Kornimate/medical-research-clean huggingface dataset:
description of treatment management of patients with major depressive disorder and inadequate response

Conditions: Major Depressive Disorder

Summary: the purpose is to assess the response of add-on therapy, based on cgi-i scale, at 4 weeks, in patients with mdd who had an inadequate disease control with antidepressant medication.

a cross-sectional observational study to describe treatment management of patients with major depressive disorder (mdd) and inadequate response to antidepressants in greece

Eligibility criteria:
inclusion criteria: * diagnosis of mdd as per dsm-iv * patients with an inadequate disease control during antidepressant therapy * patients who already receive add-on therapy and have completed 4-5 weeks of treatment at the time of their enrolment in the study. exclusion criteria: * patients fulfilling criteria for diagnosis of any other psychiatric condition (except for mdd), as per dsm-iv axis i, * concomitant organic mental disorder or mental retardation substance abuse or dependence (with the exception of nicotine dependence), as defined by dsm-iv criteria participation in another study

Keywords: antidepressant therapy, inadequate control, add-on therapy
lta assessement using aggregometer ta-8v (stago®)

Conditions: Healthy Volunteer

Summary: exploring platelet functions requires aggregation tests platelet. the haematology laboratory of hospices civils de lyon currently has two new ta-8v plate aggregation automatons® (stago). the supplier of these devices does not offer reference values for these tests. there are also no references in the data literature. therefore reference values must be established from healthy volunteer subjects. the use of these automatons is subject to the nf (french standard) en (european standard) iso (international organization for standardization) 15189 standard of the cofrac ( french accreditation comity) that requires checking their proper functioning. this audit must be traced in a method validation folder.


Eligibility criteria:
inclusion criteria: * male or female adults aged between 18 and 70 years * weighting more than 50 kg * subjects having signed informed consent * subjects registered in the french health-care system database exclusion criteria: * personal history of anemia, thrombopenia, hemorrhagic disease * caffeine intake 2 hours prior to blood sampling * tobacco intake in the half hour prior to blood sampling * use of any drug impacting platelet function * for antiplatelet agents: at least 10 days prior to blood sampling * for anti-depressants: at least 10 days prior to blood sampling * for non-steroid anti-inflammatories: at least 3 days prior to blood sampling * refusal to undergo the 3 visits and 3 blood samples of the study * refusal to sign the informed consent form * no registration in the french health-care system database * pregnant women and women who are breastfeeding

Keywords: light transmission aggregometry platelets platelet functions von willebrand disease quality assessment
a study of hlx10 in combination with carboplatin plus (+) pemetrexed with or without hlx04 compared with carboplatin+pemetrexed in 1l advanced non-squamous non-small cell lung cancer (nsclc)

Conditions: Carcinoma; Non-Small-Cell Lung

Summary: this study involves a two-part design. part 1 is designed to evaluate the safety and tolerability of the 4 drug (hlx10+hlx04+carboplatin+pemetrexed). part 2 is a randomized, open-label study, which will evaluate the safety and efficacy of hlx10 in combination with carboplatin+pemetrexed with or without hlx04(biosimilar of avastin) compared with treatment with carboplatin+pemetrexed in 1st line stage iiib/iiic or iv non-squamous nsclc. participants will be randomized in a 1:1:1 ratio to arm a (hlx10+hlx04+carboplatin+pemetrexed), arm b (hlx10+hlx04 placebo+carboplatin+pemetrexed), or arm c (hlx10 placebo + hlx04 placebo+carboplatin+pemetrexed).


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed, stage iiib/iiic or iv non-squamous nsclc 2. participants with no egfr, alk and ros1 mutation. 3. participants with no prior treatment for stage iiib/iiic or iv non-squamous nsclc 4. measurable disease as defined by recist v1.1 5. eastern cooperative oncology group performance status 0 or 1 6. adequate hematologic and end organ function exclusion criteria: 1. malignancies other than nsclc within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome 2. active central nervous system metastases 3. prior treatment with cluster of differentiation immune checkpoint blockade therapies or bevacizumab 4. has received a surgical operation within 4 weeks from the initial drug administration 5. active or suspected autoimmune diseases. subjects in a stable state with no need for systemic immunosuppressant therapy are allowed to enroll. 6. currently having or have had interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis and severe impaired pulmonary function that may interfere with the detection and management of suspected drug-related pulmonary toxicity 7. any active infection requiring systemic anti-infective therapy within 14 days prior to study drug administration 8. uncontrollable active infection(s) 9. history of immunodeficiency, including hiv antibody positive 10. active hepatitis b; or hepatitis c virus infections 11. has bleeding tendency 12. history of severe cardiovascular diseases 13. known gastrointestinal diseases as follows, gastrointestinal perforation, abdominal fistula or abdominal abscess within 6 months before signing the informed consent; history of poorly controlled or recurrent inflammatory bowel disease; active peptic ulcers, or \> moderate esophageal varices 14. pregnant or breastfeeding female
acute effects of e-cigarette aerosol inhalation

Conditions: Endothelial Dysfunction; Biochemical Markers

Summary: this study comprises a portion of a larger study designed to compare results of vascular function in non-smokers to vascular function in healthy smokers chronically exposed to nicotinized electronic cigarette aerosol versus conventional cigarettes.

here, we 1) investigate the acute effects of non-nicotinized e-cigarette aerosol inhalation in nonsmokers in terms of blood-based markers of inflammation and oxidative stress, and 2) evaluate their association with hemodynamic-metabolic mri parameters quantifying peripheral vascular reactivity, cerebrovascular reactivity, and aortic stiffness.

Eligibility criteria:
inclusion criteria: • bmi of 18.5 - 30 exclusion criteria: * cancer * hiv * mental illness * overt cardio- or neurovascular disease (prior heart attack, stroke, transient ischemic attacks) * serious arrhythmias * bronchospastic disease * upper respiratory tract infection within the past six weeks * chronic medication or antibiotics * claustrophobia / contraindications for mri

Keywords: inflammation
a study to assess the efficacy of intravenous bondronat (ibandronate) in patients with malignant and painful bone disease

Conditions: Pain; Bone Neoplasm; Neoplasm Metastasis

Summary: this 2 arm study will compare the efficacy of intravenous bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. patients will be randomized to receive either bondronat (6mg iv on days 1, 2 and 3 and then every 3-4 weeks) or zoledronic acid (4mg iv on day 1 and then every 3-4 weeks). the anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * patients with malignant bone disease; * patients with moderate to severe pain. exclusion criteria: * patients who have received a bisphosphonate within 3 weeks from the signing of the informed consent; * patients receiving concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of dosing; * untreated esophagitis or gastric ulcers; * recent or pre-scheduled radiotherapy to bone; * patients who are pregnant or breast-feeding.
open trial of miglitol in type 2 diabetic patients treated with biguanide

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the clinical efficacy and safety of miglitol in patients with type2 diabetes mellitus treated with biguanide.


Eligibility criteria:
inclusion criteria: * type 2 diabetic patients with biguanide treatment * criteria for postprandial plasma glucose and hba1c are met exclusion criteria: * type 1 diabetes * patients treated with other antidiabetic drugs or insulin

Keywords: alpa-glucosidase inhibitor,biguanide
self-administered lidocaine gel for pain management with iud insertion

Conditions: IUD Insertion

Summary: for intrauterine device (iud) insertion, currently there are no standardized clinical guidelines for pain management. the investigators aim to explore whether adequate pain relief is possible through self-administered, non-invasive means alone. reducing pain associated with iud insertion may benefit patients and providers. when patients are comfortable during their procedure, it is likely the provider can more quickly and with fewer complications perform the insertion. the investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the standard of care pain management, no intervention, prior to iud insertions. this is a superiority, blinded, randomized controlled trial.


Eligibility criteria:
inclusion criteria: elective iud insertion (any type of iud, copper or hormonal); at an out-patient setting at stanford; english or spanish speaking, and ability to give informed consent. exclusion criteria: any pre-operative use of misoprostol; or use of po pain control medication (i.e. ibuprofen or acetaminophen) prior to procedure. allergy to study medications: lidocaine, or surgical lubricant jelly, known uterine anomaly; prior cervical surgery; and no prior use of tampons.

Keywords: pain management iud insertion
clinical decision support tools for antibiotic prescribing

Conditions: Infectious Disease

Summary: the goal of this study is to assess the utility of a data visualization tool for providers' understanding patients' past microbiological culture sensitivities. providers that are ordering antibiotics for patients with previous culture data in the medical record will be asked to answer questions regarding past sensitivity results. they will be randomized to either using the visualization tool before answering the questions or using the standard medical record tools. they will then be surveyed about their decision-making, knowledge, and the usefulness of the tool.


Eligibility criteria:
inclusion criteria: * provider is caring for a patient with a previous positive urine or blood cultures * provider is caring for a patient currently in a clinical location being investigated * provider is caring for a patient with orders placed for an intravenous, intramuscular, oral antibiotics exclusion criteria: * the patient has already received the antibiotic by the time of the intervention * the antibiotic has been cancelled by the time of intervention * the research assistant is unable to reach the ordering provider before the visit is completed * participation by the clinician in the study would impede clinical care * age \< 18
bh4 in the prevention and treatment of radiation-induced skin reactions for head and neck squamous cell carcinoma (including nasopharyngeal carcinoma)

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: head and neck squamous cell carcinoma (include nasopharyngeal carcinoma) is one of the most common malignant tumor in china, and radiotherapy is the main treatment method. radiation-induced dermatitis is one of the most common complications of head and neck squamous cell carcinoma patients during radiotherapy. severe radiation dermatitis will cause secondary infection, severe pain, and even lead to the interruption of radiotherapy. on the one hand, it will affect the efficacy of tumor treatment, which may affect the long-term survival of patients, and on the other hand, it will also seriously affect the quality of life of patients. tetrahydrobiopterin（bh4）, also known as sapropterin, has been shown not only to reduce the severity of acute radiation dermatitis but also to enhance the repair of skin injury in animal experiments. it may be a new approach and method for the prevention and treatment of radiation-induced dermatitis


Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of head and neck squamous cell carcinoma (including nasopharyngeal carcinoma). 2. age ≥ 18 years old, ≤ 80 years old. 3. eastern cooperative oncology group (ecog) performance status 0-1. 4. head and neck radiotherapy alone or concurrent chemoradiotherapy, radiotherapy using intensity modulated radiotherapy. 5. blood routine examination: hemoglobin ≥ 100g/l, platelet count ≥ 75×10\^9/l, white blood cell count ≥ 3.0×10\^9/l, absolute neutrophil count ≥ 1.5×10\^9/l. blood biochemistry: total bilirubin≤1.5 upper limit of normal (uln), alanine aminotransferase (alt) and aspartate aminotransferase (ast)≤2.5 uln, serum creatinine ≤1.5 uln or creatinine clearance rate \>=60ml/min. 6. have signed informed consent form. exclusion criteria: 1. allergic to the components of sapropterin dihydrochloride tablets or severe allergic constitution. 2. poor compliance. 3. pregnant or breastfeeding. 4. any previous radiotherapy to the head and neck region. 5. patients deemed unsuitable for the study by the investigator (concomitant with any other serious disease)

Keywords: head and neck squamous cell carcinoma nasopharyngeal carcinoma radiation dermatitis sapropterin dihydrochloride bh4
effect of akb-6548 on cardiac repolarization intervals in healthy volunteers

Conditions: Healthy Volunteers

Summary: the main purpose of this study is to evaluate the effect of single oral therapeutic and supratherapeutic doses of akb-6548 on the qt interval.


Eligibility criteria:
key inclusion criteria: * healthy, non-smoking males or females, 18 and 55 years of age, inclusive * bmi 18.0 and 32.0 kg/m2, inclusive * non clinically significant 12-lead ecg * heart rate of 45 to 90 beats per minute, inclusive * mean systolic blood pressure \<141 mmhg and mean diastolic blood pressure \< 90 mmhg key exclusion criteria: * history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gi, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease * history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias, or torsades de pointes, structural heart disease, or a family history of long qt syndrome * significant abnormalities in liver function tests * history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs * history of gilbert's syndrome * positive hepatitis panel * seizure disorder or receiving anti-epilepsy medication for seizure disorder * any acute or chronic condition that, in the opinion of the investigator, may pose a safety risk to a subject in this study or which would limit the subject's ability to complete and/or participate in this clinical study

Keywords: akebia qt interval tqt pharmacokinetic anemia chronic kidney disease ckd chronic renal insufficiency renal impairment safety
the impact of performing arts on mental health, social connection, and creativity in university students

Conditions: Mental Health; Quality of Life; Social Isolation; Creativity

Summary: the goal of this clinical trial is to investigate whether the "movin' \& groovin' for wellness" (mgw) performing arts program is able to support mental, social, and emotional health in nus students. it will also assess the program's impact on students' well-being. the main questions it aims to answer are: 1. does participation in the program decrease depressive symptoms, stress levels and anxiety? 2. does the program foster creative expression among participants? 3. does the program foster social connections among participants? researchers compare the effects of the facilitated music and dance sessions (mgw program) to a control group that does not participate in these activities. participants are randomly assigned into either the experimental (mgw) group or control group. those in the experimental group are randomly allocated to one of two subgroups, where participants either experience drumming or dancing sessions first (for 5 weeks), followed by the other activity (e.g., the only difference between subgroups is the order in which they experience the facilitated sessions). both the drumming and dancing sessions are led by trained professionals. the sessions are held weekly for 10 weeks in dedicated performance rooms. participants also complete questionnaires, and have the opportunity to participate in a focus group discussion to provide feedback about the program. control group participants complete the same questionnaires at the same time points without participating in the activities. the program aims to evaluate the effectiveness of music and dance in promoting mental health, social well-being, and creativity among university students.


Eligibility criteria:
inclusion criteria: * be currently enrolled in nus * be between the ages of 18-40 years old * be fluent (speak and write) in english * able to commit to attending the live sessions for the entire 10-week period * have normal or corrected-to-normal hearing and vision exclusion criteria: * have been diagnosed with a neurological or hearing impairment, or a physical impairment that would prevent moving/dancing * are taking medicine to treat their mental health (as this would be a confound in the study)

Keywords: mental health social connection creative expression arts and health music intervention dancing drumming performing arts
identification of potential biomarkers of peptide immunotherapy. part 2 - gene array analysis

Conditions: Cat Allergy

Summary: cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis. cat-pad is a novel, synthetic, allergen derived peptide desensitising vaccine currently being developed for treatment of cat allergy. at present, the efficacy of immunotherapy (peptide or otherwise) can only be established at the conclusion of therapy. no reliable predictive biomarkers of clinical efficacy currently exist. identification of surrogate biomarkers of clinical efficacy, would facilitate clinical development of peptide immunotherapy vaccines, in addition to providing an improved understanding of the underlying molecular mechanisms of efficacy, thus providing new leads for therapeutic intervention.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-65 years. * weight \>50 kg. * a minimum 1-year documented history of rhinoconjunctivitis on exposure to cats. * positive skin prick test to cat allergen. * subjects must have regular exposure to a cat in their normal living or working circumstances throughout the course of the study. * minimum qualifying rhinoconjunctivitis symptom scores exclusion criteria: * history of asthma * history of anaphylaxis to cat allergen * history of allergen immunotherapy in the previous 10 years, or in the previous 3 years for pre-seasonal immunotherapy treatments * history of any significant disease or disorder (e.g. autoimmune, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment, severe atopic dermatitis)

Keywords: cat allergy rhinoconjunctivitis immunotherapy cat-pad
pharmacokinetics of topical sb204 in adolescents with acne vulgaris

Conditions: Acne Vulgaris

Summary: a phase 1, single-center, open-label, pharmacokinetic, safety and tolerability study of sb204 in adolescents with moderate to severe acne vulgaris

this is a single-center, open-label study to be conducted in 18 otherwise healthy adolescents with moderate to severe acne vulgaris. repeat blood samples will be obtained on day 1 and day 21 pre and post treatment to characterize systemic exposure to hmap3 and nitrate. subjects will receive a low-nitrate diet for 12 hours prior to and during the pk sampling period

Eligibility criteria:
inclusion criteria: * otherwise healthy male and female adolescent subjects with moderate to severe acne vulgaris on a 5 point iga scale * at least 20 total inflammatory lesions (papules and pustules), and at least 20 total non-inflammatory lesions (open and closed comedones) on the face, chest, back, and shoulders * age 9-16 years, 11 months inclusive * subjects with methemoglobin level less than 3% at screening and baseline by pulse co-oximeter exclusion criteria: * subjects with any other acne-like dermatological conditions such as severe, recalcitrant nodulocystic acne, acne conglobata, acne fulminans, acne secondary to medications or other medical conditions, perioral dermatitis, clinically significant rosacea, or gram-negative folliculitis; * any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc. * subjects who reside in a dwelling that relies on well water for a primary drinking source * subjects with facial hair (beards, mustaches, etc.), tattoos or other facial markings that would interfere with assessments and study drug application * transgender subjects receiving hormone supplement (male to female or female to male) * subjects with a previous history of methemoglobinemia or taking medications known to be associated with methemoglobinemia * subjects with a known history of hiv, hepatitis, or other blood-borne pathogens * females who are pregnant, planning a pregnancy or breastfeeding * subjects previously treated with nvn1000 gel / sb204
prolactin hormone in oral lichen planus

Conditions: Oral Lichen Planus

Summary: oral lichen planus (olp) is one of the most common mucosal diseases with autoimmune etio-pathogenesis with involvement of various cytokines similar to psoriasis.it generally occurs more commonly in females, in a ratio of 3:2. prolactin (prl),it is a peptide hormone that has a role in autoimmune related diseases like systemic lupus erythematosus and , rheumatoid artheritis. the role of prl in olp pathogenesis was never investigated.the aim of this study is to investigate the expression of prl receptors in tissue biopsies of olp patients.


Eligibility criteria:
inclusion criteria: * patients with oral lichen planus * systemically healthy exclusion criteria: * oral lichenoid lesions