Kornimate/medical-research-clean huggingface dataset:
a study to customize ibrutinib treatment regimens for participants with previously untreated chronic lymphocytic leukemia

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell; Small Lymphocytic Lymphoma

Summary: the purpose of this study is to evaluate the efficacy and safety of ibrutinib + venetoclax (i+v) and ibrutinib monotherapy regimens in which dosing of ibrutinib is either proactively reduced or reactively modified in response to adverse events (aes).


Eligibility criteria:
inclusion criteria: * diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma (cll/sll) as per international workshop on chronic lymphocytic leukemia (iwcll) 2018 diagnostic criteria * for ibruinib + venetociax (i+v) cohorts: eastern cooperative oncology group (ecog) performance status of 0-1. for ibrutinib monotherapy cohorts: ecog performance status of 0-2 * measurable nodal disease by computed tomography (ct), defined as at least 1 lymph node greater than and equal to (\>=) 1.5 centimeters (cm) in longest diameter * a participant using oral contraceptives must use an additional contraceptive method * a participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or until 1 month after last dose or per local label if more conservative (for example, 3 months in european union or canada and 1 month in united states) exclusion criteria: * uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura, such as those participants with a declining hemoglobin level or platelet count secondary to autoimmune destruction within the 4 weeks prior to first dose of study treatment, or the need for prednisone greater than (\>) 20 milligrams (mg) daily (or corticosteroid equivalent) to treat or control the autoimmune disease * known bleeding disorders (example, von willebrand's disease or hemophilia) * stroke or intracranial hemorrhage within 6 months prior to enrollment * known or suspected richter's transformation or central nervous system (cns) involvement * currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class ii, iii, or iv congestive heart failure as defined by the new york heart association functional classification
comparing pain and bruising of subcutaneous heparin injection

Conditions: Pain; Bruising

Summary: subcutaneous heparin injection is one of the most frequent nurses' clinical care. this study aimed to identify and compare the effects of four different injection duration on pain and bruising associated with subcutaneous injection of heparin in 90 patients. four injection methods were used for them: a: 10s injections duration b: 10s injection duration and waiting 10s before withdrawing the needle c: 15s injection duration and waiting 5s before withdrawing the needle d: 5s injection duration and waiting 15s before withdrawing the needle. bruising was measured by a flexible millimeter ruler 48h after each injection; and pain was measured by pain visual analogue scale immediately after the injection. data will be analyzed by spss.


Eligibility criteria:
inclusion criteria: * inclination to participate in the study; filling out the form of conscious satisfaction * ability to answer the questions and determining the rate of pain * not being affected by blood clotting difficulties, tissue damages, injuries, and bruises in the site of injection. exclusion criteria: * death, * discharge

Keywords: subcutaneous injection heparin injection duration bruising pain decrease pain decrease bruising
age related changes in calciotropic hormones and their impact on male osteoporosis

Conditions: Low Bone Density

Summary: the purpose of this pilot study is to generate preliminary data regarding the skeletal effects of age-related changes in calcium and vitamin d metabolism in older men.


Eligibility criteria:
inclusion criteria: * healthy men age 50 yrs and older exclusion criteria: * smokers * known history of metabolic bone disease, known history of hypogonadism or renal insufficiency.

Keywords: male osteoporosis male osteopenia calciotropic hormones
written exposure therapy for nurses

Conditions: Posttraumatic Stress Disorder; Depressive Symptoms; Burn Out; Anxiety; Work Related Stress

Summary: nurses often experience elevated levels of stress, overwork, and trauma in the workplace, leading to posttraumatic stress disorder (ptsd), depression, burnout, and even nurse turnover. while effective therapies for ptsd exist, barriers to treatment arise from nursing culture, such as workplace stigma about mental health problems, fear that psychological status may impact performance evaluations, and demands of shiftwork. there is a pressing need for scalable evidence-based interventions tailored to nursing culture to effectively address ptsd and related mental health issues. the study aimed to assess the feasibility, safety, and acceptability of a tailored evidence-based treatment, written exposure therapy (wet), for nurses experiencing work-related traumatic stress. this single-arm open pilot study with pre- and post-intervention assessments, included participants from two nursing schools' alumni. eligibility criteria included nurses screening positive for work-related trauma with a report of at least two ptsd symptoms. participants engaged in a self-administered, asynchronous, five-week online writing session, facilitated by wet-trained nurses. outcomes measures (ptsd, depression, anxiety, burnout, and intention to quit) were assessed at baseline, post-intervention, and 5-weeks follow-up.


Eligibility criteria:
inclusion criteria: * work-related trauma * posttraumatic stress disorder exclusion criteria: * current substance abuse * current suicidality * current psychiatric treatment with psychotherapy or psychotropic medications other than selective serotonin (and norepinephrine) reuptake inhibitors (ssri/snri).

Keywords: nurses written exposure therapy
looking at bile duct cancer patient experience patterns in medical trials

Conditions: Bile Duct Cancer

Summary: clinical trials can sometimes favor certain demographic groups. additionally, there is limited research that delves into the factors that influence participation in clinical trials, both positive and negative. the goal is to identify the obstacles and challenges that prevent participation in bile duct cancer clinical trials, as well as the reasons for withdrawal or discontinuation. the insights gained from this study will ultimately benefit those with bile duct cancer who may be invited to participate in medical research in the years to come.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * signed written informed consent * patient has been diagnosed with bile duct cancer exclusion criteria: * woman pregnant or susceptible to the being * inability to perform regular electronic reporting * inclusion in another investigational clinical trial

Keywords: bile duct bile duct cancer
stemchymal® for polyglutamine spinocerebellar ataxia

Conditions: Spinocerebellar Ataxias

Summary: the purpose of the clinical trial is to study the therapeutic efficacy and safety of stemchymal® infusions for polyglutamine spinocerebellar ataxia treatment by a randomized, double-blind, placebo-controlled study design. eligible subjects will receive stemchymal® through intravenous infusion.


Eligibility criteria:
inclusion criteria: 1. subjects are with genotypically confirmed sca3. 2. subjects' sara scores are in the range of 5 to15. 3. subjects are between 20 and 70 years of age. 4. subjects who have signed informed consent. 5. female subjects of child-bearing potential who are capable of conception must be post-menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing effective methods of birth control. 6. male subjects must be practicing a medically accepted form of contraception during the study period. abstinence is an acceptable method of contraception. exclusion criteria: 1. subjects who have been enrolled in any kind of cell therapy within six months prior to screening visit (visit 1). 2. female subjects who have a positive pregnancy test result. 3. subjects who have had severe vital organ diseases, including but not limited to cardiac (e.g., heart failure), liver (e.g., acute hepatic failure or chronic liver cirrhosis), lung (e.g., respiratory failure) and renal (e.g., hemodialysis or peritoneal dialysis) diseases, within six months prior to screening visit (visit 1). 4. subjects with immunological disorders (e.g., systemic lupus erythematosus), within six months prior to screening visit (visit 1). 5. subjects with other neurological disorders (e.g., alzheimer's disease), within six months prior to screening visit (visit 1). 6. subjects who had received chemotherapy/radiotherapy within five years prior to screening visit (visit 1). 7. subjects with any history of malignant tumors. 8. subjects with dementia or other psychiatric illnesses, including but not limited to disabling depression, bipolar disorder, schizophrenia. 9. subjects with a beck depression inventory second edition (bdi-ii) score of over 20 points. 10. subjects not suitable for this clinical trial according to investigator's judgment.
ultrasound guided modified pectoral plane block versus erector spinae plane block during ga in gynecomastia surgery

Conditions: Gynecomastia, Adolescent

Summary: pain of breast surgery is due to chest wall scar and arm in some cases like carcinoma or due to nerve injury.it is neuropathic or nociceptive pain.its severity is depending on the extent of surgery and the radiotherapy if needed. previous studies proved that local nerve block procedures improved the immediate postoperative pain and decreased the incidence of postoperative pain chronicity . also effective control of pain suppresses the surgical stress response minimizes the anaesthestic needs intraoperatively and decreases the opioid needs postoperatively . pectoralis nerve(pecs) ii block and erector spinae plane (esp) block are novel procedures that may provide good intraoperative and postoperative analgesia in patients undergoing surgical treatment of gynecomastia.


Eligibility criteria:
inclusion criteria: * male gender . * age : 18 - 25 years old . * physical status : asa i - ii . * body mass index(bmi) :20-30 kg/m2 * surgical treatment of gynecomastia . * duration of surgery : 60 -120 min exclusion criteria: * patient refusal . * history of opioid abuse or chronic analgesic use . * coagulopathy . * allergy to study drugs . * infection in the injection sites. * uncooperative patients.
bracing to treat knee osteoarthritis in elderly

Conditions: Knee Osteoarthritis

Summary: background: osteoarthritis (oa) is highly prevalent in the elderly, with the knee being the most commonly affected joint in this population. knee braces are often used to prevent common problems in knees during daily activities. the purpose of these devices is to decrease pain and improve functionality. in the literature some studies have tested the effectiveness of unloader brace for valgus or varus. however, the braces most used in the investigators' clinical setting and the less costly ones have not been described in quality studies in the literature. there are only few studies on this subject and they are methodologically inadequate. there are no studies that compared the effectiveness between the knee brace with metal hinges (no alignment) and knee brace without metal hinges. objective: to evaluate the effectiveness of knee braces on pain, function and quality of life in the elderly with knee oa. methods: elderly with knee oa, both genders, with pain scale 3-7cm on a 10cm pain numeric scale were included. of the 222 patients screened, 120 met the eligibility criteria and were randomized to the groups: without metal hinges, with metal hinges or control group. the groups without and with metal hinges received knee brace and were instructed to use it in daily activities, every day, during three months. assessment for pain (nps), function (womac and knee lequesne) and quality of life (sf-36) were done at baseline and after 45, 90 and 180 days by a blinded assessor.


Eligibility criteria:
inclusion criteria: * pain in numerical pain scale between 3 and 7cm; * knee ligamentous instability exclusion criteria: * fibromyalgia and neurologic disease; * knee or hip replacement * surgery scheduled in the following 6 months * start physical activity or received joint injection in the past three months * need to use walking aids or brace in knee
methadone induced memory retrieval-extinction procedure in heroin addicts

Conditions: Heroin Dependence

Summary: the study assessed the efficacy of a methadone-induced memory retrieval-extinction procedure on heroin craving and relapse. male participants aged 18-55 years old and prescribed mmt to treat heroin dependence were included in the present study, and randomly assigned to receive methadone, or receive methadone plus 10 minutes plus extinction, or receive methadone plus 6 hours plus extinction. the intervention persisted 3 times per week for 4 weeks. then the subjects were followed up once a month for cue induced heroin craving and relapse.

in the present study, we explored the effect retrieval-extinction procedure on heroin craving and relapse in heroin addicts using the methadone (a commonly used µ-opioid receptor agonist) instead of heroin as the trigger to reactivate drug memories. the subjects were randomly divided into 3 groups, in which they received methadone alone or extinction sessions 10 min or 6 hours after methadone administration. the extinction sessions were given 3 times per week for 4 weeks, each lasted for 30 min. during the extinction procedure, the subjects were exposed to images, heroin paraphernalia and mimic heroin. subjective craving, morphine urine test and physiological responses were recorded monthly for 4 months.

Eligibility criteria:
inclusion criteria: * met the diagnostic criteria of heroin dependence according to dsm-iv * were prescribed methadone maintenance treatment (mmt) and took it regularly * no change in city of residence for at least 1 year * had normal blood pressure and heart rate * had negative urine morphine screening test * primary-school level education * provide signed consent exclusion criteria: * other substance abuse(except nicotine) * had a current or past history of diagnostic and statistical manual of mental disorders, 4th edition（dsm-iv) axisⅰdisorders * had clinically evident physical disorders * neurological signs and/or history of neurological disease * noncompliance with the procedure
nilotinib in cognitively impaired parkinson disease patients 001

Conditions: Parkinson's Disease; Parkinson's Disease Dementia; Diffuse Lewy Body Disease

Summary: this pilot study will test nilotinib's ability to alter the abnormal protein build up in parkinson disease and diffuse lewey body disease patients . patients will receive nilotinib at different doses for 6 months. patients will then be tested to see if there is change in three areas: 1) has the disease symptoms changed. 2) has levels of a specific misfolded protein changed in the fluid around their brain and spine. 3) have inflammatory markers changed in the patient's blood and fluid around their brain and spine. if successful, this drug could be used to slow down or stop the progression of disorders that involve abnormal collection of misfolded proteins. however, the main purpose of this pilot study is to check for the safety of using this medication at this level.


Eligibility criteria:
inclusion criteria: 1. patients aged 40 to 90 with idiopathic parkinson's disease (significant sinemet response) on a stable medication drug regimen l-dopa and/or dopamine agonist (at least 1 month before enrollment with no new medication change) and with moderate to severe cognitive impairment (moca ≤24). inclusions criteria: 1. written informed consent 2. capability and willingness to comply with the study related criteria 3. patients between the age of 40-90 y 4. diagnosis of pd according to the uk brain bank diagnostic criteria 5. early pd subjects with mmse between 23-30. 6. hoehn and yahr stage \<2 7. stable treatment (\>4 weeks) with mao-b inhibitor (selegeline up to 10mg/d or rasagiline up to 1 mg/d) allowable 8. patients not needing dopamine agonist or levodopa therapy presently or at least for the next 6 months 9. idiopathic pd with no genetic mutations (autosomal recessive or dominant) 10. detectable levels of csf for blood and csf alpha-synuclein exclusion criteria: 1. patients with a known genetic form of pd that does not involve alpha-synuclein. 2. unwillingness to undergo lumbar punctures 3. immeasurable csf α-synuclein. 4. presence of dementia or severe cognitive impairment that would not permit the patient to give adequate feedback for potential side effects. 5. unwilling to be in an off state for updrs assessment. 6. pre-menopausal women 7. patients with autosomal recessive (parkin, pink1 or dj1) or dominant mutations (lrrk2) 8. patients with hypokalemia, hypomagnesaemia, or long qt syndrome. 9. concomitant drugs known to prolong the qt interval 10. strong cyp3a4 inhibitors 11. any drugs or foods that may interact with nilotinib as stated in the package insert (pi). 12. medical history of liver and pancreatic diseases. 13. clinical signs indicating syndromes other than idiopathic pd, including supranucelar gaze palsy, signs of frontal dementia, history of stroke, head injury or encephalitis, cerebellar sings, early severe autonomic involvement, babinski's signs. 14. history of any cardiovascular disease, including hypertension, myocardial infraction or cardiac failure, angina, arrhythmia.
speech locator_benefits in pediatric popluations

Conditions: Hearing Loss

Summary: the study seeks to evaluate the impact of speechsensor and stereozoom 2.0 on speech understanding in noise in dynamic listening conditions in pediatric hearing aid users.

the purpose of this study is to substantiate clinical performance claims regarding the benefit of the speechsensor feature on speech recognition in noise for side and rear speech as well as stereozoom 2.0 benefit data for front speech in noise. in addition, the study will yield myphonak app usability data and claims regarding children's impressions (confidence, anxiety) when given the opportunity to personalize their beamformer settings in noise during a home trial. finally, this work will confirm hearing aid intended use for pediatric hearing aid users. results will inform feature setting, provide critical post-market clinical hearing aid data and support for claims.

Eligibility criteria:
inclusion criteria: * experienced (\> 6 months), full-time hearing aid user * 10 years up to but not including 18 years of age * spoken english * ability to understand oral instruction * ability to describe listening experiences * no known neurological issues or cognitive impairment * ability to attend the in-person appointment(s) * no speech/language deficits that could compromising ability to perform tasks * healthy outer and middle ear * hearing loss consistent with fitting range of the investigational product * access to a smartphone that can be used during a home trial * informed consent (signature) of parent and consent or assent (verbal) of child exclusion criteria: * clinical contraindications (e.g., closed ear canal, absence of pinna) * known hypersensitivity or allergy to materials comprising hear-ing aid or acoustic coupling * unwilling to wear the hearing aid * unwilling or not permitted to use a smartphone * aided open-set aided speech recognition scores for speech front (+15 db snr) \< 30%
observational longitudinal study of pain in men with metastatic castrate-resistant prostate cancer

Conditions: Prostate Cancer

Summary: the first goal of this study is to learn more about the experience of pain and other symptoms in men being treated for advanced prostate cancer. the second goal of the study is to identify reliable ways of measuring pain which will be used in future clinical trials of treatments for advanced prostate cancer.


Eligibility criteria:
inclusion criteria: * the subject must be ≥ 18 years old on the day of consent. * the subject is able to understand written and spoken english. * the patient must have histologically or cytologically confirmed prostate adenocarcinoma. * the subject must have castration-resistant prostate cancer (crpc). * the subject must have metastatic disease involving bone, seen on radiographic imaging (bone scan, ct scan, pet scan, or mri). * the subject must be in a castrate state (e.g., currently receiving androgen deprivation therapy or have had an orchiectomy). * the subject must be starting any line of systemic treatment post-androgen deprivation/antiandrogen therapy, with any of the following: chemotherapy (e.g., docetaxel, paclitaxel, carboplatin, cabazitaxel, or mitoxantrone); abiraterone acetate; mdv3100; ketoconazole; a clinical trial. * the subject owns or has regular access to a telephone (cellular or land line). * the subject is willing and able to self-report pain and analgesic use via an automated telephone system. * the subject is willing and able to provide informed consent. exclusion criteria: * the subject has small cell or predominantly neuroendocrine differentiated prostate tumor.

Keywords: prostate pain assessment 12-110
collabree: a remote intervention to improve the regularity of medication intake

Conditions: Hypertension; Medication Adherence

Summary: this is a clinical study to improve the regularity of medication intake for high blood pressure. adult women and men who are over 50 years old, who have received a prescription drug for high blood pressure from mediservice, and who have to take at least 4 tablets per day (of which at least 1 dose of medication per day is for high blood pressure) can participate in this study. the investigators intend to examine whether collabree, a mobile phone application, is effective in supporting patients with hypertension to more successfully following their therapy plan in order to improve the regularity of medication intake. the study includes a 90-day intervention phase and a 90-day follow-up. the study does not require any therapy adjustments and no visits to a study center are necessary. the participants conduct the study independently at home. participants will also fill out questionnaires. participants are randomly assigned to one of 3 groups in a ratio of 1: 1: 1. two of these groups will receive the collabree mobile phone application.


Eligibility criteria:
inclusion criteria: 1. informed consent as documented by signature. 2. over 50 years of age on date of randomization. 3. patient received prescription medicine against hypertension by post from mediservice. 4. prescribed a therapy against hypertension consisting of 4 or more tablets taken per day. at least 1 dose of medication per day must be against hypertension. 5. participant administers their own medications. 6. participant owns a smartphone with a data plan or constant internet access during the study reporting events and at home to use the application. 7. minimal required smartphone operating system is ios 12 and android 8 (oreo). 8. adequate communication in german or swiss-german (all study documentation will only be set to the german language). exclusion criteria: 1. inability to operate a mobile phone and the collabree application. 2. inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. 3. enrollment of the sponsor-investigator, their family members, employees, and other dependent persons. 4. participation in another interventional clinical trial.

Keywords: digital health behavioral change