Kornimate/medical-research-clean huggingface dataset:
retaining cognition while avoiding late-life depression

Conditions: Mild Cognitive Impairment

Summary: this study will adapt problem solving therapy (pst) for individuals with mild cognitive impairment (mci) as an intervention for preventing major depression (dep). pst will be modified so as to be provided to both mci probands as well as their support person. the primary aim is to examine the effectiveness of pst in individuals with mci and the support person, at preventing dep over 12 mos. in mci probands. we also will examine the effect of exercise on preventing depression.

the recall study (retaining cognition while avoiding late-life depression) is a study for adults 60 and older who have noticed mild memory changes in themselves or a loved one. mild memory changes may feel stressful and therefore increase an individual's risk of developing depression. this research project will test whether problem solving therapy (pst) is successful in preventing major depression for those living with mild cognitive impairments. we will also examine the effect of modest exercise on mood. you will participate in 8 to 12 pst sessions over 16 weeks. all treatments are provided at no cost and there is compensation for participation.

Eligibility criteria:
mci participant inclusion criteria: 1. =\> age 60 2. modified mini mental state (3ms) =\> 80 3. mci diagnosis 4. adequate physical and sensory function to undergo np assessment 5. phq-9 score 1-9, with at least one of the cardinal symptoms of depression (low mood or anhedonia) endorsed. mci participant exclusion criteria: 1. major depressive episode or anxiety disorder within the past 1 year 2. currently taking an anti-depressant 3. history of bipolar disorder or schizophrenia 4. drug or alcohol use disorder within 12 months 5. currently taking anti-anxiety med \>4x/week for the past 4 weeks support person inclusion criteria: 1. =\> age 18 2. modified mini mental state (3ms) =\> 80 3. normal cognitive function 4. adequate physical and sensory function to undergo np assessment 5. phq-9 score 1-9, with at least one of the cardinal symptoms of depression (low mood or anhedonia) endorsed. support person exclusion criteria: 1. major depressive episode or anxiety disorder within the past 1 year 2. currently taking an anti-depressant 3. history of bipolar disorder or schizophrenia 4. drug or alcohol use disorder within 12 months 5. currently taking anti-anxiety med \>4x/week for the past 4 weeks

Keywords: mild cognitive impairment memory impairment problem-solving therapy depression prevention caregiver stress exercise
a novel mechanics-based intervention to improve post-stroke stability

Conditions: Stroke

Summary: the purpose of this study is to determine whether a novel treadmill training intervention can improve the gait stabilization strategy used by individuals who have experienced a stroke.

every year, approximately 15,000 american veterans experience a stroke, with an estimated cost of acute and follow-up care in the hundreds of millions of dollars. following a stroke, the restoration or improvement of walking is a high-ranking goal among patients, but only about half of the population is able to return to typical levels of community ambulation. the resultant decrease in independent mobility is strongly associated with a decline in quality of life. gait instability is a common contributor to limited mobility through either an increased fall-risk or fear of falling, but current interventions to address post-stroke gait instability have had limited success. this project will conduct initial testing of a novel elastic force-field designed to improve post-stroke gait stability through targeted motor learning. the results of these experiments will serve as the basis for the development of novel gait rehabilitation techniques, which have the potential to increase the quality of life of thousands of veterans and save millions of dollars.

Eligibility criteria:
inclusion criteria: * at least 21 years old * experience of a stroke 6 months prior to participation * preferred overground gait speed of at least 0.2 m/s * ability to walk at self-selected speed for 3 minutes without a cane or walker * provision of informed consent. exclusion criteria: * resting heart rate above 110 beats/min * resting blood pressure higher than 200/110 mm hg * history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living * preexisting neurological disorders or dementia * history of major head trauma * legal blindness or severe visual impairment * life expectancy \<1 yr; 8) * history of deep vein thrombosis or pulmonary embolism within 6 months * uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions * orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern.

Keywords: stroke rehabilitation gait
a study of rg-012 in subjects with alport syndrome

Conditions: Alport Syndrome

Summary: this is a phase 1, open-label, multi-center study of the safety, pharmacodynamics, and pharmacokinetics of rg-012 administered to subjects with alport syndrome.

this is a phase 1, multi-center study of the safety, pharmacodynamics, and pharmacokinetics of rg-012 administered to subjects with alport syndrome. during this open-label study, all eligible subjects will receive rg-012. the study consists of two parts (part a and part b). during part a, half of the participants will receive a single dose of rg-012 and half will receive 4 doses of rg-012 (one dose every other week for 6 weeks). all subjects will undergo two renal biopsies, one before and one after receiving rg-012, to assess the effect of rg-012 on the kidney. after completing part a, subjects will be able to enter part b of the study. during part b, all subjects will receive rg-012 every other week for 48 weeks.

Eligibility criteria:
inclusion criteria: 1. males or females, ages 18 to 65 years 2. confirmed diagnosis of alport syndrome 3. egfr between 40 and 90 ml/min/1.73m2 4. proteinuria of at least 300 mg protein/g creatinine 5. for subjects taking an ace inhibitor or an arb, the dosing regimen should be stable for at least 30 days prior to screening 6. willing to comply with contraception requirements exclusion criteria: 1. causes of chronic kidney disease aside from alport syndrome (such as diabetic nephropathy, hypertensive nephropathy, lupus nephritis, or iga nephropathy) 2. end stage renal disease (esrd) as evidenced by ongoing dialysis therapy or history of renal transportation 3. any other condition that may pose a risk to the subject's safety and well-being 4. female subjects who are pregnant or lactating

Keywords: kidney disease nephritis hereditary kidney disease hereditary nephritis
a study to evaluate the efficacy and safety of sifalimumab in adults with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: to evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active systemic lupus erythematosus (sle).

this is a phase 2b, multinational, multicenter, randomized, double-blind, placebo controlled, parallel group study to evaluate the efficacy and safety of three intravenous (iv) treatment regimens of sifalimumab (200, 600, or 1,200 mg) in adult subjects with chronic moderately-to-severely active sle with an inadequate response to standard of care (soc) for sle.

Eligibility criteria:
inclusion criteria: - fulfills at least 4 of american college of rheumatology (acr) criteria for systemic lupus erythematosus (sle) including a positive antinuclear antibody (ana) or elevated ds-deoxyribonucleic acid (dna) or sm antibody at screening - disease history of sle greater than or equal to (\>=) 24 weeks at screening - weight more than (\>) 40 kilogram (kg) - currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives - active moderate to severe sle disease based on sle disease activity score (sledai) and british isles lupus assessment group index (bilag) and physicians global assessment - no evidence of cervical malignancy on pap within 6 months of randomization - female subjects must be willing to avoid pregnancy - negative tb test or newly positive tb test due to latent tb for which treatment must be initiated at or before randomization. exclusion criteria: - active severe sle-driven renal disease or unstable renal disease prior to screening - active severe or unstable neuropsychiatric sle - clinically significant active infection including ongoing and chronic infections - history of human immunodeficiency virus (hiv) - confirmed positive tests for hepatitis b or positive test for hepatitis c - history of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes - herpes zoster within 3 months of screening - history of cancer other than basal cancer or cervical cancer treated with apparent success \>=1 year prior to randomization - receipt of a biologic agent within 5 half-lives or prior to loss of pharmacodynamic and/or clinical effect (whichever is longer) prior to screening - live or attenuated vaccine within 4 weeks prior to screening - subjects with substance abuse - subjects with significant hematologic abnormalities.

Keywords: sle systemic lupus erythematosus sifalimumab medi-545
dose range finding study of fedovapagon in men with nocturia

Conditions: Nocturia

Summary: the purpose of this study is to determine the dose level(s) of fedovapagon which result in a decrease in the mean nocturnal void frequency.

fedovapagon is a selective vasopressin v2 receptor (v2 receptor) agonist that is being developed for the treatment of nocturia. the antidiuretic effect of v2 receptor stimulation in the kidneys is well established through the use of the peptide agonist, desmopressin, which shows clinical benefit in diabetes insipidus, primary nocturnal enuresis and nocturia. nocturia, defined as the complaint that the individual has to wake at night one or more times to void, is a common complaint and shows an age-dependent increase in both prevalence and severity (number of nocturnal voids). it is the most bothersome symptom of benign prostatic hypertrophy (bph) and has been linked to an age-dependent loss in circadian release of endogenous nocturnal vasopressin and consequent over production of urine at night (nocturnal polyuria). the purpose of this phase iib study is to determine the efficacy of different doses of fedovapagon in reducing the number of times subjects with nocturia void during the night together with other parameters including increasing the time between going to bed and waking to first void. by establishing the effective doses of fedovapagon on these clinical endpoints, the data from this study will determine the most appropriate dose(s) of fedovapagon for the treatment of nocturia to be taken forward into further studies.

Eligibility criteria:
inclusion criteria: * males aged 55 or over * history and/ or symptoms of nocturia (2 - 5 voids per night) * generally well (concomitant illness / conditions well controlled) * serum sodium, potassium, chloride and bicarbonate within normal limits * no clinically significant abnormalities in other laboratory parameters, urinalysis, electrocardiogram (ecg) or physical examination * prostate specific antigen (psa) within the normal range or not considered clinically significant * ability to comply with the requirements of the study * written informed consent. exclusion criteria: -

Keywords: va106483, fedovapagon, nocturia, males, nocturnal voids, anti-diuretic
effect of a functional exercise program associated with low level laser therapy on fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to investigate the effects of a functional exercise program associated with low level laser therapy (lllt) on pain, functional capacity and quality of life of individuals with fibromyalgia. half of participants will receive functional exercise and lllt, while the other half will receive functional exercise and placebo lllt.


Eligibility criteria:
inclusion criteria: * being female; * age between 30 and 50 years; * have an ovulatory cycle; * height between 1.50m and 1.80m, body mass between 50 and 80 kg and bmi in the range of 18.5 to 29.9 kg / m2; * present a clinical diagnosis of fibromyalgia, signed by a rheumatologist according to the current criteria of the american college of rheumatology; * is at least 6 months without any physical exercise; * do not present musculoskeletal conditions that prevent them from performing the evaluation and proposed physical activity, except fm; * not having diabetes mellitus and uncontrolled blood pressure; * they do not present an inflammatory rheumatic condition or serious cardiovascular and / or pulmonary disease that prevents them from performing the evaluation and the proposed physical activity; * not having psychiatric illness or having malignant tumors; * is not pregnant * did not present dengue, zika or chikungunya in the last year; * and finally not to be hypersensitive to light. exclusion criteria: * not attend for more than two consecutive exercise sessions * at any time and for any reason expressing an intention to leave the study * present a health problem that prevents them from continuing to carry out the proposed exercises

Keywords: low lever laser therapy exercise therapy chronic pain
consequences of temporomandibular disorder on balance control

Conditions: Temporomandibular Disorder; Pathophysiology; Therapy

Summary: to evaluate the effects of the temporomandibular disorder (tmd) and its therapeutic care on postural control in somato-sensory and visual sensitization compared to control subjects matched on age, sex and lifestyle. parameters will be estimated by measures realized before the therapeutic care of the tmd (t0), then 2, 3 and 5 months after the starting care, both in tmd patients and control subjects. to evaluate also the effects of the tmd and its therapeutic care on balance control in various contexts of multi-sensory stimulation, orientation function, pain and tinnitus.

primary objective: to evaluate the effects of the temporomandibular disorder (tmd) and its therapeutic care on postural control in somato-sensory and visual sensitization compared to control subjects matched on age, sex and lifestyle.

Eligibility criteria:
inclusion criteria: * patient group: tmd patients, care: occlusal splint therapy, behavioral advices * control group: matched with tmd patients (age, sex, lifestyle). exclusion criteria: * patient group: treatment generating secondary effects in postural control (psychotrop, antidepressor, antihypertensive drugs); osteoarticular pathologies and recent trauma (\< 4 months); vertigo and dysequilibrium (\< 6 months), whiplash * control group: id. and tmd.

Keywords: temporo-mandibular dysfunction balance control orientation function
study of sgr-2921 in relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome

Conditions: Acute Myeloid Leukemia; High-Risk and Very High-Risk Myelodysplastic Syndromes

Summary: the purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (mtd) and/or recommended dose (rd) of sgr-2921.

this is a study of sgr-2921, an oral, small molecule inhibitor of cell division cycle 7-related protein kinase (cdc7), in subjects with relapsed/refractory (r/r) acute myeloid leukemia (aml) or myelodysplastic syndrome (mds) to evaluate the safety, pharmacokinetics (pk), pharmacodynamics (pd), maximum tolerated dose (mtd) and/or recommended dose (rd) of sgr-2921. exploratory cohorts may evaluate additional pk, pd, preliminary anti-tumor activity, and safety to establish the sgr-2921 rd. a planned amendment will evaluate sgr-2921 in combination with other approved aml/mds treatments such as hypomethylating agents (hma), bcl2 inhibitors, idh inhibitors or flt3 inhibitors, in patients with aml and/or mds.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age. * life expectancy ≥ 8 weeks. * confirmed diagnosis of r/r aml or high risk (hr) and very high risk (vhr) mds. * eastern cooperative oncology group (ecog) performance status ≤ 2. exclusion criteria: * active malignancies within two years prior to the first dose, or requiring ongoing treatment, not related to aml or mds. * clinical evidence of central nervous system (cns) or pulmonary leukostasis, ≥ grade 3 disseminated intravascular coagulation, or active cns leukemia. * use of experimental drug, or therapy, or anti-cancer therapy within 14 days or 5 half-lives of the first dose of study drug. * qt interval corrected for heart rate per fridericia's formula ≥470 msec during screening ecg.

Keywords: mds relapsed or refractory aml
quality of life and long-term outcome of adequately treated congenital hypothyroidism

Conditions: Congenital Hypothyroidism

Summary: the primary objective of this observational study is the evaluation of the quality of life and long-term outccome of young-adult patients with congenital hypothyroidism diagnosed by neonatal screening receiving replacement treatment with levothyroxine. the secondary objective is to relate the results to the form of hypothyroidism, the initial dose of l-t4, treatment adherence and genetics

the study protocol will be performed in 3 different phases: step1: a) enrollment of patients meeting the following criteria: * diagnosis of congenital hypothyroidism through neonatal screening adequately treated with l-t4 * confirmation of the diagnosis of hypothyroidism upon re-evaluation of the diagnosis * age 16-21 years at the time of enrollment b) information interview on the study and signing of informed consent by the patient and/or parent/guardian c) retrospective collection of the following parameters at diagnosis: * values of tsh, ft4 at diagnosis, initial dose of l-t4 * thyroid ultrasound and scintigraphy reports * genetic investigation report if available d) retrospective collection for each year of follow-up of: weight, height, tsh, ft4 and l-t4 dose step 2: a) clinical evaluation (weight, height, bmi, waist and hip circumference, blood pressure) b) evaluation of body composition by performing bioimpedance analysis c) evaluation of quality of life through administration of the sf36 test d) evaluation of cognitive abilities through administration of the wais iv test e) evaluation of any psychopathological conditions through the scl-90 psychopathological screening questionnaire f) for patients up to 18 years of age: cbcl questionnaire administered to parents to describe the patient's behaviour step 3: data collection and analysis of results

Eligibility criteria:
inclusion criteria: * diagnosis of congenital hypothyroidism by neonatal screening * start of l-t4 therapy within the first month of life * confirmation of hypothyroidism condition upon reassessment of diagnosis exclusion criteria: * other chronic diseases and/or genetic syndromes * family history of neuropsychiatric pathology * familial dyslipidemia

Keywords: quality of life congenital hypothyroidism treatment newborn screening outcome
repeat doses of a new medication (gw642444) in asthmatic patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: in order to obtain information on a wider range of doses of gw642444 (a possible new medication to treat asthma) than has been previously examined in asthmatic patients, this current study will be conducted at doses of 25 100 and 400 mcg of gw642444 and will be compared with salmeterol (50 mcg twice daily). this study will be conducted in a similar manner to a study that has already been completed (study number b2c101762) which examined repeat doses of 50, 100 and 200 mcg of gw642444. the data obtained will compliment the data from study b2c101762 and will provide confidence (or not) that the desired bronchodilation can be achieved and maintained without undesirable side effects.


Eligibility criteria:
inclusion criteria: * subjects with a documented history of persistent asthma. * current non-smokers. * clinically stable persistent asthma fev1 between 60 and 90% of predicted values. * inhaled corticosteroid therapy at a total daily dose between 200-500mcg of fluticasone or equivalent. exclusion criteria: * subjects with significant past or present disease which which may affect their safety. * upper or lower respiratory tract infection within 4 weeks of screening. * history of life threatening asthma, or asthma requiring treatment with oral corticosteroids within 3 months of study. * patients taking doses of inhaled corticosteroid \>500mcg/day and patients who have changed therapy within 8 weeks of the study. * patients weighing less than 50kg.

Keywords: tolerability pharmacodynamics safety pharmacokinetics gw642444 asthmatic patients efficacy
national cooperative growth study (ncgs): a post-marketing surveillance program for nutropin, nutropin aq, nutropin depot, and protropin

Conditions: Growth Disorders

Summary: the purpose of this multicenter, open-label, observational, post-marketing surveillance study is to collect long term safety and efficacy information on growth hormone (gh) products: protropin (somatrem for injection), nutropin (somatropin for injection), nutropin aq (somatropin for injection), and nutropin depot (somatropin for injectable suspension) in the treatment of pediatric growth disorders for which gh is prescribed.


Eligibility criteria:
inclusion criteria: * participants with open epiphyses * children of either sex who are treated with nutropin depot, nutropin aq, nutropin, or protropin for the treatment of growth failure * participants who are willing to keep follow up appointments throughout the study participation exclusion criteria: * participants treated with a non-genentech gh preparation * participants with closed epiphyses * participants with active neoplasia

Keywords: pediatric growth disorders
safety study of pertuzumab (in combination with trastuzumab and docetaxel) in indian participants with breast cancer

Conditions: Breast Cancer

Summary: this is a phase 4, single-arm, open-label, multicenter study to assess the safety and efficacy of pertuzumab in combination with trastuzumab and docetaxel for the treatment of participants with human epidermal growth factor receptor 2 (her2)-positive advanced (locally recurrent, unresectable, or metastatic) breast cancer.


Eligibility criteria:
inclusion criteria: * for women of childbearing potential and men with partners of childbearing potential, agreement to use a highly-effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and/or partner * histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection; participants with measurable and/or non-measurable disease are eligible * known and documented her2-positive * known and documented lvef of at least 50 percent (%) * adequate organ function * a negative serum beta-human chorionic gonadotropin (beta-hcg) test for women of childbearing potential (premenopausal, or less than \[\<\] 12 months of amenorrhea post-menopause, and women who have not undergone surgical sterilization \[absence of ovaries and/or uterus\]) within 7 days prior to the first dose of study treatment with the result available prior to first dosing exclusion criteria: * previous systemic non-hormonal anti-cancer therapy for the metastatic or locally recurrent disease * pregnant or lactating women * current clinical or radiographic evidence of central nervous system (cns) metastases * disease progression while receiving or within 12 months of completion of trastuzumab and/or lapatinib treatment in the adjuvant or neo-adjuvant setting * history of lvef decline to below 50% during or after prior trastuzumab adjuvant or neo-adjuvant therapy