Kornimate/medical-research-clean huggingface dataset:
lifestyle intervention for symptoms of depression with app support in general practice

Conditions: Depressive/Anxiety Symptoms; Depressive Disorder

Summary: the goal of this clinical trial is to find out whether a smartphone app can help reduce symptoms of depression by supporting healthy lifestyle changes and encouraging self-monitoring in adults who visit their general practitioner with symptoms of depression. the main questions this study aims to answer are: does a personalized lifestyle intervention delivered through the app, in addition to regular care, reduce depression symptoms more effectively than regular care alone? is this approach more cost-effective than regular care alone? researchers will compare patients who use the app alongside their regular care to patients who receive regular care without the app, to see whether the app leads to better outcomes. participants who use the app will: complete a lifestyle questionnaire focused on six themes: mental wellbeing, use of harmful substances, social relationships, healthy eating, sleep, and physical activity. set personal goals based on their results and receive tailored lifestyle advice. track their depression symptoms regularly within the app to support ongoing care. have follow-up conversations with their general practitioner or mental health nurse to discuss their progress. fill out questionnaires about their symptoms and experiences during the study.


Eligibility criteria:
inclusion criteria: * a score of \> 5 on the phq-9 * have a smartphone * be proficient in dutch exclusion criteria: * severe mental illness (such as psychosis or bipolar disorder) * severe alcohol or drug addiction requiring specialized secondary care * high suicide risk * moderate to severe cognitive impairment (as determined by the gp) patients who visit their gp for depressive symptoms but with a phq-9 of \< 6 at baseline are allowed to use the pli, but will not be included in the primary analysis.

Keywords: personalized lifestyle intervention ehealth measurement-based care depression symptomatology cluster randomized trial general practice lifestyle changes mental health support primary care
optimizing kidney transplant informed consent

Conditions: End-stage Kidney Disease

Summary: the objective of this study is to evaluate kidney transplant candidates' comprehension about increased risk donor kidneys necessary for informed consent. we have developed a web-based tool that educates and assesses candidates' comprehension (inform me), as a supplement to current informed consent processes. we will then compare the effectiveness of the current informed consent processes supplemented by inform me, with the current consent processes alone for kidney transplant.

the shortage of kidneys for kidney transplantation results in almost 10,000 deaths per year in the united states. one strategy to increase the number of available kidneys is to offer kidney transplant candidates kidneys that come from donors who have an increased risk of transmission of human immunodeficiency virus (hiv), hepatitis b and hepatitis c. increased risk kidney donors are defined as those who have engaged in behaviors associated with an increased risk of hiv, hepatitis b, and hepatitis c, and comprise approximately 9% of all us deceased organ donors. the organ procurement and transplantation network policy mandated informed consent from recipients who accept increased risk kidneys. the objective of this study is to increase study participants' comprehension about increased risk donor kidneys necessary for informed consent. to accomplish this objective, we will develop a web-based tool that educates and assesses participants' comprehension (inform me), as a supplement to current informed consent processes. we will then compare the effectiveness of the current informed consent processes supplemented by inform me, with the current consent processes alone. the tool will utilize health information technology to deliver information about the definition of, risks, benefits, and alternatives to using increased risk donor kidneys via a web-based application. computer adaptive learning will personalize information presented to each candidate according to his/her comprehension levels in interactive chapters to increase comprehension. inform me will facilitate nurses' primary role as patient educators.

Eligibility criteria:
inclusion criteria: * english-speaking * 21 years or older * kidney transplant candidates eligible: 1) completed the first phase of transplant evaluation education, and 2) wait-listed patients expected to receive a transplant within the next 6 months, returning for re-evaluation. exclusion criteria: * no special classes of study participants, including fetuses, neonates, prisoners, institutionalized individuals, or other vulnerable populations will be included in the proposed study. although pregnant women will be eligible for participation in the study, they are unlikely to be selected for kidney transplantation.

Keywords: kidney transplantation increased risk donor kidneys kidney donation organ donation human immunodeficiency virus hepatitis b hepatitis c infectious disease disease transmission centers for disease control (cdc) web-based intervention
an efficacy study of ortataxel in recurrent glioblastoma

Conditions: Glioblastoma

Summary: italian study on the efficacy of ortataxel in recurrent glioblastoma

in this phase ii study, adult patients with histologically confirmed gbm in recurrence after surgery or biopsy, standard radiotherapy and chemotherapy with temozolomide were eligible. patients included were treated with ortataxel 75 mg/m² i.v. every 3 weeks until disease progression. the primary objective of the study was to evaluate the efficacy of ortataxel in terms of progression free survival at six months after the enrolment (pfs-6).

Eligibility criteria:
inclusion criteria: * histologically confirmed gbm. * gbm in recurrence/progression after surgery (or biopsy), standard radiotherapy and chemotherapy with temozolomide. * imaging confirmation of first tumor progression or regrowth as defined by the rano criteria. * no more than one prior line of chemotherapy (temozolomide). * recovery from the toxic effects of prior therapy. * patients who have undergone recent surgery for recurrent or progressive tumor are eligible provided that: 1. surgery must have confirmed the recurrence. 2. a minimum of 14 days must have elapsed from the day of surgery to registration. for core or needle biopsy, a minimum of 7 days must have elapsed prior to registration. 3. craniotomy or intracranial biopsy site must be adequately healed and free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of registration. * age ≥ 18 years. * willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator. * karnofsky-ps ≥ 60%. * stable or decreasing dose of corticosteroids within 5 days prior to registration. exclusion criteria: * patients unable to undergo brain mri scans with gadolinium (iv). * pre-existing peripheral neuropathy, grade ≥ 2. * history of intracranial abscess within 6 months prior to registration. * anticipation of need for major surgical procedure during the course of the trial. * treatment with enzyme inducing antiepileptic agents was not allowed. however, patients whose anticonvulsant was changed to a nonenzymeinducing antiepileptic drug were eligible for entry after a 1-week ''washout'' period
efficacy of a telehealth delivered group lifestyle balance for people post stroke (tglb-cva)

Conditions: Stroke, Acute; Stroke; Stroke, Cardiovascular; Stroke (CVA) or TIA; Stroke/Brain Attack

Summary: investigators will conduct a randomized controlled trial (rct) to assess intervention efficacy of telehealth delivery of the glb-cva (tglb-cva) compared to a 6-month wait-list control (wlc) in partnership with a diverse group of patient partners and peer mentors.


Eligibility criteria:
inclusion criteria: * body mass index ≥25 * all types of stroke * able to participate in physical activity * ≥12 months post first stroke * have internet, phone, or computer access, or be willing to use one provided by the study team exclusion criteria: * contraindications for physical activity * low cognitive function * residing in hospital, acute rehab, skilled nursing facility * not fluent in the english language * pre-existing eating disorder * pregnancy
usefulness of multi-parametric, quantitative mr imaging for staging of hepatic fibrosis in the patients with chronic hepatitis

Conditions: Liver Fibrosis

Summary: liver fibrosis has been considered as irreversible change. however, recent study showed that early stage liver fibrosis could be reversible and a lot of new drugs are now developing or developed including anti-viral treatment. liver biopsy is considered as golden standard for the evaluation of liver fibrosis. but biopsy specimen through biopsy only consists of 1/50000 of the whole liver and heterogeneity of liver fibrosis, accurate diagnosis of liver fibrosis is still challenging. furthermore, its invasive nature, repeated biopsy is practically almost impossible. hence, non-invasive diagnosis of liver fibrosis is important. in this study we hypothesized that multi-parametric mr imaging including mr elastography, conventional dwi, and ivim can predict changes of liver stiffness after anti-viral therapy in patients with chronic liver disease. we will enroll 60 biopsy-proven patients and perform multi-parametric mr imaging at the enrollment and one year later to evaluate changes in quantitative values in mr.


Eligibility criteria:
inclusion criteria: * patients who had chronic hepatitis * patients who underwent liver biopsy within 6 months * patients older than 18 years old exclusion criteria: * patient who had pregnancy * patient 18 or below 18 years old

Keywords: liver fibrosis elastography mr elastography quantitative imaging
software refraction with mobilerone versus retinoscopy

Conditions: Myopia; Myopia, Moderate; Astigmatism

Summary: software refraction in the mobilerone for myopia and astigmatism is a novel medical device for myopia adults and elder children with or without astigmatism. and the investigators would like to test its accuracy and efficacy as well as safety.

it's a software installed in a mobilerone with subjective guide on screen for testing myopic refractive error with or without astigmatism for adults or elder children. the investigators would like to compare its refraction results with retinoscopy.

Eligibility criteria:
inclusion criteria: * • subject with ametropia on each eye ≤-12.00d * subject with best corrected visual acuity ≥ 20/25, no amblyopia * subject with normal transparency of eyes * subject with a healthy fundus that does not reveal major abnormalities that may affect vision due to the fluctuate situations * subject able to cooperate with the screen and the operator * subject without heavy drug treatment that may affect vision as synthetic antimalarials, corticosteroids * non-diabetic subject * non nystagmus subject * non-strabismus subject * subject who has not had eye surgery less than 1 year old exclusion criteria: * • subject with a topography showing an anomaly (keratoconus type or other) * subject with hyperopia or presbyopia * subject with mild myopia ≥ -1.00d * subject who cannot speak with the operator including those staff of local optometrists or ophthalmologists

Keywords: software refraction subjective refraction mobilerone myopia astigmatism
linperlisib combined with camrelizumab and pegaspargase in advanced or relapsed/refractory nk/t-cell lymphoma

Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type; T-lymphoblastic Lymphoma

Summary: the patients diagnosed with relapsed/refractory or advanced nk/t-cell lymphoma (r/r nktcl) were selected as the research objects. to explore effective and safe treatment for advanced or r/r nktcl, the combination of pi3k-δ inhibitor linperlisib with pd-1 blockade camrelizumab and anti-metabolic agent pegaspargase was applied for the treatment.

this is a prospective, single-arm, single-center ib/ii clinical trial that included an initial safety run-in phase with safety monitoring before the main enrollment (expansion phase).the aim of phase ib is to evaluate the recommended phase 2 dose and dose-limiting toxicity (dlt), and the aim of phase ii study is to evaluate, for the first time, the safety and efficacy of the treatment of linperlisib combined with pd-1 blockade camrelizumab and pegaspargase in patients diagnosed with advanced or r/r enktl, respectively.

Eligibility criteria:
inclusion criteria: * histopathology and immunohistochemistry confirmed diagnosis of enktl according to who 2016 criteria. * refractory or relapsed after initial remission, or ann-arbor stage iii-iv de novo patients * pet/ct or ct/mri with at least one objectively evaluable lesion. * expected to survive more than 3 months. * general status ecog score 0-2 points. * the laboratory test within 1 week before enrollment meets the following conditions: blood routine: wbc≥3×10e9/l, plt≥75×10e9/l, anc≥1.5×10e9/l. scr≤1.5 mg/dl,gfr≥50 ml/min. liver function: alt \& ast≤3 times the upper limit of normal, tbil ≤2 times the upper limit of normal. serum fibrinogen level≥1.0 g/l. •sign the informed consent form exclusion criteria: * patients with cns involvement, or with other neoplasm; * patients has received pi3k inhibitor treatment before enrollment * poor performance status, ecog≥2; * patients in lactation or pregnancy； * patients (male or female) have the possibility of childbirth but are unwilling or have not taken effective contraceptive measures； * patients allergic to any of the study drugs； * patients with active infection； * patients with a history of immunodeficiency, including hiv positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; * patients with a history of interstitial pneumonia, non infectious pneumonia, or highly suspected interstitial pneumonia; * patients with a history of neurological or psychiatric disorders, including epilepsy or dementia, in the past * according to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect patient completion of the study.

Keywords: r/r enktl linperlisib pd-1 blockade pegaspargase
study of the potential of a macronutrient balanced normocaloric diet to treat lifestyle diseases

Conditions: Obesity; Diabetes Mellitus, Type 2; Cardiovascular Diseases

Summary: one of today's major health problem in the western world is related to lifestyle. lifestyle diseases include obesity, type 2 diabetes, cardiovascular diseases and different types of cancers. for many years, a low-fat diet has been recommended to reduce obesity and lifestyle diseases, but replacing fat with carbohydrates has lead to an increase of these diseases. overweight is associated with a chronical low-degree inflammation, and later studies have shown that carbohydrates have an effect on the mechanisms of inflammation. previous studies in the investigators group has shown that in healthy, but slightly overweight persons, a balanced diet of lower carbohydrate content regulates the gene expression in a manner that leads to less inflammation. in this study the investigators will look at morbid obese women (bmi\>35) to see if the same, balanced diet can improve the inflammatory profile of the women.

the hypothesis of this proposal is that a carbohydrate-rich diet may cause a major deregulation of hormonal balance, causing both acute and chronic systemic inflammatory reactions mediated by white blood cells. we furthermore postulate that a carbohydrate-rich diet is a major risk factor in the development of obesity and life style diseases directly resulting from chronic systemic inflammation. we therefore want to use an integrated multidisciplinary systems biology approach to identify the hormones, genes and pathways specifically responding to a dietary carbohydrate reduction, to develop biomarkers that can be used for risk assessment, to identify molecular pathways and build mathematical models that describe the link between diet and inflammation, and use this knowledge to provide personalised dietary advice.

Eligibility criteria:
inclusion criteria: * bmi \> 35 kg/m2 exclusion criteria: * allergies (fish, nuts, eggs) * patient under treatment/using medicine that can influence results * pregnancy and lactation

Keywords: obesity diabetes mellitus, type 2 cardiovascular diseases
phase 1b study in patients with short-lasting unilateral neuralgiform headache attacks (sunha)

Conditions: Short Lasting Unilateral Neuralgiform Headache Attacks

Summary: this exploratory open-label phase 1b, ascending dose study is to evaluate the effects of psilocybin on cognition in patients with chronic short-lasting unilateral neuralgiform headache attacks (sunha)

the study aims to: determine the safety and tolerability of psilocybin when administered to patients with chronic sunha determine the effects of psilocybin on cognition when administered to patients with chronic sunha explore the change in frequency, duration, and intensity of headache attacks with escalating doses of psilocybin in patients with chronic sunha

Eligibility criteria:
inclusion criteria: \* diagnosed with chronic sunha exclusion criteria: \* other comorbidities
study for the treatment of anemia in patients with non-myeloid malignancies receiving multicycle chemotherapy.

Conditions: Anemia

Summary: comparing two drugs to treat subjects with non-myeloid malignancies receiving multicycle chemotherapy.

the purpose of this study is to compare the effect of darbepoetin alfa and epoetin alfa for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.

Eligibility criteria:
inclusion criteria: - planned chemotherapy treatment - anemia (hemoglobin concentration less than or equal to 11.0 g/dl) - adequate renal and liver function - subjects must provide written informed consent exclusion criteria: - known history of seizure disorder - known primary hematologic disorder causing anemia other than non-myeloid malignancies - unstable / uncontrolled cardiac condition - clinically significant inflammatory disease - known positive test for hiv infection - neutralizing antibodies to rhuepo - epoetin alfa or darbepoetin alfa therapy within 4 weeks before randomization - received any investigational drug or device within 30 days before randomization - pregnant or breast feeding - not using adequate contraceptive precautions - previously randomized into this study - known hypersensitivity to recombinant mammalian-derived product - concerns for subject's compliance

Keywords: non-myeloid malignancy chemotherapy-induced anemia
pre- or per-dialytic physical exercise : a cardioprotective role?

Conditions: Chronic Kidney Diseases

Summary: this study aims at evaluating, in chronic kidney disease patients on dialysis, the effect of acute per- or pre-dialytic physical exercise on regional myocardial function and myocardial stunning, blood viscosity, arterial stiffness, variability of sinus rhythm, dialysis efficacy, inflammation, mineral and bone disorders, myokines and cardiac remodeling markers.


Eligibility criteria:
inclusion criteria: * patient aged ≥ 20 to ≤ 79 years * undernourished patient according to the arnos score : ≥ 2 * no medical contraindication to physical activity * life expectancy greater than 6 months * patient on hemodialysis for more than 3 months * patients with relatively good echogenicity exclusion criteria: * patient is participating in another category i interventional study, or has participated in another interventional study within the past 3 months * the patient is in an exclusion period determined by a previous study * the patient is under legal protection or under guardianship or curatorship * it turns out to be impossible to give the patient informed information, or the patient refuses to sign the consent * pregnant, parturient or breastfeeding patient * patient with a contraindication to retraining * patient with valvular heart disease, arteriopathy of the lower limbs stage iii and iv, amputation or knee or hip prosthesis * patient with musculoskeletal problems * patient with severe respiratory failure * paired sleep apnea syndrome * bmi\> 35 * patient with automatic implantable defibrillator * heart transplant * uncontrolled high blood pressure * ejection fraction \<45% * unstabilized coronaries * non-contributory stress ultrasound

Keywords: chronic kidney disease on dialysis physical exercise regional myocardial function myocardial stunning
prostatic artery embolization for benign prostatic obstruction

Conditions: Hyperplasia Prostatic; Lower Urinary Tract Symptoms; Prostatic Diseases; Urological Manifestations

Summary: the aim of this study is to investigate the safety and efficacy of prostatic artery embolization (pae) for patients who refuse or are not eligible for surgery with moderate-severe lower urinary tract symptoms or indwelling catheter secondary to benign prostate obstruction due to benign prostatic hyperplasia.

this is a prospective study investigating the safety and efficacy of pae for patients who refuse or are not eligible for surgery and who suffers from moderate-severe lower urinary tract symptoms or indwelling catheter secondary to benign prostatic obstruction due to benign prostatic hyperplasia. it may form the grounding for further research in the shape of a larger randomised clinical trial. our hypothesis is that pae will eliminate the need for indwelling catheter and improve ipss 6 months post-procedure. 1, and 6 months follow-up. main outcome ability to void after removal of indwelling catheter secondary outcomes international prostate symptom score (ipss) quality of life (qol) international index of erectile function (iief) prostate volume peak void flow (qmax) post-void residual (pvr) classify complications according to society of interventional radiology (sir) guidelines for reporting prostate-specific antigen (psa)

Eligibility criteria:
inclusion criteria: * indwelling catheter secondary to benign prostatic hyperplasia (bph) or * moderate-severe obstructive luts secondary to bph refractory to medical treatment * unsuitable for turp or refuse surgery exclusion criteria: * bladder dysfunction(and known neurological conditions affecting bladder function) * urethral strictures * bladder neck contracture * known sphincter anomalies * big bladder diverticulum or stones * kidney insufficiency (egfr \< 45) * coagulation disturbances * severe atheromatous or tortuosity of arteries * allergy to contrast medium * unable to undergo mr imaging * urological malignancy

Keywords: benign prostatic obstruction benign prostatic enlargement benign prostatic hyperplasia prostatic artery embolization quality of life ipss dan-pss complications