Kornimate/medical-research-clean huggingface dataset:
feasibility study of mfolfox6 in patients with advanced colorectal cancer

Conditions: Colorectal Cancer

Summary: we performed a feasibility study of mfolfox6 in advanced colorectal cancer in japan and to estimate the safety and efficacy of this regimen.

a multicenter open-label, single-arm feasibility study is conducted on patients with histological stage iv colorectal cancer given oxaliplatin, leucovorin plus fluorouracil. the usefulness of this regimens as therapy for colorectal cancer was evaluated by the disease-free survival rate (dfr), overall survival rate (os), incidence and severity of adverse event.

Eligibility criteria:
inclusion criteria: 1. histological diagnosis of colorectral adenocarcinoma. 2. measurable or assessable lesions. 3. age: 15 \~ 75 years. 4. performance status (ecog): 0 \~ 2. 5. prior chemotherapy within 2 regimens. 6. adequate function of major organs (bone marrow, heart, lungs, liver etc.). wbc 3,500/mm3. hb 10.0 g/dl. platelet count 100,000/mm3. got and gpt 2.5times the upper limit of normal (excluding liver metastasis). t-bil 3.0mg/dl. creatinine within the upper limit of normal. normal ecg (not considering clinically unimportant arrhythmias and ischemic changes). (10) predicted survival for \>8 weeks. (11) able to give written informed consent. exclusion criteria: 1. severe pleural effusion or ascites. 2. metastasis to the central nervous system (cns). 3. active gastrointestinal bleeding. 4. active infection. 5. uncontrolled ischemic heart disease. 6. serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure). 7. active multiple cancer. 8. severe mental disorder. 9. pregnancy, possible pregnancy, or breast-feeding. 10. patients with neuropathy ≥ grade 2 11. judged to be ineligible for this protocol by the attending physician.
latanoprost versus tafluprost: 24-hour intraocular pressure (iop)

Conditions: Primary Open Angle Glaucoma; Ocular Hypertension

Summary: * main objective is to compare the ability of latanoprost 0.005% preservative-added ophthalmic solution versus tafluprost 0.0015% preservative-free ophthalmic solution, both given once a day at the evening, in reducing 24-hour intraocular pressure (iop) in patients with primary open angle glaucoma (poag) and/or ocular hypertension (oht) at first diagnosis. first efficacy variable will be the difference between mean nocturnal iop values after three months of treatment: nocturnal iop is defined as the mean value between 2am and 6am measurements. * secondary objectives will be the comparison between latanoprost 0.005% and tafluprost 0.0015% ophthalmic solution about: * mean 24-hour iop values after three months of treatment * iop values at these time-points: 10am (± 1 hour), 2pm (± 1 hour), 6pm (± 1 hour), 10pm (± 1 hour), 2am (± 1 hour) and 6am (± 1 hour) after three months of treatment


Eligibility criteria:
inclusion criteria: * male and female patients \> 45 years * damage of the optic nerve and alterations of the visual field in case of poag, no defects at the optic nerve and at the visual field in case of oht * untreated iop \> 24 mm hg but \< 32 mm hg in at least one eye at baseline (10am) and central corneal thickness between 500 and 600 μm * negative pregnancy test (fertile women). fertile women attending the study must express clear will to avoid pregnancy during all the study period and in the next three months * informed consent before starting the study exclusion criteria: * secondary glaucoma (sturge-weber syndrome, neurofibromatosis i, neovascular glaucoma, steroid glaucoma, etc) * anterior segment anomalies (cataract, irido-corneal disgenesy, congenital ectropion uvae, etc) * past ocular surgery, except cataract surgery in the previous 6 months * corneal abnormalities that can influence iop measurements (corneal oedema) * positive pregnancy test or breast-feeding woman. no will to avoid pregnancy during all the study period and in the next three months
emotional processing and oxytocin mechanisms in premenstrual dysphoric disorder: a pilot study

Conditions: Premenstrual Dysphoric Disorder

Summary: this research study will look at brain and symptom differences among women with severe premenstrual mood symptoms. one goal of this study is to look at the effects of taking a nasal spray containing oxytocin (a hormone made in the brain) on brain areas involved in emotion regulation while viewing pictures during a neuroimaging (fmri) session. the investigators will also look at whether oxytocin improves premenstrual mood symptoms.

purpose: the primary objective of this pilot study is to use functional neuroimaging techniques to begin to identify the central brain networks that may contribute to impairment in emotion regulation, interpersonal relationships, and marital and family function in women with premenstrual dysphoric disorder (pmdd), particularly for those women who also have a history of early life abuse (ela). based on the evidence that the mammalian neuropeptide oxytocin (ot), best known for its role in lactation and parturition, plays a seminal role in social affiliation, emotion regulation, attachment, maternal behavior, trust, and protection against stress; and because ot neural pathways and receptors are prominently expressed in brain regions involved in emotion regulation and maternal/affiliative behavior; the study will: 1) use intranasal ot administration as a probe to assess whether it modifies activation of brain regions involved in emotion regulation in response to an emotional processing task; and 2) whether daily intranasal ot administration during the premenstrual phase improves symptoms in women with pmdd with or without a history of ela.

Eligibility criteria:
inclusion criteria: * in order to be eligible to enter this study, subjects will have met pmdd study entry criteria in the diagnostic feeder study (irb# 05-3000) * 18 to 52 years of age * regular menstrual cycles * ability to give informed consent exclusion criteria: * current psychiatric diagnosis of substance abuse or claustrophobia (fear of closed places) * pregnancy (based on urine pregnancy test) or breastfeeding * use of psychiatric medication (e.g. for depression, anxiety), hormonal medication, other agents that alter mood or thinking, or street drugs * any foreign iron or steel metal objects in the body, such as a pacemaker, shrapnel, metal plate, certain types of tattoos, or metal debris

Keywords: premenstrual dysphoric disorder premenstrual syndrome pms pmdd
hepatic xenetix-ct perfusion

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to prospectively determine the diagnostic value of xenetix-ct perfusion for the discrimination between well-differentiated hepatocellular carcinomas (hcc) and poorly/moderately differentiated hcc, in histo-pathologically proven hcc, and with the aim to cover the entire liver.


Eligibility criteria:
inclusion criteria: * subjects diagnosed for hcc and planned for surgery (lobectomy or transplantation) within a timeframe of 30 days between first imaging procedure used for the study and surgery. exclusion criteria: * subjects who have undergone prior tace (transarterial chemo embolization), prior rfa (radio frequency ablation) or prior sirt (selected internal radio therapy) within one year before inclusion.

Keywords: ct perfusion hepatocellular carcinoma xenetix contrast agent
a 6 week study to determine the effectiveness of r228060 in adult subjects with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this research study is to determine the effectiveness of 2 target doses of r228060 in comparison with placebo during 6 weeks of treatment in moderately to severely depressed adult subjects with major depressive disorder. approximately 488 subjects will be involved in the study.


Eligibility criteria:
* generally healthy adults on the basis of a physical examination, medical history, ecg and laboratory work-up. * subject needs to meet criteria for diagnosis of moderate or severe major depression as defined by the protocol. * the subject also needs to be an outpatient to participate in this study.
contingency management for recovery oriented activities at recovery houses

Conditions: Substance Use Disorders

Summary: in this study, the investigators will implement contingency management at rural recovery houses, where individuals with substance use disorders reside. contingency management is a behavioral intervention in which participants receive incentives (rewards) when they complete planned tasks that are consistent with their recovery efforts. house staff members will also participate in this study and will be trained to provide contingency management to residents. the investigators will compare recovery houses that implement contingency management to matched houses that do not, and the main outcomes will be engagement in the planned activities and retention in the recovery houses. participants will receive contingency management for up to 12 weeks and follow-up will occur 6 months post-treatment.


Eligibility criteria:
inclusion criteria: 1. age 18 or older; 2. a resident of the recovery house; and 3. able to provide informed consent. exclusion criteria: 1. expected to be discharged from the recovery house in the next two months; 2. experiencing uncontrolled mania, psychosis or suicidality.

Keywords: contingency management rural recovery houses
treatment for subjects with active rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to assess the safety of etanercept liquid administered once weekly to subjects with ra.


Eligibility criteria:
inclusion criteria: - fulfill the 1987 american rheumatism association (ara) criteria for ra - active ra at the time of enrollment, receipt of concomitant methotrexate at a dose of up to 25 mg a week is permitted - screening lab results must demonstrate: * ast and alt less than or equal to 2 times the upper limit of normal hemoglobin greater than or equal to 8.5 g/dl; * platelet count greater than or equal to 125,000/cm3; * white blood cell count (wbc) greater than or equal to 3500 cells/cm3; * serum creatinine less than or equal to 2 mg/dl - before any study specific procedure is performed, the subject must provide informed consent for participation in the study exclusion criteria: - previous receipt of etanercept - receipt of antibody to (tumor necrosis factor) tnf alpha or other tnf inhibitors within 90 days of day 1 - currently enrolled in other investigational device or drug trials, or participation in investigational trial within the past 30 days - receipt of intra-articular corticosteroids within 14 days prior to day 1 - receipt of any disease-modifying anti-rheumatic drugs (dmards) within 28 days of day 1 - receipt of cyclophosphamide within 6 months of day 1 - concomitant corticosteroids greater than 10 mg/day of prednisone (or equivalent) during 14 days prior to day 1 - dose of nonsteroidal anti-inflammatory drug (nsaid) must be stable for 14 days prior to day 1 and must not exceed the recommended dose in the product information sheet - subject is not using adequate contraception - subject is pregnant or breast-feeding - subject has significant concurrent medical disease

Keywords: rheumatoid arthritis ra etanercept immunex amgen
subthalamic nucleus stimulation electrode and psychiatric lesion effects in parkinson's disease

Conditions: Parkinson Disease

Summary: this is a pilot, prospective, monocentric study concerning 15 parkinson's disease patients requiring deep brain stimulation implantation. the primary objective is to evaluate the psychiatric lesion effects of deep brain stimulation in patients with parkinson's disease, using the young mania rating scale (ymrs), big five inventory and the hamilton depression rating scale (hamd 21).

the patients included were adults suffering from parkinson's disease (according to icd-10). they had no severe psychiatric disorders, and no major neurocognitive disorders contraindicating surgery. an initial evaluation will be carried out 72 hours after surgery, then after one month, and finally 3 months after surgery.

Eligibility criteria:
inclusion criteria: * major patient * diagnosis of parkinson's disease (icd-10) * l-dopa test must be positive * participants who gave their informed, written consent exclusion criteria: * severe psychiatric disorder * major neurocognitive disorder contraindicating surgery

Keywords: brain stimulation
rate control in atrial fibrillation

Conditions: Rapid Ventricular Response Atrial Fibrillation

Summary: rate control in atrial fibrillation is a usual battle in emergency departments. oral medications have a natural superiority to intravenous ones because they are easy-to-use and decrease the workload in busy emergency departments. this study wants to find an effective oral medication for rate control in rapid ventricular response atrial fibrillation. propranolol and metoprolol, diltiazem and verapamil are compared in patients with a stable hemodynamic status.


Eligibility criteria:
inclusion criteria: * age more than 18 years old * stability in hemodynamic exclusion criteria: * systolic blood pressure less than 90 mm hg * altered mental status attributable to rapid ventricular response atrial fibrillation * acute pulmonary edema attributable to rapid ventricular response atrial fibrillation * chest pain attributable to rapid ventricular response atrial fibrillation * allergy to propranolol or metoprolol or verapamil or diltiazem * history of asthma
perfusion assessment of wound closure techniques in primary total knee arthroplasty

Conditions: Total Knee Arthroplasty

Summary: this study will assess which of the three most common methods of wound closure in primary total knee arthroplasty (staples, interrupted vertical mattress, or running subcuticular suture) provide the best wound vascular perfusion. this can be achieve by using spy intra-operative vascular angiography, which is commonly used in clinical practice to assess perfusion of wound closure at the clinic. by understanding the differences in perfusion afforded by different closure techniques, surgeons will then be able to select the technique that optimizes this parameter so as to avoid complications such as tissue necrosis, wound dehiscence, or infection.


Eligibility criteria:
inclusion criteria: * ≥ 18 years old * primary diagnosis of osteoarthritis * surgical indication for index total knee arthroplasty exclusion criteria: * previous surgery about the knee * systemic corticosteroid use * active infection of any kind or chronic infection with hiv, hepatitis c, or syphilis

Keywords: tka wound closure wound perfusion
risk adapted sabr(sabr) in stage i nsclc and lung metastases

Conditions: Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Summary: this study is designed to evaluate the safety of stereotactic ablative radiotherapy (sbrt) in selected patients with stage i non small cell lung cancer (nsclc) or metastatic lung cancer to demonstrate the feasibility and risks of using an ablative dose-adapted scheme with fff beams. other aims are to evaluate the incidence of acute and late complications; to evaluate tumour response to local radiation therapy by means of ct, pet/tc and mri and to evaluate the impact of local therapy on overall and disease-free survival.

the intervention (dose and fractions) depends on topographical parameters: lung disease (primary, peripheral nodes or mediastinal nodes), distance to chest wall, tumour size and distance to main bronchus.

Eligibility criteria:
inclusion criteria: * histologically-confirmed primary lung cancer or lung metastasis from another primary tumour or positive pet/ct suggestive for primary tumour(suv max\> 4). * tumour size \< 5 cm in diameter prior to treatment. * medically inoperable patients as determined by the multidisciplinary thoracic tumour board, or medically operable patients who refuse surgery. * life expectancy of \>12 months. * criterion for medical inoperability include: overall clinical assessment at the ucla thoracic tumour board. reduced pulmonary function (fev1, dlco, etc) based on one major or two minor criterion as described below: minor criteria: age \> 75, fev1 51- 60% predicted, or fev1 1-1.2l, dlco 51%-60% predicted, pulmonary hypertension, poor left ventricular function (ef \ 45 mmhg. * age \> 18 years. * kps \> 70. * barthel score \>40 * baseline computed tomography scans of the chest, pulmonary test function, and positron emission tomography no more than 2 months before treatment. * if a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented. * ability to understand and the willingness to sign a written informed consent. exclusion criteria: * prior thoracic radiation treatment wich dose contribution can be expected in the new sbrt plan. * more than two lesions per lobe. * active infections requiring systemic antibiotics. * age \<18 years old. * kps \< 70. * barthel total score \< 40.

Keywords: carcinoma, non-small-cell lung neoplasm metastasis radiosurgery
study to evaluate the antiviral efficacy, safety and tolerability of tenofovir disoproxil fumarate versus placebo in pediatric participants with chronic hepatitis b infection

Conditions: Chronic Hepatitis B

Summary: the primary objective of this study is to evaluate the antiviral efficacy of tenofovir disoproxil fumarate (tenofovir df; tdf) versus placebo in pediatric population (aged 2 to \< 12 years at the time of enrollment) with chronic hepatitis b (chb) infection.


Eligibility criteria:
key inclusion criteria: * male or female, 2 to \< 12 years of age * weight ≥ 10 kg * chronic hbv infection ≥ 6 months * hepatitis b e antigen (hbeag)-positive or hbeag-negative * hbv viral load ≥ 100,000 copies/ml * alanine aminotransferase (alt) ≥ 1.5 x the upper limit of the normal range (uln) at screening * creatinine clearance ≥ 80 ml/min/1.73m\^2 * absolute neutrophil count (anc) ≥ 1,500/mm\^3, hemoglobin ≥ 10 g/dl * negative pregnancy test at screening * no prior tenofovir df therapy (participants may have received prior interferon-alfa and/or other oral anti-hbv nucleoside/nucleotide therapy; participants must have discontinued interferon-alfa therapy ≥ 6 months prior to screening; participants experienced on other anti-hbv nucleoside/nucleotide therapy must have discontinued therapy ≥ 16 weeks prior to screening to avoid flare if randomized to the placebo arm) key exclusion criteria: * pregnant or lactating * decompensated liver disease * received interferon therapy within 6 months of screening * received anti-hbv nucleoside/nucleotide therapy within 16 weeks of screening * alpha-fetoprotein levels \> 50 ng/ml * evidence of hepatocellular carcinoma (hcc) * co-infection with human immunodeficiency virus (hiv), acute hepatitis a virus (hav), hepatitis c virus (hcv), or hepatitis d virus (hdv) * chronic liver disease not due to hbv * history of significant renal, cardiovascular, pulmonary, neurological or bone disease * long term non-steroidal, anti-inflammatory drug therapy note: other protocol defined inclusion/exclusion criteria may apply
acetaminophen and social processes

Conditions: Borderline Personality Disorder

Summary: recent research has identified heightened sensitivity to social rejection as a core feature of bpd. rejection sensitivity can trigger the aggressive, impulsive, and self-injurious behaviors characteristic of the disorder. therefore targeting therapy towards the reduction of rejection sensitivity may improve the low rates of effectiveness of current pharmacological and behavioral therapies. therefore, this proposal tests a theoretically-based pharmacological approach that specifically targets the heightened sensitivity to rejection experienced by bpd patients. in prior research with normal controls, it was shown that chronic treatment with the physical pain-killer acetaminophen (e.g. tylenol) reduced both neural responses to social rejection (using fmri) as well as self-reported feelings of rejection in a daily diary study. it is the aim of this research project to determine if the over-the-counter analgesic, acetaminophen (active ingredient in tylenol), can reduce symptoms and behaviors in bpd patients. the goal of this proposal is to use an open-label design to determine if acetaminophen improves symptoms in bpd patients.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of borderline personality disorder * 18 years or older * if on psychiatric medication, must be on a stable dose * able to swallow tablets exclusion criteria: * current, primary substance abuse, particularly alcoholism * current eating disorder * history or current psychotic disorder * suicidal ideation or behavior requiring imminent inpatient treatment * pregnancy * participants whose medication has not been stable for more than 4 weeks * impaired liver function (\> 1.25x the upper limit of the reference range) * conditions that can affect immune system functioning.

Keywords: borderline personality disorder rejection social pain
extended reality behavioral activation: an intervention for major depressive disorder

Conditions: Major Depressive Disorder; MDD; Depression

Summary: the primary aims of this study are to assess the feasibility, acceptability, and tolerability of using an immersive extended reality (xr) headset to engage in behavioral activation (ba) for individuals diagnosed with major depressive disorder (mdd). the secondary aim of this study is to explore the efficacy of using xr to enhance ba therapy in a clinical mdd population.

this is a treatment development trial. participants will be randomized to receive either xr-enhanced behavioral activation or traditional behavioral activation. all groups will follow a brief-ba protocol developed for primary care settings over a four-session, three-week treatment period.

Eligibility criteria:
inclusion criteria: * patient must meet dsm v criteria for mdd * patient must be at least 18 years of age * patient must be english speaking exclusion criteria: * substance use disorders in past year * any psychosis or bipolar disorder * any seizure in the last 6 months or untreated epilepsy * current nonsuicidal self-injury or parasuicidal behavior * current suicidal urges and intent * changing psychotherapy treatment within four months of study entry * changing psychotropic medication(s) within two months of study entry

Keywords: extended reality virtual reality behavioral activation depression