Kornimate/medical-research-clean huggingface dataset:
dyadic neurofeedback for emotion regulation in youth with maternal adversity

Conditions: Emotional Dysfunction; Early Life Stress

Summary: this study will examine the effect of a real-time functional magnetic resonance imaging (fmri) dyadic neurofeedback protocol with mothers and their adolescent daughters. mothers will view a moving bar showing their daughters' brain activity on a computer screen while talking to their daughters.

the current study will determine the effects of a real-time functional magnetic resonance imaging dyadic neurofeedback (rtfmri-dnf) protocol that will train mothers with a history of adverse childhood experiences (aces) to regulate adolescents' activation in the anterior insular cortex (aic) - a key brain region for er. the proposed study will test the efficacy of this protocol to promote healthy er-related neurodevelopment in adolescents with a maternal history of adversity. the proposed study will use dnf to provide neurofeedback from the adolescent's aic to the parent as the parent and adolescent engage in an emotion discussion task together. parents and adolescents (n=10 dyads) will communicate via microphones and noise-canceling headphones while the adolescent is undergoing fmri scanning. specific aims of the current study are: (1) to determine the brain response to aic dnf adolescents, and (2) to determine effects of dnf on parenting behaviors. this study is significant because engaging with parents in dnf can promote positive er development in adolescents at risk due to the intergenerational effects of aces.

Eligibility criteria:
inclusion criteria: all participants inclusion criteria: * biological female * sufficient english fluency to complete tasks * co-residing at least 4 days per week inclusion criteria for adult participants: * primary caregiver for more than 50% of child's lifespan * history of at least two adverse childhood experiences * biological parent of adolescent participant inclusion criteria for adolescents: * eligible for fmri * right-handed * body mass index between 16 and 40 (inclusive) * age 14-17 years exclusion criteria: exclusion criteria for all participants: * current psychiatric diagnosis exclusion criteria for adolescent participants: * neurodevelopmental delay * history of psychiatric disorder * medications influencing fmri * medical conditions influencing fmri
study of 68ga /131i sgmib-zt-199 pet imaging targeting her2-positive in the diagnosis of metastatic breast cancer

Conditions: HER2-positive Breast Cancer

Summary: to evaluate the safety, biodistribution, radiation dosimetry, and uptake in tumor lesions of patients with her2-positive metastatic breast cancer after injection of \[131i\]/\[68ga\]sgmib-zt-199.


Eligibility criteria:
inclusion criteria: * breast cancer patients. 1. women aged between 18 and 75 years old. 2. patients with breast cancer confirmed by histological examination or imaging. 3. her2 positive diagnosis confirmed by puncture by immunohistochemistry or fluorescence in situ hybridization (her2 positive is defined as immunohistochemistry result of 3+ (ihc 3+); or immunohistochemistry result of 2+/positive in situ hybridization result (ihc 2+/ish+)). 4. renal function: serum creatinine less than or equal to the upper limit of the normal range; electrocardiogram: no significant abnormalities. 5. patients of childbearing age can cooperate with contraception. 6. willing and able to cooperate with all items of this study. exclusion criteria: * subjects meeting any of the following criteria will be excluded from the study: 1. severe hepatic or renal insufficiency; 2. participation in another study protocol or clinical care within the past year that has resulted in radiation exposure exceeding an effective dose of 50 msv in addition to the radiation exposure expected from participation in this clinical study. 3. participation in this study is considered unsuitable by other investigators. 4. pregnant women and other groups unsuitable to receive radiation. 5. alcohol allergy, etc.

Keywords: her2-positive metastatic breast cancer positron-emission tomography
efficacy of high density voltage and fractionation map guided ablation in patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to evaluate the efficacy of high density voltage and fractionation map guided ablation compared to anatomy-based circumferential pulmonary vein isolation in patients with atrial fibrillation

in this study, a test group includes those who undergoing atrial fibrillation(af) ablation guided by high density voltage and fractionation map. a control group will be chosen from database of patients who underwent af ablation between 2018-2019. a control group includes the same number of consecutive patients who underwent anatomy-based circumferential pulmonary vein (pv) isolation.

Eligibility criteria:
inclusion criteria: * 1. age over 20 years old and under 80 years old 2. patients with non-valvular atrial fibrillation 3. patients having af even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks 4. patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them 5. patients who are available of follow-up at least for more than three months after catheter ablation exclusion criteria: 1. patients unsuitable for catheter ablation because the size of left atrium is over 6.0 cm 2. patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease. 3. patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation 4. patients in the subject group vulnerable to clinical study 5. patients who had undergone a prior catheter ablation for atrial fibrillation
the study of sarcopenia and aging biomarkers by the metabolomics

Conditions: Sarcopenia; Aging

Summary: with the rapid growth of the global elderly population, the studies of the biomarkers of the sarcopenia and aging are under investigation in different ways. the investigators use metabolomics to explore the biomarkers of the sarcopenia and aging of the senior adults.

metabolomics is the emerging platform technology to address the complexity of a living system. in translational research, metabolomics approaches may enable the detection of multiple disease risk factors and interactions, disease progression, and response of patients to a particular therapy with or without side effects. metabolomics may provide comprehensive information and improve diagnosis and prognosis which are particularly promising in human complex degenerative diseases. the investigators use metabolomics to explore the biomarkers of the sarcopenia and aging of the senior adults.

Eligibility criteria:
inclusion criteria: * residents of the chang gung health and culture village * mostly independent and do not require nursing assistance * capable of managing their daily living activities * aged ≧ 60 exclusion criteria: * none.

Keywords: sarcopenia aging biomarkers metabolomics
efficacy and safety of single-session endoscopic stone extraction

Conditions: Choledocholithiasis With Acute Cholangitis

Summary: this is a retrospective study, including approximately 600 patients with acute cholangitis accompanied with choledocholithiasis, who treated with single-session or two-session endoscopic stone extraction at beijing friendship hospital. the investigators assessed the outcomes of single-stage and two-stage endoscopic stone extraction.

acute cholangitis is an acute inflammation caused by obstruction of the bile duct, of which choledocholithiasis is the most common cause. without timely removal of the obstruction or control of the infection, cholangitis can get worse and even become life-threatening. therefore, timely and effective treatment is essential for patients with acute cholangitis combined with choledocholithiasis. endoscopic retrograde cholangiography (ercp) is used as the first-line treatment for choledocholithiasis-associated acute cholangitis. previous guidelines recommended two-session endoscopic therapy. endoscopic biliary drainage as the initial treatment, followed by endoscopic stone extraction after cholangitis improved. in recent years, studies have found that single-session endoscopic stone extraction is safe and effective for patients without serious organ function impairment. meanwhile, single-session endoscopic lithotomy can avoid the second ercp intervention, which can relieve the pain of patients, reduce medical costs and shorten the length of hospital stay. however, there is still insufficient evidence on the effectiveness and safety of early single-session ercp lithotomy. the aim of this study is to evaluate the efficacy and safety of single-session endoscopic stone extraction for acute cholangitis associated with choledocholithiasis, so as to provide reference of clinical treatment. in a retrospective analysis, approximately 600 patients with acute cholangitis accompanied with choledocholithiasis, who treated with single-session or two-session endoscopic stone extraction at beijing friendship hospital were studied. the investigators assessed the outcomes of single-stage and two-stage endoscopic stone extraction.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old 2. patients met the tokyo guidelines 2018 (tg18) diagnosis of acute cholangitis 3. imaging examination confirmed the presence of choledocholithiasis 4. patients received endoscopic single-session stone extraction or two-session treatment involving stone removal after drainage exclusion criteria: 1. common bile duct with benign or malignant stenosis 2. changes in the anatomical structure of the stomach or duodenum 3. patients complicated with severe acute pancreatitis 4. patients who underwent endoscopic intervention before admission 5. patients received percutaneous transhepatic cholangio drainage (ptcd) or other invasive interventions besides endoscopic treatment

Keywords: choledocholithiasis acute cholangitis endoscopic retrograde cholangiopancreatography
evaluation of an intensive training program for patients with hereditary spastic paraparesis spg4/spast

Conditions: Hereditary Spastic Paraparesis

Summary: hereditary spastic paraparesis is a group of inherited neurological diseases. only symptomatic treatments exist for the moment. the modifspa study (cf citation) carried out by the team showed that patients perceived a feeling of effectiveness of physiotherapy on lower limb spasticity. the aim of the walk-up study is to objectivize this feeling of efficacy on gait disorders in these patients. this is an interventional study using physical training. the study is prospective, open, randomized in 2 parallel groups, one of which is a control group. analyses will be comparative between the 2 groups during the course of the study.

following an initial study carried out by the team (cf citation), physiotherapy appeared to be the most useful therapy for coping with spasticity, particularly when practised at least 3 times a week. the hypothesis is that this feeling experienced by patients is accurate, and that more frequent physiotherapy (3 additional sessions/week) significantly improves patients' walking speed, with a functional objective. the main aim of the walk-up study is to evaluate the efficacy of a 6-week intensive physical rehabilitation program on walking speed in patients with spg4 / spast-hsp. this is the most frequent genotype in hereditary spastic paraparesis. all patients included in the study will receive at least one physiotherapy session per week in a liberal practice.

Eligibility criteria:
inclusion criteria: * patient with molecular diagnosis of hereditary spastic paraparesis based on pathogenic variant of spast gene, * walking possible for 6 minutes without human assistance (one or more technical aids are authorized: e.g. cane, walker, orthoses), * at least 1 physiotherapy session per week already in place. * understanding of the protocol * possibility of connecting to the internet from home to access video material provided as part of the protocol. exclusion criteria: * botulinum toxin injection within 2 months of protocol inclusion * discontinuation of private physiotherapy, * refusal to participate in the protocol, * participation in another interventional clinical trial evaluating a health product or in a randomized clinical trial * pregnant women * not affiliated to a social security scheme or beneficiary of such a scheme * patient under guardianship or trusteeship

Keywords: physical rehabilitation program hereditary spastic paraparesis
validation of a novel functional food designed to meet the nutritional needs of people living with parkinson's disease

Conditions: Constipation; Parkinson Disease

Summary: constipation is a common complication and non-motor symptom of parkinson's disease (pd) and affects up to 80% of people with pd. it is in fact within the non-motor symptoms that nutrition and dietetic intervention could have the greatest impact. research suggests that increasing the amount of fibre in the diet could help to alleviate the effects of constipation. inulin is a type of fibre widely found in a variety of vegetables, and recent studies have shown that inulin can improve constipation in people with pd. with the assistance of a food company, the investigators have developed a functional drink, enriched with chicory inulin and other key nutrients, including b-vitamins and vitamin d (which are suggested within the literature to be beneficial in pd). therefore, the investigators plan to conduct a 12-week feasibility study to test the effect of this novel functional drink on gut health outcomes, nutritional status, and overall quality of life in people living with pd.


Eligibility criteria:
inclusion criteria: * diagnosis of parkinson disease (pd) * aged ≥18 years * individuals with the capacity to provide informed consent exclusion criteria: * individuals with pd living in institutional care or in hospital * drug, infection or toxin induced parkinsonism * individuals with diabetes * b12 injection users * currently taking antibiotics * using supplements containing the nutrients of interest (b-vitamins, inulin, probiotics) * any other medical, cognitive or psychosocial issue, or co-enrolment in another study, that could interfere or disrupt adherence to the study requirements * an allergy to any of the ingredients in the functional and/or control drinks * consuming a fermented food and/or probiotic yogurts on a daily basis

Keywords: constipation fibre b-vitamins functional food nutritional status parkinson disease
virtual reality for non-cardiac chest pain

Conditions: Gastrointestinal Diseases; Chest Pain

Summary: the purpose of this study is to determine if virtual reality (vr) will improve symptoms in non-cardiac chest pain (nccp).

the primary aim of this study is to assess the overall feasibility of virtual reality for the treatment of noncardiac chest pain and identify problems, issues, or challenges that may impact the performance of a future clinical trial. as such, the study will focus on willingness to participate, patient adherence, patient retention, and burdensomeness of the intervention and survey instruments. as a lesser objective, we will assess the effectiveness of virtual reality in patients with noncardiac chest pain at improving pain severity, symptom hypervigilance, anxiety, quality of life, and resilience.

Eligibility criteria:
inclusion criteria: * symptoms of non-cardiac chest pain (recurrent anginal-like or atypical chest pain) * negative prior cardiac evaluation (at a minimum, including electrocardiogram) * prior esophagogastroduodenoscopy and/or barium esophagram to rule out severe esophagitis, stricture, or motility abnormality exclusion criteria: * initiation of a proton pump inhibitor (ppi) within 8 weeks * major concomitant illness * current drug or alcohol use that that would interfere with adherence to study requirements * symptoms of vertigo or dizziness that would limit tolerability of the vr headset

Keywords: virtual reality
perfusion ct as a predictor of treatment response in patients with hepatic malignancies

Conditions: Neuroendocrine Tumors; Brain (Nervous System) Cancers; Colon/Rectal Cancer; Colon Cancer; Hepatobiliary Cancers; Hepatocellular Carcinoma (Hepatoma); Liver

Summary: a research study of liver perfusion (how blood flows to the liver over time). we hope to learn whether perfusion characteristics of liver masses may be predictive of response to treatment and whether liver perfusion characteristics can be used to follow response to treatment.


Eligibility criteria:
inclusion criteria:3.1.1 patients with suspected or biopsy-proven liver masses including unresectable hepatocellular carcinoma (hcc), unresectable colon cancer metastases to the liver, and metastatic neuroendocrine tumors to the liver will be eligible for enrollment. 3.1.2 patients who have undergone prior chemotherapy more than one year prior to the study are eligible for enrollment. 3.1.4 patients must be 18 years or older. patients must not be pregnant and, if of child-bearing age, must take precautions not to become pregnant. 3.1.5 no life expectancy restrictions. 3.1.6 ecog and karnofsky performance status will not be employed. 3.1.7 patients with renal failure are ineligible for this study (glomerular filtration rate (gfr) must be \> 60) 3.1.8 ability to understand and willingness to sign a written informed consent document. exclusion criteria:3.2.1 patients who have undergone prior chemoembolization of hepatocellular carcinoma (hcc) are ineligible for enrollment. patients who have undergone chemotherapy within one year prior to the study are also ineligible for enrollment. 3.2.2 no restrictions regarding use of other investigational agents. 3.2.3 patients with severe contrast allergy are ineligible. 3.2.4 patients who are pregnant or are trying to become pregnant are excluded from this study. 3.2.5 patients who are cancer survivors or human immunodeficiency virus (hiv)-positive will not be excluded.
t&b depletion non malignant

Conditions: Graft Versus Host Disease

Summary: • the primary aim of the present trial is to assess in a randomized fashion the benefit on standard graft-versus-host disease (gvhd) prophylaxis of the addition of atg-fresenius s ® in transplants from matched related donors (mrd) and of anti-cd20 rituximab in transplants from matched unrelated donors (mud). both safety and efficacy of the treatment will be assessed, in particular in respect to the clinical status of the patient, i.e. prevention of graft failure and chronic gvhd and of ebstein barr virus (ebv) viremia for mud patients. the conditioning proposed combines myeloablative drugs with a favorable safety profile such as treosulfan, thiotepa (tepadina®) and fludarabine with the intent to reduce the traditional immediate and late toxicity of busulfan and cyclophosphamide.

for patients transplanted from a mrd the primary end-point is the cumulative incidence of a combined end-point defined as the time from randomization to: * primary and secondary graft failure, * agvhd ii-iv, * cgvhd, * death, whichever occurs first. for patients transplanted from a mud the primary end-point is the cumulative incidence of a combined end-point defined as the time from randomization to: * agvhd ii-iv, * ebv viremia, whichever occurs first.

Eligibility criteria:
inclusion criteria: * non malignant haematological and inherited metabolic disorders benefiting from an allogeneic hsct conditioned with a myeloablative regimen * availability of a matched related donor (mrd) or matched unrelated donor (mud) * lansky or karnofsky index ≥ 60 * inherited metabolic disorders: dq ≥ 70 (+ mri loes score ≤ 9 for adrenoleukodystrophy) * adequate cardiac, renal, hepatic and pulmonary functions as evidenced by: * serum creatinine ≤ 1.5 × upper limit of normal (uln) * heart shortening fraction (left-ventricle) \> 28 % or lvef \> 55% * serum bilirubin ≤ 1.5 × uln (except for wolman disease), * ast and alt ≤ 2.5 × uln (except for thalassemic syndromes and wolman disease) * pulmonary function: if cooperative: fev1 and fvc on pulmonary function testing \> 60 %; if non cooperative: pulse oximetry \> 95 % in room air * availability of autologous back up marrow (\> 2 x 108 tnc+ cells/kg or \> 2 x 106 cd34+ cells/kg) for mud * adequate contraception in female patients of child-bearing potential * signed informed consent exclusion criteria: * any malignancy * liver cirrhosis evidenced on liver histology (performed in suspicious cases or in case of wolman disease) * hiv- positivity * clinically significant pleural effusion or ascites * pregnancy or lactation * known hypersensitivity to trial drugs * participation in another experimental drug trial in the 2 months preceding enrollment * non-cooperative behaviour or non-compliance * previous hsct

Keywords: indication for hsct matched related donor mrd matched unrelated donor mud
impact of cyclic prolonged parenteral nutrition in neonates

Conditions: Cholestasis in Newborn

Summary: the aim of our study is to compare the incidence of pnac in newborns receiving cyclic versus continuous parenteral nutrition (pn) in those newborns who need prolonged pn. the secondary aims are to compare incidence of sepsis and catheter related sepsis, mean length of hospital stay, mortality, nutritional status at two years of chronological age and predisposing factors to the development of parenteral nutrition associated cholestasis (pnac) between the two groups, and to evaluate the adverse effects of the method of cycling used. this was a single-center, prospective randomized not blinded study was conducted in a level 3 neonatal intensive care unit from july 2010 to january 2015. infants with hemodynamic instability until a stable situation, congenital hepatic disease, preterm infants with diagnosis of respiratory distress syndrome or persistent ductus arteriosus and lack of authorization from the parents or guardians were excluded.


Eligibility criteria:
inclusion criteria: * newborns who needed long-term pn for more than ten days and were diagnosed with a pathology that makes likely the need to extend it. exclusion criteria: * infants with hemodynamic instability until a stable situation, congenital hepatic disease, preterm infants with diagnosis of respiratory distress syndrome or persistent ductus arteriosus and lack of authorization from the parents or guardians

Keywords: intrahepatic cholestasis infant newborn cyclic parenteral nutrition
okko health hyperacuity, contrast and colour game validation in age-related macular degeneration

Conditions: Age-Related Macular Degeneration

Summary: smartphone apps have the potential to measure standard metrics of visual function. in addition, new tests may serve as digital biomarkers to detect early progression of disease, assess risk of developing disease or expand the patient's clinical picture. smartphones are inherently advantageous to reduce the reliance on specialist bulky and costly equipment that currently only exists in specialist clinics. while there are some smartphone apps available for vision monitoring, very few have any clinical evidence to support reliability, validity and diagnostic accuracy. the okko health app (www.okkohealth.com) is a smartphone app available on apple ios and android platforms, consisting of short games with applied vision science technology to measure visual function in an engaging way. the app has one game per function, each on average 1-2 minutes. there are 4 game modes available testing visual acuity, contrast sensitivity, colour sensitivity and hyperacuity. this study will aim to validate these measures of visual function against gold standard clinical tests.


Eligibility criteria:
inclusion criteria: * participants with amd in at least one eye * willing to travel to the clinic in exmouth/bristol * able to hold and use a smartphone exclusion criteria: * significant ocular pathology other than amd * unable to provide written informed consent