Kornimate/medical-research-clean huggingface dataset:
to study generic diclofenac sodium topical gel 1% in the treatment of osteoarthritis of the knee (degenerative joint disease presented as joint pain, stiffness, swelling and restricted motion).

Conditions: Osteoarthritis

Summary: this is a randomized, double-blind, placebo-controlled, parallel-design, multiple-site clinical study to evaluate the therapeutic equivalence of diclofenac sodium gel, 1% (glenmark pharmaceuticals ltd) to voltaren® gel (diclofenac sodium topical gel) 1% (novartis consumer health, inc) in patients with osteoarthritis (oa) of the knee


Eligibility criteria:
inclusion criteria: 1. healthy male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of oa of the knee according to the american college of rheumatology (acr) criteria. 2. oa symptoms for at least 6 months prior to screening. 3. baseline western ontario mcmaster osteoarthritis (womac) pain subscale of \> 9 on a 20 point scale for the target knee immediately prior to randomization. exclusion criteria: 1. history of oa pain in the contralateral knee requiring medication within 1 year prior to screening. 2. history of secondary oa, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia. 3. history of gastrointestinal bleeding or peptic ulcer disease. 4. known allergy to aspirin or nonsteroidal anti-inflammatory drug (nsaid). 5. use of anticoagulants, ace-inhibitors, cyclosporine, diuretics, lithium, or methotrexate prior to 30 days of screening. 6. concomitant use of systemic corticosteroids, topical corticosteroids, or immunosuppressive drugs or their use prior to 30 days of screening.
the effect of propolis mouthwash compared to chlorhexidine mouthwash on oral and cardiovascular health

Conditions: Blood Pressure; Periodontal Diseases

Summary: the oral microbiome has recently emerged as a key contributor in nitric oxide (no) homeostasis and vascular control by increasing nitrite bioavailability. antibacterial mouthwash containing chlorhexidine has been shown to be effective in inhibiting the nitrate-reducing activity of oral bacteria, and increasing blood pressure in normotensive and hypertensive individuals. recent research has also shown that chlorhexidine mouthwash lowered salivary ph and increased salivary lactate and glucose. this was also associated with changes on the activity and diversity of oral bacteria that are susceptible to increase the risk of periodontal disease. on the other hand, mouthwash containing propolis has similar antimicrobial effects than chlorhexidine, but adding some positive outcomes such as increased salivary antioxidant capacity. this may suggest that propolis mouthwash modulates the activity/diversity of oral bacteria. thus, this study aims to investigate the effect of propolis mouthwash on the nitrate-reducing activity of oral bacteria and vascular function compared to chlorhexidine in healthy humans.

methods: participants: adult healthy and non-smoker individuals will be recruited. the study will be approved by the human ethics committee of the university of plymouth. main protocol: participants will visit the laboratory on two different occasions. at the first visit, basic anthropometrical measurements will be taken before to collect a blood (6 ml) and saliva (3 ml) samples under fasting conditions. then, the nitrate reducing capacity of oral bacteria will be measured using a 10 ml of a free-nitrite water solution containing sodium nitrate. participants will rinse their mouth for 5 min. then, the mouth rinse will be collected into a sterile tube to analyse the absolute concentration of nitrite. following this, blood pressure will be taken in triplicate on the left arm using an electronic sphygmomanometer. then, microvascular function will be measured on the left forearm (extensor digitorum) using a hyperaemia reactive test. at the end of this visit and following a double-blind and non-cross over design participants will be allocated in one group: 1) chlorhexidine mouthwash or 2) propolis mouthwash. participants will be given 14 tubes of 10 ml of mouthwash to rinse their mouth twice a day for a week before to return to the laboratory a week later and to undertake the same measurements.

Eligibility criteria:
inclusion criteria: healthy individuals between 18 and 50 years old exclusion criteria: 1. smoking 2. to have hypertension, dyslipidaemia, diabetes, cancer or other physiological and mental disorders 3. existing interventions affecting the oral bacteria: mouthwash, tongue scrapes 4. to have taken antibiotics within the last month. 5. in females, to have irregular menstrual periods, less than or greater than 28 days over the last 3 months
a randomized clinical trial for depressed mothers at primary care level

Conditions: Depression

Summary: a randomized clinical trial was carried out at primary care level in santiago, chile to compare a pharmacological intervention for depressed mothers controlled by phone from a central level (tm) and the usual treatment (th) and its impact on children's mental health. hypothesis: pharmacological intervention for depression controlled by phone from a central level will be more effective than usual care in depressed mothers.

aim:to compare a pharmacological intervention for depressed mothers controlled by phone from a central level (tm) and the usual treatment (th) and its impact on children's mental health. material and methods: a rct wasw carried out at primary care clinics in santiago.sample:three hundred and forty five depressed women . one children of each mother was randomly selected. women are randomly assigned to receive the usual therapy or a pharmacological intervention with periodical telephone contacts with medical collaboration personnel, to reinforce compliance with treatment and educate about the disease, for 6 months. women were blindly evaluated at 3, 6 and 12 months with the hamilton depression rating score (hdrs) and the sf-36 to assess depressive symptoms and quality of life, respectively; the dyadic adjustment scale to assess marital adjustment. child psychopathology was assessed with the child behavior checklist (cbcl), the brief psychiatric rating scale for children (bprs-c), screen for child anxiety related emotional disorders(scared)and the children's depression inventory.

Eligibility criteria:
inclusion criteria: * depressed mothers with al least one child aged 6-16 exclusion criteria: * currently treatment for depression,psychosis,bipolar depression,alcohol or drug abuse, gravidity.

Keywords: depression primary care pharmacotherapy
long covid and its associations with health outcomes in older adults

Conditions: Long COVID; COVID-19 Pandemic; Elderly Infection; Vaccine Reaction; Lifestyle Factors; Reinfection

Summary: the peking university health cohort in anning, yunnan (pkuhc-an) is a prospective cohort study carried out in anning, yunnan. the primary aim of this study is to investigate the impact of covid-19 on older adults' health, and to provide high-quality evidence of real world research for the optimization of prevention and control strategies of covid-19 and other emerging infectious diseases. data will be collected regarding health status, history of covid-19 infections and vaccines, lifestyle and socioeconomic characteristics, as well as the short- and long-term health outcomes.

covid-19 pandemic attributed to a great number of mortalities around the world in the last 3 years. about 46% of the global population are estimated to have been infected by the omicron variant and its sublineages. health outcomes post covid-19 has been of great concern globally since more and more people infected by sars-cov-2. integrated efforts should be made to estimate the incidence of reinfections and long covid in china, especially among older adults who are vunlerable and susceptible to covid-19. in view of this, the peking university health cohort study in anning, yunnan aims to investigate the impact of covid-19 on older adults' health, and to provide high-quality evidence of real world research for the optimization of prevention and control strategies of covid-19 and other emerging infectious diseases. data will be collected regarding health status, history of covid-19 infections and vaccines, lifestyle and socioeconomic characteristics, as well as the short- and long-term health outcomes.

Eligibility criteria:
inclusion criteria: * 1. ≥60 years * 2. resided in anning in the past half year and have no plan to move out in next 1 year * 3. older adults who are willing to participate in this study with informed consent exclusion criteria: * 1. unable to answer questions or communicate * 2. older adults who are not willing to participate in this study or without informed consent
a study of atezolizumab as first-line monotherapy for advanced or metastatic non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: this was a phase ii, open-label, prospective, multicenter study designed to evaluate the efficacy and safety of single-agent atezolizumab as a first-line therapy in participants with locally advanced or metastatic non-small cell lung cancer (nsclc). in addition, the primary biomarker objective was to measure blood tumor mutational burden (btmb) and evaluate whether it can predict for improved clinical outcome with atezolizumab.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 1 * histologically or cytologically confirmed stage iiib-ivb nsclc * for participants who have received prior neo-adjuvant/adjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease: a treatment-free interval of at least 6 months prior to enrollment * participants with any programmed death-ligand 1 (pd-l1) test result by immunohistochemistry (ihc) are eligible for the study * participants without a pd-l1 test result are eligible for the study * measurable disease per recist v1.1 * adequate hematologic and end-organ function * agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods among women of childbearing potential exclusion criteria: * prior treatment with immunotherapy for any stage nsclc, including early-stage (neoadjuvant or adjuvant) disease * participants with epidermal growth factor receptor (egfr) sensitizing mutations and anaplastic lymphoma kinase (alk) rearrangements * active central nervous system (cns) metastases requiring treatment * spinal cord compression not definitively treated or not clinically stable * leptomeningeal disease * uncontrolled tumor-related pain * uncontrolled pleural, pericardial effusions, or ascites requiring recurrent drainage procedures * uncontrolled or symptomatic hypercalcemia * malignancies other than nsclc within 5 years prior to enrollment, except for those curatively treated with negligible risk of metastasis or death * pregnant or lactating women * history of autoimmune disease, significant pulmonary disease, or significant cardiovascular disease * positive human immunodeficiency virus (hiv) or hepatitis b or c * active tuberculosis * severe infection or major surgery within 4 weeks, or oral or iv antibiotics treatment within 2 weeks prior to enrollment * prior treatment with or hypersensitivity to study drug or related compounds * prior allogeneic bone marrow or solid organ transplant * administration of a live, attenuated vaccine within 4 weeks prior to enrollment * treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to enrollment * treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to enrollment
oral versus injectable risperidone for treating first-episode schizophrenia

Conditions: Schizophrenia

Summary: this study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.

schizophrenia is a severely disabling brain disorder. people with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. proper treatment of first-episode schizophrenia may increase the chances of controlling disease progression on a long-term basis. people experiencing their first episode of schizophrenia are more responsive to treatment than those with chronic schizophrenia, but are also more susceptible to adverse treatment side effects. atypical antipsychotic medications have been shown to produce fewer adverse side effects than older "typical" antipsychotics. risperidone is a type of atypical antipsychotic medication that is used to control the symptoms of schizophrenia. this study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia. participants in this open label study will be randomly assigned to receive either orally administered risperidone or long-acting risperidone administered via injection. participants assigned to oral risperidone will receive medication in doses that are determined to be optimal by the study psychiatrist. participants assigned to long-acting risperidone will receive an injection of risperidone once every 2 weeks. dosages will begin at 25 mg and will be adjusted as necessary to achieve the optimal dosage. following 2 to 3 months to achieve outpatient risperidone dosage stabilization, the randomized medication conditions will begin and participants will be monitored for 1 year. study visits will occur once weekly throughout the study. they will include group therapy meetings focused on everyday living skills; family education about schizophrenia; assessments of medication response; and individual meetings with a case manager for counseling and evaluations of schizophrenia symptoms.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of schizophrenia, schizoaffective disorder (depressed type), or schizophreniform disorder * first major episode of psychotic symptoms occurred within 2 years prior to study entry * participant in the ucla center for neurocognition and emotion in schizophrenia exclusion criteria: * neurological disorder or injury (e.g., encephalitis, epilepsy, traumatic brain injury) * mental retardation (e.g., premorbid iq less than 70) * significant alcohol or substance abuse within 6 months prior to study entry * inability to complete research measures in english * any condition that may make risperidone use medically inadvisable

Keywords: schizoaffective disorder, depressed type schizophreniform disorder first-episode schizophrenia injectable risperidone
a study (study 1) to evaluate the safety and efficacy of fmx103 1.5% topical minocycline foam in the treatment of facial papulopustular rosacea

Conditions: Facial Papulopustular Rosacea

Summary: the primary objectives of this study are to determine the efficacy and safety of fmx103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.

this is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy of fmx103 topical foam containing 1.5% minocycline compared to vehicle, in the treatment of participants with moderate-to-severe facial papulopustular rosacea. qualified participants will be randomized in a 2:1 ratio (active:vehicle) to receive 1 of the following 2 treatments: * fmx103 minocycline foam 1.5% * vehicle foam participants will be assigned to 1 of 2 treatments according to the randomization schedule. participants will apply (or have applied) the study drug topically once daily for 12 weeks as directed. participants will be advised to use the study drug at approximately the same time each day. both the investigator and participant will be blinded to the study drug identity. participants will return for visits at weeks 1, 4, 6, 8, 10, and 12. efficacy evaluations (inflammatory lesion counts and investigator's global assessment \[iga\] score) will be performed at weeks 4, 8, and 12 during the study. note: originally the two studies fx2016-11 and fx2016-12 were combinedly presented in the protocol registration form under one nct number (nct03142451), and later separated since results were analyzed separately.

Eligibility criteria:
inclusion criteria: 1. moderate-to-severe rosacea (as per the iga score) on the proposed facial treatment area consisting of: 1. at least 15 and not more than 75 facial papules and pustules, excluding lesions involving the eyes and scalp; 2. no more than 2 nodules on the face. 2. presence of or history of erythema and/or flushing on the face. exclusion criteria: 1. presence of any skin condition and/or excessive facial hair, on the face that would interfere with the diagnosis or assessment of rosacea. 2. moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema. 3. history of hypersensitivity or allergy to minocycline, any other tetracycline, or of any other component of the formulation. 4. active ocular rosacea (eg, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

Keywords: topical minocycline foam 2-arm study inflammatory lesion counts investigator's global assessment score
the role of traditional music therapy on burnout syndrome among healthcare workers: psycho-neuro-immuno-endocrine aspects

Conditions: Burnout, Professional

Summary: the goal of this clinical trial study is to learn about the role of traditional music therapy on burnout syndrome among healthcare workers, based on psychology, neurology, immunology, and endocrinology aspects. the main questions it aims to answer are : 1. how traditional music therapy can improve psychological aspects (emotional exhaustion, depersonalisation, and personal accomplishment) among healthcare workers with burnout syndrome? 2. how traditional music therapy can improve neuroautonom aspects (heart rate variability) among healthcare workers with burnout syndrome? 3. how traditional music therapy can improve immunology aspects (iga and t cell regulator) among healthcare workers with burnout syndrome? 4. how traditional music therapy can improve endocrinology aspects (cortisol and endorphine) among healthcare workers with burnout syndrome?

the goal of this clinical trial is to learn about the role of traditional music therapy on burnout syndrome among healthcare workers. the investigators will collected about 80 participants, which eventually get divided into intervention (40 participants) and control (40 participants) group. participants will get examined using maslach burnout inventory-human service survey for rating their burnout sydnrome. before starting the intervention, both group will get assessed for their heart rate variability, iga and t cell regulator level, and cortisol and endorphine level. after that, intervention group will get traditional music therapy and educational video 3 session a week for about 4 weeks. and control group will only get educational video. both group will be assessed for their heart rate variability and their laboratory markers three times, 2 weeks after starting the intervention, right after finishing all intervention session on week 4, and 2 weeks after the intervention is done. investigators will compare the results between control group (educational video only without any music therapy) and intervention group (traditional music therapy and educational video) to see if there are any role of traditional music therapy on burnout syndrome based on psychology-neuroautonom-immunology-endocrinology aspects.

Eligibility criteria:
inclusion criteria: * agreed to participate in this study by signing an informed consent sheet * above 18 years old * doctors or nurses working in rsup dr kariadi semarang * mbi-hss score show intermediate-severe burnout * meet the requirements for an hrv examination * have been working for minimum one year on each instalation exclusion criteria: * above 60 years old * have history of chronic illness such as cancer, thyroid, and cardiovascular disease * taking drugs that affect central nervous system * hearing loss and disorder * psychosis, anxiety,depression and any other psychological disorder * pregnant women * does not like music

Keywords: burnout syndrome music therapy healthcare workers maslach burnout inventory heart rate variability t cell regulator iga cortisol endorphine
the pre-hospital evaluation of sensitive troponin (presto) study

Conditions: Chest Pain; Acute Coronary Syndrome; Heart Attack

Summary: the aim of the study is to assess whether a decision aid that is currently used in hospitals across greater manchester to determine how likely it is that a patient has a serious heart problem is still accurate in the pre-hospital environment.

the investigators will aim to recruit up to 700 participants, aged 18-100, who call 999 with a complaint of chest pain and are subsequently attended by the ambulance service. a blood sample will be taken in the ambulance as well as information about the participant's symptoms, past medical history, physical examination findings and heart tracing findings. the participant will then be transferred to hospital, where another blood sample will be taken. both of these blood samples will be analysed at a later date for the cardiac marker, troponin. participants will then be followed up after 30 days via screening of their clinical records and contacting their gp. the investigators will gather information on the participant's initial admission to hospital, as well as any further hospital admissions and investigations that have occurred within the 30 days since this admission. the information collected will include data on serial cardiac marker testing; other laboratory analyses; length of stay; all imaging investigations and procedures; and details of any haemorrhagic complications.

Eligibility criteria:
inclusion criteria: * adult patients (\>18 years) * called 999 for an emergency ambulance because they have experienced pain, discomfort or pressure in the chest, epigastrium, neck, jaw or upper limb without an apparent non-cardiac source * treating paramedic suspects these symptoms may be caused by acute coronary syndromes. exclusion criteria: * patients with unequivocal evidence of st elevation myocardial infarction who are being immediately transferred for primary percutaneous coronary intervention * patients in whom an alternative diagnosis (other than acute coronary syndromes) is suspected, which would necessitate transfer to hospital * patients who have not experienced symptoms in the previous 24 hours * patients who lack the capacity to provide written informed consent, either because they lack the mental capacity to provide written informed consent or because effective communication is not possible (e.g. non-english speakers in the absence of adequate translation services)

Keywords: t-macs pre-hospital environment