Kornimate/medical-research-clean huggingface dataset:
patient activation in dialysis

Conditions: Renal Dialysis; Kidney Failure, Chronic

Summary: patient activation refers to patients' willingness and ability to make independent actions to manage their health and care and requires knowledge, skill and confidence. this study aims to explore activation levels of incident dialysis patients at start of dialysis and after 3 months of dialysis.

patient activation refers to patients' willingness and ability to make independent actions to manage their health and care and requires knowledge, skill and confidence. this study aims to explore activation levels, using the 13 item pam-13 survey, of incident dialysis patients at start of dialysis and after 3 months of dialysis.

Eligibility criteria:
inclusion criteria: -incident dialysis patients commencing at satellite healthcare during study recruitment dates exclusion criteria: * age \< 18 years * started dialysis more than 3 weeks prior to identification * transitioning to dialysis at a participating center from a non-participating center, when that patient has been on dialysis for more than 3 weeks at any center. * transitioning to dialysis after kidney transplant failure * inability to participate because of cognitive impairment or active psychological condition

Keywords: patient activation self management
safety, tolerability, and efficacy study of valoctocogene roxaparvovec in hemophilia a with active or prior inhibitors

Conditions: Hemophilia A With Inhibitor; Hemophilia A With Anti Factor VIII

Summary: this phase i/ii clinical study will evaluate the safety and efficacy of valoctocogene roxaparvovec in patients with severe haemophilia a and inhibitors to fviii. part a of the study will involve subjects who have active inhibitors to fviii, and part b involving subjects with a prior history of inhibitors.


Eligibility criteria:
inclusion criteria: 1. males ≥ 18 years of age with hemophilia a and documented prior residual fviii activity ≤ 1 iu/dl including, but not limited to, at the time of detected inhibitors, at the time of signing the informed consent. 2. history of a positive inhibitor result with the first positive result at least 12 month prior to screening. part a: demonstrated no immunological tolerance to exogenous fviii. part b: demonstrated tolerance to exogenous fviii and negative fviii inhibitor screening titer \< 0.6 bu. 3. prophylactic or on-demand hemophilia therapy in the last 12 months. bleeding, inhibitor \& hemophilia therapy hx over previous 12 months. 4. sexually active participants must agree to use an acceptable method of effective contraception. participants must agree to contraception use for at least 12 weeks post-infusion. 5. willing to abstain from consumption of alcohol for at least the first 52 weeks following bmn 270 infusion. exclusion criteria: 1. detectable pre-existing antibodies to the aav5 capsid. 2. any evidence of active infection or any immunosuppressive disorder; patients with hiv infection and undetectable viral load are not excluded. 3. currently undergoing, or plan to receive during the study, immune tolerance induction therapy or prophylaxis with fviii (part a only). 4. significant renal dysfunction or liver dysfunction, infection or history of hepatic malignancy. 5. evidence of any bleeding disorder not related to hemophilia a.

Keywords: gene therapy clotting disorders blood disorder blood coagulation disorders inherited blood coagulation disorders hematologic diseases coagulation protein disorders hemorrhagic disorders genetic diseases factor viii coagulants hemophilia a aav5 vector
application of ectoin® rhinitis nasal spray in patients with acute rhinosinusitis

Conditions: Sinusitis

Summary: this is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of ectoin® rhinitis nasal spray. in addition the effectiveness and safety shall be compared to a sinupret forte. the patient applies ectoin® rhinitis nasal spray or takes sinupret forte according to the instructions for use. the observation takes place over a period of 14 days. response to treatment is recorded at day 7 and day 14 by the physician and in daily by the patient in a dairy.


Eligibility criteria:
inclusion criteria: * female or male individuals ≥ 18 years * patients with acute rhinosinusitis which are treated with ectoin® rhinitis nasal spray or sinupret forte during the observational period exclusion criteria: * contra indications according to the label

Keywords: sinusitis, rhinosinusitis, ectoin, ectoine, bitop, sns, sns01
genetic testing for type 2 diabetes

Conditions: Diabetes Mellitus

Summary: in this 6-month randomized, controlled trial, we examined whether providing participants with genetic test results and counseling regarding their risk for type 2 diabetes would motivate them to improve their health behaviors and lose weight to reduce their diabetes risk. we hypothesized that participants who received conventional diabetes counseling plus genetic test results and counseling would have at least 6 lb greater weight loss at 3 months than participants who received conventional diabetes counseling without genetic test results.

in this 6-month randomized, controlled trial, we evaluated the impact of genetic testing for type 2 diabetes on psychological, health behavior, and clinical outcomes. eligibility criteria included age 21 to 65 years, overweight or obese (body mass index \[bmi\] \>27 kg/m2), and no prior diagnosis of type 2 diabetes. at baseline, participants (n=601) had conventional risk factors assessed, including demographics, fasting plasma glucose (fpg), and family history. they also provided blood samples for genetic testing of tcf7l2, pparg, and kcnj11, three genes that confer elevated risk for development of type 2 diabetes. participants were then randomized to receive conventional counseling plus control eye disease counseling (cr+eye) or conventional counseling plus genetic test results (cr+g). two to four weeks following the baseline visit, when the genetic test results were available, participants returned for a visit with a genetic counselor. all participants received conventional risk counseling based on their lifetime population risk, fpg results, and family history. next, participants were informed of their randomization assignments; cr+eye participants received counseling on eye diseases, whereas cr+g participants received genetic counseling. then perceived risk, affect, self-efficacy, and readiness to change were assessed. all other outcomes were also assessed at 3 and 6 months.

Eligibility criteria:
inclusion criteria: * body mass index \>27 kg/m2 * baseline fasting plasma glucose \<=125 mg/dl exclusion criteria: * prior diagnosis of type 2 diabetes * fasting plasma glucose \>125 mg/dl on more than one occasion * hba1c \> 7% * taking diabetes medication * actively losing weight * enrolled in research study focusing on lifestyle changes * unable to provide informed consent or answer survey questions unassisted * residing in nursing home or receiving home health care * active diagnosis of psychosis or dementia * at least one error on 6-item cognitive screener

Keywords: genetic screening
acp-family programme for palliative care patients and their family member

Conditions: Palliative Care

Summary: the goal of this clinical trial is to test the effectiveness of a structured, family-supported, patient-centred advance care planning (acp) in palliative care patients and their family members. the main question it aims to answer is: • the effectiveness of the acp intervention on promoting end-of-life decision making and psychological outcomes in patients and family members. participants will be assigned to either the acp-family group (acp-family) to receive a structured, family-supported, patient-centred acp intervention or usual palliative care (acp-uc) at the hospital. researchers will compare the acp-family and acp-uc groups to see if the acp-family group will produce better outcomes than the acp-uc group.

this is a two-arm parallel randomized controlled trial with follow-ups at 6 and 12 months, aiming to examine the effectiveness of a structured, family-supported, patient-centred acp programme for adult palliative care patients and their families. this study will randomize 170 palliative care patients and their family members to the structured, family-supported, patient-centred acp programme (acp-family) or acp service under usual care (acp-uc). within one month, they will receive two 60-90 minute sessions of the family-supported, patient-centred acp programme covering five elements in acp discussions delivered by a trained acp facilitator; or usual care provided by the respective hospital. all discussion sessions in the acp group will be recorded for quality checking. it is hypothesized that, as compare to acp-uc, the acp-family group will significantly improve eol decision making outcomes including (i) prediction accuracy of patient's treatment preferences between palliative care patients and their family members, (ii) new acp documentation in palliative care patients, and (iii) family-reported patient's eol care preferences was respected for deceased patients; and 2. psychological outcomes including family member's decision-making confidence, anxiety, depression, and quality of communication regarding eol, and patient's decisional conflict, and perceived quality of communication regarding eol. in addition, 3. we also explore the potential moderating effect of type of hospital setting on the effectiveness of the acp-family on these patient and family outcomes.

Eligibility criteria:
inclusion criteria: patient: * aged ≥ 18, * receiving palliative care at the study hospitals, * able to communicate in cantonese, and * cognitively intact (abbreviated mental test (amt) score ≥ 7)13 at the time of recruitment family member: * aged≥ 18 * able to communicate in cantonese, and * nominated by the patient who is likely to make substituted decisions for the patient in future health care issues. exclusion criteria: * are engaging in acp discussion with healthcare professionals in the hospital at the time of recruitment.

Keywords: advance care planning palliative care family decision making
phase ii clinical trial of och-ncnp1

Conditions: Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Secondary Progressive

Summary: this study is designed to assess the efficacy and safety of och-ncnp1 compared to placebo in subjects diagnosed with relapsing remitting multiple sclerosis (rrms) and secondary progressive mltiple sclerosis (spms) .


Eligibility criteria:
inclusion criteria: * subject with multiple sclerosis eligible for enrolment in the study must meet all of the following criteria: 1. provision of written informed consent to participate in this study 2. patients diagnosed as relapsing remitting multiple sclerosis based on modified mcdonald criteria in 2017 3. relape must have been confirmed by a neurologist at least twice within 24 months, or once within 12 months before enrollment 4. have at least one t2 lesion on mri scans at screening 5. edss less than or equal to 7 6. 20 =\< age \< 65 7. promise to prevent conception for at least 90 days after the last administration 8. neurological stability has been confirmed by a neurologist exclusion criteria: * subject with ms patients meeting any of the following criteria must not be enrolled in the study: 1. diagnosed as neuromyelitis optica 2. women who are pregnant or lactating 3. patients who is prohibited mri 4. patients who are allergic to gd-contrast medium 5. history of liver diseases or liver transplantation 6. liver dysfunction in the screening test and baseline physical examination 7. history of cancer past five years 8. negative for herpes zoster virus antibody 9. positive for syphilis serum reaction 10. positive for beta-glucan or positive for t-spot 11. positive for anti-aquaporin 4 antibody 12. history of hiv infection 13. history of hbv or hcv infection 14. history of transplantation 15. use of any other investigational agents and/or experimental agents within 4 months prior to the first anticipated administration of study medication. 16. history of blood donation (200 ml within 2 months, 400 ml within 3 months) prior to the first anticipated administration of study medication 17. lymphocyte number \< 600 /mm3 in peripheral blood 18. current diagnosed or suspected infectious diseases 19. compromised patients 20. inflammatory bowel disease 21. subjects with prolongation of qt/qtc interval 22. history or have risk of torsade de pointes 23. taking the medicine which has risk of prolongation of qt/qtc interval 24. history of severe allergy of medicine or food 25. history or current of drug/ alcohol addiction 26. bronchial asthma 27. epilepsy other protocol-defined exclusion criteria may apply
efficacy of baduanjin exercise in covid-19 contraction patients with idiopathic chronic fatigue

Conditions: Chronic COVID-19 Syndrome

Summary: post-covid recovery is associated with reduced functional fitness/capacity, low quality of life, and physical disabilities in those who survived after contracting the disease. the unpleasant symptoms of chronic post-viral/post-covid syndrome (chronic fatigue perception, variant nonspecific myalgia, bad mood or depression, and insomnia or sleep disturbances) usually magnify the symptoms of already existing previously diagnosed concurrent untreatable chronic disorders , including the idiopathic chronic fatigue (icf).(leszczak et al., 2024) baduanjin exercise training (bet) is one of the chinese traditional health-qigong exercises that not only integrate slow coordinating postures/positions, breathing techniques, musculoskeletal stretching movements/positions, and meditative mind but also plays a strong role concerning health benefits (e.g. musculoskeletal pain-reducing, sleep disturbance-enhancing effects, and fatigue-reducing effects) (zou et al., 2018).

forty idiopathic chronic fatigue (icf) patients will be randomly assigned into two equal groups (n=20) 1. study group (20 patients) this group will be supervised daily, except fridays, during the 60-minute session of 12-week bet) or waitlist group 2. control group (20 patients)

Eligibility criteria:
inclusion criteria: * • 40 patients will be recruited in the study. * age ≥ 18 to ≤ 50 years old * achieved three diagnostic items/criteria of icf will be included in this bet trial: fatigue lasting over 6 months, which significantly limits daily activities, reducing the person's usual activity level by more than 50%, as confirmed by a doctor. at least three of the following symptoms: generalized muscle weakness difficulty sleeping frequent headaches a painful throat muscle tenderness throughout the body migratory joint pain swollen lymph nodes in the neck or armpits fatigue lasting more than a day after typical activities exclusion criteria: * patients with a history of medical or complementary treatments for icf disorder in the 6 months before contracting covid or after recovery. * individuals who have engaged in therapeutic exercise, pharmacological treatments, or complementary therapies for post-covid symptoms within the last six months prior to enrollment. * icf patients regularly using antidepressants or antipsychotics were excluded. * those who take sleeping pills regularly were also excluded. * patients with autoimmune diseases, malignant conditions, anemia, endocrine disorders, systemic diseases, or osteoarthritis affecting the cervical spine, lumbar region, or limbs were excluded. * individuals with abnormal results in laboratory tests, including neurological, neurophysiological, cardiological, liver/kidney function tests, or urine/stool analyses (as determined by a physician) were excluded.
pediatric performance and satisfaction of oticon medical ponto on softband.

Conditions: Hearing Loss

Summary: the study is a non-interventional, observational, study on users of ponto sound processors who use their sound processors on a softband solution. the purpose of this study is to assess subjective benefit by evaluating performance and overall satisfaction of the ponto on a ponto softband in pediatric users.


Eligibility criteria:
inclusion criteria: * currently using oticon medical ponto sound processor on oticon medical softband exclusion criteria: * not
coronary anatomy study and times since the onset of acute myocardial infarction symptoms in women until the opening of the artery (tapac study)

Conditions: Myocardial Infarction

Summary: tapac study is an an investigator-driven, observational, prospective,cohort aimed at evaluating differences between men and women in patients undergoing primary angioplasty : hospital medical care, successful markers myocardial reperfusion and the anatomical substrate by describing the underlying coronary anatomy will be compared.

tapac study is an an investigator-driven, observational, prospective,cohort aimed at evaluating differences between men and women in patients undergoing primary angioplasty : hospital medical care, successful markers myocardial reperfusion and the anatomical substrate by describing the underlying coronary anatomy will be compared.

Eligibility criteria:
inclusion criteria: patients with: * aged 18 years or over. * ami (acute mycardial infarction ) with st segment elevation and indication of primary angioplasty in whom at least one diagnostic procedure with coronary angiography is performed. exclusion criteria: patients with: * life expectancy of less than one year. * previous ami. * previous coronary revascularization.

Keywords: acute coronary syndrome primary angioplasty gender
a registry for participants with chronic hypoparathyroidism

Conditions: Hypoparathyroidism

Summary: the main aim of this study is to find out the long-term safety and effectiveness profile of recombinant human parathyroid hormone (1-84) (rhpth\[1-84\]) treatment in participants with chronic hypoparathyroidism under conditions of routine clinical practice. participants will be treated according to their clinic's standard practice determined by the treating doctors. each participant will fill out a study questionnaire during a routine doctor visit.


Eligibility criteria:
inclusion criteria: * participants diagnosed with chronic hypoparathyroidism, that is, hypoparathyroidism with a duration of longer than 6 months, including: 1. adult participants (greater than or equal to \[\>=\] 18 years of age) who are receiving for chronic hypoparathyroidism any of the following options: standard therapy, standard therapy plus rhpth(1-84), or rhpth(1-84) therapy alone. 2. pediatric participants (less than \[\<\] 18 years of age) who are receiving for chronic hypoparathyroidism any of the following options: standard therapy, standard therapy plus rhpth(1-84), or rhpth(1-84) therapy alone. exclusion criteria: * participants or legally acceptable representatives unable to provide informed consent. * participants using rhpth(1-34) or who used rhpth(1-34) for more than 2 years are excluded. participants who had been treated with rhpth(1-34) within 3 months of enrollment are also excluded as are participants currently using rhpth(1-34). for us sites only: participants treated with rhpth(1-84) prior to the us recall may use rhpth(1-34) only while rhpth(1-84) is unavailable due to the recall. * participants currently enrolled in an interventional clinical study (whether or not the study is related to hypoparathyroidism); note that this does not include participants enrolled in other observational registries. * history of hypoparathyroidism resulting from impaired responsiveness to pth (pseudohypoparathyroidism).

Keywords: chronic hypoparathyroidism rhpth(1-84) observational study parathyroid hormone (pth) drug registry rhpth(1-34)
a study in adults with hereditary angioedema (hae) who currently receive icatibant at home

Conditions: Hereditary Angioedema (HAE)

Summary: the main aim of this study is to describe the treatment patterns, characteristics and outcomes of people with hae who are currently receiving icatibant in the homecare setting in the united kingdom (uk). participants will be treated with icatibant according to their routine practice via homecare service for icatibant within the uk. data will be directly collected from participants via study diaries and questionnaires. participants will be contacted approximately every 90 days during study duration (this can occur via phone or as a face-to-face visit).


Eligibility criteria:
inclusion criteria * participants self-administering or receiving care assisted administration of icatibant treatment for patient confirmed diagnosis of hae type i or ii in the homecare setting * participants who are able and willing to complete the study questionnaires * participants who are willing to be visited or contacted by a member of the homecare or research team at pre-arranged intervals in order to complete questionnaires exclusion criteria - participants who have received icatibant as an investigational medicine as part of a clinical trial

Keywords: drug therapy
study of sgr-3515 in participants with advanced solid tumors.

Conditions: Advanced Solid Tumor

Summary: the purpose of this study is to learn about the effects of a new study drug, called sgr-3515 that may be a treatment for advanced solid tumors.

sgr-3515-101 is a phase 1, first-in-human, single agent, dose-escalation study designed to evaluate the safety, tolerability, dose limiting toxicities, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of sgr-3515 and to identify the maximum tolerated dose, recommended phase 2 dose and schedule of sgr-3515, in participants with advanced solid tumors hypothesized to be sensitive to wee1/myt1 inhibition and any solid tumors with designated molecular perturbation relevant to dna damage repair pathway, including but not limited to ccne1 amplification.

Eligibility criteria:
inclusion criteria: * diagnosis of advanced/metastatic solid tumor * measurable disease per recist version 1.1 * eastern cooperative oncology group (ecog) performance status of 0 or 1 * participant must understand and sign an informed consent form (icf) prior to any study-related assessments/procedures * adequate bone marrow and organ function * women of child-bearing potential (wocbp) or males must agree to use highly effective contraception for the duration of study and for 90 days after the last dose of study drug exclusion criteria * participants with primary central nervous system (cns tumors). * participant has received prior systemic anti-cancer treatments or other investigational agents ≤ 21 days of first dose of study drug, or 5 half-lives, whichever is shorter * participant who has received definitive local control radiation (any dose greater than 50 gy) \< 42 days prior to the first dose of study drug. * participant who has received major surgeries ≤ 21 days prior to first dose of study drug * participants who have not recovered to grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding grade 2 alopecia, peripheral neuropathy and ototoxicity. * participant who has another clinically significant invasive malignancy, as determined by the investigator, ≤ 2 years prior to the first dose

Keywords: solid tumor advanced solid tumor