Kornimate/medical-research-clean huggingface dataset:
a study to assess and compare the effects of 5 mg vs. 20 mg desloratadine on the development of cold urticaria lesions

Conditions: Acquired Cold Urticaria

Summary: the aim of this study is to compare cold urticaria lesions by thermography, volumetry and digital time lapse photography in acu patients treated with placebo, 5 mg and 20 mg desloratadine. hypothesis: the updosing of desloratadine (20 mg)is more effective in the treatment of acu symptoms as compared to standard doses (5 mg desloratadine) and placebo.


Eligibility criteria:
inclusion criteria: 1. outpatients with acu for more than 6 weeks. urticaria symptoms must comprise wheal and itch. 2. history of beneficial effects of antihistaminic treatment. 3. age between 18 and 75 years. 4. female patients must be using a highly effective method of birth control (such as implants, injectables, combined oral contraceptives, some iuds, sexual abstinence,vasectomised partner), or they must be postmenopausal, surgically sterilised, or hysterectomised. 5. voluntarily signed written informed consent. exclusion criteria: 1. the presence of permanent severe diseases, especially those affecting the immune system, except acu 2. the presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract) 3. history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia 4. history or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy 5. evidence of severe renal dysfunction 6. evidence of significant hepatic disease (liver enzymes twice the upper reference value) 7. history of adverse reactions to dl, loratadine, or other ingredients of the imp 8. presence of active cancer which requires chemotherapy or radiation therapy 9. presence of acute urticaria, angioedema, or larynx edema 10. history or presence of alcohol abuse or drug addiction 11. participation in any clinical trial within 4 weeks prior to enrolment 12. commitment to an institution in terms of § 40 abs. 1 nr. 4 amg 13. intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study 14. intake of oral corticosteroids within 14 days prior to the beginning of the study 15. use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study 16. pregnancy or breast-feeding

Keywords: urticaria cold urticaria acquired cold urticaria
bortezomib plus cisplatin in recurrent or metastatic breast cancer

Conditions: Metastatic Breast Cancer; Recurrent Breast Cancer

Summary: this a phase 1 study to evaluate the safety and preliminary efficacy of cisplatin combined with bortezomib in patients with recurrent or metastatic breast cancer.


Eligibility criteria:
inclusion criteria: 1. women aged 18 years and above with pathologically confirmed recurrent or metastatic advanced breast cancer ; 2. the patient has tumor specimens (formalin-fixed, paraffin-embedded or fresh pre-treated recurrent tumor tissue); 3. patients who have failed standard treatment in the late stage; 4. at least one measurable lesion; 5. ecog ps : 0-2 points; 6. estimated survival period ≥12 weeks; 7. the function level of major organs meets the following standards: 1) the blood routine examination standards must meet: anc ≥1.5×109/l, plt ≥75×109/l, hb ≥85g/l (no blood transfusion and blood products within 14 days, no use of g-csf and other hematopoietic stimulating factors for correction) 2) biochemical examinations must meet the following standards: tbil \<1.5×uln, alt, ast \<2.5×uln, alt, ast \<5×uln for patients with liver metastasis, bun and cr ≤1×uln or endogenous creatinine clearance ≥50ml/min (cockcroft-gault formula); 8. women of childbearing age must have taken reliable contraceptive measures, or have undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and are willing to use appropriate contraceptive methods during the trial and 8 weeks after the last administration of the trial drug. 9. the subjects voluntarily join this study, have good compliance, and cooperate with follow-up. exclusion criteria: any of the following will be considered as meeting the exclusion criteria of the study: 1. patients with acute active hepatitis b or acute active hepatitis c; 2. any serious underlying disease, comorbidity and active infection 3. currently receiving other anti-tumor treatments; 4. history of epilepsy or epileptic-induced condition; 5. patients who are pregnant or breastfeeding; 6. those with poor compliance or unable to undergo normal follow-up; 7. allergic to study drugs; 8. patients diagnosed with other malignant tumors within 5 years, except for the following: surgically resected non-melanoma skin cancer, adequately treated cervical carcinoma in situ, surgically radically treated ductal carcinoma in situ, or malignant tumors diagnosed 2 years ago with no current evidence of disease and untreated ≤ 2 years before randomization; 9. the researcher determines other situations that may affect the conduct of the clinical study and the determination of the study results.

Keywords: breast cancer bortezomib cisplatin
iron status in women of reproductive age reproductive age

Conditions: Iron Metabolism Disorders

Summary: analyzed iron status, hfe mutations and ethnicity for women in five primary care centers in the united states and canada using de-identified data from the heirs study.

heirs included a cross-sectional screening study of 101,168 patients, 25 years of age or older, in the primary care setting. participants were recruited from four centers in the u.s .and one in canada from february 2001 to february 2003. we will evaluate results for women aged 25-44 years of age who are self-reported as asian, black, hispanic or white. the lower detection limit for the serum ferritin (sf) assay in the heirs study was 15 μg/l and therefore the definition of iron deficiency will be sf concentration ≤ 15 μg/l. elevated sf concentrations, possibly indicative of elevated iron stores, will be classified by two definitions: 1) sf concentration \> 300 μg/l and 2) sf \>200 μg/l in combination with tsat \>45%. proportions will be compared by pearson's chi-square. logistic regression models will be used to identify independent associations with measures of iron deficiency and elevated iron stores.

Eligibility criteria:
inclusion criteria: 1. primary care women included in the heirs study with in the age range of this study 2. self designation as asian american, african american, hispanic american or white. exclusion criteria: 1. age \>44 years 2. self-described ethnicity other in than inclusion criterion 2.
research of prevention and intervention of mental health problems

Conditions: Anxiety; Depression; Alcohol-abuse

Summary: the purpose of this research is to establish a suitable community-based model for chinese culture,to improve the community recognition of common mental disorders,as well as its treatment and control.

the project will select seven metropolis,through multi-center collaborative research,use of interdisciplinary methods and combining qualitative and quantitative research methods.community resources will be integrated so as to build the chinese model of community mental health services and to establish the routine for common mental disorders. evaluation criteria for community mental health needs to be developed for the process of health education and intervention techniques.

Eligibility criteria:
inclusion criteria: 1. general population: 13-65-year-old, 2. high-risk groups: not yet shown symptoms of mental disorders, but exposed to epidemiological risk factors for anxiety,depression and alcohol abuse.a part may be at risk for future depression,anxiety and alcohol abuse,for example: post-disaster population,stress-related groups, the unemployed and laid-off people, high risk of psychological disorders (chronic treatment of various medical institutions and disabled, the mentally ill family members). 3. early stage of mental disorders in population:the subjects have the problem of depression, anxiety or alcohol abuse, but not yet diagnosed with depression, anxiety disorders or alcohol abuse. exclusion criteria: those who have been diagnosed with depression,anxiety or alcohol abuse and other psychiatric disorders will be excluded from this study.

Keywords: mental health education community-based
effectiveness of nutritional program among diabetic patients

Conditions: Dyslipidemia Associated With Type II Diabetes Mellitus

Summary: dyslipidemia is very common in type 2 diabetes mellitus affecting around 72%-85% of diabetic patients.the exact mechanism of lipoprotein abnormalities in diabetes is not very well understood. insulin resistance, rather than hyperglycemia, has been implicated in the pathogenesis of diabetic dyslipidemia because lipoprotein changes including an increase in triglycerides (tg), increase in vldl particles, small dense ldl particles and a decrease in hdl level have been shown in patients with impaired fasting glucose and impaired glucose tolerance and t2dm

hypertriglyceridaemia(htg) occurs due to both increased production and decreased clearance, and it is the most common abnormality of diabetic dyslipidemia. insulin resistance causes increased production of vldl . in addition to increased secretion of vldl, there is decreased clearance of vldl due to decreased hepatic uptake and impaired activity of lipoprotein lipase.management of dyslipidemia in patients with diabetes is an important step in the prevention of cardiovascular disease, the most common cause of death in the diabetic population. diabetic dyslipidemia treatments can be divided into non-pharmacological and pharmacological. non-pharmacological treatment includes ; medical nutrition therapy, weight loss, and physical activity. diabetic patients should increase the intake of plant stanols/sterols, viscous fiber (legumes, citrus, oats), n-3 fatty acids and decrease the intake of saturated and trans-fatty acids. american diabetes association recommends the mediterranean diet or dash (dietary approaches to stop hypertension).

Eligibility criteria:
inclusion criteria: * 1-clinical diagosis of type2diabetes 2-clinical diagnosis of hyperlpidemia 3-must be helpful patient 4-age below 70year exclusion criteria: 1-insulin dependant diabetes 2- pregnancy 3-heart disease 4- renal disease. 5-pregnancy -
deep versus superficial heating in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: heat therapy is frequently prescribed to patients with symptomatic knee osteoarthritis (oa). deep hyperthermia via localized microwave diathermy is effective in several musculoskeletal painful conditions. however, the efficacy of superficial heating is controversial. furthermore, no clinical trials have yet directly compared the effects of these treatment modalities in knee oa. hence, the purpose of the present study is to compare the effects of deep and superficial hyperthermia, induced via microwave diathermy and hot packs, respectively, on pain and function in patients with symptomatic knee oa.


Eligibility criteria:
inclusion criteria: * men and women aged 18 years or older * moderate, mono or bilateral knee osteoarthritis * pain lasting for at least three weeks exclusion criteria: * inability or unwillingness to sign informed consent * previous surgery on the affected knee * intra-articular injections with steroids or hyaluronic acid in prior 6 months * physical therapy for knee problems in prior 6 months * congenital or acquired inflammatory or neurological (systemic or local) diseases involving the knee * chronic nsaid or steroid treatment * cognitive or psychiatric disorders * pregnancy or breastfeeding * contraindications to hyperthermia (cancer in prior 2 years or active cancer treatment, local thrombosis, impaired arterial circulation, altered cutaneous thermal sensitivity, local infections or systemic acute infections, metal implants or prosthesis, severe osteoporosis

Keywords: hyperthermia microwave diathermy hot packs pain physical function
post trial analysis of a primary prevention study in asian indians

Conditions: Diabetes

Summary: an extended follow-up study of nct00819455 conducted 5 years post randomization. in this study we estimate the incidence of type 2 diabetes among participants enrolled in the diabetes prevention programme. this will provide comparison of the progression to diabetes among group motivated through text messages and the group educated only during enrollment. a total of 537 participants were enrolled in the primary study and are invited to participate in a follow-up visit 3 years post active trial period.


Eligibility criteria:
inclusion criteria: participants of the primary prevention programme - nct00819455. exclusion criteria: unwilling for participation
cluster-rct collective nasopharyngeal covid-19 testing amongst pupils

Conditions: Peer Group; Parents

Summary: does the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test?

in order to control the outbreak of cluster infections on school during the covid-19 pandemic, regular rounds of collective nasopharyngeal swab testing were organized. however, it is unclear under which circumstances nasopharyngeal swab testing is better accepted by young children. due to the closing of schools, and the different logistic situations in schools, a natural pragmatic rct formed. in some cases, children could observe their peers before having their own test, while for others the view was blocked. also, sometimes parents would be present during a test procedure when the school was closed, while they were not present when the school was open. to date, it is unclear whether these two variable elements influence a child's resistance to be tested. therefore a cluster-randomized controlled trial with testing site as the unit of randomisation will be set-up. four conditions will be tested. on the individual level, the resistance of their peers before their own testing will be taken into account. the aim of the study is to compare whether (1) the visibility of nasopharyngeal swab testing on their peers and (2) the presence of their parents impacts a child's resistance towards the test. additionally, the impact of whether or not their peers resisted the test impact predicts the likelihood of their own resisting behaviour.

Eligibility criteria:
inclusion criteria: * undergoing a nasopharyngeal covid-19 swab test exclusion criteria: -

Keywords: public health pediatric nasopharyngeal collective testing
community health workers using patient stories to support hypertension management

Conditions: Hypertension

Summary: community health workers (chws) using patient stories to support hypertension management is a randomized controlled trial to evaluate the implementation of a chw-delivered culturally appropriate storytelling intervention for english and spanish-speaking patients diagnosed with hypertension who receive care at community health center settings.

community health workers (chws) using patient stories to support hypertension (htn) management is a chw-delivered culturally appropriate storytelling intervention for patients diagnosed with htn. we will develop and test interactive videos presenting stories of patients who have successfully made changes enhancing blood pressure control; and integrate this new tool with a chw approach to management of hypertension. this two site, two-armed randomized controlled trial aims to recruit 252 english and spanish speaking patients with uncontrolled htn. all participants are randomized to receive five visits (two in-person and 3 telephone calls) with chws either immediately (intervention condition (i)) or 6 months after enrollment (delayed intervention (di)). intervention participants receive the intervention immediately and di participants receive print materials at enrollment and are telephoned 4-6 months after enrollment to schedule an in-person visit at the health enter to begin receiving the intervention protocol.

Eligibility criteria:
inclusion criteria: * english and spanish speaking patients * male or female between the ages of 30 and 80 * diagnosis of htn and uncontrolled htn, defined as (a) having an average systolic bp greater than or equal to 140 and /or diastolic bp greater than or equal to 90 over the past 12 months or (b) most recent bp reading within the previous 6 months as systolic bp greater than or equal to 140 and /or diastolic bp greater than or equal to 90. * willingness to be randomized to either intervention or delayed intervention exclusion criteria: * pregnant women * patients planning to leave the community health center in the next year * adults unable to consent
randomized study of a simple weight loss program for obese patients with obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the purpose of the study is to determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate obstructive sleep apnea (osa) when compared to usual patient care. the secondary purpose of the study is to determine if the amount of weight loss achieved in a 6 month period results in improvements in snoring and other symptoms and in the frequency of apnea on overnight monitoring.

the purpose of the study is to determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate obstructive sleep apnea (osa) when compared to usual patient care. the secondary purpose of the study is to determine if the amount of weight loss achieved in a 6 month period results in improvements in snoring and other symptoms and in the frequency of apnea on overnight monitoring. primary objective * to determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate osa when compared to usual care. * to determine if the amount of weight loss achieved in a 6 month period result in improvements in objective measures of sleep disordered breathing (ahi). secondary objective * to determine if the weight loss achieved in 6 months result in improvements in osa symptoms (e.g., snoring, sleepiness) and quality of life. * to determine if metabolic parameters (e.g., lipids, glucose) improve. * to determine if there is improvement in sleep structure and oxygenation during sleep.

Eligibility criteria:
inclusion criteria: * patients who have undergone a sleep study at the london health sciences centre or st. thomas elgin general hospital sleep laboratory and who are newly diagnosed with obstructive sleep apnea * patients with an age over 18 years * patients who have an apnea-hypopnea index (ahi) of 5-40 per hour (mild-to-moderate osa) * patients who have an elevated body mass index (bmi) of 28 to 39 kg/m2 * patients who have an epworth sleepiness scale score ≤11 exclusion criteria: patients will not be recruited: * if they are on weight loss medications * if they have seen a registered dietician in the preceding 6 months for dietary counseling * if they have attended a weight loss program in the last 6 months * if they have a history of a car accident related to sleepiness or report sleepiness when driving * if they work in a safety critical occupation and require treatment for work reasons * if they have serious or unstable cardiac co-morbidity * if they are unable or unwilling to provide informed consent * if they are pregnant * if they are unwilling to return for follow-up visits

Keywords: obesity obstructive sleep apnea
expanded access use of nogapendekin-alfa inbakicept in the reversal and maintenance of absolute lymphocyte count (alc) for the treatment of lymphopenia induced by chemotherapy, immunotherapy, and/or radiation therapy

Conditions: Lymphopenia

Summary: this is a protocol for expanded access use of nogapendekin-alfa inbakicept (nai) in participants with lymphopenia induced by chemotherapy, immunotherapy, and/or radiation therapy who may benefit from its use, and who are ineligible to participate in a clinical trial using nai. the primary objective of this protocol is to evaluate the reversal and maintenance of absolute lymphocyte count (alc) with nai.

it is now well established that patients undergoing standard of care chemotherapy, immunotherapy, and/or radiation therapy sustain the adverse effects of these agents with a reduction in lymphocyte count (lymphopenia), and a significant clinical effect of reduced overall survival across all tumor types. severe lymphopenia is defined as absolute lymphocyte count (alc) \< 1,000 lymphocytes per microliter as determined by the complete blood count (cbc) differential analysis. no current therapy exists for the regeneration and proliferation of the most important immune cells in the blood compartment responsible for cytotoxicity of tumor cells, the lymphocytes. expanded access of nai for the treatment of lymphopenia addresses an unmet medical need, since no therapy is currently approved to reverse a low lymphocyte count and maintain lymphocytes within the normal range. by offering patients the ability to treat lymphopenia, the potential exists of increasing overall survival.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old. 2. adult patients with solid tumors who progressed on standard-of-care treatment chemotherapy and/or immunotherapy and/or radiation therapy requiring second line or greater standard-of-care treatment with: * chemotherapy and/or * radiation therapy and/or * immune checkpoint inhibitor therapy and/or any therapy investigator deems appropriate at that institution 3. lymphocyte status meeting one of these conditions: * baseline absolute lymphocyte count (alc) \<1,500 cells/μl (mild lymphopenia) prior to treatment initiation in first line therapy or alc \<1000 cells/μl (severe lymphopenia) during and or following progression after first line therapy * anticipated treatment-induced lymphopenia (alc reduction ≥20% from baseline based on reduction during first line therapy) * persistent lymphopenia (alc \ 2 months during first line therapy treatment) exclusion criteria: 1. active uncontrolled autoimmune disease requiring immunosuppression 2. participants with liquid tumors 3. concurrent solid organ transplantation

Keywords: lymphopenia lymphopenia induced by chemotherapy lymphopenia induced by radiation therapy lymphopenia induced by immunotherapy absolute lymphocyte count