Kornimate/medical-research-clean huggingface dataset:
mirtazapine reduces icd shocks in icd patients with depression and anxiety

Conditions: Depression; Anxiety

Summary: the purpose of this study is to evaluate if the use of antidepressant medication in depressed patients with implantable cardioverter defibrillator reduces the number of icd's shocks as it improves depressive affect.

episodes of arrhythmia remain present even after icd implantation, this is specially true in depressed patients. it is hypothesized that improving mood state by means of an antidepressant drug . namely mirtazapine. could be responsible of alleviating the number of appropriate shocks delivered by the cardioverter. this could be due to a direct effect of the drug itself or an indirect effect of improving anxious and depressive affect. the mood and anxiety state are measured with the hads scale

Eligibility criteria:
inclusion criteria: * cardioverter implanted patients * depression * anxiety exclusion criteria: * heart failure * other diseases reducing physical fitness
mk0557 for the treatment of cognitive impairment in patients with schizophrenia (0557-027)

Conditions: Paranoid Schizophrenia; Schizophrenia

Summary: the purpose of this study is to determine the safety and effectiveness of an investigational drug for the treatment of cognitive impairment in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * patient is clinically stable, on current antipsychotic medication for at least 3 months and current dose for 2 months * patient has a 6th grade reading level or better and has completed at least 6 years of formal education * females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout study * patient has had a stable living arrangement for at least 3 months prior to study start * patient is in general good health based on screening assessments exclusion criteria: * patient has a major disease/disorder that may interfere with cognitive testing (such as mental retardation) and/or pose a risk upon study participation * patient has a history of head trauma with loss of consciousness greater than 15 minutes * patient has had warfarin treatment, mao inhibitors, clonazepam, clozapine or st. john's wort within 1 month of screening * patient has had ect treatment within 6 months of screening * patient requires treatment with antihistamines or certain other medications listed in the protocol * patient has a history of liver disease that has been active within the last 2 years, or a history of cancer within past 5 years * patient has a history of alcohol or drug dependence within past year or alcohol or drug abuse within 3 months of screening

Keywords: undifferentiated schizophrenia residual schizophrenia
the effects of tactile speech feedback on stuttering frequency

Conditions: Stuttering

Summary: the purpose of this research project is to test the effects of exposure of different forms of tactile speech feedback on overt stuttering frequency.

a new medical grade device (fda - category exempt) has been newly designed and built at the university of mississippi within the departments of communication sciences \& disorders, exercise science, and computer and electrical engineering. the device records either sound waves (via a small standard microphone) or three dimensional accelerometer data from the throat of a stuttering subject. this data is digitally signal processed, and "fed back" to the user in the form of a small vibrating disk/film that can be held between the fingers or mounted on the skin. this feedback data does not require the subject to attend to the incoming signal.

Eligibility criteria:
inclusion criteria: * adults diagnosed with persistent developmental stuttering exclusion criteria: * subjects below 18 years of age

Keywords: stuttering haptic feedback fluency
efficacy of peg-interferon α-2a in hepatitis b patients treated by entecavir without hbeag loss

Conditions: Hepatitis B

Summary: for hbeag (+) hepatitis b patients who have been treated by entecavir for 48 weeks but without hbeag loss, switching to peg-interferon may increase the response rate. in the investigators study, patients were divided into two groups. in group a, patients continued entecavir for another 72 weeks. in group b, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

for hbeag positive hepatitis b patients who have been treated by entecavir for 48 weeks but without hbeag loss, switching to peg-interferon may increase the response rate. in our study, patients without hbeag loss to 48 weeks entecavir treatment were divided into two groups. in group a, patients continued entecavir for another 72 weeks. in group b, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

Eligibility criteria:
inclusion criteria: * age between 18 and 50 years old * hbsag(+) and hbeag(+) for over 6 months before entecavir treatment * treated by entacavir for 48 weeks with hbeag seroconversion exclusion criteria: * pregnant women * decompensated liver disease * combination infection of hcv, hav, or hev * combination infection of hiv * any contraindication of interferon α

Keywords: hepatitis b sequential peg-interferon-2a to entecavir
osteoplasty in conjunction with surgical treatment of mandibular grade ii furcation defects

Conditions: Furcation Defects; Periodontal Diseases

Summary: teeth with furcation grade ii defects will be treated with open flap debridement, with or without osteoplasty. the study is designed to examine the effect of osteoplasty in the treatment of teeth with furcation grade ii defects with open flap debridement.


Eligibility criteria:
inclusion criteria: * periodontal disease stage iii or iv according to 2018 criteria * undergoing periodontal therapy (active or supportive) and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade ii with ppd\>4mm, and the furcation fornix must be above a tangential line from the distal to mesial interproximal crestal bone level on bitewing radiographs * competent to give consent exclusion criteria: * previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment * present or past use of bisphosphonate treatment * pregnant or nursing subjects * patients classified as \> class ii according to asa classification * previous surgical therapy of included furcation defects * inability to comprehend and respond to the quality of life questionnaire * dental restorations or prosthesis involving the furcation area * root fractures or suspected fractures/infractions * caries lesions in the furcation area * no systemic antibiotic treatment within 3 months prior to intervention
enhancing diabetes and hypertension self-management rural appalachian patients in patient-centered medical homes

Conditions: Diabetes Mellitus, Type 2; Hypertension

Summary: the goal of this r34 planning project is to test the feasibility and acceptability of a 12-week modified diabetes and hypertension self-management program using trained health coaches.

west virginians have one of the highest prevalence of comorbid diabetes and hypertension in the nation that pose an enormous disease and economic burden in this medically underserved state. self-management of these two commonly found chronic conditions are an essential component of comprehensive disease management. the goal of this r34 planning project is to test the feasibility and acceptability of a 12-week culturally-tailored, multimodal, diabetes and hypertension self-management program with a core (diet and physical activity) versus core plus (diet, physical activity and medication adherence) to an enhanced usual care (euc) control group. seventy-five eligible adults with comorbid diabetes and hypertension will be randomized with a 1:1:1 ratio, based on allocation sequence generated by the bio-statistician investigator in the team. the study will examine the extent to which key components (diet, physical activity, and medication adherence) contribute to the differences in clinical outcomes (hba1c and blood pressure) between three groups using quantitative and qualitative focus groups and the re-aim evaluation framework. the longer term effects of the intervention will be evaluated in a subsequent r01 clinical trial.

Eligibility criteria:
inclusion criteria: * english speaking adults ≥ 18 years of age; * co-occurring diagnosis of type 2 diabetes and hypertension * body mass index ≥ 25.0 * willing to be randomized, and complete the intervention and all assessments. exclusion criteria: * currently pregnant or breastfeeding * diagnosed with a severe mental illness * have any condition that requires physical activity limitations or is contraindicated for the dietary assessment to stop hypertension (dash) diet * inability to complete the study protocol.

Keywords: diabetes hypertension self-management
a randomized, placebo-controlled study of the safety and efficacy of efavirenz, didanosine, and stavudine in combination with or without hydroxyurea in antiretroviral naive or experienced hiv-infected patients

Conditions: HIV Infections

Summary: to determine the virologic benefits associated with the addition of hydroxyurea (hu) to combination drug therapy with didanosine (ddi), stavudine (d4t), and efavirenz (dmp) in hiv-infected patients. to assess the safety and tolerance of this regimen, with or without hu.

hu or placebo is added 30-60 days after the initiation of dmp, ddi, and d4t combination therapy. patients are stratified according to antiretroviral experience (naive or experienced). patients are followed for 48 weeks to determine safety, efficacy, and effect of treatment on viral, immunologic,and biochemical parameters.

Eligibility criteria:
inclusion criteria patients must have: * hiv infection, as documented by a licensed elisa that is confirmed either by western blot, positive hiv culture, positive hiv antigen, positive plasma hiv rna, or a second antibody test positive by a method other than elisa. * cd4 cell count of at least 100 cells/mm3 within 30 days of study entry. * over 500 hiv-1 rna copies/ml as measured by the roche amplicor or ultra sensitive assay within 30 days of study entry. * treatment-experienced patients must have documented hiv rna values of less than or equal to 100,000 copies/ml within 30 days of study entry. prior treatment: excluded: acute therapy for an infection or other medical illness. acute therapy must have been completed 14 days prior to the time of study entry. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: malignancy requiring systemic therapy. patients with the following prior conditions are excluded: * history of acute or chronic pancreatitis. * history of generalized peripheral neuropathy. * inability to tolerate ddi at 200-400 mg/day or d4t at 60-80 mg/day. for purposes of this study, intolerance will be defined as the same recurrent toxicities requiring dose interruptions and dose reductions or permanent discontinuation of the drugs (other than grade 3 or 4 anemia). prior medication: excluded: antiretroviral therapy. if antiretroviral-experienced, no prior nnrti's or hu and no more than 12 weeks experience with ddi and/or d4t. protease inhibitor experience is allowed. experienced patients must be on a stable antiretroviral therapy 30 days prior to study screening and continue this regimen until study entry. risk behavior: excluded: current ethanol abuse by personal history or a report from a primary physician.

Keywords: didanosine drug therapy, combination stavudine hydroxyurea anti-hiv agents
mechanistic studies on video-guided acupuncture imagery treatment of pain

Conditions: Pain

Summary: the aim of this proposal is to investigate brain response and connectivity changes evoked by video-guided acupuncture imagery treatment (vgait) and verum and sham acupuncture in healthy and patient populations to elucidate the underlying brain mechanisms of mind-body interaction, imagery, and acupuncture.


Eligibility criteria:
inclusion criteria: * right handed healthy male and female adults aged 18-60 * no contraindications to fmri scanning exclusion criteria: * current or past history of major medical, neurological, or psychiatric illness * any pain disorder * pregnancy * non-fluent speaker of english
compare two anti-scorpion venom serum in children

Conditions: Scorpion Sting

Summary: the morbidity associated with scorpion sting intoxication presents an endemic pattern in the country, where there are highly venomous species of scorpions so the scorpion sting intoxication (ippa) is considered a medical emergency. on the other hand, there is scarce scientific literature from different controlled studies evaluating anti-scorpion serum, considering clinical severity scales, lab results and their safety. the aim of this study is to compare the efficacy and safety of scorpion sting treatment, using two sera, one produced by birmex versus alacramyn ® (bioclon).

we consider relevant conduct this study because the poisoning scorpion bite represents a public health problem. this is a randomized clinical trial, which included 120 subjects of both sexes aged 0 and 15 years old and residents of the state of guanajuato, divided into 2 groups: 60 patients received antiscorpion serum of birmex and 60 patients receive other commercial serum (alacramyn).

Eligibility criteria:
inclusion criteria: 1. scorpion sting 2. either sex 3. age 1 to 15 years 4. signing an informed consent (signed by parent or guardian) 5. being residents of the state of guanajuato exclusion criteria: 1. previous treatment with gamma globulin or immunoglobulin 2. blood transfusion at any stage of life 3. patients treated with drugs that interact with anti-scorpion serum 4. history or history of sensitivity or intolerance to anti-scorpion serum or horse products 5. pregnancy 6. any immunodeficiency 7. patients who have participated in a research protocol in the previous month.

Keywords: anti-scorpion venom serum venom efficacy safety children
a study of avutometinib (vs-6766) + defactinib in recurrent kras g12v, other kras and braf non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer; KRAS Activating Mutation

Summary: this study will assess the safety and efficacy of avutometinib (vs-6766) monotherapy or vs-6766 in combination with defactinib in subjects with recurrent non-small cell lung cancer.

this is a multicenter, open-label phase 2 study designed to evaluate safety and tolerability and efficacy of avutometinib (vs-6766) versus avutometinib (vs-6766) in combination with defactinib in subjects with kras and braf mutant nsclc following treatment with an appropriate platinum-based regimen and an approved immune checkpoint inhibitor (cpi).

Eligibility criteria:
inclusion criteria: * male or female subjects ≥ 18 years of age * histologic or cytologic evidence of nsclc * known kras or braf mutation * the subject must have received appropriate prior therapy * measurable disease according to recist 1.1 * an eastern cooperative group (ecog) performance status ≤ 1 * adequate organ function * adequate recovery from toxicities related to prior treatments * agreement to use highly effective method of contraceptive exclusion criteria: * systemic anti-cancer therapy within 4 weeks of the first dose of study therapy * history of prior malignancy, with the exception of curatively treated malignancies * major surgery within 4 weeks (excluding placement of vascular access) * history of treatment with a direct and specific inhibitor of mek, kras or braf except for treatment of braf v-600e mutant nsclc * exposure to strong cyp2c9 and cyp3a4 inhibitors or inducers within 7 days prior to the first dose and during the course of therapy * symptomatic brain metastases requiring steroids or other local interventions. * known sars-cov2 infection ≤28 days prior to first dose of study therapy * active skin disorder that has required systemic therapy within the past 1 year * history of rhabdomyolysis * concurrent ocular disorders * concurrent heart disease or severe obstructive pulmonary disease * subjects with the inability to swallow oral medications

Keywords: nsclc kras-g12v g12v braf v600e kras
indicators of operative and postoperative complications in patients operated for hip fracture

Conditions: Hip Fracture

Summary: patients operated for hip fractures are older and have several conditions that have negative influences on the perioperative and postoperative prognosis. hip fractures can also be painful, which is stressful for the physiology of the patient. many old patients have received to little fluid intake. they often have diuretic therapy, which even worsens dehydration/hypovolemia. some patients have to wait several days for surgery. several studies have shown a high degree of complications and an increased mortality in this patient group. early preoperative optimization can improve the outcome. the available methods for optimization of the patient are complicated and time consuming. the investigators wish with this study to try new approaches to find which patients still are dehydrated when they come to the operation ward. the aim is to measure the color and density of the urine as well as to register the the variability in the plethysmographic curve before spinal anaesthesia. these results will be compared to circulatory instability during and after surgery as well as to postoperative complications.

all patients with hip fractures planed fore surgery at the hospital in norrkoping will come into consideration to participate in study. many will however not be able to give consent. these will not be included in the study. directly preoperatively urine will be collected. color and density will be measured/registered. the pulseoximeter reading will be registered (saturation, pulse, pi and pvi) before spinal anaesthesia and after spinal anaesthesia as well as during the surgery. two to three days postoperatively a follow up will be performed, to register complications (circulatory instability, confusion, infection, affected kidney function/creatinine rise). 30 day postoperative mortality will also be controlled. these results will be compared, to see if pulse oximeter readings or urine concentration can predict complications.

Eligibility criteria:
inclusion criteria: * patients with hip fracture * operation for the hip fracture * informed consent exclusion criteria: * patients not giving consent * patients not being able to understand information

Keywords: hip fracture mortality complications
tl938 and trastuzumab for patients with her2-positive metastatic colorectal cancer

Conditions: Colorectal Cancer Metastatic; Advanced Colorectal Cancer

Summary: this is a phase ii trial designed to determine the optimal dose and evaluate the effectiveness of tl938 and trastuzumab in treating patients with her2+ colorectal cancer that has metastasized or recurred and is inoperable.


Eligibility criteria:
inclusion criteria: 1. age 18 years old and above, male or female; 2. her2-positive, ras wild-type, unresectable or metastatic colorectal cancer and prior treatment with fluoropyrimidine, oxaliplatin, irinotecan, and an anti-vascular endothelial growth factor (vegf) monoclonal antibody (mab). patients whose tumors were deficient in mismatch repair (dmmr) proteins or were microsatellite instability-high (msi-h) must also have received an ant-programmed cell death protain-1 mab; 3. at least one measurable lesion; 4. eastern cooperative oncology group (ecog) score of 0, 1, or 2; 5. a minimum life expectancy of \>3 months; 6. adequate bone marrow reserve, hepatic, renal, and coagulation function; 7. other inclusion criteria apply for participating in the study. - exclusion criteria: 1. prior anti-her2 targeting therapy; 2. any systemic ant-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion \>30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for nan-target lesions used to relieve symptoms within 2 weeks prior to enrollment; 3. participation in another interventional clinical trial 2 weeks prior to enrollment or within 5haif-lives from the last dose of ip (whichever is shorter); 4. surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment; 5. any unresolved toxicities from prior therapy greater than grada 1, at the time of screening; 6. active central nervous system (cns) metastases. asymptomatic cns metastases with no steroid use within the last 30 days prior to enrollment is eligible; 7. any other primary malignant tumors within 3 years (except for cured skin basal cell carcinoma and carcinoma in situ of cervix, low risk cancer such as low grade prostate cancer or ductal carcinoma in situ of the breast; 8. any active infection which has not been controlled at screening; 9. other exclusion criteria apply for participating in the study. -

Keywords: oncology tl938 colorectal cancer her2
a long term follow-up study of fabry disease subjects treated with flt190

Conditions: Fabry Disease; Lysosomal Storage Diseases

Summary: fabry disease is a rare, x-linked inborn error of glycosphingolipid metabolism caused by an abnormal gene encoding the α-galactosidase a (αgla) enzyme. the αgla enzyme is ubiquitously expressed throughout the body and is responsible for the breakdown of glycosphingolipids, deficiency of which results in the accumulation of specific glycosphingolipids that are associated with the pathophysiology of the disease. current treatment for fabry disease is limited to the symptomatic management of pain, conventional management of complications, and methods to increase the availability of functional αgla. this clinical study aims to investigate the long-term safety and durability of αgla in patients who have been dosed with a new gene therapy product (flt190) in earlier clinical studies.


Eligibility criteria:
inclusion criteria: * subjects who have previously received flt190 * provision of full informed consent and able to comply with all requirements of the study including long-term follow-up for 60 months (5 years) post-treatment. exclusion criteria: * n/a

Keywords: gene therapy
prostaglandin f2-alpha (pgf2α) in vitiligo

Conditions: Vitiligo

Summary: study the cutaneous expression of pgf2α in vitiligo patients and compare it with normal control subjects.

measurement of tissue levels of pgf2α in vitiligo patients and compare them with healthy controls.

Eligibility criteria:
inclusion criteria: * patients with non-segmental vitiligo. * both sexes. * age \< 18 years old. * new cases or cases not receiving any medications for at least 3 months ago. exclusion criteria: * age: patients \< 18 years. * segmental or universal vitiligo. * pregnant and lactating females.