Kornimate/medical-research-clean huggingface dataset:
evaluation of ganovo （danoprevir ） combined with ritonavir in the treatment of sars-cov-2 infection

Conditions: COVID-19

Summary: evaluation of the efficacy and safety of ganovo combined with ritonavir for patients infected with sars-cov-2.

given no specific antiviral therapies for new coronavirus pneumonia approved yet and ganovo, an oral hepatitis c virus protease inhibitor, approved in china in june 2018 , this open, controlled trial will evaluate the efficacy and safety of ganovo in hospitalized patients infected with sars-cov-2.

Eligibility criteria:
inclusion criteria: * aged 18-75 years old; * pneumonia patients with new coronavirus infection were confirmed to be positive by rt-pcr and clinical manifestations. the diagnosis standard refers to the diagnosis and treatment plan for pneumonia with new coronavirus infection (current trial version); * patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 7 days); * women and their partners who have no planned pregnancy for nearly half a year and are willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration; * agree not to participate in other clinical research within 30 days from the first administration of the study drug to the last administration; * patients who voluntarily sign informed consent. exclusion criteria: * the pneumonia patients with severe new coronavirus infection met one of the following conditions: respiratory distress, rr \>= 30 times / min; or sao2 / spo2 \<93% in resting state; or arterial partial pressure of oxygen (pao2) / concentration of oxygen (fio2) \<300mmhg (1mmhg = 0.133kpa); * pneumonia patients with severe new coronavirus infection meet one of the following conditions: respiratory failure and need mechanical ventilation; or shock; or other organ failure combined with icu monitoring treatment; * severe liver disease (such as child pugh score \>=c, ast \> 5 times upper limit); * patients with contraindications specified in the instructions of ritonavir tablets; * the pregnancy test of female subjects in the screening period was positive; * the researchers judged that it was not suitable to participate in this clinical trial (for example, patients who may be transferred to another hospital during the study period; patients with multiple basic diseases, etc.).
efficacy of inhaled albuterol spiromax® in subjects with persistent asthma with steady state pharmacokinetics

Conditions: Asthma

Summary: the primary objective of this study is to evaluate the efficacy of albuterol spiromax® versus placebo in subjects with persistent asthma.


Eligibility criteria:
inclusion criteria: * written informed consent/assent * at least 12 years of age at screening * general good health * persistent asthma for ≥3 months, with an fev1 50-80% predicted and ≥15% reversibility * taking inhaled corticosteroids at a stable dose (≤ equivalent of 500mcg of fluticasone propionate/day) for at least 4 weeks prior to the screening visit. * ability to perform spirometry in an acceptable manner as per protocol guidelines * other inclusion criteria apply exclusion criteria: * a known hypersensitivity to albuterol or any of the excipients in the formulations. * history of a respiratory infection or disorder that has not resolved within 1 week preceding the screening visit (sv). * history of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation. * any asthma exacerbation requiring oral corticosteroids within 3 months of the sv. a subject must not have had any hospitalization for asthma within 6 months prior to the sv. * hospitalization due to asthma exacerbation 2 or more times in the past year * initiation of immunotherapy or dose escalation during the study period * other exclusion criteria apply.

Keywords: asthma dry powder inhaler short-acting beta2-agonist saba bronchoconstriction bronchodilation bronchodilator metered dose inhaler albuterol spiromax®
respiratory mechanics and gas exchange characteristics in patient with sars-cov-2

Conditions: Covid19; ARDS, Human

Summary: the combination of different ventilatory strategies and its effects on respiratory mechanics and gas exchange in patients under mechanical ventilation with acute respiratory distress syndrome secondary to coronavirus-19 has been scarcely described.

investigation in mechanically ventilated patients with with acute respiratory distress syndrome (ards) secondary to coronavirus-19 (covid-19) is emerging due to presumed differences with typical ards from other origin. considering these issues, the effects of ventilatory strategies such as positive end expiratory pressure, end inspiratory pause and fraction of inspired oxygen on respiratory mechanics and gas exchange must be studied in order to characterize the behavior of covid-19 ards during invasive mechanical ventilation and choose the best combination of ventilatory settings. in this study the investigators will evaluate the changes in respiratory mechanics and gas exchange produced by low and high positive end expiratory pressure, low and high inspired oxygen fraction and the application of end inspiratory pause during volume controlled mechanical ventilation.

Eligibility criteria:
inclusion criteria: * older than 18 years old * less than 72 hs since ards diagnosis * moderate to severe ards * central venous catheter and arterial line available * need of neuromuscular blocking agents * supine position * informed consent accepted * airway opening pressure lower than 20 cmh2o exclusion criteria: * rass target higher than -5 * copd diagnosis * pneumothorax * intracraneal hypertension * pregnancy * cardiac inssuficiency uncompensated * chest wall deformity * bronchopleural fistula * contraindication to use esophageal manometry
targeted next generation sequencing for the efficacy of trastuzumab neoadjuvant chemotherapy in breast cancer

Conditions: Observational; Prospective

Summary: to explore the genetic background of patients with her2 positive breast cancer that benefit from trastuzumab combined with neoadjuvant chemotherapy, identify clinically actionable mutations that associated with trastuzumab resistance or drug efficacy, we designed this observational phase ii trial. the primary endpoint is genetic profile of her2+ breast cancer patients treated with trastuzumab combined neoadjuvant chemotherapy. secondary endpoints included pathological complete response (pcr) rate and safety.

currently, patients with stage ii-iii breast cancer still accounts for a large population in china, and neoadjuvant therapy is considered the standard treatment for them. the pathological complete response (pcr) rate takes for an indicator for regimens efficacy, and the achievement of pcr after neoadjuvant chemotherapy is associated with favorable outcomes including disease-free survival and overall survival. her2+ breast cancer represents an invasive and poor prognosis subtype, and the efficacy of neoadjuvant therapy for these patients has been greatly augmented by the addition of trastuzumab. however, more than 50% of her2+ breast cancer patients treated with trastuzumab combined neoadjuvant chemotherapy cannot achieve pcr, even experience primary drug resistance and rapid disease progression. therefore, to explore the genomic features of the population that benefited from trastuzumab combined with chemotherapy is of great significance for personalized treatment of her2+ breast cancer, aiming to avoid overtreatment and identify clinically actionable mutations for future therapy instructions.

Eligibility criteria:
inclusion criteria: * women aged 18-70 years old at the time of diagnosis of primary breast cancer * eastern cooperative oncology group (ecog) performance status score 0 or 1 * stage iii breast cancer according to the 7th edition of cancer staging manual of american joint committee on cancer (ajcc) * full assessment of er, pr and her2 status of primary tumor in accordance with the american society of clinical oncology (asco) guidelines * pathological diagnosis and all courses of treatment confirmed exclusion criteria: * any known metastatic disease, by physical exam or by imaging studies such as computed tomography (ct)/magnetic resonance imaging (mri), at the time of study entry * any previous exposure to chemotherapy, radiotherapy, or endocrine therapy * left ventricular ejection fraction (lvef) \< 55% by echocardiogram (echo) or multigated acquisition scan (muga) or significant clinical symptoms or signs of heart failure * major organ dysfunction, inclusive of bone marrow, renal, liver and hepatic function, that would prohibit patients from receiving standard chemotherapy

Keywords: breast cancer her2 positive next generation sequencing trastuzumab neoadjuvant chemotherapy
allergy to neuromuscular blocking agents and pholcodine exposure

Conditions: Neuromuscular Blocking Agents Anaphylaxis

Summary: the main objective of this study is to compare pholcodine exposure in patients having presented with a perianaesthetic anaphylactic reaction to a nmba (cases) to pholcodine exposure in matched anaesthetised patients with injection of nmba, who did not present with an anaphylactic reaction (controls). the secondary objectives of the study are: * to compare anti-pholcodine ige, anti-ammonium iv ige and total ige levels between the case and control groups. * to study the concordance between exposure to pholcodine in cases and controls, by means of a patient self-questionnaire on the one hand and, on the other hand, by a computerized drug history, supplemented where relevant by the drug master file. * to study the impact of taking 1, 2 or 3 sources in account for pholcodine exposition. * to study the association between exposure to pholcodine and the presence/levels of pholcodine-specific ige, reflecting sensitisation to pholcodine. * to study nmba and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to (at least) one nmba.


Eligibility criteria:
inclusion criteria: * male or female, age ≥ 2 years old. * referred to anaesthesia-allergy consultation within (approximately) 6 to 12 weeks of occurrence of peranaesthetic anaphylactic reaction during anaesthesia with administration of nmbas (only for case patient). * having given his/her consent (or the 2 parents consent for minors). * affiliated with a social security scheme or dependent. * able to answer a medicinal product intake questionnaire * in a clinical condition compatible with skin tests (no skin disease or psychiatric illness, etc.) (only for case patient) * having stopped any anti-histamine treatment at least 8 days previously (only for case patient). * with positive skin test for the suspected nmba (ony for case patient). * patient anaesthetised in a control recruitment centre (only for control patients) * having undergone anaesthesia with nmba injection, without onset of peranaesthetic anaphylactic reaction whatever his medical history (only for control patients) exclusion criteria: * patients who have refused, or are unable to give their consent * patients who have had negative control skin tests * anaphylaxis suspected to be related to other drugs given on induction of anaesthesia, eg. antibiotics * having presented with anaphylactic reaction during a previous anaesthesia without nmba injection * pregnant females at inclusion or during 12 months before anaesthesia

Keywords: anaphylaxis pholcodine neuromuscular blocking agents
safety and efficacy of uc-mscs in patients with plaque psoriasis

Conditions: Moderate and Severe Plaque Psoriasis

Summary: this is a study in patients with moderate to severe chronic plaque psoriasis.all the participants will be randomized into three groups, high-dose uc-mscs, low-dose uc-mscs, or methotrexate group.this study is designed to prove that uc-mscs is safe and effective.

psoriasis is a chronic, incurable, immune-mediated dermatological disease, and it is considered that immune system dysregulation is the important cause of the disease.umbilical cord derived mesenchymal stem cells (uc-mscs) have be proven safe and effective for the treatment of various intractable autoimmune and inflammatory disorders because of their distinct immunomodulatory properties. patients will be randomized into three groups.in one group patients will be treated with 1x10\^6 cells/kg in 0,1,2,3,5,7 week, in the second group patients will be treated with 3x10\^6 cells/kg in 0,1,2,3,5,7 week,in the third group patients will be treated with 5-25mg methotrexate from 0 to 15 week in this study, researchers will determine the safety of uc-mscs that a patient can tolerate without causing side effects. moreover researchers will also be assess the efficacy and sustainability of uc-mscs in 52 weeks.

Eligibility criteria:
inclusion criteria: * male or female patients ≥18 years old with moderate-to-severe psoriasis. * diagnosis of plaque psoriasis at least 6 months before entering the study. * moderate-to-severe plaque psoriasis(pasi≥10，or bsa≥10% and dlqi score≥10). * failure after conventional therapy. * no other treatment for psoriasis during the period of the trial. * willing and able to comply with all study requirements and provide informed consent. exclusion criteria: * other types of psoriasis,such as pustular, erythrodermic and guttate psoriasis). * drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium). * ongoing use of other psoriasis treatments. * ever use of any biologic drug directly targeting il-17,il-23,tnfa etc. * active systemic infections during the last two weeks (exception: common cold) prior to initiation of the trial and any infections that reoccur on a regular basis. * history of malignancy . * evidence of infection with hiv, hepatitis b or hepatitis c. * pregnant or lactating females, or willing to have a baby during the trial. * can not be traced on time.

Keywords: psoriasis uc-mscs
audit and screening study to determine the prevalence of peripheral arterial disease

Conditions: Peripheral Arterial Disease

Summary: the primary objective of the study is to establish the prevalence of lower extremity peripheral arterial disease (pad), defined as an ankle-brachial index of less than or equal to 0.9, in subjects with at least two of the specified cardiovascular disease (cvd) risk factors, with no overt cardiovascular disease.


Eligibility criteria:
inclusion criteria: * males aged 45 years or above or females aged 55 years or above (age related cvd risk factor). * at least two other risk factors for cvd: cigarette smoking, diabetes mellitus, hypertension, low hdl or high ldl cholesterol, strong family history of coronary heart disease, elevated waist circumference, aboriginal and/or torres strait islander. * willingness to participate in study and sufficient command of the english language to read and complete study questionnaire. exclusion criteria: * less than 2 risk factors for cvd (other than age), symptoms of pad, coronary heart disease or coronary heart disease risk equivalents * no lipid data collected in the last 12 months * serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise safety or successful participation in the study.

Keywords: peripheral arterial disease cardiovascular disease vascular disease
effectiveness of a web and mobile guided psychological intervention for depressive symptoms in turkey

Conditions: Depressive Symptoms

Summary: the aim of this study is to test the clinical effects of a web and mobile application of guided problem solving therapy for depressive symptoms among the general population in turkey.

in turkey, there are serious deficiencies in mental health care. among these, undertreatment of mentally ill patients, lack of psychologists and inadequate psychosocial and rehabilitation options for patients and their relatives are important prohibiting factors that reduce patients' outreach for getting help. while depression is highly prevalent (4.4%), only a small number of people seek professional help (18%) in turkey. innovative solutions are needed to overcome this treatment gap. online problem-solving therapy (pst) is a brief intervention proven to be effective in the treatment of depression, although little is known about its clinical effects in turkey. the aim of this study is to test the clinical effects of a web and mobile application of pst for depressive symptoms among the general population in turkey. participants will be recruited through announcements in social media and the middle east technical university. a randomized controlled trial with a sample size of 444 participants randomized across three groups will be utilized. the first experimental group will receive direct access to the web version of the intervention; the second experimental group will receive direct access to the mobile app of the intervention as well as automated supportive text messages based on pst. the control group consists of a wait-list and for ethical reasons, participants in this group will gain access to the intervention (either web or mobile application) four months after the baseline. the intervention is based on an existing pst for the turkish population, "her sey kontrol altinda" (hska).

Eligibility criteria:
inclusion criteria: * turkish participants living in turkey are eligible if the applicants are aged between 18-55 years and have mild to moderate depressive symptoms (beck depression inventory-ii score between 10 and 29). exclusion criteria: * participants will be excluded if they have a bdi-ii score above 29, or a medium-to- high suicidal risk (according to the mini-international neuropsychiatric interview) and are advised to contact a psychiatrist or clinical psychologist.

Keywords: randomized controlled trial mobile application problem-solving therapy online guided intervention
suspicion of non ige-mediated cow's milk protein allergy: prevalence and evolution

Conditions: Food Allergy in Infants; Proctocolitis; Atopic Dermatitis; Reflux, Gastroesophageal; Tolerance

Summary: cow's milk protein allergy (cmpa) is often evoked in infants, in particular in front of delayed symptoms such as rectal bleeding, atopic dermatitis, excessive crying, reflux, failure to thrive... but in case of non ige-mediated cmpa, the only way to diagnose this allergy is to proceed to an elimination-reintroduction test over a period of 2 to 4 weeks, to improve symptoms first, and then provoke them. even if the diagnosis is confirmed, we speculate that non ige-mediated cmpa has a faster resolution than other cmpa. the first aim of this study is to estimate the prevalence of non ige-mediated cmpa in a cohort of infants with delayed symptoms which could be relied to a cmpa. the second goal is evaluate the age of tolerance in non ige-mediated cmpa with oral food challenge for milk ever 2 months after 4 months of age.


Eligibility criteria:
inclusion criteria: * infants under 4 months age with delayed symptoms evoking cmpa exclusion criteria: * exclusively breastfed infants * no improvement of symptoms despite amino acid formula * patients with symptoms of food protein induced enterocolitis * patients who do not have diagnostic oral food challenge within 3 months after the start of elimination diet
adjunctive intravenous ascorbic acid for advanced non-small cell lung cancer

Conditions: Lung Cancer

Summary: this is a two arm rct evaluating the effect of intravenous vitamin c versus placebo in patients with incurable non-small cell lung cancer. participants in both arms will be receiving platinum doublet chemotherapy with or without concurrent immunotherapy as standard care. we plan to enroll 90 patients over 5 years.


Eligibility criteria:
inclusion criteria: 1. adults (≥18 years of age) seen at tohcc with stage iiib or iv primary non-small cell lung cancer 2. eligible and scheduled for first line platinum-doublet chemotherapy with or without concurrent immunotherapy exclusion criteria: 1. ecog status greater than 2 2. previously received ivc within 6 months prior to randomization 3. biochemical deficiency in g6pd 4. estimated glomerular filtration rate (egfr) less than 45 ml/min 5. currently taking insulin or warfarin 6. history of severe renal dysfunction or hemochromatosis 7. previously undergone cytotoxic chemotherapy or immunotherapy within 12 months prior to randomization 8. if pregnant or planning to become pregnant: not a carrier of the gene for g6pd deficiency 9. currently taking an investigational product or participation in an investigational study within the past 30 days 10. any reason which, under the discretion of the principal investigator or delegate, would preclude the patient from participating
99tc-mdp treatment for knee osteoarthritis

Conditions: Treatment Outcome

Summary: osteoarthritis (oa) of knee is the most common form of arthritis in the world1e, and it has received growing attention in the society because of the increase of old age population, disabled people, and medical expenses from this disease. 99tc-mdp is effective for rheumatoid arthritis. therefore, the investigators try to investigate the effects of 99tc-mdp treatment in patients with osteoarthritis of knee as compared with celecoxib.

the prevalence of osteoarthritis of the knee (oa) is increasing worldwide and this burden will continue to increase owing to aging of the general population 99tc-mdp is effective for rheumatoid arthritis. consequent to an increase in incidence is the rise in the number of patients with knee oa who are prone to further deterioration of the knee. it therefore is important to better understand, control, and attempt to prevent further progression of disease in patients with knee oa. limitations in walking, stair climbing, and squatting are common patient complaints that greatly interfere with activities of daily living and recreation. currently there is no definite consensus on the standardized management of oa. oral analgesic and anti-inflammatory agents are perhaps the most commonly prescribed treatments to alleviate knee oa symptoms. the failure of nonsurgical therapies to modify quality of life in knee oa patients is not surprising given their inability to alleviate physical manifestations of oa. surgical knee oa interventions generally result in good to excellent patient outcomes. however, there are significant barriers to considering surgery, which limits clinical utility. 99tc-mdp is actually the decay product of 99mtc-mdp (99mtc-methylene diphosphonate, a us food and drug administration-approved radioactive agent widely used for bone scintigraphy). 99tc-mdp (chengdu yunke pharmaceutical, sichuan, china) is a kind of anti-inflammatory drug patented in china (patent no. zl94113006.1). it was approved for production by the state food and drug administration of china in october 1997. 99tc-mdp has been demonstrated to be safe and effective in the clinical treatment of immune diseases, such as rheumatoid arthritis (ra), ankylosing spondylitis (as) and certain bone diseases, such as skeletal metastases from cancer in china. 99tc-mdp also showed clinical effect on knee oa in our practice. therefore, the investigators try to investigate the effects of 99tc-mdp treatment in patients with osteoarthritis of knee as compared with celecoxib.

Eligibility criteria:
inclusion criteria: 1. participants with painful osteoarthritis; 2. the standard uptake value (suv) of oa related knee greater than 10 on 18f- sodium fluoride bone scan; 3. participants voluntarily participate in the trial, and signed the informed consent. exclusion criteria: 1. knee joint replacement; 2. inflammatory arthritis or joint infection of knee; 3. nervous joint disease; 4. fracture of joint; 5. gout arthritis of the knee; 6. traumatic arthritis.

Keywords: 99tc-mdp osteoarthritis celecoxib