Kornimate/medical-research-clean huggingface dataset:
antidepressant and antipsychotic to treat attenuated positive and negative symptoms

Conditions: Prodromal Schizophrenia; Psychotic Disorders

Summary: the recognition and prevention (rap) program is conducting a research study comparing an antidepressant, sertraline, alone versus in combination with a second-generation antipsychotic, risperidone, to evaluate their ability to reduce unusual thoughts, suspiciousness and other unusual experiences, to improve reasoning ability, memory, attention and social skills in adolescents.

eligible patients are enrolled in a 16-week trial consisting of symptom and side effects ratings (10 visits), monthly blood and urine tests, and neuropsychological testing at the first and last visits. at the initial appointment, all patients are assigned to sertraline and are randomly assigned to an adjunctive risperidone or placebo group. the treating physician is also blind to the medication assignment, which allows both the doctor and the patient to assess side effects and symptom improvement, unbiased by expectation. all patients receive an active medication.

Eligibility criteria:
inclusion criteria: * participants are between the ages of 12 and 22. * participants are english-speaking. * participants are experiencing one or more symptoms like unusual thoughts, suspiciousness, or unusual perceptual experiences. * participants meet additional rap criteria (evaluated during screening and interview). exclusion criteria: * participants have been diagnosed with an axis i psychotic disorder, including: schizophreniform disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features. * participants have a history of neurological, neuroendocrine, or other medical conditions known to affect the brain. * participants have a medical condition that contraindicates treatment with sertraline or risperidone. * participants have past or current substance dependence. * participants are currently taking and responding well to antidepressant or antipsychotic medication

Keywords: clinical high risk attenuated positive symptoms attenuated negative symptoms cognition functional status prodromal psychosis
azd6244 versus pemetrexed (alimta®) in patients with non-small cell lung cancer, who have failed one or two prior chemotherapy regimen

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to assess the effect and safety of azd6244(arry-142886)versus pemetrexed in the second or third line treatment of advanced non-small cell lung cancer. following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the us will be treated with either azd6244 or pemetrexed. treatment will be continued for as long as patients receive clinical benefit.


Eligibility criteria:
inclusion criteria: * diagnosed with non-small cell lung cancer * previously received one or two chemotherapeutic treatments exclusion criteria: * previous therapy with mek inhibitor or pemetrexed * any recent surgery, unhealed surgical incision or severe condition such as uncontrolled cardiac disease or chronic gastrointestinal diseases

Keywords: nsclc advanced non-small cell lung cancer azd6244
postoperative intensive care surveillance

Conditions: Post-operative Adhesion(s)

Summary: several score systems were created to stratify perioperative risk and predict mortality. the study rises from the needing of a rapid and simple system to identify the patient worthy of postoperative intensive surveillance. in the first phase authors retrospectively investigated on patients underwent to elective surgery searching for determining factors (dfs) for postoperative icu admission. later, researchers prospectively studied how dfs could predict the admission in icu of consecutive patients scheduled for elective surgery during a three-months period and created an index, named pois (post-operative intensive surveillance), based on the results of this analysis. authors used surgical invasiveness (si), diabetes mellitus (dm), myocardiopathy (mcp), cerebrovascular disease (cvd), body mass index (bmi), age, serum creatinine level (scr), tiffenau index (ti) and male sex for the development of the original model. authors classified si from g1 (lowest) to g5 (highest). the results show that the power of prediction of postoperative morbidity of pois and possum resulted coincident and better than the american society of anesthesiology scoring system.


Eligibility criteria:
inclusion criteria: * elective surgery exclusion criteria: * multiple surgery * age less than 18
photodynamic therapy for benign dermal neurofibromas- phase ii

Conditions: NEUROFIBROMATOSIS 1

Summary: the investigators wish to determine the time to disease progression for benign neurofibromas treated with levulan kerastick topical photosensitizer and red light photodynamic therapy (pdt) in patients with neurofibromatosis type 1 (nf1). the investigators also wish to measure tumor size for control and treatment tumors in order to gain insights into tumor growth rates.

neurofibromas contain a large quantity of fibrous matter, and it is not anticipated that significant reductions in tumor size can be achieved in large, long established, tumors. cutaneous neurofibromas, which do not usually become apparent until puberty, continue to increase in size and number throughout adulthood. the psychosocial burden of these disfiguring tumors is significant, and the targeted age group (14-30) is at a life period associated with an acceleration in tumor growth. it is for these reasons that the investigators hope to affect the growth rate of less established tumors, in order to prevent or lessen this burden as the patient progresses further into adulthood. therefore, the investigators wish to determine the time to disease progression (defined as 50% growth in size over baseline) for benign neurofibromas treated with pdt in patients with neurofibromatosis type 1 (nf1) in subjects aged 14-30. the treatment will consist of choosing several neurofibromas of similar size, and applying a topical drug called levulan, or just the topical application alone (a placebo). within 24 hours of drug treatment, the neurofibromas will be illuminated with red light (both levulan and placebo). the levulan is what is known as a photosensitizer, and will be activated by the red light to potentially kill some of the tumor cells. approximately every 6 months after, for three years, the tumors will be measured by digital photography and ultrasound to see if they are growing more slowly than the ones with the placebo application alone.

Eligibility criteria:
inclusion criteria: 1. patient is 14 years or older. 2. diagnosed nf1, determined by american academy of neurology guidelines (see diagnosis section). 3. tumor location: cutaneous, trunk, or limbs only. 4. tumor type: superficial dermal neurofibromas ≤4mm deep. 5. patient has provided written informed consent. 6. patient is willing to and can comply with study follow-up requirements. 7. absence of any other malignancy. exclusion criteria: 1. life expectancy less than 3 years. 2. pregnancy. 3. cutaneous photosensitivity to the wavelengths used to active pdt. 4. a diagnosis of porphyria. 5. allergy to aminolevulinic acid or any of the topical solution vehicle components. 6. previous chemotherapy within 6 weeks of proposed pdt. 7. other concurrent tumor therapy.

Keywords: nf1 neurofibroma neurofibromatosis type 1
tobacco, alcohol, prescription drug, and illicit substance use- electronic spanish platform

Conditions: Tobacco Use; Alcohol Abuse; Prescription Drug Abuse; Substance Use

Summary: the goal of this study is to validate the taps-esp as a screen and assessment that can be used in primary care for the screening and treatment of substance use.

this phase ii study seeks to conduct further research to validate the taps-esp as a spanish language version of the screening and brief assessment and pave the way for its broad dissemination in the healthcare system. the investigators will use a novel application of a type 1 hybrid effectiveness-implementation design, adapted to a screening validation study. the investigators will conduct a large-scale study to validate the taps-esp against established diagnostic and biomarker metrics, replicating the design of the seminal english-language taps study.

Eligibility criteria:
inclusion criteria: * age 18 or older * current patient of the clinic * spanish-language preferred * ability to read spanish exclusion criteria: * unable to provide informed consent * inability to comprehend or read spanish * inability to self-administer the ipad tool due to physical limitations
the effects of neuromuscular electrical stimulation in individuals with urinary incontinence after prostatectomy

Conditions: Urinary Incontinence

Summary: the aim of this study is to investigate the effects of neuromuscular electric stimulation on urinary symptoms, quality of life, sexual function, perception of improvement and patient satisfaction in individuals with post-prostatectomy urinary incontinence

one of the two most common complications after prostatectomy surgeries is urinary incontinence (ui) and the other is erectile dysfunction. there are conservative and surgical treatment options in post-prostatectomy urinary incontinence. one of the conservative treatment options is neuromuscular electrical stimulation application. since electrical stimulation applications, used in the treatment of post-prostatectomy urinary incontinence, are usually given together with other treatment protocols, there are limitations in clearly demonstrating the effects of neuromuscular electrical stimulation on post-prostatectomy urinary incontinence.

Eligibility criteria:
inclusion criteria: * being a male individual with stress or stress-dominant mixed urinary incontinence symptoms after undergoing prostatectomy surgery in the urology clinic * being over 40 years old * volunteering to participate in the study exclusion criteria: * severe cardiovascular disease (unstable angina and arrhythmia patients, heart failure patients ect.) * those with sensory loss * presence of ongoing urinary infection * only urgency urinary incontinence * having a pacemaker * active cancer treatment (radiotherapy, chemotherapy), * those who have undergone transurethral prostatectomy (tur-p) surgery * those who have a problem that interferes with cooperation and understanding
pre-exposure prophylaxis of sars-cov-2 infection (covid-19) by monoclonal antibodies with early access authorization in immunocompromised patients. a prospective cohort.

Conditions: COVID-19; Immunocompromised Host

Summary: this prospective cohort of patients, receiving pre exposure prophylaxis by anti-sars-cov-2 monoclonal antibodies, is designed to evaluate the treatment protection against sars-cov-2 variants of concerns


Eligibility criteria:
inclusion criteria: * adults (18 years-old or more) * patient who received the first administration of evusheld at 300 mg for less than 4 months and should receive a second dose, according to french recommendations or patient scheduled to receive or having received less than a month ago an injection of anti-sars-cov-2 monoclonal antibodies, as pre-exposure prophylaxis at 600 mg, according to the french sars-cov-2 rt recommendations * qpcr negative at baseline * sars-cov-2 rt-qpcr negative at inclusion * patients who remain seronegative after a complete covid-19 vaccination schedule * immunocompromised patients : hemopathy : chronic lymphoid leukemia, non hodgkin's lymphoma, hsct transplant recipient : kidney, liver, lungs patients receiving anti cd20 or others immunosuppressor * life expectancy \> 3 months * social security affiliation * lack of a legal protection measure * signed informed consent exclusion criteria: * participation to another clinical study * state medical aid * ongoing or scheduled plasmapheresis or immunoadsorption * pregnant / lactating woman * patient whose isolation period is underway following contact with a confirmed case of sars-cov2 infection * hypersensitivity to one of the active substances or to one of the excipients

Keywords: post-exposure prophylaxis antibodies monoclonal neutralizing antibodies
a trial of gfh018 and toripalimab in combination with concurrent chemoradiotherapy in stage iii nsclc chemoradiotherapy in stage iii nsclc

Conditions: NSCLC, Stage III

Summary: this is a phase ii trial assessing the efficacy and safety of gfh018 and toripalimab in combination with concurrent chemoradiotherapy (ccrt) in patients with unresectable, locally advanced, stage iii non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * newly diagnosed, pathologically (histologically or cytologically) confirmed, locally advanced, unresectable stage iii nsclc * eastern cooperative oncology group (ecog) performance status 0-1 * measurable disease (according to recist v1.1 criteria) * life expectancy \> 6 months exclusion criteria: * has small cell lung cancer (sclc) or tumors with the presence of small cell elements. * has received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for stage iii nsclc * prior exposure to immune-mediated therapy, including but not limited to, tgfβ inhibitors, anti ctla-4, anti-pd-1, anti-pd-l1, and anti pd l2 antibodies. * known allergy or hypersensitivity to any of the ips or any of the ip excipients. * patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 gy in total (v20) of more than 35% of lung volume.

Keywords: locally advanced unresectable nsclc tgf-βri pd-1
kinesiophobia, quality of life, and cognitive functions in fibromyalgia syndrome

Conditions: Fibromyalgia; Kinesiophobia; Cognitive Dysfunction

Summary: although one of the most evidence-based treatment protocols is based on exercise strategies in patients with fibromyalgia syndrome, fear and avoidance of physical activity; named 'kinesiophobia' may hinder the patients from the exercises. cognitive dysfunctions are seen frequently in fibromyalgia syndrome. the aim of this study, to assess the relationship between kinesiophobia and cognitive functions, disease severity, quality of life, physical activity level, pain intensity, and anxiety/depression level in fibromyalgia patients. additionally, the investigators aimed to compare the kinesiophobia level and cognitive functions between patients with fibromyalgia syndrome and control subjects.

cognitive dysfunction, including learning difficulties, memory, attention, and executive dysfunctions are frequent in fibromyalgia syndrome. kinesiophobia is defined as fear and avoidance of physical activities, and it can lead to increased disability in patients with chronic pain. although there is a relationship between cognitive functions and physical performance in fibromyalgia syndrome, the relationship between kinesiophobia, fibrofog, and quality of life are required to be investigated. the aims of this study are: 1. to compare the kinesiophobia and cognitive functions in fibromyalgia syndrome with healthy volunteers 2. to examine the relationship between the severity of kinesiophobia, cognitive functions, disease activity, quality of life, physical activity level, depression and anxiety severity in fibromyalgia syndrome. the hypothesis is, the patients diagnosed with fibromyalgia syndrome have higher kinesiophobia severity and worse cognitive functions, and also that kinesiophobia severity is associated with cognitive dysfunction, disease severity, physical activity level, and psychiatric symptoms in patients with fibromyalgia syndrome.

Eligibility criteria:
inclusion criteria: -fibromyalgia syndrome exclusion criteria: * education year \< 5 * inflammatory rheumatic disease * malignancy * psychiatric disease * alcohol/substance addiction * central nervous system disease * history of head trauma * chronic pain conditions other than fibromyalgia syndrome

Keywords: fibromyalgia kinesiophobia cognition quality of life
psychological study in children with mucoviscidosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis is the most common serious genetic disease in europe. it is a multi-disciplinary disease, causing multiple organ damage. it is a painful disease and a source of anxiety and depression. the aim of this study is to assess the link between pain experienced during care and anxiety in children aged over 8 with cystic fibrosis.


Eligibility criteria:
inclusion criteria: * have cystic fibrosis * child aged over 8 years and under 18 years * presence of at least one parent at the time of inclusion * to be present for a scheduled hospitalisation at the resources and competence centres for cystic fibrosis * do not object to the research exclusion criteria: * under 8 or over 18 years of age * lack of at least one parent at the time of inclusion * presence of chronic co-morbidities * difficulty reading and understanding french * objection to taking part in research

Keywords: cystic fibrosis children pain anxiety
a phase iii trial on adjuvant temozolomide with or without interferon-alpha in newly diagnosed high-grade gliomas

Conditions: Anaplastic Oligoastrocytoma; Anaplastic Astrocytoma; Glioblastoma

Summary: this study is being conducted to help determine whether the addition of interferon-alpha(α-ifn),which were determined sensitized the activity of temozolomide(tmz) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma.

this study is being conducted to help determine whether the addition of interferon-alpha(α-ifn),which were determined sensitized the activity of temozolomide(tmz) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma. four weeks after radiotherapy, newly diagnosed who iii-iv glioma patients will be randomised into two groups: tmz group or tmz+ α-ifn groups.

Eligibility criteria:
inclusion criteria: * age: 18 years to 75 years * newly diagnosed who iii-iv glioma after operation and radiotherapy * karnofsky performance score ≥ 60 * adequate bone marrow, liver and renal function * ability of subject to understand character and individual consequences of the clinical trial * written informed consent * anticipating survival ≥2 months exclusion criteria: * refusal to participate the study * known hypersensitivity or contraindication to temozolomide * incompletely radiation * pregnant or lactating females * malignant tumor other than brain tumor * contraindicated for mri examination * unable to comply with the follow-up studies of this trial * purulent and chronic infected wounds * uncontrolled psychotic disorders or epilepsy

Keywords: high-grade glioma chemotherapy temozolomide interferon-alpha
dlbs1033 treatment in diabetic with peripheral arterial disease

Conditions: Diabetes; Peripheral Arterial Disease

Summary: this is a prospective, randomized, double-blind, double-dummy, and controlled study of dlbs1033 for the improvement of ankle-brachial index in diabetic patients with peripheral arterial disease (pad). it is hypothesized that the addition of dlbs1033 on top of aspirin treatment will augment significantly the resting abi in diabetes patient with pad in comparison with that of aspirin alone.

subjects in this study will be screened consecutively and eligible subjects will be randomized to receive aspirin tablet 80 mg once daily and either the investigational drug (dlbs1033 tablet 490 mg three times daily) or its placebo, for 12 weeks. diabetic subjects who have been being under therapy with aspirin can directly start with study treatment. for those who are currently not under therapy with aspirin, there will be a run-in period during which they will receive (or be switched to) aspirin treatment, for two weeks. after then, they will receive study medication. clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and at the interval of six weeks over the twelve week-course of therapy.

Eligibility criteria:
inclusion criteria: * signed informed consent before any trial related activities. * male or female subjects of 40 - 65 years of age. * diagnosis of diabetes mellitus defined as hba1c level of ≥ 6.5% (for newly diagnosed diabetes) or based on medical history. * presence of peripheral arterial disease with resting ankle-brachial index (abi) of 0.41-0.90 inclusive exclusion criteria: * females of childbearing potential: pregnancy, breast-feeding, and the intention of becoming pregnant. * recent stroke attack, myocardial infarction/unstable angina/acute coronary syndrome, coronary artery bypass surgery (cabg) or percutaneous transluminal coronary angioplasty (ptca)/stent within 3 (three) months prior to screening. * impaired liver function: serum alt \> 2.5 times upper limit of normal. * impaired renal function: serum creatinine ≥ 1.5 times upper limit of normal. * concomitant use of other antithrombosis drugs or any antiplatelets other than the study medication. * subjects with concurrent herbal (alternative) medicines or food supplements * subjects with any other disease state, including chronic or acute systemic infections, uncontrolled illnesses or other chronic diseases, which judged by the investigator, could interfere with trial participation or trial evaluation. * subjects with high risk of bleeding: * subjects with prior experience with dlbs1033 or other oral lumbrokinase products. * subjects with known or suspected allergy to any of study medications used in the study, including other lumbrokinase products. * subjects with known or suspected allergy or resistant to aspirin.

Keywords: dlbs1033 peripheral arterial disease ankle-brachial index
the effect of anti-inflammatory cryoagent on the level of postoperative pain in patients with symptomatic irreversible pulpitis and apical periodontitis.

Conditions: Postoperative Pain

Summary: * the aim of this study is comparative between: 1. intra-radicular cryotherapy using cold anti-inflammatory {ketorolac tromethamine at 2-5c}. 2. intra-radicular final flush anti-inflammatory {ketorolac tromethamine at room temperature}. * in terms of: c. level of post-operative pain {pop} using a visual analog scale {vas}. d. level of substance p in periapical fluid will be analyzed by enzyme-linked immunosorbent assay (elisa) kit. outcomes : * primary outcomes: level of post-operative pain. * secondary outcomes: level of substance p expression


Eligibility criteria:
inclusion criteria: 1. patients that will be diagnosed with symptomatic irreversible pulpitis and apical periodontitis. 2. patient age ranging from 18-40 years. 3. males or females. 4. lower premolars. 5. medically free patients. 6. teeth with mature apex. 7. teeth without any type of root resorption. exclusion criteria: 1. patients with other pulpal diagnosis. 2. medically compromised patients. 3. vulnerable group; pregnant females, mentally ill, etc... 4. patients taking analgesics or anti-inflammatory drugs. 5. teeth with open apex.