Kornimate/medical-research-clean huggingface dataset:
effectiveness of cognitive behavioral therapy for insomnia in young adults with chronic pain

Conditions: Insomnia; Chronic Pain; Insomnia Due to Medical Condition

Summary: the aim of the young adult cognitive behavioral therapy (yac) study is to evaluate the effectiveness of the delivering online "zzz's with empirical support (doze) app, a unique digital cognitive behavioral therapy for insomnia (cbti) in young adult patients with chronic pain.

sleep, activity, and pain interactions have the potential to impact almost all important protective and regulatory processes in the body. long-term sleep disruption is associated with increased pain sensitivity, prolonged pain duration, and development of chronic pain. degree of pain relief can directly impact the quality and disruption of sleep, mood, behavior, social participation, and has a devastating impact on health related quality of life (hrql). cognitive behavioral therapy for insomnia (cbti) is a behavioral modification approach and is currently a frontline therapy for adults with sleep disorders. however, cbti is still in early stages of development for adolescent and young adult populations, and less so for youth with comorbid mental and physical health conditions and chronic pain. primary aim: assess the feasibility of implementing the doze app. secondary aim: 1). to examine the variance in effectiveness outcomes, including sleep health, pain, and overall health related quality of life (hrql). 2). to determine the required sample size for a future definitive trial.

Eligibility criteria:
inclusion criteria: * young adult patients aged 18 - 25 years old, who have * non-malignant chronic pain lasting more than 3 months, with * diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria for insomnia, * english speaking with * access to a mobile phone or a computer with internet access. exclusion criteria: * patients who require urgent cbt treatment as per their health care provider * patients who have received cbt in the past 3 months * patients participating in other psychological treatments and/or drug trials during the study * patients who have other significant medical conditions- life threatening (e.g. cancer), neurological conditions (e.g. epilepsy) * patients who have other significant psychiatric conditions-severe depression or active suicide intent * situations resulting in forced sleep disruption or derangement of sleep schedule such as night shift work \> 2 nights per week in the past 3months, pregnancy or breastfeeding. * inability to communicate with health care providers or the research personnel * inability to fill out self-report questionnaires, study materials, or follow instructions.

Keywords: insomnia pain
a study to assess the safety of grf6021 infusions in subjects with parkinson's disease and cognitive impairment

Conditions: Parkinson Disease

Summary: this study will evaluate the safety, tolerability, and potential effects on cognition of grf6021, a plasma-derived product, administered as an intravenous (iv) infusion, to subjects with parkinson's disease and cognitive impairment.

this is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of grf6021, a plasma derived product, administered by intravenous (iv) infusion to subjects with parkinson's disease (pd) and cognitive impairment. the study duration for the subjects will be approximately 7 months.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease (pd), with at least 1 year of pd symptoms. * diagnosis of pd with mild cognitive impairment (pd-mci) or probable or possible parkinson's disease dementia according to movement disorder society's clinical diagnostic criteria. * score on the montreal cognitive assessment (moca) of 13-25. * modified hoehn and yahr stages 1-4. * modified hachinski ischemic scale (mhis) score of 4 or less. exclusion criteria: * history of blood coagulation disorders or hypercoagulability. * current use of anticoagulant therapy. use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable. * prior hypersensitivity reaction to any human blood product or any iv infusion. * treatment with any human blood product, including transfusions and iv immunoglobulin, during the 6 months prior to screening. * history of immunoglobulin a or haptoglobin deficiency; stroke, anaphylaxis, or thromboembolic complications of iv immunoglobulins. * heart disease, as evidenced by myocardial infarction, unstable, new onset or severe angina, or congestive heart failure in the 6 months prior to dosing * hemoglobin \< 10 g/dl in women and \< 11 g/dl in men.

Keywords: brain diseases central nervous system diseases nervous system diseases neurodegenerative diseases neurocognitive disorders mental disorders parkinson's disease dementia
modifying progesterone and estradiol levels to prevent postpartum cigarette smoking relapse and reduce secondhand smoke exposure in infants and children

Conditions: Smoking; Smoking Cessation; Smoking Reduction

Summary: the investigators aim to address the following specific aims: * determine the efficacy of prog in preventing postpartum smoking relapse and reducing smoking relapse risk factors. * examine the effects of this maternal smoking intervention on infant health. * examine racial and ethnic differences in intervention outcomes.

this good clinical practice clinical trial will be implemented by an experienced, transdisciplinary, and productive team of investigators to enhance the diversity of the study sample and generalizability of results. we will enroll healthy pregnant women (following enrollment, all subsequent study procedures will be completed postpartum) or postpartum women on hormonal birth control or no hormonal birth control with either a recent history of smoking and a desire to remain abstinent after childbirth, or who are currently smoking and motivated to quit smoking. participants will be recruited throughout the continental united states (us) and will participant in an observational arm of the study. participants living in minnesota (our clinical site) will receive a 12-week course of exogenous progesterone. all participants will be followed for six months with remote visits, self-administered surveys, and self-collection of dried blood spots to measure hormones and smoking-related biomarkers.

Eligibility criteria:
inclusion criteria: * ability to provide informed consent, * aged 18 to 45 years old * self-reported stable physical and mental health 1. self-report uncomplicated pregnancy at gestational week 30 or beyond, or 2. self-report the birth of a child within the past 6 months * history of ≥ 4 cigarettes per month during the six months prior to pregnancy * at enrollment, self-report of motivation to become and/or remain abstinent after delivery ≥ 6 on a 10 point likert-type scale * willingness to protect against pregnancy following day 0 to week 12 of the study * participants must live in the continental us and have a device to fully participate in the protocol exclusion criteria: * current daily use of nicotine replacement therapy or smoking cessation medications, with the exception of e-cigarettes * current major depressive disorder based on the patient health questionnaire-9 (phq-9) and the beck depression inventory * contraindication to progesterone treatment (e.g., current use of drugs that may inhibit cyp3a4; current or history of deep vein thrombosis, pulmonary embolus, clotting or bleeding disorder, hypertension, stroke, heart disease, or liver dysfunction or disease; or peanut allergy), * current or within the past 3 months treatment for illicit drug use or alcohol use * any condition or issue that, in the opinion of the clinical team, precludes participation in the trial.
a randomized phase 2 study of ixabepilone plus carboplatin and paclitaxel plus carboplatin in advanced nonsmall-cell lung cancer

Conditions: Advanced/Metastatic Non-Small Cell Lung Cancer

Summary: the purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta iii (βiii)-tubulin-positive tumors.


Eligibility criteria:
inclusion criteria: * histologically confirmed non-small cell lung cancer (nsclc)(squamous cell, adenocarcinoma, large cell, or bronchoalveolar carcinoma) * stage iiib nsclc with pleural effusion, stage iv nsclc, or recurrent disease following surgery with or without radiation therapy * available paraffin-embedded tissue to measure the expression levels of βiii tubulin * disease measurable by response evaluation criteria in solid tumors, with at least 1 target lesion situated outside any previous radiotherapy field * karnofsky performance status of 70-100 * life expectancy of at least 3 months * men and women, ages 18 years and older exclusion criteria: * uncontrolled brain metastases * peripheral neuropathy greater than grade 1 * fewer than 4 weeks from prior radiation therapy or locoregional surgeries to randomization date (less than 1 week from focal/palliative radiotherapy or minor surgery) * any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix * known hiv-positive status * absolute neutrophil count lower than 1500 cells mm\^3 * total bilirubin level higher than upper limit of normal (uln) as defined by the institution (with the exception of elevation due to gilbert's syndrome) * aspartate transaminase or alanine transaminase level higher than 2.5\*uln * serum creatine level of 1.5 mg/dl or higher * renal function with a creatinine clearance of less than 50 ml/min (as calculated with the cockcroft and gault equation) * any prior antineoplastic systemic regimens.
stress echocardiography versus exercise ecg (execg) in women with chest pain

Conditions: Coronary Artery Disease

Summary: the overall question the investigators would like to help answer is whether se with or without mce data can be widely used as a first line investigation in women with no previous history of coronary artery disease (cad) who present with chest pain of recent onset. in order to answer this question the investigators will look at the following: i) is se superior to execg in terms of cost to diagnosis and negative predictive value of cad? ii) what is the additive value of myocardial perfusion data to wall motion data for predicting significant cad on angiography and future cardiac events in women? iii) what is the additive value of carotid ultrasonography in a large population of women referred for stress testing?

the investigators plan to perform a prospective study on all women seen in our racpc with no previous history of cad and intermediate pre-test probability of cad as determined by national institute for health and care excellence (nice) guidelines, who require a functional test as part of their assessment. all patients that meet the inclusion criteria and do not meet any of the exclusion criteria will be approached for consent to the study. patients who can perform greater than 5 metabolic equivalents (mets) on the duke activity status index (dasi) questionaire will be randomised between undergoing an exercise ecg (ex-ecg) or exercise stress echo (ese). the dasi is a 12-item questionnaire that estimates self-reported physical work capacity and is converted to an estimate of peak metabolic equivalents. patients who do not meet this criteria, will undergo a pharmacological stress echocardiogram using dobutamine (dse), including myocardial contrast echocardiography (mce). investigations will continue to be performed as per standard clinical departmental protocols as described below. in addition, all patients will undergo carotid ultrasonography. the techniques used are described for completeness as they are all well-established in clinical practice.

Eligibility criteria:
inclusion criteria: * age 30 years and above * no previous history of coronary artery disease * chest pain of presumed cardiac origin, which has occurred in the last month prior to the clinic appointment. exclusion criteria: * electrocardiogram diagnostic of cardiac ischaemia and/or infarction (st-segment deviations\>0.5mm, or t-wave inversion). * previous history of coronary artery disease * chest pain in the last 24 hours * inability to provide informed consent * pregnancy
rwe of brentuximab vedotin consolidation in patients with rr hl who receive salvage chemotherapy and asct

Conditions: Hodgkin Lymphoma, Adult; Relapsed Hodgkin's Disease, Adult; Refractory Hodgkin Lymphoma

Summary: this is a multicenter, observational real world study with prospective follow up that will evaluate the treatment approach in patients with relapsed/refractory chl who undergo asct in argentina.

the purpose of the study is to gather real world evidence of the proportion and characteristics of patients with relapsed refractory chl who undergo asct, who receive consolidation with bv, and to study the factors that determine bv consolidation after asct in real world setting. this study will evaluate the treatment approach in patients with relapsed/refractory chl who undergo asct. all consecutive adult patients with relapsed/refractory chl who undergo asct, regardless of the prior indication to receive or not bv consolidation therapy, will be included in this study and prospectively followed according to local practice. patients will be treated and monitored by their physicians according to local clinical practice and guided by the local approved label for patients receiving bv consolidation. usual follow-up will be determined by the treating physicians' standards of care, and no scheduled patient visits are required for the conduct of this study. there are no visits or specific procedures planned by protocol, however, baseline and follow up data will be gathered every time the patient's response to treatment is assessed or has a medically important event. all patients that undergo asct will be included in final analysis of the primary objectives (full study population). patients that receive bv consolidation or not (non-bv consolidation) will be included in the analysis. patients included in the study are expected to be recruited during 24 months and followed up to progression, death, lost to follow or end of study (12 months after the inclusion of the last patient), whatever occurs earlier.

Eligibility criteria:
inclusion criteria: * patients 18 years or older. * all patients with histologically confirmed chl who are primary refractory or relapse and receive asct as part of their salvage therapy. * signature of the form consent for participation in the study. exclusion criteria: * patients with relapsed/refractory chl not suitable for asct.

Keywords: relapsed/ refractory hodgkin lymphoma autologous stem cell transplant consolidation brentuximab vedotin
effect of concentrated growth factors on short implant-supported overdentures

Conditions: Partially Edentulous Patients

Summary: the purpose of this study will be to evaluate the effect of concentrated growth factors on stability and radiographic outcome of short implant supported mandibular assisted overdenture

a controlled clinical trial will be performed upon patients attending the outpatient clinic of faculty of dentistry tanta university.ten male patients will be selected for this study. split mouth study design will be used in this study where, group i represented the right side of the patients' mandibular posterior region will be restored with short implant in place of first molar and group ii represented the left side of the patients' mandibular posterior region will be restored with short implant in place of first molar and concentrated growth factors. the patients will receive partial mandibular assisted overdenture with o-ring attachment on the implant. stability of implant and radiographic evaluations will be carried out for every patient at regular recall visits at the time of insertion, 6 and 12 months

Eligibility criteria:
inclusion criteria: * patients between 20 to 65 years old. class i kennedy's classification good oral hygiene. exclusion criteria: * bad oral hygiene. para functional habits ex. (bruxism, clenching,)

Keywords: cgf, overdenture
healthy oils for women (how study)

Conditions: Metabolic Syndrome

Summary: the purpose of this study is to understand the role of a dietary oil to alter chronic disease risk factors in women who are at risk for heart disease and/or diabetes. the investigator's previous study showed that safflower oil reduced trunk fat mass in women with diabetes. the investigators believe safflower oil can also attenuate criteria of metabolic syndrome through reduction in trunk fat mass.

the long-term goal is to develop effective and novel dietary and lifestyle strategies to reduce the progression of metabolic syndrome to chronic diseases such as coronary heart disease. the rationale for conducting this research study is that there are few effective strategies that target changes in body composition and metabolism as a means to attenuate metabolic syndrome. the investigators plan to test the central hypothesis and accomplish the overall objective of this research by pursuing the following three specific aims. specific aim 1: quantify the extent that linoleic acid reduces trunk adipose mass in women with metabolic syndrome. specific aim 2: measure changes in visceral adipose tissue specific aim 3: determine the time-dependent effect of linoleic acid to increase adiponectin levels.

Eligibility criteria:
inclusion criteria: * female * post-menopausal (cessation of menses ≥12 months) * age ≥ 50 and ≤ 69 years * at least one of the following metabolic syndrome criteria * elevated triglycerides (\>150mg/dl) * reduced hdl-c (\<50mg/dl) * elevated blood pressure (\>130mm hg systolic or \> 85 mm hg diastolic) * elevated blood glucose (\>100mg/dl and \<126mg/dl) * obese (bmi ≥ 30 kg/m² and ≤ 55 kg/m²) * stable medical therapy for past 3 months * stable body weight (within ± 2 kg) for past 3 months * waist circumference \>88cm (35 inches) exclusion criteria: * substance abuse * current/previous diagnosis of type 2 diabetes or fasting blood glucose ≥126 mg/dl * current use of medications or supplements known to affect body composition * current or previous use of oral hypoglycemic agents or exogenous insulin. * impaired cognitive function * current or previous diagnosis of renal, heart, or circulatory disease * gastrointestinal diseases or disorders

Keywords: safflower oil linoleic acid dyslipidemia hypertension
development of rational ways of medical and non-medical treatment methods for metabolic syndrome

Conditions: Metabolic Syndrome

Summary: metabolic syndrome: aetiology, pathogenesis, diagnosis, clinical management and prognosis

purpose: to create the complex scientifically proved concept of metabolic syndrome (мs) development based on elaboration of the new methods of clinical diagnostics of мs components and highly effective мs clinical management in comparative studying of clinical, laboratory and cost effectiveness. participants and methods: this clinical study included 351 adults (184 female) in the scientific research institute of cardiology and internal diseases (almaty, the republic of kazakhstan). statistical analysis was performed using microsoft excel-2008 in updating lapach, chubenko et al (2000) and spss for windows v.17.0.

Eligibility criteria:
inclusion criteria: * written consent form * age\> 25 years * skinfold thickness \> 0,7 cm bp\> 130/85 mm hg or a patient on antihypertensive medications fasting blood glucose \> 6.1 mmole/l, or 2-hour postprandial glucose level \> 11.1 mmole/l / or a patient with type 2 diabetes blood cholesterol \> 5.6 mmole/l possibility of treatment \> 6 months follow-up \> 1 year exclusion criteria: * complete immobilization of a patient (paresis /paralysis) * patients with severe concomitant diseases of the kidneys and (or) of the liver * early post-operative condition * mental illness * pregnancy * persons who are in prison * persons who are in military armed forces

Keywords: metabolic syndrome diabetes mellitus, hypertension overweight analimentary detoxication
cangrelor ticagrelor transition study

Conditions: Coronary Artery Disease

Summary: to demonstrate that patients treated with cangrelor can be directly switched to oral ticagrelor and that patients treated with ticagrelor can be switched to cangrelor without a significant decrease in the extent of inhibition of platelet aggregation.


Eligibility criteria:
inclusion criteria: * greater than / equal to 18 and less than 75 years of age 1. previous myocardial infarction defined by admission to the hospital with elevation of markers of injury or the presence of pathologic q waves on at least 2 contiguous electrocardiogram (ecg) leads. or 2. previous revascularization by percutaneous coronary intervention (pci) or coronary artery bypass graft (cabg) surgery. and 3. treatment with aspirin (asa) 81 mg daily. exclusion criteria:
nutrient intake in children with attention deficit hyperactivity disorder

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: specific nutrient deficiencies have been described in children with adhd including zinc, magnesium, calcium, and essential fatty acids. in addition, children with adhd have been noted to behave and concentrate better in some studies when the ratio of protein compared with carbohydrate in their diets was increased, however, this was anecdotal information noted from studies designed to study other factors, so its not clear if the increased protein is actually the cause of the improved behavior. in our clinical practice, we have noted a high incidence of what appears to be carbohydrate "craving" among children with adhd, which can put children at risk for obesity, diabetes type ii, and additional dysregulation of mood and concentration. carbohydrate craving is a well-documented phenomenon in adults, particularly those with certain patterns of obesity, mood disorders, or those undergoing smoking cessation programs. it has not been studied in children, however. thus, this initial study was designed to determine 1) whether or not children with adhd have different patterns of nutrient intake compared with children in the same family and children in families without a child with adhd, 2) if the described nutrient deficiencies are due to decreased intake, and 3) whether there is an increased occurrence of carbohydrate craving, based on parents' perceptions, eating patterns, and actual intake, among children (or certain subgroups of children) with adhd. the information gained from this study will be used to design additional studies to test causative hypotheses and intervention strategies.

three day prospective diet records will be completed on 25 children aged 5-13 with adhd, their sibling controls, and 25 children from control families without adhd in order to assess their protein, carbohydrate, fat, calorie, and multiple specific nutrient intakes. in addition, a questionnaire will be completed on each child describing several aspects of eating behavior, food choices, and gastrointestinal, allergic, and infectious concomitants.

Eligibility criteria:
children with adhd (combined or hyperactive-impulsive subtype) by parent and teacher rating scales, history, and interview who do not have a medical or neurologic problem that influences eating, who are not on medication for adhd or another medication that may influence eating, aged 5-13 years with a sibling in the same age range meeting the same criteria but without adhd. this sibling must have a normal parent rating scale and not have been held back in school or been on medication or diagnosed with a learning, developmental, or neuropsychiatric disorder. controls must meet the same criteria, and may not have a first-degree relative with adhd. all participants must have a normal intellect, and may not have an autistic spectrum disorder or major depression.

Keywords: adhd attention deficit hyperactivity disorder carbohydrate craving