Kornimate/medical-research-clean huggingface dataset:
a clinical trial to evaluate safety and efficacy of endovascualr denervation in treatment of cancer pain

Conditions: Liver Cancer; Pancreas Cancer; Stomach Cancer; Bile Duct Cancer

Summary: a prospective, multicenter, self-control clinical trial aim to enroll 110 patients suffered from upper abdominal (liver, pancreas, stomach, etc.) cancers . patients who have taken at least one opioid drug for pain for two weeks and still have a vas pain scale greater than 6 will receive endovascular denervation (edn). they will be followed up for 3 months. the vas scales, quantity of analgesics as represented by morphine equivalent and quality of life scores will be compared before and after edn. safety parameters such as arterial deformation, embolism, infection, liver and kidney functions will also be monitored.


Eligibility criteria:
inclusion criteria: * males or females with ages of 25 to 75; * clinically diagnosed as primary or secondary upper abdominal cancers (liver, pancreas, stomach, etc); * patients who have taken at least one opioid drug for pain for two weeks and still have vas pain scale 》6; * expected lifetime 》4 months; * agrees to take part in the trial and signs the written, informed consent. exclusion criteria: * women who are pregnant, or breast feeding, or having pregancy plan; * bleeding tendency or other coagulation related diseases; * acute or severe systemic infection; * past history of receving denervation procedure in aorta; * no plans for surgical or interventional procedures in 3 months; * history of stroke or tia within 2 weeks; * acute coronary events within 2 weeks; * other conditions that deem unsuitable for the procedure, in the opinions of investigators.

Keywords: cancer； pain
trauma informed treatment algorithms for novel outcomes

Conditions: Post-Traumatic Stress Disorder

Summary: this randomized controlled trial (rct) will examine the feasibility, acceptability, and preliminary efficacy of a beginning treatment for post-traumatic stress disorder (ptsd) with behavioral activation (ba). cambodian men and women who screen positive for ptsd will be randomized to receive six individually delivered sessions of either: 1) stabilization techniques alone (st); or 2) st+ba. after two months, all participants who continue to report clinically meaningful elevations in ptsd will receive eye movement desensitization reprocessing (emdr). all participants will complete a follow-up assessment at four months post-randomization.

nearly half of the cambodian population reports elevated levels of psychological distress and ptsd. the high levels of psychological distress are linked directly to the report of remote and more recent trauma exposures, the most notable of which is the agrarian political regime of the khmer rouge during the 1970s, which occurred in the aftermath of the vietnam war. during this period, approximately 1.5 million cambodian residents died of starvation and sickness, 500,000 individuals were executed, and another two million were displaced over the course of several years. political stability took shape in the early 1990s after the enactment of the united nations transitional authority in cambodia. however, the prior violence undermined an already fragile healthcare system, including mental health institutions and physicians providing direct patient care. the combination of high trauma exposure, sustained conflict, and limited psychiatric capacity has created heightened vulnerability for cambodians, and the need to assist those struggling with ptsd. there is a pressing need to reverse this trajectory using novel approaches to address mental health needs that are effective and scalable, providing a strong basis to conduct the proposed work in cambodia. in partnership with the cambodian department of mental health and substance abuse, ministry of health, this nih-sponsored study will examine the feasibility, acceptability, and preliminary efficacy integrating ba into trauma treatment that is being delivered by the mekong project in cambodia.

Eligibility criteria:
inclusion criteria: * trauma exposure and screens positive for ptsd as measured by the dsm-5 ptsd checklist (pcl-5), a 20-item scale to measure severity of ptsd symptoms * able to communicate in khmer * able to provide informed consent as defined by ability to accurately paraphrase the purpose exclusion criteria: * active psychosis or developmental disorder that precludes an individual's ability to provide informed consent * severe alcohol or substance use disorder a determined by the alcohol, smoking, and substance involvement screening test (assist) note: * use of psychiatric medications will be allowed but our preliminary work revealed fewer than 5% of all individuals receive medications for ptsd

Keywords: randomized controlled trial post-traumatic stress disorder global health mental disorders
effect of ruxolitinib on tumor infiltrating myeloid cells

Conditions: Prostate Cancer

Summary: ruxolitinib will be dispensed to patients candidate to prostatectomy immediately after histological diagnosis of prostate adenocarcinoma. the treatment will be given for 28 days followed by a prostatectomy thereafter. tumor material and blood samples will be analysed before, during and after the treatment with ruxolitinib.

patients with suspected localized prostate cancer will undergo biopsies spotting different prostate sites, as per standard clinical practice. patients with histologically confirmed prostate adenocarcinoma and candidate for prostatectomy, after signing the informed consent form, will receive ruxolitinib for 4 weeks (the time normally elapsing between histological diagnosis and surgery) and will thereafter undergo prostatectomy. remaining biological material from the diagnosis and the prostatectomy will be sent to the molecular oncology laboratory for molecular analysis. in addition, blood samples will be drawn before, during ruxolitinib treatment (week 2), at the end of treatment (week 4), and after prostatectomy (week 5), to assess the frequency and subtype of immune subsets and the circulating levels of cytokines and secreted. patients will be monitored for occurrence of adverse events/surgical complications during treatment and up to 4 weeks after the intervention.

Eligibility criteria:
inclusion criteria: * age 18-70 years * histological diagnosis of prostate adenocarcinoma * stage ≥t2b for which surgery is indicated * no distant metastasis (m0) * nlr ≥3 in the blood or nlr ≥3 in the tumor biopsies or a percentage of mdscs ≥ 30% in the tumour biopsies * ps (ecog scale) 0-1 * adequate hepatic function: alt and asat ≤ 2.5 x uln, bilirubin ≤ 1.5 uln (exception if gilbert's syndrome ≤ 2.5 x uln) * adequate renal function: calculated creatinine clearance ≥ 50 ml/min according to the formula of cockcroft-gault * hemoglobin ≥ 10 g/dl, leukocyte count ≥ 4.0 x 103/µl, platelet count ≥ 200 x 103/µl * informed consent as documented by the patient's signature exclusion criteria: * no history of coagulation disorders and normal inr * significant cardiovascular disorders in the last 12 months * other clinically significant concomitant disease states which in the opinion of the investigator may represent contraindications to study participation * known or suspected non-compliance * participation in another study with investigational drug within the 30 days preceding and during the present study * ongoing treatment with strong cyp3a4 inhibitors or dual cyp2c9 and cyp3a4 inhibitors
a study of the use of methotrexate in the treatment of chronic idiopathic urticaria

Conditions: Urticaria

Summary: the purpose of this study is to determine whether methotrexate produces significant improvement in chronic idiopathic urticaria, compared with placebo

chronic idiopathic urticaria is thought to affect approximately 0.1% of the population. it can be very disabling and difficult to treat. antihistamines are the only drugs licensed for treatment of urticaria, however there is a group of severely affected patients with chronic idiopathic urticaria who fail to respond. previous trials have shown ciclosporin to be beneficial, and small studies support the use of intravenous immunoglobulins and plasmapheresis. however, not only are these options expensive, but since chronic idiopathic urticaria may persist for years, their prolonged use may be limited by adverse effects. we have previously published a report of 2 patients who responded to methotrexate, and wish to properly evaluate the efficacy of methotrexate in the treatment of ciu. in the first part of the study patients will be given either placebo or methotrexate for 8 weeks and in the second part of the study, non-responders will be offered open labelled methotrexate for 8 weeks.

Eligibility criteria:
inclusion criteria: * severe unremitting chronic idiopathic urticaria * disease resistant to treatment with antihistamines * aged 18 years or more exclusion criteria: * predominant physical urticaria * urticarial vasculitis * any contraindication to the use of methotrexate, eg. pregnancy / breast feeding, women wanting to conceive or man wanting to father a child within 12 months of entry, use of drugs which interact, underlying medical conditions * use of immunosuppressant within 4 weeks of entry

Keywords: chronic idiopathic urticaria methotrexate
ai powered mapping technology for identifying arrhythmias

Conditions: Arrhythmias, Cardiac

Summary: exploratory, hypothesis-generating study evaluating the impact of vmap on procedural efficiency, acute success, and work flow optimization.

the registry is a retrospective and prospective, post-approval, multicenter, single-arm, all-comers registry with two cohorts: retrospective cohort: approximately 60 patients across two sites. prospective cohort: approximately 50 patients across two sites. this registry aims to collect real-world data on the clinical utility, safety, and procedural efficiency of vmap-guided ablation procedures.

Eligibility criteria:
inclusion criteria: * a cardiac ablation (de novo or repeat) procedure will occur guided by vmap. * a confirmed cardiac arrythmia has been identified on a 12-lead ecg. * the patient is greater than or equal to 18 years old. * the patient can provide written informed consent. exclusion criteria: * non-inducible arrhythmia (unless pre-mapped via vmap prior to the procedure). * patients in whom no ablation was performed. * inability to obtain 12-lead ecg of sufficient quality for vmap analysis.
b-vitamin levels and adverse pregnancy outcomes

Conditions: Birth Defect; Pregnancy Loss; Pregnancy Complications; Pregnancy Induced Hypertension; Recurrent Pregnancy Loss; Health Problems in Pregnancy; Gestational Diabetes; Gestational Hypertension; Preterm Birth

Summary: this prospective nested case-control study aims to examine the effects of blood vitamin b levels in first-trimester pregnant women on the pregnancy outcomes

folate deficiency can cause severe adverse pregnancy outcomes, such as neural tube defects. effective folate functioning requires essential metabolic interactions with other b vitamins including vitamin b2, vitamin b3, vitamin b6, and vitamin b12, which can also influence pregnancy outcomes independently. for example, animal and family studies have identified that niacin (b3) deficiency can lead to congenital malformations. however, how folate and related b-vitamin levels interact with each other while affecting various pregnancy outcomes including abortion, birth defects, pregnancy complications, etc. is unclear. besides, folate levels in previous studies were mostly measured in plasma which are easily influenced by dietary factors, instead of red blood cell folate which can reflect the long-term status. moreover, the difference in the risk of neural tube defects across a range of maternal red blood cell folate concentrations has been largely ignored. using data of pregnant women recruited at beijing obstetrics and gynecology hospital from december 2020 to december 2021, this case-control study aims to examine the association of folate and related b-vitamin levels in first-trimester blood samples (plasma and red blood cell) with pregnancy outcomes, particularly the association between niacin deficiency and birth defects.

Eligibility criteria:
inclusion criteria: * pregnant women with 6-13(+6 days) gestational weeks * resided in beijing in the past year * pregnant women who intend to have antenatal examinations and delivery at beijing obstetrics and gynecology hospital * pregnant women who are willing to participate in this study with informed consent exclusion criteria: * women with hepatitis b, syphilis, hiv/aids and other infectious diseases.

Keywords: vitamin b pregnancy outcome
telemedicine as a means to achieving good diabetes control among patients with type 2 diabetes

Conditions: Type 2 Diabetes; Poor Glycemic Control; Medication Adherence

Summary: the aim of the study is to investigate the effect of telemedicine among the group of type-2-diabetics who, despite rehabilitation, remain poorly regulated. to describe the patients with regards to vulnerability and social resources and to determine wich groups benefit the most from telemedicine.

type-2-diabetes is a growing healthcare problem. both because of the increasing amount of patients and because of the complications of diabetes. non-pharmacological treatment is considered fundamental in the treatment of patients with type-2-diabetes. in the community of copenhagen, all patients diagnosed with diabetes receive rehabilitation. the rehabilitation consists of counseling with regards to nutrition, physical activity, smoking cessation and education about diabetes. some patients however, remain poorly regulated despite rehabilitation as well as pharmacological treatment. a total number of 165 patients will be randomized to intervention group or standard care.

Eligibility criteria:
inclusion criteria: * hba1c \> 7,5% * bmi \> 25 * spoken danish * completed a rehabilitation program more than 6 months ago exclusion criteria: * hba1c \< 7,5% * bmi \< 25 * need of interpreter

Keywords: type 2 diabetes quality of life lifestyle intervention telemedicine videoconference
rasburicase versus allopurinol in tumor patients at risk for hyperuricemia and tumor lysis syndrome

Conditions: Tumor Lysis Syndrome; Cancer; Hyperuricemia

Summary: this is a randomized, multi-center, open-label, parallel group study with three arms: * rasburicase alone * rasburicase followed by allopurinol * allopurinol alone the primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.

after signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.

Eligibility criteria:
inclusion criteria: 1. meets high risk or at potential risk for tumor lysis syndrome (tls): a patient is at high risk for tls if he/she presents with: * hyperuricemia of malignancy (plasma uric acid \> 7.5 mg/dl); * a diagnosis of very aggressive lymphoma/leukemia based on the revised european-american lymphoma (real) classification of lymphoma/leukemia; * acute myeloid leukemia (aml); * chronic myeloid leukemia (cml) in blast crisis; or * high grade myelodysplastic syndrome (refractory anemia with excess blast, chronic myelomonocytic leukemia, and refractory anemia with excess blast in transformation) only if they have \> 10% bone marrow blast involvement and are given aggressive treatment similar to aml. a patient is at potential risk for tls if he/she presents with: * a diagnosis of aggressive lymphoma/leukemia based on the real classification of lymphoma/leukemia plus 1 or more of the following criteria: * lactate dehydrogenase (ldh) \>= 2 x upper limit of normal (uln) (iu/l) * stage iii-iv disease * stage i-ii disease with at least 1 lymph node/tumor \> 5 cm in diameter in addition to the above-mentioned eligibility criteria, the patients should have the following criteria: 2. eastern cooperative oncology group (ecog) performance status 0-3 3. age \>= 18 years 4. life expectancy \> 3 months 5. negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (for both males and females). a pregnancy test may be performed on serum or urine human chorionic gonadotropin (hcg). 6. signed written informed consent

Keywords: hyperuricemia tumor lysis syndrome leukemia lymphoma myelodysplastic syndromes solid tumor cancers solid tumor cancers with hyperuricemia hyperuricemia (cancer patients only) tumor lysis syndrome (cancer patients only)
effects of flumazenil on brain excitability

Conditions: Stroke; Healthy

Summary: this study will investigate the effects of the drug flumazenil on brain excitability and the drug's relationship to a natural brain chemical called gaba. flumazenil is commonly used in hospitals to reverse the effects of a group of drugs called benzodiazepines, one of which is valium. benzodiazepines act by enhancing the effects of gaba. healthy volunteers 21 years of age and older may be eligible for this study. candidates will be screened with a medical history and physical and neurological examinations. participants will have transcranial magnetic stimulation (tms) four times on two different days, before and after receiving an intravenous (through a vein) infusion of either flumazenil or placebo (an inactive sugar solution), as follows: tms study 1 drug or placebo infusion tms study 2 - 15 minutes after infusion tms study 3 - 60 minutes after infusion tms study 4 - 120 minutes after infusion in transcranial magnetic stimulation, a very brief electrical current is passed through an insulated coil wire placed on the scalp. these currents stimulate the cortex (outer part of the brain). they may cause muscle, hand, or arm twitching if the coil is near the part of the brain that controls movement, or they may affect other reflexes or movements. during the study, subjects may be asked to make movements, do simple tasks or tense muscles. to record the electrical activity of muscles, electrodes will be taped to the skin over the muscles tested. in some cases, the studies will be videotaped. flumazenil will be infused through a catheter (thin plastic tube) attached to a needle placed in an arm vein. on one day, subjects will receive a 1-mg injection of flumazenil followed by a continuous infusion of 0.5 mg of the drug for about 30 minutes. on the other day, they will receive placebo, administered in the same manner.

the purpose of this study is to investigate the effects of flumazenil on cortical excitability in healthy human volunteers. flumazenil acts as a potent benzodiazepine (bzp)-specific antagonist by competing at the central synaptic gamma-aminobutyric acid (gaba) receptor site. however, the relationship between gaba and flumazenil without bzps is not well known. we plan to determine if intravenous (iv) administration in therapeutic dosage alters cortical excitability as measured by transcranial magnetic stimulation (tms). the long-term plan is to identify a pharmacological method to reduce cortical inhibition that might be useful in stroke rehabilitation.

Eligibility criteria:
only healthy volunteers, who are age 21 or older. no history of surgery with metallic implants or known metallic particles in the brain. patients cannot be pregnant (as tested with a pregnancy test). patients with a psychiatric illness are not eligible. no history of seizures. no cardiovascular disease or drug therapy for chronic depression. no hypersensitivity to benzodiazepines and related drugs. no history of drug abuse and/or chronic alcoholism.

Keywords: motor cortex drug gaba cortical modulation magnetic stimulation healthy volunteer
glecaprevir/pibrentasvir drug use results survey in patients infected with hepatitis c virus genotype 1-6

Conditions: Hepatitis C Virus (HCV)

Summary: this multi-center, post-marketing, observational study evaluates the real world safety and effectiveness of glecaprevir plus pibrentasvir use in participants infected with the hepatitis c virus genotype 1 - 6.


Eligibility criteria:
inclusion criteria: * patients with chronic hepatitis c virus infection and administering glecaprevir plus pibrentasvir. exclusion criteria: * patients previously treated with glecaprevir plus pibrentasvir.

Keywords: chronic hepatitis c virus (hcv) genotype glecaprevir pibrentasvir sustained virologic response chronic hepatitis c virus genotype 1 chronic hepatitis c virus genotype 2 chronic hepatitis c virus genotype 3 chronic hepatitis c virus genotype 4 chronic hepatitis c virus genotype 5 chronic hepatitis c virus genotype 6
suprainguinal fascia iliaca (sifi) block improves analgesia following total hip arthroplasty

Conditions: Hip Osteoarthritis; Primary Total Hip Arthroplasty; Pain

Summary: the purpose of this study is to learn if using a suprainguinal fascia iliaca (sifi) injection technique (also called a "nerve block") that numbs the nerves going to the side and front of the upper leg will improve pain control after surgery. the sifi technique uses a numbing solution (local anesthetics) that is injected next to nerves in the hip to reduce pain. this block may affect movement in the leg and make the legs weak. the amount of leg weakness is not known and assessment of this will be included in the study. many institutions use the sifi block for patients having total hip replacements, with the hope of providing good pain relief combined with improved mobility after surgery.


Eligibility criteria:
inclusion criteria: * english speaking * between 18 and 75 years old * american society of anesthesiologists (asa) 1-3 patients undergoing primary total hip arthroplasty exclusion criteria: * asa 4 or 5 * revision hip arthroplasty * diagnosis of chronic pain * daily chronic opioid use (over 3 months of continuous opioid use) * inability to communicate pain scores or need for analgesia * acute hip fracture * infection at the site of block placement * age under 18 years old or greater than 75 years old * pregnant women * intolerance/allergy to local anesthetics * weight \<50 kg * suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years. * uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance * current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.

Keywords: suprainguinal fascia iliaca (sifi) nerve block