Kornimate/medical-research-clean huggingface dataset:
exercise post-diagnosis of breast cancer

Conditions: Breast Cancer

Summary: the investigators are doing this study to determine if there are body composition changes after a 12-week exercise program in breast cancer patients and determine what factors contribute to sustained physical activity after the 12-week exercise program intervention.

the study is enrolling breast cancer patients up to 2 years after their diagnosis in a 12-week exercise program. the participants will either participate in: group 1-participating in an exercise program with biometric evaluations or group 2-biometric evaluations but not participating in the exercise program. at the end of the 12-week exercise program, participants in group 1 will be randomized to either: a) continuing with exercise group classes or b) continuing with exercise individual classes. both group 1a and 1b participants will be followed for the remainder of the year and be evaluated for continued physical activity. all group study participants' biometrics will be assessed at baseline and at the end of 12-weeks, with continued annual medical review follow-up for a total of 5 years.

Eligibility criteria:
inclusion criteria: * new diagnosis of breast cancer (within the past 2 years, any subtype, stage i-iii) * can be undergoing neo/adjuvant treatment (surgery, chemotherapy, radiation or endocrine therapy) * participant is willing and able to comply with the protocol for the duration of the study including undergoing scheduled exercise sessions, completing questionnaires and biometric/biomarker studies * participant must be able to lie flat on their back for up to 10 minutes * participant must be able to stand without aid for at least 2 minutes exclusion criteria: * participant with breast cancer recurrence * metastatic breast cancer * uncontrolled psychiatric disorder that can affect self-assessment * pregnant patient * participants with any internal artifact (e.g. pacemakers, internal fixation, arthroplasty) or other physical impairment that would alter the body composition assessment
just-in-time intervention to reduce alcohol-facilitated intimate partner violence perpetration

Conditions: Alcohol Drinking; Aggression; Emotion Regulation

Summary: acute alcohol intoxication is a robust predictor of intimate partner violence (ipv) perpetration for young adult men and women; therefore, interventions delivered proximally to drinking episodes - a period of high risk - are needed to reduce alcohol-facilitated ipv. this project seeks to improve public health by delivering a just-in-time text messaging intervention proximally to drinking episodes and evaluating the impact of the intervention on alcohol-facilitated ipv in a sample of at-risk young adult men and women. additionally, through an innovative design this project is poised to answer these important questions: whether receiving a message, when, for whom, what type, and under what conditions this just-in-time messaging intervention leads to reductions in alcohol use and ipv perpetration.


Eligibility criteria:
inclusion criteria: * 18-30 years old * consumed alcohol an average of 2 times per week in last 3 months * at least two instances of heavy episodic drinking in last month * currently in a romantic relationship * history of ipv perpetration within last 3 months * willing to provide cell phone number and carrier and receive text messages for 30 days exclusion criteria: * none
awareness training in children with autism spectrum disorder.

Conditions: Autism; Autism Spectrum Disorder

Summary: the proposed protocol aims to facilitate awareness and understanding of autism spectrum disorder among children aged 8 to 14 with an iq between 85 and 115. conducted once a week for 60 minutes, the protocol encompasses two initial group sessions followed by 5 group meetings, introducing activities to foster self-awareness, cognitive understanding, and an inclusive environment. subsequently, the protocol advances to 12 individual sessions focused on emotional well-being and self-awareness, integrating oculus technology and chest sensors for heart rate monitoring. initiating the intervention, individual family meetings are scheduled to outline intervention goals and phases. the initial group sessions focus on social bonding, cognitive understanding, and creating an accepting atmosphere among participants. utilizing activities addressing neurodiversity awareness and technological tools like tablets, the sessions encourage discussions on individual differences and sensitivities. the subsequent individual sessions are structured to explore personal values, identify inner critical voices, and develop emotional awareness through exercises exploring emotions and physical sensations. progressively, the intervention introduces mindfulness, guiding participants to acknowledge emotions as normal and encouraging alignment of daily actions with personal values. following this, sessions center on building observational skills, recognizing past behaviors, and fostering strengths tied to values. participants are encouraged to distinguish between their critical "consultant" and the value-driven "explorer," fostering personal growth and reflection. the protocol's later stages delve into identifying personal strengths linked to core values and exploring value-driven goals. visual exercises, metaphors, and flexible self-views are emphasized, promoting adaptability and self-evolution. the protocol concludes by advocating a flexible self-view, embracing change, and connecting oneself to ever-evolving metaphors like "a cup with changing contents" or "the ever-changing sky." these sessions culminate with visual relaxation facilitated through oculus technology while simultaneously monitoring participants' heart rates using chest sensors. this comprehensive approach integrates technological tools with emotional and cognitive exercises, providing a multifaceted framework to enhance self-awareness and promote acceptance within the context of neurodiversity.


Eligibility criteria:
inclusion criteria: * 85\<iq\<115 exclusion criteria: * presence of other medical disorders

Keywords: autism children asd awareness
a multidimensional strategy to improve quality of life of patients with multiple symptoms and palliative care needs

Conditions: Palliative Medicine

Summary: a nationwide, cross-sectional study, to determine the prevalence of symptoms of patients in the palliative phase in various care settings will be performed within a set period of two weeks in september 2018 and two weeks in november 2018. the participating settings will be selected by a total of seven coordinators, one for each consortium of palliative care in the netherlands. to identify common combinations of symptoms and for multidimensional screening the utrecht symptom diary-4 dimensional (usd-4d) and utrecht symptom diary (usd), a dutch instrument based on the edmonton symptom assessment scale, will be used. the current protocol focuses on the cross-sectional study.

the utrecht symptom diary-4 dimensional (usd-4d), a dutch instrument based on the edmonton symptom assessment scale, will be used for multidimensional screening and assessment of intensity and prevalence of symptoms. the questionnaire assesses twelve symptoms: pain, sleeping problems, dry mouth, dysphagia, anorexia, constipation, nausea, dyspnoea, fatigue, anxiety, depressed mood and confusion. this is measured on a numeric scale from 0 (no complaints) to 10 (worst imaginable or intolerable). the prevalence of symptoms will be described by frequencies, dichotomizing symptom scores in absent (0 on nrs) or present (1 or higher on nrs). symptom scores of 4 or higher on nrs are considered clinically relevant. there is a possibility to add two more complaints not enlisted and to prioritise the problems which should be addressed first by the hcp. quality of life is assessed using a (un)well-being measure and the opportunity to score the experienced value of life. finally, five multidimensional questions will screen for mental capacity ("draagkracht"), the relationship with loved ones and thoughts concerning end of life. these multidimensional questions will be filled out together with the hcp. therefore the hcp decides beforehand whether those questions will be asked. the usd-4d will be filled out only once by participating patients without follow-up. the patients will be asked to fill out the following characteristics: age, gender, education level, cultural background, living situation, underlying disease, comorbidities, performance score, medication groups and interventions. the estimated time to fill out both questionnaires is fifteen to twenty-five minutes.

Eligibility criteria:
patient selection will be performed by health care providers in the participating settings. inclusion criterium: • patients of whom the health care professional answers "no" to the question "would i be surprised if this patient died in the next 12 months ?". exclusion criterium: •patients unable or unwilling to self-assess their symptoms
a study to assess the efficacy and safety of axs-02 in subjects with knee oa associated with bone marrow lesions

Conditions: Osteoarthritis, Knee

Summary: this is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the efficacy and safety of axs-02 in subjects with knee osteoarthritis associated with bone marrow lesions.


Eligibility criteria:
key inclusion criteria: * male at least 50 years of age, or postmenopausal female * meets the acr clinical criteria for knee osteoarthritis * bone marrow lesion of the knee present on mri * additional criteria may apply key exclusion criteria: * previous surgery on index knee * any prior use of bisphosphonates within 6 months of screening * additional criteria may apply

Keywords: bone marrow lesions axs02 axsome knee oa osteoarthritis
a retrospective study of patients with tk2d

Conditions: Thymidine Kinase 2 (TK2)

Summary: this is a medical chart review study to collect information for patients who have been taking pyrimidine nucleosides for treatment of tk2 deficiency. information from the time of onset of symptoms will be collected to describe the pre treatment course of tk2 deficiency.

data to be collected from the time of onset of symptoms related to tk2 deficiency includes medical conditions and/or adverse events (aes); these should include relationship to tk2 disease and/or pyrimidine nucleosides, as appropriate, as well as date of onset and severity, when available. when available, test reports may be obtained as well as available research biological samples (eg, blood or tissue samples that may be tested for biomarkers of disease and/or effects of medications to treat the mitochondrial disease).

Eligibility criteria:
inclusion criteria: 1. signed informed consent by the patient or parent(s)/legally authorized representative (lar) and/or assent by the patient (when applicable), unless the associated institutional review board (irb) or ethics committee (ec) provides an appropriate consent waiver 2. confirmed genetic mutation in the tk2 gene 3. availability of medical records for each patient from the time of onset of symptoms 4. patient has taken pyrimidine nucleos(t)ides (dcmp/dtmp and/or dc/dt) as substrate enhancement therapy for tk2 deficiency 5. most recent patient visit at which efficacy and/or safety parameters were collected occurred between 01 june 2018 and 15 december 2018 exclusion criteria: 1. presence of other genetic disease or polygenic disease

Keywords: myopathy, muscle weakness, hypotonia, dysphagia, ptosis
a study to compare the safety, pharmacokinetics and pharmacodynamics of ypi 011 to rabeprazole in healthy adult subjects

Conditions: Gastroesophageal Reflux Disease

Summary: a study to compare the safety, pharmacokinetics and pharmacodynamics of ypi 011 to rabeprazole in healthy adult subjects

this study is to compare the safety, pharmacokinetics and pharmacodynamics of ypi 011 to rabeprazole in healthy adult subjects

Eligibility criteria:
inclusion criteria: * age 19\~55 years in healthy volunteers * bmi is more than 18.0 kg/m\^2 , no more than 28.0 kg/m\^2 * subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing exclusion criteria: * presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system * subjects who were judged ineligible by the investigator
a study evaluating gs-9620 in treatment naive subjects with chronic hepatitis c

Conditions: Hepatitis C

Summary: dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). dose escalation or repetition will be governed by pre-specified safety and activity rules. subjects will be confined on either days 1-3 and/or days 8-10. follow-up visits are also required periodically through day 43. study procedures involve taking blood samples for pharmacokinetic, pharmacodynamic, virologic, and safety assessments.


Eligibility criteria:
inclusion criteria: * males and females 18-65 years old * chronic hcv infection for at least 6 months, treatment naive * hcv viral load \> 100,000 iu/ml at screening * monoinfection with hcv 1 genotype * hepatitis b surface antigen negative * screening ecg without clinically significant abnormalities * bmi 18-33 kg/m\^2 * creatinine clearing \> 70 ml/min * negative pregnancy test at screening exclusion criteria: * pregnant or lactating subjects * co-infection with hepatitis b virus (hbv) or hiv * history of gilberts disease * particular abnormal laboratory parameters * diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe chronic obstructive pulmonary disease (copd), malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed * evidence of hepatocellular carcinoma * on-going alcohol abuse * positive uring drug screen

Keywords: hepatitis hepatitis c chronic hcv hcv treatment naive gilead gs-9620
feasibility and safety of using nasal high flow oxygen postoperatively to reduce respiratory complications

Conditions: Cancer of the Esophagus

Summary: the use of nasal high flow in patients undergoing oesophagectomy is a novel technique that has not been previously studied. nasal high flow will be delivered postoperatively to patients undergoing oesophagectomy in a tertiary cancer referral centre. this single-centre cohort study will evaluate the safety of using nasal high flow in oesophagectomy patients. physiological parameters, adverse events and clinical outcome will be recorded in consecutive patients undergoing oesophagogastric surgery. this study will challenge the hypothesis that the use of nasal high-flow will lower the rates of breathing complications such as pneumonia thereby reducing the demands on intensive care, shortening hospital stay and improving patient quality of life. the results will inform the design of a larger multicentre clinical trial comparing nasal high flow to conventional methods by facilitating sample size calculation.

respiratory complications including pneumonia, pleural effusion, adult respiratory distress syndrome and pulmonary embolism will be recorded. the primary endpoint will be the rate of postoperative respiratory complications within 30 days of oesophagectomy. technical complications related to nasal high flow administration will be recorded and reasons for discontinuing nasal high flow documented. other outcome including mortality, hospital stay, surgical complications and respiratory complications within 90 days of surgery will be considered as secondary endpoints. these data will assess the feasibility and safety of using nasal high flow in patients undergoing oesophagectomy. the rate of respiratory complications will be determined in a cohort of consecutive surgical patients together with other measures of outcome to form the basis of a series worthy of reporting. this may help gain insight into whether using nasal high flow could benefit patients, and whether further research to compare nasal high flow to conventional respiratory support would be of value.

Eligibility criteria:
inclusion criteria: * over 18 years old * undergoing ivor-lewis (2-stage) oesophagectomy * successfully extubated within 4 hours after surgery exclusion criteria: * history of bullous emphysematous disease * lack of capacity to consent * significant air leak during surgery * incurable disease found at surgery leading to no surgical resection * failure of extubation and spontaneous breathing within 4 hours after surgery
kabat technique vs neural mobilization in bells palsy

Conditions: Bell&#39;s Palsy

Summary: the goal of this study is to compare the effect of kabat technique and neural mobilization with facial exercises in improving functional outcomes of patient with bells palsy

bells palsy is seventh cranial nerve disorder which causes muscle weaknesss on one side of the face .various approaches are applied to restore facial function but this study aims to distinguish kabat technique and neural mobilization .this study will assess and compare the functional recovery of facial muscles and improvemrnt in facial symmetry .this will help determine which intervention is more effective .

Eligibility criteria:
inclusion criteria: * patient diagnosed with bells palsy in less than 2 weeks exclusion criteria: * head injuries recent surgeries psycological issues multiple sclerosis

Keywords: kabat technique house brackman scale neural mobilization bells palsy facial disability index
molecular imaging of her2 expression in breast cancer using [99mtc]tc-g3-(g3s)3c before chemo/targeted therapy

Conditions: Breast Cancer Female

Summary: the study should evaluate distribution of \[99mtc\]tc-g3-(g3s)3c in patients with primary her2-positive and her2-negative breast cancer

overall goal of the project: to determine her2 expression level in primary breast cancer before neoadjuvant system therapy (chemotherapy or/and targeted therapy). phase i. distribution of \[99mtc\]tc-g3-(g3s)3c in patients with primary breast cancer. the study should evaluate distribution of \[99mtc\]tc-g3-(g3s)3c in patients with primary her2-positive and her2-negative breast cancer.

Eligibility criteria:
inclusion criteria: 1. subject is \> 18 years of age 2. availability of results from her2 status previously determined on material from the primary tumor and metastatic ln, either a. her2-positive, defined as a dako herceptest™ score of 3+ or fish positive or b. her2-negative, defined as a dako herceptest™ score of 0 or 1+; or else if 2+ then fish negative 3. hematological, liver and renal function test results within the following limits: * white blood cell count: \> 2.0 x 109/l * hemoglobin: \> 80 g/l * platelets: \> 50.0 x 109/l * alt, alp, ast: =\< 5.0 times upper limit of normal * bilirubin =\< 2.0 times upper limit of normal * serum creatinine: within normal limits 4. a negative pregnancy test for all patients of childbearing potential. sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination 5. subject is capable to undergo the diagnostic investigations to be performed in the study 6. informed consent exclusion criteria: 1. any system therapy (chemo-/targeted therapy) 2. second, non-breast malignancy 3. active current autoimmune disease or history of autoimmune disease 4. active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. known hiv positive or chronically active hepatitis b or c 5. administration of other investigational medicinal product within 30 days of screening 6. ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to us national cancer institute's
effectiveness and safety of breeded leech for symptomatic primary arthrosis of the first carpometacarpal joint

Conditions: Rhizarthrosis

Summary: in this trial the investigators want to prove the efficacy and safety of a one-time topical leech application at patients with symptomatic primary arthrosis of the first carpometacarpal joint in comparison to the standard therapy with topical diclofenac.


Eligibility criteria:
inclusion criteria: * male and female patients aged 35 to 85 years * pain intensity in the region of the thumb base in pain phases ≥ 40 mm on the vas of 0 to 100 mm (relative to the last 24 hours) * complaints for at least 3 months * x-ray stadium eaton i-iv at least once secured exclusion criteria: * anticoagulation (marcumar, heparin) * haemophilia, v. willebrandt jürgens syndrome, thrombocytopathy and other blood anomalies * combination therapy of asa and thienopyridines * pain medication with opioid analgesics * systemic medication with corticoids or immunosuppressants * intraarterticular injections or rso within the last 3 months * past or planned surgery on the affected joint in the next 2 months * pregnancy, lactation * insulin-dependent type i diabetes mellitus * acute psychotic disorders * severe comorbidity
neuroplasticity technology for attention-deficit/hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this study evaluates the impact of computerized inhibitory control training on attention-deficit hyperactivity disorder (adhd) symptoms and adhd-linked neural signatures in children with adhd. children were randomly assigned to adaptive computerized training (n=20) or non-adaptive computerized training control (n=20) with identical stimuli and goals.

both medication and cognitive behavioral therapy are effective treatments for many children, however, adherence to both medication and therapy regimes is low. thus, identifying effective adjunct treatments for adhd is imperative. previous studies exploring computerized training programs as supplementary treatments have targeted working memory or attention. however, many lines of research point to inhibitory control (ic) playing a central role in adhd pathophysiology. ic abnormalities in children with adhd have been evidenced both in behavioral performance on computerized tasks as well as in the structure and function of neural systems known to support ic function. furthermore, these ic abnormalities have been linked to symptom severity. given findings that the most successful training interventions for children with adhd are those that have implemented ic training along wtih working memory or attention and previous work demonstrating that ic is a central deficit for children with adhd, it is surprising that no studies have sought to investigate programs that specifically target ic. investigators hypothesize that training ic alone will decrease symptoms of adhd, and information confirming this hypothesis would contribute to making training regimens for children with adhd efficient by identifying the primary cognitive skill that requires intervention. to test this, they administer a randomized control trial of either adaptive of non-adaptive stop signal reaction time (ssrt) tasks to children with adhd and assess effects of training on adhd symptoms and neural activity.

Eligibility criteria:
inclusion criteria: * diagnosis of inattentive or combined subtype adhd by a licensed clinician and consistent acess to wi-fi at home. exclusion criteria: * any known genetic abnormalities, a diagnosis of autism spectrum disorder, or current use of medication for psychiatric disorders other than adhd (e.g. depression, anxiety).
study of travatan and cosopt in primary open-angle glaucoma or ocular hypertension

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: to compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular hypertension


Eligibility criteria:
inclusion criteria: * patient with open-angle glaucoma or ocular hypertension exclusion criteria: * by age