Kornimate/medical-research-clean huggingface dataset:
the safety and efficacy of intravenous anidulafungin as a treatment for azole-refractory mucosal candidiasis (frmc)

Conditions: Candidiasis

Summary: anidulafungin is an antifungal agent of the echinocandin class which is highly active in vitro against fluconazole resistant candida species. the efficacy of anidulafungin has demonstrated in various animal models of fluconazole-resistant mucosal disease; as well as, in phase 2 esophageal candidiasis studies. this study is intended to offer patients with frmc an alternate therapy with amphotericin b or with other agents whose efficacy and/or safety are inadequate in the treatment of this disease.


Eligibility criteria:
inclusion criteria: * diagnosis of definite azole-refractory mucosal candidiasis (oral or oropharyngeal candidiasis or esophageal candidiasis), i.e., patients who have not responded to a prior 14-day course of fluconazole at a dose of at least 200 mg daily or other azole (e.g. voriconazole) * grade 1 or higher mucosal disease and microscopic or culture confirmation of yeast exclusion criteria: * pregnant female * hypersensitivity to anidulafungin or echinocandin therapy * hypersensitivity to tween 80 (polysorbate 80) or tartaric acid * abnormal blood chemistries: bilirubin \>2 times the upper limit of normal; ast (aspartate aminotransferase) or alt (alanine aminotransferase) \> 4 times the upper limit of normal * less than four weeks since prior participation in an investigational drug or device study with the exception of antiretroviral agents or licensed agents * patients taking other systemic antifungal therapies while on this study

Keywords: azole-refractory mucosal candidiasis mucosal candidiasis
the effects of mixhers hertime supplements on menstrual symptoms

Conditions: Healthy; Premenstrual Dysphoric Disorder; Premenstrual Syndrome

Summary: the purpose of this study is to assess mixhers hertime supplements efficacy in alleviating menstrual cycle symptoms.

all participants, after providing written informed consent, will drink a daily self-administered powder-mix supplement in water of either placebo or mixhers hertime for 120 consecutive days. surveys will be administered electronically to each participant in the first month to assess baseline menstrual cycle symptoms. in addition, before starting the supplement, participants will take the electronic survey "the premenstrual symptoms screening tool". during the first month of taking the supplement, participants will take an allergy and constitutional symptom survey electronically to assess for any adverse reactions to the product. each month for four months, participants will complete an electronic survey assessing menstrual cycle symptoms after a menstrual cycle is completed.

Eligibility criteria:
inclusion criteria: * must be biologically female, must have a regular menstrual cycle (defined as a menstrual bleed every 23-35 days), must be a student, staff, or faculty member at midwestern university glendale, arizona campus exclusion criteria: * not pregnant or planning to become pregnant, must not be on anticoagulants, must not have allergies to lemon or stevia

Keywords: pms (premenstrual syndrome) pmdd (premenstrual dysphoric disorder) period symptoms menstrual cycle menstrual cramping menstrual bleeding
neurophysiological evaluation of training effect on cancer-related weakness

Conditions: Breast Cancer

Summary: breast cancer patients often suffer from long-term physical symptoms of weakness. in this study, investigators propose to compare how two different low intensity physical exercise training programs can improve handgrip strength for breast cancer patients with symptoms of weakness. using brain imaging, the study will also investigate changes in brain structure, and muscle activity associated with handgrip.

participants will be randomized to either a no treatment group or one of two low intensity 6-week exercise training. outcomes will be measured at baseline, post-intervention and 4 weeks post intervention.

Eligibility criteria:
inclusion criteria: * female aged 40-75 yrs * right handed, as determined by the edinburgh inventory (oldfield, 1971) * proficient in english * must be available for the familiarization, and testing sessions exclusion criteria: * symptoms for mild or severe depression as determined by a patient health questionnaire (phq-8) score \>14 * significant cognitive impairments as defined by a score \<28 in the folstein mini-mental screening examination (mmse, folstein et al .1975). * participated in any type of motor imagery or strength training program in the last 5 years, or plan to start any motor imagery or physical strength training program for the 3 months duration of the study * neurological, psychiatric, musculoskeletal or other types of disorder that may affect participants sensorimotor function and cognitive abilities * current medication believed to affect cognitive/psychomotor function (i.e., opioid, analgesics, anxiolytics or antidepressants) * history of alcohol, smoking, and drug abuse * any contraindication for mri

Keywords: fatigue breast cancer force motor imagery cancer treatment
a study of ly2189265 in japanese patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to assess dose-response characteristics in japanese patients with type 2 diabetes taking ly2189265 monotherapy.


Eligibility criteria:
inclusion criteria: * japanese patients with type 2 diabetes with a body mass index (bmi)≥18.5 kilograms per square meter (kg/m\^2) but \<40.0 kg/m\^2. * patients who are oral antidiabetic drug (oad) naïve or are taking oad monotherapy except for a dipeptidyl peptidase-4 inhibitor (dpp-iv) and are willing to discontinue their oad. * patients who are oad naïve with screening glycosylated hemoglobin (hba1c) value of 7.0% to 9.5% and randomization hba1c value of 7.0% to 9.5%, or who are taking oad monotherapy with screening hba1c value of 6.0% to 8.5% and randomization hba1c value of 7.0% to 9.5%. * patients who have, in the opinion of the investigator, a stable weight during the 12 weeks prior to screening. exclusion criteria: * patients who are currently taking prescription medications to promote weight loss * patients who are receiving chronic systemic glucocorticoid therapy, or have received such therapy within 4 weeks immediately prior to screening. * patients who have a known clinically significant gastrointestinal disorder, have undergone excision of all or any part of the gastrointestinal tract, have undergone gastric bypass surgery for treatment of obesity, or chronically take drugs that directly influence gastrointestinal motility. * patients who have poorly controlled hypertension, renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension. * patients who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis. patients who have amylase and/or lipase of 1.5 times or more the upper limit of the reference range. * have a family history, obvious clinical signs, or symptoms of medullary carcinoma of thyroid.

Keywords: metabolic diseases glucose metabolism disorders diabetes glp-1 lilly
psychological problems in post thyroidectomy patients

Conditions: Post-Thyroidectomy Hypoparathyroidism

Summary: quality of life (qol) refers to perceived well-being, and encompasses the evaluation of physical health, and physical, social, and psychological functioning . the assessment of quality of life (qol) post-thyroidectomy has gained significant attention in the medical community. multiple studies have delved into the long-term consequences of thyroidectomy, aiming to evaluate the impact on patients' overall well-being and functional status. by examining numerous aspects, such as the physical, psychological, and social dimensions of qol, researchers have provided valuable insights into the outcomes of thyroidectomy, hence contributing to improving patient care and enhancing their postoperative experiences.

regarding the psychological dimension of qol, several studies have emphasized patients' emotional well-being post-thyroidectomy. findings have demonstrated that, while many individuals experience temporary emotional disturbances related to the surgery, long-term psychological outcomes generally improve over time. in fact, the majority of patients report higher levels of self-esteem and body image post-thyroidectomy, as the removal of a diseased or abnormal thyroid gland can alleviate anxiety and distress associated with the underlying condition. however, additional research is needed to explore the specific factors contributing to these positive psychological outcomes and to identify potential interventions for those experiencing psychological distress following thyroidectomy . thyroidectomy is the treatment of choice in thyroid cancer patients, and the prevalence of thyroid cancer has shown a gradual increase over the past two decades. thyroid surgery is also indicated in certain forms of benign thyroid disorder, such as nontoxic goiter and graves' disease. although thyroidectomy is a universal operation, few studies to date have investigated the impact of thyroidectomy on qol .

Eligibility criteria:
inclusion criteria: * 1-gender: both males and females 2- post thyroidectomy patients: patients who will be planned to undergo different types of thyroidectomy for conditions such as thyroid cancer, benign thyroid disease (goiter), or hyperthyroidism (e.g., graves' disease) and admitted as inpatients. 3- age range: participants within certain age range (e.g., 18-75 years). 4-consent: ability to provide informed consent to participate in the study. 5-stable medical condition: exclusion criteria: 1. patients who were previously diagnosed with any psychiatric diseases. 2. medications: use of medications that could affect outcome of the study e.g., antidepressants, corticosteroids and benzodiazepines 3. pregnancy: current pregnancy or breastfeeding. 4. age: less than 18 years or more than 75 years old. 5. patients with any organ failure e.g (heart failure, end-stage renal disease requiring dialysis and liver failure) and cancers other than thyroid cancer.
activating messages for enhancing primary care practice (amep2): effectiveness study

Conditions: Depression

Summary: this trial consists of two linked substudies. substudy 1: activating messages for enhancing primary care practice (amep2): effectiveness study substudy 2: activating messages for enhancing primary care practice (amep2): toxicity study the purpose of the effectiveness study is to assess the comparative effectiveness of three multimedia educational interventions (a targeted educational video, a tailored interactive multimedia computer program, and an "attention control") for increasing the likelihood that primary care patients with significant depressive symptoms will seek appropriate care (n = 510). the primary study outcomes are provision of minimally acceptable initial care, reductions in depression-related stigma, and improvement in depression symptoms. (see process of care and patient outcomes in primary outcome measure section.) the purpose of the toxicity study is to assess the potential benefits (reduced stigma) and harms (inappropriate prescribing) associated with three multimedia depression educational interventions when administered to patients with few or no depressive symptoms (n = 308). the primary outcomes relating to this outcome are reducing depression-related stigma and reducing unnecessary prescribing. (see toxicity in primary outcome measure section.) both studies will look at the secondary outcome measure of patient requests for depression treatment.

this project is an investigator-initiated study involving two sequential phases and is funded by the national institute of mental health. phase i included the use of marketing research (i.e. focus groups, adaptive conjoint analysis, and other survey methods) to produce two clinic-based interventions: a public service announcement (psa) and interactive multimedia computer program (imcp). the two clinic-based interventions are intended to include messages that will activate patients to talk with their physicians about specific health concerns (depression) and/or any depressive symptoms they've been experiencing. in phase ii (as described in this registration protocol), those interventions will undergo assessment in a randomized controlled effectiveness trial (rct) in primary care settings in sacramento and san francisco.

Eligibility criteria:
inclusion criteria: * age 25-70 * visual acuity and manual dexterity to operate a laptop computer exclusion criteria: * currently being treated for depression with anti-depressant medications
proteasomal inhibition for patients with mis-sense mutated dysferlin

Conditions: Dysferlinopathy

Summary: dysferlin is a protein with an important role in the repair of muscle surface membranes. mutations in dysferlin cause different forms of muscular dystrophies. dysferlinopathies are inherited in an autosomal recessive manner, and many patients with this disease harbor mis-sense mutations in at least one of their two pathogenic dysf alleles. these patients have significantly reduced or absent dysferlin levels in skeletal muscle, suggesting that dysferlin encoded by mis-sense alleles is rapidly degraded by the cell's quality-control system. in a series of in-vitro experiments we showed that mis-sense mutated dysferlin can be salvaged from degradation by proteasomal inhibition. this resulted in an increase of functional dysferlin protein and a subsequent repair of plasma membranes of cultured patient-derived muscle cells. in this proof-of-concept study we would like to test wether proteasomal inhibition can salvage mis-sense mutated dysferlin in patients harboring certain dysferlin mis-sense mutations.


Eligibility criteria:
inclusion criteria: * must carry at least one allele of a salvageable mis-sense mutation of dysferlin * age ≥ 18 years * written informed consent exclusion criteria: * bleeding disorder * acute or chronic kidney failure (ccl \<50 ml/min) * advanced liver disease or active hepatitis * congestive heart failure nyha iii and iv * pregnancy or nursing * immunosuppression (prednisolone doses below 20 mg/d are allowed) * therapy with strong inhibitors of cytochrome p450 3a4 * hcv or hiv infection * regular alcohol consumption (\>14 drinks a week) * drug addiction
wxeliri versus folfiri regimen in the treatment of advanced colorectal cancer patients

Conditions: Colorectal Cancer

Summary: the aim of this study is to compare weekly-xeliri(wxeliri) regimen versus folfiri regimen in the treatment of advanced colorectal cancer patients. the hypothesis is the efficacy of wxeliri is not less than folfiri with tolerable toxicity.

the combination of irinotecan and fluorouracil drugs regimen is frequently used in patients with advanced colorectal cancer. according to the previous data, higher rate of diarrhea was observed in the combination of irinotecan and capecitabine (xeliri) regimen, compared to the combination of irinotecan and 5-fluorouracil (folfiri) regimen. however, the modified weekly xeliri regimen, which was investigated in our previous single armed study, show tolerate toxicities compared with folfiri, without compromising efficacy. it is supposed that wxeliri regimen is no less less than folfiri regimen in efficacy.

Eligibility criteria:
inclusion criteria: * second-line treatment for advanced colorectal cancer,irinotecan was not previously used. * age range 18-70 years old * ecog performance status 0-1 * life expectancy of more than 3 months * adequate organ function exclusion criteria: * previous serious cardiac disease * history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * pregnant or lactating women * chronic inflammatory bowel disease or intestinal obstruction * serious uncontrolled diseases and intercurrent infection

Keywords: advanced colorectal cancer folfiri xeliri
a study in subjects with recurrent malignant glioma

Conditions: Glioma

Summary: an open-label phase 2, multicenter study in participants with recurrent malignant glioma.


Eligibility criteria:
inclusion criteria 1. histologically confirmed diagnosis of grade 3 or 4 malignant glioma. 2. all subjects who have a first or second recurrence following primary management with surgical resection or biopsy, radiotherapy and up to 2 prior systemic treatments with addition of: * no prior bevacizumab treatment is allowed for cohort 1 and cohort 2. * subjects must have disease progression following prior bevacizumab treatment for cohort 3. * for all cohorts, no prior anti-vascular endothelial growth factor (vegf/vegfr) therapy except for bevacizumab as specified above. 3. karnofsky score of 70% or greater. 4. adequately controlled blood pressure (bp) with or without antihypertensive medications, defined as bp less than 150/90 mmhg at screening and no change in antihypertensive medications within 1 week prior to the screening visit. 5. adequate renal function, adequate bone marrow function, adequate blood coagulation function and adequate liver function, as defined in protocol. 6. no evidence of hemorrhage on the baseline magnetic resonance imaging (mri) scan other than in those subjects who are stable grade 1. exclusion criteria: 1. females who are pregnant or breastfeeding. 2. subjects who received enzyme-inducing anti-epileptic agents within 14 days before the first dose of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone, or oxcarbazepine). 3. active infection requiring intravenous antibiotics. 4. therapeutic anti-coagulation with warfarin, aspirin, nonsteroidal anti-inflammatory drugs or clopidogrel (low molecular weight heparin is acceptable). 5. subjects with 24-hour urine protein greater than or equal to 1 gm. 6. prior surgical resection within 4 weeks, or prior stereotactic biopsy within 2 weeks, of screening visit. 7. prior radiotherapy within 12 weeks unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field, or there is biopsy-proven unequivocal viable tumor on histopathologic sampling. 8. prior chemotherapy (6 weeks for nitrosoureas), or any investigational agent within 4 weeks unless the subject has recovered from all anticipated toxicities associated with that therapy; prior bevacizumab therapy (cohorts 1 and 2); for cohort 3, prior bevacizumab therapy within 3 weeks. 9. significant cardiovascular impairment: history of congestive heart failure greater than new york heart association (nyha) class ii ; unstable angina; myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment. 10. prolongation of qtc interval to greater than 480 msec. 11. active hemoptysis (bright red blood of at least 1/2 teaspoon) within 3 weeks prior to the first dose of study drug.
change your life with seven sheets of paper

Conditions: Postnatal Depression

Summary: the aim of this study is to deliver cbt based intervention called "change your life with 7 sheets of paper" to women with mild to moderate postnatal depression (pnd) through trained traditional birth attendants (tbas). participants will be recruited from low income area in karachi pakistan. edinburg postnatal depression scale (epds) will be used to screen mothers having children between birth till 12 months. group intervention will be delivered through trained tbas.

the prevalence rate of pnd in pakistani women and its effect on the growth and development of young children and child mortality is very high. despite availability of interventions to improve maternal health, the major issue in implementation of those interventions is because of limited availability of trained health professionals . therefore the aim of this study is to train tbas in delivering cognitive behaviour therapy (cbt) based intervention called "changing your life with seven sheets of paper". participants will be recruited from low income area in karachi. total 36 participants will be recruited and randomized into 2 groups; intervention and treatment as usual (tau) group. total 8 sessions will be delivered by trained tbas over the period of 3 months.

Eligibility criteria:
inclusion criteria: * mothers with a child between 0-12 months * women who score 14 or above on edinburgh postnatal depression scale (epds) * age range between 18 to 45 years * women able to provide written informed consent. exclusion criteria: * severe depression or any other major psychiatric disorder * severe suicidal ideation * currently receiving any psychiatric or psychological treatment * intellectual disability in mother * chronic medical condition * having children with intellectual or physical disability

Keywords: postnatal depression cognitive behaviour therapy traditional birth attendants low income country
mobile mental health stigma reduction intervention among black adults

Conditions: Anxiety; Depression; Health Knowledge, Attitudes, Practice; Stigmatization; Mobile Phone Use

Summary: major depressive and anxiety disorders are highly prevalent in the general population and are a leading cause of disability. black adults have a high burden of depression and anxiety. this study aims to assess a self- administered video-based intervention to reduce mental illness stigma and medical mistrust among black adults with moderate to severe depression or anxiety.

major depressive and anxiety disorders affect 57.3 million adults in the u.s. these disorders are also highly stigmatized. stigma refers to negative attitudes or beliefs about mental illness, or negative behaviors directed toward persons with mental illness (pwmi) is a leading and fundamental cause of health inequities. the efficacy and precision of anti- stigma interventions to improve mental health outcomes among underserved black adults are grossly limited and represent a critical public health gap. studies show stigma compounds disabilities related to the primary symptoms of mental illness and increases morbidity and premature mortality related to mental illness. compared with white adults, black adults with mental illness have more chronic disease, and more severe illness at presentation. meta-analyses have consistently shown that both face-to-face and video-based contact with individuals with mental illness can reduce stigma. recent studies that distinguished contact delivery showed effect size for video-based contact to be comparable to face-to-face contact. contact interventions, which are premised on the idea that positive and voluntary contact with pwmi can effectively reduce mental illness stigma, are aimed at reducing stigma and improving health outcomes. the primary objective of this study is to evaluate the efficacy of a self-administered, video-based mobile app intervention aimed at reducing mental illness stigma among black adults. black adults with moderate to severe depression or anxiety will be recruited to participate in the randomized controlled trial (rct). participants will be randomly assigned to one of three arms: two video-based intervention arms and one waitlist control arm. the video-based intervention will include first-hand lived experience stories of mental health and one's recovery journey.

Eligibility criteria:
inclusion criteria: 1. if you identify as black american or black immigrant 2. experience or been diagnosed with depression and/or anxiety 3. age 18-45 years 4. own a smartphone with internet access 5. have not seen a psychiatrist or therapist in the last 12 months or have not been in routine healthcare 6. english speaking exclusion criteria: 1. visual, hearing, voice, or motor impairments that would prevent engagement in study procedures, 2. diagnosis of psychotic disorder or severe suicidality for which participation would be inappropriate.

Keywords: stigma digital mental health community engaged research black adult mobile health