Kornimate/medical-research-clean huggingface dataset:
a web app for patients with alcohol and drug use problems in primary care

Conditions: Alcohol Abuse; Drug Abuse

Summary: the objective of this pilot study is to evaluate the feasibility and technical merit of a web application for patients in primary care called check-up and choices (cc).

the overall objective of this project is to develop, evaluate, and disseminate a web application called check-up and choices (cc). cc will be developed for use in primary care. it would tightly integrate screening for heavy drinking and drug use, a brief motivational intervention for hazardous or heavy drinkers, a moderation training protocol for less dependent problem drinkers, and an abstinence-oriented protocol for more dependent drinkers and drug abusers. the brief motivational intervention will be tailored to the patient's age. its purpose will be to motivate problem drinkers to change their drinking. the action-oriented moderation and abstinence protocols are cognitive-behavioral interventions (cbis) that provide patients with the skills to maximize their chances of success with changing their drinking and/or drug use. the investigators have already developed these elements but they are not integrated into a single program with appropriate branching between them. nor has the content been tailored for use in primary care.

Eligibility criteria:
inclusion criteria: * physicians, * nurses, * nurse practitioners, * physician's assistants, * psychologists embedded in primary care settings, and * other mental health counselors embedded in primary care settings.

Keywords: alcohol abuse drug abuse hazardous alcohol use hazardous drug use
inter individual variation in weight loss response to exercise

Conditions: Obesity

Summary: the identification and characterization of individuals who vary in their response to exercise-induced weight loss is important. weight loss in response to exercise is variable and it remains unknown who will succeed, why, and more importantly how to improve weight loss efficacy. this study will examine changes in behavioural, metabolic, physiological and biochemical variables in response to a 12 week supervised exercise programme and evaluate their association with weight loss in overweight and obese sedentary individuals. our hypothesis is that changes in the plasma levels of appetite related hormones undermine the inter individual variation in weight loss in response to exercise. this study will improve the understanding of variability to exercise-induced weight loss and allow more individually tailored and appropriate strategies for weight management programmes.

purpose - to identify predictors of weight loss in overweigh/obese volunteers following a 12 week supervised exercise programme, and to characterise the variability in weight loss response. method - longitudinal study aiming to identify predictors of weight loss in response to a 12-week exercise programme in healthy overweight/obese volunteers. subjective and objective measures of appetite, cardiovascular fitness, anthropometry, body composition, resting metabolic rate (rmr), fat and carbohydrate oxidation in the fasting state will be measured at baseline, before participants enroll for the study and after the exercise intervention. the preload/test-meal paradigm (using a high and low-energy preload: hep vs lep) will be used to assess short-term appetite control before and after the exercise intervention following a randomized single-blinded crossover design. moreover, the long-term effects of exercise on cytokine plasma levels and fasting and postprandial levels of appetite related hormones/metabolites will also be assessed at baseline and end of the study. participants will act as their own controls throughout the study.

Eligibility criteria:
inclusion criteria: * 25\<bmi\<35 kg/m2 * weight stable on the last three months (\<2kg) * not currently dieting to lose weight * with an inactive lifestyle (not engaged in strenuous work or in regular brisk leisure time exercise more than once a week or in light exercise for more than 20 minutes/day in more than 3 times/week) exclusion criteria: * history of endocrine/cardiovascular/pulmonary/kidney disease, anaemia, gout, depression or other psychological disorders * eating disorders * drug or alcohol abuse within the last two years * current medication known to affect appetite or induce weight loss. * those with a planned surgery during the study period or participating in another research study will also not be accepted to take part in this study

Keywords: obesity appetite body composition energy compensation
partial breast versus whole breast irradiation in elderly women operated on for early breast cancer

Conditions: Breast Carcinoma

Summary: the purpose of this trial is to investigate the difference in late radiation morbidity between partial breast irradiation and whole breast irradiation given to women operated on with breast conservation surgery for early breast cancer with a low risk of local recurrence.

the study is 2-armed. in both treatment arms the radiotherapy consists of 40 gy in 15 fractions, 2.67 gy per fraction. the primary endpoint in the trial is late radiation morbidity evaluated as fibrosis, secondary endpoints are other types of late morbidity, rate of local recurrence and an attempt to establish a genetic risk profile for development of late radiation morbidity. the hypothesis is that women operated with breast conservation for a breast carcinoma with low risk of local recurrence can be offered partial breast irradiation without risking more late radiation morbidity compared to whole breast irradiation.

Eligibility criteria:
inclusion criteria: * women 60 years or older * operated for unilateral, unifocal early breast cancer pt1, pn0, m0, grade i or ii, positive estrogen and/or progesterone receptor, her2 negative exclusion criteria: * lobular carcinoma
neonatal electrical activity at different altitude levels

Conditions: Altitude Hypoxia; Neonatal Encephalopathy

Summary: in this study, the objective is to compare neonatal cerebral electrical activity within 3 days after birth across different altitude areas using amplitude-integrated electroencephalography (aeeg), and establish reference value for each altitude level.


Eligibility criteria:
inclusion criteria: 1. singleton term infants (gestational age between 37 0/7 and 41 6/7 weeks) born in the participating hospital. 2. infants appear well as defined by normal vital signs (heart rate ranging from 110 to 180 beats/min, respiratory rate ranging from 30 to 60 breaths/min, temperature ranging from 36.5°c to 37.5°c), absence of signs of illness such as cyanosis, respiratory distress and heart murmur. 3. the mother is permanent residence of the current altitude level and live in the study area for the entire duration of pregnancy. exclusion criteria: 1. need for supplemental oxygen or assisted ventilation. 2. any evidence of intrauterine distress such as meconium-stained amniotic fluid, apgar score \<7 at 1 or 5 min. 3. referred to neonatal intensive care unit or neonatology department for any reason other than observation. 4. with major congenital anomaly. 5. probes cannot be properly placed due to scalp lesions or hematomas. 6. reject or withdraw from the study.

Keywords: altitude neonate amplitude integrated electroencephalography
parenting intervention and metabolic syndrome

Conditions: Metabolic Syndrome

Summary: this study aimed to test the effect of a parenting intervention on metabolic syndrome in african american youth. the investigators hypothesized that a parenting intervention would produce reductions in metabolic syndrome, particularly for those families that started out high in difficulties with parenting.

in this study, the investigators conducted a parenting intervention (strong african american families, or saaf). families (mothers with their 11 year old child) were randomized to either the parenting intervention or to a control group. those in the intervention group received 7 group sessions with the parent and child aimed at promoting better family relationships. those in the control group received 3 mailings about child development and stress management. at age 25, youth were assessed on metabolic syndrome. the investigators hypothesized that the parenting intervention would produce reductions in metabolic syndrome relative to the control group, particularly for those families that started out high in difficulties with parenting.

Eligibility criteria:
inclusion criteria: 5th graders - exclusion criteria: none -
frailty syndrome in daily practice of interventional cardiology ward

Conditions: Frail Elderly Syndrome; Coronary Heart Disease; Acute Coronary Syndrome; Coronary Artery Bypass Grafting; Percutaneous Transluminal Coronary Angioplasty

Summary: the impact of frailty on immediate and long term outcomes of invasive treatment of coronary artery disease is not fully characterized. the assessment of frailty may help physicians in the selection of best treatment option and in the timing and modality of the follow-up. the frailty syndrome in daily practice of interventional cardiology ward (frapica) study is designed with the aim to validate the use of the fried frailty scale and instrumental activities of daily living scale (iadl) as prognostic tools in patients admitted to hospital for symptomatic coronary artery disease, either stable, unstable, or acute coronary syndrome (acs). the frapica study is a single center prospective study enrolling patients aged ≥65 years. the aims are (1) to describe fried frailty scale and iadl scale distribution before hospital discharge and (2) to investigate the prognostic role of fried frailty and iadl scores. the outcomes are: (1) results of invasive treatment, (2) its complications (periinterventional mi, contrast-induced nephropathy, blood loss), (3) three-year all-cause mortality, cardiovascular mortality, stroke, myocardial infarction, reintervention, heart failure, hospital readmission for any cause, and a composite of the above mentioned. ancillary analyses will be focused on different clinical presentations, different tools to assess frailty and risk stratification. the frapica program will fill critical gaps in the understanding of the relation between frailty, cardiovascular disease, interventional procedures and outcome. it will enable more personalized risk assessment and identification of new targets for interventions.


Eligibility criteria:
inclusion criteria: * aged ≥ 65 * symptomatic coronary artery disease a) stable b) unstable c) nstemi d) stemi * written, informed consent exclusion criteria: * lack of consent

Keywords: frailty syndrome coronary heart disease coronary revascularization major adverse cardiovascular events arterial stiffness applanation tonometry lean body mass st2 biomarker
access to healthcare, patient comprehension and future plans of women undergoing surgery for a vesicovaginal fistula in niamey, niger

Conditions: Vesicovaginal Fistula; Delivery of Healthcare

Summary: evaluate access to healthcare, comprehension of pre-operative counseling and post-operative goals of women treated for vesicovaginal fistula in niger through use of a questionnaire.


Eligibility criteria:
inclusion criteria: * women who underwent surgery for repair or vesicovaginal fistula exclusion criteria: * none
effects of baclofen on presynaptic inhibition in humans

Conditions: Spasticity, Muscle; Spinal Cord Injuries

Summary: this study examines the role of the gaba-b receptor in long-lasting presynaptic inhibition of primary afferents in human participants. participants will come in for two visits, receiving baclofen (a gaba-b receptor agonist) on one visit and a placebo during the other. electro-physiological measures will be use during both visit to asses presynaptic inhibition.

the ability to execute purposeful movements relies on sensory information coming from the body. this sensory information tells us where are limbs are in relation to the rest of our body (posture sense), how fast they are moving (kinesthetic sense), how forcefully we are making a contraction (muscular sense) and if we are being contacted by external objects, changes in temperature, pain, etc (somatic sense). without these senses, the investigators could not make well-controlled movements or navigate in our environment safely. because of the importance of these sensory inputs, the nervous system has designed a highly regulated system to control the amount and quality of sensory inflow entering into both the spinal cord and brain. the investigators wish to re-investigate how sensory pathways from our body controls the inflow of sensory inputs in adults with and without neurological injury. specifically, the investigators want to test if the long-lasting suppression of sensory inflow by other sensory nerves is regulated by gaba-b receptors. the investigators will test this by giving participants the gaba-b receptor agonist baclofen. nerve stimulation and muscle responses will be used to understand how sensory transmission is being controlled in the spinal cord and the gaba-b receptors involvement. results from these studies will provide important fundamental information about how normal sensory inflow is controlled so that the investigators can better understand how it may be altered after injury to the brain and spinal cord. this information will open new avenues of study into the treatment of sensory-related dysfunction such as spasticity and motor incoordination that occurs after central nervous system injury or disease.

Eligibility criteria:
inclusion criteria: * healthy adults between the ages of 18 and 65 years. * general good health exclusion criteria: * contraindications to baclofen such as a known hypersensitivity to baclofen, renal impairment, stroke, epilepsy, pregnancy and lactation. * injury to peripheral nerves or muscles. injury to nerves or muscles will confound the interpretation of the spinal reflex data. * participants with spinal cord injury already taking oral baclofen to manage spasticity.
prevalence of thrombophilic gene polymorphism (mthfr c677t) in covid-19patients

Conditions: COVID 19 Associated Coagulopathy

Summary: aim of the study is to find the prevalence of thrombophilic gene methylene tetrahydrofolate reductase (mthfr) gene polymorphism in a sample of covid-19 patients, aiming at early detection of mthfr mutant patients and guiding preventive therapy.

the inflammatory component of severe acute respiratory syndrome coronavirus-2 (sars-cov-2) creates a prothrombotic state that necessitates a thrombophylactic strategy for hospitalized patients. such strategies are difficult to be standardized because certain individuals can have prothrombotic conditions, such as inherited thrombophilia, which predispose them to an additional coagulative risk. whether outside the hospital or when admitted, patients with inherited thrombophilia need special anticoagulant attention. identifying such patients, especially in susceptible populations like the egyptian people, will aid primary providers in risk stratification for choosing the optimal anticoagulation plan. case-control study which will be conducted on 33 patients who had been diagnosed as covid-19 at ain-shams university isolation hospitals and 13 healthy controls. patients will be subjected to: thorough history taking, thorough clinical assessment,covid-19 pcr+/- radiological data collection, assessment of mthfr c677t genotypes were determined by rt- pcr of 2 ml edta blood sample, follow up patient for 28 days as regard development of vascular thrombotic manifestation (d. dimer, ll duplex, or ct chest with pulmonary angiography if needed).

Eligibility criteria:
inclusion criteria: * all adult patients diagnosed as covid -19 by rt-pcr will be included exclusion criteria: * patients younger than 18 years old patients on antithrombotic treatment before covid-19.
pivotal study of proton radiotherapy treatments using fixed beam chair-based delivery system

Conditions: Thoracic Cancer; Pancreatic Cancer Non-resectable; Brain Cancer; Head Cancer; Neck Cancer

Summary: this study with chair-based, gantry-less proton system (cbgs) (aka p-cure proton beam therapy system or fixed beam chair-based delivery system) is composed of 3 arms, as following: arm1: patients with locally recurrent, previously irradiated thoracic cancer indicated for re- irradiation. arm2: patients with recurrent head and neck, brain and spinal cord tumors, indicated for re- irradiation. arm3: patients with unresectable pancreatic cancer. the primary objectives of the study for all arms are: 1. to describe the efficacy (local control after 3 month) and acute toxicity for patients treated with a fully-integrated cbgs and (2) to compare treatment plans between the fully-integrated cbgs and photon therapy defined for each patient, based upon oar sparing for comparable target coverage.


Eligibility criteria:
inclusion criteria: * pathologically (histologically or cytologically) proven malignancy * treatment planning analysis shows advantage to proton over photon treatments * both malignancies (such as thoracic tumors) as well as metastatic lesions (such as metastatic breast cancer or colorectal cancer to the lungs) are allowed * patient must have ct confirmation of the tumor * patients must have a life expectancy of \> 6 months * patients must have measurable disease to be treated with proton radiation (minimum tumor dimension at least 10 mm on ct imaging). * patients must be a candidate for definitive radiation dose * there are no limits on prior therapy. patients are allowed to have prior chemotherapy and surgery. patients are allowed to have concurrent chemotherapy with radiation treatment. patients are allowed to have chemotherapy or surgery after radiation treatment exclusion criteria: 1. severe, active co-morbidity, defined as follows: 1. unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months 2. transmural myocardial infarction within the last 6 months 3. chronic obstructive pulmonary disease exacerbation or other respiratory illness other than the diagnosed lung cancer requiring hospitalization or precluding study therapy within 30 days before registration 4. acquired immune deficiency syndrome (aids) based upon current cdc definition (protocol may be significantly immunosuppressive endangering aids patients) 2. pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception 3. patients with life expectancy \< 6 months 4. patients that participate in another, active clinical trial carried out concurrently with this protocol
a 52-week, placebo- and active- controlled (roflumilast, daliresp® 500µg) study to evaluate the efficacy and safety of two doses of chf6001 dpi (tanimilast) as add-on to maintenance triple therapy in subjects with copd and chronic bronchitis. (pillar)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to evaluate the efficacy and the safety of two doses of chf6001 (tanimilast) as add-on to maintenance triple therapy in the target patient population.


Eligibility criteria:
inclusion criteria: * adults aged ≥ 40 years, with copd and with chronic bronchitis. * current smokers or ex-smokers (history of ≥10 pack years). * post-bronchodilator fev1 \<50% of the patient predicted normal value and fev1/fvc ratio \< 0.7. * at least, one moderate or severe copd exacerbation in the previous year. * cat score ≥10. * subjects on regular maintenance triple therapy for at least 12 months prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to screening visit. exclusion criteria: * subjects with current asthma. * subjects with moderate or severe copd exacerbation 4 weeks before study entry and randomisation * subjects with known α-1 antitrypsin deficiency as the underlying cause of copd. * subjects with primary diagnosis of emphysema not related to copd. * subjects with known respiratory disorders other than copd. * subjects with lung volume reduction surgery. * subjects with active cancer or a history of lung cancer. * subjects under roflumilast treatment within 6 months before study entry. * subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation. * subjects with clinically significant cardiovascular condition. * subjects with neurological disease. * subjects with clinically significant laboratory abnormalities. * subjects with moderate or severe hepatic impairment.

Keywords: copd chronic bronchitis pde4 inhibitor anti-inflammatory respiratory drug tanimilast
the immuno-response to primary cryotherapy for the treatment of prostate cancer

Conditions: Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Summary: this randomized pilot phase i trial studies how well sargramostim after cryotherapy works in treating patients with prostate cancer. biological therapies, such as sargramostim, use substances made from living organisms that may stimulate the immune system in different ways and stop tumor cells from growing. cryosurgery, also known as cryotherapy, kills tumor cells by freezing them. giving sargramostim after cryotherapy may work better in treating prostate cancer.

primary objectives: i. determine an unknown normal immune response (t cell and b cell) to post-cryotherapy treatment for prostate cancer. ii. detect the altered immune response (t cell and b cell) post-gm-csf (sargramostim) response and post-cryotherapy for the prostate cancer. patients are randomized to 1 of 2 treatment arms. arm i (treatment): patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously (sc) on days 1, 3, 5, 8, 10, and 12. arm ii (control): patients undergo cryotherapy on day 0. after completion of study treatment, patients are followed up for 6 months.

Eligibility criteria:
inclusion criteria: * patients diagnosed with prostate cancer that elect to undergo primary cryotherapy of the prostate * patients who are diagnosed with clinical stage t1a -t2c prostate cancer * gleason score sum of less than or equal to 7 * prostate-specific antigen (psa) \< 20 ng/dl * patient will read, understand and sign the informed consent and health insurance portability and accountability act (hipaa) agreement * patients must have a life expectancy of at least one year exclusion criteria: * known hypersensitivity to granulocyte macrophage colony stimulating factor (gm-csf) or yeast * anticipated blood donation within the next 90 days * magnetic resonance imaging (mri), computed tomography (ct) and bone scan evidence of metastatic prostate cancer regardless the psa level; (the indication for which is clinically driven and at the discretion of the treating physician) * any history of current or within the past 48 hours of acute or chronic bacterial, fungal or viral infectious disease * documented excessive leukemic myeloid blasts in the bone marrow or peripheral blood (\>= 10%) in the past 6 months * previous organ transplant * immunosuppression including primary, secondary, iatrogenic and idiopathic * other serious diseases (hematological, hepatic, renal, respiratory, central nervous system, autoimmune or psychiatric) * enrollment in other studies for any disease in the past 30 days * diagnosis of cancer that in not considered cured, except basal cell carcinoma (bcc) of skin * prior transurethral resection of the prostate with a large tissue defect (at the discretion of the investigator) * history of abdominoperineal resection for rectal cancer, rectal stenosis, or other major rectal pathology * patient currently receiving lithium, steroid, chemotherapy or radiotherapy treatment * patients with a hemoglobin of less than 12%