Kornimate/medical-research-clean huggingface dataset:
hypofractionated radiotherapy for soft tissue sarcomas

Conditions: Soft Tissue Sarcoma

Summary: one of the main challenges in treating sarcomas with radiation is the toxicity to normal structures around the sarcoma. early reports suggest hypofractionated radiotherapy will be safe and effective for treatment of soft tissue sarcomas. however, given the rarity of this disease, the diversity of histological sub-types, and the variety of locations where these can occur (anywhere in the body), more data is needed to provide understanding of the safety and efficacy of hypofractionated radiotherapy for treatment of this disease. the hypothesis is that by using hypofractionated radiotherapy, highly conformal high dose radiation can be delivered to soft tissue sarcomas, while respecting established normal tissue constraints and that local control rates will be greater than historical rates reported with conventional fractionation. eligible participants with biopsy proven soft tissue sarcoma will be on study for up to 60 months.


Eligibility criteria:
inclusion criteria: * biopsy proven soft tissue sarcoma, either localized and inoperable/unresectable or metastatic, that is deemed by the treating physician to be targetable with hypofractionated radiotherapy. * participant refuses surgery or is aware that surgery is not recommended for them * karnofsky performance status \> 60 * able to understand and sign an informed consent form exclusion criteria: * pregnant * chemotherapy or systemic anti-cancer treatment within the preceding two weeks * unable to undergo imaging or positioning necessary for radiotherapy planning * prior radiation therapy in the field that, at the discretion of the treating physician, prevents safe delivery of hypofractionated radiotherapy.

Keywords: hypofractionated radiotherapy
evaluation of ifnγ and inflammatory mediators in patients with malignancy-associated hemophagocytic lymphohistiocytosis

Conditions: Hemophagocytic Lymphohistiocytosis

Summary: this observational study is designed to determine the levels of pro-inflammatory markers in patients diagnosed with m-hlh, and to assess whether the cytokine profiles bear an ifnγ signature.

this is a observational study designed to determine the levels of inflammatory markers in patients diagnosed with m-hlh and to assess the relationship between the biomarkers and disease activity in these patients during the m-hlh course. inflammatory markers will also be measured in a group of control patients diagnosed with hematological malignancy but without hlh. inflammatory markers include ifnγ and ifnγ-induced chemokines cxcl9 and cxcl10. in addition to the blood samples for the biomarker analysis, relevant information gathered by the treating physician will be collected in a data collection form. whenever possible, collection of serum samples for biomarker analysis and relevant information should occur at m-hlh diagnosis, at regular time intervals during the treatment course as well as at resolution or reactivation of the disease. blood samples will also be sent to the study sponsor (novimmune s.a.) for cytokine testing. before participant's samples are sent to the sponsor for testing, participant's name and any personal identifying information will be coded to protect participant's privacy.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with hlh in the context of a malignancy. the diagnosis of m-hlh will be established by the treating physician. 2. the patient or patient's legal representative (in case the patient is \< 18 years old) must have consented to the use of their clinical data for research purposes at the site. 3. for the control group, patients with a diagnosis of hematological malignancy and never diagnosed with hlh or no suspicion of hlh exclusion criteria: n/a

Keywords: hemophagocytic lymphohistiocytosis malignancy-associated hemophagocytic lymphohistiocytosis m-hlh patients with known diagnosis of malignancy without hlh interferon gamma ifnγ biomarkers inflammatory markers blood draws data collection
measurements to assess severity of epicardial stenoses

Conditions: Coronary Artery Disease

Summary: newly developed diagnostic parameters have potential to differentiate between epicardial disease and microvascular dysfunction with the help of anatomical details and physiological endpoints and can be used in present clinical settings.

the pressure drop coefficient (cdp) is a functional index based on hyperemic dp and u measurements. the lesion flow coefficient (lfc) combines the functional index cdp with an atomic measure (percentage area stenosis) as a single parameter.

Eligibility criteria:
inclusion criteria: * abnormal myocardial stress perfusion (spect) lv ef \> 25% exclusion criteria: * lv \ 2.5 gm/dl type ii hit significant co-morbidities pregnant women

Keywords: abnormal stress test fractional flow reserve pressure drop coefficient lesion flow coefficient
self-help treatment for insomnia in breast cancer patients

Conditions: Insomnia

Summary: the main goal of this population-based study is to assess the efficacy of two forms of cognitive-behavioral therapy (cbt) to treat various levels of insomnia symptoms in women with breast cancer: a professionally administered form and a patient self-administered form. it is hypothesized that the two treatment conditions will be associated with significantly greater improvements in sleep, psychological distress, fatigue, cognitive functioning, and quality of life, relative to the control condition (i.e., usual care). it is also hypothesized that the magnitude of effect sizes obtained in association with treatment at each time assessment will be greater for the professionally administered treatment than the self-administered treatment.


Eligibility criteria:
inclusion criteria: * to be receiving treatment for a diagnosis of breast or gynaecological cancer * to obtain a score of 8 or higher on the insomnia severity index (isi) or to be using a hypnotic medication ≥ 1 night per week exclusion criteria: * to have received a diagnosis or being treated for : * a sleep disorder other than insomnia (e.g., sleep apnea) * a severe psychiatric disorder (e.g., psychotic disorder) * a severe cognitive disorder (e.g., dementia)
the effectiveness of flash glucose monitoring system on glycemic control in patients with new-onset type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Flash Glucose Monitoring

Summary: the purpose of this study is to determine if flash glucose monitoring system improves glycemic control in adults with new-onset type 2 diabetes

people with new-onset type 2 diabetes who achieve and sustain glycemic targets is important for reducing the risk of complications and all-cause mortality.glucose monitoring is the key point of diabetes management.continuous glucose monitoring(cgm)can identify day-to-day glucose profiles to guide management decisions.flash glucose monitoring is a variant of cgm and is factory calibrated,requiring no finger pricks.the purpose of this study is to determine if flash glucose monitoring improves glycemic control in adults with new-onset type 2 diabetes.

Eligibility criteria:
inclusion criteria: * peolpe with type 2 diabetes in accordance with the dignosed criteria of cds2017 * type 2 diabetes duration of \<6months * with certain read-write ability * willing to use fsl or follow study protocol exclusion criteria: * acute complication of diabetes condition(dka,hhh) * pregnancy,lactating or planning pregnancy * allergy to adhesive tape * skin with large area of rubefaction and wounds

Keywords: type 2 diabetes glucose management flash glucose monitoring system
arterial ph selectively predicts intensive care unit transfer from the emergency department in obese patients with acute dyspnea

Conditions: Dyspnea; Respiratory Failure

Summary: this study evaluates the prognostic value of arterial blood gas analysis in a cohort of emergency department patients presenting with shortness of breath of any cause, comparing obese and non-obese patients.

factors associated with admission to intensive care unit (icu) or ed mortality before transfer to the icu are analyzed in obese (bmi ≥ 30kg.m-2) and non-obese patients subgroups.

Eligibility criteria:
inclusion criteria: * patients who presented with acute dyspnea in the ed * patients who had an abg analysis as part of the ed standard management exclusion criteria: * patients with treatment limitation decisions made by the medical teams against icu admission, including severe cognitive impairment or palliative care , * patients with immediate transfer to icu due to shock and hemodynamic instability at ed admission

Keywords: dyspnea ph blood gas analysis emergency department intensive care unit
efficacy and saffety of oral immunotherapy to pistachio

Conditions: Allergy; Food Allergy

Summary: the objectives of this study are (i) to evaluate the efficacy of oral immunotherapy to pistachio by evaluating the daily oral tolerance of 2g pistachio, by evaluating the long-term tolerance of 15g pistachio (sustained unresponsiveness) and by decreasing pistachio-specific ige, (ii) evaluating the efficacy of pistachio immunotherapy on cashew tolerance, (iii) and to evaluate the safety of pistachio immunotherapy.


Eligibility criteria:
inclusion criteria: * patients under 18 years of age with a proven allergy to pistachio and followed in the pediatric allergology unit of the nancy university hospital. * patients who have received oral immunotherapy to pistachio for at least 18 months at 31/12/2022 exclusion criteria: * patients who have received oral immunotherapy to pistachio for less than 18 months. * patients lost to follow-up for more than 2 years or last consultation dating from 2020 or earlier
we walk plus study for older adults with intellectual disabilities

Conditions: Intellectual Disability

Summary: determine the feasibility and acceptability of we walk plus intervention to promote physical activity and improve cognition for older adults with intellectual disabilities (id).

we walk plus study consists of: (1) a user friendly physical activity tracker (i.e., fitbit charge hr ); (2) user-centered social networking (e.g., fitbit community); and (3) the icardia platform for monitoring daily fitbit physical activity and wear time and sending personalized text-messages targeting physical activity and self-efficacy. the specific aims of this two-arm rct pilot are to: 1) assess the feasibility and acceptability of the we walk plus intervention and 2) explore the preliminary efficacy of we walk plus on physical activity and well-being.

Eligibility criteria:
inclusion criteria: * men and women with mild or moderate intellectual disabilities; * ages 35-60; * able to speak, read english and willing to provide consent to enroll; * able to follow instructions and walk, physically inactive; * willing to receive sms, wear fitbit throughout the study; * living with family or in a community residence; * support persons are willing to assist participants to ensure the fitbit functions properly. exclusion criteria: * inability to follow instructions; * diagnosis of coronary disease or uncontrolled hypertension, smokers, physically active; * participating in a health promotion program; * having mental illness or behavior problems; * support persons unable or unwilling to assist participants with fitbit devices, if needed.

Keywords: physical activity walking older adults with an intellectual disability
folic acid and vitamin b12 in young indian children

Conditions: Diarrhea; Pneumonia

Summary: hypothesis: supplementation of two recommended daily allowances (rda) of folic acid with or without simultaneous administration of vitamin b12 reduces the rates of acute lower respiratory tract infections (alri), clinical pneumonia and diarrhea. design/methods we will conduct a preventive randomized placebo controlled clinical trial of folic acid and vitamin b12 supplementation in 1000 children aged 6 to 30 months living in a low to middle-income socioeconomic setting in new delhi, india. children aged 6-30 months will be identified through a survey. eligible and willing children aged 6-30 months will be randomized to 4 treatment groups. trial to enrollment informed consent will be obtained by the study physician/supervisor. at enrollment a baseline form will be filled and the child weight and length taken. the baseline blood samples will be collected. the supplements will be given daily for 6 months. morbidity will be ascertained through biweekly home visits by field workers.

pneumonia and diarrhea are among the leading causes of poor health and death in young children of developing countries. many of these children have inadequate intakes of several vitamins and minerals. folate and vitamin b12 are important for normal function of the immune system. deficiencies of these vitamins are often part of general malnutrition and might be responsible for the excess morbidity and mortality seen in malnourished children. in a recent cohort study in almost 2,500 indian children we demonstrated that those with poor folate status had higher rates of diarrhea and pneumonia. this study also showed that children that were not breastfed had poor folate status and our analyses suggested that the effect of breastfeeding in preventing respiratory and gastrointestinal infections could be explained by the folate content of breast milk. the finding that poor folate status is related to increased susceptibility to childhood infections needs to be confirmed in well conducted clinical trials in populations where folate deficiency is prevalent. this trial aims to examine whether daily supplementation of 2 recommended doses of folate or vitamin b12 or both will lessen the incidence of acute lower respiratory tract infections and diarrhea. we will also measure if the supplementation improves the weight and length of supplemented children.

Eligibility criteria:
inclusion criteria: * age: 6 to 30 months * either sex * likely to reside in area for next 6 months exclusion criteria: * severe systemic illness requiring hospitalization * severe malnutrition, i.e. weight for height \< -3 z of the who standard for this age group. for ethical reasons these children require micronutrient supplementation and adequate medical care. * non consent * consuming vitamin supplements that include folic acid and vitamin b12. * severe anemia (hb \< 7 g/dl).

Keywords: nutrition children folate vitamin b12 india homocysteine methyl malonic acid
bariatric surgery and cardiovascular responses to sodium nitrate

Conditions: Hypertension

Summary: inorganic nitrite and nitrate can be reduced to no and no-related species such as s-nitrosothiols via the nitrate-nitrite-no pathway. this is due to the reduction of nitrate to nitrite by the action of bacteria in the mouth and the reduction of nitrite to no depending on the acidic ph on the stomach or by enzymes with nitrite-reductase activity. the acidic environment of the stomach is very important to the formation of no and s-nitrosothiols and several studies suggest that changes in gastric ph can affect this conversion. in this context, bariatric surgery, by altering the anatomy of the stomach and increasing gastric ph, can affect the nitrate-nitrite-no pathway and change the antihypertensive and antioxidant effect of sodium nitrate.


Eligibility criteria:
inclusion criteria: * for volunteers who underwent bariatric surgery: 1. female; 2. age over 18 years old and under 60 years old; 3. having had bariatric surgery more than 1 and a half years ago; 4. present stabilized weight loss; * for voluntary controls: 1. female; 2. age over 18 years old and under 60 years old; exclusion criteria: * for volunteers who underwent bariatric surgery and controls: 1. having uncontrolled blood pressure (above 160/100 mmhg), even with use regulate up to two antihypertensive agents; 2. hypertensive patients must be using a maximum of two antihypertensives; 3. have diabetes mellitus or other endocrinopathy; 4. have kidney or liver failure; 5. individuals who smoke.
trial of vitamins among children of hiv-infected women

Conditions: HIV Infections; Pregnancy Complications

Summary: the purpose of this study is to examine the effects of multivitamin (b, c, e) supplementation on reducing the risk of morbidity and mortality outcomes among children born to hiv positive mothers, compared to placebo supplementation.

an increasing body of evidence supports the efficacy of single and, more recently, multiple micronutrient supplementation in reducing morbidity and mortality in susceptible populations. for example, we recently completed a multiple micronutrient supplementation trial in hiv-positive tanzanian women that showed a significant reduction in pre-term birth, fetal loss, and low birthweight. in children, we and others have also demonstrated the beneficial effects of vitamin a supplementation in reducing diarrheal disease and mortality. our next priority is to evaluate the efficacy of multiple micronutrient supplementation in susceptible children. children born to hiv-infected women are at risk of multiple micronutrient deficiencies due to poor dietary intake, malabsorption, and increased metabolic needs. in addition, these children, if hiv-infected themselves, are at significantly higher risk of death due to infectious illnesses compared to their non-infected peers. in this study, we propose to study the efficacy of micronutrient supplementation in reducing the risk of morbidity and mortality outcomes among children born to hiv positive mothers, compared to placebo supplementation.

Eligibility criteria:
inclusion criteria: singleton, live born infants born to hiv-infected women exclusion criteria: infants with multiple congenital abnormalities

Keywords: birth outcomes nutrition hiv aids vitamins multivitamins maternal and child health outcomes tanzania africa
testosterone therapy in hypogonadal men treated with opioids

Conditions: Hypogonadism

Summary: the purpose of this study is to evaluate the efficacy of testosterone replacement therapy in men with low testosterone due to opioid treatment on body composition, the haemostatic system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids, sexual function and quality of life. male patients on opioids for non-malignant diseases aged 18-59 years diagnosed with hypogonadotrophic hypogonadism, referred from day hospitals and outpatient populations. 40 patients are randomized to either testosterone undecanoate i.m. or placebo i.m., i.e. 20 patients per arm a double blinded randomized placebo controlled trial

the study duration is 24 weeks. patients are treated with testosterone undecanoate 1000 mg/4 ml, intramuscular (i.m.) or placebo at 0, 6 and 18 weeks. outcome measures will be evaluated at 0 and 14 weeks.

Eligibility criteria:
inclusion criteria: * male patients 18-75 years * treatment with opioid for \>3 months, daily dose \>50-100 mg * total testosterone \< 12 mmol/l * follicle stimulating hormone (fsh)/luteinizing hormone (lh) levels normal og below normal laboratory values * normal prolactin levels exclusion criteria: * hematocrit\> 54% at screening * prostate specific antigen (psa) \> 3 ng/ml * severe organic and mental disease * current or present cancer diagnosis * previous venous thrombotic embolism and cerebrovascular disease * uncontrolled hypertension * epilepsy or migraine not adequately controlled by therapy * severe benign prostate hypertrophy with symptom score \>19 * sleep apnea * alcohol or drug abuse * implantation of sustained action sex hormone in the last 12 months * use of oral, buccal or transdermal testosterone in the last two weeks * treatment with glucocorticoids \> 5 mg/day or 5 alfa reductase inhibitors * hypersensitivity to nebido
partially-blind (observer-blind) study of safety and immunogenicity of two malaria vaccines in ghanaian children

Conditions: Malaria

Summary: this study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old ghanaian children. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

this study will be conducted in a partially blind fashion: it will be observer-blind as to which vaccine was administered, and open as to the vaccination schedule. one group of children on the 0, 1, 2-schedule will receive a rabies vaccine as a control. one group on the same schedule will receive the rts,s/as02d experimental vaccine as an active comparator.

Eligibility criteria:
inclusion criteria: * a male or female child between 5 months and 17 months of age at the time of first vaccination. * written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child. * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * proof that child has received a full 3-dose regimen of licensed hepatitis b vaccine in infancy. exclusion criteria: * acute disease at the time of enrolment. * serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests. * laboratory screening tests for haemoglobin, total white cell count, platelets, alt and creatinine out of acceptable limits. * planned administration/administration of a vaccine (not in the scope of the study) within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled yellow fever or measles vaccine. * use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of the study vaccine, or planned use during the study period. * administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * simultaneous participation in any other clinical trial; * previous participation in any other malaria vaccine trial; * any twins * history of allergic reactions (significant ige-mediated events) or anaphylaxis to previous immunizations. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.

Keywords: vaccine prophylaxis plasmodium falciparum malaria plasmodium falciparum malaria