Kornimate/medical-research-clean huggingface dataset:
high-dose rifampicin for the treatment of tuberculous meningitis: a dose-finding study

Conditions: Tuberculosis, Meningeal

Summary: tuberculous meningitis (tbm) is the most severe form of tuberculosis infection with high mortality. current treatment regimens are not based on clinical trials. rifampicin is a key drug for tbm, but its penetration into the brain is limited, suggesting that a higher dose may be more effective. there are several highly relevant, outstanding questions related to the appropriate dose of rifampicin for tbm, before a multicenter phase 3 trial can be performed. these are: 1. previous phase 2a randomized clinical trial (done in the same setting as this proposed study) suggests that high doses of intravenous rifampicin (600mg, circa 13 mg/mg) for tbm is safe and associated with a survival benefit in adults. given that i.v. rifampicin is not readily available, this needs to be confirmed using an equivalent higher oral dose of rifampicin. 2. recent pharmacokinetic analysis of a continuation trial comparing 600 mg i.v. rifampicin with 750 mg and 900 mg oral rifampicin suggests that an even higher dose may be needed; but this has not been examined 3. based on those previous data, there is a need to explore a longer duration of high-dose rifampicin for a subsequent phase 3 randomized clinical trial; treatment response in the investigators previous trial suggest that the optimal duration may be \> 14 days. 4. there is a need to explore relevant treatment endpoints besides mortality including neurological, neuroradiological and inflammatory response.


Eligibility criteria:
inclusion criteria: 1. male or female, aged 15 years or above. 2. clinical suspicion of tbm and csf/blood glucose ratio \< 0.5. 3. none or less than 3 days of anti-tuberculosis chemotherapy taken for the current infection. 4. patient or representative (if the patient is incapacitated) is willing and able to give informed consent for participation in the study. 5. willingness to allow storage of specimens. exclusion criteria: patients may not enter the study if any of the following apply: 1. liver dysfunction (alt \> 5 times upper limit); kidney dysfunction (egfr \< 50 ml/min) 2. pregnancy or breastfeeding (negative urine pregnancy test for all females of child-bearing age). 3. confirmed cryptococcus meningitis (lfa), or confirmed bacterial meningitis (microscopy). 4. rapid clinical deterioration at time of presentation (e.g. signs of sepsis, decreasing consciousness or signs of cerebral oedema, or herniation)

Keywords: tuberculous meningitis rifampicin dose finding study pharmacokinetics
a compassionate use program to provide access to sodium thiosulfate

Conditions: Cisplatin-Induced Hearing Loss in Children Who Had Standard-risk Hepatoblastoma

Summary: this is a cup which is designed to provide treatment access of sts to pediatric patients for the protection from cisplatin-induced hearing loss in children who had standard-risk hepatoblastoma. approximately 10 patients will be treated as part of this program as specified below: sodium thiosulfate vials i.v. 80 mg/ml. this compassionate use program for sts will consist of 2 phases: screening: patients will only be able to participate in this cup if they meet the eligibility criteria. treatment: any clinical assessments, physical examinations, and dosage changes will be determined by the treating physician as per local standard medical practice. all serious adverse events (saes) will be reported. all related non-serious adverse events (aes) will be reported where "related" means any event where a causal relationship between sts and the event is at least, a reasonable possibility. all non-serious aes leading to dose modification or discontinuation will be reported. pregnancies, outcomes of pregnancies, and exposure through breastfeeding will also be reported.


Eligibility criteria:
inclusion criteria: i-1. children older than 1 month and younger than 18 years of age who had standard-risk hepatoblastoma that had not been treated previously with sts and receive cisplatin. i-2. a written informed consent was provided from all the patients and/or parents or legal guardians of children. exclusion criteria: e-1. any previous participation in an sts clinical trial. e-2. participation in another clinical study with an investigational product during the most recent chemotherapy course. e-3. patients with a known hypersensitivity to sts or any of the excipients of the product. e-4. patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) or major surgery within 3 weeks prior to sts treatment. e-5. persistent toxicities (\>common terminology criteria for adverse event (ctcae) ctcae grade 2) caused by previous cancer therapy, excluding alopecia. e-6. breast feeding or pregnant women.

Keywords: cisplatin hearing loss hepatoblastoma
music interventions for patients undergoing hemodialysis

Conditions: Renal Failure

Summary: fatigue is found to be one of the most persistent problems among patients in treatment with hemodialysis, and associated with impaired health-related quality of life. a few, non-randomized controlled trials have found positive effects on fatigue by offering pre-recorded music intra-dialytic, however, without conclusive results. so far, no studies have investigated the feasibility of integrating person-tailored live music interventions performed by professional musicians into a hemodialysis setting. this leaves a deficit in knowledge for intervention planning, understanding and effectiveness of live music on fatigue, wellbeing and feelings of meaningfulness in this group of patients. methods: a pilot randomized controlled trial combined with qualitative methods. the data collection will involve recruitment of 24 patients from an outpatient clinic over a six-week period. the patients will be randomized into either an intervention group or a control group. patients in the intervention group will be offered a 30-minute session of patient-tailored live music intervention per week for six consecutive weeks. patients in the control group will receive standard care. quantitative analysis on immediate post-dialysis fatigue (vas), and long-term fatigue (mfi-20), anxiety, depression (hads) and treatment satisfaction (vas) will show the potential effectiveness of intervention. qualitative analysis of informal-interviews (patients/staff), observational data (patients) and focus group interviews (staff/musicians) will explore an in-depth understanding of whether music will improve wellbeing and create feelings of meaningfulness among this group of patients as well as to assess feasibility acceptability among patients, musicians and staff. perspectives: this trial will ensure a firm methodological approach for the development of a future definitive randomized controlled trial of music intervention for fatigue reduction and wellbeing among hemodialysis patients.


Eligibility criteria:
inclusion criteria: * age 18+ * scheduled to receive hemodialysis treatment * able to understand written and spoken danish exclusion criteria: * deafness * severe mental illness

Keywords: music intervention feasibility kidney failure mixed method renal dialysis randomized controlled pilot study
a first-in-human, jab-8263 in adult patients with advanced tumors

Conditions: NSCLC; SCLC; CRPC; ESCC; Ovarian Carcinoma; AML; MF; Malignant Tumor

Summary: this is a phase 1/2a, first-in-human, open-label study of jab-8263, this study has two parts: solid tumor dose escalation and expansion study and hematology tumor dose escalation and expansion study. these two parts will determine the maximum tolerated dose (mtd), recommended phase 2 dose (rp2d) and assess the dlt of jab-8263 in treatment with patients with advanced solid tumors and hematology tumors separately. 30 subjects each will be enrolled.

jab-8263 is a small-molecule inhibitor of the highly conserved bromodomain pockets of the bromodomain and extraterminal (bet) proteins. the objectives of this study are: to determine the maximum-tolerated dose (mtd) and assess the dose-limiting toxicity (dlt) of jab-8263 as a single agent to adult subjects with advanced malignant tumors. to assess the safety and tolerability of jab-8263 to characterize the pharmacokinetic (pk) parameters and pharmacodynamics (pdc).to evaluate preliminary antitumor activity of jab-8263

Eligibility criteria:
inclusion criteria: * subjects must meet all the following criteria in order to be included in the research study: 1. subject must be ≥18 years-of-age at the time of signature of the informed consent form (icf). 2. eastern cooperative oncology group (ecog) performance status score of 0 or 1. 3. subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or have a tumor for which no standard therapy(ies) exists. 4. subjects with recurrent/refractory aml according to who 2016 5. subjects with life expectancy ≥3 months. 6. patients with solid tumor must have at least one measurable lesion as defined by recist v1.1. 7. patients who have sufficient baseline organ function. exclusion criteria: 1. history (≤3 years) of cancer that is histologically distinct from the cancer under study. 2. known serious allergy to investigational drug or excipients 3. active brain or spinal metastases 4. history of pericarditis or grade ≥2 pericardial effusion 5. history of interstitial lung disease. 6. history of grade ≥2 active infections within 2 weeks 7. known human immunodeficiency virus (hiv) infection 8. seropositive for hepatitis b virus (hbv) 9. seropositive for hepatitis c virus (hcv), or hcv-rna viral levels are not detectable. 10. any severe and/or uncontrolled medical conditions 11. history of myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident 12. impaired cardiac function or clinically significant cardiac diseases 13. qtcf \>470 msec at screening 14. history of medically significant thromboembolic events or bleeding diathesis 15. unresolved grade \>1 toxicity 16. history of malignant biliary obstruction 17. pregnant or breast-feeding
randomized controlled trial of conventional vs theta burst rtms

Conditions: Major Depressive Disorder

Summary: this trial will compare a novel form of rtms, intermittent theta burst stimulation to the standard conventional high frequency left sided stimulation protocol. the left dorsolateral prefrontal cortex will be the site of stimulation in both treatment conditions. the site of stimulation will be targeted using mri co-registration. the study seeks to determine if the two treatment protocols have similar effectiveness in treating major depression.


Eligibility criteria:
inclusion criteria: * outpatients * voluntary and competent to consent * mini-international neuropsychiatric interview (mini) confirmed diagnosis of mdd, single, recurrent * between ages 18-65 * failed to achieve a clinical response to an adequate dose of an antidepressant based on an antidepressant treatment history form (athf) score of ≥ 3 in the current episode or have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (athf 1 or 2) * have a score of ≥ 18 on the hamd-17 item * have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening * able to adhere to the treatment schedule * pass the tms adult safety screening (tass) questionnaire * have normal thyroid functioning based on pre-study blood work exclusion criteria: * have a history of substance dependence or abuse within the last 3 months * have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump * have active suicidal intent * are pregnant * have a lifetime mini diagnosis of bipolar i or ii disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms * have a mini diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than mdd

Keywords: depression magnetic brain stimulation treatment-resistant
im versus 5-fu versus imi versus mal-pdt in treatment of actinic keratosis

Conditions: Keratosis, Actinic

Summary: a multi-centre randomised controled single blind clinical phase iv trial with the aim to determine the most effective treatment in terms of lesion reduction, costs and patient satisfaction in treatment of actinic keratosis (ak), when comparing topical treatment with photodynamic therapy (pdt), 5% 5-fluorouracil (5-fu) cream, 5% imiquimod (imi) cream and ingenol mebutate (im) gel.

skin cancer is the most common cancer in caucasians and therefore a major public health issue. its incidence is increasing rapidly. actinic keratosis (ak) is the most prevalent precancerous chronic skin condition. it can transform into squamous cell carcinoma (scc). ak's generally arise in a skin area that has diffuse precancerous damage, a phenomenon called field cancerization. because of its precancerous character, it is advised to treat ak and herewith prevent development into scc. the most frequently used field-directed treatments in the netherlands are photodynamic therapy (pdt), topical 5% f-fluorouracil (5% 5-fu) and topical 5% imiquimod (5% imi). lately another topical product is approved by dutch healthcare insurances: ingenol mebutate (im). up to date, which treatment the patient will receive, does not rely on evidence-based-medicine, but generally on the preference of the physician. current national and international guidelines state no clear recommendations for the best choice of therapy. the aim of this study determine which treatment is the most effective treatment in terms of lesion reduction, costs and patient satisfaction when comparing topical treatment with photodynamic therapy (pdt), 5% 5-fluorouracil (5-fu) cream, 5% imiquimod (imi) cream and ingenol mebutate (im) gel, in treatment of actinic keratosis (ak).

Eligibility criteria:
inclusion criteria: * patients older than 18 years * fitzpatrick skintype i-iv * clinically confirmed diagnosis of ak * one joint area of minimal 25 cm2 and maximal 100 cm2 of ak * minimum of 5 ak lesions * ak olsen grade i-iii * location: head/neck area exclusion criteria: * received any kind of treatment for ak in the past 3 months * (non)melanoma skin cancer in target area * immuno-compromised status * use of systemic retinoid in the past 3 months * use of immunosuppressant drugs in the past 3 months and / or at time of treatment (such as oral glucocorticoids, cytostatic, antibodies, drug acting on immunophilins, interferon, opioids, tumor necrosis factor (tnf) binding proteins, mycofenolate mofetil (mmf), biologic agents). inhalation corticosteroids / nasal corticosteroids are permitted. * porphyria * not able to give informed consent * allergy to study drugs or peanut/nut/soy products * pregnant and breastfeeding women * female in child bearing potential not using contraceptive measures, during and till 3 months post-treatment * genetic skin cancer disorders * not understanding dutch language

Keywords: keratosis, actinic treatment outcome cost-effectiveness economic evaluation imiquimod photodynamic therapy topical fluorouracil ingenol mebutate
dementia pain management educational program

Conditions: Dementia

Summary: this study aims to develop and test a scale for exploring hospital nurses' knowledge about dementia pain and dementia pain management.

the researcher recruited 285 nurses from three hospitals, and divided them into the experimental group and the comparison group. the experimental group took two-hour online course about dementia pain care in two weeks. the comparison group took two-hour online course about dementia care in two weeks. the nurses performed a post-test after the two-week course immediately; two weeks later, the second post-test was performed again.

Eligibility criteria:
inclusion criteria: * nurses working in district hospitals, regional hospitals, or medical centers. exclusion criteria: * nurses working with obstetrics, pediatrics, or outpatient.
microbotox for lower face rejuvenation

Conditions: Botulinum Toxin; Rejuvenation; Therapy; Neck

Summary: the purpose of this study is to evaluate the efficiency of the intradermal injection of botulinum toxin in lower face rejuvenation. the study will also compare this intervention with the "nefertiti lift" intramuscular injection technique.

the abobotulinumtoxina will be used for the intervention. the abobotulinumtoxina will be prepared by adding 2.5 cc of normal saline to a 500-unit dysport© (ipsen ltd, berks, uk) vial. further dilution to the appropriate microbotox concentration will be done in the syringe itself. each 1ml syringe of microbotox solution will contain 20-28 units of onabotulinumtoxina per ml of solution. preinjection frontal, oblique and lateral patient pictures will be taken (at rest and with contraction) injection points: a series of 100-150 intradermal microdroplets injection points 1 cm apart will be delivered in the lower face. the area to be injected is bounded by a line 3 fingerbreadths above and parallel to the lower border of the mandible, 1 fingerbreadth posterior to the depressor anguli oris, and all the way down over the cervicomental angle and anterior neck to the upper border of the clavicle, and posteriorly to the anterior border of the sternocleidomastoid. in the average patient, 2 syringes of 28 units per ml of microbotox will be used to cover the entire area. in heavier necks, 3 syringes of 28 units per ml will be used. in thinner necks, 2 syringes of 20 units per ml will be used. follow up will be done at 15 days for post injection pictures. a total of 15 patients will be recruited

Eligibility criteria:
inclusion criteria: female patients presenting to our clinic for neck rejuvenation who: * were deemed nonsurgical candidates for neck rejuvenation * were not willing to undergo invasive surgical procedures * had a medical contraindication to surgery exclusion criteria: * patients with lower face botulinum toxin injection in the past 12 months * patients with resorbable lower face fillers injection in the past 12 months * patients with previous permanent lower face fillers injection * pregnant patients * lactating patients * patients with preexisting neuromuscular conditions (myasthenia gravis, eaton lambert syndrome) * patients using medication that could potentiate the effect of botulinum (ex: aminoglycoside antibiotics) * patients with sensitivity to botulinum toxin or human albumin
assessing interventions of diet in ibd

Conditions: IBD (Inflammatory Bowel Disease); Ulcerative Colitis (UC); Crohn Disease (CD)

Summary: in this study, we are trying to learn how certain diets affect people with inflammatory bowel disease (ibd). we want to understand what makes it hard or easy for them to stick to different eating plans, like intermittent fasting, the mediterranean diet, and the low fodmap diet. by finding out how these diets help with symptoms and which ones are easier to follow, we hope to improve the quality of life for people with ibd.

this study aims to explore the impact of specific dietary interventions on individuals living with inflammatory bowel disease (ibd). by examining dietary patterns such as intermittent fasting, the mediterranean diet, and the low fodmap diet, we seek to identify barriers to adherence and facilitators that make these eating plans sustainable. additionally, we aim to evaluate the perceived benefits of these diets in managing ibd symptoms and their influence on overall quality of life. the findings will provide valuable insights to develop patient-centered nutritional strategies that enhance adherence and therapeutic outcomes in ibd care.

Eligibility criteria:
inclusion criteria: * adults (18+ years) diagnosed with ulcerative colitis or crohn's disease. * having willingness to use their personal smartphone to access the app * able to understand the indication by the registered dietitian. * able to provide informed consent. * willingness to attempt intervention diet and commit to study procedures. exclusion criteria: * pregnant women. * currently being treated for eating disorders, schizophrenia, psychosis, or other acute mental disorders. * currently being treated for chemotherapy. * diabetes * advance chronic kidney disease * short bowl syndrome

Keywords: ibd low fodmap diet mediterranean diet intermittent fasting ulcerative colitis crohn&#39;s disease
patient education and text message reminders in colonoscopy

Conditions: Colon Disease; Educational Problems

Summary: this study will be conducted to examine the effects of detailed education and text message reminders given to patients undergoing colonoscopy on bowel cleansing, vital signs and anxiety.

i̇ntroduction: the highest level of bowel preparation before the colonoscopy procedure is necessary for the successful completion of colonoscopy. considering that the bowel preparation procedures required for colonoscopy are performed by patients, it is very important to inform patients about the content and duration of diet and bowel preparation practices. today, with the widespread use of technology in our lives, technological education methods such as web-based trainings, text message reminders, telemedicine methods have started to be used in patient education methods as well as classical methods. purpose: this study will be conducted to examine the effects of detailed education and text message reminders given to patients undergoing colonoscopy on bowel cleansing, vital signs and anxiety. method: this study will be a randomized controlled trial. hospital. the sample of the study will include individuals who will undergo colonoscopy procedure in the endoscopy unit of a state hospital and who meet the inclusion criteria. data will be collected using personal information form, beck anxiety scale, boston bowel readiness scale. in this study, in addition to the standard patient education protocol, the effectiveness of colonoscopy education with more intensive content and supported by visuals and diagrams will be evaluated in the education group. individuals in the other group will receive text message reminders, which is one of the new methods that have started to be used in patient education with the technology that has become widespread today. conclusion: it is thought that more intensive and materialized trainings and text message reminders to patients compared to standard colonoscopy preparations will increase the level of bowel cleansing, improve vital signs and reduce anxiety.

Eligibility criteria:
inclusion criteria: individuals who understand turkish individuals who know how to use a phone and read text messages individuals over 18 years of age patients undergoing colonoscopy for the first time exclusion criteria: patients with cognitive dysfunction patients with neuro-psychiatric disorders individuals who do not know how to use a phone individuals undergoing colonoscopy in emergency situations individuals who did not give consent to participate in the research

Keywords: colonoscopy patient education