Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of low-dose pentavalent antimony for treatment of cutaneous leishmaniasis

Conditions: Cutaneous Leishmaniasis

Summary: the purpose of this study is to determine whether low-dose pentavalent antimony is equally effective when compared to the standard-dose regimen in patients with cutaneous leishmaniasis. the study will be done in a field clinic in the state of bahia, brazil.

the first-choice drug for the treatment of cutaneous leishmaniasis in brazil is the pentavalent antimonial meglumine antimoniate. the treatment with meglumine antimoniate is toxic and at least some of the more relevant adverse events associated with that drug are dose-dependent. recently, some research developed in brazil has shown evidence that lower doses of pentavalent antimony are equally efficacious as compared to the standard-dose regimen. that evidence has been obtained in patients from the state of rio de janeiro who were infected by leishmania (viannia) braziliensis. the purpose of the study is to evaluate the safety and efficacy of the low-dose pentavalent antimony regimen in patients with cutaneous leishmaniasis infected by leishmania (viannia) braziliensis living in a rural area of the state of bahia, brazil, where cutaneous leishmaniasis is highly endemic. the usefulness of the study is based on the possibility to reduce the toxicity observed during treatment and the treatment costs. the main comparison of the therapeutic response is going to be made between two groups composed of an equal number of properly randomized patients with localized cutaneous leishmaniasis treated with any of the following drug schemes: * meglumine antimoniate (calculated dose based on the concentration of pentavalent antimony) 5 mg/kg/d intravenous for 20 days * meglumine antimoniate (calculated dose based on the concentration of pentavalent antimony) 15 mg/kg/d intravenous for 20 days the clinical outcomes of cure or failure will be evaluated until the third month of follow-up.

Eligibility criteria:
inclusion criteria: * presence of 1 to 9 cutaneous lesions clinically compatible with leishmaniasis * disease duration of 2 to 20 weeks * positive leishmanin skin test * parasitological diagnosis confirmed through culture or genus-specific polymerase chain reaction (pcr) for leishmania spp exclusion criteria: * history of past episode of leishmaniasis * mucosal disease * disseminated disease * use of drugs with anti-leishmanial activity * contraindications for using pentavalent antimony: * pregnancy * renal failure * heart failure * hepatic failure * other diseases: * active tuberculosis * hanseniasis

Keywords: cutaneous leishmaniasis leishmania braziliensis pentavalent antimony meglumine antimoniate
non invasive assessment of liver fibrosis in children: comparison of shearwave elastography, fibrotest and liver biopsy

Conditions: Liver Fibrosis; Children

Summary: the purpose of this study is to determine if swe and fibrotest®/ fibromax®, alone or associated, are effective methods to assess liver fibrosis in children.

liver biopsy will be the gold standard to assess fibrosis using ishak score and morphometric evaluation of fibrosis. all children included will have a measure of liver stiffness using swe with 5 measures performed in the area where the biopsy is performed and 5 measures in an other place in the liver. fibrotest®/ fibromax® will be performed on blood sample. all exams will be done within 1 month. diagnostic performance of swe and fibrotest®/ fibromax® will be assessed respectively. algorithm using the results of both technics will be tested in order to test diagnostic performance and to obtain better performances.

Eligibility criteria:
inclusion criteria: * age \< 18 years; * indication to liver biopsy; * informed consent of both parents and child if applicable; * social insurance exclusion criteria: -

Keywords: diagnostic liver fibrosis ishak score fibrotest shearwave elastography liver biopsies
open label extension in cancer patients

Conditions: Neoplasms; Bone Metastases

Summary: to evaluate the safety and efficacy of anti-ngf ab in cancer patients with pain due to bone metastases who participated in the double-blind study a4091003 and who wish to receive open-label therapy.


Eligibility criteria:
inclusion criteria: * prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma that has been diagnosed as having metastasized to bone; * karnofsky performance score ≥40% at baseline; * patients randomized and treated with intravenous study drug in double-blind study a4091003. exclusion criteria: * patient was withdrawn from study a4091003 for an adverse event or serious adverse event; * occurrence of any adverse event or condition during study a4091003 or since termination from that study that, in the opinion of the investigator, would put the patient at increased safety risk or should exclude the subject from participating in the open-label extension study a4091029.

Keywords: cancer pain ngf open-label extension
hybrid apc for gastric low grade intraepithelial neoplasia

Conditions: Gastric Low Grade Intraepithelial Neoplasia

Summary: this cohort study aims to investigate the clinical efficacy and safety of hybrid apc for treatment of gastric low grade intramucosal neoplasia.

this cohort study aims to investigate the clinical efficacy and safety of hybrid apc for treatment of gastric low grade intramucosal neoplasia. successful ablation is defined as no evidence of local recurrence at 12 months after hybridapc upon follow up endoscopy. this is defined as absence of lgin, hgin and cancer in biopsies obtained at all locations during followup endoscopy.

Eligibility criteria:
inclusion criteria: 1. low grade intraepithelial neoplasia of stomach with size≤20 mm 2. endoscopic diagnosis suspected gastric lgin with biopsy confirmed gastric lgin 3. endoscopic appearance according to paris classification of type 0-iia, iib or iic 4. patients with informed consent exclusion criteria: 1. patients who had previous endoscopic treatment (including apc, emr, esd) for gastric lgin, hgin or gastric carcinoma. 2. endoscopic evidence of ulcer 3. biopsy confirmed hgin 4. endoscopic diagnosis suspected hgin while biopsy confirmed lgin 5. pregnancy 6. informed consent not available

Keywords: gastric low grade intraepithelial neoplasia hybrid apc endoscopic ablation
use of a hypochlorous acid spray solution in the treatment of covid-19 patients : covicontrol study .

Conditions: SARS CoV 2 Infection

Summary: the objective is to evaluate the efficacy and safety of nasal spray and mouth spray application with hypochlorous acid-containing solution versus placebo as a curative treatment for hospitalized sars-cov-2 positive patients and for symptomatic sars-cov-2 positive patients followed as outpatients

the covicontrol study is a prospective, multicenter study . it is a randomized, controlled, double-blind study. the covicontrol study will be conducted in tunisia at the covid patient management centers in the emergency departments of monastir (fattouma bourguiba) and sousse (hospital of sahloul). after initial medical evaluation, every patient who meet the inclusion criteria, will receive randomly either a spray of solution containing hypochlorous acid or placebo as detailed above according to the predetermined randomization. for each patient included, one nasal spray in each nasal nostril /3 hours and two oral sprays/3 hours either by a solution of hypochlorous acid (need defender) or by a placebo. for 5 days none of the treating physician or nurses are aware about the nature of medication receive. in both arms, patients can receive antipyretics, antibacterials, antivirals, antifungals and anti-inflammatories at the discretion of the treating physician. \* patients follow-up : during the study , a research member maintains contact (face-to-face if hospitalized or by telephone if ambulatory) at d2, d3, and d5 with participating patients to ensure compliance with treatment and report on disease progression: disappearance or persistence of symptoms, need for hospitalization, need for intensive care, duration of hospitalization, need for respiratory assistance (cpap, niv, optiflow, vm), duration of respiratory assistance, survival or death. at day 3 :a nasopharyngeal swab will be taken to check the viral load using quantitative rt pcr.at d10 and d30, data on disease progression will be collected one last time.

Eligibility criteria:
* inclusion criteria : * patients with symptoms of covid who are over 18 years of age and whose nasal swabs have been positive for sars-cov-2 based on rt-pcr testing less than 3 days . * patients must have the ability to understand and be willing to sign a written informed consent document from the patient or legal representative. * the patient must be able and willing to comply with the requirements of this study protocol. * exclusion criteria: 1. history of allergy to hypochlorous acid solution . 2. oral lesions contraindicating the use of hypochlorous acid solution. 3. patients receiving any other investigational agent in a clinical trial. 4. intubated patient on mechanical ventilation or with uncontrolled disease : congestive heart failure, idm, uncontrolled epilepsy or psychiatric illness. 5. uncertain patient follow-up during the study.
nigella sativa oil extract and xenograft bone graft in treatment of infra-bony defects

Conditions: Localized Aggressive Periodontitis

Summary: the aim of this study will be to evaluate, clinically, and radiographically the effect of nigella sativa oil extract mixed with xenograft versus xenograft alone in the treatment of intra-bony defects in patients with aggressive periodontitis.

in 10 patients, twenty sites in subjects with, localized aggressive periodontitis, with cal ≥ 5 will be included in the present study. sites will be allocated randomly to be surgically treated with, nigella sativa oil extract mixed with xenograft or xenograft alone. at baseline, 3, 6 after surgery, the following clinical parameters (pd, cal, bop) and cbct at baseline and 6 months x-ray will be recorded.

Eligibility criteria:
inclusion criteria: * systemically healthy patients were selected * patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing. * patients should demonstrate their ability to maintain good oral hygiene exclusion criteria: * • smokers and pregnant patients. * medically compromised patients and systemic conditions precluding periodontal surgery. * subjects who do not comply with oral hygiene measures as evidenced in recall visits. * restoration or caries in the site to be treated or non-vital tooth * restoration or caries in the site to be treated or non-vital tooth

Keywords: nigella sativa oil extract localized aggressive periodontitis
european all-comers' multicentric prospective registry on luminor© drug eluting balloon in the superficial femoral artery and popliteal artery with 5 years follow-up.

Conditions: Angioplasty; Peripheral Arterial Disease; Drug-eluting Balloon; Femoral Artery; Paclitaxel

Summary: the objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the luminor© deb in de-novo and restenotic-fp lesions. for de-novo and restenotic lesions, especially for calcified and/or long lesions/occlusions, the use of debulking devices to improve recalibration and drug penetration will be evaluated in a specific sub-group.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * rutherford clinical category 2-5 * the subject is legally competent, has been informed of the nature, the scope, and the relevance of the study, voluntarily agrees to participation, is willing to provide 5-year informed consent and has duly signed the informed consent form (icf) * significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery * tasc ii class a to d lesions * de novo lesion(s), non-stented or stented restenotic lesion(s) * proximal margin of target lesion(s) starts at the ostium of the superficial femoral artery, just below the common femoral bifurcation * distal margin of target lesion(s) terminates at bifurcation of popliteal artery and ≥1 cm above the origin of the tp trunk (p3) * a patent inflow artery free from significant lesion (≥ 50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of iliac or common femoral inflow artery lesions); successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤ 30% without death or major vascular complication * successful wire crossing and pre-dilatation (1min min, with under sizing of 1mm compared to ref diameter) of the target lesion; use of crossing devices allowed if necessary. use of laser or atherectomy is allowed if necessary, during the index procedure. bailout stenting is allowed if necessary, after deb use * at least one patent native outflow artery to the ankle, free from significant (≥ 50%) stenosis as confirmed by angiography (treatment of outflow disease is not permitted during the index procedure) exclusion criteria: * women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children * patient is contraindicated to use luminor drug eluting balloon per the current instructions for use (ifu) * life expectancy of \< 1year * patient is currently participating in an investigational drug or other device study or previously enrolled in this study * inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication * sudden symptom onset, acute vessel occlusion, or acute or sub-acute angiographically visible thrombus in target vessel
emotional awareness and expression therapy (eaet) or cognitive behavior therapy (cbt) for older veterans with chronic musculoskeletal pain

Conditions: Musculoskeletal Pain

Summary: a randomized clinical trial for veterans age 50 years and older with chronic musculoskeletal pain in which emotional awareness and expression therapy (eaet) is compared against cognitive behavior therapy (cbt) to evaluate acceptability, feasibility, and efficacy of the two treatments on pain and other outcomes, as well as potential mediators of treatment response.

outpatient veterans age 50 years and older at the west los angeles va medical center who have chronic musculoskeletal pain complete baseline questionnaires and are randomized into one of two forms of psychotherapy: emotional awareness and expression therapy (eaet), which helps patients make connections between avoided or conflicted emotions and pain, or cognitive behavior therapy (cbt), which teaches pain coping skills. each treatment is delivered by an experienced therapist and includes one 90-minute individual session and eight 90-minute group sessions (in small groups of 8 veterans). patients in both conditions complete post-treatment and 3-month follow-up questionnaires. outcomes of each type of psychotherapy are compared and mediators of treatment response are evaluated.

Eligibility criteria:
inclusion criteria: * veteran; * age 50 years and older; * 3 months of musculoskeletal pain including low back pain and other regional pain syndromes (e.g. neck, leg, pelvic pain and temporomandibular joint disorders), whiplash, widespread pain (e.g. fibromyalgia), or tension headaches. exclusion criteria: * leg pain greater than back pain (to exclude radiculopathy in isolation); * electromyography (emg)-confirmed "tunnel" syndromes (e.g. carpal or tarsal tunnel syndrome) without any other pain complaints; * autoimmune disease that typically generates pain (e.g. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, ankylosing spondylitis); * confirmed hip or knee osteoarthritis without any other pain complaints; * cancer pain, sickle cell disease, neuralgias (e.g. trigeminal neuralgia), burn pain, infection associated with pain (e.g. vertebral infection), cauda equina syndrome, gout as the only pain complaint, migraine or cluster headaches only; * uncontrolled severe psychiatric disorder including current psychotic disorder (e.g. schizophrenia or bipolar i disorder not controlled with medications), dissociative identity disorder, or active suicide/violence risk in the past 6 months; * moderate to severe cognitive impairment or dementia (mini-mental state exam score ≤ 25); * active severe alcohol or substance use disorder that inhibits the participant's ability to attend sessions or participate in homework; * currently with pain-related litigation or applying for compensation or compensation increase (e.g. applying for va service connection or applying for va service connection increase for pain); * unable to fluently read/converse in english; * planning to move from the area in the next 6 months.

Keywords: chronic pain psychotherapy musculoskeletal disease
blended care for the discontinuation of benzodiazepine use

Conditions: Benzodiazepine Dependence; Benzodiazepine Dependent; Benzodiazepine Withdrawal

Summary: this study aims to compare two strategies performed by gps to help patients taking benzodiazepines on a daily basis for at least six months to discontinue their use. the first strategy consists of the usual or standard support provided by the gp, which often starts with a discontinuation advice or letter, the second is blended support where face-to-face consultations with the gp are alternated with web-based self-learning by the patient.


Eligibility criteria:
inclusion criteria: * patients aged 18 and older capable of giving informed consent, * having his/her global medical file managed by one of the participating general practitioners * receiving prescriptions of (z-)bzds from participating gp for use on a daily basis * reporting daily intake (≥ 80% of days) of (z-)bzds in the last 6 months for a primary indication of sleeping problems exclusion criteria: * presence of any severe psychiatric and neurologic condition that in the judgment of the treating gp implies a contraindication for (z-)bzd withdrawal * presence of terminal illness * any cases where stopping of (z-)bzds might be harmful * unwillingness or inability to provide informed consent * not having e-literacy (being familiar with email and internet use) * patients with a substance use disorder (other than (z-)bzd) will also be excluded from the study because in these cases there is often a sub-therapeutic (z-)bzd dependence and/or comorbid psychological/psychiatric comorbid conditions requiring specialist care.

Keywords: benzodiazepines blended care
exploring physical and psychological needs and quality of life in patients with advanced cancer receiving immunotherapy

Conditions: Cancer; Immunotherapy; IrAE; Distress, Emotional; Care Need; Financial Toxicity; Quality of Life

Summary: during the immune checkpoint inhibitor therapy (icit), most of the patients stay at home, but there is lacking of the studies to explore their physical and psychological distress, financial toxicity, care needs, and quality of life. therefore, the aims of this program are to (1) explore the immune-related adverse event (irae) severity, distress, financial toxicity, and quality of life and examine the psychometric testing of the functional assessment of cancer therapy-immune checkpoint modulator (fact-icm); (2) establish the line group for assessing irae severity and change trajectory of quality of life in one-year follow-up and (3) combined retrospective chart review and the finding in aim (2) to develop the risk prediction model in order to identify the high risk population.

to achieve aim 1, a cross-sectional design is conducted to explore irae severity, distress, financial distress, and quality of life in mixed type of cancer patients receiving icit. a structural questionnaire will be used including common terminology criteria for adverse events (ctcae) 33 items, distress thermometer (dt), the comprehensive score for financial toxicity (cost), fact-icm, and eortc-qlq c30. correlation analysis and exploratory factor analysis will be used to examine the psychometric testing of fact-icm. to achieve aim 2 and 3, a prospective cohort study will be conducted to recruit 200 patients in first course receiving icit and follow for 1 year using line to report symptoms in weekly reporting within 3 months and once in 3-4 weeks in 4th -12th months during treatment. data will be collected at five times (before treatment for baseline, the 3th, 6th 9th 12th months) using a set of questionnaires including ctcae 33 items, dt, cost, supportive care needs scale-short form34, and fact-icm.

Eligibility criteria:
inclusion criteria: * (1) patients diagnose cancer and are informed * (2) aged ≥18 years old * (3) conscious clear and able to communicate exclusion criteria: * (1) patients who are under other clinical trial
a study comparing the efficacy and safety of abciximab, an anti-platelet therapy, in combination with two different heparin regimens in patients undergoing percutaneous coronary intervention.

Conditions: Angioplasty, Transluminal, Percutaneous Coronary

Summary: the purpose of this study is to compare the safety and effectiveness of abciximab, an anti-platelet therapy, versus placebo in patients undergoing percutaneous coronary intervention when administered in combination with two different heparin regimens. please see attached results.

this is a randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of abciximab, an anti-platelet therapy, in combination with two different heparin regimens in patients undergoing percutaneous coronary intervention. patients will be randomly assigned to one of three treatment groups: abciximab/low-dose weight-adjusted heparin, abciximab/standard-dose weight-adjusted heparin, or placebo/standard-dose weight-adjusted heparin. the primary outcomes of the study include the number of deaths, myocardial infarctions, or repeat revascularizations within 6 months, and the number of deaths, myocardial infarctions, or severe myocardial ischemia leading to urgent repeat percutaneous coronary intervention or urgent coronary artery bypass surgery within 30 days. please see attached results. abciximab bolus plus 12-hour infusion with standard-dose weight-adjusted heparin; abciximab bolus plus 12-hour infusion with low-dose weight-adjusted heparin; placebo bolus plus 12-hour infusion with standard-dose weight-adjusted heparin

Eligibility criteria:
inclusion criteria: * patients referred for elective or urgent percutaneous coronary intervention with an fda-approved device * having a target artery (native or graft) stenosis of 60% by visual estimation exclusion criteria: * patients with unstable angina/non-q-wave myocardial infarction meeting epic criteria within the previous 24 hours, or with acute q-wave myocardial infarction meeting epic criteria with onset of chest pain within previous 24 hours * with active internal bleeding, having a condition that may increase the risk of bleeding, or currently receiving administration of oral anticoagulants at the time of study entry * with confirmed hypertension with systolic blood pressure \>180 mm hg or diastolic blood pressure \>100 mm hg * having had a percutaneous coronary intervention within the previous 3 months * having an unprotected left main coronary artery stenosis \> 50%

Keywords: angioplasty, transluminal, percutaneous coronary