Kornimate/medical-research-clean huggingface dataset:
orchestra pregnancy observational study in poland

Conditions: Type 1 Diabetes Mellitus; Pregnancy

Summary: the aim of this project is to document the use of insulin pump therapy (csii), including sensor augmented pump therapy (sap), before, during and after pregnancy in women with type 1 diabetes mellitus benefiting from the orchestra donation of paradigm real-time and paradigm veo pumps in poland.

the project is designed as a multi-center prospective observational post-market-release study to be conducted in up to 30 centers in poland. total duration of the study per patient will be up to 22 months (up to 12 months pre-conception phase, pregnancy, and 6 weeks after delivery). the optimal study start is the beginning of pre-conception phase, however, pregnant women up to the 16th week of pregnancy can participate in the study too. the study end is 6 weeks after delivery. if conception does not occur within 12-months, the patient's study participation is terminated, and the insulin pump might be taken away from the patient. the following therapy is decided by the investigator. if the pump is not taken away after the 12-month of trial period for conception, the patient can continue insulin pump therapy until the pump is needed for another patient.

Eligibility criteria:
inclusion criteria: 1. female diagnosed with diabetes mellitus type 1 2. subject indicated by hcp to start insulin pump therapy (csii) or sensor augmented pump therapy (sap) due to the desired or established pregnancy 3. hcp has prescribed the use of orchestra donated device to the subject independently of the study 4. signed patient informed consent (pic) 5. subject is 18 to 45 years old, planning immediate pregnancy (within the next 12 months) or being pregnant within the first trimester until the 16th week of amenorrhea 6. subject has been on mdi for at least 3 months before starting pump therapy exclusion criteria: 1. subject was enrolled in the registry earlier, and terminated it (for any reason) 2. participation in any other interventional clinical trial - currently and/or in the last 3 months before the signature of pic 3. subject uses an insulin pump that was not donated by the orchestra foundation 4. pregnant women with longer than 16 weeks of pregnancy/amenorrhea 5. subjects who need assisted in vitro fertilization 6. subjects with diabetes mellitus type 2, gestational diabetes, mody or any other type of diabetes than type 1 7. subject under the age of 18 8. subject legally incompetent 9. subject cannot read or write

Keywords: type 1 diabetes mellitus - t1dm pregnancy insulin pump glucose sensor continuous subcutaneous insulin infusion - csii sensor augmented pump - sap continuous glucose monitoring - cgm
user-centred assistive system for arm functions in neuromuscular subjects

Conditions: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Muscular Dystrophy, Becker; Muscular Dystrophy, Limb-Girdle Type 2

Summary: restore a lost function is a special experience for people affected by neuromuscular evolutive diseases. "from the patient's point of view improvement is measured by regaining lost abilities,-by being able to do something -anything-today i couldn't do yesterday ". upper limb pain, stiffness and activity limitations have a crucial role in reducing patients' autonomy and worsening quality of life. real users' needs have been identified thought several workshops, and even if the commercial products might assure a benefit to some users and meet most of their requirements, so far a validation of the use of such devices by people with neuromuscular disease is missing. we aim at field-testing the improvement in arm functions provided by the use of some commercial devices and assessing their impact to users' quality of life and independence. this step is essential to assure a widespread accessibility to these devices for most of the potential users, possibly providing health providers with direction and guidance towards health technology assessment. clinical trial design - the study proposes on-field validation of jaeco wrex, passive antigravity exoskeleton; and armon ayura, motorized arm exoskeleton for gravity compensation in a randomized controlled trial with crossover design. the clinical study will is multi-centric, involving both medea and valduce, and received the ethical committee approval.


Eligibility criteria:
inclusion criteria * signed informed consent (we will expose the family the aims of our study and carefully describe the need of compliance with them) * diagnosis of muscular dystrophy (genetic, histological and biochemical if necessary),specifically with duchenne, becker and limb girdle type 2 muscular dystrophy. no muscle biopsy will be performed, except in case there is a diagnostic need. * being wheelchair bound * having a scoring at the mrc scale for upper limb at the deltoid, biceps, triceps brachii muscles ranging from 2 to 4. exclusion criteria * presence of additional diseases (for example: family history of mental retardation, epilepsy, cerebral palsy) * behavioral and psychiatric disturbances (emotional problems, depression) * absence of compliance to the study of the family and the caregivers

Keywords: assistive devices randomized controlled trial (rct) upper limbs robotic devices
transurethral ventral wall of urethra-preserving enucleation of prostate

Conditions: Benign Prostatic Hyperplasia

Summary: in this study, the investigators designed a randomized and double-blind prospective trial to evaluate the efficiency and safety of the investigators new approach-transurethral ventral wall of urethra-preserving enucleation of prostate in comparison with turp for the hyperplasia weighing more than 45 g.

although in recent dozen of years, laser operation and other safer minimally invasive surgeries have been well-developed, transurethral resection of the prostate (turp) is still the gold standard for the surgical treatment of benign prostatic hyperplasia, despite of its various complications, and not suitable for the hyperplasia over 80 g which should be resected under open surgery. in this study, we design a randomized and double-blind prospective trial to evaluate the efficiency and safety of our new approach-transurethral ventral wall of urethra-preserving enucleation of prostate in comparison with turp for the hyperplasia weighing more than 45 g.urodynamic examination \[maximum flow rate (qmax), detrusor pressure, and so on\], transrectal color doppler ultrasonography for the prostate, blood routine, blood electrolyte, prostate specific antigen (psa), international prostate symptom score (ipss), the quality of life (qol), blood loss during operation, and the weight of resected prostate were studied before and after the operation.

Eligibility criteria:
inclusion criteria: * bph was diagnosed by dre, ultrasonography, ct or mr * ipss:\>15 * qmax:≤10ml/s and volume of bladder \>200ml * the weight of prostate \>45g exclusion criteria: * patient with other aggravating malignant tumor * total-psa\>20ng/ml, or 4\<total-psa\<20ng/ml but the value of free-psa/total-psa\<0.16 * the maximum press of detrusor muscle \<15cmh2o * patient with urethral stricture * patient with urinary infection * patient with nervous system disease * patient with surgical contraindication, such as severe cardiac or lung disease, diaphragmatic hernias, and so on

Keywords: benign prostatic hyperplasia transurethral resection of prostate transurethral enucleation of prostate
virtual reality before pediatric endoscopy

Conditions: Pediatric Anxiety Disorders

Summary: brief summary: clinical study the purpose of this clinical study is to evaluate whether the use of virtual reality (vr) before endoscopy reduces anxiety levels and positively impacts vital signs in children. this study aims to answer the following key questions: does the vr application reduce pre-endoscopy anxiety in children? does the vr application improve vital signs such as heart rate, blood pressure, and oxygen saturation in children? researchers will compare the effects of the vr application with standard care to assess its effectiveness. participants: the experimental group will undergo a 15-minute vr session before the endoscopy. the control group will receive standard care without vr. anxiety levels and vital signs will be measured throughout the study. this study aims to explore whether vr technology can serve as an effective stress management tool during pediatric medical procedure


Eligibility criteria:
inclusion criteria: * children aged 8 to 17 years. * scheduled to undergo an endoscopy procedure. * able to provide assent, and their parents or legal guardians provide written informed consent. * no prior exposure to virtual reality applications. * willing to participate in the study. exclusion criteria: * presence of a chronic medical condition affecting cardiovascular or respiratory systems. * diagnosed with a severe psychiatric disorder. * known visual or auditory impairments that could prevent participation in a virtual reality session. * history of seizures or epilepsy. * unwillingness to participate or inability to comply with study procedures.

Keywords: virtual reality, anxiety, endoscopy, pediatric, vital signs
the effect of the role performance strengthening program on the adaptive performance and competence of nurses

Conditions: Adaptation; Competence; Psychiatric Nursing; Psychoeducation; Mixed Method Implementation Study

Summary: the "role performance strenghthening program (rpsp)" based on the roy adaptation model was structured to increase the competence and adaptive performance levels of nurses working in pandemic units and to strenghthen role performance of nurses. in the measurements made after the completion of the program, it was determined that the competence and adaptive performance level of the nurses increased. it was found that the roy adaptation model was suitable for use in research to be conducted on a nurse sample regarding coping with the challenges caused by coronavirus pandemic. it is recommended that the rpsp be included in institutional training programs.

it has been understood that supporting the mental health and resilience of nurses who are vulnerable to the difficulties experienced during the pandemic process is of great importance. in this context, it has been revealed that there is a need for supportive psychiatric nursing practices; that psychiatric nurses need to help their colleagues cope with difficulties during difficult processes such as the pandemic. based on this need, a psychoeducation program was written in this doctoral thesis to support and strengthen nurses during the pandemic process. this program, called "role performance strengthening program", is shaped within the framework of cognitive behavioral approach elements and is based on the roy adaptation model. it is thought that the competence and adaptive performance level of nurses will increase through this structured psychoeducation program; therefore, the competence and adaptive performance level of nurses will be maintained and even increased during difficult processes such as the pandemic.

Eligibility criteria:
inclusion criteria: * working as a nurse in pandemic clinics, pandemic intensive care units or the orange area of the emergency room, * having a competency score average below 26 as a result of measurements made with the nursing competency scale, * accepting to participate in the research in writing and verbally, * accepting to participate in all sessions of the role performance strenghthening program. - exclusion criteria: • it has been determined that the person is continuing a therapy program to cope with the problems he/she experiences due to working during the pandemic. -

Keywords: psychiatric nursing psychoeducation role performance roy adaptation model coronavirus pandemic
comparing exercise programs for managing knee osteoarthritis

Conditions: Knee OA; Osteoarthritis; Osteoarthritis (OA) of the Knee

Summary: the goal of this clinical trial is to assess and compare the effectiveness of three different exercise modalities-whole-body vibration exercise, progressive resistance exercise, and home-based exercise -in improving quadriceps isometric muscle strength, physical function, balance, knee pain, osteoarthritis symptoms, and overall quality of life in individuals with knee osteoarthritis. the main questions it aims to answer are: * how do wbv, pre, and home-based exercise compare in improving quadriceps strength in people with knee osteoarthritis? * which exercise modality leads to the greatest improvements in physical function, balance, knee pain, and quality of life? researchers will compare the three exercise regimens to determine which is most effective for improving knee function and relieving osteoarthritis symptoms. participants will: * engage in whole-body vibration exercise, progressive resistance exercise, or home-based exercise for 3 weeks. * undergo assessments before and at the end of the exercise program, including tests for physical function and balance (timed up and go test, 5x sit to stand test) and questionnaires to evaluate knee osteoarthritis symptoms (womac), quality of life (sf-36), and self-reported knee pain (numeric rating scale).


Eligibility criteria:
inclusion criteria: 1. participants between the ages of 45-70, 2. diagnosed with knee osteoarthritis according to acr criteria (unilateral or bilateral), 3. having grade 2 or 3 tibiofemoral knee osteoarthritis according to kellgren-lawrence staging, 4. having knee pain due to oa for a minimum of 3 months prior to enrollment, 5. patients whose medical treatment is not expected to change during the study period. exclusion criteria: 1. having or had undergone knee surgery, 2. patients unable to walk without support, 3. having musculoskeletal limitations that prevent participation in resistance exercises (contracture, fracture, etc.), 4. other neurological, cardiac, respiratory and systemic diseases that will affect physical activity, 5. currently implementing a regular exercise or physical therapy program specific to knee oa

Keywords: exercise knee osteoarthritis pain strength whole-body vibration
study of aripiprazole in the treatment of children and adolescents with autistic disorder (ad)

Conditions: Autistic Disorder

Summary: this study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (ad).


Eligibility criteria:
inclusion criteria: * meets current diagnostic and statistical manual for mental disorders-fourth edition (dsm-iv) diagnostic criteria for ad and demonstrates serious behavioral problems. diagnosis confirmed by autism diagnostic interview- revised (adi-r) * cgi score \> = 4 and and aberrant behavior checklist (abc) irritability/agitation subscale score \> = 18 at screening and baseline (randomization) * mental age of at least 18 months * male or female 6 to 17 years of age, inclusive, at the time of randomization exclusion criteria: * patients considered treatment resistant to neuroleptic medication based on lack of therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks each. * patients previously treated and not responding to aripiprazole treatment * the patient is currently diagnosed with another disorder on the autism spectrum, including pdd-nos, asperger's disorder, rett's disorder, fragile-x syndrome or childhood disintegrative disorder * current diagnosis of bipolar disorder, psychosis, or schizophrenia, or major depression * a seizure in the past year * history of severe head trauma or stroke * patients undergoing non-pharmacologic therapies (e.g., psychotherapy, behavioral modification) must have started at least 2 months prior to the initial screening visit and must remain in a consistent treatment program for the duration of the study.

Keywords: serious behavioral problems in children and adolescents with ad behavioral problems
sleep, circadian rhythms and cluster headache

Conditions: Cluster Headache

Summary: the purpose of this study is to assess both the sleep and circadian (24-hourly biological rhythms) physiology of people with cluster headache. for sufferers with the episodic form of the disorder this will involve observation at two separate time points, once when experiencing attacks (in-bout) and once when attack free (out-of-bout). the study will include measurement of basic rest-activity patterns, sleep timing and timing of individual attacks, as well as a more detailed study recording sleep and circadian rhythms under clinical conditions over consecutive nights. studying the differences in these processes in single individuals when they are both experiencing and free from attacks might provide insight into the brain mechanisms involved in triggering the bouts of attacks and individual attacks themselves. an improved understanding of this area may help design improved treatment options in future.


Eligibility criteria:
inclusion criteria: * diagnosis of cluster headache or closely related primary headache disorder exclusion criteria: * abnormality on screening investigations that increase risk of participation * alcohol consumption exceeding 21 units per week

Keywords: cluster headache trigeminal autonomic cephalalgias sleep circadian rhythms
cognitive behavioral therapy for post-traumatic stress disorder in individuals with severe mental illness

Conditions: Stress Disorders, Post-Traumatic; Schizophrenia

Summary: this study will develop a cognitive behavioral therapy (cbt) program to treat symptoms of post-traumatic stress disorder (ptsd) in people with severe mental illnesses who are treated within community mental health systems.

a significant proportion of people with smi who are treated within the public sector also suffer from ptsd. evidence suggests that these individuals often receive inadequate mental health services because effective treatments have not been explored. this study will develop and implement a cbt treatment that is designed specifically for the smi/ptsd population. in the first year of the study, a treatment manual and a cbt treatment model, including education, social skills training, and exposure therapy, will be developed. in the following two years, the treatment program will be tested in individuals with smi and ptsd. scale ratings, self-report checklists, and daily logs of behavior will be used to assess ptsd symptoms. scale ratings and self-report surveys will also be used to measure hostility, functional status, depression and schizophrenia symptoms, and satisfaction with the study. assessments will be made throughout the study.

Eligibility criteria:
inclusion criteria: * diagnosis of ptsd and schizophrenia or schizoaffective disorder * active involvement in case management exclusion criteria: * suicide risk

Keywords: psychotic disorders
the vitality mammography messaging study

Conditions: Breast Cancer Female

Summary: the investigators will be conducting a randomized controlled trial amongst members of a wellness program to test receipt of mammogram using the whatsapp social media platform and testing various messages.

the investigators will be conducting a randomised control trial to test the efficacy of whatsapp messages to increase receipt of mammography amongst eligible women who are members of the vitality health promotion programme and are also on the discovery health medical scheme. the study will test a message that 1) has a link to a platform created by the radiology society of south africa which allow members to select a range of practices to book a mammogram, against 2) a message that gives names and telephone numbers of radiology practices in a 5 km radius of the members home address, against 3) a group with a link to an online platform as well as telephone numbers of radiology practices, against 4) a group where a standard message reminding to go for mammogram will be sent, but without names and telephone numbers of the radiology practices, against 5) a control group where no messages relating to mammography will be sent.

Eligibility criteria:
inclusion criteria: * females aged 50 to 75 years, who are members of the discovery health medical plan and who are also members of vitality and who have not had a screening mammogram in the preceding three years and who have not previously been diagnosed with breast cancer. exclusion criteria: * cpa blocks * if member's address location, based on their discovery profile, was further than 5km radius to the radiologist practice

Keywords: mammography screening social media
risk of covid-19 infection after vaccination

Conditions: Vaccination; Infection; Covid19

Summary: the purpose of this observational nationwide study is to evaluate the effects of three different covid-19 vaccines for the outcome of different severities of incident covid infection.


Eligibility criteria:
inclusion criteria: * living in sweden and vaccinated with bnt162b2, mrna-1273 or chadox1 * all individuals with a previous covid-19 infection * controls matched 1:1 to the groups above exclusion criteria: * none

Keywords: covid-19 vaccination nationwide observational study
relationship between delirium severity by cam-icu 7 and 4c mortality score of the covid-19 patients in icu

Conditions: Delirium; Covid19; Intensive Care Unit Delirium

Summary: aim: to investigate whether the 4c mortality score, which measures the severity of covid-19, and the cam-icu 7 score , which measures the severity of delirium, in icu. to compare two scores in terms of the number of days without intubation and 28 day mortality rates in icu.


Eligibility criteria:
inclusion criteria:patients hospitalized in the intensive care unit diagnosed with covid-19 will include in the study exclusion criteria:there is no exclusion criteria
evaluate retention rate of topiramate, levetiracetam and oxcarbazepine in a long-term epilepsy treatment

Conditions: Epilepsy

Summary: the objective of this study is to compare 2-year retention rate of topiramate, levetiracetam and oxcarbazepine in a long term epilepsy treatment.

primary objective the objective of this study is to compare 2-year retention rate of topiramate, levetiracetam and oxcarbazepine in a long term epilepsy treatment. secondary objective the main secondary objective of this study is to evaluate confounding factors associated with retention rate of topiramate compared with other anticonvulsants. 1. baseline characteristics * seizure type * gender * age of onset 2. treatment regimen * number of concomitant medication * type of drug combination * final target dose * titration speed other secondary objectives the other secondary objectives of this study are to compare followings by each medication: * rate of seizure reduction (≥75%, ≥50%) * rate of seizure freedom

Eligibility criteria:
inclusion criteria: * subjects who began their treatment with topiramate, levetiracetam or oxcarbazepine as mono or add-on therapy with conventional drugs. * subjects who are with partial or generalized epilepsy exclusion criteria: * subjects who administered combination therapy in topiramate, levetiracetam or oxcarbazepine * subjects who have past experience of surgery for epilepsy treatment * subjects who were not followed up for at least 1 year

Keywords: topiramate oxcarbazepine levetiracetam retention rate