Kornimate/medical-research-clean huggingface dataset:
increasing treatment seeking among suicidal veterans calling the crisis line

Conditions: Suicide

Summary: the goal of this research plan is to test the effectiveness of a brief, cognitive behavioral (cb) intervention to promote behavioral health treatment engagement among at-risk veterans who call the crisis line but are resistant to behavioral health services.

the goal of this research plan is to test the effectiveness of a brief, cognitive behavioral (cb) intervention to promote behavioral health treatment engagement among at-risk veterans who call the crisis line but are resistant to behavioral health services. this randomized controlled trial will recruit 80 veterans who report current suicidal ideation at the time of the crisis line call and are resistant to seeking behavioral health treatment. half of the participants will receive the brief, individualized cb intervention and half will receive standardized procedures from va's crisis line (i.e., usual care). the effectiveness of the intervention will be tested on 1) attitudes toward behavioral health treatment rates, and 2) initiation of and adherence to treatment (assessed by the number of sessions attended). the investigators will also assess the impact of the intervention on suicidal ideation (si) and explore the impact on the most common symptoms observed in veteran suicide decedents (e.g., depression).

Eligibility criteria:
inclusion criteria: inclusion criteria for the study are as follows: * individuals 18 and older who call the veteran crisis line * have a phone number where they can be reached, be it a land line or a cell phone * deemed by the crisis line responder to be at risk for suicide, but not imminent risk * refuse a referral to the spc or to a behavioral health treatment provider during the call * report current suicidal ideation (si) during the call based on administration of a standard item * have not been in behavioral health treatment in the past. presence of si will be subsequently confirmed by the research assistant using the columbia suicide severity rating scale, a validated instrument. exclusion criteria: exclusion criteria are being judged by the crisis line responder to show: * debilitating cognitive impairment * active psychosis or mania * acute alcohol or drug intoxication
lamivudine plus adefovir versus telbivudine plus adefovir in lamivudine resistant chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: no study has reported on the comparative effect of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir in hbeag-positive lamivudine-refractory chronic hepatitis b patients who have suboptimal response to lamivudine plus adefovir. the goal of this study is to compare the efficacy of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir directly in patients with lamivudine-refractory chronic hepatitis b patients who have suboptimal response to lamivudine plus adefovir for at least 12 months.


Eligibility criteria:
inclusion criteria: * hbeag positive * lamivudine and adefovir at least 12 months over 6 months lamivudine treatment for ymdd positive patients * hbv dna over 300 copies/ml exclusion criteria: * decompensated cirrhosis * renal failure * prior interferon usage * evidence of hcc or prior organ transplantation

Keywords: lamivudine telbivudine adefovir lamivudine resistance
pharmacokinetic, safety, and tolerability study of risperidone ism® at different dose strengths

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this clinical trial is designed to evaluate different dosages of risperidone ism, a new long-acting injectable form.

this clinical trial will try to characterize and document the pharmacokinetics of risperidone ism in schizophrenic or schizoaffective patients after one intramuscular injection at different dose strengths.likewise, the safety and tolerability of risperidone ism will be evaluated in the above mentioned population. following confirmation of eligibility and a washout period for study-prohibited drugs, a total of 33 subjects will be randomized in a 1:1:1 ratio to receive a single intramuscular (im) injection of one of the following dosages of study drug: group 1: 50 mg risperidone ism group 2: 75 mg risperidone ism group 3: 100 mg risperidone ism several blood samples for plasma pharmacokinetic (pk) assessments will be obtained pre-dose and post-dose. safety assessments will be conducted at each pre-specified time points.

Eligibility criteria:
inclusion criteria: * capable of providing informed consent. * male or female aged ≥ 18 years to \< 65 years * current diagnosis of schizophrenia or schizoaffective disorder, according to the structured clinical interview for diagnostic and statistical manual of mental disorders clinical trials (scid-ct) or the dsm-iv-tr * medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment * score of ≤ 4 (moderately ill) on the clinical global impression - severity of illness (cgi-s) * if a sexually active female of childbearing potential, using a medically accepted contraceptive method. exclusion criteria: * presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator may interfere with the interpretation of safety and pk evaluations * if female, a positive serum pregnancy test, or planning to become pregnant between now and one month after the last dose of trial medication, or currently breastfeeding a child * history of neuroleptic malignant syndrome and current or past history of tardive dyskinesia * positive urine drug/alcohol screen finding, unless the positive finding can be accounted for by documented prescription use. * in the investigator's opinion, at imminent risk of committing self-harm * use of depot antipsychotics within the last three months * receipt of any investigational drugs within the last three months * current participation in any other clinical trial

Keywords: pharmacokinetics safety risperidone ism® intramuscular schizophrenia
tobacco cessation in postmenopausal women (part ii) - 2

Conditions: Tobacco Use Disorder

Summary: the purpose of this study is to evaluate the effects of ert on appetitive behavior and withdrawal in short-term smoking cessation in postmenopausal females on transdermal nicotine replacement


Eligibility criteria:
inclusion criteria: (same as part i) exclusion criteria: same as part i, with the addition of those who have had a past reaction to transdermal nicotine patch or have active skin diseases will be excluded.

Keywords: smoking
safety and efficacy of krp203 in subacute cutaneous lupus erythematosus

Conditions: Subacute Cutaneous Lupus Erythematosus

Summary: this study will assess the safety and efficacy of krp203 in clinically active subacute cutaneous lupus erythematosus patients, who have demonstrated inadequate response to standard treatment, such as antimalarials.


Eligibility criteria:
inclusion criteria: * male and female patients,18 to 65 years of age inclusive, who have been defined as having scle based on the typical clinical picture and the characteristic histopathological features as described by sontheimer et al. at least three months before study entry (screening) exclusion criteria: 1. patients with preexisting nephritis, central nervous or pulmonary involvement or any major internal organ damage, either related or unrelated to lupus, which are deemed by the investigator to be clinically significant. patients having signs or symptoms of other autoimmune diseases such as systemic lupus erythematosus or sjogren's syndrome are allowed to enter the study at the investigator's discretion. 2. patients who have been treated with: * immunoglobulins and/or monoclonal antibodies within 6 months prior to randomization. * rituximab, cyclophosphamide, or other immunosuppressive treatments with effects potentially lasting over 6 months, within 12 months prior to randomization. * a medium or high dose (≥ 1 mg prednisone or equivalent per body weight kg) corticosteroid therapy in the last 8 weeks prior to randomization. * antimalarial agents (hydroxychloroquine, chloroquine or quinacrine) in the last 6 weeks prior to randomization. * biologic therapies, such as etanercept, within the last 4 weeks prior to randomization. * any other immunosuppressive or immunomodulatory therapy such as methotrexate, azathioprine, cyclosporin a or mycophenolate, thalidomide, retinoids or dapsone in the last 4 weeks prior to randomization. * total lymphoid irradiation or bone marrow transplantation. 3. pregnant, planning to get pregnant, and/or lactating females or males planning to father a child within time period of the study or subsequent exclusionary period. other protocol-defined inclusion/exclusion criteria may apply

Keywords: lupus erythematosus skin lupus
diagnostic efficacy and prognostic value of 18f-fdg pet/ct (mr) in pediatric solid blastoma

Conditions: 18F-FDG; Neuroblastoma; Hepatoblastoma; Wilms Tumor

Summary: the primary histologic origin of extracranial solid tumors in children is malignant embryonic cells, including neuroblastoma (nb) , hepatoblastoma(hb), and kidney, wilms' tumor(wt). their main clinical symptoms are large abdominal masses, the most common lymph node metastasis . nb accounts for 15% of childhood cancer deaths, but some low-risk nb can disappear on its own. the international neuroblastoma risk group staging system (inrgss) was used to determine risk before nb treatment, whereas the inrgss was entirely based on the neuroblastoma diagnosis, illustrating the importance of imaging in the assessment of nb.18f-fdg is the most commonly used agent in pet imaging of tumor. it can reflect the glucose metabolism of tumor and is widely used in the diagnosis, staging, evaluation of curative effect and prognosis prediction of tumor in this study, the investigators retrospectively analyzed 18f-fdg pet/ct or pet/mri images from patients with nb, hb, and wt. the investigators sought to assess whether these images provide useful information for diagnosis and prognosis.


Eligibility criteria:
inclusion criteria: 1. age \< 18 years, 2. have pathological results or definite clinical diagnosis as the gold standard. exclusion criteria： 1. had surgery or chemotherapy before imaging, 2. accompanying other tumors, 3. diabetic patients or patients with fasting blood glucose ≥ 200 mg/dl.
bilateral movement training for people with stroke

Conditions: Stroke; Cerebrovascular Accident; Cardiovascular Disease; Brain Injury

Summary: the investigators hypothesized that bilateral handgrip force training would result in significant improvements in paretic hand, arm movements and daily functional performances. in order to investigate whether the improvement of paretic hand could facilitate the motor recovery of paretic arm and functional performances, the investigators also hypothesized that motor recovery and functional performances improvements of paretic arm and hand have strongly correlation.

objective: to investigate the training effects of interlimb force coupling training on paretic hand and upper extremity outcomes in patients with chronic stroke; to analyze the relationship between motor recovery of paretic hand, arm and functional abilities. design: a double-blind randomized controlled trial with outcome assessment at baseline and after 4 weeks intervention. setting: department of physical medicine and rehabilitation in taipei veterans general hospital. participants: thirty-three subjects (mean age = 55.1 ± 10.5 y/o) with chronic stroke were recruited and randomized assigned to training (n=16) and control group (n=17). interventions: interlimb force coupling training task included different gripforce generation on the both hands. main outcome measures: barthel index (bi), and the upper extremity motor control of fugl-meyer assessment (fma-ue), motor assessment score (mas), and the wolf motor function test (wmft). all assessment was executed by a blinded evaluator, and data management and statistical analysis was also conducted by a blinded statistic researcher.

Eligibility criteria:
inclusion criteria: 1. at least 6 months since stroke 2. three or fewer incidents of unilateral stroke confirmed by taking the participant's medical history ability to follow researcher's instructions 3. ability to flex and extend the paretic arm and hand 4. modified ashworth score (mas) ≦3 for wrist and finger joints 5. mini-mental state examination (mmse) score should 24 or higher 6. no other orthopedic neurological disorders 7. brunnstrom stage 3 or 4 8. no joint in other experimental rehabilitation or drug studies 21 exclusion criteria: 1. unstable cardiovascular conditions 2. uncontrolled hypertension (190/110 mm hg) 3. severe orthopedic or pain conditions 4. dementia (mini-mental state examination score \< 22) 5. aphasia with inability to follow researcher's commands 6. severe joint contracture of bilateral upper extremities that would impact the movement performances of upper extremities

Keywords: stroke, cerebrovascular accident, rehabilitation, upper extremity
non-invasive assessment of pulmonary vascular resistance in elderly patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension; Cor Pulmonale

Summary: many studies have evaluated the viability of measuring the pulmonary vascular resistance (pvr) by non-invasive methods in patients with pulmonary hypertension, pulmonary thromboembolism, ischemic cardiopathy and valvular disease. the investigators have not found other studies which evaluate the pvr in elderly patients with copd. the hypothesis is that in patients with copd, the severity of obstruction, expressed by gold class, is associated with an increase of pvr.


Eligibility criteria:
inclusion criteria: * diagnosis of copd stage ii, iii or iv according to the gold guidelines * signed the informed consent exclusion criteria: * ischemic cardiopathy * severe valvular disease * atrial fibrillation * left bundle branch block

Keywords: copd pvr
effect of lower limb resistance versus endurance training in smokers

Conditions: Smoking

Summary: patients was selected based on inclusion and exclusion criteria. experimental group was treated with resistance training while control group received endurance training. data was collected by spirometry and international physical activity questionnaire readings was recorded in every session for baseline, 3rd week and 6thweeks.

experimental group will receive lower limb strength training and control group will receive endurance training. both groups will receive treatment for three days a week and each session will be given according to fitt formula. measurement will be recorder pre-treatment and post treatment of both groups at baseline, third , and 6 th week.

Eligibility criteria:
inclusion criteria: * young cigarette smokers (10 cigarette/day for at least 10 years) * male * age 25-45 years * sedentary lifestyle * body mass: less than 80kg * bmi:22-30 exclusion criteria: * heart or pulmonary disease * msk disorder * incapable of realizing the protocol of exercises, * recent surgery * recent trauma. * any infective respiratory illness.
group education curriculum for older teens with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: smart t1d is a research study that offers interactive diabetes education for teens with type 1 diabetes in peer groups led by diabetes nurse educators. participants in the study will be randomly assigned to either receive three of the group sessions in addition to their routine clinic care or to receive their usual diabetes clinic care.

the objective of this 12-month pilot randomized controlled trial is to evaluate the impact of a 3-session group educational curriculum, compared to standard care, on self-care adherence and transition readiness in adolescents with type 1 diabetes in the boston children's hospital (bch) diabetes program. adolescents (15-18 years) with t1d will be randomized to receive a 3-session group curriculum ("smart t1d" - self-management, adherence and readiness for transition in t1d) in addition to usual care (intervention group) or to receive usual care with individual diabetes visits (control group) and electronic newsletters to match for attention.

Eligibility criteria:
inclusion criteria: * enrolled in the pediatric diabetes clinic at boston children's hospital * age 15-18 years at enrollment * diabetes duration \>1 year * ability to speak/read english * visits to any bch diabetes program site ≥1 times over the past 6 months * hemoglobin a1c at clinic visit prior to enrollment 7.5%-11% exclusion criteria: * major medical or psychiatric comorbidities * established patients of one of the diabetes nurse educators delivering the intervention

Keywords: diabetes mellitus, type 1 adolescence
a study of ly3463251 in healthy participants

Conditions: Healthy

Summary: the purpose of this study is to evaluate the safety and tolerability (side effects) of single (part a) and multiple (part b) doses of the study drug when it is administered subcutaneously (under the skin) into the abdomen. this is a two-part study. participants will enroll in only one part. for each participant, part a will last about 10 weeks and part b will last about 23 weeks, including screening.


Eligibility criteria:
inclusion criteria: * healthy males and females exclusion criteria: * diagnosed with type 1 or type 2 diabetes * women who are of childbearing potential or who are breastfeeding * donated blood of more than 500 millilitres (ml) within the previous 3 months of study screening * have used any tobacco product within 3 months of day -1, or are unwilling to refrain from the use of tobacco during the study
mother-caregivers of children with duchenne muscular dystrophy

Conditions: Other Diseases or Conditions

Summary: the incidence of duchenne muscular dystrophy (dmd) is approximately 1 in 3.500 male newborns. during its progression there is loss of mobility, swallowing difficulties and a significant reduction in respiratory capacity. due to the severity and consequences, is inevitable the need for a caregiver, that normally rely the mother.

the duchenne muscular dystrophy (dmd) is a neuromuscular disease characterized by genetic alteration, whose consequence is the progression of muscle degeneration. the mother-caregiver dedicates herself entirely to her son, putting aside the care of their physical and psychological health. the responsibility and workload to care for the child is high. because of this extreme amount of work associated with other factors such as stress, this mothers-caregivers are more likely to develop hypertension, respiratory disease, susceptibility to infections, depression, anxiety, insomnia, impaired immune and cardiovascular problems. moreover, they are more likely to develop sleep disorders, those who may cause a high health risk, since many sleep disorders are related to cardiovascular, respiratory, neurological and immune systems.

Eligibility criteria:
inclusion criteria: * mothers-caregivers of children and adolescents with dmd * mothers of children and adolescents without any neuromuscular disease and that does not have any chronic disease (bronchiolitis obliterates, cystic fibrosis, a genetic syndrome) exclusion criteria: * volunteers with low levels of education (voluntary functional illiterate) that prevents the questionnaires and understanding of the guidelines made * working mothers of nocturnal period

Keywords: duchenne; mothers caregivers; sleep; hormonal profile; cardiac profile; biochemical profile; inflammatory profile.
bn83495 in prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of the study is to evaluate the pharmacodynamic profile and safety of bn83495 in patients with prostate cancer with disease progression while on androgen ablative therapy

evaluate the pd profile of bn83495 after 28 days of daily oral administration in patients with locally advanced or metastatic prostate cancer on androgen ablative therapy and with rising prostatic specific antigen

Eligibility criteria:
inclusion criteria: * confirmed and locally advanced or metastatic prostate cancer with rising prostate-specific antigen (psa), while on androgen ablative therapy. * over age 18. * demonstrated psa "biochemical failure". * adequate bone marrow and hepatic function exclusion criteria: * luteinizing hormone-releasing hormone analogue treatment and treated with more than one additional second line of endocrine therapy * prior treatment with ketoconazole * prior chemotherapy for hormone refractory prostate cancer * pre-existing cardiac failure and/or clinically significant abnormal ecg or echo

Keywords: pharmacodynamic profile and safety of bn83495
effect of fish oil on insulin sensitivity

Conditions: Metabolic Syndrome X; Type 2 Diabetes Mellitus; Sarcopenia

Summary: the purpose of this study is to determine whether a prolonged (9 month) high (6g/d) of marine oil improves insulin sensitivity and glucose control in subjects with impaired glucose regulation.

the incidence of type 2 diabetes is related both to age and obesity. the disease impacts on quality of life and treatments represent a major health cost. prevention or delayed onset of the disease remains a key target. animal studies have shown that provision of high amounts of fish oil in the diet improves insulin sensitivity but human trials have proved equivocal. recent dose-response trials in animals have shown the improved insulin sensitivity only occurs when the proportion of n-3 long chain polyunsaturated fatty acids (n-3 pufa), docosahexaenoic acid and eicosapentaenoic acid, exceeds 14% of the total phospholipid fraction within tissue cell membranes. to achieve such values in humans would require a high dose of n-3 pufa supplied over a prolonged period of time. this is tested within the current study where a daily dose of 6 g day of fish oil (containing a total of 3g docosahexaenoic acid plus eicosapentaenoic acid) is supplied for 9 months. as well as improving control of glycemia increased insulin sensitivity may also enhance protein metabolism and reduce the impact of frailty in older subjects.

Eligibility criteria:
inclusion criteria: * men and post-menopausal women aged 40-65 years * recruited from the surrounding community of aberdeen * insulin resistance with either 1. venous plasma fasting glucose \> 5.0, \< 7.0 mmo/l, 2. venous plasma 2-h 75-g ogtt \> 5.0, \< 11.1 mmol/l 3. newly diagnosed with type 2 diabetes; must be asymptomatic and detected during our screenings and not require oral hypoglycemic or insulin therapy, hba1c \< 7.0% exclusion criteria: * diabetes requiring oral hypoglycemic therapy or insulin * treatment with anticoagulants, regular steroids or non-steroidal anti-inflammatory drug treatment, tricyclic antidepressants, anti-arrhythmics * hepatic failure * renal failure * significant respiratory disease * anaemia * cardiovascular disease * malignancy * thromboembolic or coagulation disorders * alcoholism or other substance misuse * eating disorders or significant psychiatric disorders