Kornimate/medical-research-clean huggingface dataset:
the effects of cognitive remediation on cognitive function in remitted bipolar disorder - a proof of concept study

Conditions: Bipolar Disorder

Summary: cognitive remediation (cr) is a new psychological treatment, which aims to improve cognitive function and coping skills. several studies have recently demonstrated that cr improves cognitive and occupational function in patients with schizophrenia and with depression (e.g. wykes et al 2007, elgamal et al 2007). however, it is unclear whether cr improves cognitive and socio-occupational function in individuals with bipolar disorder (bd) and, if so, what impact this might have on these people's abilities in terms of work, coping strategies, quality of life, and everyday safety. the aim of the present phd study is to investigate if cr has beneficial effects on cognitive and socio-occupational function in patients with previous mania and depression who experience persistent cognitive difficulties. such effects would suggest implementation of cr in future treatment of bipolar disorder in order to facilitate the patients' ability to cope with the responsibilities related to work and everyday life. the hypotheses of the present study are that cr (in comparison to standard treatment) will 1) improve verbal learning and recall; and 2) improve sustained attention, executive function and psychosocial function.


Eligibility criteria:
inclusion criteria: * bipolar disorder in complete or partial remission (hamilton depression rating scale score of max 14 and young mania scale score of max 14) * subjective complaints of moderate to severe cognitive problems on the massachusetts general hospital cognitive and physical functioning questionnaire (cpfq) (fava et al 2006) (score at least 4 on at least 2 domains) exclusion criteria: * current ect treatment * drug and/or alcohol abuse * schizophrenia * significant risk of suicide * use of benzodiazepines equivalent to more than 22,5 milligrams of alopam

Keywords: bipolar disorder cognitive remediation cognition cognitive function mood disorders affective disorders
local cerebral oxygenation in chronic pain patients utilizing spinal cord stimulation

Conditions: Chronic Pain

Summary: the primary objective of the study is to determine changes in cerebral nociceptive hemodynamic response (blood oxygenation/flow) before, during and following spinal cord stimulation (scs). objective measurements of cerebral nociceptive hemodynamic responses will be obtained with the cerevu sensor and ropa system and will be analyzed offline and compared against subjective measures of pain. proprietary analysis algorithms will be incorporated and developed to understand how the objective measurements correlate with subject reported pain levels


Eligibility criteria:
inclusion criteria: 1. be 18 years of age or older at the time of enrolment 2. diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months 3. subject has a minimum visual analog scale (vas) score of 50 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline or a 5 on a numerical rating scale (nrs) 4. be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician 5. be willing and capable of giving informed consent 6. be willing and able to comply with study-related requirements, procedures, and visits exclusion criteria: 1. subject is pregnant or nursing 2. have a medical condition or pain in other area(s), not intended to be treated with scs, that could interfere with study procedures, as determined by the investigator 3. have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes 4. have an existing drug pump and/or scs system or another active implantable device such as a pacemaker, deep brain stimulator (dbs), or sacral nerve stimulator (sns) 5. have prior experience with scs 6. be concomitantly participating in another clinical study 7. subject has secondary gain issues that could interfere with the study measures or outcomes 8. subject is contraindicated for use of non-invasive cerebral oxygenation measurements (e.g., at risk for sensor displacement such as facial cosmetic. non-intact skin on the forehead, or ent surgery) 9. subject is allergic to any adhesives, materials or fluids in or used in conjunction with the cerevu sensor
trial of juvista (avotermin) following removal of ear lobe keloid scars

Conditions: Keloid

Summary: this trial will assess the safety and efficacy of 50 and 200ng juvista per linear cm of wound margin administered by intradermal injection following the excision of keloid scars on the ear lobe. ear lobe keloids commonly occur after ear piercing and can be particularly distressing for patients as they are very difficult to conceal and are usually bilateral. as the recurrence rate and growth rate of keloids can vary significantly between individuals, trial subjects will have bilateral ear lobe keloids and will act as their own control. one ear lobe will be treated with juvista following keloid excision and one with placebo.


Eligibility criteria:
inclusion criteria: * patients aged 18-85 years who have given written informed consent. * patients with bilateral ear lobe keloid scars suitable for surgical excision which will result in a single wound on each ear lobe no greater than 2cm long and restricted to the skin, fat and fibrous tissue of the ear lobe. * patients with, in the opinion of the investigator, clinically acceptable results for the laboratory tests specified in the trial protocol. * female patients of child bearing potential who are using a highly effective method(s) of contraception and agree to do so from at least the screening visit until one month after administration of the final study dose. exclusion criteria: * patients who have had ear lobe keloids treated with irradiation, cryosurgery, corticosteroids, or other pharmacological agents in the three months prior to the first trial dose administration. * patients with a history of a bleeding disorder. * patients who on direct questioning and/or physical examination have past or present evidence of eczema or psoriasis local to the site of administration, uncontrolled diabetes (fasting plasma glucose concentration consistently at or above 7.0mmol 1-1 (126 mg dl-1), severely immunocompromised patients and/or malignant skin tumours e.g. melanomas, squamous or basal cell carcinomas. * patients with a skin disorder, not related to the keloid disease, that is chronic or currently active and which the investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial * patients with a history of malignancy in the last 5 years. * patients with a history of hypersensitivity to any of the drugs or dressings used in this trial. * patients who are taking, or have taken any investigational product or participated in a clinical trial in the three months prior to first trial dose administration. * patients undergoing investigations or changes in management for an existing medical condition. * patients who, in the opinion of the investigator, are unlikely to complete the trial for whatever reason. * female patients who are pregnant or lactating. * patients with a creatinine clearance (clcr) of 80ml/min or less.
immunogenicity against sars-cov-2 in covid-19 close contacts

Conditions: Covid19; Vaccine Reaction

Summary: this study will investigate the presence of sars-cov-2 neutralizing antibody and its association with demographic information, medical history of sars-cov-2 infected individuals, exposure history of close contacts, vaccination status, and compliance with the strategies for self-quarantine to prevent the transmission in the community where sars-cov-2 infected individuals were home-quarantined and treated.

in the 4th outbreak of the covid-19 pandemic in ho chi minh city since 27 april 2021, asymptomatic or mild covid-19 patients were self-quarantined and treated at home. this home care setting could yield risk of sars-cov-2 transmission from the index cases to the people living surroundings. therefore, this study will be performed to investigate the immunogenicity against sars-cov-2 in household members or people lived in the same municipality with home-quarantined covid-19 patients. all people over 18 years old, living in 2 blocks (v and y) of ngo gia tu apartment, which is located in district 10, ho chi minh city, will be recruited into this study. a survey will be conducted using a questionnaire to collect the data related to the basic demographic information, medical history of sars-cov-2 infected individuals, exposure history of close contacts, vaccination status, and compliance with the strategies for self-quarantine to prevent the transmission in the community. at the time of recruitment, covid-19 rapid antigen detection tests using nasopharyngeal swabs will be performed for all study subjects. in addition, a total of 5ml of intravenous blood samples will be collected for serum extraction and dna isolation. sars-cov-2 neutralizing antibody levels in serum samples will be evaluated by a surrogate virus neutralization test by using neutralisa kit® (euroimmun, luebeck, germany). dna will be isolated and stored for further use in investigating the association of ace2 genetic polymorphisms with the prevalence of sars-cov-2 neutralizing antibodies.

Eligibility criteria:
inclusion criteria: * people who lived in the two blocks (v and y) of ngo gia tu apartment, located in district 10, ho chi minh city, vietnam, from july to september 2021 * 18 years of age and older * ability to understand and willingness to sign a written informed consent document. exclusion criteria: * people who were diagnosed with primary or secondary immunodeficiencies induced by diseases or medical treatments (immunosuppressants, chemotherapy, radiation therapy, ect.)
5 year long-term follow up in pediatric participants who received pegintron plus rebetol in p02538 part i (p02538 pt 2)

Conditions: Hepatitis C, Chronic

Summary: study p02538 part 2 is a 5-year long term follow-up (ltfu) study in pediatric participants who were treated with at least one dose of peginterferon alfa-2b (peg-ifn) and ribavirin (rbv) and who completed the follow-up in the p02538 part 1 study (nct00104052). no study drug therapy will be administered during the p02538 part 2 study. durability of virologic response will be assessed for participants who attained sustained virologic response (svr) in part i of this study by performing annual hepatitis c virus ribonucleic acid (hcv-rna) testing. in addition, this study will characterize long-term safety in all participants who received peg-ifn plus rbv treatment.

during the part 2 ltfu, participants will be evaluated at years 1, 2, 3, 4, and 5. each participant's first ltfu visit will be scheduled approximately 1 year after the post-treatment follow-up week 24 visit in part 1 of this study (nct00104052).

Eligibility criteria:
inclusion criteria: * informed consent must be obtained from the participant or the participant's parent or legal guardian prior to any long-term follow-up study-related procedures. according to local laws and/or irb/iec requirements, participants may also need to provide written assent. * the participant must have received at least one dose of peginterferon alfa-2b and ribavirin in the protocol no. p02538 study. * the participant must have completed the 24-week post-treatment follow-up in the p02538 part 1 study. all participants whether sustained responders, relapsers, or nonresponders are eligible to participate. exclusion criteria: * concurrent participation in any other clinical study. * retreatment with any antiviral or immunomodulatory drug for chronic hepatitis c after completion of, or discontinuation from, the treatment phase of the p02538 part 1 study. * any condition that in the opinion of the investigator would make the participant unsuitable for enrollment.
effects of inhibition compression versus scapular mobilization technique on shoulder in patients with mastectomy

Conditions: Mastectomy; Lymphedema

Summary: a mastectomy is a medical surgery in which the breast is removed whole or in part. breast cancer is the second most prevalent cancer diagnosed in women. rotator cuff dysfunction-related shoulder pain is a common symptom associated with mastectomy, reconstruction, and therapy for breast cancer.) patients who get treatment for breast cancer report reduced strength (prevalence 17-33%), loss of upper limb range of motion (prevalence 2-51%), and reduced ability to carry out daily life tasks.

the study aims to observe the effectiveness of inhibition compression therapy versus scapular mobilization on shoulder in patients with mastectomy. by investigating the effectiveness of inhibition compression therapy versus scapular mobilization, this study can contribute to improved pain management, enhanced quality of life, and reduced healthcare utilization for breast cancer survivors. it will be randomized control trial (rct). the study will be conduct in gujranwala institute of nuclear medicine. it will be non-probability convenience sampling technique. duration of the study will be 6 months after the approval of synopsis

Eligibility criteria:
inclusion criteria: * age 40 to 75 years (42) * unilateral breast cancer followed by chemotherapy or radiations. (27) * modified radical mastectomy surgery (27) * limited rom of shoulder * female exclusion criteria: * patients with recurrent breast cancer (42) * history of ischemic heart disease * history of high blood pressure * history of other surgery * any neurological issue
carbohydrate counting training in type 2 diabetes

Conditions: Diabetes Mellitus Type 2; Sarcopenia

Summary: this study aimed to evaluate the efficacy of carbohydrate counting in individuals with type 2 diabetes receiving intensive insulin therapy. in addition, the sarcopenia status in this patient group and the effect of carbohydrate counting on sarcopenia were also evaluated.

participants with type 2 diabetes receiving intensive insulin treatment were randomized and divided into 2 groups: education and control groups. participants in the control group continued their standard medical and medical nutrition treatments. participants in the training group received advanced carbohydrate counting training consisting of 3 sessions in addition to standard medical and medical nutrition therapy. the measurements of the participants in the training and control groups were repeated three times at the beginning of the study, in the 12th week and in the 24th week of the study. a questionnaire form containing sociodemographic information was completed by face-to-face interview method. in addition, biochemical (hba1c, fasting plasma glucose (fpg), c peptide, total cholesterol, hdl, ldl, triglyceride, estimated glomerular filtration rate) and anthropometric and body composition (weight-height, bmi, fat mass, fat ratio, muscle mass, lean tissue mass, waist circumference), hand grip strength and blood pressure measurements of the patients were taken at the beginning, 12th week and 24th week of the study. in addition, a 24-hour retrospective food consumption record was applied to evaluate the energy and nutrient intakes. the calculation of the energy, macro and micro-nutrient intakes of the participants was carried out using the turkish nutrition database ebispro for windows program (version 7.2)

Eligibility criteria:
inclusion criteria: * a history of type 2 diabetes mellitus * using insulin for more than one year * being over 18 years old * receiving basal and bolus insulin treatment * not having received carbohydrate counting training before * not receiving treatment with sulfanylurea drugs from oral anti-diabetics. exclusion criteria: * being pregnant or breastfeeding or planning a pregnancy during the study period, * discontinuing insulin treatment during the study period * having active proliferative retinopathy, severe nephropathy, severe or newly diagnosed cardiac disease within 6 months or stage iii-iv heart failure, * having dementia or psychosis and cognitive impairment, * receiving glucocorticoid treatment, being fed enterally or parenterally and receiving nutrition treatment due to another/concomitant disease, having end-stage renal or hepatic/ renal disease (other than proteinuria) * having liver disease/microangiopathy diseases * having clinical cancer, chronic respiratory disease or amputations, * having any disease or condition that would prevent completion of the study.

Keywords: diabetes carbohydrate glycemic control insulin sarcopenia
effect of footwear on the clinical, functional, and biomechanical aspects in elderly women with knee osteoarthritis (oa)

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to determine whether inexpensive, flexible and non-heeled footwear is effective in improving of clinical, functional and gait biomechanics in elderly women with knee osteoarthritis.

* the clinical and functional aspects will be evaluated using a visual analogue scale (vas) for pain, western ontario and mcmaster universities (womac) and lequesne questionnaires of quality of life in patients with knee osteoarthritis and testing of six-minute walk (6mwt). * biomechanical analysis of gait will be performed by infrared cameras and a force platform. from the data of kinematics and kinetics, will be calculated moments of the knee joint strength by inverse dynamics. the process (steps) will be divided as follows: * step 1, in this step there will be sorting and initial assessment of potential participants; pain will be evaluated through vas, function and quality of life by means of questionnaires womac and lequesne and the 6mwt, and by evaluating the biomechanics of gait. * step 2,(3 month follow-up), both groups will be evaluated again by the vas and womac and lequesne questionnaires. * step 3, after 6 months of starting the monitoring process, both groups will be reevaluated through the vas, womac, lequesne, 6mwt and biomechanical analysis of gait. this step is the final evaluation, characterizing the end of intervention.

Eligibility criteria:
inclusion criteria: * kellgren and lawrence grade 2 or 3 * being able to walk independently for at least 6 hours per day without the aid of canes or attendant to perform their activities of daily living * knee pain between 3 and 8 on the visual analogue scale exclusion criteria: * previous history of surgery on knees, ankles and hips in the last 2 years * neurological disease * bmi \> 35 kg/m2 * difference in lower limb length \> 1 cm * prostheses and / or lower limb orthoses * having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively * present at the knee joint instability (positive test results in the medial collateral ligament, lateral, anterior and posterior drawer) * oa of the hip and / or ankle incapacitating or diagnosed oa in lower limbs and spine * inflammatory arthritis (eg. rheumatoid arthritis) * asymptomatic oa of one or both knees * dementia or inability to provide consistent information * introduction of nonsteroidal anti-inflammatory drugs and analgesic medications 8 weeks before inclusion or change of dosage of the same after the inclusion * being under physiotherapy or acupuncture treatment * patients with an indication of prosthesis or orthosis * patients who are already using a flexible and non-heeled shoes for more than 25 hours per week (3 ½ hours per day) over the past 6 months

Keywords: knee osteoarthritis shoes gait biomechanics
ultrasound assessment of sarcopenia in patients with chronic liver disease: the sarcoliver study

Conditions: Liver Cirrhosis; Non-Alcoholic Fatty Liver Disease; Hepatocellular Carcinoma

Summary: sarcopenia is a complex multifactorial syndrome which could be present in older age (primary sarcopenia) or earlier in chronic disease (secondary sarcopenia). even if in patients with chronic liver disease an association among sarcopenia and poor clinical outcomes is well known, the data available about the prevalence of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma are very variable according to the populations in object and, furthermore, few data are available regarding the use of muscular ultrasound to detect this condition. the aim of this study is to define the prevalence of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma in follow-up at our center and the clinical outcomes associated with this condition, and to determine the reliability of muscular ultrasound to diagnose the condition of sarcopenia through a comparison with other validated techniques such as computed tomography, magnetic resonance imaging and dual-energy x-ray absorptiometry.


Eligibility criteria:
inclusion criteria: * ability to express informed consent * diagnosis of liver cirrhosis or non-alcoholic fatty liver disease or hepatocellular carcinoma based on clinical characteristics, biochemical serum tests and liver imaging examination or liver histologic examination if available exclusion criteria: * inability to express informed consent * pregnancy * presence of a concomitant oncologic disease different from hepatocellular carcinoma * presence of a concomitant gastrointestinal disease able to influence the absorption and digestion of nutrients (e.g. inflammatory bowel disease, celiac disease, short-bowel syndrome, congenital defects of metabolism) * presence of a concomitant gastrointestinal or neurologic disease able to influence the ability of feeding (e.g. dysphagia, parkinson disease, neuromuscular diseases, diseases of the autonomic nervous system, cognitive impairment or dementia) * chronic kidney disease from stage 3 b (iiib) according to kidney disease: improving global outcomes (kdigo) classification (egfr \<45ml/min/1.73m2) * chronic heart failure from stage ney york heart association (nyha) ii * concomitant infection from mycobacterium tuberculosis or human immunodeficiency virus or chronic parasitic infections
neuroimaging studies of depression in parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to investigate similarities and differences in the neural pathways of depressed parkinson's patients, non-depressed parkinson's patients, and healthy controls using magnetic resonance imaging (mri) of the brain and neuropsychological assessment.

depression is a common and potentially serious complication of parkinson's disease (pd). studies show that approximately 40 percent of pd patients are depressed. there is evidence that these patients have deficits in neuropsychological function relative to non-depressed pd patients. despite the widespread toll on emotional health posed by pd, few studies have undertaken a comprehensive examination of the neural underpinnings of parkinsonian depression. in this project, we will compare depressed versus non-depressed parkinson patients to a sample of demographically-matched healthy controls using neuropsychological assessment and magnetic resonance imaging (mri). to investigate possible effects of anti-parkinsonian medication on mood, cognitive function, and neural response, pd patients will be tested both off and on parkinsonian medications.

Eligibility criteria:
inclusion criteria: * right-handed * willing/able to undergo magnetic resonance imaging (mri) exclusion criteria: * history of neurological condition other than parkinson's disease * history of psychiatric condition other than depression * history of substance abuse/dependence

Keywords: parkinson's disease magnetic resonance imaging (mri) neuropsychological assessment