Kornimate/medical-research-clean huggingface dataset:
pain resilience for low back pain.

Conditions: Chronic Low Back Pain (CLBP)

Summary: chronic pain affects about 20% of adults in the u.s. and can lead to serious personal, social, and economic challenges. it is often treated with medications, including opioids, which carry risks of dependence. while pain education (pe) helps people better understand their pain and may reduce symptoms, it generally has only modest effects when used alone. the purpose of this study is to explore whether combining pain education with other treatments-such as physical therapy, cognitive behavioral techniques, and healthy lifestyle strategies-in a multi-modal resilience approach can offer greater benefits. the study aims to answer the following question: can a combined, whole-person approach improve outcomes in people with chronic pain more effectively than pain education alone?

chronic pain is pain that lasts beyond the typical healing duration, and is typically defined as lasting for at least 3-6 months. approximately 20% of the adult u.s. population experiences chronic pain. there are a variety of risk factors for developing chronic pain. female sex, older age, living in poverty, having chronic health conditions or a disability and being a veteran are among the risk factors for chronic pain. chronic pain impacts quality of life as well as worker productivity. chronic pain presents an economic burden beyond absenteeism and lost wages and costs the healthcare system upwards of $300 billion for a range of services including medication for pain management, surgeries, and disability compensation. additionally, opioid prescription for chronic pain is a primary driver of opioid use disorder. teaching those with chronic pain how to effectively manage their pain can improve quality of life and reduce the risk of developing dependency on opioid medication. the non-pharmacologic and non-invasive treatment of chronic pain includes physical therapy, cognitive behavioral techniques, and strategies for promoting a healthy lifestyle. pain education (pe) has been advocated as a methodology to reduce chronic pain. pe teaches that pain is not simply the result of tissue damage. rather, the foundation of pe is education about the factors that can contribute to pain such as emotions, beliefs, and past experiences.4 however, pe is a singular modality that produces small effects. a multi-modal resilience approach model may produce larger effects.

Eligibility criteria:
inclusion criteria * adults experiencing chronic pain of any diagnosis for a duration of at least 6 months. * ability to read and understand english. exclusion criteria * experiencing acute pain related to a recent injury or pain lasting less than 6 months. * inability to read or understand english.
inside: identification of genomic screening pathways in cancer patients with dna repair alterations

Conditions: Prostate Cancer

Summary: 400 patients will be enrolled and divided into 3 cohorts: cohort a: patients with high risk localized prostate cancer (pc) defined as \>ct3 or psa \> 20 ng/ml or presence of ece or svi at mpmri; cohort b: patients with de novo metastatic hormone sensitive prostate cancer (mhspc); cohort c: patients with metastatic castration resistant prostate cancer (mcrpc) progressing on a standard treatment.

in this study 150 patients will be enrolled in cohort a, 100 patients in cohort b and 100-150 patients in cohort c. considering the known frequency of ddr and mmr germline/somatic alterations, it is expected to see: * 15-23 patients with germline/somatic ddr defects and 5-7 mmr alterations in cohort a; * 20-25 patients with germline/somatic ddr defects and 5-7 mmr alterations in cohort b; * 25-35 patients with germline/somatic ddr defects and 7-10 mmr alterations in cohort c. patients within cohort a will be followed up with psa every 3 months for 3 years and early scans. they will also receive a blood sample for ctdna/ctc before (when feasible) and after radical treatment, 6 months and 12 months (if not progressed), at time of psa or radiological progression; patients within cohort b will be followed up with psa and scans every 3 months. they will also receive a blood sample before (when feasible) or after the start of systemic treatment, 6 months and 12 months (if not progressed), at time of psa or radiological progression. patients within cohort c will be followed up with psa monthly and scans every 3 month. they will also receive a blood sample for ctdna/ctc before (when feasible) or after the start of systemic treatment, 6 months and 12 months (if not progressed), at time of psa or radiological progression.

Eligibility criteria:
inclusion criteria: * age \> 18 years * diagnosis of prostate cancer as indicated below: cohort a: patients with high risk localized prostate cancer (defined as \>ct3 or psa \> 20 ng/ml or presence of ece or sviat mpmri), with tissue available from diagnostic biopsy/ prostatectomy undergoing or who underwent curative treatment (prostatectomy/ radical radiotherapy) but have not started a fu pathway. cohort b: patients with de novo metastatic hormone sensitive prostate cancer (mhspc) with tissue available from diagnostic biopsy of the primary and when possiblepossible, from a metastatic site. patients must either have not started a standard treatment or have started for not longer than 3 months. cohort c: patients with metastatic castration resistant prostate cancer tissue (mcrpc) progressing on a standard treatment with available from biopsy of a metastatic site, and when possiblepossible, from the primary. * ability to understand and consent to informed consent; * patient must be compliant with receiving a biopsy of the metastatic site (cohort c) and with fu assessments schedule exclusion criteria: • patients not willing to comply with study's procedures or fulfilling the inclusion criteria.

Keywords: prostate cancer mhspc castration-resistant parp inhibitory mcrpc
pivotal bioequivalence fdc nifedipine / candesartan vs. loose combination of single components, fed

Conditions: Hypertension, Essential

Summary: randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence of a new fixed dose combination (fdc) tablet of nifedipine gits and candesartan with the corresponding loose combination under fed conditions.

clinical pharmacology

Eligibility criteria:
inclusion criteria: * the informed consent form must be signed before any study specific tests or procedures are done * confirmation of the subject's health insurance coverage prior to the first screening visit * healthy male subject * ethnicity: caucasian * age: 18 to 45 years (inclusive) at the first screening visit * body mass index (bmi) above or equal 18, and below or equal 29.9 kg / m² * ability to understand and follow study-related instructions exclusion criteria: * suspicion of drug or alcohol abuse * regular daily consumption of more than 1 l of xanthin-containing beverages * intake of foods or beverages containing grapefruit within 2 weeks prior to the first study drug administration (the same applies to pomelos and st. john's wort) * use of medication within 4 weeks prior to the first study drug administration which could interfere with the investigational products (e.g. cyp3a inhibitors or cyp3a inducers) * examples for cyp3a inhibitors: erythromycin, inhibitors of human hiv protease (e.g. ritonavir, saquinavir), amiodarone, diltiazem, verapamil, fluconazole, itraconazole, ketoconazole, clarithromycin, telithromycin, nefazodon, cimetidine; * examples for cyp3a inducers: rifampicin, carbamazepin, phenytoin, phenobarbital, or products containing st. john's wort; * systolic blood pressure below 116 or above 145 mmhg (after at least 15 min supine) * at the first screening visit * diastolic blood pressure above 95 mmhg (after at least 15 min supine) * heart rate below 45 or above 95 beats / min (after at least 15 min supine) at the first screening visit * clinically relevant findings in the physical examination * positive urine drug screening or alcohol breath test * exclusion periods from other studies or simultaneous participation in other clinical studies

Keywords: essential hypertension, blood pressure, nifedipine, candesartan, fdc
a randomized, multicenter study of the safety and performance of fabian prico for saturation targeting with non-invasive respiratory support

Conditions: Respiratory Insufficiency Syndrome of Newborn

Summary: this study is planned as a part of the post market clinical follow-up (pmcf) on a ce marked product. the purpose of this study is to assess, in a routine clinical environment at two centers the use of fabian-prico with noninvasive ventilation and its safety and performance at targeting and maintaining accurate spo2 levels.

this is a randomized cross-over study. subjects will be assigned to two, nominally 12-hour interventions, one with standard manual titration of fio2 and the other with automated adjustment (prico). the order of these two interventions will be random. in addition to the ventilators data, basic demographics (i.e., gestational age, birth weight, age, weight at study) of the participating infants will be recorded in the ecrf. this study has no additional follow-up visits.

Eligibility criteria:
inclusion criteria: * infants in the neonatal unit that require non-invasive respiratory support and supplemental oxygen provided by fabian therapy evolution ventilator * \<37 + 0 weeks gestation * \<10 kg at study entry * fio2 \> 0.25 * informed consent form obtained as per ec requirements exclusion criteria: * not expected to complete 24 hours of non-invasive respiratory support * congenital anomalies * uncontrolled hemodynamics * severe airflow obstruction * intracranial hypertension * start of caffeine therapy within 12 hours * attending physician does not believe participation in the study is in the patient's best interest
screening tool to identify the dominant pain mechanism in cancer survivors: painscan

Conditions: Cancer Survivors; Cancer Pain

Summary: development and internal validation of an easy-to-use tool for clinical pain assessment. the tool has to be applicable in any clinical practice and without the need for expensive and complicated hospital tools to identify the source of persistent pain after the treatment of cancer.

an adequate selection of physiotherapy treatment for persistent pain after the treatment of cancer, depends highly on the mechanism of the pain. pain can arise from a damaged nerve or tissue (skin, lymphatic system...). but when pain becomes chronic, alterations to the central nervous system can occur, as regulations of the facilitating and inhibiting mechanisms. these alterations may cause central sensitization pain. the body is now sensitized and cannot distinct harmful from harmless stimuli. each type of pain requires a specific treatment, therefore identification of the pain mechanism is crucial. up till now, expensive and complex tests were performed in a hospital setting to determine if a patient suffers from neuropathic, nociceptive or central sensitization pain. this study aims for developping an assessment tool that does not require expensive devices but can be easily performed by any physiotherapist, within the timeframe of a standard consultation.

Eligibility criteria:
inclusion criteria: * patient treated for primary cancer: breast, prostate, lung/bronchus, colon/rectum, gynecologic (uterus or ovary) * complete remission * curative treatment finished * ongoing hormonal and targeted treatment permitted * patient experiences pain (nrs minimum 3/10 during the past week) exclusion criteria: * active metastasis * palliative status * other type of cancer than mentioned in inclusion criteria * pregnancy

Keywords: pain cancer chronic pain persistent pain
effectiveness of nursing care bundle for the prevention of intraventricular hemorrhage in preterm infants

Conditions: Intraventricular Hemorrhage of Prematurity; Nursing Caries

Summary: existing measures to prevent intraventricular hemorrhage in preterm infants include preventing premature delivery, pre-natal administration of corticosteroid, active treatment of chorioamnionitis, and improvement of postnatal resuscitation and transfer process. many overseas studies show that nursing care can reduce the risk of intraventricular hemorrhage and death, but there is no such study in taiwan. objective: to explore the effect of bundle nursing care on prevention of ivh in premature infants.

a quasi-experimental study design was employed and a total of 230 preterm infants with birth weight less than 1,500 g or gestational age ≤30 weeks will be recruited at the neonatal intensive care unit of national taiwan university hospital. the infants will be divided into 200 in the control group and 30 in the experimental group. enrollment began after approval was granted by the institutional review board. eligible hospitalized preterm infants that met the inclusion criteria from january 2017 to december 2029 were selected for the control group by retrospective cohort and matched by the gestational age, birth weight and delivery method with the experimental group. the experimental group received bundle nursing care within 3 days after birth in addition to routine nursing care after consent was given and the informed consent form was signed. the study tools include 1. intervention tools: small towel or head positioning pillow (tortle midliner) and timer; 2. data collection: self-created questionnaire on awareness and behavior for preventing intraventricular hemorrhage in preterm infants in nurses, medical record and bundle care implementation record. the data were analyzed by descriptive statistics, t-test, chi-square test and logistic regression using spss 26 statistical software. the expected results are reduction in the incidence of intraventricular hemorrhage, the length of stay in the intensive care unit and mortality.

Eligibility criteria:
inclusion criteria: * inborn preterm infants * preterm infants with birth weight less than 1,500 g or gestational age ≤30 weeks exclusion criteria: * preterm infants with congenital malformations * genetic syndromes * congenital infections of the torchs group(syphilis, rubella, herpes, toxoplasmosis, and cytomegalovirus) * resuscitation and pneumothorax at birth.

Keywords: premature infants bundle care intraventricular hemorrhage (ivh)
a study to assess the impact of speed and site of subcutaneous injection on pain, tolerability, safety, and pharmacokinetics of gantenerumab in healthy participants

Conditions: Healthy Volunteer

Summary: the purpose of this randomized, open-label, parallel-group, placebo-controlled study is to assess pain following subcutaneous (sc) administration of gantenerumab as a high-concentration liquid formulation (hclf) at different injection speeds. the total duration of the study for each healthy participant will be up to approximately 21 weeks.


Eligibility criteria:
inclusion criteria: * healthy male and female participants (healthy status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram, hematology, blood chemistry, coagulation, serology, and urinalysis) * body mass index between 18.0 and 30.0 kilograms per meter squared (kg/m\^2), inclusive * female participants of childbearing potential must commit to use two acceptable forms of contraception during the study and until at least 6 months after the follow-up visit exclusion criteria: * history of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis * history or suspicion of drugs of abuse or alcohol addiction * smokers who smoke more than 10 cigarettes per day or equivalent amount of tobacco as determined by history * pregnant or lactating women * positive result on hepatitis b virus (hbv), hepatitis c virus (hcv), or human immunodeficiency virus (hiv)-1 and -2 * any familial history of early onset alzheimer's disease * prior administration of gantenerumab * participation in an investigational drug medicinal product or medical device study within 90 days before dosing or within seven times the elimination half-life, whichever is longer * any abnormal skin conditions or potentially obscuring tattoos, pigmentation, or lesions in the area intended for sc injection
the intervention of multi-vitamin with minerals to hyperuricemia

Conditions: Hyperuricemia

Summary: to evaluate the validity of multi-vitamin-and-minerals intervention on uric acid metabolism in hyperuricemic adults.

hyperuricemia is a type of metabolic diseases which caused by purine metabolic disorder and (or) uric acid excretion disorder. uric acid is produced by cell metabolism and food purine metabolism as the end-point product. excess alcohol and purine-rich food intake together with abnormal function of purine metabolic key enzyme are the main causes leading increasing serum level of uric acid. it has been a focus in nutritional area that a safer approach of preventing hyperuricemia by adjustment of nutritional intake. primary studies found that proper supplement of microelements showed significant regulations in inflammation and oxidative stress induced by elevating level of uric acid. therefore, this study will be conducted to test whether the supplement of multi-vitamins with minerals will lower the level of blood uric acid and improve the imbalance of microelement metabolism or not. the investigators will recruit 200 subjects of study who would be divided into four groups and accept intervention of high-dose multi-vitamins with minerals, low-dose multi-vitamins with minerals, hypouricemic tablets and placebo, respectively. after intervention of 3 or 6 months, serum uric acid and purine metabolism function will be detected. this study could provide references for illuminating the mechanism in purine metabolism and nutritional measures to control the pathological development of hyperuricemia.

Eligibility criteria:
inclusion criteria: * under the dietary pattern of normal intake of purine, the level of serum uric acid is higher than 420μmol/l for male or 360μmol/l for female (not be detected twice at the same day). exclusion criteria: * gouty arthritis, tophus or gouty nephropathy. * complications including diabetes, cardiovascular diseases (angina, myocardial infarction) and so on. * taken hypouricemic medicine in the last week before intervention, including allopurinol, benzbromarone, probenecid and so on. * had an operation in the past year. * malnutrition or severe obesity, bmi\ 30.0 kg/m2. * mental diseases, tumor, hepatic cirrhosis or other diseases that may interfere with the intervention. * alcohol abuse (\>80g/d)
fixed dose combination versus free combination of tiotropium and olodaterol in copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study. patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either fdc (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the respimat® inhaler. the purpose is to show non-inferiority between the fdc and the free combination of tiotropium and olodaterol in patients with copd.


Eligibility criteria:
inclusion criteria: * male or female patients. * patients 40 years of age or older. * patients with a smoking history \> 10 pack years. * diagnostic of copd with post-bronchodilator fev1 (forced expiratory volume in one second) \>= 30% and \<80% of predicted normal and post-bronchodilator fev1/fvc (forced vital capacity) \<70% at screening. * symptomatic patients with cat (copd assessment test tm) score \>= 10 at screening. * further inclusion criteria apply. exclusion criteria: * copd exacerbation or symptoms of lower respiratory tract infection within 6 weeks prior to screening. * patients with a current diagnosis of asthma. * further exclusion criteria apply.
a study of the safety and effectiveness of an hiv vaccine for hiv-positive patients receiving anti-hiv drugs for at least 2 years

Conditions: HIV Infections

Summary: the purpose of this study is to see if 2 study vaccines, alvac-hiv (vcp1452) and gp160 mn/lai-2, are safe and effective in boosting the body's attacks on hiv in hiv-positive patients. hiv-infected patients who have been treated with anti-hiv drugs for a long time may have weakened immune responses. one way to strengthen these responses may be to have a safe and effective vaccine, which will boost immune responses that are specific to hiv.

hiv-infected patients treated with antiretroviral therapy for prolonged periods of time may show decreased levels of hiv-specific immune responses. in these patients, a prime-boost vaccine strategy may induce both humoral and cell-mediated immunity. the hypothesis of this study is that the vaccine strategy selected will be both safe and immunogenic in the patient population being tested. patients continue antiretroviral medications throughout the course of this study. all patients receive intramuscular injections of alvac-hiv (vcp 1452) and recombinant soluble gp160 mn/lai-2 on days 0, 30, 90, and 180. patients are monitored for safety 30 minutes after each immunization and by telephone contact within 72 hours of each vaccination. in addition, each patient records adverse events in a diary. patients have regular physical exams, pregnancy tests, and blood drawn for virologic and immunologic assessments. the induction of hiv-specific responses will be measured.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are hiv-positive. * have a viral load (amount of hiv in the blood) of less than 50 copies/ml. * have been taking anti-hiv drugs for at least 2 years. * are already participating in ongoing clinical trials at the aaron diamond aids research center. * are at least 19 years old. * practice abstinence or use 2 barrier methods of birth control, both men and women who are able to have children. exclusion criteria patients will not be eligible for this study if they: * have hiv infection that is spreading through the body even though they are taking anti-hiv drugs. * are breast-feeding. * are pregnant. * are allergic to eggs and/or neomycin. * show evidence of poor immune responses.

Keywords: recombinant proteins hiv envelope protein gp160 aids vaccines anti-hiv agents treatment experienced hiv therapeutic vaccine