Kornimate/medical-research-clean huggingface dataset:
drug interactions between dolutegravir and escalating doses of rifampicin

Conditions: Hiv; Tuberculosis

Summary: this is a drug interaction study in hiv negative, tb-monoinfected participants coming to the end of continuation phase of tb therapy, to study the pharmacokinetic changes to dolutegravir when administered with standard, medium and high dose rifampicin.


Eligibility criteria:
inclusion criteria: * ability to give informed consent prior to participation * willing and able to comply with all study requirements * receiving standard doses of rif and inh * hiv antibody negative * male or non-pregnant, non-breastfeeding female * study participation will not extend length of att by more than 4 weeks exclusion criteria: * \< 18 years * body weight \< 50 kg * egfr \< 60 ml/min * abnormal lfts including alt \> 2.5 uln * hiv antibody positive * non-standard tb regimen (containing rhze) * women of childbearing age unless using effective contraception * family history of sudden cardiac death * prior history of cardiac disease that precludes the use of low dose digoxin * medical or psychiatric condition that might affect participation in the study based on investigator judgement * regular consumption of grapefruit or grapefruit juice * ecg abnormalities that preclude the use of low dose digoxin (intermittent complete heart block, second degree av block, supraventricular arrhythmia associated with conducting pathways, ventricular tachycardia or fibrillation)
chemotherapy of nsclc with or without icotinib

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: epidermal growth factor receptor (egfr) mutations occur in up to 50% of asian patients with non-small cell lung cancer (nsclc). treatment of advanced nsclc patients with egfr-tyrosine kinase inhibitors (egfr-tki) confers a significant survival benefit. this study assessed the efficacy and safety of chemotherapy with or without icotinib in patients undergoing resection of stage ib to iiia egfr-mutated nsclc.


Eligibility criteria:
inclusion criteria: * patients undergoing completely resection of egrf mutation-positive nsclc * staging ⅰb (with high risk factor) to ⅲa * ps = 0 or 1 * adequate hematological, biochemical and organ functions exclusion criteria: * systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating
hypersensitivity to opening of bkca channels in post-traumatic headache

Conditions: Post-Traumatic Headache

Summary: the aim is to investigate whether opening of large conductance calcium-activated potassium (bkca) channels induces headache with migraine-like features in people with persistent post-traumatic headache (pth) attributed to mild traumatic brain injury (mtbi).


Eligibility criteria:
inclusion criteria: * age 18 to 65 years of age upon entry into screening * history of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the international classification of headache disorders, 3rd edition (ichd-3) * ≥ 4 monthly headache days on average across the 3 months prior to screening provision of informed consent prior to initiation of any study-specific activities/procedures. exclusion criteria: * \> 1 mild traumatic injury to the head * history of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache) * history of moderate or severe injury to the head * history of whiplash injury * history of craniotomy * history or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) than, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion * the subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior * female subjects of childbearing potential with a positive pregnancy test during any study visit * cardiovascular disease of any kind, including cerebrovascular diseases * hypertension (systolic blood pressure of ≥150 mmhg and/or diastolic blood pressure of ≥100 mmhg) prior to the start of infusion on the experimental day * hypotension (systolic blood pressure of ≤90 mmhg and/or diastolic blood pressure of ≤50 mmhg) * initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion * intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start * baseline headache intensity of \>3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache) * baseline headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features

Keywords: headache pain
thermic & lipemic properties of dietary carbohydrates

Conditions: Exogenous Obesity; Dietary Modification

Summary: the purpose of this study is to determine if consumption of meals containing carbohydrates with different glycemic index (a high glycemic index meal and a low glycemic index meal)have different effects on energy expenditure, type of metabolic fuels used for energy, blood lipids and lipoproteins, and sensations of hunger, fullness, and the hormones related to satiety.

little is known about the metabolic effects of chronic dieting and weight cycling in humans, but limited evidence suggests that fatty acid oxidation may be depressed leading to periodic elevation of circulating lipids associated with meal ingestion and preferential storage of fat in adipose tissue. with the traditional approach of restrictive dieting failing to result in permanent weight loss and, possibly producing abnormalities in lipid metabolism, it is important to evaluate alternative approaches to achieve a healthy body weight through improved metabolism. in this study the investigators will test the postprandial metabolic effects of standard mixed meals containing carbohydrates with high glycemic index and compare these effects to responses obtained with standard mixed meals, matched for protein and fat content but containing carbohydrates with low glycemic index.

Eligibility criteria:
inclusion criteria: * body mass index between 25 and 30 kg/m2 * having regular menses * willing to refrain from restrictive dieting during the course of the study exclusion criteria: * pregnant or currently planning a pregnancy * cigarette smoking * taking medications to induce weight loss or change appetite * history of cardiovascular disease * history of metabolic disorders, including diabetes

Keywords: energy metabolism lipids lipoproteins satiety glycemic load insulin
peripheral nerve stimulation in diabetic patients

Conditions: Diabetic Polyneuropathy

Summary: the prevalence of diabetes mellitus (dm) in industrialized countries is estimated to be about 7.3% and its incidence has been growing in recent years. the prevalence of diabetic neuropathy in the diabetic patient population is up to 50%. when limb surgery is necessary, it is reasonable to assume that diabetic patients will benefit from a peripheral regional anesthesia because of the severe comorbidities associated with dm. on the other hand, the use of regional anesthesia (ra) has generally not been recommended in patients with preexisting neuropathies mainly because of medical liability issues, as worsening neuropathy could be attributed to nerve damage caused by the regional anesthetic. the current state of the art of peripheral regional anesthesia for the identification of correct placement of an injection needle suitably close to the target nerve is to elicit a motor response by current injection through the needle. constant reduction of the current as the nerve is approached ensures close proximity so that an effective nerve block is obtained when the local anesthetic is delivered through the needle, and absence of a motor response at 0.3 ma is generally accepted as a safety marker to avoid harmful intraneural injection. an important deficit in our understanding is whether diabetic neuropathy influences the stimulation parameters for peripheral nerve stimulation (pns), possibly decreasing safety. the currently proposed research is guided by the hypothesis that nerves in patients with dm are more resistant to stimulation and the current thresholds for pns have to be set much higher to prevent injections from occurring within the epineurium. the investigators will examine the effect of dm on nerve excitability in a blinded, prospective, observational case control trial. accordingly, the investigators have defined following aims: specific aim 1: to characterize the required stimulation current in patients with and without diabetes mellitus. specific aim 2: follow-up to examine if the rate of adverse neurologic events is higher in diabetic patients. specific aim 3: guided by the results, formulate recommendations for the performance of regional anesthesia in patients with a history of dm. these experiments will provide better understanding of the needle-current-nerve relationship during peripheral nerve stimulation. findings from this study will have a major impact on patient safety, especially in the subgroup with preexisting neuropathy, undergoing regional anesthesia.


Eligibility criteria:
inclusion criteria: * patients of both sexes * age more than 18 years * american society of anesthesiology status 1 to 4 * signed informed consent exclusion criteria: * pregnancy * allergies to local anesthetics * unwillingness or incapability to sign informed consent * any preexisting neurological deficit of the lower limb that cannot be attributed to diabetic neuropathy * ongoing dual anti-platelet therapy

Keywords: regional anesthesia peripheral nerve stimulation diabetes diabetic neuropathy
effect of a pharmaceutical intervention on the level of control of the asthmatic patient

Conditions: Asthma

Summary: measurement of disease control, treatment adherence and patient knowledge of his/her medication in patients that are receiving a pharmaceutical intervention compared with those patients who receive regular pharmaceutical care.


Eligibility criteria:
inclusion criteria: * patients who have given their informed consent and expressed interest in participating in the study * asthmatic patients exclusion criteria: * patients with communication difficulties. * persons who obtain symbicort but not for their own use. * patients with other major diseases: heart problems, copd, emphysema, lung cancer, aids. * patients with a respiratory infection. * patients with seasonal asthma. * pregnant women * patients who have previously participated in a health education study in asthma.

Keywords: asthma pharmaceutical intervention effect of a pharmaceutical intervention on the level of control of the asthmatic patient
internet-based treatment of generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to determine whether internet-administered cognitive behavior therapy is a feasible treatment for generalized anxiety disorder.


Eligibility criteria:
inclusion criteria: * satisfy dsm-iv criteria for generalized anxiety disorder * living in sweden and being able to read swedish * access to computer with internet connection exclusion criteria: * currently receiving other psychological treatment * non-stable use of psychoactive medication * deemed suicidal * deemed to suffer from other psychological disorder, e.g. psychosis, bipolarity etc.

Keywords: cognitive behavioral therapy internet anxiety generalized anxiety disorder
cranial ultrasound for prehospital ich diagnosis

Conditions: Intracerebral Hemorrhage; Acute Ischemic Stroke

Summary: to evaluate the feasibility of emergency medical system (ems)-performed cpocus in the field for diagnosis of acute intracerebral hemorrhage (ich)

with the over-arching goal of achieving early diagnosis of intracerebral hemorrhage (ich) with cpocus, this study hypothesizes that (a) emergency medical system (ems) personnel can competently perform cpocus in the field in a timely fashion in a large majority of stroke patients; (b) acquired pocus images can be successfully and securely transmitted for a remote physician interpretation in a timely manner; and (c) cpocus will have a greater sensitivity and specificity than clinical scores as a screening tool for ich identification in pre-hospital settings.

Eligibility criteria:
inclusion criteria: * any patient deemed to have a stroke like presentation or possibility of brain hemorrhage in the clinical judgement of the emergency medical services (ems) provider and a decision to transfer the patient to the nearest emergency department (ed) for further evaluation has been made will be eligible for the study * 18 years old or older * transfer initiated by ems to the ed for further evaluation * performing ultrasound will not interfere with the care or triage as part of routine care exclusion criteria: * less than 18 years old * incarcerate patients * penetrating cranial/head trauma or scalp wound * any patient where performing ultrasound will interfere with the care * patients who decide not to be transported to ed

Keywords: computed tomography (ct) scan
inhibitory capabilities among women with eating disorders

Conditions: Food Response; Food Stop; Food Response-inhibition

Summary: the goal of the study is to increase the flexible behavior toward food via inhibition training among restrained eaters. the expectation is that the train will increase food consumption, decrease food-related anxiety and affect implicit attitudes towards palatable foods


Eligibility criteria:
inclusion criteria: * diagnosis of restrained eaters * adults ages 18-40 exclusion criteria: * current history or diagnosis of the following according to the criteria of the dsm-5: schizophrenia, schizoaffective disorder, hallucinations, unspecified psychotic disorder (nos), a mental disorder due to acquired head injury, bipolar disorder, mental disorder as a result of organic development. * abuse or addiction to drugs and alcohol.
diagnosis and definition of local involvement of musculoskeletal tumors: assessment of ultra-high field mri exploration contribution

Conditions: Sarcoma

Summary: sarcomas are aggressive malignant tumors issued from mesenchymatous cells. their curative treatment is mainly surgical, especially in soft tissue sarcomas, which are mostly localized in limbs. surgical margins remain a major prognosis factor and are directly linked to recurrence risk. curative surgery applies resection margins removing healthy tissue surrounding the tumor and is meticulously planned thanks to tight cooperation between expert surgeons and radiologist, based on pre-operative magnetic resonance imaging(mri). resection planning optimizes chances to perform a safe carcinological resection procedure sparing these structures. resection planning is based upon conservation (or sacrifice) of anatomic compartments limited by fascia and routine mri might also be outdated in some cases to predict whether the fascia is involved in the tumor or not. such uncertainties complexify the surgical procedure, lead to unnecessary healthy tissue sacrifices and increase functional impairments, which can be significant. a new mri offering higher spatial resolution could allow tumoral satellites, previously undetected on conventional mri, which might explain some of the observed recurrences. ultra-high field mri, considered as harmless and without pharmaceutical agent injection, could bring benefits to tumoral extension comprehension and should be considered as a breakthrough in medical oncology field. this is particularly true in soft tissue sarcoma pathology field, where the only curative treatment to date remains surgery. it will be propose in this project to determine the contribution of ultra-high field mri in soft tissue sarcomas management and to evaluate for the first time the potential superiority of 7 tesla imaging over routine mri through usual data comparison in 20 patients between 1,5tesla and 7 tesla mri.


Eligibility criteria:
inclusion criteria: * major patients * all patients with soft-tissue sarcoma * patients agreeing to participate in the study and having signed a consent exclusion criteria: * patients with a contraindication to mri will be excluded: claustrophobia, metallic foreign bodies, cardiac pacemakers, implantable chamber. there is no known additional risk for 7tesla mri scanning. the same contraindications as those of conventional mri prevail. * patients with bone-component sarcomas will be excluded in order to have a homogeneous group of tumors localized only in the soft tissues (and simpler analysis in high-field mri because of the risk of artifacts related to bone). * intermediate malignancies will be excluded for the same reasons.
to study the function of the retina in glaucoma patients using perg

Conditions: Glaucoma

Summary: the purpose of this trial is to evaluate the performance of a new diagnostic device in the diagnosis and management of glaucoma. we will use this new device (perg) to evaluate the function of the retina in glaucoma patients. this device is safe for the patients.

glaucoma is one of the leading causes of blindness worldwide. it's an optic neuropathy characterized by the progressive death of retinal ganglion cells. in laboratories, it's possible to measure the electrical activity of retinal ganglion cells (rgc). some researchers found that rgc showed electrical anomalies before dying. this decrease of electrical activity can be measured by using pattern electroretinography (perg). unfortunately, these measures could not be obtained in clinics before this new device. for this reason, diopsys developed a new device that can measure perg directly in clinics, allowing physicians to have these data earlier to help them diagnose pathologies such as glaucoma or other ganglion cells abnormalities. currently, it is known that glaucoma is difficult to diagnose in the early stages and it's challenging to decide when to start a treatment. in this study, our purpose is to use this new device to evaluate its efficacy in the diagnosis and management of glaucoma.

Eligibility criteria:
inclusion criteria: * glaucoma (all types of glaucoma); * ocular hypertensive (suspicion of glaucoma); * control patients (without any suspicion/sign of glaucoma); * have given written informed consent, prior to any investigational procedures; * aged 18 years of either sex. exclusion criteria: * patients not able to understand the character of the study * participation in other clinical research within the last 4 weeks * other diseases that may cause visual field loss or optic disc abnormalities * systemic diseases that may affect perg amplitude such as diabetes, parkinsonism, multiple sclerosis * poor best corrected visual acuity outside the limits recommended for the test * patients with high myopia (\>5d)

Keywords: glaucoma
implications of stress management program

Conditions: Chronic Conditions, Multiple

Summary: previous studies indicated that patients with diabetes mellitus and hypertension had higher level of perceived stress, used maladaptive coping strategies and poor health-related quality of life. therefore, stress management program was applied to reduce their perceived stress, improve their coping strategies, improve their health-related quality of life and psychological health of the patients with type 2 diabetes mellitus and hypertension in current study. the main objectives of the current study were to observe the effects of stress management program on perceived stress, coping strategies and health-related quality of life using pre-experimental research design. patients with diabetes mellitus type 2 and hypertension were selected through purposive sampling technique to apply the eclectic approach of the stress management program. total 110 patients with type 2 diabetes and hypertension completed the program from 114 patients who gave inform consent for participation in the first session. perceived stress scale, whoqol and coping strategies questionnaire were administered at the pre and post-levels of the program. further, base line of targeted domains variables was also filled from the participants at pre, mid and post-levels to access the efficacy of the program which was formulated according to previous research data by the researcher. the stress management program consisted of 10 session which were delivered to eight groups (diabetic and hypertensive) in five weeks. each session had the duration 90 minutes and two sessions were conducted in one week.


Eligibility criteria:
inclusion criteria: * patients with type ii diabetes or hypertension with at least three months duration of illness * had not attended any psychological intervention or stress management program earlier exclusion criteria: * patients who had any other physical/ mental illnesses along with diabetes or hypertension * patients with type i diabetes * patients with gestational diabetes or hypertension * had diabetes or hypertensive condition from less than three month * had co morbidity of diabetes and hypertensive chronic conditions

Keywords: diabetes hypertension chronic condition stress management program perceived stress coping strategies
assessment of cancer related brain fog using the test of strategic learning

Conditions: Brain Fog

Summary: the inova research team will ask people who have had an experience of breast cancer and related changes to their cognition to complete some scales that researchers have established describe brain fog (called patient reported outcomes) and compare those results to the tosl results. this will be done twice to see if changes are detected similarly on both types of measures.

current brain fog research struggles to clearly define and measure brain fog because the changes are more subtle than typically show up on "objective" tests. these subtle changes on the tests, may not appear subtle in everyday life. this disconnect can lead to people managing cancer feeling unheard or unbelieved about their experience with brain fog. however, cognitive research outside of the cancer population has developed and tested tests that are more sensitive to cognitive changes and improvements. the goal of this initial research project is to test a more sensitive test, called the test of strategic learning (tosl), to see if it is sensitive enough to objectively measure brain fog. one other problem with previous brain fog research is that it has not included a diverse population. therefore, what we think we know about brain fog may not be true for everyone with brain fog. the diverse population in the dmv area that inova serves deserves to have their experiences represented in the research.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * ecog performance status ≤ 2 * patients diagnosed or with a history of breast cancer within the last 5 years. * life expectancy of at least 3 months * subject reports experiencing brain fog or cognitive impairment that the subject attributes to cancer or cancer therapy * able to sit for one hour and attend and respond to verbal and written instructions. * able to use a computer exclusion criteria: * brain metastases from breast cancer * severe hearing or visual impairment * unable to give informed consent * unable to read and write in english * those diagnosed with history of neurologic injuries or disorders (e.g. seizures, strokes, traumatic brain injury, brain surgery, neurodegenerative disorders) other than those attributable to cancer or cancer therapy.

Keywords: breast cancer