Kornimate/medical-research-clean huggingface dataset:
hope pilot for veterans with complex diabetes

Conditions: Diabetes; Depression

Summary: the purpose of this study is to determine if behavioral health coaching for rural veterans with diabetes and depression will improve self-management behaviors and lead to improvement in diabetes care outcomes (e.g., ha1c) and improvement in reported depressive symptoms.

the co-occurence of diabetes and depression is highly prevalent and has dramatic consequences for quality of life and health. due to the complex interrelation between diabetes and depression, patients often experience both psychological and physiological difficulties. these comorbid problems demand focused interventions that blend physical and emotional health treatments with self-management strategies.rural-dwelling veterans with diabetes and depression are typically treated in community-based outpatient clinics (cbocs). patients with diabetes in rural areas tend to have more problems controlling their blood sugar, blood pressure and cholesterol compared to urban patients; thereby increasing their risk of diabetic complications. similarly, rural patients with depression have similar barriers to care that increase their risk of poorer health outcomes as well. using behavioral health coaches (bhcs)to deliver telephone-mediated therapies may enhance the reach of treatments for co-occurring diabetes and depression. the implementation of such treatments requires the development and testing of therapeutic manuals and bhc training protocols to ensure standardization and effectiveness. the bhc intervention has been labeled health outcomes through patient empowerment (hope) and will be offered to eligible patients receiving care through medvamc and its cbocs. preliminary data obtained through this pilot grant is to support a larger va grant.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes and primary care physician intent to treat * clinically significant symptoms of depression per self-report * ha1c average of 7.5 or greater in past 12 months and no ha1c \< 7.0 in past 12 months. exclusion criteria: * factors that render a telephone-based behavioral activation intervention inappropriate * significant cognitive impairment * meet criteria of bipolar, psychotic or substance abuse disorder * serious medical issues; e.g., terminal cancer * reports severe depression or suicidal ideation

Keywords: behavioral health coaching diabetes emotional health
the effect of hot bag/warm application on feet after cesarean delivery on postpartum comfort, pain and flatus

Conditions: Cesarean Section Complications; Pain; Postpartum Anxiety

Summary: the postpartum period is a process in which both physical (bleeding, infection, anemia) and emotional (delay in breastfeeding and mother-baby relationship) problems occur in women. among the conditions that physically affect the woman who has had a cesarean section, a decrease in bowel movements is often seen and this decrease can last for 24 hours or longer. initiation of bowel movements after surgery, time of first flatulence and defecation are important factors that determine postoperative patient comfort.

pain after cesarean section is usually associated with incision site and uterine contractions. there are various medical treatment and midwifery applications for the resolution of pain and gas output after cesarean section. recently, it has been stated that in addition to the treatments applied after surgery, non-drug methods should be used to increase the effectiveness of recovery. these methods include applications such as hot application, abdominal massage, music therapy, chewing gum. the effect of hot application in patients with post-operative gas problems is the acupuncture points of the foot, warm and moist heat stimulation and the small intestine, colon, anus and other reflective areas. activates blood circulation. it is predicted that postpartum comfort will increase in the postpartum postpartum, whose pain decreases with postpartum heat application and intestinal mobility returns to normal. the aim of this study is to determine the effect of applying heat to the feet after cesarean section on postpartum comfort, pain and gas output.

Eligibility criteria:
inclusion criteria: * over 18 years old * can read and understand turkish * no history of any medical illness * singular pregnancy * no complications during or after surgery * those who have not had any problems during pregnancy * giving birth to a live baby * no diagnosed psychological disorder * women who do not pass gas before applying heat exclusion criteria: * from gas before hot application * hearing loss * the baby is in intensive care * women with vascular diseases * women who were taken to the intensive care unit after surgery due to any complications

Keywords: cesarean section pain postpartum comfort
interstitial lung disease in early rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Interstitial Lung Disease

Summary: the purpose of this study is to determine how interstitial lung disease can be predicted over time in early rheumatoid arthritis. the investigators will study blood and phlegm samples from participants, along with quality of life questionnaires to determine if and how the presence of ild may impact the participants quality of life over time.

participation involves 5 study visits over an 18 month timeframe. during each of these visits, a recent medical history and physical exam will take place, blood and phlegm will be collected, quality of life questionnaires will be administered, and a ct-scan of the chest and pulmonary function testing may be performed.

Eligibility criteria:
inclusion criteria: 1. age 18 - 90 years 2. diagnosis of "early ra" with or without ild as defined by acr/eular 2010 criteria and confirmed by a member of the ild or rheumatology programs at national jewish health (njh) 3. able to read, speak, and understand english 4. able and willing to perform all study related tasks, including returning to njh every 6 months for an 18 month period of time exclusion criteria: 1. subjects who do not meet all inclusion criteria 2. pregnant women

Keywords: interstitial lung disease ild pulmonary fibrosis rheumatoid arthritis ra rheumatology
efficacy of maraviroc in modulating atherosclerosis in hiv patients.

Conditions: HIV Infection With Other Conditions; Cardiovascular Risk Factor; Atherosclerosis; Inflammation

Summary: the investigator tested the efficacy of maraviroc intensification on down-regulating atherosclerotic progression in hiv infected patients with optimal viro-immunologic control and at high cardiovascular risk.

experimental ccr5 antagonism with maraviroc in atherosclerosis-prone mice and preliminary data in humans suggest an anti-atherosclerotic effect of the drug. the investigators assessed the impact of maraviroc treatment in hiv-infected patients on several subclinical indicators of atherosclerosis and putative mechanisms for such an effect. hiv-treated patients under effective antiretroviral (art) therapy, with a framingham risk score \>20% and a brachial flow-mediated dilation (bfmd) \<4%, as indices of high cardiovascular risk, were recruited. maraviroc (300 mg per os for 24 weeks) was administered on top of art to all participants using a cross-over design. brachial fmd, carotid-femoral pulse wave velocity (cfpwv) and carotid intima-media thickness (cimt) were measured as non-invasive markers of atherosclerosis. vascular competence, as expressed by the ratio of circulating endothelial micro-particles (emps) to endothelial progenitor cells (epcs), as well as markers of systemic inflammation, monocyte activation and platelet activation were assessed.

Eligibility criteria:
inclusion criteria: * eligible patients were consecutive ≥50-year-old individuals, treated for over 1 year with an effective protease inhibitor art regimen (hiv rna \ 300/ mm3 for at least 6 months and a framingham risk score \>20% and bfmd \<4%. exclusion criteria: * patients over 70 years of age, with life expectancy \< 12 months, with known platelets functional defects or alcohol chronic abuse were excluded.

Keywords: hiv maraviroc atherosclerosis
insulin glargine u300 vs insulin degludec u100 in impact on the glycaemic and cardiovascular factors

Conditions: Diabetes Mellitus, Type 2

Summary: to compare the impact of insulin degludec (ideg-100) and insulin glargine u300 (iglar-300) on cardiovascular risk parameters - glycaemic variability (gv), oxidative stress, arterial stiffness and lipid parameters - in insulin naive patients with dmt2.

we recruited a total of 25 patients (23 completed the study) with t2dm who had uncontrolled disease on two or more oral antidiabetic drugs. after the wash-up period, they were randomized alternately to first receive either ideg-100 or iglar-300 along with metformin. each insulin was applied for 12 weeks. at the beginning and the end of each phase, biochemical and oxidative stress parameters were analysed and augmentation index was measured. on three consecutive days prior to each control point, patients performed a 7-point smbg profile. oxidative stress was assessed by measuring thiol groups and hydroperoxides (d-rom) in serum. for augmentation index measuring, we used sphygmocor (atcor medical, sydney, australia) which allow non-invasive measurement of aix on radial artery using strain gauge transducer placed on the tip of a pencil-type tonometer. this method is based on the principle of applanation tonometry

Eligibility criteria:
inclusion criteria: * a history of dmt2 for at least 1 year * aged between 18 and 65 years (women obligatory postmenopausal) * uncontrolled glycaemia on two or more oral antidiabetic drugs * no prior use of insulin * hba1c ≥7.5% * receiving statins (if not on statins, they were put on it) * not on antiaggregant therapy (if on antiaggregants, they were temporarily excluded from therapy) exclusion criteria: * the presence of malignant disease * chronic liver disease * renal impairment with creatinine clearance \< 60 ml/s * severe cardiovascular disease or history of cardiovascular incidents (stroke, myocardial infarction, peripheral amputation) * rheumatic and autoimmune diseases and the usage of glitazones or anticoagulant therapy

Keywords: diabetes mellitus type 2 degludec glargine u300 glucose variability lipids arterial stiffness oxidative stress
primary paclitaxel plus gemcitabine in patients with stage ii and iii breast cancer

Conditions: Breast Cancer

Summary: this is an open labeled phase ii single arm trial. the patients with clinical stage ii and iii will undergo core-needle biopsy of breast tumor for histologic diagnosis, immunohistochemical studies for estrogen receptor (er), progesterone receptor(pr), her-2/neu and others. pet or ultrasound results will determine the positivity of lymph node metastasis.

patients will be treated as follows: pg x 4®operation®ac x 4®radiation ± tamoxifen/ai(postmenopausal) intravenous infusion of paclitaxel 80 mg/m2, over 60 min, on d1 and d8 followed by intravenous infusion of gemcitabine 1200 mg/m2, over 30 min, on d1 and d8 the cycle repeats every 3 weeks for 4 times. premedication includes antiemetics, dexamethasone, famotidine, pheniramine as routinely given. after the operation, standard adjuvant chemotherapy (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2, every 3 weeks x 4 cycles) will be given.

Eligibility criteria:
inclusion criteria: * all patients must have histologically confirmed and newly diagnosed breast cancer: node-positive stage iia and any stage iib, iii. pet results will determine node positivity. if pet was not utilized, sonographically positive node should be confirmed cytologically by fine needle aspiration. * no prior hormonal, chemotherapy or radiotherapy is allowed. * no breast operation other than biopsy to make diagnosis is allowed. * age: 18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ecog 0-1) * adequate hematopoietic function: absolute granulocyte count ³1500/mm3, platelet ³100,000/mm3, hemoglobin ³ 10 g/mm3 * adequate renal function: serum creatinine £ 1.5 mg/dl * adequate hepatic function: total bilirubin: £ 1.5 mg/dl, ast/alt: £ two times normal, alkaline phosphatase: £ two times normal * adequate cardiac function: normal or nonspecific ekg taken within 1 mo of enrollment * adequate mental function to understand and sign the consent exclusion criteria: * patients who received hormonal, chemotherapy or radiotherapy for breast cancer * patients who underwent surgery for breast cancer * patients with node-negative stage iia breast cancer * patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
a study evaluating the immunogenicity of different clinical trial materials of ad26.rsv.pref- based vaccine in adults aged 60 - 75 years old

Conditions: Respiratory Syncytial Virus Prevention

Summary: the purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses induced by vaccination with one dose of the phase 3 clinical trial material (ctm) compared with one dose of the phase 2b ctm.


Eligibility criteria:
inclusion criteria: * willing and able to adhere to the prohibitions and restrictions specified in the protocol * before randomization, a participant must be postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and not intending to conceive by any methods * in the investigator's clinical judgment, participant must be in stable health at the time of vaccination. participants may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider. participants will be included on the basis of medical history, and vital signs performed between informed consent form (icf) signature and vaccination * must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study * from the time of vaccination through 3 months after vaccination, agrees not to donate blood exclusion criteria: * known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) * abnormal function of the immune system resulting from clinical condition or medication * history of acute polyneuropathy (example, guillain-barré syndrome) or chronic idiopathic demyelinating polyneuropathy * history of thrombosis with thrombocytopenia syndrome (tts) or heparin-induced thrombocytopenia and thrombosis (hitt) * has had major surgery (per the investigator's judgment) within 4 weeks before administration of the study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination
intensity training and cardiovascular health in colombian adults

Conditions: Metabolic Diseases

Summary: several studies have shown relationship between exercise intensity and improvement cardiometabolic health. it has been suggested that high intensity interval training and also moderate training generate positive effects on metabolic risk factors. for these reasons, it is necessary to clarify which type of training, is more effective to improve cardiometabolic health in latinamerican population.


Eligibility criteria:
inclusion criteria: * written informed consent. * interested in improving health and fitness. exclusion criteria: * systemic infections. * weight loss or gain of \>10% of body weight in the past 6 months for any reason. * currently taking medication that suppresses or stimulates appetite. * uncontrolled hypertension: systolic blood pressure 160 mm hg or diastolic blood pressure 95 mm hg on treatment. * gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy). * asthma. * diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dl), or use of any anti-diabetic medications. * currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months). * any active use of illegal or illicit drugs. * current exerciser (\>30 min organized exercise per week). * indication of unsuitability of current health for exercise protocol (parq). * any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
development and initial application of a combined exercise and psychological intervention program for patients after esophagectomy

Conditions: Esophageal Cancer; Exercise Training; Psychotherapy; Rehabilitation

Summary: esophageal cancer imposes a significant burden in china, accounting for over 60% of the global disease burden. while surgery remains a common and highly effective treatment for esophageal cancer, patients often experience multiple physical and psychological symptoms postoperatively, severely affecting their recovery outcomes and quality of life. although existing exercise or psychological intervention programs have shown some effectiveness, issues such as relatively singular intervention content, imprecise intervention timing, and vague intervention details persist. this project, based on previous research foundations (including the development of symptom measurement tools and the identification of key recovery periods), is guided by symptom management theory and knowledge translation models. taking a perspective of the synergistic impact of physical and psychological symptoms, the study focuses on patients undergoing esophageal cancer surgery. initially, evidence-based literature review, focus group interviews, and expert consultations were conducted to develop a combined exercise and psychological intervention program, integrating subjective (csca_ec) and objective (6mwt) measurement indicators, named "recovery for ec." subsequently, the program was preliminarily applied in clinical settings using a mixed-methods approach, combining quantitative quasi-experimental design (108 cases) and qualitative interviews to assess its acceptability. the final clinical trial version of the recovery for ec program was developed to provide patients with a tool for self-monitoring recovery outcomes and offer clinical healthcare professionals guidance for implementing precise and personalized rehabilitation management.


Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of esophageal cancer by pathological biopsy. 2. undergoing surgical treatment. 3. age ≥ 18 years old. 4. the patient is able to communicate effectively in language. 5. the patient is fully aware of their condition and willingly participates in the investigation. exclusion criteria: 1. patients with consciousness disorders. 2. patients with severe physical illnesses who are unable to cooperate with the investigation. 3. participation in other studies.

Keywords: esophageal cancer esophagectomy rehabilitation
effect of caffeine on cognition in alzheimer's disease

Conditions: Alzheimer Disease

Summary: sporadic alzheimer's disease is a multifactorial illness arising a major medico-economic stakes for our aging societies. there is currently no curative treatment available. coffee is a complex beverage with psychostimulant properties whose main effective element, caffeine, has a pleiotropic effect on the central nervous system. caffeine pharmacological properties enable its use like an alzheimer's disease symptomatic treatment. its supposed benefits mustn't obscure anxiety and insomnia caffeine effect at large dose, which alzheimer's patients might be more vulnerable. the main study objective is to evaluate placebo-controlled caffeine efficacy (30 treatments weeks) on cognitive decline in alzheimer's disease dementia at beginning to moderate stage (mmse 16-24).


Eligibility criteria:
inclusion criteria: * age ≥ 50 at screening * probable alzheimer dementia according to the criteria of the national institute on aging-alzheimer's association; diagnosis must be supported by brain imaging (ct or mri) and blood test (including ionogram, kidney and liver function, calcemia, crp, tsh, b12 vitamins and folates) performed in routine care * mmse score ≥16 * presence of an informant and caregiver, living with the patient * iache and/or memantine treatment non-compulsory ; if implemented it must be effective and stable for 2 months before the selection visit and must remain stable for the duration of the study exclusion criteria: * patients who refuse to adopt a low caffeine diet (eviction of tea, caffeinated sodas, chocolate in large quantities) * current major depressive episode according to dsm-5 criteria * another chronic pathology of the central nervous system * major anxiety according to the clinician (consistent with the corresponding npi-r items that must indicate a severity \>2 and an impact \>3) * sleep disorders defined by severity and an impact on npi-r; a patient fitted for osa may be included if the device has been in use for 3 months and well tolerated (stable) * decompensated heart disease or severe rhythm disorder (excluding slow, treated and stable chronic atrial fibrillation) * active smoking * for childbearing women : pregnancy in progress or planned (a pregnancy test will be performed) * patients who take forbidden treatment : * psychotropic treatments introduced or modified \< 2 months before inclusion * chronic use of cyp1a2 inducing or inhibiting drugs * all caffeine-containing specialties * drugs that influence caffeine metabolism * drugs that may interact with caffeine

Keywords: alzheimer's disease caffeine cognitive impairment
therapeutic efficacy of orbital radiotherapy in patients with graves' orbitopathy

Conditions: Graves Ophthalmopathy

Summary: the purpose of the present interventional study is to assess the changes in the therapeutic response, ocular manifestations of graves' orbitopathy and quality of life during the first year after orbital radiotherapy. the main questions it aim to answer are: 1. how effective is orbital radiotherapy used as first- or second-line treatment in patients with graves' orbitopathy? 2. how does the quality of life changes after orbital radiotherapy? participants have active moderate-to-severe graves' orbitopathy and are treated with low dose fractionated orbital radiotherapy for two weeks. during the follow-up period they undergo regular ocular examinations and fill out a disease-specific questionnaire.

orbital radiotherapy is a well-established second-line therapy for moderate-to-severe forms of graves' orbitopathy. however, the question about it efficacy is still controversial. the purpose of the present interventional study is to assess the changes in the therapeutic response, ocular manifestations of graves' orbitopathy and quality of life during the first year after orbital radiotherapy. the main questions it aim to answer are: 1. how effective is orbital radiotherapy used as first- or second-line treatment in patients with graves' orbitopathy? 2. how does the quality of life changes after orbital radiotherapy? participants have active moderate-to-severe graves' orbitopathy untreated or already treated with systemic glucocorticoids and are referred to low dose fractionated orbital radiotherapy, total dose 20 gy divided into 10 sessions, 2 gy for each session. a concomitant intake of low-dose glucocorticoids is prescribed to all patient. during the follow-up period they undergo regular ocular examinations (at 1st, 3rd, 6th and 12th month), which includes comprehensive ocular status, hormonal and immunological testing and evaluation of the current therapeutic response. the patients also fill out a disease-specific questionnaire (at 3rd, 6th and 12th months).

Eligibility criteria:
inclusion criteria: - active moderate-to-severe graves' orbitopathy exclusion criteria: * contraindications for orbital radiotherapy