Kornimate/medical-research-clean huggingface dataset:
clinical trial of continuing treatment for patients who have participated on a prior protocol investigating tanespimycin

Conditions: Advanced Malignancies

Summary: the primary purpose of this study is to provide treatment to patients who have participated on a prior protocol investigating tanespimycin (kos-953,17-aag)


Eligibility criteria:
inclusion criteria: * age \>= 18 years * participated in and completed a previous tanespimycin protocol without evidence of unacceptable toxicity and is deemed by the investigator to be deriving benefit from the tanespimycin drug as defined in the previous protocol * all patients must rollover to this continuation protocol within 30 days of the last dose of tanespimycin in the previous protocol, unless previously approved by the medical monitor * all adverse events from the prior protocol, must have resolved to nci ctcae (v. 3.0) grade \<= 2 * the following laboratory results, within 10 days of tanespimycin administration: * hemoglobin \>= 8 g/dl * absolute neutrophils count \>= 1.0x 10\*9\* /l * platelet count \>= 50 x 10\*9\* /l * serum bilirubin \<= 2 x uln * ast \<= 2.5 uln * serum creatinine \<= 2 x uln * ecog performance status of 0, 1 or 2 * signed informed consent exclusion criteria: * pre-existing neuropathy of ctcae grade \>= 3 due to any cause * documented hypersensitivity reaction of ctcae grade \>= 3 to prior therapy containing cremophor (for those patients receiving tanespimycin injection) * pregnant or breast-feeding women * administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic), excluding tanespimycin within 21 days prior to receipt of study medication * any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient

Keywords: this is an open-label continuing treatment protocol in patients with advanced malignancies who will receive tanespimycin
comparison of two different doses of azithromycin for treatment of yaws

Conditions: Yaws

Summary: the study will be a single blinded, randomized, controlled open label non-inferiority phase iii, trial with two parallel groups, conducted in ghana and papua new guinea (png). the ultimate goal is to establish if a 20mg/kg dose of azithromycin is as effective as a 30mg/kg dose in the treatment of yaws. approximately 600 clinically and serologically diagnosed yaws patients will be included in the study. patients will be randomized to receive treatment with the two antibiotic regimens as follow: (i) regimen i (azt20): single oral dose of 20 mg/kg azithromycin (ii) regimen ii (azt30): single oral dose of 30 mg/kg azithromycin. the follow-up period of patients will be 6 months. assessments before, during and after the antibiotic treatment will include full medical history, clinical assessment of the lesion and, laboratory investigations. the primary efficacy parameters are healing of the lesion at 4 weeks and a four-fold decline in rpr titre at 6 months after start of treatment.


Eligibility criteria:
inclusion criteria: * aged 6 to 16 years * clinical lesion consistent with primary or secondary yaws -primary ulcer or papilloma * dually-positive chembio dpp syphilis screen \& confirm * informed consent and assent (for children 12-16 years) exclusion criteria: 1. known allergy to azithromycin or macrolides. 2. treatment with long-acting penicillin or alternative antibiotic with activity against t. pallidum within the last 3 months (ceftriaxone, azithromycin or doxycycline, amoxicillin). 3. patients with current treatment with any drugs likely to interact with the study medication. 4. patients who are unable to take oral medication or having gastrointestinal disease likely to interfere with drug absorption. 5. patients who may not be able to comply with the requirements of the study protocol including follow up visits. 6. patients who are not willing to give informed consent (patient and/or parent/legal representative), or who withdraw consent.
optimization of the tb treatment regimen cascade

Conditions: Tuberculosis, Pulmonary

Summary: - hypothesis: double dose rifampicin together with earlier monitoring of sputum conversion using vital staining reduces unfavorable outcome of cat. 1 first-line tb treatment without excess serious toxicity, and allows early switch to specific treatment of mdr-tb without using cat. 2 retreatment regimen - general study design: this open label, randomised clinical trial is intended as a pilot study on the efficacy and safety of high-dose rifampicin and feasibility and added value of auramine and/or fda vital staining sputum smear after 2 weeks of intensive treatment phase. if this proof-of-concept study provides substantial indication of benefit without indication of excess toxicity, the data from the study will be used to design a larger scale, cluster-randomized study. the aim of this cluster randomised study would be to provide definite proof of the benefit of the intervention on adverse treatment outcomes and lack of excess toxicity associated with high dose rifampicin. in addition, the cluster-randomized study would provide a more precise assessment of the suppression and prevention of (acquired) resistance endpoints. an interim analysis is thus planned at the time the last recruited patient finishes treatment, i.e. about 9 months after the end of recruitment. it will focus on assessment of drug toxicity versus suggested benefits of the intervention. this analysis will be primarily performed for the go/no-go decision and design considerations for the cluster-randomized trial. the decision on proceeding to the cluster randomized study will be based on the absence of excess toxicity, a trend toward a reduction of unfavourable outcomes (excluding relapse), and possible favourable effects on initially present low-resistance mutations / mutations acquired during treatment. it will also allow to adapt the design of the larger study particularly regarding the algorithm for resistance screening, and whether or not treatment shortening could be justified with rapid initial conversion.


Eligibility criteria:
inclusion criteria: * diagnosed with smear-positive pulmonary tb * 15 years or older * able and willing to provide written informed consent exclusion criteria: * contacts of mdr-tb patients and other mdr-tb suspects diagnosed with resistance on rapid dst for rifampicin performed prior to start of treatment according to ntp guidelines * smear-negative pulmonary and extra-pulmonary tb cases * patients in need of hospitalization because of very bad general condition or complications * patients with clinically active liver disease, for the study defined as jaundice confirmed by a local medical officer (government) * any known hiv-positive patient (although none are expected) * any patient with known hepatitis b or c infection * pregnant women; in addition, patients in the intervention arm who become pregnant during treatment will be switched to the control arm

Keywords: bangladesh rimfapicin
simvastatin for intracerebral hemorrhage study

Conditions: Intracerebral Hemorrhage

Summary: study objective: to analyze if statins are effective in ameliorating perihematomal edema evolution thereby reducing mortality and improving functional outcomes following spontaneous intracerebral hemorrhage (ich).

intracerebral hemorrhage (ich) causes 10% to 15% of first-ever strokes, with a 30-day mortality rate of 35% to 52% with only 20% expected to be functionally independent at 6 months. no medical or surgical interventions have been found to alter the natural evolution of this disease. the high risk for mortality and poor outcomes seems to occur despite relatively small hematoma volumes and small amounts of neuronal tissue at risk for injury. the reasons for this observation remain unknown; however perihematomal edema formation and inflammation that follows ich seems to play an important role. the simvastatin for intracerebral hemorrhage study is a prospective double blinded placebo controlled randomized (1:1) clinical trial that compares outcomes in patients receiving generic simvastatin 80 mg for 14 days or until death or discharge with patients in the placebo group. the hypothesis for our study is that statins ameliorate perihematomal edema evolution thereby reducing mortality and improving functional outcomes following intracerebral hemorrhage (ich). this hypothesis in turn is based on animal data showing suppression of inflammatory reaction and improved neurological outcomes following administration of statins to rodents with experimental ich, and on a retrospective review of patients admitted to the johns hopkins hospital over the last 7 years with spontaneous ich which showed significantly better outcomes (decreased 30 day mortality secondary to decreased perihematomal edema) in patients on statins at the time of admission.

Eligibility criteria:
inclusion criteria: * patient with ct evidence of ich admitted within 24 hours of onset of symptoms. exclusion criteria: * age \ 85 * admission glasgow coma score (gcs) \< 6 * ich volume \< 10 cc * ich secondary to trauma, aneurysm, arterio-venous malformation (avm), tumor or post surgical * multiple ich * associated subdural hematoma or significant subarachnoid hemorrhage * history of prior neurologic disease with modified rankin scale (mrs) \> 1 * hematoma evacuation, hemicraniectomy, clot lysis * myopathy * active liver disease * pregnancy * statin allergy * patients on statins prior to admission * patients with an acute indication for statin therapy (unstable angina)

Keywords: intracerebral hemorrhage edema statins
safety and efficacy of tll018 in patients with plaque psoriasis

Conditions: Moderate to Severe Plaque Psoriasis

Summary: this study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 70 subjects with moderate to severe plaque psoriasis.

successfully screened subjects will be randomized in a ratio of 2:2:2:1 and stratified to previous biologics use for psoriasis. after a 4-week screening period (day -28-0), subjects will be randomly assigned to treatment for 12 weeks. clinical psoriasis area and severity index (pasi), physician's global assessment (pga), dermatological quality of life index (dlqi), physical exams and laboratory tests will be performed at baseline, the end of weeks 4, 8 and 12 respectively.

Eligibility criteria:
inclusion criteria: * have had a diagnosis of moderate to severe plaque psoriasis for at least 6 months prior to baseline; * subjects with moderate to severe plaque psoriasis covering ≥10% bsa, with a pasi ≥12 and spga score ≥3 at baseline; * able and willing to give written informed consent. exclusion criteria: * other types of psoriasis (such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, etc.); * current drug-induced psoriasis, e.g., a new onset of psoriasis or an exacerbation of psoriasis induced by beta blockers, calcium channel blockers, antimalarial drugs or lithium; * history or symptoms of malignancy in any organ system regardless of treatment, and regardless of evidence of recurrence or metastasis; * any uncontrolled clinically significant laboratory abnormality that would affect interpretation of study data or the subject's participation in the study.
impact of group participation on adults with aphasia

Conditions: Aphasia, Acquired; Stroke; Rehabilitation; Language Disorder, Acquired

Summary: the purpose of the study is to examine the impact of group participation on adults with aphasia. participants will complete a standard pre-and post-assessment of language abilities (speech, comprehension, reading, and/or writing). then participants will attend 90-minute weekly reading group sessions during an academic semester.

the objective of this research is to determine if attendance in groups positively impacts language skills, activity/participation, and/or quality of life in persons with aphasia. this study will employ a university-clinic based outpatient group to administer language intervention. the specific aims of this study are to determine if group participation improves (1) life participation as measured by self-report questionnaires, (2) intervention-specific language skills as measured by treatment-related measures (e.g., reading comprehension and written expression), and (3) performance on non-treated language test scores as measured by a language assessment battery. participants will complete 4-5 individual testing sessions (e.g., initial assessment and pre-/post-testing), 7-12 group sessions (90-minute weekly reading group session), and 7-12 independent sessions at home (e.g., completion of weekly reading assignments). the participants will read through a designated book incrementally across multiple weeks. the activities completed during the group sessions will focus on improving reading comprehension and written expression skills. participants will read assigned passages at home and during the group sessions. participants will complete a copy and recall treatment (cart) worksheet independently to facilitate improvements in writing keywords related to the reading materials. cart involves copying target words and progresses to writing words from recall (beeson, et al.). participants will complete a reading comprehension worksheet and engage in discussion regarding the assigned book chapter. reading comprehension and written expression data will be collected and analyzed to compare the pre-treatment baseline performance from the first treatment session to the post-treatment performance from the last treatment session. pre-and post-testing scores will be analyzed to investigate the change in scores across the 2-time points to determine the relative effectiveness of book club participation for improving reading comprehension, written expression, and life participation.

Eligibility criteria:
inclusion criteria: * age 18 years or older * pre-morbid proficient speaker of english * diagnosis of adult-onset aphasia * vision and hearing sufficient to complete assessments exclusion criteria: * no history of childhood speech or language difficulties * no history of major psychiatric illness, cognitive impairment, or neurological disorders such as seizures
impact of exercise on ashtma in adults

Conditions: Asthma; Physical Inactivity

Summary: the aim of this study is to evaluate if physical activity could improve asthma control and management in adults. with this purpose we enroll asthmatic patients between 18-64 years old, and randomized them into 2 groups: in the first, patients will receive some workshops about asthma en physical exercise; in the second no educational intervention will be done. all patients will use a step counter in order to evaluate their activity during the study. spirometric values and questionnaries about asthma control and quality of life will be recorded for all patients. finally 2 groups will be comparated in order to search any difference in quality of life and asthma control.

52 asthmatic will be enrolled and randomized into 2 groups. all patients will send a weekly summary of their physical activity (mean number of steps and time of physical activity). all patients will be undergone to a medical visit at month 1 and 3 since study start. in each visit a spirometry, a feno, acq and aqlq questionnaires will be done. the patients of the intervention group will receive 3 workshops about asthma and physical exercise in order to provide information, medical support, and to resolve any question or difficulty about it. the workshops will be al week 1, 2 and 4 since study start.

Eligibility criteria:
inclusion criteria: * asthma well controlled * sedentarism (\<150 min physical activity/day and/or \<7000 daily steps) exclusion criteria: * pregnancy * cardiological, not well controlled deseases * other cronic pulmonary deseases * bad asthma control * not sign ic * unable to practice physical activity (for cognitive or physical conditions) * no devices able to count steps and physical activity

Keywords: asthma sedentarism spirometry physical excercise
evaluation of a novel methodology in the assessment of urethral function using ss-rbx.

Conditions: Urinary Incontinence, Stress

Summary: ss-rbx will be used to evaluate pharmacodynamic changes in urethral function using a novel methodology


Eligibility criteria:
inclusion criteria: * female * stress urinary incontinence exclusion criteria: * bladder outflow obstruction * neurological disease
aggressive weight loss program in chronic plaque psoriasis

Conditions: Psoriasis

Summary: chronic plaque psoriasis is frequently associated with obesity and previous studies have shown that a calorie-controlled diet inducing body weight loss improves symptoms and increases the response to pharmacologic treatment. besides, clinical improvement has been directly correlated with the amount of weight loss. short-term very low-calorie ketogenic diets are responsible for substantial weight loss and attenuate systemic inflammation to a higher extent than moderately hypocaloric diets. this intervention has been recently demonstrated to restore, after only 4 week, the response to biological therapy in a patient suffering from relapsing moderate-to-severe plaque psoriasis and obesity-related metabolic syndrome. we investigated the efficacy of an aggressive weight loss program with a ketogenic induction phase in a single-arm trial that could provide the rationale for a large randomized trial.


Eligibility criteria:
inclusion criteria: * stable chronic plaque psoriasis * overweight/obese (body mass index \>25 kg/m2) exclusion criteria: * pregnancy and/or lactation * insulin-dependent diabetes mellitus * a psychiatric disorder * current or previous (\<1 year since last chemo- or radiotherapy) neoplastic disease * established vascular disease * recent (6 months), history of diet-induced or unintentional weight loss * moderate-to-severe heart failure * arrhythmia or conduction disorder * renal failure (creatinine \>1.5 mg/dl) * liver failure (child-pugh ≥ a) * any type of gastrointestinal disease * moderate-severe hypoalbuminemia (\<3.0 g/dl) * altered serum electrolytes * refusal to give written informed consent
molecular mechanisms of fibrillin/ltbp superfamily in renal fibrosis and cardiorenal syndrome

Conditions: Renal Fibrosis, CKD

Summary: this project is to understand the ltbp4 expression in human renal fibrotic tissues. the investigators will exam major location of ltbp4 expression and check any similar or discrepancy in renal fibrosis with different etiologies.

the investigators will obtain the residual renal tissues with different etiologies and check the expression of ltbp4. the location and quantitation of ltbp4 in renal tissues will be checked. it will be great to understand the association between the severity of fibrosis and the expression of ltbp4 and other matrix proteins.

Eligibility criteria:
inclusion criteria: * abnormal kidney function, proteinuria, hematuria exclusion criteria: * n/a

Keywords: ltbp4
validation of serum creatinine dosage and renal clearance

Conditions: Kidney Failure

Summary: this study has an open study design. the gfr will be measured using the renal clearance of inulin (inutest) in volunteers with different stage of renal disease or without renal disease. a blood sample will be obtained for measuring serum creatinine in different laboratories.

in this study we will investigate the correlation between the gfr as measured by inulin clearance (golden standard) and the estimated gfr as measured by laboratories which used different serum creatinine assays in patients without renal disease and in patients with different stage of kidney failure.

Eligibility criteria:
inclusion criteria: * normal weight as defined by a body mass index of 18 to 30 kg/m2. * subject is competent and willing to sign informed consent form after being given all the detailed information about the study. informed consent form signed voluntarily. * the subjects must be in stable clinical condition, with stable serum creatinin at least for 6 months. * persons with different stage of chronic renal disease and without kidney disease (living donors) who need an evaluation of the gfr or admitted volunteers who easily obtain urine samples. exclusion criteria: * transplant patients * medication that will influence the serumcreatinine. * morbid obesity * pregnant, lactating females or females with childbearing potential without adequate contraception (use of oral contraceptives, iud or condoms with spermicide). * history of allergy or hypersensitivity to inulin * donation of blood in the 60 days preceding the first visit. * liver disease, heart failure, nephrotic syndrome. * patients in critically ill conditions. * malnutrition * postrenal kidney failure
cerebral tissue oxygenation in very low birthweight infants in the first 3 days of life

Conditions: Infant, Very Low Birth Weight

Summary: the purpose of this study is to examine the range of cerebral tissue oxygen saturation in healthy and sick very low birthweight infants during the first 72 hours of life.

in this observational trial we want to examine cerebral tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and hbd as measured by near infrared spectroscopy during the first 72h of life in very low birthweight infants. differences between relatively healthy and sick preterm infants will be explored. a focus is to find differences between those infants who develop germinal matrix hemorrhage and those who are at risk only but do not develop hemorrhage.

Eligibility criteria:
inclusion criteria: * very low birthweight infants
high flavonols cocoa intake for the improvement of body fat composition in athletes

Conditions: Healthy Subjects

Summary: the decrease in body fat percentage improves exercise performance, reducing race time. the intake of cocoa improves the body fat composition in obese and diabetic people by improving their cardiovascular disease risk factors. although epidemiological studies indicate that healthy subjects who consume cocoa have lower body fat composition, there is no study indicating whether cocoa improves fat composition in athletes. the aim of the study was to determine if the intake of cocoa rich in flavonoids improves the fat composition of athletes, modifying the systemic levels of adipokines (folistatin, myostatin and leptin), resulting in an improvement of physical performance.

the objective of this project was to investigate the effects of chronic daily consumption of high in flavanols cocoa in body composition and performance of endurance athletes: a randomized, blinded, parallel placebo controlled intervention study was carried out in endurance athletes . the number of male athletes enrolled in the study was 40, with ages between 18 and 50 years and an aerobic power consumption of oxygen greater than or equal to 55 ml / kg / min). the intervention was carried out for 10 weeks. cocoa or placebo (maltodextrin) were supplied in sachets of a single daily dose. cocoa provided 425 mg of flavanols/ day. athlete's body composition was evaluated by dual-energy x-ray absorptiometry (dexa). exercise performance was evaluated with a treadmill test protocol determining the maximum aerobic capacity and also by determining the time necessary to run a kilometer at maximum speed. adipokines (follistatin, myostatin and leptin) in plasma and serum samples were determined by elisa. diet was determined by three 24h-recall questionnaries and a food frecuency questionnaire.

Eligibility criteria:
inclusion criteria: * men. * age between 18 and 50 years * aerobic power of oxygen consumption greater than or equal to 55 ml / kg / min exclusion criteria: * intake of chronical medication. * intake any type of nutritional or ergogenic supplements. * vegetarian or vegan diet * smoke. * any diagnosed disease at the time of inclusion or during the study

Keywords: nutritional supplement high in flavanoids cocoa body fat composition physical exercise performance