness; * subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; * subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, drug-uncontrollable hypertension, diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases; * diagnosed with congenital or acquired immunodeficiency, hiv infection, lymphoma, leukemia or other autoimmune diseases; * history of coagulation dysfunction (e.g. coagulation factor deficiency, coagulation disease); * subjects receiving anti-tb treatment; * subjects receiving other research drugs within 6 months before vaccination; * subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days); * subjects receiving blood products within 3 months before administration; * subjects vaccinated with live attenuated vaccine within 14 days before vaccination; * subjects vaccinated with other vaccine within 7 days before vaccination; * the researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.
predictive value of precise dapt score in stemi patients after primary pci

Conditions: ST-segment Elevation Myocardial Infarction (STEMI)

Summary: to investigate the predictive value of precise dapt score in relation to coronary slow flow \& other short term major adverse cardiovascular events (mace) post ppci .

coronary artery disease (cad) is the leading cause of death around the world and more than 4 million people die every year due to cad in europe.\[1\] the incidence of st elevation myocardial infarction (stemi) appears to be declining; however, it is still an important issue in cardiovascular medicine.\[2\] initial risk assessment is important for stemi to estimate adverse cardiovascular outcomes. previous studies demonstrated that increased age, advanced killip class, heart rate, arterial hypotension, increased serum creatinine, white blood cell counts, and hemoglobin levels were predictors of in-hospital and early mortality in patients with stemi treated with primary percutaneous coronary intervention (ppci).\[3,4 \]therefore, risk scores including the aforementioned parameters were developed to estimate mortality in patients with stemi. no-reflow is still a challenging major issue in the management of the patients with stemi undergoing primary pci. it is defined as inadequate myocardial perfusionthrough a given segment of the coronary circulation without angiographic evidence of mechanical vessel obstructionas \[5\] angiographic no-reflow defined as less than thrombolysis in myocardial infarction (timi) 3 flow \[6\] and angiographic success was defined as timi grade 3 flow . precise-dapt score includes age, creatinine clearance, white blood cell counts, hemoglobin levels, and prior spontaneous bleeding \[7\]. all these factors have a close relationship with coronary artery disease (cad) and complications \[8-10\]. therefore, in this study, we aimed to evaluate the association of admission precise-dapt score with the development of slow flow \& bleeding \& othershort term cardiovascular complications that develop in patients with stemi treated with primary pci.

Eligibility criteria:
inclusion criteria:1.subjects diagnosed as stemi accordind to fourth universal definition with age range from 18 to 75 years underwent ppci at cardiology hospital assiut university hospital.\[11\]. 2..patients elegable for ppci with stemi within 12 h of symptom onset, provided it can be performed expeditiously (i.e. 120 min from stemi diagnosis)\[12\] - exclusion criteria:1-late presentation with stemi more than 12 hr \& door to ballon more than 120 min including rescue pci . 2- cardiogenic shock 3-patients known to have autoimmune disease (e.g vasculitis ) 4- platelate count less than 100000 iu . 5- prothrombin concentration less than 60% 6- patients taking triple anti thrombotics . -
combined effect of tryptophan rich diet and acupuncture on depression related to premenstrual dysphoric disorder

Conditions: Premenstrual Dysphoric Disorder

Summary: premenstrual dysphoric disorder (pmdd) is a severe form of premenstrual syndrome (pms) affecting up to 8% of reproductive age women. it is characterized by physical and psychological symptoms that occur in the luteal phase of the menstrual cycle, prior to the onset of menses, and leads to negative impact on the psychosocial functioning of affected individuals. selective serotonin reuptake inhibitors are usually used to treat pmdd but they have several side effects so it is important to use complementary treatment such as tryptophan-rich diet and acupuncture for women with pmdd . the purpose of the current study is to determine the combined effect of tryptophan-rich diet and acupuncture on depression related to premenstrual dysphoric disorder

this study will be conducted on 39 participants suffering from premenstrual dysphoric disorder (pmdd). they will be recruited from horus university, new damietta, egypt.

Eligibility criteria:
inclusion criteria: * all females will be clinically diagnosed with premenstrual dysphoric disorder (pmdd) as confirmed and referred from the gynaecologist. * all females will be firstly assessed by hamilton depression rating scale (hdrs) for two months to confirm depression related to pmdd before participating in the study. * their ages will be ranged from 20 to 30 years. * their bmi will be ranged from 20 to 25 kg/m. * being virgin. * having regular menstruation for the last 6 months (every 28- 35 days with no intermittent bleeding). * all females have a sedentary lifestyle. * voluntary acceptance of participation in the study exclusion criteria: * using hormonal contraception (such as oral contraceptives and injections). * menstrual irregularity. * using diuretics or psychiatric medications. * using chronic non-steroidal anti-inflammatory drugs. * pre-diagnosed with any other psychological problems not related to pmdd. * follow any exercise programs.
cognitive aspects of adolescent suicide

Conditions: Suicide, Attempted

Summary: the purpose of this project is to pilot a new scale, the desperation scale, in a sample of young adolescents (aged 10-16) seen in the pediatric emergency room who require a psychiatric consultation. the proposed study is designed to assess the psychometric properties of this new scale and to provide information about the cognitive state of young suicidal individuals. it is hypothesized that this scale will be able to discriminate between those who are suicidal and those who are not. data obtained in this pilot study will provide information about the usefulness of the construct of desperation and will guide future projects aimed at the assessment and treatment of suicidal individuals. the use of cognitive factors to predict suicidal behavior is appealing because they allow the clinician to tap into an individual's perception of his/her life circumstances. however, we believe the popular conceptualization of suicide as a result of "hopeless" thinking ignores an important aspect of suicidal behavior-the motivation to escape. we propose that a model of suicidal behavior that includes escape motivation, which we call the desperation model, will be better able to predict suicide than existing measures. we conceptualize desperation as consisting of three core elements: a sense of entrapment, feelings of anxiety/agitation, and a sense of time urgency. the current pilot study will test a 35-item scale that assesses these three elements of desperation. a pilot study of the desperation scale is currently being conducted at the cornell university medical center (p.i. p.m. marzuk) with depressed, adult inpatients. our study is original in its use of the scale with an adolescent population and its focus on patients in the emergency room, when they are presumably in a "purer" suicidal state. it is hypothesized that those who are admitted to the emergency room for recent suicidal behavior will endorse feelings of entrapment, anxiety, and time urgency.


Eligibility criteria:
inclusion criteria: * young adolescents seen in the pediatric emergency room at yale-new haven hospital who require psychiatric consultation and who give consent to participate exclusion criteria: * diagnosis of a psychotic or organic brain disorder or inability to read the study questionnaire due to low iq, learning disability, or non-english speaking status

Keywords: suicide