Kornimate/medical-research-clean huggingface dataset:
pilot study of a brief behavioural activation intervention for depressed patients in primary care

Conditions: Major Depressive Disorder

Summary: this study will explore the effectiveness of a brief psychological intervention for depressed outpatients in primary care. participants will attend two intervention sessions with a psychologist and use a mobile activity/goal setting application for 6 weeks.

this study will evaluate the feasibility and effectiveness of a two-session psychologist-led behavioural activation intervention, with adjunctive use of a free activity/goal setting app, for depressed patients in primary care. outpatients in primary care with major depressive disorder will be recruited to complete two intervention sessions with the primary care psychologist, as well as use the mobile activity scheduling app for 6 weeks. symptom measures will be administered prior to both intervention sessions and 6-weeks after the first intervention session.

Eligibility criteria:
inclusion criteria: * depression is the primary concern; * score of 10 or greater on a depression screening tool; * have access to an iphone or ipad. exclusion criteria: * another psychological disorder is the primary concern (e.g., anxiety disorder, personality disorder); * concurrent alcohol or drug use disorder; * unstable dose of psychotropic medication (i.e., any psychotropic medication doses will need to be stable for at least four weeks prior to enrolment); * current participation in other regular psychological treatment (e.g., cognitive behavioral therapy, counselling); * at a high risk/emergent risk for suicide.

Keywords: behavioural activation psychological treatment primary care
cardioseq: impact of wgs in individuals with cvd

Conditions: Cardiovascular Diseases

Summary: this is a prospective, single-center, open-label study to investigate the diagnostic efficacy of the trugenome cvd test and its impact on clinical management compared to usual care in individuals with cardiovascular disease. diagnostic yield and changes of management (com) will be assessed both within the wgs group and compared to a contemporaneous, matched (2:1) usual care (uc) group sourced from ehr records.

the trugenome cardiovascular disease (cvd) test which consists of an in-silico 200 gene cardiovascular disease panel, a further 4 genes with cardiovascular disease risk alleles, 10 pharmacogenomic genes, 35 non-cardiovascular acmg secondary finding genes and a polygenic risk score (prs) for coronary artery disease (cad) will be utilized in this study.

Eligibility criteria:
inclusion criteria: 1. individuals ≥18 years of age 2. stable ambulatory patients with a cardiology visit within the past year or scheduled within the next 90 days. 3. at least one of the following clinical diagnoses: a. any aortopathy, b. dyslipidemia, c. coronary or peripheral arterial disease, d. heart failure or cardiomyopathy, e. any arrythmia 4. must be able to read, understand, and sign an informed consent exclusion criteria: 1. individuals with a previously confirmed molecular diagnosis of a known genetic disease with an associated cardiovascular phenotype inclusive of monogenic cardiovascular diseases, chromosomal aneuploidies, and microdeletion disorders. 2. bone marrow transplant recipients 3. individuals with severe cognitive dysfunction or diminished capacity who are unable to provide informed consent 4. patients undergoing active chemotherapy treatment for cancer 5. patients with end-stage renal disease 6. patients with poor medical prognosis with a life expectancy \<1 year 7. principal investigator decides for any reason the study is not in the best interest of the patient
intrauterine device versus uterine artery embolization for adenomyosis

Conditions: Adenomyosis

Summary: the primary purpose of this study is to compare the therapeutic efficacy of intrauterine device and uterine artery embolization for uterine adenomyosis.

screening * history, physical examination * laboratory test (hemoglobin) / mri * pictorial blood loss assessment chart * symptom/quality of life score intervention * intrauterine device or uterine artery embolization * adverse event montoring follow-up visit #1 (1 month) * vital signs * blood test (hemoglobin) / ultrasound * adverse event monitoring follow-up visit #2 (3 month) • mri only for embolization patients follow-up visit #3 (6 months) * blood test (hemoglobin) / ultrasound * pictorial blood loss assessment chart * symptom/quality of life score follow-up visit #4 (12months) * blood test (hemoglobin) / ultrasound * pictorial blood loss assessment chart * symptom/quality of life score

Eligibility criteria:
inclusion criteria: 1. women with symptomatic fibroids (age: 19 - 48 years old) 2. hemglobin \< 12g/dl, 3. symptoms of adenomysis (menorrhagia, dysmenorrhea) exclusion criteria: 1. gynecologic malignancy 2. ongoing infection or inflammation 3. coagulopathy (platelet \ 1.5) 4. concomitant endometriosis 5. pregnancy
analysis of pharmacodynamic changes with auy922a, an hsp90 inhibitor

Conditions: Advanced Solid Malignancies

Summary: the principal research objective of this additional research protocol is to support the collection, storage and use of tumour and surrogate (peripheral blood mononuclear cells - pbmncs). the objective of this study is to perform assays to study pharmacodynamic (pd) markers that confirm target modulation.

study objectives - 1. evaluation of hsp70, p-erk, erk, p-akt and akt in peripheral blood mononuclear cells (pbmnc). evaluation of p-akt and akt will be done by commercially available meso scale discovery (msd) enzyme linked immunosorbent assay (elisa) kits, while hsp70 will be studied using elisa techniques developed within the institute of cancer research. 2. evaluation of hsp70, p-akt, akt, p-erk, erk, her-2 and p-her2 in tumour tissue. evaluation of p-akt, akt, p-erk, erk, her-2 and p-her2 will be done by commercially available msd elisa kits, while hsp70 will be studied using elisa techniques developed within the institute of cancer research. study design - all patients entering the open label, phase i dose escalation and phase ii expansion arms of auy922a at the royal marsden hospital will be asked to participate in this study. patients will not have to attend additional appointments for this study and samples will be taken during visits for the planned phase i/ii clinical trial. consent to donate samples for this research study is voluntary and patients will be asked to sign a separate consent form.

Eligibility criteria:
inclusion criteria: * all patients entering the open label phase i dose escalation and phase ii expansion arms of auy922a at the royal marsden hospital will be asked to participate in this study. patients will not have to attend additional appointments for this study and samples will be taken during visits for the planned phase i/ii clinical trial. * consent to donate samples for this research study is voluntary and patients will be asked to sign a separate consent form. exclusion criteria: * any patient who has not entered the open label phase i dose escalation and phase ii expansion arms of auy922a will not be asked to participate. * patients with advanced cancers which are not safely biopsiable will not be eligible to participate. * patients with known coagulation disorders.

Keywords: heat shock protein 90 inhibitor (hsp90) pharmacodynamic blood biopsy solid malignancies
a clinical study of treating influenza with liugan shuangjie heji

Conditions: Influenza

Summary: this prospective randomized controlled trial studies the efficacy and safety of treating influenza with the reconciling exterior and interior therapy. a total of 300 cases of seasonal flu in beijing is to be collected, and divided into one treatment group and two control groups. patients in the treatment group will receive liugan shuangjie heji, while patients in control groups will receive shufeng jiedu capsule and oseltamivir phosphate capsule respectively, for a course of 5 days. the study assesses the efficacy and safety of treating influenza with the reconciling therapy based on the following outcome measures: the time it takes from the medicine intake to 0.5℃ drop of body temperature, and the time it takes for the body temperature to return to normal.


Eligibility criteria:
inclusion criteria: 1. the disease in flu season of flu, in line with the western medicine clinical diagnostic criteria for influenza; 2. all influenza patients with tcm syndrome differentiation for the table is cold in the exterior and heat in the interior; 3. the course of the disease within 48 hours, the axillary temperature is 38.0 degree or higher; 4. aged between 18 to 65 years; 5. voluntary and signed informed consent. exclusion criteria: 1. the first time to see a doctor have used traditional chinese medicine, or antiviral drugs; 2. routine blood wbc is greater than the upper limit of normal; 3. chest x-ray examination with inflammatory exudation images; 4. with cardiovascular, liver, kidney and hematopoietic system such as severe primary disease, immunodeficiency disease, cancer, mental illness, without self-knowledge, liver and kidney function significantly abnormal liver meritorious service is more than 1.5 times higher than normal; 5. pregnancy, nursing mothers, and allergic constitution; 6. participated in clinical subjects for nearly three months.

Keywords: reconciling exterior and interior therapy influenza
flossing with chlorhexidine

Conditions: Gingivitis

Summary: to determine if flossing with a dental floss presoaked in chlorhexidine, an anti-microbial mouth wash, would improve the clinical signs of gingivitis, an inflammation of the gums characterized by red, swollen, bleeding gums. and to determine if applying chlorhexidine via dental floss would result in tooth staining, which is common with chlorhexidine mouthwashes.

purpose of study: to determine if dental floss presoaked in 0.12% chlorhexidine is more effective at reducing the signs of gingivitis, such as bleeding, than a dental floss in placebo solution of 0.1% quinine sulphate. trial design: the study will consist of a double-blinded, placebo-controlled parallel three-month clinical trial. randomization of subjects into study groups: subjects randomized with a computer-generated randomization table and balanced block design to make the two groups equal in number of subjects. trial schedule: 1. screening for potential subjects \& consent obtained. calibration of examiner. 2. week -1: professional prophylaxis consisting of scaling and polishing. 3. week 0: baseline data (gi, si, pi, bop, pd) collected on subjects enrolled into the study. ohi - flossing. subject randomized into a study group. 4. week 6: subjects reassessed for gi, si, pi, bop, pd. compliance check. replenish floss supply. subject concerns or questions addressed. 5. week 12: subjects reassessed for gi, si, pi, bop, pd. all floss boxes and logbook returned. subject concerns or questions addressed. subject exited from study and returned to the care of his or her regular dental professional. measurements for data collection (done in this order): 1. gingival index (gi) (modification of löe \& silness, 1963) 2. stain index (si) 3. plaque index (pi) (modification of silness and löe, 1964) 4. bleeding on probing (bop) 5. probing depth (pd)

Eligibility criteria:
inclusion criteria: to be considered for inclusion into the study, subjects must fulfill the following conditions: * 18 years and older * have gingivitis (i.e., have pocket depths of 4 mm or less), but not periodontitis * willing to floss every day and have the necessary dexterity to floss * have a minimum of 20 natural teeth, including 4 molars * have at least 10 bleeding sites * be a non-smoker exclusion criteria: subjects will be excluded from the study, if they have any of the following conditions: * pregnant or plan to be pregnant within the next 3 months * allergic to chlorhexidine or quinine sulphate * require pre-medication with antibiotics for dental treatment * currently taking antibiotics * currently taking dilantin, cyclosporin a, nifedipine or other calcium channel blockers, aspirin or anti-coagulants * currently using chlorhexidine or whitening products * have active carious lesions * have orthodontic braces * have more than 2 crowns or bridges * have more than 2 implants * have full or partial dentures * have periodontitis, i.e., pocket depths of 5 mm or more in more than 2 sites in the mouth

Keywords: gingivitis chlorhexidine dental floss rct bleeding on probing gingival and plaque indices
an observational study to register the incidence of breast cancer and current clinical care patterns in kenya

Conditions: Breast Cancer

Summary: this observational study, conducted by the kenya society for hematology and oncology, will develop a breast cancer and care registry (brecc) for kenya. data on demographic, clinical and pathological characteristics, treatment and clinical outcome will be collected from newly diagnosed breast cancer patients. breast cancer patients will be recruited into this registry cohort and followed up for a period of not less than five years.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed breast cancer * no previous interventional therapy for breast cancer * ability to provide written informed consent as per gcp and local regulations exclusion criteria: * participation in other clinical study where the diagnosis and treatment protocol is stated prior to enrolment * inability to assess and follow up patient outcomes, for example quality of life due to psychiatric illness or who/ecog performance status iv or worse
correlation between nocturnal oxygen desaturation and glycemic control in diabetic patients with obstructive sleep apnea

Conditions: Obstructive Sleep Apnea; Diabetes Mellitus, Type 2

Summary: nocturnal reduction in blood oxygen is expected independently associated with the development of worsened glycemic control in individuals with type 2 diabetes mellitus. the aim of the present study is to assess the correlation between nocturnal oxygen desaturation assessed by overnight pulse oximetry and glycemic control in diabetic patients with obstructive sleep apnea.

introduction: obstructive sleep apnea syndrome (osas) is a prevalent illness showing a heterogeneous symptom presentation, which ranges from low clinical suspicion to evident limitations in the quality of life. the main reasons for this variability relate to its potential association with major concomitant diseases, which include diabetes and a variety of cardiovascular pathologies. (1). also, osa is a known risk factor for many comorbid disorders, causing resistance to conventional treatments and increasing the risk of mortality, which multiplies health care expenditures and even though the distribution of comorbidities differs between men and women, their effect progressively increases with osa severity (2,3) occurrence of apneic events and reduction in blood oxygen and elevations in blood carbon dioxide are sensed by chemoreceptors in the brain and carotid bodies, which trigger brief microarousals and result in sleep fragmentation (4). nocturnal reduction in blood oxygen has also been independently associated with the development of worsened glycemic control in individuals with type 2 diabetes (4). aim of the work: to assess the correlation between nocturnal oxygen desaturation assessed by overnight pulse oximetry and glycemic control in diabetic patients with obstructive sleep apnea. material and methods: this study will be conducted on all patients referred for evaluation of sleep related breathing disorders. all medical files were reviewed. data collected included .full medical history, demographics, measurements of weight and height, body mass index in kg/m2, neck circumference (nc), epworth sleepiness scale (ess) scores, measurements of overnight pulse oximetryglyceminc control (measurement of glycated hb, fasting and 2h postprandial blood sugar)the diagnosis that was concluded after a polysomnography study.

Eligibility criteria:
inclusion criteria: * all patient swith type 2 diabetes, referred for evaluation of sleep related breathing disorder exclusion criteria: * patients less than 18 years old and patients receiving treatment for sleep related breathing disorders were excluded
prognosis and influencing factors of asthma in children aged 5-12 years

Conditions: Asthma in Children

Summary: the goal of this observational study is to 1)analyze the basic information of confirmed cases of asthma in children aged 5-12 years old hospitalized in the first affiliated hospital of guangzhou medical university from 2009 to 2020, 2)investigate the onset of asthma after 13 years old, 3)conducte lung function, blood and airway inflammation indicators, blood il13 and il1rl1 levels, 4)analyze the prognosis and influencing factors of children with asthma in this age group.participants will be asked to fill a case report form and questionnaires. besides, they should provide examination results like lung function, total ige, expired nitric oxide, blood and sputum granulocyte counts, and determination of blood il13 and il1rl1 levels over the past 6 months.

research methods: part i: retrospective analysis of hospitalized cases of asthma in children aged 5-12 years old from 2009 to 2020: (1) general information of the children (gender, age and bmi); (2) special medical history of parents; (3) the history of respiratory virus infection in the early life; (4) that age of the first occurrence of asthma; (5) the number of wheezes in the 12 months before the diagnosis of asthma; (6) specificity; (7) trigger factors of symptoms; (8) time pattern of symptom manifestations; (9) illness severity; (10) airway inflammation pattern; (11) baseline of lung function; (12) anti-inflammatory treatment; (13) reactions to drug therapy. (14) coinfected diseases or complications. (15) genetic information. part ii: patients who are lost to follow-up will be excluded. the patients will be divided into asthma relief group and asthma continuation group according to whether they had relapsed asthma after 13 years old. the case report form and c-act/act questionnaire will be filled out. patients should provide examination results like lung function, total ige, expired nitric oxide, blood and sputum granulocyte counts, and determination of blood il13 and il1rl1 levels over the past 6 months. part iii: univariate and multivariate analyses will be performed for different prognostic outcomes of asthma in children aged 5 to 12 years.

Eligibility criteria:
inclusion criteria: * hospitalized children with asthma (age range 5-12 years old) from 2009 to 2020 in the first affiliated hospital of guangzhou medical university were collected. diagnostic criteria were included by referring to global initiative for asthma and guidelines for diagnosis, prevention and treatment of pediatric bronchial asthma revised in 2008. exclusion criteria: * children who declined follow-up * children with pulmonary and tracheal dysplasia, bronchiolitis obliterans, and other conditions leading to wheezing

Keywords: prognosis risk factors phenotype persistent asthma
feasibility of intratumoral washing fluid for detecting egfr mutations in lung cancer

Conditions: Non Small Cell Lung Cancer; EGFR Gene Mutation

Summary: the purpose of this study is to evaluate the relevance of intratumoral washing for detection of egfr mutation (including t790m positivity).

this is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of egfr mutation (including t790m positivity) using cobas real-time pcr and droplet digital pcr (ddpcr) in patients with nsclc.

Eligibility criteria:
inclusion criteria: * age ≥ 20 years * obtained written informed consent * patients diagnosed with nsclc by histology or cytology and inoperable stage iv at the time of study enrollment * patients with the following egfr gene mutations: e19del, l858r alone or concurrent rare egfr gene mutations (t790m, g719x, exon 20 insertion, s768i) * patients previously treated with egfr-tkis such as gefitinib, erlotinib, afatinib, dacomitinib as first line therapy * patients who had shown clinical benefits (cr, pr, sd) from egfr-tkis and had been confirmed pd on those therapy according to recist v 1.1. * patients who underwent liquid biopsy (plasma) for egfr mutation at the time of pd on egfr-tkis * patients who plan to undergo tissue biopsy for egfr mutation at the time of pd on egfr-tkis exclusion criteria: * patients who withdraw informed consent * patients who are unable to undergo liquid biopsy (plasma) and tissue biopsy for egfr mutation based on the investigator's judgement

Keywords: carcinoma, non-small-cell lung egfr genes bronchoscopy liquid biopsy t790m
use of inhaled nitric oxide to prevent pulmonary hypertension associated to stored blood transfusion

Conditions: Hypertension, Pulmonary; Hemolysis

Summary: the objective of this study is to assess if prolonged storage time of a packed red blood cell unit may cause pulmonary vasoconstriction after transfusion, in a susceptible population such as cardiac surgery patients. the investigators will also evaluate the potential reversal effect of inhaled nitric oxide on pulmonary vasoconstriction induced by stored blood transfusions.

patients will be randomized into one of the three groups: i. blood transfusion stored for less than 10 days ii. blood transfusion stored for more than 30 days iii. blood transfusion stored for more than 30 days days plus inhalation of nitric oxide at 80 part per million for an hour during blood transfusion.

Eligibility criteria:
inclusion criteria: 1. provide written informed consent 2. elective cardiac or aortic surgery 3. one or more blood transfusions scheduled for clinical reasons 4. presence of an arterial catheter and pulmonary arterial catheter exclusion criteria: 1. emergent cardiac surgery. 2. patients requiring irradiated or washed blood transfusions.

Keywords: catheterization, swan-ganz cardiac surgical procedures blood transfusion nitric oxide
hypoxi for women with lipedema

Conditions: Lipedema

Summary: the proposed study is for women with lipedema, a painful fat disorder where fat cannot be lost from the legs and hips with diet and exercise. the study will compare the use of the specialized exercise equipment called hypoxi, which is like a bike but you lie down and air circulates around the participant's legs like a vacuum with pressure increasing and decreasing in cycles over time. the goal of the study is to see if using a hypoxi bike compared to a regular recumbent (sit down) bike helps women with lipedema lose weight. the women with lipedema in the study will have the option to use a whole-body suit that works like a pump and was designed to improve blood circulation in the body. the body suit is called dermology and can be used before the hypoxi exercise equipment but will be optional for the women in the study. the study is 16 weeks long for 20 women with lipedema. ten women with lipedema will exercise with hypoxi for 8 weeks then switch to a recumbent bike for the second 8 weeks. the other 10 women will exercise on a recumbent bike for 8 weeks then switch to hypoxi for 8 weeks in the second half of the study. baseline, mid-study, and end of study data will be collected including measurements of body composition and shape, a blood draw at the beginning, middle and end, and questionnaires. this study will be listed on clinicaltrials.gov for more information.


Eligibility criteria:
inclusion criteria * female * 18-65 years of age * lipedema any stage * weight \< 300 lbs. * able to participate for 4 months * self-reported weight stable * able to use hypoxi equipment \& recumbent bike * able to undergo baseline, mid- and end-study in tucson. exclusion criteria * hip width \> 30 inches (76.2 cm) * waist width \> 46 inches * pregnancy * use of weight loss medication within 3 months of the study * history of myocardial infarction * new york heart association functional class ii or above congestive heart failure * sustained tachycardia above calculated maximum heart rate limit