Kornimate/medical-research-clean huggingface dataset:
longitudinal study to investigate different transcranial electrical stimulation

Conditions: Dementia; Degenerative, Dementia Mixed

Summary: this research investigates the effect of different frequencies of tacs (0 hz, 30 hz, 50 hz, 70 hz, 90 hz) and trns with cognitive exercises in a regimen protocol of weeks, everyday. the study design is a longitudinal study design in which participants receive different tes randomly ordered. treatments occur for 4 weeks, then 12 weeks of no treatment (wash-out period), repeated for each tes treatment type. participants have the option of having their choice of music in the background while they perform cognitive exercise.

this research will investigate the effect of applying transcranial electrical stimulation (tes) with different parameters when paired with cognitive exercises with optional background music on older adults in a longitudinal study. in addition, the investigators will investigate and explore novel technological methods not only to monitor the plausible changes due to intervention. since most technological intervention on dementia have a demanding and costly protocol, it would be of great interest to personalized optimum treatment strategy. the investigators will use egocentric spatial assessment using our virtual reality navigation (vrn) and functional near infrared spectroscopy (fnirs) measurements and analysis to develop the monitoring technologies. vrn measures how people orient themselves in a non-familiar environment; the investigators hypothesize it is deteriorated significantly in alzheimer's even at its onset. fnirs measures oxygenated and deoxygenated blood flow to the brain and it may help to understand neuronal changes due to intervention.

Eligibility criteria:
inclusion criteria: * ability to read, write and speak english fluently * moca score between 5 and 24 exclusion criteria: * being diagnosed with parkinson's, parkinsonian dementia, huntington disease, speech significant aphasia and intellectual disability, major depression/anxiety, bipolar disorder, schizophrenia or any other major mood disorder. * having a hhistory of epileptic seizures or epilepsy * inability to adequately communicate in english * impaired vision or hearing severe enough to impair performance in cognitive tests * current substance abuse disorder * currently participating in another therapeutic study for dementia * plan to change the medication during any treatment period (5 weeks including the pre-post assessments)

Keywords: dementia, alzheimer, cognitive impairment
prpp model for evaluation the effect of non-pharmaceutical therapies

Conditions: Fibromyalgia

Summary: to assess the application of partially randomized patient preference (prpp) trial model which concerns the patients' preference on evaluation the therapeutic effect of non-pharmaceutical therapy, and to observe the therapeutic effect of two kinds of non-pharmaceutical therapies (acupuncture and cupping therapy) for fibromyalgia.


Eligibility criteria:
inclusion criteria: * patients with fibromyalgia diagnosed according to criteria formulated by american college rheumatology 2002; * patients whose scores for pain intensity is more than 30mm; * patients who are 20 to 60 years old; * patients who fully understand the process of this research and who are willing to provide informed consent. exclusion criteria: * the widespread muscular-skeletal pain is caused by some kind of disease, surgery, or other external interference factors (except fibromyalgia); * patients with mental disorders, or other serious organic diseases, such as organ failure; * patients who take oral anodyne medications or accept other interventions for pain relief during the treatment; * pregnant or lactating women; * patients currently participating in another clinical trial.

Keywords: cupping therapy acupuncture partially randomized patient preference fibromyalgia criteria formulated by american college rheumatology 2002
national prospective cohort for monitoring children with severe autoimmune cytopenia.

Conditions: Cytopenia; Autoimmune Haemolytic Anaemia; Thrombocytopenic Purpura, Immune

Summary: this study aims to study prospectively the clinical and paraclinical evolution and prognostic factors of autoimmune haemolytic anemias, evans syndromes and chronic immunological thrombocytopenic purpura of children in france.

these autoimmune haematological diseases are rare diseases affecting the child, often very young, and serious and potentially life-threatening. international literature data are scarce, and include individual cases or small series. they do not allow to determine an optimal therapeutic strategy in case of escape from the first-line treatments. existing treatments (long-term corticosteroid therapy, immunoglobulins, splenectomy, immunosuppressants, chemotherapies, and more recently anti-cd20 antibodies) are inconsistently effective, and often associated with serious side effects. the seriousness of these diseases, the therapeutic difficulties, and the absence of a targeted research project in france, led to the implementation of this study. this study aims to study prospectively the clinical and paraclinical evolution and prognostic factors of autoimmune haemolytic anemias, evans syndromes and chronic immunological thrombocytopenic purpura of children in france.

Eligibility criteria:
inclusion criteria: * age strictly below 18 years of age at initial diagnosis * affiliate child or beneficiary of a social security scheme * child residing in metropolitan france * diagnosis of autoimmune haemolytic anemias, evans syndrome and / or chronic immune thrombocytopenic purpura * free, informed, written and signed consent exclusion criteria: * diagnosis of constitutional haemolytic anemia * diagnosis of platelet constitutional disease

Keywords: children
study of a drug [dcvax (tm)-prostate] to treat prostate cancer when hormone therapy is no longer effective.

Conditions: Prostate Cancer

Summary: the purpose of this clinical research study is to assess the safety and efficacy of an investigational therapy called dcvax(tm)-prostate.

patients with hormone refractory prostate cancer are eligible if they have a rising psa or three or fewer metastatic lesions. the experimental therapy uses a patient's own white blood cells and "teaches" the cells to recognize a "flag" on prostate cancer cells. this may help the immune system destroy prostate cancer cells. side effects reported from the phase i/ii trial include skin reactions of redness, pain \& swelling at the injection site, and short-lived headache, fever \& fatigue. full details are available in the informed consent.

Eligibility criteria:
inclusion criteria * hormone refractory prostate cancer (hrpc) \&#8211; progressive disease despite androgen deprivation and serum testosterone \<50ng/dl; progression defined as either: 1. rising psa over 6 months with at least a 50% increase between the 1st and 3rd measurement, and the 3rd measurement \>2.0 ng/ml; or 2. progression of metastatic lesion on bone scan, or 3. progression of lymph node metastasis by ct scan. * zubrod or ecog performance status of 0-1. * three or fewer bone metastases on a bone scan with minimal symptoms. * no lymph node lesions greater than 3.0 cm at longest diameter. * adequate hematological, hepatic and renal function. exclusion criteria * history of other active malignancy. * prior chemotherapy, radiation therapy, immunosuppressive or investigational therapy for metastatic disease in previous 12 months. * strong opioids, immunosuppressives, megestrol acetate or other estrogenic hormones (e.g., saw palmetto, pc-spes) within 1 month prior to enrollment. * brain, liver, or lung metastases; uncontrolled heart, liver, lung, or renal diseases or other serious illness. * prior splenectomy. * history of severe asthma, anaphylaxis, or other serious adverse reactions to vaccines or any of the antigens included in the skin test. * history of moderate to severe lower limb lymphedema, or recent signs of deep venous thrombosis (dvt) or thrombo-embolic disease, or impending stroke. * history of immunodeficiency or autoimmune disease; positive hiv, hbsag or anti-hcv. * impending untreated spinal cord compression or urinary outlet obstruction. * any medication that might affect immune function. (exceptions: nonprescription doses of nsaids; acetaminophen or aspirin; low doses of antihistamine therapy; normal range doses of vitamins; and h2 blockers).

Keywords: prostate cancer oncology urology hormone refractory prostate cancer
patient-reported outcomes after percutaneous coronary intervention

Conditions: Coronary Artery Disease

Summary: the main objective is to investigate i) continuity of care, ii) health literacy and self-management, iii) adherence to treatment, and iv) patient preferences, healthcare utilization and costs, and to determine associations with future short- and long-term health outcomes in patients after percutaneous coronary intervention.

concard will use multiple designs. (1) an inductive exploratory design including in-depth interviews on patients' experiences of healthcare delivery will provide a context for the quantitative data to develop the content of the cohort study and trial intervention. (2) a prospective cohort design with a 1-year follow-up period will include data on patient-reported outcomes, and a 10-year follow-up for adverse events. in translation and adaptation of patient-reported outcome measures, a methodological design will be applied. (3) a discrete choice experiment will investigate patient preferences for aftercare and cardiac rehabilitation.

Eligibility criteria:
inclusion criteria: * patients undergoing percutaneous coronary intervention * ≥ 18 years of age * living at home at the time of inclusion. exclusion criteria: * patients who do not speak norwegian/danish * patients who are unable to fill in the questionnaires due to reduced capacities * institutionalized patients * patients with expected lifetime less than one year * percutaneous coronary intervention without stent implantation * patients undergoing percutaneous coronary intervention related to transcatheter aortic valve implantation or mitraclip examination * previous enrollment in concard (readmissions).

Keywords: adherence to treatment continuity of care health literacy patient involvement patient preferences percutaneous coronary intervention rehabilitation
safety and immunogenicity study of a liquid pentavalent combination vaccine

Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type B

Summary: the purpose of this study is to evaluate the safety and immunogenicity of an indigenously developed liquid pentavalent (diphtheria, tetanus, pertussis, hepatitis b and hib) combination vaccine in healthy indian infants as a part of the routine immunization in accordance with the epi schedule.


Eligibility criteria:
inclusion criteria: * healthy children in the age group six to eight weeks * born after a normal gestational period (36 - 42 weeks) * mother's hbsag assured negative. * father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form. * parents willing to fill the diary card exclusion criteria: * administration of immunoglobulin or any blood products since birth. * use of any investigational, on-registered drug, or vaccine other than the study vaccine (with the exception of opv \& bcg vaccine) during the study period or within 30 days preceding the first dose of the study vaccine. * previous vaccination or evidence of infection with dtp. * history of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics. * major congenital or hereditary immunodeficiency. * infants having evidence of disease or fever, history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a cns disorder at the time of vaccination. * infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures, encephalopathy and hypersensitivity reaction. * parent/s or guardian of subject unable to maintain diary card * simultaneous participation in any other clinical study

Keywords: vaccine prevention diphtheria tetanus pertussis hepatitis b haemophilus influenzae type b healthy infants
identification of potential biomarkers of response to peptide immunotherapy for ragweed allergy

Conditions: Ragweed Allergy

Summary: the aim of the study is to identify changes in potential biomarkers after peptide immunotherapy for that may subsequently be developed as biomarkers that correlate with clinical efficacy.


Eligibility criteria:
inclusion criteria: * enrolled in study tr002 but have not yet commenced dosing exclusion criteria: * none; no criteria additional to tr002 exclusion criteria are applicable to this study

Keywords: ragweed allergy immunotherapy
laparoscopic roux-en-y gastric bypass versus laparoscopic biliopancreatic diversion (bpd)- duodenal switch for superobesity

Conditions: Obesity; Diabetes; Hypertension

Summary: the purpose of this study is to compare the outcome in a broad perspective after laparoscopic roux-en-y gastric bypass and laparoscopic bpd-duodenal switch in the treatment of superobesity (body mass index \[bmi\] \> 50 kg/m2).

surgery is the only treatment of morbid obesity that has proven to result in efficient and long lasting weight loss. there are few studies comparing different surgical techniques, especially in a randomized setting. superobesity (bmi \> 50 kg/m2) demands an efficient surgical approach to result in satisfying weight loss. laparoscopic techniques have been established to perform roux-en-y gastric bypass and biliopancreatic diversion with duodenal switch which both are good options for treating superobesity. this study aims to compare the outcome after surgery in a broad perspective (weight loss, metabolic normalization, gastro-intestinal side effects, eating patterns, body composition, health economics). patients will be randomized to either surgical procedure and will be followed for five years.

Eligibility criteria:
inclusion criteria: * bmi 50-60 kg/m2 exclusion criteria: * prior obesity operation * prior major abdominal surgical procedure * severe disabling cardiopulmonary disease * malignancy * oral steroid treatment * condition associated with poor compliance

Keywords: obesity surgery gastric bypass biliopancreatic diversion with duodenal switch laparoscopy
lifestyle interventions for long term diabetes control

Conditions: Type 2 Diabetes

Summary: lifestyle interventions have been shown to reduce heart disease risk and improve blood sugar control in clinical trials. this project will investigate whether those lifestyle interventions can be implemented long-term, in usual practice settings, by using dietitian case managers to coordinate lifestyle change in cooperation with fitness instructors and primary care clinicians.

the proposed randomized trial investigates the effectiveness of lifestyle case management to encourage long-term lifestyle modifications in diet and physical activity, improve control of type 2 diabetes, reduce risk factors for progression of type 2 diabetes and cardiovascular disease, and improve quality of life, among health plan enrollees with type 2 diabetes and obesity. patients agreeing to participate are randomly assigned to one of two conditions: 1) lifestyle case management, in which initial 12 month intensive diet and physical activity intervention is followed by 30 months of active maintenance directed by dietitians and physical trainers (the "lifestyle case management" group); 2) lifestyle intervention, in which there is no formal maintenance following the intensive lifestyle intervention (the "lifestyle intervention" group). because the lifestyle case management intervention incorporates the content of the lifestyle intervention, we will be able to assess the incremental effectiveness of providing post-intervention lifestyle case management on glycemic control, cardiovascular risk, body composition, diet and physical activity habits, and health care utilization.

Eligibility criteria:
inclusion criteria: * treated for type 2 diabetes within one year prior to their entry into the trial, have a bmi at or above 30, and are 18 years of age or older exclusion criteria: * 1) end-stage renal disease (defined as being on dialysis), 2) active foot ulcers or infections (defined as an open wound or requiring drug therapy), 3) pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer) that precludes diet and physical activity changes

Keywords: behavior therapy dietary control exercise diabetes mellitus behavior modification blood glucose clinical trial diabetes education health behavior health care service utilization obesity quality of life
guided participation discharge program for very preterm infants

Conditions: Very Premature Baby

Summary: this study aimed at investigating the feasibility of a new guided participation (gp) discharge program for parents of very preterm infants. a randomized controlled trial was conducted in a neonatal intensive care unit. the intervention included three structured gp sessions and one follow-up phone call. the control group received usual care. outcomes measured included parents' efficacy and satisfaction with parenting, and perceived stress. data collection was conducted at baseline, on day of discharge, after the follow-up phone call, and 1 month after discharge. the outcomes were analyzed on the basis of intention-to-treat principles.


Eligibility criteria:
for infants: inclusion criteria: - a gestational age of ≤32 weeks at birth exclusion criteria: * have congenital malformation(s) * need to undergo a major surgery for parents: inclusion criteria: - must be the infant's primary caregiver inclusion criteria: - diagnosed with a mental illness
evaluation of an antithrombotic therapeutic strategy in pregnant women

Conditions: Placental Vascular Pathologies; Venous Thromboembolism Diseases

Summary: the venous thromboembolism is one of the first causes of maternal mortality. until 2003, only a few recommendations were available on the optimal use of antithrombotic therapy as a preventive measure against thromboembolism in pregnant women. in this study, we propose : 1. to gather the experts who took part in the french consensus conference and the local experts to create a score in accordance with the national and international consensus and to give some precise therapeutic strategies. 2. to evaluate the discriminant, feasible and useful character of this new score by a prospective multicentric study including 2000 pregnant women with a risk of thromboembolism or placental vascular pathology who will benefit from therapeutic strategies defined by the new score. .

purpose : to create a score inspired by our first experience i.e. simple, standardized and quickly usable in day-to-day practice to individualize antithrombotics prescription to women at risk.

Eligibility criteria:
inclusion criteria: * multiparous or primiparous parturients followed in one of the participating centers * presenting at least one risk factor of venous thromboembolic pathology and/or placental vascular pathology exclusion criteria: * parturient that can't be followed * unknown familial or personal previous history * parturient with a contraindication to use of the treatment recommended by the therapeutic strategy

Keywords: venous thromboembolism diseases placental vascular pathologies antithrombotic treatment symptomatic thromboembolic events pregnant women score therapeutic strategies heparin aspirin pregnancy pathology
a pan-asian clinical database of egfr exon 20 insertion mutated nsclc

Conditions: Advanced EGFR Exon 20 Insertion Mutated Non-Small Cell Lung Cancer

Summary: there are limited in depth studies on the epidemiology and clinical management of egfr exon 20 insertion mutated nsclc in asia. in addition, there is preliminary data suggesting the exact location of the insertion and variant may influence the response and efficacy to novel egfr targeted therapies. this study aims to fill this knowledge gap, by comprehensively characterising the epidemiology and clinical outcomes of asian advanced egfr exon 20 insertion mutated nsclc patients.

this study will be a multi-center observational study and will enroll patients with advanced egfr exon 20 insertion mutated nsclc. the study will include patients recruited from countries across asia, including sites in, but not limited to - hong kong, korea, singapore, taiwan and thailand. there will be approximately 20-30 sites recruiting for the study. in singapore, sites may include national cancer centre singapore (nccs), national university hospital (nuh) and tan tock seng hospital (ttsh). approximately 600 patients will be enrolled retrospectively.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed advanced nsclc 2. positive testing result from any locally approved test (including but not limited to rt-pcr, cobas and ngs) for egfr exon 20 insertion mutation 3. diagnosis date from 1 jan 2013 to 31 dec 2024 (to allow for minimum 12 months of follow-up clinical and treatment outcome data) 4. male or female adults, age as defined by local regulations exclusion criteria: 1. patients without an egfr exon 20 insertion mutation

Keywords: egfr exon20 insertion nsclc (non small cell lung cancer)