Kornimate/medical-research-clean huggingface dataset:
estimate the efficiency of the association of an injection of ketamine and the venlafaxine in the severe major depressive disorder for six weeks

Conditions: Major Depressive Disorder

Summary: the objective of this study is to evaluate the effectiveness of ketamine (infusion of 0.5mg/kg) and venlafaxine compared to the use of venlafaxine alone in the treatment of major depression (madrs score ≥ 20 ) to six weeks of treatment.


Eligibility criteria:
inclusion criteria: * patients aged 18 or over, * introducing a single depressive episode or recurrent unipolar * responding to the diagnosis of severe major depressive episode according to dsm iv (diagnostic and statistical manual of mental disorders - fourth edition): madrs score ≥ 20, * absence of treatment with ketamine for analgesia or anesthesia during the last 6 months * affiliate (or beneficiary) to a social security system * informed consent signed exclusion criteria: * contraindication to ketamine administration or treatment with venlafaxine; * failure of treatment with venlafaxine in the current episode (as low as 150 mg for 15 days); * axis i diagnosis according to dsm iv bipolar disorder (type i, ii or iii), schizoaffective disorder, schizophrenia, alcohol and other toxic or weaned for at least 6 months; * current episode resistant stage v according to the classification of thase and rush (failed a course of bilateral ect); * major depressive episode with severity criteria (significant risk of suicide is a madrs score ≥ 5-si; decubitus complications, intravenous hydration); * episode currently being treated with fluoxetine; * patients hospitalized without their consent or measure of legal protection (guardianship, curatorship); * affection organic likely to affect cognitive abilities and brain structures (eg, hiv, ms, lupus, parkinson's disease, epilepsy, dementia ...) or decompensation; * pregnancy or breastfeeding underway.
antioxidant supplements in the reversal of schistosomal peri-portal fibrosis

Conditions: Schistosomiasis; Liver Fibrosis; Periportal Fibrosis; Oxidative Stress

Summary: liver fibrosis is the most serious complication of schistosomiasis mansoni. however only limited proportion of subjects with infection develop this pathology and there is limited knowledge on risk factors for the differential morbidity patterns observed in endemic communities. our preliminary cross-sectional study indicated that serum levels of antioxidants may be related with the development of fibrosis. the present project is a randomised double blinded placebo controlled prospective study investigating the role of food based antioxidant supplements on the outcome of anti-schistosomal chemotherapy with regards to the extent of fibrosis reversal.

schistosomiasis is the second leading parasitic disease worldwide, after malaria. liver fibrosis is the most serious complication of schistosomiasis mansoni which can lead to reduced work capacity and early death in endemic countries. there is, however, limited knowledge on the development of liver fibrosis and the differential patterns morbidity observed in endemic communities. our preliminary cross-sectional study in ethiopia seems to indicate that serum levels of antioxidants may influence the development of fibrosis. the present project is a translational study combining basic antioxidant laboratory work with is a randomised double blinded placebo controlled prospective study in endemic areas in ethiopia, investigating the role of food based antioxidant supplements on the outcome of anti-schistosomal chemotherapy with regards to the extent of fibrosis reversal. in addition, analysis of dietary intakes of antioxidants among communities with comparable levels of s. mansoni infection but with differing levels of schistosomal periportal fibrosis will be undertaken to compare serum levels of antioxidants and prevalence of liver fibrosis. furthermore we plan to assess development of schistosomal peri-portal fibrosis in a cohort of students established 9 years back who had comparable levels of community prevalence of schistosomiasis but with differing access to fruits and vegetables. research on this topic has a high priority globally which is in line with the millennium development goals. knowledge in this field will also add to our understanding of fibrosis development in general and to the efficacy of clinical treatment of schistosomiasis in particular.

Eligibility criteria:
inclusion criteria: * subjects with schistosomal periportal fibrosis will be eligible for the study exclusion criteria: * subjects with acute malaria, tuberculosis or other chronic diseases such as diabetes mellitus, cardiovascular disease or cancer will be excluded from the study.

Keywords: schistosoma mansoni schistosomiasis periportal fibrosis antioxidant fibrosis reversal
fresh corneal lenticule implantation and autologous serum - case report

Conditions: Keratoconus; Keratoconus of Right Eye; Keratoconus, Unstable, Right Eye

Summary: the aim of our study is to investigate the feasibility and the effect of fresh lenticule implantation as allogenic graft that will be taken from myopic patients to implant in patients with keratoconus disease using visumax femtosescond laser- smile module surgery with primary objective to increase central corneal thickness and secondary to improve visual acuity and reduces k-values and to show the autologous serum drop improve the recovery of patients with mild dry eye in keratoconus disease.

a 19-year-old female patient with keratoconus and chronic hydrops cornea referred to the cornea department of our clinic with thin cornea and hydrops in chronic stage and minimal dry eye symptoms. minimum corneal pachymetry in the right eye was 378 µm as measured by optical coherence tomography(as-oct-zeiss). atlas corneal topography showed steep k-values 82.60 ax.37 and flat k 75.15 d ax 127 with -7.45 corneal astigmatism. her best corrected visual acuity was 0.0.5 in right eye and 1.0 in the left eye. slit lamp examination showed intense punctate epitheliopathy (figure 1), tear film break-up time (tbut) was measured as 7-8 sec and schirmer test was 10 mm in right eye, and the other eye examinations were determined normally.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age, male or female, of any race * willingness and ability to follow all instructions and comply with schedule for follow-up visits * for females: must not be pregnant exclusion criteria: * contraindications, sensitivity or known allergy to the use of the test article(s) or their components * if female, pregnant
dynamics of the capillary lactate levels in ohca

Conditions: Out-Of-Hospital Cardiac Arrest

Summary: serial capillary lactate measurements during cardiopulmonary resuscitation (cpr) in patients with out-of-hospital cardiac arrest (ohca).

capillary lactate measurements will be measured every ten minutes during cpr in ohca.

Eligibility criteria:
inclusion criteria: * adults with ohca exclusion criteria: * children with ohca * trauma * hypothermia

Keywords: out-of-hospital cardiac arrest lactic acid cardiopulmonary resuscitation survival
safety and efficacy of win-901x in asthma

Conditions: Asthma

Summary: this clinical trial is designed to evaluate the efficacy, dose-response and safety of win-901x in asthma patients.

double blinded, randomized, placebo controlled, multi-center, phase 2 : exploratory clinical study to evaluate the efficacy, dose-response and safety of win-901x in asthma patients

Eligibility criteria:
inclusion criteria: * greater than or equal to 20 and less than 80 years of age * have physician diagnosed asthma with irreversible airway obstruction at least 6 months prior to the screening * fev1 between 60% and 85% before inhaling fast-acting bronchodilator at screening * no history of smoking at least one year prior to the screening * having voluntarily signed an informed consent exclusion criteria: * have visited emergency room due to the worsening asthma symptoms, within 4 weeks before the screening * have been hospitalized due to an acute worsening of asthma within 3 months before the screening * have a history of laryngitis, pyrexia, sinusitis, otitis media, respiratory tract infection, and infectious rhinitis within 4 weeks prior to the screening * have malignant tumor

Keywords: asthma bronchial diseases respiratory tract diseases lung diseases, obstructive lung diseases
effect of motor imagery training on ataxic children after medulloblastoma resection

Conditions: Cerebellar Ataxia

Summary: background: after resection of medulloblastoma in children they suffer from signs and symptoms of ataxia which impedes their activities of daily living. purpose: to investigate the effect motor imagery training on balance, severity of ataxia and gait parameters on children after resection of medulloblastoma. methods: fifty children surfing from cerebellar ataxia after medulloblastoma resection were selected from tumors hospital of cairo university, their age ranged from seven to nine years old, they were randomly assigned into two matched control and study groups. the control groups received the selected physical therapy program while, the study group received motor imaginary training in addition to the selected physical therapy program. both groups were evaluated by ataxic rating scale, pediatric berg balance scale and kinematic gait analysis by kinovea software.

motor imagery is an effective method to enhance motor performance applied in rehabilitation programs it did not impose a physical load on patients, was confirmed through clinical evidence from meta-analysis. motor imagery means thinking in motor task with executing it to activate motor cortical areas as 25% of the brain neurons are mirror neurons and fire by thinking.

Eligibility criteria:
inclusion criteria: * the children had signs of ataxia * loss of balance * able to understand and execute test instructions * the children are in the follow up period after medulloblastoma resection. exclusion criteria: * medically unstable * visual impairment * increased intracranial pressure * any other neuromuscular diseases.
safety and efficiency study of valproic acid in ham/tsp

Conditions: HTLV-I-Associated Myelopathy

Summary: reversible acetylation of the histone tails plays an important role in the control of specific gene expression. mounting evidence has established that histone deacetylase inhibitors such as valproic acid (vpa)selectively induce cellular differentiation and apoptosis in variety of cancer cells. in a single-center, one year open-label trial, 19 ham/tsp patients were treated with oral doses of vpa (20mg/kg/day). primary end-points were the therapeutic safety and the effect on htlv-1 proviral load (a significant and sustained decrease was expected). secondary end-point was the neurological status before and after one-year treatment.


Eligibility criteria:
inclusion criteria: * ham/tsp patients diagnosed on who criteria * obtained informed consent. exclusion criteria: * patients with hepatic or nephrologic disease * valproic acid allergy * pregnancy.

Keywords: htlv ham/tsp valproic acid proviral load
clinical intramuscular gene transfer of raav1.cmv.hufollistatin344 trial to patients with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: the proposed clinical trial is an outgrowth of the safety record and functional improvement seen in the bmd follistatin gene therapy trial. in this study the investigators propose to inject aav1.cmv.hufs344 at a total dose of 2.4e12 vg/kg to six dmd patients. this dose will be divided between gluteal muscles, quadriceps and tibialis anterior. this is a wider distribution of vector than given to bmd patients, who overall improved the distance walked on the 6mwt without adverse events related to viral transduction into a single muscle.

the primary objective of this study is safety and endpoints will include hematology, serum chemistry, urinalysis, immunologic response to raav1 and follistatin, and reported history and observations of symptoms. efficacy measures will be used as secondary outcomes and include the distance walked on the 6mwt, functional tests by pt, life quality questionnaire, mri, eim, and muscle biopsy. subject will have follow up visits on days 7, 14, 30, 45, 60, 90, 180 and 9,12, 18 and 24 months post-gene transfer.

Eligibility criteria:
inclusion criteria: * age 7 or older * confirmed dmd gene mutations * impaired muscle function based on clinical evidence including difficulty climbing stairs, getting from the floor (gowers' sign), and weakness of individual muscles of extremities * males of any ethnic group will be eligible * ability to cooperate with study procedures including muscle testing. * willingness of sexually active subjects with reproductive capacity to practice reliable method of contraception * subjects must be on stable dose of prednisone for three months at time of enrollment or be started on oral dose of daily prednisone regimen for 30 days prior to gene transfer. study participants will continue prednisone post gene transfer unless there is adverse event that warrants prednisone taper or withdrawal. exclusion criteria: * active viral infection based on clinical observations. * the presence of a dmd gene mutation without weakness or loss of function * symptoms or signs of cardiomyopathy, including: * dyspnea on exertion, pedal edema, shortness of breath upon lying flat, or rales at the base of the lungs * echocardiogram with ejection fraction below 40% * serological evidence of hiv infection, or hepatitis a, b or c infection * diagnosis of (or ongoing treatment for) an autoimmune disease * concomitant illness or requirement for chronic drug treatment that in the opinion of the pi creates unnecessary risks for gene transfer * subjects with raav1 binding antibody titers \> 1:50 as determined by elisa immunoassay * abnormal laboratory values for liver, kidney, cbc, in the clinically significant range, based upon normal values in the nationwide children's hospital laboratory

Keywords: dmd muscular dystrophy follistatin
cash (cavernous angiomas with symptomatic hemorrhage) trial readiness

Conditions: CCM; Cavernoma; Cerebral Cavernous Malformation; Cerebral Cavernous Malformations 1; Cerebral Cavernous Malformations 2; Cerebral Cavernous Malformations 3; Cavernous Angioma

Summary: brain cavernous angiomas with symptomatic hemorrhage (cash) are rare, but they exact a heavy burden of neurologic disability from recurrent bleeding, for which there is no proven therapy. this trial readiness project aims to address current critical obstacles in identifying cases at multiple sites, characterizing their relevant features, and measuring their outcome. the timing cannot be more opportune, with therapeutic targets already identified, exceptional collaboration among researchers and with the patient community, and several drugs ready to benefit from a track to clinical testing in the next five years.

the trial readiness grant mechanism, funded by ninds, proposes to address knowledge gaps and establish a research network as infrastructure for future research. this project includes an observational cohort study of 181 patients with an operational goal of demonstrating the feasibility of screening, enrollment rates, baseline disease categorization and follow-up of cash using common data elements at multiple sites, and to assess the following endpoints for 123 participants enrolled at centers prespecified to do prospective follow-up: (1) the rates of recurrent hemorrhage; (2) the reliability of imaging biomarkers including quantitative susceptibility mapping and permeability measures which have been shown to correlate with lesion activity, and (3) change in functional status during prospective follow-up.

Eligibility criteria:
inclusion criteria 1. 18 years of age and older 2. diagnosed with a brain ca (single or multiple) 3. had a sh within the past year (with demonstrated new lesional bleeding or hemorrhagic growth on diagnostic studies and attributable new symptoms) 4. subject is able to provide informed consent exclusion criteria 1. spinal ca as source of sh 2. prior brain irradiation 3. cases where verification of sh with clinical and imaging review cannot be accomplished 4. prior or planned treatment of the symptomatic lesion (after neurosurgical consultation) to be eligible for aims 2 and 3, cash cases enrolled in aim 1 will be further excluded from follow-up and baseline validation (fubv) for the following reasons: 1. contraindication for administration of contrast agent or otherwise unwilling or unable to undergo research mri studies 2. pregnant or breastfeeding women 3. homeless or incarcerated persons, or other reason a subject will be unable/unlikely to return for follow-up visits

Keywords: ccm (cerebral cavernous malformations) dynamic contrast enhanced quantitative perfusion (dceqp) quantitative susceptibility mapping (qsm) cerebral cavernous malformation cavernoma cavernous angioma
panitumumab irdye800 optical imaging study

Conditions: Head and Neck Cancer

Summary: phase i trial to evaluate the safety of escalating dose levels of conjugated panitumumab-irdye800 in subjects with head and neck squamous cell carcinoma (hnscc) that undergo surgery with curative intent.

this is a phase i trial that is designed to evaluate the safety of escalating dose levels of conjugated panitumumab-irdye800 used in subjects with head and neck squamous cell carcinoma (hnscc) that undergo surgery with curative intent. safety data from this trial will be studied to assist in the selection of dose levels of panitumumab-irdye800 for future research. it is hoped that this study will also help in finding better methods for identifying cancer intraoperatively for a more complete surgical resection.

Eligibility criteria:
inclusion criteria * biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck * patients diagnosed with any t stage, any subsite within the head and neck that are scheduled to undergo surgical resection. patients with recurrent disease or a new primary will be allowed. * planned standard of care surgery with curative intent for squamous cell carcinoma * age ≥ 19 years * have life expectancy of more than 12 weeks * karnofsky performance status of at least 70% or ecog/zubrod level 1 * have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results: hemoglobin ≥ 9 gm/dl; white blood cell count \> 3000/mm3; platelet count ≥ 100,000/mm3; serum creatinine ≤ 1.5 times upper reference range exclusion criteria * received an investigational drug within 30 days prior to first dose of panitumumab irdye800 * myocardial infarction (mi); cerebrovascular accident (cva); uncontrolled congestive heart failure (chf); significant liver disease; or unstable angina within 6 months prior to enrollment * history of infusion reactions monoclonal antibody therapies * pregnant or breastfeeding * evidence of qt prolongation on pretreatment ecg (greater than 440 ms in males or greater than 450 ms in females) * magnesium or potassium lower than the normal institutional values * patients receiving class ia (quinidine, procanamide) or class iii (dofetilide, amiodarone, sotalol) antiarrhythmic agents. * patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis * tsh \> 13 micro international units/ml

Keywords: panitumumab optical imaging
does the mode of anesthesia affect the feto-maternal outcome in category-1 caesarean section

Conditions: Anesthesia; Adverse Effect; Newborn Morbidity

Summary: spinal anesthesia (sa) has become the standard technique in elective cesarean section (cs) as it results in less maternal and neonatal morbidity than general anesthesia (ga) (grade-a recommendation, nice). for women requiring emergency cs, rapid sequence general anesthesia (rsga) is commonly used because this technique is faster to perform than sa. though several randomized trials have compared the maternal and fetal outcome between these two anesthetic techniques, the studies with respect to category 1 cs (emergent conditions that hold immediate threat to life of the woman or fetus) are limited.

full term pregnant females will be included in this study. they will be allocated into two groups: (group g): will receive rapid sequence general anesthesia, and (group s): will receive spinal anesthesia. after preoperative assessment and investigations by the attending anesthesiologist, the decision of the anesthetic approach will be decided by the attending anesthesiologist according to indications for cs. before induction of anesthesia intravenous (iv) ranitidine 50 mg will be administered after establishing an iv access. on the operating table, vital signs will be monitored for all parturients throughout the surgery according to the standard departmental protocol. fetal well being will be assessed after delivery by using 1 minute and 5 min apgar score and umbilical cord ph . in addition to maternal vital signs intra-operative then follow up any complications that may occur to the mother post-operative.

Eligibility criteria:
following inclusion criteria: * american society of anesthesiologists physical status (asa) \< iii * age 18-40 year * gestational age\>37 weeks * emergency cesarean delivery * singleton pregnancy the exclusion criteria are: * twin pregnancy * disagreement of the patient * neurological impairment * congenital fetal abnormality * body mass index \> 40 kg/m2; and * sensitivity to any of the drugs used during the emergency cs.

Keywords: emergency cesarean section general anesthesia spinal feto-maternal
database for interstitial lung disease

Conditions: Lung Diseases, Interstitial

Summary: the purpose of this study is to establish a clinical database for patients bearing at risk for ild (interstitial lung disease) and to set up a prospective ild screening program for these patients.


Eligibility criteria:
inclusion criteria: * age: ≥ 18 years * patients with a known systemic disease bearing a risk for ild * signed informed consent (for prospective part) exclusion criteria: * age \< 18 years * comorbidities severely limiting life-expectancy (e.g. severe cardiovascular conditions, malignant disease)