Kornimate/medical-research-clean huggingface dataset:
the effects of attention retraining in ms

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to determine whether neuropsychological rehabilitation focused on attention retraining and teaching compensatory strategies has positive effects on cognitive performance, quality of life (qol)and perceived cognitive deficits in patients with ms. the hypothesis is that the neuropsychological intervention shows positive effects on cognitive performance, qol and perceived cognitive deficits.

background: cognitive impairments are a typical manifestation of multiple sclerosis (ms). according to previous studies, neuropsychological rehabilitation may improve cognitive performance in ms. however, the quality of previous studies is low and, accordingly, the evidence on the effects of neuropsychological rehabilitation is low to modest. objective: to study whether neuropsychological rehabilitation improves cognitive performance, qol and perceived cognitive deficits in patients with ms. methods: altogether 100 patients with ms are randomised either to intervention or to control group in three different study sites. all the study subjects are assessed with neuropsychological tests as well as self-rating questionnaires evaluating mood, qol, cognitive deficits, fatigue and impact of the disease at baseline, after three months (immediately after intervention) and after six months. patients in the intervention group are offered with neuropsychological rehabilitation conducted once a week during thirteen weeks. patients in the control group do not receive any intervention. results: the effects of intervention on cognitive performance, qol and perceived cognitive impairments are evaluated using appropriate statistical procedures and comparing the differences between the intervention and the control group. the present status: the baseline assessments have been performed and the intervention will be conducted between september and december, 2011.

Eligibility criteria:
inclusion criteria: * clinically definite ms * edss \< 6 * age 18-58 years * subjective cognitive problems and objective decline in attention exclusion criteria: * other neurological disease than ms * psychiatric diagnosis * severe depression * secondary progressive or primary progressive course of ms * edss\>=6 * alcohol or drug abuse * relapse during the preceding month of study entry * neuropsychological rehabilitation during the study * no subjective cognitive cognitive problems and /or no decline in attention * overall cognitive impairment (performance in all tests of brbnt under -1.5 sd compared to norms of healthy controls)

Keywords: neuropsychological rehabilitation multiple sclerosis rct study
identification and characterization of monogenic diabetes

Conditions: Diabetes

Summary: type 1 diabetes is a multifactorial disease, with a strong genetic contribution of hla genes, and minor contributions of many additional genes. the investigators hypothesis is that in addition to multifactorial inheritance, there are subtypes of diabetes that are caused by defects in single genes (monogenic diabetes). the aim of this project is to identify these genes, based on detailed clinical and characterization of patients, and to describe the corresponding genetic diabetes entities with respect to the genetic and molecular defect, clinical features and biochemistry. based on the investigators study design, most of these diabetes entities will be caused by mutations affecting the two copies of the corresponding gene. in addition, the investigators will study the relatives of the patients, and explore if carriers of these genetic defects (i.e. only one copy of the gene being defective) may have a predisposition to common forms of diabetes, mainly type 2 diabetes.

in the first phase of the study the investigators will recruit patients and families, with a strong bias for "extreme" forms of diabetes (very early onset and/or syndromic diabetes) and familial context suggestive of monogenic inheritance (e.g. consanguinity, multiplicity of diabetic siblings) and perform genetic studies on these to identify the genes. after obtaining informed consent, the investigators will collect clinical information on diabetes and other associated diseases and features, family information on diabetes, and collect blood samples for dna, rna, serum and cell lines. the investigators will then perform genetic studies to identify the genes responsible for these monogenic forms of diabetes. after identification of genes, the second phase of the study will be to test the consequence of carrier status for the identified mutations on metabolic traits related to glucose metabolism. for this, after obtaining informed consent, the investigators will extend the recruitment of the initial families (after gene identification) to recruit relatives who may be carriers of these mutations. the investigators will determine the carrier status of these subjects and perform a detailed clinical description as well as metabolic studies to evaluate their glucose metabolism. this study will lead to the identification of new monogenic diabetes entities, and their corresponding genes, and may also result in the identification of new genes predisposing to common forms of diabetes. this project has implication for diagnosis of these monogenic forms of diabetes, and may result in some cases in improved care for the patients, including prevention and treatment.

Eligibility criteria:
inclusion criteria: * first phase: to have an "extreme" form of diabetes, based on clinical, phenotypic and familial criteria. parents and siblings of the proband will be sampled. * second phase: (after gene identification): to be a relative of the proband, potential carrier of the mutation exclusion criteria: * non consent to participate to the study

Keywords: diabetes neonatal consanguinity monogenic metabolism
a retrospective study to evaluate the effectiveness of onabotulinumtoxina in preventing headaches in patients with chronic migraines

Conditions: Chronic Migraine, Headache

Summary: this study will evaluate the effectiveness of onabotulinumtoxina to prevent headaches in patients with chronic migraine.


Eligibility criteria:
inclusion criteria: * history of chronic migraines * 15 or more headache days over a 30 day period * a minimum of 2 consecutive treatment cycles of 100 units onabotulinumtoxina and a minimum of 2 consecutive treatment cycles with the onabotulinumtoxina dosing between 155 and 195 units exclusion criteria: * any treatment cycle dose of onabotulinumtoxina greater than 200 units
enabling sleep apnea patient-centered care via an internet intervention

Conditions: Sleep Apnea Syndromes

Summary: the purpose of this study is to examine the effect of different methods of providing education about sleep apnea and continuous positive airway pressure therapy (cpap) use and how that education might help to improve health outcomes and the amount of time cpap is used.

poor treatment adherence with cpap therapy is well-documented. set against a backdrop of telemedicine applications that have grown as fast in unsubstantiated claims and assumptions of patient satisfaction, diagnostic accuracy, clinical efficacy, and cost-effectiveness as they have in technological sophistication and capabilities, the evaluative aspect of this proposal is designed as as a randomized, controlled clinical trial-usual care patients (control) versus i-pap patients (intervention). an important empirical-methodological advantage of the project is the objective measurement of cpap adherence, which is measured by internal microprocessor as the "amount of time cpap is used at the prescribed pressure." this objective measurement allows feedback of treatment adherence and efficacy to both patient and provider, and the i-pap intervention was designed around this central feature.

Eligibility criteria:
inclusion criteria: * age \> 18 years * confirmed diagnosis of osa * being newly prescribed cpap therapy * having chronic symptoms as noted on screening symptom checklist * fluency in english exclusion criteria: * cognitive impairment sufficient to cause inability to complete the protocol (mmse \< 24/30) * residence in a geographical area outside of san diego county * fatal comorbidity (life expectancy less than 6 months as indicated by treating physician) * significant documented substance/chemical abuse or other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment

Keywords: chronic obstructive sleep apnea sleep apnea sleep apnea treatment
a study to investigate the efficacy and safety of nt 201 (botulinum toxin) compared with placebo for the treatment of adult participants with essential tremor in the arm

Conditions: Essential Tremor of the Upper Limb

Summary: the purpose of this study is to determine whether a single treatment with administration of nt 201 (botulinum toxin) is superior to placebo (no medicine) for one-sided treatment of essential tremor in the arm (unilateral period). participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation. the following treatment cycle will investigate the safety and tolerability of two-sided treatment with nt 201 (botulinum toxin) (open label bliaterial period). all participants will receive nt 201 treatment.


Eligibility criteria:
inclusion criteria: - score of ≥ 2 (at least 1 cm tremor amplitude) in at least two out of three maneuvers of test item 4 (upper limb tremor) confirmed by an independent tetras expert by means of video assessment. exclusion criteria: * history or presence of day-to-day fluctuations in et which would jeopardize meaningful tremor assessment over time, e.g. severe tremor on one day and minimal or no tremor on another day. * other neurological signs, such as dystonia, ataxia, or parkinsonism, which in the judgment of the investigator could interfere with the et diagnosis and/or assessment of et in uls. * tremor types other than et
copper cu 64 tp3805 pet in detecting prostate cancer in patients with persistently elevated psa

Conditions: Prostate Cancer

Summary: this pilot phase i trial studies how well copper cu 64 tp3805 positron emission tomography (pet) works in detecting prostate cancer in patients with persistently elevated prostate specific antigen (psa). the copper cu 64 tp3805 pet scan uses copper cu 64 tp3805, a compound made of a radioactive agent attached to a molecule that looks like a hormone that binds to cancer cells to detect prostate cancer during pet scans. copper cu 64 tp3805 pet may be able to see tumors at an earlier stage than the standard of care.

primary objectives: i. to assess the ability of cu-64-tp3805 (copper cu 64 tp3805) to detect prostate cancer (pc), or absence thereof, within the prostate gland.

Eligibility criteria:
inclusion criteria: * ability to provide signed informed consent and willingness to comply with protocol requirements * persistently elevated psa * scheduled for magnetic resonance imaging (mri) fusion/transrectal ultrasound (trus) biopsy, followed by histology * agree to use an acceptable form of birth control for a period of 7 days after the cu-64-tp3805 injection exclusion criteria: * participating would significantly delay the scheduled standard of care therapy * administered a radioisotope within 10 physical half-lives prior to study drug injection * have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study
comparison of prescription lidocaine patch to over the counter lidocaine patch and placebo for back pain and arthritis

Conditions: Back Pain; Arthritis

Summary: a comparison of transdermal patches for efficacy, side effects and quality of life for patients with back pain and arthritis. the three arms in the trial were; prescription strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo.

in this comparison of; lidocaine 5%, lidocaine/menthol 1.25% and placebo for patients with back pain and arthritis, subjects had to qualify by meeting various inclusion and exclusion criteria. subjects signed an informed consent and were randomized in a double blinded fashion to one of the three arms. after randomization subjects completed a baseline questionnaire regarding how pain affects their lives. then they began therapy with their blinded product. this same questionnaire was administered after the second day of therapy and after the final day on day 10. responses at the day two and ten endpoints were compared to baseline to access the response of each arm.

Eligibility criteria:
inclusion criteria: * diagnosis of back pain * diagnosis of arthritis exclusion criteria: * pregnancy or expected pregnancy in the next three months * allergic to any lidocaine, menthol and methylparaben * no reliable access to the internet * baseline average pain intensity of 1,2,9 or 10 on a scale of 0-to 10. * pain on the area of the body not conducive to patch therapy (eg fingers, toes etc)
evaluating the safety and effectiveness of the flex robotic system for the surgical removal of colorectal lesions

Conditions: Colorectal Neoplasm

Summary: this clinical trial assesses the safety and effectiveness of a new device called the flex robotic system in the surgical removal (resection) of colorectal lesions. when an area of abnormal tissue called a lesion is found in the colon or rectum, it is often not known if the lesion is cancerous or non-cancerous. recommendation to remove the lesion may be made. current methods of resection can be challenging and time-consuming. the flex robotic system is a new device that provides a stable working environment, better ability to grasp and cut lesions, and better tissue handling when performing a resection. the flex robotic system may be more effective at removing colorectal lesions than standard resection techniques.

primary objective: i. to assess the rates of complete en bloc resection and adverse events of the flex robotic system for distal colorectal lesions. outline: patients undergo resection with flex robotic system on study. patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.

Eligibility criteria:
inclusion criteria: * age \>= 22 years (minimum age approved for use) * polypoid (0-is) and non-polypoid (0-iia, 0-iib and 0-iic) lateral spreading lesions according to paris classification * colorectal lesions situated between 5 and 15 cm from the dentate line * colorectal mucosal lesions ranging from 1.5 to 7 cm in maximum diameter * colorectal subepithelial lesions \< 2 cm in size * absence of uncorrectable bleeding disorder or coagulopathy * platelet count \> 50,000 * international normalized ratio (inr) \< 1.5 * ability to give informed consent exclusion criteria: * inability to receive general anesthesia * presence of medical conditions for which a transanal approach is contraindicated (e.g., anal stricture, radiation proctopathy) * excavated (0-iii) colorectal lesions according to paris classification * suboptimal colon preparation * clinical discretion of the provider
developing an objective measure of experienced pain

Conditions: Pain, Acute

Summary: pain is a public health challenge around the world. however, there is no single standardized measure of pain, to the point that the estimated prevalence of chronic pain in adults ranges between 2% and 64% depending on the methods and definitions used. existing measures of pain are known to present several problems and results can be hardly compared between people. the investigators propose and empirically validate a new, simple method to measure experienced pain in clinical trials. the method provides an objective, cardinal measurement of experienced pain which is comparable between people and the investigators test whether it is better able to measure experienced pain than existing procedures. the investigators test the new method in healthy participants using standard protocols (electrical and heat stimuli). the investigators also aim to validate the measure using a causal manipulation which relies on the administration of a topical analgesic product compared to a placebo.

the aim of this study is to establish and validate the proposed method of measuring pain using different pain stimuli. the investigators correlate these measurements with physiological data such as skin-conductance, heart-rate variability, pupil dilation, and with established measures of pain such as numeric rating scale (nrs), visual analog scale (vas), general labeled magnitude scale (glms). in addition, the investigators study the test-retest reliability of our measure of pain and its ability to capture a reduction in experienced pain due to a topical analgesic product compared to a placebo treatment.

Eligibility criteria:
inclusion criteria: * age 18-60 years. * ability and willingness to participate in the study * declaration of consent * good english language skills (to ensure understanding of all instructions and the declaration of consent). exclusion criteria: * inability to give the declaration of consent (e.g. due to linguistic difficulties understanding the study information) * any neurological disorders * reduced general health / chronic diseases (e.g. autoimmune disease, severe cardiovascular diseases, insulin-dependent diabetes, severe depression); chronic pain disorders * pregnancy * in the week before the experimental session self-reported intake of drugs which could influence pain perception (e.g. cannabis and adhd medications).

Keywords: measurement of pain pain
immunogenicity and safety of concomitant administration of mmr™ rha and varivax® by intramuscular versus subcutaneous route (v205c-011)

Conditions: Measles; Mumps; Varicella

Summary: primary objective: to compare if, when given concomitantly with varivax® by the same route at 12-18 months of age using separate injection sites, a single dose of m-m-rtmii administered by im route is as immunogenic as a single dose of m-m-rtmii administered by sc route in terms of response rates to measles, mumps and rubella at 42 days following the vaccination. and/or to compare if, when given concomitantly with m-m-rtmii by the same route at 12-18 months of age using separate injection sites, a single dose of varivax® administered by im route is as immunogenic as a single dose of varivax® administered by sc route in terms of response rate to varicella at 42 days following the vaccination secondary objectives: * to summarise the antibody titres to measles, mumps, rubella and varicella at 42 days following the vaccination in children immunised with m-m-r™ii and varivax® administered concomitantly at two separate injection sites by the same route im or sc, * to evaluate the safety profiles of m-m-r™ii and varivax® administered concomitantly at two separate injection sites by the same route im or sc.


Eligibility criteria:
inclusion criteria: 1. healthy subject of either gender, 2. age 12 to 18 months , 3. consent form signed by both parent(s) or by the legal representative properly informed about the study, 4. parent(s) / legal representative able to understand the protocol requirements and to fill in the diary card. exclusion criteria: 1. prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine, 2. known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster, 3. any recent (≤30 days) exposure to measles, mumps or rubella, 4. any recent (≤30 days) exposure to varicella or zoster involving: 5. any recent (≤3 days) history of febrile illness 6. any severe chronic disease, 7. active untreated tuberculosis, 8. known personal history of seizures, 9. any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems, 10. any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection, 11. any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed 12. any recent tuberculin test (≤7 days) or scheduled tuberculin test through visit 2, 13. any previous (≤150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 2, 14. any recent receipt of an inactivated or a live vaccine (≤30 days) or scheduled vaccination through visit 2

Keywords: prevention of : measles, mumps, rubella and varicella diseases
psma pet imaging of recurrent prostate cancer

Conditions: Prostate Adenocarcinoma; Prostate Cancer

Summary: the purpose of this study is to see if a new diagnostic research agent named 68ga-hbed-cc-psma can show prostate cancer on a pet/ct scan that cannot be seen on other standard imaging even when the psa levels are very low.


Eligibility criteria:
inclusion criteria: * biopsy proven adenocarcinoma of the prostate * initially treated with definitive local therapy (surgery and radiation therapy are the most common treatments, but other treatments are also eligible) * for patients initially treated with surgery, radiation therapy, brachytherapy, or cryotherapy: * psa ≥ 0.2 ng/ml in at least two consecutive tests within 6 months of date of consent for patients * note: the most recent psa value must be within 6 weeks of consent * for patients who have received additional treatment in the recurrent or metastatic setting: ° psa ≥ 2 ng/ml above the most recent therapy nadir * age ≥ 18 years * patient must be able to tolerate pet/ct or pet/mr imaging exclusion criteria: * patient with claustrophobia that would preclude pet/ct or pet/mr imaging or other contraindications to ct imaging.

Keywords: prostate cancer prostatectomy biochemical recurrence ga-hbed-ipsma 16-306
phase 2 study of ds-8500a in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the objective of this study is to evaluate the efficacy and safety of ds-8500a compared with placebo in japanese patients with type 2 diabetes mellitus.

the objective of this study is to evaluate the efficacy and safety of ds-8500a 10 mg and 75 mg administered orally, once daily, for 28 days, compared with placebo, in japanese patients with type 2 diabetes mellitus in a double-blind, placebo-controlled parallel-group design. the primary endpoint is the change in 24-hour weighted mean glucose at day 28 from baseline. the safety, pharmacokinetics, and pharmacodynamics of ds-8500a will be evaluated as well.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 20 years at the time of informed consent * japanese patients with type 2 diabetes * patients who have hba1c ≥ 7.0% and \< 10.0% if untreated with antidiabetic agent. * patients who have hba1c ≥ 6.5% and \< 9.5% if treated with antidiabetic agent. exclusion criteria: * patients aged ≥ 70 years at the time of informed consent * patients with a history of type 1 diabetes or diabetic ketoacidosis * patients receiving or requiring treatment with insulin * patients with a body mass index (bmi) of \< 18.5 kg/m2 or ≥ 35.0 kg/m2 * patients with an estimated glomerular filtration rate (egfr), \< 45 ml/min per 1.73 m2 * patients with fasting plasma glucose ≥ 240 mg/dl

Keywords: type 2 diabetes mellitus