Kornimate/medical-research-clean huggingface dataset:
the effect of milk proteins on satiety, food intake and metabolic control (glycemia) in early adulthood

Conditions: Hyperglycemia; Lack of Satiety

Summary: the purpose of this study is to develop and test modified milk protein products to determine the effects of amino acids on food intake, satiety, insulin secretion and glucose control by insulin-independent action in healthy adults.

1. a total of 33 males and females will participate in the study. capillary blood samples will be collected from all participants to measure plasma glucose over a 3.5 hour postprandial study. 2. intravenous blood samples will be collected from a subset of 12 (6 males and 6 females) participants for determination of insulin, satiety hormones, acetaminophen (gastric emptying rates), and determination of amino acid profiles.

Eligibility criteria:
inclusion criteria: * bmi 20 - 24.9 kg/m2 * healthy as determined by screening questionnaire * male or female * non-smoking * normal fasting plasma glucose (\<5.5 mmol/l), but not below 3.3 mmol/l. * prior use of acetaminophen exclusion criteria: * gastrointestinal conditions or illness (including, but not limited to, lactose intolerance, celiac, crohn's, ulcerative colitis (uc), irritable bowel disorder (ibd) * weight loss or weight gain of more than 5 kg during the previous 2 months * taking medication or protein supplements (excluding oral contraceptive, multivitamins and folic acid) * serious medical condition (ie. renal, liver) * lack of appetite or skipping breakfast * restrained eaters as defined as having a three factor eating questionnaire-cognitive restraint \>16 * smoking * reported intolerance to milk or very low consumption (\< 2 servings per week) as assessed by in-person screening. or not liking of the research foods. * food allergies or intolerances as well as anaphylactic or life-threatening allergies - food or otherwise * diabetes or other metabolic diseases that could interfere with study outcomes * acetaminophen, codeine or opioid allergy * pregnant or breast feeding * typical alcohol consumption of not more than 4 drinks per sitting

Keywords: satiety glycemia milk protein
preemie prep for parents (p3): home antenatal prematurity education

Conditions: Premature Birth; Decision Making; Prenatal Care; Resuscitation; Infant, Premature

Summary: the preemie prep for parents (p3) mobile intervention will be tested in an outpatient population of pregnant women at risk of preterm birth and their partners. the study is a randomized controlled trial (rct) comparing knowledge and preparedness for decision making between a group receiving the p3 texts and videos and a group receiving links to american college of obstetricians and gynecologists (acog) prematurity patient education handouts.

this is a randomized controlled study focused on an outpatient population of pregnant women at risk of preterm birth and their partners. the objective is to test the efficacy of the preemie prep for parents (p3) intervention on prematurity knowledge and preparedness for decision making. participants are recruited from their obstetric clinic appointment between weeks 16 and 21, and randomized 1:1 to either the p3 intervention, or access to electronic acog handouts (active control). any participating partners are assigned to the same arm as their pregnant partner. the participants in the p3 group will then receive a schedule of automated text messages, with video links, up to twice a day. these videos and messages are based on information relevant to their gestational age. at study entry, participants will complete measures of their health literacy, anxiety, decision self-efficacy, and subjective global health. as pregnancy continues, questionnaires will be sent to participants at the start of their 25th, 30th, and 34th weeks. these questionnaires will include prematurity knowledge questionnaires (specific to their gestational age), a preparation for decision making scale, and an anxiety measure. at study completion, within two weeks of either preterm childbirth or completion of the 34 week questionnaire, participants will be asked to also complete the educational-aid questionnaire.

Eligibility criteria:
inclusion criteria: * pregnant woman or her partner * at risk for preterm birth, as indicated by: history of spontaneous preterm birth (during the 34th week or earlier), shortened cervical length, multiple gestation, fetal growth restriction, chronic hypertension, history of preeclampsia, and/or diabetes requiring medications. * gestational age of 16-21 weeks at recruitment. * owns a smartphone. * able to speak english exclusion criteria: • pregnancies with known significant birth defects.

Keywords: gestational age multi-media mobile application anxiety clinical trial random allocation
national lung cancer registry in men and women based on diagnosis in algeria

Conditions: Oncology & Epidemiology & Lung Cancer

Summary: national, prospective, multicentric, non-interventional registry-based study, conducted among oncologists, pulmonologists in community and university hospitals, from the public sector in algeria. the study will collect information on the characteristics, and lung carcinomas patterns of patients whose lung cancer diagnosis was confirmed by a pathologist during the study period.

the study consists of: * all patients meeting inclusion/exclusion criteria presenting to their oncologists/pulmonologists for a routine visit during recruitment period will be sequentially asked to participate to the study. * the patients who do not consent will only be reported as new case of lung cancer for the incidence study. the patients who consent to participate to the study will perform four in-hospital visits (inclusion visit, visit at 3, 6 and 12 months). in addition to the 4 visits, a phone contact with the patients every 6 months at years 2,3, 4 and 5 will be done by the investigator or one of his/her authorised representative or the cro or during a routine visit to the investigator, to check the patient's survival status. the study duration 72 months

Eligibility criteria:
inclusion criteria: * men or women diagnosed with lung cancer all types and stages confirmed over 12 months of recruitment period by a pathologist * aged at least18 years at diagnosis * patients who provide their informed consent form exclusion criteria: * patients who did not provide the informed consent form * patients with a mental or psychological disorder according to their treating clinicians

Keywords: lung cancer epidemiology algeria registry
improving dynamic balance and gait adaptability using treadmill training

Conditions: Multiple Sclerosis; Stroke; Parkinson Disease

Summary: balance and gait problems in subjects with neurological disease lead to reduced mobility, loss of independence and frequent falls. treadmill training is a widely used form of treatment and it has been used in subjects with neurological disease to ameliorate walking and balance deficits. the virtual reality treadmill as a therapeutic tool has been recently introduced to practice gait adaptability elicited by aligning foot placement relative to the projected visual context. forty-eight subjects with neurological disease will receive treadmill training treatment randomly divided in traditional treadmill training and virtual reality treadmill training. the aim of this randomized controlled study is to assess whether treadmill training with virtual reality is better than traditional treadmill training in improving dynamic balance and cognitive aspects in subjects with neurological diseases.


Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis (no relapse within the previous three months;), parkinsons disease (hoenhn and yahr scale ≤4), stroke (time from onset \>2 months) * able to walk 20 meters with or without assistive device * cognitive impairment (mmse score ≥ 21) exclusion criteria: * unable to understand the aim of the study and unable to sign the informed consent * steroidal drugs therapy for subjects with multiple sclerosis * subjects with psychiatric disorders * subjects with visual impairments * subjects with cardiovascular disease
mhealth intervention supporting hiv treatment adherence and retention

Conditions: HIV; Adherence; Retention

Summary: despite advances in antiretroviral treatment (art) over the past 10 years, the incidence of hiv in the united states remains stagnant with over 50,000 new cases annually. hiv-infected individuals inconsistently engaged with care are less likely to receive art which is associated with correspondingly adverse clinical outcomes in the long term and increased risk of transmission. mobile health (mhealth) strategies including cell phone and text messaging have shown success in the developing world for medication adherence, yet mhealth interventions have not been developed to improve retention in hiv care. this strategy needs to be tested to demonstrate feasibility, acceptability and preliminary effectiveness in supporting hiv treatment adherence in rhode island. the miriam hospital immunology center is an urban hiv-clinic that provides comprehensive primary and specialty care for over 1400 hiv-infected patients. it is the largest hiv clinic in rhode island with patients also referred from eastern connecticut and southern massachusetts. in 2010, there were 165 new patients in clinic, 70 of whom were diagnosed within 1 year of entering care. in this environment, we propose a pilot study with the following specific aims: specific aim 1: to pilot a bidirectional mhealth intervention among individuals at high risk of loss to follow-up, including those with a recent hiv diagnosis or those re-engaging in hiv care. hiv-infected persons (n=30) with a recent diagnosis or re-engaging in care at the immunology center at tmh will be recruited to participate in a bidirectional mhealth intervention that delivers automated, regularly scheduled appointment and medication adherence reminders in an individualized format, and also allows individuals to request motivational enhancement and problem-solving support to address barriers to care. specific aim 2: to assess the impact and acceptability of the pilot intervention through qualitative interviews. all participants will also be invited to complete individual in-depth interviews which will assess acceptability and effectiveness of the pilot mhealth intervention, such as content and frequency of automatic messages, for retention and medication adherence for hiv-infected individuals in ri. the results of this study will provide preliminary data to inform an r21 or r34 application to determine efficacy of an mhealth intervention among hiv-infected persons at high-risk for loss to follow-up.


Eligibility criteria:
inclusion criteria: * hiv infected * age \>/= 18 * patient at the miriam hospital immunology center * has cell phone that can send and receive text messages * english speaking only exclusion criteria: -

Keywords: hiv adherence retention texting
cap-ketamine for antidepressant resistant ptsd

Conditions: PTSD; Posttraumatic Stress Disorder

Summary: the purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo, in reducing symptoms of posttraumatic stress disorder (ptsd) in an active duty military and veteran population.

in this 2-site clinical trial, intended to evaluate the safety and efficacy of repeated doses of ketamine for treatment resistant ptsd, veterans and active duty military personnel who meet criteria for ptsd and the additional inclusion and exclusion criteria will be randomized to one of three treatment arms (placebo, low dose ketamine, high dose ketamine). participants receive the study drug via intravenous infusion twice per week for 4-weeks.

Eligibility criteria:
inclusion criteria: * male or female veterans or active duty military personnel between the ages of 18 and 70 years * diagnosis of ptsd * history of trialing one or more antidepressant medications with little to no ptsd symptom improvement * ability to provide written informed consent exclusion criteria: * females who are currently pregnant or breastfeeding * current high risk for suicide * history of severe head injury

Keywords: ptsd ketamine veteran military clinical trial
safety, tolerability, pharmacokinetics, and pharmacodynamics of qau145 in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this study will investigate the safety, tolerability, pharmacokinetic, and pharmacodynamic response of patients with cystic fibrosis to administration of qau145 via intranasal spray.


Eligibility criteria:
inclusion criteria: * male and female (women must be post-menopausal or surgically sterile) subjects with cystic fibrosis ages 18 to 50. exclusion criteria: * any presence of seasonal or non-seasonal allergies affecting the nose, nasal passages, throat or sinuses within 2 weeks prior to dosing. * any upper respiratory tract infection or signs or symptoms within 2 weeks prior to dosing. * any presence of nasal polyps or structural abnormalities, frequent history of nose bleeding, or any recent nasal surgery (within 12 weeks prior to dosing).

Keywords: cystic fibrosis, qau145, nasal potential difference
investigation of plasma mitochondrial dna level in septic patients

Conditions: Sepsis; Inflammation

Summary: to determine the plasma levels of mtdna in icu department patients with and without sepsis and evaluate their association with severity, systemic inflammation and outcomes. plasma from control, septic and severe septic patients will be collected. the level of mtdna and systemic cytokine will be measured.

clinical protocol: patients were enrolled into one of three cohorts: (i) sepsis defined as suspected infection and systemic inflammatory response, (ii) septic shock defined as sepsis plus hypotension, and (iii) control defined as non-infected patients without systemic inflammatory response. methods: plasma levels of mtdnas were measured using real-time quantitative polymerase chain reaction. levels of mtdnas were compared among each group, and linear regression was used to assess the association between mtdnas, il-6, tnf a and il-1b in patients with sepsis. the correlation between plasma mtdna and severity, systemic inflammation and outcomes will be analyzed.

Eligibility criteria:
inclusion criteria: * diagnosis of sepsis and severe sepsis was according to the following guild-line. "surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012" exclusion criteria: * patients lost following-up. patients who refuse to sign the consent form.

Keywords: sepsis mitochondrial dna systemic inflammation outcome
epleraf-study: eplerenone in the prevention of atrial fibrillation recurrences after cardioversion

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to determine whether eplerenone reduces atrial fibrillation (af) recurrences within the first 8 weeks after electrical cardioversion of persistent af.


Eligibility criteria:
inclusion criteria: * persistent atrial fibrillation (af), af persistence for \> 7 days but \< 1 year * total af history \< 2 years * written informed consent of the patient * age ≥18 years * female patients are sterilised or postmenopausal or apply an adequate method for contraception (pearl index \<1%) and have a negative pregnancy test (ß-hcg) and do not breastfeed/nurse. exclusion criteria: * hemodynamic instability or symptoms not allowing cardioversion to be delayed for 3 weeks * myocardial infarction within the last 3 months * heart failure nyha class iii - iv * uncontrolled hypertension, defined as a systolic blood pressure \> 160 mm hg and/or a diastolic blood pressure \> 95 mm hg (anti-hypertensive treatment is allowed). * pre-treatment with an aldosterone antagonist or other potassium sparing diuretics * instable angina pectoris * use of digitalis * use of class i or class iii antiarrhythmic drugs (must be stopped at least 5 half-life before) * contraindication or hypersensitivity to ß-blockers * open heart surgery within the last 3 months * pregnancy * acute and reversible illnesses * acute and chronic infection * alcohol or drug abuse or a severe progressive extracardiac disease * untreated manifest and latent hyper- or hypothyroidism or \< 3 months peripheral euthyroidism (normal ft3) * moderate to severe renal insufficiency (creatinine clearance less than 50 ml/min) * patients with liver cirrhosis (child-pugh class c) * co-administration of strong cyp3a4 inhibitors (e.g. itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nephazodon) * hypersensitivity against eplerenone and/or one of the other components of the tablet (see fachinformation) * serum potassium \> 5 mmol/l * patients unlikely to comply with the protocol

Keywords: atrial fibrillation electrical cardioversion prevention of atrial fibrillation recurrence mineralocorticoid receptor blocker eplerenone recurrence of atrial fibrillation after cardioversion
chronic insomnia and csf markers of dementia - effects of treatment

Conditions: Insomnia Chronic

Summary: the longstanding view has been that insomnia, and other forms of sleep disturbance, emerge as a consequence of dementia and are the result of progressive neuronal damage. however, there is growing evidence that the direction of causation may go both ways, with sleep disturbance potentially increasing vulnerability to dementia. longitudinal studies have found that sleep disturbance often precedes and increases risk for dementia by several years. the purpose of this study is to examine whether treatment of insomnia with cognitive behavioral therapy (cbt-i) is associated with a decrease in dementia biomarkers found in cerebrospinal fluid (csf). fifteen adults age 30-50 with chronic insomnia will undergo overnight polysomnography and csf sampling in the morning. this will be followed by 8 weeks of treatment with cbt-i and then repeat csf sampling.


Eligibility criteria:
inclusion criteria: * age 30-50 * men and women * meet dsm5 diagnostic criteria for insomnia disorder exclusion criteria: * diagnosis or evidence of sleep disorders other than insomnia as determined by the screening questionnaires and clinical history * women who have been pregnant or lactating within the past six months * non-fluency in spoken or written english * current or past month shiftwork defined as working during the evening or night shift * current use of medications or otc products that impact sleep * evidence of neurological abnormalities that could include the risks associated with lumbar puncture (e.g.papilledema, mass lesion, chiari malformation).
a six-month prospective follow-up study of wb001

Conditions: Postpartum Depression

Summary: this study is a 6-month follow-up study to wb001-001 conducted to assess and evaluate the durability of the effect of {wb001+tau} beyond the 8-week treatment period.

this study is a 6-month prospective, observational follow-up study to the wb001-001 trial. participants will be a convenience sample of those enrolled in the wb001-001 parent trial who consent to participate in a follow-up study at baseline for wb001-001. after completion of wb001-001's eot assessment, those consenting to participate in the current study will be screened to confirm eligibility. eligible participants will complete six assessment batteries (patient-reported outcomes \[pros\]) on a monthly basis for a 6-month observation period.

Eligibility criteria:
inclusion criteria: 1. must have prior enrollment in the wb001-001 trial and completion of week 8/eot 2. must be willing and able to comply with all study procedures exclusion criteria: 1. documented ae or sae at wb001-001 week 8 related to participant safety, by investigator judgement

Keywords: postpartum depression
efficacy of continuous skin to skin care (technique kangaroo: tk) after birth for low birth weight (lbw) infants and their mothers in developing countries

Conditions: Low Birth Weight

Summary: the purpose of this study is to examine the efficacy of technique kangourou (tk) between low birth weight (lbw) infants and their mothers started as soon as possible within 24 hours after birth in developing country. for the purpose of this study, tk is defined as skin-to-skin direct and continuous (24 hours) contact between lbw infants and their mothers or any other people who substitute mothers.


Eligibility criteria:
inclusion criteria: * birth weight (bw) \< 2500g * delivery at maternity of chum (birth \< 24 hours) * without serious congenital malformation * sat o2 \>=95％, hr \> 100 / min, rr \< 60 / min, capillary refilling time \< 3 sec * the mother and the family are motivated to practice tk. * the mother and the family available to practise tk should be healthy. exclusion criteria: * apnea of prematurity \>20 sec * with intravenous infusion

Keywords: maternal and child health developing country skin to skin care newly born low birth weight infants and their mothers (delivery at university hospital center, mahajanga, madagascar)
pilot, syndros, decreasing use of opioids in breast cancer subjects with bone mets

Conditions: Bone Metastases; Breast Cancer; Pain

Summary: in patients with cancer induced bone pain, addition of syndros will improve pain relief and decrease opioid requirement.

this a prospective single arm study enrolling patients with bone metastases from breast cancer who have been on opioid therapy for bone pain for at least 4 weeks. all patients start on syndros at 4.2 mg po bid for 3 days, if tolerated without side effects the dose is increased to 8.4 mg qam and 4.2 mg qpm for an additional 3 days. if the patient continues to tolerate the medication, the dose will be increased to 8.4 mg bid for the rest of the study period (total of 8wks). for patients who have side effects secondary to sydnros, the dose will be decreased. side effect assessment will be done by the research team 2 days after making the dose adjustment. if subject continues to have side effects, dose will be held until resolution of symptoms. if the study medicine is held for more than a week continuously, they will be taken off the study. in addition, they will have baseline blood and urine collected for biomarkers and also complete study related questionnaires (for secondary end points). they are also provided an opioid drug diary which they will take home during visit 1 to record their opioid pain medication use. research staff will be calling patients on a weekly basis to reinforce opioid drug diary, assess for syndros side effect, and adjust dose of syndros. at the end of 8 weeks blood and urine is collected again and they will complete the study questionnaires.

Eligibility criteria:
inclusion criteria: 1. be capable of understanding the investigational nature of the study and all pertinent aspects of the study 2. be capable of signing and providing written consent in accordance with institutional and federal guidelines 3. have metastatic breast cancer with bone metastases 4. be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff 5. age ≥ 21 years 6. must be on opioid therapy for bone pain for at least 4 weeks exclusion criteria: 1. have a known sensitivity to dronabinol or alcohol 2. have a history of hypersensitivity reaction to alcohol 3. using medical marijuana currently 4. using syndros for nausea or appetite stimulant 5. receiving or have received disulfiram- or metronidazole- containing products within past 14 days 6. are currently pregnant or are of child-bearing age and refuse to use adequate contraception 7. have a history of psychiatric illness 8. have a history of seizure disorders

Keywords: breast cancer bone metastases pain opioid syndros bone pain