Kornimate/medical-research-clean huggingface dataset:
e-support groups in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: primary objectives: * to determine the feasibility of program (80% retained with 75% overall attendance, and completed immediate follow-up questionnaires from 75% of participants). * to determine the efficacy of program (evaluated by decreased loneliness, operationalized as decreased total score on the ucla loneliness scale from pre to post intervention). secondary objective: * to determine whether program will affect depression and quality of life.

this study involves prospective data collection from an intervention to investigate the impact of participation by ms patients in a 12-week guided online social support group. all outcomes will be compared to active control group. at the completion of a 12-week interval, all participants (placebo and treatment) will complete follow-up questionnaires. three months after completing, participants will be sent follow-up questionnaires that will be evaluated as a 6-month follow-up, to assess retention of benefits. social support has been linked to better health outcomes in many clinical populations. multiple sclerosis (ms), a chronic neurological disease that affects over 400,000 people in the united states, involves physical and cognitive disability that can have negative consequences on social integration. this can lead to social isolation, which may be dynamically related to depression, fatigue, and disease progression. the aim of the present study is to investigate the impact of support group involvement on persons with ms. outcomes of interest include mood, loneliness, and quality of life (qol). many people with ms feel isolated and are unable to participate in support groups that meet in locations that may be far from home, difficult to travel to (due to physical disability or lack of resources), or may not be convenient for their schedules. another hindrance is the apprehension that ms patients sometimes experience when they encounter patients with severe physical disability, or worse impairment than their own. for these reasons, the study is introducing remote support groups to be conducted via the internet, "e-support." attending a remote, internet based support group may be more appealing to patients with ms as it obviates the need to travel, thereby reducing cost, time, and energy.

Eligibility criteria:
inclusion criteria: * diagnosis of ms (any disease type) * age 18 or over * willingness to sign informed consent document exclusion criteria: * unable to obtain access to the internet

Keywords: depression social isolation
evaluation of joint position sense in carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: the aim of the study was to investigate the validity and reliability of the kforce sens® for the evaluation of wrist joint position sense in individuals with cts. wrist joint position sense was assessed with kforce sens® and baseline® electrogoniometer. the validity and reliability of the kforce sens® for wrist position sense evaluation were investigated by comparing the two data sets.


Eligibility criteria:
inclusion criteria: * mild to moderate cts confirmed with emg * having symptoms for at least 3 months * not receiving medical treatment and physiotherapy until 3 months before the study at the latest exclusion criteria: * having trauma in the affected extremity in the last 6 months * having cervical radiculopathy * having brachial plexopathy * having cognitive problems * having neurological problems * being pregnant

Keywords: joint position sense electrogoniometer carpal tunnel syndrome
cll11: a study of obinutuzumab (ro5072759 [ga101]) with chlorambucil in patients with previously untreated chronic lymphocytic leukemia (stage 1a)

Conditions: Lymphocytic Leukemia, Chronic

Summary: this open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (ro5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (cll). patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either ro5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m\^2 cycle 1, 500 mg/m\^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. anticipated time on study treatment is \>6 months and follow-up for disease-progression and safety will be at least 5 years. in the us, this trial is sponsored/managed by genentech.

protocol bo21004 is divided into 3 separate unique protocol ids for reporting results on clinicaltrials.gov because there are 3 separate primary analyses conducted at different time-points. * bo21004 (stage 1a) \[nct01010061\] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (glb) compared to chlorambucil (clb) reported here. * bo21004 (stage 1b) \[nct01998880\] includes the analysis of 2 of the 3 arms rituximab plus chlorambucil (rclb) compared to chlorambucil (clb) reported separately. * bo21004 (stage 2) \[nct02053610\] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (glb) compared to rituximab plus chlorambucil (rclb) reported separately.

Eligibility criteria:
inclusion criteria: * adults \>/=18 years * documented cluster of differentiation antigen 20 (cd20) + b-cell chronic lymphocytic lymphoma (b-cll) * previously untreated chronic lymphocytic leukemia (cll) requiring treatment according to the national cancer institute (nci) criteria * total cumulative illness rating scale (cirs) \> 6 and/or creatinine clearance \< 70 ml/min exclusion criteria: * prior cll therapy * transformation of cll to aggressive non-hodgkin's lymphoma (nhl) (richter's transformation) * history of other malignancy unless the malignancy has been in remission without treatment for \>/=2 years prior to enrolment, and except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate cancer, or ductal carcinoma in situ (dcis) of the breast treated with lymphectomy alone * positive hepatitis serology (hbv, hcv) or positive hiv or human t cell leukemia virus (htlv) testing * patients with active infection requiring systemic treatment
use of cold-fx to prevent respiratory infections in community dwelling seniors

Conditions: Respiratory Tract Infection

Summary: seniors are a population vulnerable to respiratory infections. it is hypothesized that regular use of cold-fx following an influenza vaccination would potentially augment immune response in the elderly. use of cold-fx may also provide additional protection again respiratory infection and reduce the incidence and severity of respiratory infections in otherwise healthy seniors.

eligible seniors will be randomly placed into three groups to receive 400 mg/day, 800mg/day or a placebo for a period of six months beginning in october. daily dosing will be recorded as well as any symptoms not related to having a respiratory infection. for seniors who experience a respiratory infection, they are asked to call a study nurse who will take a nasopharyngeal swab. the seniors are also asked to record on a diary card the severity of their symptoms on a scale from 0-3 (none, mild, moderate, severe). symptoms include cough, fever, runny nose, stuff nose, aches and pains, headache, chills, sneezing, ear aches and fatigue.the swab will be taken to the lab for testing for upper respiratory viruses.

Eligibility criteria:
inclusion criteria: * age 65 years of age and older * current season influenza immunization * available for follow-up visits * willing and able to sign written informed consent exclusion criteria: * hiv infection * malignancy (under active observation or treatment) * unstable cardiovascular diseases * renal abnormalities (serum creatine \>200umol/l) * pulmonary disease (chronic bronchitis, emphysema, or asthma requiring treatment in the last 3 months with oral steroids - prednisone \>10mg/day, other chronic respiratory illness) * acute or active chronic liver disease * neurologic or psychiatric disease (progressive or currently under treatment * active tuberculosis * multiple sclerosis * bleeding disorders * planned surgery over the course of the trial * on immunosuppressive therapy * taking oral steroids at dose = to prednisone 10 mg/day or more * taking phenelzine, pentobarbital, haloperidol, warfarin, heparin * use of natural health products(except the study product and vitamins and minerals with a dose \<600 mg/day of vitamin e and containing no vitamin k) including echinacea or ginseng-containing products (tea, capsules, extracts, tablets) * current alcohol/drug abuse * major surgery in the past 6 months * allergies to ginseng

Keywords: respiratory infection influenza
a trial to assess the antipsychotic efficacy of iti-007

Conditions: Schizophrenia

Summary: the study will be conducted as a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.


Eligibility criteria:
inclusion criteria: * male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia * experiencing an acute exacerbation of psychosis exclusion criteria: * any subject unable to provide informed consent * any female subject who is pregnant or breast-feeding * any subject judged to be medically inappropriate for study participation
investigating the inotropic potential of apelin

Conditions: Heart Failure

Summary: the apelin-apj system is a recently discover hormone system that has several important actions in the cardiovascular system. apelin causes the heart pump with more force and also causes blood vessels to relax. studies to date show that people with reduced pumping function of the heart have lower levels of apelin in the bloodstream compared to people with normal heart function. we have previously given apelin to healthy volunteers and people with reduced pumping function and this increases the heart's contraction. however, this has only been assessed over a short time period, around fifteen minutes, and we now want to know if this effect is seen over a longer period.


Eligibility criteria:
inclusion criteria: healthy volunteers: \>18yrs heart failure patients; * new york heart failure class ii-iv * ejection fractional \<35% or fractional shortening \<20% within previous 6months. exclusion criteria: all subjects, * females of child bearing age not on adequate contraception * lack of informed consent * age \<18yrs * current involvement in any other research study * systolic bp \>190 or \<100 * malignant arrhythmias * renal or hepatic failure * haemodynamically significant aortic stenosis * severe or significant co-morbidity * pacemakers healthy volunteers * any regular medication * previous history of any cardiovascular disease

Keywords: apelin heart failure pulmonary artery pressure inotropic diuretic
the trimaxx coronary stent trial

Conditions: Coronary Artery Disease

Summary: the primary objective of the trial is to demonstrate the safety and feasibility of treating coronary artery lesions which have not been previously treated with the trimaxx coronary stent system as compared to the reported results for commercially available non-drug eluting coronary stent systems which are indicated for the same treatments.

the trimaxx study is a prospective, multicenter, non-randomized, single-arm trial intended to demonstrate the safety and feasibility of the trimaxx cornary stent system. the study will enroll 100 subjects with de novo native coronary artery lesions who meet the eligibility criteria and agree to participate in the study. subjects will be enrolled in a sequential manner. the safety and feasibility of the trimaxx stent will be evaluated by comparing the mace rate that is observed 30 days post-procedure to the mace rate for commercially available non-drug eluting stents. secoandry evaluations will include analysis of clinical and angiographic parameters at 6 months. all subjects will undergo assessments at 30 days and at 6 months. additionally, all subjects will undergo a follow-up angiogram at 6 months.

Eligibility criteria:
inclusion criteria: * eligible for catheter based treatment * single coronary lesion requiring treatment * lesion is accessible with stent device * completes informed consent for participation * stable condition (no symptoms of heart attack within 72 hours prior to treatment) exclusion criteria: * normal lab values * previous treatment in the affected artery

Keywords: coronary stent
biofilm investigation on bearing components of explanted hip joint prosthesis

Conditions: Sonication; Total Hip Replacement; Biofilm

Summary: in this study the investigators sonicate the bearing components of the explanted hip prosthesis which allows highly sensitive detection of in vivo biofilms (qualitatively and quantitatively). the hip prosthesis bearing components are composed from different material. the purpose of this study is to analyse the resistance against biofilm adhesion of ceramic, metal and polyethylene prosthesis components through microbiologic analysis of sonicates.

the main reasons for hip prosthesis failure are aseptic loosening and periprosthetic joint infection (pji). the real frequency of pji is probably largely underestimated because of non-standardized definition criteria, diagnostic procedure, treatment algorithm and other confounders. therefore, data from joint registries are not reflecting the frequency of pji and can be misleading; particularly low-grade pji can be frequently misdiagnosed as aseptic failure. microbiological analysis of sonicate has in comparison with joint aspirate significantly higher sensitivity and specificity, which allows better detection of low grade infection. with aspiration only free-floating, high metabolically active, planktonic form of bacteria could be collected. contrarily, the less metabolically active bacteria are hidden under the biofilm can remain undetected. sonication of prosthetic material mechanically dislodge the biofilm from surface and expose the sessile bacteria for the microbiological analysis. all foreign materials provoke biofilm formation however, different materials showed different resistance for biofilm adhesion. in this study patients with pji are undergoing standard one- or two- stage revision procedure of the hip. the removed bearing components will be sonicated and sent in microbiological analysis. the ceramic, metal and polyethylene prosthesis components will undergo qualitative and quantitative microbiological analysis. the materials will be compared regarding to the presence of biofilm formation.

Eligibility criteria:
inclusion criteria: * subject must be aged 18 or more. * subject must be scheduled to undergo an explanation of the hip endoprosthesis during the 1- or 2- stage revision procedure because of the septic or mechanical indication. * subject must personally sign and date the informed consent document indicating that the subject has been informed of all pertinent aspects of the study. exclusion criteria: * patient not scheduled for the index operation procedure with removal of hip endoprosthesis

Keywords: biofilm periprosthetic joint infection hip endoprothesis ceramic bearing components sonication low grade infection joint aspiration
evaluation of nutritional status, eating habits and improvement of symptoms with a nutritional intervention in women with endometriosis

Conditions: Endometriosis

Summary: the study aims to investigate the nutritional status and eating habits of women suffering from endometriosis and chronic pelvic pain in relation to describe the possible improvement of clinical symptoms following a nutritional intervention. the primary aim is to describe and evaluate the impact of nutritional intervention on clinical symptoms (pain, quality of life and intestinal function) in women suffering from endometriosis with chronic pelvic pain. the first secondary aim will be to describe and evaluate the impact of the nutritional intervention by describing the changes in some specific areas of the patients (sexual, psychological) together with the quantification of some routine blood chemistry parameters (inflammatory markers, levels of proteins and vitamins) . the second secondary objective will be aimed at describing the changes in clinical symptoms and the parameters mentioned above in patients based on the severity/stage of the pathologies under study.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of endometriosis +/- chronic pelvic pain * no menopause (at least 1 menstrual cycle in the previous 6 months) * informed consent from the patient and / or an authorized legal representative exclusion criteria: * postmenopause * pregnancy * hysterectomy or oophorectomy * chronic diseases that affect the gastrointestinal absorption of nutrients (celiac disease, chron's disease, ulcerative colitis, cystic fibrosis) * history of kidney stones, cancer (except basal cell carcinoma) or diabetes * modification in the course of the therapeutic intervention of the therapy for endometriosis

Keywords: endometriosis diet inflammation chronic pelvic pain
treatment of chronic postherpetic pain with fat grafting

Conditions: Post Herpetic Neuralgia; Herpes Zoster

Summary: this study evaluates the possible beneficial effect of fat grafting for post herpetic neuralgia.

herpes zoster (hz),is a condition caused by varizella-zooster virus (vzv), the disease is caused by reactivation of a latent vzv-infection in the sensory ganglia. clinically the condition is characterized by a painful, unilateral, vesicular rash. pain is the most prominent symptom in around 90% of patients. in 10% of patients this pain remains and becomes chronic. post-herpetic neuralgia is a chronic pain syndrome that occurs after the dermal manifestations disappears. treatment is complex and mainly topical or systemic. for many patients this is not sufficient and they live with constant pain. fat grafting has shown promise in treating several different painful conditions such as post mastectomy pain syndrome, painful scars etc. this study investigates is phn can be treated by fat grafting.

Eligibility criteria:
inclusion criteria: * age over 18 * pain in area of former vzv-infection. * pain present over 3 months after reactivation of vzv and is present at least 4 days a week and of intensity \>3 on the vas-scale. exclusion criteria: * psychiatric illness that could potentially affect the study. * other indication for fat grafting than pain.

Keywords: chronic pain herpes zoster pain
computerized tool for preventing prenatal drinking

Conditions: Foetal Exposure During Pregnancy

Summary: an innovative, self-administered computerized screening and brief intervention (sbi) for drinking during pregnancy will be adapted for use with non-pregnant childbearing age women and its efficacy will be tested in a small trial. study findings will inform a larger randomized control trial for a primary prevention tool with the potential for broad health impact.

this study evaluates a recently piloted, self-administered, computerized tool for reducing prenatal drinking that added novel components of drink size assessment and drink size feedback to traditional screening and brief intervention (sbi). the bilingual (english and spanish) electronic sbi or "e-sbi" will be adapted for use with non-pregnant women and a small trial of its efficacy will be conducted in two public health clinics. the effects of drink size assessment by itself and of depression as a modifier of e-sbi efficacy will also be studied. study findings will help design a larger trial of e-sbi's efficacy for reducing prenatal alcohol use. an experimental design will be used for the proposed small trial. two hundred women, who have not been pregnant in the past year and report alcohol at risky levels will be randomly assigned to e-sbi or usual care. participants will complete baseline, 3-month and 6-month follow-up assessments. these assessments will examine drinking and pregnancy as well as possible negative outcomes, such as increased drug use associated with the e-sbi. to address methodological limitations in prior research, the study design incorporates drink size assessment to better measure drinking outcomes, minimizes assessment reactivity for controls at baseline, and includes a booster e-sbi at the 3-month follow up. this allows for the examination of whether drink size assessment reduces drinking by itself and if its effects are equivalent to that of the full e-sbi. with these design innovations, the study is expected to provide information that can be more rigorously assessed in a subsequent multi-arm trial. because it sets the stage for a phase ii trial of e-sbi efficacy for reducing prenatal alcohol use, our proposed study is of significance for improved maternal and child health. findings will also impact the larger intervention literature on cost-effective strategies to reduce alcohol-related harm.

Eligibility criteria:
inclusion criteria: * not pregnant in the last 6 months, drank alcohol in the past year, alcohol consumption was at risky levels, exclusion criteria: * not fluent in english or spanish,

Keywords: risky alcohol use pregnancy
whole body periodic acceleration on activity and sleep in parkinson's disease

Conditions: Sleep Disorders; Physical Activity

Summary: whole-body periodic acceleration (wbpa) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders including cardiovascular disease. during wbpa, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. thus, this treatment is best described as a form of "passive exercise." the frequency of the translation (up to 180 cycles/minute; cpm) as well as the distance traveled (2-24mm) by the bed can be adjusted by the patient or health care professional. the science behind the therapeutic effects of wbpa still remains largely unknown. the investigators are observing how wbpa may impact on sleep and activity in individuals with parkinson's disease.

sleep disturbances are common in individuals with parkinson's disease. whole-body periodic acceleration (wbpa) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders. during wbpa, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. thus, this treatment is best described as a form of "passive exercise." wbpa has been shown in previous studies to increase nitric oxide. increased levels of nitric oxide have been shown to improve sleep patterns in other populations. the current pilot study will investigate how wbpa will impact upon sleep disturbances in subjects with parkinson's disease who suffer from abnormal sleep patterns. the investigators will record sleep patterns and activity levels using a jawbone u3® activity monitor.

Eligibility criteria:
inclusion criteria: * healthy individuals between the ages of 50-80 * individuals with parkinsons disease between the ages of 50-80 * individuals with a smart phone exclusion criteria: * any condition that prevents you from lying flat on your back, any other neurological condition than parkinson's disease.