Kornimate/medical-research-clean huggingface dataset:
daa treatment in donor hcv-positive to recipient hcv-negative liver transplant

Conditions: End Stage Liver Disease; Hepatitis C

Summary: this is a single center study for the donation of hepatitis c virus (hcv)-positive livers to hcv negative recipient patients, with preemptive, interventional treatment to prevent hcv transmission upon transplantation.

patients will be selected based on diminished likelihood of receiving a liver from the waitlist within a period during which they would be likely to succumb to severe comorbidities. this will be determined in part through use of a patient's model of end stage liver disease (meld) score, listing status, and clinical judgment. to ensure maximal benefit for the recipient, only high quality donor livers will be accepted.

Eligibility criteria:
inclusion criteria: * recipient is age ≥ 18 years * met massachusetts general hospital (mgh) transplant center criteria, listed for liver transplant * hcv naïve * able to sign informed consent exclusion criteria: * pregnant or nursing (lactating) women * human immunodeficiency virus (hiv) positivity * need for dual organ transplant * any contra-indication to liver transplantation per center protocol

Keywords: hcv epclusa esld
comparison of two different insole types in painful flexible flatfoot

Conditions: Flatfoot

Summary: the purpose of this study is to compare computer aided design/computer aided manufacturing (cad/cam) and semi-custom insole types on pain, quality of life and physical performance and also to decide whether they are necessary in treatment of painful flexible flatfoot.


Eligibility criteria:
inclusion criteria: * minimum subtalar pronation of 5 degrees while standing (tibiocalcaneal angle, measured with goniometer), * minimum of + 6 points on the foot posture index, exclusion criteria: * treatment of the foot for at least six months, * leg length discrepancy of more than 1 cm, * history of lower extremity surgery, and no disease that could affect lower extremity biomechanics.

Keywords: orthotic insoles pain quality of life athletic performance
martial arts as early intervention for teen drug abuse

Conditions: Adolescent; Substance Use

Summary: this is a stage 1a/1b behavioral therapy development project with the aim of developing and piloting an early intervention based upon traditional martial arts for adolescents who are in the early stages of substance use/misuse. the primary aims of this study are: 1) to develop a manualized version of an existing, typical traditional martial arts program, modified to target a reduction in substance use and the associated behavioral and psychosocial problems for adolescents in the early stages of substance use or misuse, based on principles derived from empirically-based prevention programs. 2) to obtain preliminary pilot data on recruitment feasibility, validity of assessments, and estimates of the effect size of the intervention in reducing substance use and improving prosocial behavioral and psychosocial outcomes. 3) to refine and further develop the manualized program based on pilot data and utilizing feedback from the initial cohort of participants, traditional martial arts program instructors and substance abuse treatment experts. the goals of these revisions would be to maximize the impact of the program on substance use and behavioral outcomes, while retaining the core features of a traditional martial arts program to ensure the feasibility of implementing, sustaining, and disseminating such a program in existing community-based martial arts programs. 4) to develop procedures for training interventionists (i.e., martial arts instructors and research assistants) and for monitoring program adherence to ensure fidelity. 5) to conduct a small pilot study of the refined manualized program to enable us to estimate the effect size of the intervention and provide information for estimating power for a larger randomized controlled trial should the results of this intervention prove promising in terms of positive impact on the primary and secondary outcome measures: decreased drug use and improvement in psychosocial functioning and behavioral problems (including aggression).


Eligibility criteria:
inclusion criteria: subjects must: 1) be 13 through 17 years old, 2) be of estimated average intelligence (iq\>80), 3) have current or recent drug/alcohol use as evidenced by a history of substance use of at least 2 times in the 12 weeks prior to study inclusion, and 4) be medically healthy. exclusion criteria: subjects will be excluded if they 1) meet criteria for substance dependence (other than for nicotine) based on consensus between the composite international diagnostic interview- substance abuse model (cidi-sam) and clinical interview, 2) have a history of or currently have psychosis (not explained by drug use), or bipolar disorder that is currently unstable, 3) are currently receiving psychotherapy or some form of behavioral therapy, 4) have a chronic medical illness or condition that would keep them from fully participating in physical activity, 5) have been started on a psychotropic medication in the 30 days prior to study inclusion, or 6) are pregnant.

Keywords: adolescent substance use early intervention martial arts karate
effectiveness of trauma-focused cognitive-behavioral therapy (tf-cbt) for children with post-traumatic stress disorder (treatchildtrauma)

Conditions: Post-Traumatic Stress Disorder

Summary: this multi-site randomized controlled trial compares the effectiveness of trauma-focused cognitive-behavioral therapy (tf-cbt) as developed by cohen, mannarino \& deblinger (2006) with a wait-list condition in a population of children aged 7-16 years who were exposed to traumatic events beyond the age of three years, at least three months ago, and developed posttraumatic stress disorder (ptsd). primary aims are to provide evidence that tf-cbt exceeds spontaneous remission of posttraumatic stress symptoms and to assess maintenance of treatment gains at 6 and 12 months post-treatment. secondary aims are to evaluate the effectiveness of tf-cbt in reducing other psychopathology and cognitive distortions of patients and caregivers and to explore moderators and mediators of treatment response. the trial will contribute to implement an evidence-based treatment for traumatized children across a variety of healthcare settings in germany. the novel aspect is to evaluate the effectiveness of tf-cbt with a broad range of traumatized "real-world" patients in the context of the german mental healthcare system.

complete study protocol (in german) available from the pi lutz.goldbeck@uniklinik-ulm.de

Eligibility criteria:
inclusion criteria: * age 7-16 years * exposure to a traumatic event (index trauma) after the age of 3 years, at least 3 months before assessment * ≥35 points on the clinician -administered ptsd scale for children and adolescents (caps-ca) total symptom severity score and at least one symptom per ptsd cluster related to the index trauma according to dsm iv diagnostic criteria * ptsd should be the main mental health problem, patients with co-morbid mental disorders are included * no major brain injury of the child due to the traumatic event (glasgow coma scale \<9 points at primary medical examination) * co-operation of at least one non-offending primary caregiver (improves treatment outcome) * living within reasonable distance (max 1 hour of travel) to the treatment center to allow treatment on a weekly basis (feasibility) exclusion criteria: * psychosis * acute suicidality * psychopharmacological medication started or changed up to 6 weeks before first assessment

Keywords: ptsd children and adolescents post-traumatic stress disorder in children and adolescents
the effect of pilates group exercise program

Conditions: Sedentary Lifestyle

Summary: introduction and aim: the pilates exercises were introduced by joseph pilates in the 1920s, originally called 'centering'. these exercises work on 6 simple principles with or without special equipment. these principles are; centering, concentration, tenderness, flow and respiration. (yamato et al., 2016) functional movement analysis is a screening system developed by physiotherapist gray cook. functional deficits of the person are detected by 7 different movements (cook, burton and hoogenboom 2006a, cook, burton and hoogenboom 2006b). in a single study they compared in the literature that assessed the effect of pilates exercises on functional movement, this activity was explored on recreational runners (laws, williams and wilson 2017). the aim of this study was to investigate the effect of 12-week pilates group exercise training on functional movement scores in sedentary women. secondarily; posture, depression level and quality of life will be evaluated. material-methods: this study has been reviewed by ethics committee of non-interventional researches of the university of medipol in istanbul and its ethical conformity has been approved. (10840098-604.01.01-e.45484). participants were informed of the voluntary consent form and signed the consent form. participants 20 sedentary women were included in the study between 30-50 years of age. evaluations demographic information (age, occupation, height, weight) of the persons will be recorded.functional movement analysis; postural analysis, depression level; health related life quality will be recorded. application pilates exercises will be applied by a qualified physiotherapist with an internationally recognized certificate on the subject. participants will be asked to come up with suitable outfits. the exercise room will be set at the ideal temperature and well ventilated. the exercises to be done in the form of group exercises will be started with an entry level, and the level of the exercises will be increased appropriately in the following weeks. each group will consist of no more than 10 people and the exercises will continue for three sessions per week for 12 weeks. the evaluations will be repeated before exercise, at the end of 12 weeks of exercise and after 3 months from finish of the exercise period.


Eligibility criteria:
inclusion criteria: * have not had a surgical operation involving the musculoskeletal system in the past six months. * not to have a systemic disease leading preventing from exercise. * not having had any exercise in the last 3 months. exclusion criteria: * do not want to continue exercises. * to feel pain, discomfort during tests.

Keywords: sedentary pilates exercises functional movement screen posture quality of life
analyzing orthopedic patient experience patterns in medical trials

Conditions: Orthopedic Disorder

Summary: clinical study enrollment has historically been heavily biased toward specific demographics. several people will be invited to participate in this study so that it may collect a variety of data about orthopedic clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal. people with orthopedic disorders who are invited to take part in medical research will benefit from the analysis of the data.


Eligibility criteria:
inclusion criteria: * patient has been diagnosed with orthopedic disorder * patient has self-identified as planning to enroll in an interventional clinical trial * patient is 18 years old exclusion criteria: * ecog score of 4 * patient is pregnant * inability to perform regular electronic reporting * patient does not understand, sign, and return consent form

Keywords: orthopedic
positron emission tomography - computed tomography (pet-ct) scan as a diagnostic method in unknown primary tumors

Conditions: Unknown Primary Tumor

Summary: is pet-ct scan better than pet or ct alone in diagnosing primary tumours in patients with unknown primary tumors? can information obtained with pet-ct replace other clinical and radiological investigations? is pet/ct cost-effective?

patients who fulfill the international definition of unknown primary tumors can be included, except: * young men (\<55 years) with growing mid-line tumors where a germ cell tumor could be expected will not be included. * patients with lymph-node metastases with squamous cell carcinoma in the head and neck region will not be included. * women with adenocarcinoma in lymph nodes in the axilla will not be included.

Eligibility criteria:
inclusion criteria: * unknown primary tumors exclusion criteria: * young men (\<55 years) with growing mid-line tumors where a germ cell tumor could be expected will not be included. * patients with lymph-node metastases with squamous cell carcinoma in the head and neck region will not be included * women with adenocarcinoma in lymph nodes in the axilla will not be included

Keywords: unknown primary tumor pet-ct
knee osteoarthritis, aging and metabolic syndrome

Conditions: Knee Osteoarthritis

Summary: osteoarthritis (oa) is the most prevalent form of arthritis. its pathogenesis remains poorly understood. though historically regarded as a disease of mechanical degeneration, it is now appreciated that inflammation plays an important role in oa pathogenesis

1. place of the study: sohag university hospital. 2. type of study: cross-sectional observational study 3. study period: six months to one year the study will include patients who met the american college of rheumatology (acr) clinical criteria for knee oa . the following details will be obtained: * demographic data : age ,sex ,marital status ,occupation ,residence ,education level ,anthropometrical measures which included waist circumference (wc) and blood pressure (bp) will be obtained,history of chronic diseases (eg; diabetes mellites, hypertension) * clinical information: symptom and its duration. plain radiographs of at least one knee \[anteroposterior (a/p), lateral} will be taken. * laboratory findings included fasting blood sugar, serum levels of triglycerides, high-density lipoprotein cholesterol and total cholesterol.

Eligibility criteria:
inclusion criteria: * patients who met the american college of rheumatology (acr) clinical criteria for knee oa and had symptomatic oa of at least 1 knee (index knee), with a kellgren / lawrence (k/l) score ≥ 1 in that knee exclusion criteria: * any patient with a history of trauma to the knee * any other form of arthritis (e.g., rheumatoid arthritis, seronegative spondyloarthropathies, gout, pyrophosphate disease, or other crystal arthropathy)

Keywords: knee osteoarthritis aging metabolic syndrome
study on early intra-aortic balloon pump placement in acute decompensated heart failure complicated by cardiogenic shock

Conditions: Cardiogenic Shock

Summary: the aim of the study is to demonstrate the superiority of early intra-aortic balloon pump implantation at admission over local clinical practice (pharmacological only) in acute decompensated heart failure patients with cardiogenic shock, with respect to 60-day survival or successful bridge to heart replacement therapies (heart transplant or left ventricular assist device implantation).

cardiogenic shock (cs) is the most severe form of acute heart failure, with in-hospital mortality up to 50%. failure to improve mortality has been reported, despite observed improvements in hemodynamics. previous studies on cs have almost exclusively been focused on cs following an acute coronary syndrome (acs). chronic heart failure patients with acute decompensation (adhf) and cs represent a unique physiologic phenotype compared with acs patients, which may lead to a differential response to device therapy. recent evidences emphasize that intra-aortic balloon pump (iabp) is not recommended for patients with acs-related cs, but it is associated with a high likelihood of bridge to durable left ventricular assist device or heart transplant without the need for escalation to more potent temporary mechanical circulatory support devices, when implanted in adhf patients. data retrieved from the available literature in the setting of patients with cs not related to acs are poor even in large, well-reported registries. accordingly, altshock-2 trial has been designed to test the superiority of early iabp implantation at admission over local clinical practice (pharmacological only) in adhf patients with cs, with respect to 60-day survival or successful bridge to heart replacement therapies

Eligibility criteria:
inclusion criteria * age ≥ 18 and \< 75, men and women; * need of vasoactive agents to maintain sbp \> 90 mmhg or map \> 60 mmhg. * left ventricle systolic function ≤35% * scai b-d according to cswg definition (jacc 2022) exclusion criteria * septic shock with evident septic focus; * severe peripheral vascular disease * cs secondary to cardiac and non-cardiac surgery; * acute myocardial infarction within 1 month; * suspected or documented myocarditis * pulmonary embolism * chronic end-stage organ dysfunction that would preclude heart transplant/durable vad * ominous prognosis (life expectancy \< 1 year); * any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial * pregnant, lactating or women planning pregnancy during the course of the trial.

Keywords: acute decompensated heart failure cardiogenic shock intra-aortic balloon pump
pecto-intercostal fascial block for postoperative analgesia after cardiac surgery

Conditions: Coronary Artery Disease; Sternal Pain

Summary: the purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (pifb) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.

the purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (pifb) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline. specific aim 1: to determine whether or not a pifb with bupivacaine can reduce postoperative pain after cardiac surgery. this will be assessed through: (aim 1a) opioid consumption in the first 48 hours postoperatively (aim 1b) patient self-reported pain scores during their hospital stay specific aim 2: to estimate the effect size in order to obtain information that can be used to power future research on the use of regional modalities of analgesia for cardiac surgeries.

Eligibility criteria:
inclusion criteria * patients 18 years of age or older * undergoing cardiac surgery with sternotomy, limited to cabg, cabg+valve surgeries and isolated valve surgeries. exclusion criteria * current participation in another interventional study * preoperative lvef \< 30% * use of mechanical circulatory support * emergent procedures * aortic surgeries, transplants ventricular assist device insertions, bentall, or grafts * minimally invasive cardiac procedures or those with thoracotomy approach * patients receiving other modalities of regional anesthesia like intrathecal morphine * chronic opioid use for chronic pain conditions with tolerance (total daily dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year) * current use of tca, gabapentin, or pregabalin * hypersensitivity to bupivacaine * women who are pregnant or breastfeeding * non english speaking

Keywords: cardiopulmonary bypass cardiac surgery sternotomy
qualitative study for pain measurement using innovative health technology

Conditions: Pain Measurement; Pain, Chronic; Pain, Acute; Pain, Cancer

Summary: the present study is a multicenter, explorative, qualitative study. the primary endpoint of this study is to evaluate to which extent the collection of data with regard to pain caused by illness or treatment can be optimized using health technology solutions. for this evaluation semi-structured qualitative interviews with 8-10 patients will be conducted. secondary variables are the evaluation of the patients' pain experience and the general patients' willingness to collect data with regard to pain by using technological devices themselves or with support of healthcare professionals.

the present multicenter study is an explorative, qualitative study. it shall be evaluated from the patients' point of view if and how the collection of data with regard to pain, caused by illness or treatment, can be optimized using health technology solutions. a health technology solution could for example be an app for registering the intensity and localization of pain. the aim of this study is to examine, if such a solution would be accepted by patients with acute or chronic pain and how a fitting solution should be designed to meet the patients' requirements. existing methods for pain measurement as well as possibilities for the development of new methods will be examined and evaluated during the interviews. to arguable this issue the interviews comprise different topics like: * the patients pain experience in everyday life, e.g. how the patients cope with pain in everyday life and how and if this is documented; * experiences with and the thought of regular pain recording; * an evaluation if patients tend to be willing to record their pain using technological devices by themselves or rather with support of healthcare professionals. it is the aim to use the results of this study for the development of a new and improved version of pain registration. the results of the study will be summarized in a report and handed over to a startup company. thereupon the startup company has the possibility to develop a technological solution that represents the patients' need at its best.

Eligibility criteria:
inclusion criteria: * 18 years or older * pain intensity \> 4 (numeric ranking scale 0-10) * legal capacity * written informed consent exclusion criteria: * lack of willingness to cooperate * lack of consent * lack of ability to follow instructions * younger than 18 years

Keywords: pain measurement pain, chronic or acute pain, cancer health technology