Kornimate/medical-research-clean huggingface dataset:
an open label pharmacokinetic study of naftin for tinea corporis

Conditions: Tinea Corporis

Summary: this is an open label, multi-center, multi-application pharmacokinetic study in pediatric subjects with tinea corporis.


Eligibility criteria:
inclusion criteria: * male or females 2 to 11 years, 11 months of any race. females of child producing age (started menarche) must have a negative urine pregnancy test. * presence of tinea corporis characterized by clinical evidence of a tinea infection at multiple sites covering a total of at least 1% body surface area. * koh positive and culture positive baseline skin scrapings obtained from the site most severely affected of the overall severity. * subjects must be in good health and free from clinically significant disease that might interfere with the study evaluations. exclusion criteria: * tinea infection of the scalp, face, groin, and/or feet. * a life-threatening condition (ex. autoimmune deficiency syndrome, cancer) within the last 6 months * subject with abnormal findings-physically or laboratory- that considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results. * subjects with a known hypersensitivity or other contradictions to study medications or their components.

Keywords: ringworm
home administration of nivestimtm in the primary prophylaxis of chemotherapy-induced febrile neutropenia

Conditions: Non-Interventional Study

Summary: non-interventional, non-comparative, national, multi-site, single-arm prospective observational study to investigate home administration of nivestim in the primary prophylaxis of chemotherapy-induced febrile neutropenia


Eligibility criteria:
inclusion criteria: * male and female patients ≥ 18 years * declaration of informed consent signed by patient * patients with a solid tumour or with a malignant haematological tumour * patients who have been prescribed cytotoxic chemotherapy, irrespective of current cycle * gcsf-naïve patients or patients pre-treated with gcsf who received no gcsf in the last three months before enrolment * patients starting primary prophylactic treatment using nivestimtm either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy-induced fn exclusion criteria: * patients with chronic myeloid leukaemia (cml) or with myelodysplastic syndrome (mds) * patients who are hypersensitive to one of the excipients of nivestimtm * patients not undergoing chemotherapy * patients being treated curatively or as secondary prophylaxis with g-csf

Keywords: non-interventional study
basic life support (bls) and barriers to cross-cultural education

Conditions: Medical Education

Summary: this is a randomized, multi-center intervention trial comparing two educational programs on healthcare provider performance in the botswana national hospital system. this study addresses the critical question of how to effectively and consistently measure and associate cpr knowledge and psychomotor skills, enabling the optimization of the learners' environment.

context: the world health organization (who) estimates that more than 16 million people die from cardiovascular diseases each year, accounting for more than one-third of global deaths. almost half of these deaths take place in hospitalized settings. standard acute medicine education programs have had limited success in training hospital based healthcare providers to acquire, retain, and transfer knowledge and skills to impact patient outcomes in both developed and developing countries. there is a gap between the cognitive knowledge and critical thinking skills attained during courses and the technical and team skills actually performed by hospital-based healthcare providers. this gap between existing knowledge and performed skills restricts care delivery, underutilizes available resources, and contributes to the number of preventable deaths. this gap is further accentuated in resource limited settings, where barriers to implementation of successful acute medicine training programs are often accentuated. primary objective: 1. to determine selected cognitive knowledge and critical thinking skills which are associated with technical and team skills performance assessed immediately following basic life support (bls) for health care providers course training. secondary objectives: 1. to identify cultural, healthcare environment and educational barriers that currently impede acquisition, retention, and transfer of knowledge and skills in acute medicine educational programs in resource limited settings.

Eligibility criteria:
inclusion criteria: 1. healthcare providers involved in patient contact. 2. participation in bls for healthcare provider course exclusion criteria: 1. have received formal basic life support training in previous 12 months. 2. inability to perform or complete cognitive and skills assessment testing (pre, immediate post, 3 or six month post). 3. healthcare personnel performing an educational rotation at the district or referral hospital will not be eligible due to loss of follow-up.

Keywords: bls training cpr post graduate education resource-limited settings medical education cpr retention cultural barriers
6 weeks treatment of locally advanced breast cancer with bibw 2992 (afatinib) or lapatinib or trastuzumab

Conditions: Breast Neoplasms

Summary: an open-label, randomized three-arm phase ii trial to explore the efficacy of bibw 2992 as a single agent versus lapatinib versus trastuzumab in patients with her2-positive treatment-naïve stage iiia locally advanced breast cancer. additional information will be obtained on the safety profile and pharmacokinetics of bibw 2992.


Eligibility criteria:
inclusion criteria: 1. female, age 18 years or older. 2. histologically proven breast cancer who have not received any prior therapy. 3. locally advanced disease stage iiia with no evidence of distant metastatic disease other than anatomical site lymph nodes. 4. her2-positive. exclusion criteria: 1. absolute neutrophil count (anc) less than 1500/mm3. 2. platelet count less than 100 000/ mm3. 3. hemoglobin level less than 9.0 g/dl. 4. bilirubin greater than 1.5 mg/di. 5. aspartate amino transferase (ast) or alanine amino transferase (alt) greater than twice the upper limit of normal. 6. serum creatinine greater than 1.5 times of the upper normal limit. 7. significant or recent acute gastrointestinal disorders with diarrhea 8. pregnancy or breast-feeding. 9. organ system dysfunction including cardiac (lvef \< 50%). 10. prior chemotherapy, radiotherapy or hormone therapy. previous treatment with trastuzumab, egfr, or egfr/her2-inhibitors. 11. other malignancies diagnosed within the past five years. 12. serious active infection. hiv, active hepatitis b or c.
deprexil in subjects with signs and symptoms of depression

Conditions: Depression

Summary: the purpose of the study is to assess the efficacy of deprexil administration in combination with relaxation psychotherapy in the treatment of patients with signs and symptoms of depression. the duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. the estimated number of persons to be recruited and randomized for the study is 200.


Eligibility criteria:
inclusion criteria: * mild or moderate symptoms and signs of depression for more than 3 months and less than 3 years of duration. * signed informed consent exclusion criteria: * severe symptoms and signs of depression or suicide proneness. * pregnancy or breastfeeding * receiving other experimental drug * use of anti-depressive medication within 15 days

Keywords: depression dietary supplement deprexil
complicated outcome prediction after liver resection

Conditions: Liver Neoplasms

Summary: although mortality after liver surgery reduced during the last three decades to less than 2%, post-operative course is still complicated in a range of 20-50% of cases.the identification of one or few factors which could detect the real risk of complicated post-operative outcome, may help anesthesiologist to decide whether admit a patient to icu or not.the primary aim of this study was to evaluate whether rri, alone or along with other items, can predict post-operative complication after hepatic resection.


Eligibility criteria:
inclusion criteria: patients resectable and affected by primary and secondary liver disease exclusion criteria: subjects affected by kidney disease and/or cirrhosis and pregnant patients were excluded from the trial. patients who should have needed nephrectomy during the operation would be also excluded.
hearing loss and communication needs in a group care setting for older adults

Conditions: Age-related Hearing Loss

Summary: the purpose of this study is to develop and test a multicomponent hearing care intervention for the pace staff members in order to learn more about communication and engagement.

the long-term objective of this proposal is to increase the accessibility and affordability of hearing loss treatment for older adults with hearing loss, with a particular interest in adults that have mild cognitive impairment (mci) or dementia. age-related hearing loss (arhl) in persons with mci or dementia may exacerbate dementia-related symptoms such as depression, apathy, agitation/aggression. moreover, engagement and activity participation are recognized as critical aspects of dementia care management, but those individuals who also experience arhl are at a disadvantage. a pilot testing of behavioral communication intervention will be completed at multiple program for all-inclusive care for the elderly (pace) sites in new england. a multicomponent hearing care intervention will be tested that includes staff training and non-custom personal amplification use with older adults in a group care setting. this feasibility study will lead to the refinement of the intervention protocols to be used in a future grant application that will test the real-world efficacy of the intervention.

Eligibility criteria:
inclusion criteria: * pace staff who work in the day health center and are available to attend the training on-site at pace are eligible for inclusion. all staff are invited to join the training (via zoom, if necessary), but to complete the research activities, they have to complete the training in-person due to the hands-on component of learning to use the hearing device. exclusion criteria: * staff members who cannot attend the (virtual) in-person training.
aromatase inhibitors in the treatment of male infertility

Conditions: Obesity; Oligospermia

Summary: obesity is associated with an increase in blood levels of estrogen. estrogen or "female hormone" is believed to have a negative effect on sperm production. aromatase inhibitors such as anastrozole work to decrease the production of estrogen and increase testosterone in the body. by decreasing the level of estrogen, sperm production should improve. in this study, the investigators will try to determine the benefit of anastrozole in obese men and follow pregnancy outcomes.


Eligibility criteria:
inclusion criteria: 1. male partner of a couple presenting for infertility work up after one year of unprotected intercourse 2. moderate oligozoospermia (defined as mean sperm count ≤ 20 × 106/ml and ≥ than 3 × 106/ml) of at least two separate occasions spanning a minimum of two weeks 3. obese men bmi ≥ 30 4. fsh and lh levels \< 10 miu/ml exclusion criteria: 1. severe oligozoospermia: sperm count \< than 3 × 106/ml, including azoospermia 2. age less than 18 or greater than 65 years 3. pyospermia or leukospermia: defined by white blood cells ≥ 1 million leukocytes per milliliter of semen 4. cryptorchidism 5. vasectomy reversal 6. regular use of tobacco products 7. bmi \< 30 8. use of anabolic steroids or testosterone replacement 9. all patients with abnormal initial liver function tests "ast or alt" will be excluded form the study

Keywords: obesity low sperm count male infertility
drug use investigation of azithromycin iv for pneumonia or pelvic inflammatory disease (regulatory post marketing commitment plan)

Conditions: Pneumonia; Pelvic Inflammatory Disease

Summary: to collect the efficacy and safety information of azithromycin iv related to their appropriate use in daily practice


Eligibility criteria:
inclusion criteria: * male or female patients who are prescribed zithromac iv for pneumonia or pelvic inflammatory disease. exclusion criteria: * subjects who have been prescribed zithromac iv for pneumonia or pelvic inflammatory disease.

Keywords: pneumonia pelvic inflammatory disease zithromax zithromac japanese regulatory post marketing commitment plan
efficacy and safety of tazarotene gel in nail psoriasis

Conditions: Nail Psoriasis

Summary: the aim of this study is to determine the efficacy and safety of topical application of the gel compared to placebo in nail psoriasis.


Eligibility criteria:
inclusion criteria: * key inclusion criteria: * mild to moderate nail psoriasis on at least one fingernail exclusion criteria: key exclusion criteria: * any other skin condition, with a potential to affect the nails or to interfere with evaluation of the disease; * history of hypersensitivity to retinoids or to other components of the trial medication * topical treatment of nails with antipsoriatics in the 4 weeks preceding the treatment phase; * systemic treatment of psoriasis within the three months before the treatment phase of the trial or during the trial * intralesional steroid injection before the treatment phase of the trial * phototherapy before the treatment phase of the trial; * any chronic infection or condition capable of interfering with the conduct of the trial; * evidence of drug or alcohol abuse; * symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks preceding the treatment phase of the trial; * participation in another clinical trial within the last 4 weeks prior to first treatment in this clinical trial; * pregnancy or nursing;
medical and surgical treatment for idiopathic granulomatous mastitis

Conditions: Granulomatous Mastitis

Summary: this study evaluates the clinical response rate of topical steroids in the treatment of idiopathic granulomatous mastitis in female adults. half of the participants will receive topical steroid and the other half will receive local wide surgical excision.

idiopathic granulomatous mastitis (igm) is a rare benign inflammatory breast disease of unknown etiology.it may present with many findings that clinically and radiologically mimic breast cancer. although igm as a disease has been known for nearly four decades, the optimal treatment approach has not been established. surgical intervention in the form of wide surgical excision was the mainstay of treatment before 1980, and is still performed depending on local expertise and preference. currently,surgical treatment and systemic steroid treatment are frequently employed. with the consideration of side effects of longterm systemic (oral) steroid usage, topical steroid without systemic use were assessed and showed satisfactory curative effect. but the data concerning the use of topical steroid therapy are still very limited.

Eligibility criteria:
inclusion criteria: * idiopathic granulomatous mastitis exclusion criteria: * breast carcinoma

Keywords: granulomatous mastitis topical steroids
dose escalation study of kylo-0603 in healthy subjects

Conditions: Nonalcoholic Steatohepatitis

Summary: this clinical trial is the first-in-human study of kylo-0603. the purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of food of kylo-0603 in healthy chinese adult subjects.

the study consists of three parts: single ascending doses (part 1), food effect (part 2) and multiple ascending doses (part 3).

Eligibility criteria:
inclusion criteria: * men and women aged 18 to 55 years old, inclusive; * body mass index (bmi) between 19 kg/m2 and 30 kg/m2, inclusive； * having no clinically significant disorder, condition or disease at screening and before first dosing; * female subjects must not be able to get pregnant and male subjects must agree to adhere to contraception restrictions; * willing to comply with protocol required visits and assessments, and provide written informed consent. exclusion criteria: * history of cardiovascular, respiratory, digestive, liver, urinary, hematological, endocrine, metabolic, immune, cutaneous, or psychoneurotic diseases； * history of evidence of malignant tumor or gilbert syndrome; * positive screen of hepatitis b surface antigen, hepatitis c virus, human immunodeficiency virus or syphilis infection; * history of tuberculosis infection; * history of alcohol abuse within 12 months before dosing; * history of drug abuse within 3 months before screening; * history of blood donations or blood loss of 400 ml and more within 3 months before dosing; * pregnant or breast-feeding women; * other exclusion criteria applied per protocol.
alcohol counseling for telephone quitline callers

Conditions: Smoking; Nicotine Dependence; Alcohol Dependence

Summary: the goal of this study is to train phone counselors working for the new york (ny) state smokers' quitline to advise callers who drink at hazardous levels to limit or abstain from alcohol use to determine whether this improves smoking cessation outcomes so that we can establish effect size estimates for a full scale multi-site trial.

this is a developmental study to: 1) create and beta test an alcohol counseling protocol with 25 quitline callers and 2) train quitline specialists to provide an alcohol intervention using at least 100 pilot quitline callers to ensure that specialists in the alcohol intervention + standard care condition provide counseling that addresses hazardous drinking with a high level of alcohol intervention strategies and skill. after this phase of the study is complete, a developmental randomized clinical trial will be conducted with 1,948 ny quitline callers who drink at hazardous levels to compare practical counseling + smoking cessation print materials added to standard care (pc + sc condition) to alcohol intervention counseling + alcohol-focused print materials added to standard care (ai + sc condition). efficacy data from this trial will be used to determine effect size estimates for both quitdate and 7-month self-reported point prevalence abstinence rates. reduction in alcohol consumption and reduced drinking as a mediator of smoking cessation outcome will be secondary outcomes. other mediators and moderators of alcohol intervention effects will also be examined as an exploratory outcome. if the effect size estimates are sufficiently large and medically important to pursue a definitive trial, these data will be used to propose a full scale multi-site large study. if an alcohol intervention is shown to enhance treatment outcome in a large-scale study, alcohol interventions with quitline counselors could be translated for use by the entire ny state quitline and other quitlines across the country. this may increase the effectiveness of quitline interventions and thus has the potential to reach millions of smokers, thereby bolstering tobacco and cancer control efforts across the united states.

Eligibility criteria:
inclusion criteria: * adults (18+ years) * cigarette smokers requesting assistance with quitting smoking * hazardous drinkers (per niaaa criteria) exclusion criteria: * eligible for enhanced services program

Keywords: smoking tobacco drinking
evaluation of the efficacy and safety of nano-s1

Conditions: COVID-19 Pneumonia

Summary: this study aims to assess the efficacy of the efficacy and safety of investigational drug (nanos) in patients with mild to moderate covid-19 at high risk for progression to severe covid-19, including death.

we conducted a prospective randomized double-blind clinical trial over five months to determine the efficacy of nanos compared to placebo. the effectiveness of treatment was measured by the significant decline in the number of cases of covid-19 infection and/or a decrease in the viral load determined by sars-cov-2 cycle threshold (ct) value using rt-pcrs test.

Eligibility criteria:
inclusion criteria: 1. participants are hospitalized in a covid unity or outpatient follow-up by the investigator 2. participants who have positive sars-cov-2 test result and the onset of symptoms of covid-19 ≤7 days prior to randomization, not exceed the 7th day since the beginning of disease symptoms; and the randomization's day. 3. present at least one of these symptoms: participants who have one or more mild or moderate covid-19 symptoms: fever, general signs such as: headaches, asthenia, myalgia, arthralgia, etc... ent signs such as: sore throat, anosmia, agueusia, hypoacusis, deafness, etc... digestive signs such as: diarrhea, vomiting, abdominal pain, etc... respiratory signs such as: dyspnea, cough, etc... and cutaneous signs such as: skin rash, livedo, etc... 4. present an oxygen saturation patients with spo2 \&gt; 94% at room air 5. present at least one of these risk factors: participants who satisfy one or more than one of the following high risks for progression to severe covid-19, including death: age 65 years old or -age between 18 and 64 years old with at least one of these risk factors: obesity (bmi\&gt; 30 kg/m2),and/or diabetes under treatment and/or cardiovascular disease (including hypertension and stable angina) high blood pressure and/or chronic obstructive pulmonary disease (copd) disease and/or asthma and/or neoplasia (solid tumour; hematological malignancy) neoplasia, and/or a blood disease and/or heart failure and/or chronic renal failure (cl creat\&gt; 30mml/min) and/or unstabe angina and/or autoimmune disease. 6. have signed the informed consent to participate in this trial. exclusion criteria: * non observance.non-compliant patient with drawal of consent. patient who refuses blood samples.

Keywords: argent colloidal
olanzapine versus comparator in the treatment of bipolar disorder

Conditions: Bipolar Disorder

Summary: the purpose of this trial is compare the efficacy of olanzapine and lithium carbonate in the treatment of bipolar disorder, manic or mixed episodes, in chinese patients.


Eligibility criteria:
inclusion criteria: * male or female in- or out-patients at least 18 years of age * patient must have a diagnosis of bipolar i disorder and currently display acute manic or mixed episodes (with or without psychotic features) according to the dsm-iv based on clinical assessment * patients must have a level of understanding sufficient to agree to all tests and examinations required by the protocol * patients must have a y-mrs total score of greater than or equal to 20 at both visits 1 \& 2 * patients must be considered reliable exclusion criteria: * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry * serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months * current or past diagnosis of schizophrenia or other psychotic disorder (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the dsm-iv * documented history of intolerance to olanzapine or lithium carbonate * treatment with clozapine within 4 weeks prior to visit 2. treatment with other antipsychotic drugs or mood stabilizers within 2 days prior to visit 2