Kornimate/medical-research-clean huggingface dataset:
comparison between histidine-tryptophan-ketoglutarate cardioplegia and cold blood cardioplegia for myocardial protection for fallot tetralogy patients undergoing total repair

Conditions: Anesthesia

Summary: randomized clinical trial: comparison between histidine-tryptophan-ketoglutarate cardioplegia and cold blood cardioplegia for myocardial protection for fallot tetralogy patients undergoing total repair this study aims to compare htk cardioplegic solution and cold blood cardioplegia to provide optimal myocardial protection for a patient with tetralogy of fallot planned for total repair.


Eligibility criteria:
inclusion criteria: * pediatric patients with tetralogy of fallot spectrum. * sex (males and females) * age 6 months- 5 years. exclusion criteria: * persistent left svc draining in the coronary sinus. * mental or neurologic disorders. * preoperative critically ill patients. * parents or legal guardian refusal. * fallot repair with transannular patch( as it will affect on the rv function as a single agent after reperfusion)
circuit training in children with cerebral palsy

Conditions: Spastic Cerebral Palsy

Summary: the aim of our study is to reveal the results of circuit training to be applied to the children with cerebral palsy (cp) for improving their muscular strength and trunk control and also to determine their effects in terms of activity limitations and participation limits.

according the power analyzes totally 62 children, as 31 per each group, who were diagnosed with spastic type cp and accepting participation for the study will be included in this study. for every case, socio demographic data and clinical features will be recorded. in the first session their gross motor function, muscular tonus in lower extremities, isometric strength of lower extremity muscles, functional muscular strength of the trunk and the lower extremities, walking speed and main mobility, functional motor performance will be assessed by a physiotherapist. also satisfaction of children from the exercises, activity and participation level and quality of life will be evaluated. then covariant focused randomization method will be used for having similarity in terms of factors such as; age, gender and motor function levels and also for having a balanced and equal case number of control and intervention group. the control group participants will continue to their own previous physiotherapy approaches (bobath approach, traditional physiotherapy, etc.). "circuit exercise training" will be given to the intervention group participants during 10 weeks, 3 times a week and that changes 50-60 minutes. at the end of the 10 weeks, the above evaluation parameters will be repeated

Eligibility criteria:
inclusion criteria: * the children who were diagnosed with spastic type cerebral palsy. * is aged between 6-18, * is on the i,ii and iii levels according to gross motor function classification system exclusion criteria: * having any surgical operation related to lower extremities for the last 1 year, * having botulinum toxin injection or intrathecal pump for the last 6 months, * taking a new medicine or medicine change for the last 1 month, * visual, hearing and epilepsy problem, * inability to contınuously attend the exercise program, * mental problem that could not be cooperated.

Keywords: circuit exercise trunk control functional strength training
biomarkers in first episode schizophrenia

Conditions: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder, Depressed Type

Summary: this study will identify and evaluate relevant biomarkers and structural brain imaging for understanding potential biological illness related mechanisms in medication-naïve subjects with early psychosis before and after initiation of antipsychotic medication

it is currently unknown whether deterioration early in the course of psychotic illness represents medication toxicity or the natural course of the illness. the study will help clarify this issue in observing 70 schizophrenic patients before and after they are prescribed an antipsychotic via standard of care. in addition, schizophrenia is a heterogeneous disorder and a putative brain-derived neurotrophic factor (bdnf) deficit, while possibly a common pathway, may not fully capture the biological diversity-the supplemental biomarkers will allow us to perform a more comprehensive assessment of factors contributing to clinical course. taken together analysis of these biomarkers in relation to clinical course and in relation to healthy subjects will inform us about biological mechanisms contributing to illness onset, effects of antipsychotic medication on these mechanisms, and the predictive value of the biomarkers for clinical course. this information will provide the foundation for future early intervention trials targeting biological mechanisms utilizing a personalized medicine approach. the baseline visit for 70 schizophrenic patients and 70 healthy age and gender matched controls consists of structural and functional mri in addition to a blood draw for biomarkers including bdnf, inflammation markers, dna, oxidative stress, and folate status and additionally a salivary cortisol sample collection. biomarkers and imaging will be repeated after 8 weeks of antipsychotic treatment in patients.

Eligibility criteria:
inclusion criteria: 1. male or female 2. ages 15-40 years 3. schizophrenia, any subtype or schizophreniform disorder 4. sufficient proficiency in english or spanish to complete assessments (us) exclusion criteria: 1. major depression by the diagnostic and statistical manual of mental disorders iv criteria 2. calgary depression scale for schizophrenia (cdss) score of 7 or greater. 3. clinical global assessment of severity of suicidality of 3 (moderate) or greater. 4. serious suicide attempt within three years 5. treatment with an antipsychotic or antidepressant within the last six months 6. active alcohol or other substance abuse or dependence within one month 7. unstable medical illness
dynamic mri evaluation post operative stapled trans anal rectal resection (starr) procedure

Conditions: Obstructive Defecation Syndrome; Outlet Obstruction

Summary: the purpose of this study is to assess the effects of the stapled trans anal rectal resection (starr) procedure for patients with obstructive defecation syndrome. this involves a dynamic pelvic mri and obstructive defecation score (ods) at 6 month post starr procedure.

the use of dynamic pelvic mri has greatly impacted our preoperative evaluation of pelvic floor disorders, both anatomically and functionally. the starr procedure is a new approved procedure for patients with obstructive defecation, who have failed conservative therapy of medications and aggressive pelvic floor retraining. most patients have also been screened for colonic transit problems. the traditional study for evaluating these patients was defecating proctograms. with the advent of the dynamic pelvic mri, we are now beginning to understand the interaction of the entire pelvic structure in the complex act of defecation. this study is providing us a different view of the pelvic structures to better understand the pathophysiology of this disorder. the defecating proctogram, though informative in certain cases, lacks information outside the rectum. we wish to evaluate and compare our preoperative dynamic pelvic mri with a six month dynamic pelvic mri in 10 patients. we also will compare pre and post op obstructive defecation scores (ods). we expect this small sample to direct us to a much more pointed evaluation of this disorder.

Eligibility criteria:
inclusion criteria: * patients willing to have a follow-up with a dynamic pelvic mri and complete an obstructive defecation score (ods) at 6 month post starr procedure at mayo clinic - jacksonville exclusion criteria: * patients with medical devices/implants or who cannot have follow-up dynamic pelvic mri

Keywords: dynamic pelvic mri dynamic mri starr procedure starr ods obstructive defecation syndrome outlet obstruction obstructed defecation stapled trans anal rectal resection
next generation probiotics (ngps) for metabolic health

Conditions: Microbial Colonization

Summary: to identify differences in the intestinal microbiota by metagenomics analyses between lean and obese subjects


Eligibility criteria:
inclusion criteria: 1. females. 2. age between 20 to 50 years. 3. obtained his/her informed consent after verbal and written information. 4. sufficient general health and orientation for participating in the study as evaluated by the study personnel. 5. have a high probability for compliance with and completion of the study. 6. available for study visits and availability for food 7. normal gastrointestinal function. 8. willingness to provide faecal, urine and blood samples and keep food diary exclusion criteria: lactobacillus rhamnosus gg or reuteri, bifidobacteria enriched products) in the past 6 weeks. 12. use of anti-obesity drugs. 13. active or recent (last 3 months) participation in a weight loss program including weight change (increase or loss) of 3 kg during the past three months. 14. special diets e.g. vegetarian, vegan, diets with intention to use certain limited food groups only (like paleo diet, egg-grape diet etc.) 15. history of chronic active inflammatory disorders. 16. history of bariatric surgery. 17. regular use of non-steroidal anti-inflammatory drugs, corticosteroids, or equivalent immunomodulatory drugs. 18. ongoing or recent (last 3 months) antibiotic treatment. 19. immunosuppression or ongoing therapy causing immunosuppression. 20. use of vitamin supplementations beyond recommended daily intake levels during the previous 2 months and during the study, except for vitamin d supplementation up to 20 μg/day.
personalized fet in rif patients with displaced dating

Conditions: Infertility, Female

Summary: the endometrium becomes receptive as a result of a series of timed hormonal events during the menstrual cycle. the exposure of the endometrium to progesterone after ovulation initiates morphological and functional alterations that result in the change from a pre-receptive to a receptive endometrium. the morphological changes observed on histology for each specific day after ovulation were described by noyes and his colleagues in 1950. an endometrial biopsy that shows a difference of more than 2 days between the histologic dating and actual day after ovulation is considered to be "out of phase" however, the clinical application of the noyes criterion is relatively limited. we have verified the noyes criterion in natural cycle in previous study which conducting endometrial biopsies respectively on day 3, 5, 7, 9 and 11 of post-ovulation (po+3/5/7/9/11)(unpublished data). the clinical value of the endometrial histological dating in rif patients in natural cycle is still to be answered. in this study, we tried to investigate the clinical effects of pfet in unexplained rif patients according to the use of classic histologic endometrial dating to estimate the timing of the window of implantation and to adjust embryo transfer time in natural cycle.


Eligibility criteria:
inclusion criteria: 1. rif patients (rif is defined as the absence of a gestational sac on ultrasound at 5 or more weeks after 3 embryo transfers with high quality embryos or after the transfer of ≥10 embryos in multiple transfers); 2. out of phase dating patients; 3. fet in natural cycle; 4. single blastocysts embryo transfer; exclusion criteria: 1. uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus and uterine mediastinum), intrauterine adhesions, endometriosis,adenomyosis, hydrosalpinx, and uterine fibroids (submucosal fibroids, non-mucosal fibroids\> 4 cm and/or endometrial pressure);
b14 meningococcal carriage in seine-maritime population: prevalence study and search of risk factors

Conditions: Meningococcal Infections

Summary: our main objectives are to evaluate the importance of meningococcal carriage and to determine the predisposing factors


Eligibility criteria:
inclusion criteria: * living in the area of dieppe * parental authority assent if necessary exclusion criteria: * child under supervision

Keywords: carriage neisseria meningitidis risk factors
migration pattern of c-stem amt versus exeter in total hip arthroplasty

Conditions: Coxarthrosis

Summary: hypothesis: migration of c-stem amt is equal to the well documented exeter prosthesis in norway it is annually performed approximately 600 primary and 100 revisions tha. osteolysis around the prosthesis is one of the major difficulties while performing revision surgery. c-stem is a triple tapered cemented prosthesis designed to increase the stress and strain of proximal femur and thereby decreasing osteolysis. we are planning til include 70 patients and randomize to c-stem amt or exeter prosthesis. both prosthesis will be combined with previously non documented "marathon" acetabular prosthesis. the result will be followed clinically and with rsa and dxa. soft endpoint after 2 years


Eligibility criteria:
inclusion criteria: * coxarthrosis exclusion criteria: * age over 80 * major medial condition such as renal failure, chronic obstructive lung disease heart failure etc

Keywords: coxarthrosis hip rsa dxa c-stem amt marathon
investigating proximal migration in trabecular metal cups used in acetabular revision surgery

Conditions: Prosthesis Loosening

Summary: this study is intended to compare the proximal migration of the tantalum design (tm) with a cemented cup used in conjunction with bone allografting in cases with major bone loss. a group of patients with good periacetabular bone stock are included to analyse the differences between the tantalum and titanium design regarding risk of loosening and differences in clinical outcome measures. radiostereometry (rsa) is used to accurately measure migration and rotation of the revision cups.

acetabular component loosening is often associated with periacetabular bone loss. different approaches are described to address the bone defects in acetabular revision surgery. several authors have reported inferior results when uncemented titanium alloys and older porous coated designs are used in acetabular revisions with significant bone loss. cemented fixation of the revision cup with impaction bone grafting (big), introduced more than three decades ago has today a thorough documentation. the tantalum designs, with inherent properties such as high volumetric porosity, low modulus of elasticity and high friction against the bone, have been suggested to improve the fixation of the acetabular component. several authors have been reporting promising short- and medium-term results using the tm designs in acetabular revisions with large periacetabular bone defects. proximal migration measured with radiostereometry (rsa) has been suggested to predict risk for late aseptic loosening in hip prosthesis surgery. this study was primarily to compare the proximal migration of the tantalum design with a cemented cup used in conjunction with bone allografting in cases with major bone loss. a group of patients with good periacetabular bone stock are included to analyse the differences between the tantalum and titanium design. rsa is used to accurately measure migration and rotation of the revision cups.

Eligibility criteria:
inclusion criteria: all patients with a loose acetabular component, undergoing revision exclusion criteria: patient not able to understand the intention of the study
effects of pulmonary rehabilitation on quality of life and health in pulmonary arterial hypertension patients

Conditions: PAH; CTEPH

Summary: pulmonary hypertension (ph) is a major global health concern, affecting approximately 1% of the world's population. with global aging and increased life expectancy, its incidence continues to rise. ph is a progressive and disabling disease, with studies showing its progression correlates with worsening symptoms and increased mortality. even with targeted medications, the prognosis remains poor across ph subtypes, with pah patients showing only a 49% 7-year survival rate. the 2022 esc/ers guidelines emphasize that ph management requires a comprehensive, multidisciplinary approach. beyond pharmacological and surgical treatments, rehabilitation has demonstrated benefits in improving exercise capacity, quality of life, functional class, and peak oxygen consumption. however, research on specific and effective comprehensive pulmonary rehabilitation programs remains lacking.


Eligibility criteria:
inclusion criteria:confirmed ph diagnosis: right heart catheterization-confirmed pulmonary hypertension meets 2022 esc/ers guidelines diagnostic criteria for: * group 1 (pah) or * group 4 (cteph/other pulmonary artery obstructions) stabilized treatment status: group 1 (pah): received ≥3 months of targeted drug therapy group 4 (cteph): completed ≥6 sessions of bpa\* or reached therapeutic endpoint functional capacity: who functional class i-iii age: ≥18 years consent: willing to provide written informed consent - exclusion criteria:physical limitations: unable to perform pulmonary rehabilitation exercises due to disability or congenital malformations cardiopulmonary testing contraindications: medically unfit to complete cpet (cardiopulmonary exercise testing) after evaluation poor compliance: history of non-adherence making protocol completion unlikely life expectancy: prognosis ≤1 year -
effect of a health promotion intervention for people with chronic pain at a healthy life centre

Conditions: Chronic Pain

Summary: the study's primary objective is to test the hypothesis that a group-based health promotion intervention with patient education and practical exercises delivered at a healthy life centre increases patient activation in people living with chronic pain. due to many people living with chronic pain, interventions focusing on self-management and coping are on the agenda in primary care. this study will investigate whether a healthy life centre in a municipality is a suitable setting for interventions targeting people living with chronic pain. short and long term effect of an intervention developed in a health promotion and salutogenic framework will be investigated in a randomized clinical trial.

previous research indicates that if self-management interventions are developed within a health promotion framework focusing on the participants' strengths, there is a beneficial effect on patient activation and thus on self-management behaviour. however, there is a lack of knowledge about which interventions will improve patient activation for persons with chronic pain. to be sustainable, such interventions should be delivered using the least possible amount of resources needed to get an effect. one way to do so is to deliver the intervention in primary care instead of in hospitals. the healthy life centre is ideally situated to deliver these interventions. this is especially true due to their task of focusing on health promotion but also because they are set up to deliver low level interventions, meaning that it should be easy for everyone to access their services.

Eligibility criteria:
inclusion criteria: * pain for 3 months or more * able to participate in one hour physical activity exclusion criteria: * not fluent in norwegian * chronic pain arising from active malignant disease * serious mental health illness * substance abuse issues

Keywords: patient education as topic health promotion patient participation self efficacy
role of the kallikrein-kinin system in septic cardiomyopathy

Conditions: Sepsis

Summary: the purpose of this study is to investigate whether there are differential expressions of molecules in the kallikrein-kinin system (kks) pathway in septic cardiomyopathy, and to analyze their regulatory mechanisms and gene expression changes.

this study is designed as a prospective, single-center, prospective case-control study. the research plan mainly aims to collect clinical data and blood samples from patients with septic cardiomyopathy and the control group within the next 3 years (october 2023 to october 2025). diagnostic criteria are as follows: (1) diagnosis of sepsis is based on the sepsis 3.0 criteria, which is defined as a rapid increase in sofa score by ≥2 points after infection as a clinical criterion for sepsis-related organ dysfunction. (2) diagnostic criteria for septic cardiomyopathy include: diagnosis of sepsis and elevation of cardiac markers \[cardiac troponin i (ctni) or bnp\]; systolic dysfunction: echocardiography shows lvef \ 200 pg/ml; left ventricular fractional shortening (fs) \> 25%; normal or increased wall thickness, decreased left ventricular filling rate.

Eligibility criteria:
inclusion criteria: (1) age range greater than 18 years. (2) patients diagnosed with septic cardiomyopathy. (3) clear determination of the cause of myocardial injury, such as the source of infection, bacterial culture results, etc. (4) patients who are capable of cooperating and completing the necessary examinations and treatments. - exclusion criteria: (1) presence of other significant underlying cardiovascular diseases, such as coronary heart disease, heart failure, etc. (2) presence of other organ dysfunction that poses a significant threat to life, such as respiratory failure, liver failure, etc. (3) presence of severe infections or inflammatory diseases unrelated to myocardial injury, such as severe acute pancreatitis. (4) history of receiving interventional treatments, such as immunomodulatory agents, anti-inflammatory drugs, etc. (5) pregnant or lactating women. (6) pediatric patients who are under the age of majority. -

Keywords: sepsis; septic cardiomyopathy; kks
an intervention to improve prolapse using femmeze® (v1)

Conditions: Rectocele; Pelvic Organ Prolapse

Summary: the main purpose of the feasibility study is to identify the patient experience of femmeze® which is a device aimed at improving posterior vaginal compartment prolapse (rectocele) for women with obstructive defaecation. the investigators want to investigate implementation and preliminary effectiveness of the device. the method of investigation will be a pre-post intervention design, which involves asking 30 women to use femmeze® over a period of 8 weeks. this is an academic study on a labelled indication (http://www.nres.nhs.uk/search/?q=medical+devices).

aim evaluate the feasibility of the femmeze® device to improve management of posterior vaginal compartment prolapse addressing implementation of the intervention and preliminary effectiveness. objectives * demonstrate effectiveness of the device (comfort, ease of use, empty the rectum of stool more easily than their current approach and quality of life) * identify which stage of prolapse the device would be most suitable * identify any changes to the device or instructions for use (needs adjustment to its design in terms of length/width) the study will use a pre-post intervention design with the aim of evaluating the feasibility of the intervention (using the device); and identifying any implementation issues and preliminary effectiveness. the participants will be followed prospectively to compare the device against their own usual care. usual care in this context will be using their fingers to help empty their rectum of stool. participants will be invited to complete a semi-structured interview to understand their lived experience. a patient and public involvement group has contributed to improving the study methods.

Eligibility criteria:
inclusion criteria: * adult women (over 18 years of age) with symptoms of obstructive defaecation * not undergone posterior vaginal compartment prolapse surgery exclusion criteria: * cognitive impairment * hand disability * refuse to give informed consent * pregnancy * less than 12 weeks post-partum * neurological disease

Keywords: splinting