Kornimate/medical-research-clean huggingface dataset:
clinical trial for gnx80 in intermittent claudication

Conditions: Intermittent Claudication

Summary: this is a phase 4, randomized clinical trial to evaluate whether gnx80 vs. placebo, prescribed for 6 months to patients with intermittent claudication(ic) would lead to an improvement in the walking distance.

a prospective, randomized, placebo-controlled, double-blinded, multi-center, phase iv, exploratory clinical trial to demonstrate the effect of improving the walking distance by gnx80 in patients with intermittent claudication

Eligibility criteria:
inclusion criteria: * age of at least 20 years * angiographically confirmed peripheral arterial disease * intermittent claudication for more than 6 months exclusion criteria: * severe impairment of heart, liver, or kidney function * limitation of walking ability due to respiratory insufficiency or to an orthopaedic condition * poorly controlled diabetes mellitus * positive pregnancy test * planned surgical or endovascular procedures other than for the treatment of ic
desvenlafaxine monotherapy in dysthymia

Conditions: Dysthymic Disorder

Summary: this multi-centred study will be conducted at two centres. the design will be an open label, flexible-dose study. this investigation will evaluate the efficacy of desvenlafaxine monotherapy for patients who meet diagnostic criteria for dysthymia.

primary objective: to investigate the efficacy, safety, and tolerability of open-label desvenlafaxine monotherapy in dysthymic subjects. secondary objectives: to evaluate the efficacy of desvenlafaxine on clinical measures relating to improvement of depressive symptoms, quality of life and occupational functioning. it is hypothesized that dysthymic subjects will show significant improvement in depressive symptoms after 8 weeks of treatment with desvenlafaxine. there will be significant improvement in measures of quality of life and stress coping at end of treatment, compared to baseline. there will also be significant improvement in measures of occupational functioning at end of treatment, compared to baseline.

Eligibility criteria:
inclusion criteria: * male and female patients between 18-65 years. * primary diagnosis of dysthymic disorder, as defined by dsm-iv criteria (300.4). * madrs score ≥15 at screening and baseline. * supportive therapy, and use of zopiclone for sleep and low-dose benzodiazepines on an as needed basis for anxiety, is allowed at any time. * written informed consent exclusion criteria: * co-morbid diagnosis of any other axis i disorders (other than anxiety disorders such as generalized anxiety disorder, social anxiety disorder and post-traumatic stress disorder, provided that dysthymic disorder is currently the diagnosis). * meet dsm-iv criteria for a current episode of major depression within two months prior to screening or who have received treatment for a major depressive episode within six months prior to screening. * substance abuse or dependence including alcohol, within 6 months prior to screening. * patients on the following prohibited treatments: 1. psychotropics such as other ssris, other snris, lithium, sibutramine, tramadol, st. john's wort, within 2 weeks of randomization 2. agents that impact significantly on serotonin metabolism (e.g. maois, tryptophan, triptans) within 2 weeks of randomization * have received physical therapies for depression (e.g. ect, rtms) within the 3 months prior to randomization. * previous non-response to a therapeutic trial of desvenlafaxine (at least 50 mg/day for 2 months). * clinically significant abnormalities in hematology, clinical chemistry, urinalysis or ecg at the screening visit, as judged by the principal investigator. * presence of medical or psychiatric condition deemed by the investigator to interfere with study procedures or endpoint data.

Keywords: desvenlafaxine open-label flexible-dose dysthymic disorder anxiety disorders generalized anxiety disorder social anxiety disorder post-traumatic stress disorder
what is the optimal training model for cervical awareness?

Conditions: HPV Infection; Cervical Cancer; Cervical Dysplasia

Summary: cervical cancer represents the fourth most prevalent malignant disease and the fourth leading cause of mortality among women on a global scale. despite screening and preventive vaccination efforts, cervical cancer remains a significant cause of morbidity and mortality in low- and middle-income countries.

a number of studies have been conducted with the aim of raising awareness about hpv and cervical cancer. however, there is currently no evidence-based consensus on the most effective method of education. the objective of this study is to identify the optimal training method by conducting a randomised controlled trial among healthcare professionals. the training methods under consideration are as follows: 1) video-based training, 2) classical lecture training, 3) brochure, 4) audio recording (radio broadcast). prior to the commencement of the designated training methods, participants will be required to complete a web-based pre-test. subsequent to this, the system will automatically assign each participant to a training intervention. upon completion of the training programme, participants will be required to undertake a second test, the results of which will inform the selection of the most effective training method. this study will be conducted separately in several distinct healthcare professional groups. each randomized controlled trial will include 400 participants. planned groups include: public health nurses medical doctors medical interns midwives the objective is to identify the most effective educational intervention for improving awareness of hpv and cervical cancer prevention within each group.

Eligibility criteria:
inclusion criteria: being over 18 and under 40 * female doctors, female nurses and female health technicians * working in our hospital * having sufficient mental capacity * not having a visual or auditory disability * volunteering to participate in the study exclusion criteria: * under 18 and over 40 * not being a healthcare worker * not having enough mental capacity * having a visual or auditory disability * patients who did not volunteer to participate in the study
effect of covid-19 related containment in children

Conditions: Post Traumatic Stress Disorder

Summary: the current pandemic situation (sras cov2) is an unprecedented event and a source of stress potentially aggravated by containment. the child revised impact event scale (cries-13) was evaluated in children 8 years or older in survivors of traumatic events, flood, stay in intensive care, or war (bosnia). in this study cries-13 will be used to determine the prevalence of precursor signs of post-traumatic stress in children aged 8 to 15 confined between march 17, 2020 and may 2020

parents of children aged 8 to 15 will be approached from different levels / places of selection / recruitment. a clinical researcher of pediatric clinical investigation center will collect the responses. if one of the holders of parental authority and the child agree to participate, an information notice will be sent to them, then they will be contacted by telephone by a clinical research assistant to answer the questionnaire. in large families, the cries-13 of the holder of parental authority and of the child will be applied for each of them whose age corresponds to the inclusion criteria. the duration of the study / participant call and effective response to the questionnaire by the holder of parental authority and the child will takes a maximum of 20 minutes.

Eligibility criteria:
inclusion criteria: * binomial of child (aged between 8 and 15) and one of its holders of parental authority agreeing to participate exclusion criteria: * children aged under 8 and over 15 * children whose parents are opposed * children refusing to participate * holders of minor parental authority
a clinical trial to study the effect of imagined progressive movements in patients with paralysis of one side of the body.

Conditions: Stroke

Summary: the aim of the study to evaluate the effect of graded motor imagery on upper limb motor functions and quality of life in patients with stroke that was conducted in two centers in india. the primary outcome measures were upper limb motor functions at 6 weeks and secondary outcome measure was quality of life at 6 weeks. research hypothesis: there would be significant effect of gmi on upper limb motor functions and quality of life in patients with stroke.

graded motor imagery (gmi) is essentially a brain based treatment, targeting the activation of different brain regions in a graded manner. gmi is a three stage treatment programme comprising of left right discrimination training, explicit motor imagery and mirror therapy. in this study, gmi approach is applied on the patients with stroke to enhance their upper limb motor functions and quality of life. conventional treatment: patients of group a and group b had received conventional treatment for 6 weeks. conventional treatment consists of task oriented upper extremity functional exercises. components of task oriented training include weight bearing, supportive reactions, and reaching, grasping, holding and release activities. it was performed five days a week for six weeks of one hour duration. graded motor imagery: patients of group a had received gmi programme with conventional treatment for 6 weeks. it is a three stage process, was performed five days a week for six weeks of one hour duration. it comprises of: * left right discrimination training (implicit motor imagery) - 2 weeks * explicit motor imagery (imagined movements) - 2 weeks * mirror therapy - 2 weeks

Eligibility criteria:
inclusion criteria: * age (between 45 to 65 years) * individuals who experienced one episode of stroke only. * both males and females were included in the study * both ischemic \& haemorrhagic stroke individuals were included in the study * duration of stroke between 1 to 6 months * mini mental status examination (mmse) (score \> 23) * patients with brunnstrom stage 1 \& 2 exclusion criteria: * individuals having any musculoskeletal disorders * individuals having any neurological disorder other than stroke * individuals with any visual impairment * individuals having any systemic disease * non cooperative patients * patients suffering from psychological problems

Keywords: upper extremity, motor imagery, mirror therapy
bupropion treatment for youth smoking cessation

Conditions: Nicotine Dependence

Summary: the purpose of this study is to 1) evaluate the safety and efficacy of two doses of bupropion sr (150mg/day and 300mg/day) when compared to placebo, as an aid to smoking cessation in adolescents and 2) to examine which factors, such as medication adherence, nicotine dependence, and motivation to quit, affect treatment outcome.


Eligibility criteria:
inclusion criteria: * 14 to 17 years of age * smoked at least 6 cigarettes per day * exhaled co greater than or equal to 10 ppm * made at least two previous quit attempts * weighed at least 90 pounds * able to read english at least the 6th grade level * motivated to quit smoking as evidenced by willingness to commit to study protocol requirements for the duration of the study * provided active parental consent and youth assent exclusion criteria: * current use of tobacco products other than cigarettes, unless willing to abstain from these products for the study duration * current use of other treatments for smoking cessation * history or current diagnosis of panic disorder, psychosis, bipolar disorder, or eating disorder * history of abuse or dependence on alcohol or other recreational or prescription drugs in the three months preceding the study * current evidence of clinical depression or attention deficit/hyperactivity disorder * use of any psychoactive drug and/or any type of antidepressant with in four weeks of the treatment phase of the study * predisposition to seizure or tic disorders or a personal history of a seizure disorder, family history of seizure disorders, or treatment with medication or therapies that increase the risk of seizures * significant history of or current clinical evidence of cardiovascular disease * (females)pregnancy (urine pregnancy test), lactation or, if sexually active, unwillingness to use a medically acceptable form of contraception for the duration of the study * only one member of a household was allowed to participate in the study concurrently.
association of anticholinergic burden with onset of delirium in older adults with alzheimer dementia:

Conditions: Delirium; Anticholinergic Adverse Reaction; Alzheimer Disease

Summary: drugs with anticholinergic properties are commonly prescribed to older persons despite growing evidence of their significant adverse effects. however, limited data are available concerning their contribution to time of onset of delirium. this study aimed to determine the potential association of higher anticholinergic burden to early-onset of delirium superimposed dementia in the older adult.


Eligibility criteria:
inclusion criteria: * 65 years and older and diagnosis or fellow-up of alzhemier dementia in outpatient clinic. exclusion criteria: * the patients with a history of other than alzhemier dementia or neurodegenerative disease (epilepsy, multiple sclerosis, parkinson disease, etc.), terminal illness (malignancy, advanced organ failure) were excluded.
a multiple-dose study of blu-5937 in chronic pruritus associated with atopic dermatitis

Conditions: Chronic Pruritus; Atopic Dermatitis

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, parallel design study of blu-5937 for the treatment of chronic pruritus in adult subjects with atopic dermatitis (ad).

the study will consist of a 37-day screening period (including a 7-day run-in period), a 4-week treatment period followed by a follow-up visit approximately 2 weeks after the last dose of study drug.

Eligibility criteria:
inclusion criteria: * willing to participate and is capable of giving informed consent * clinically confirmed diagnosis of active ad with at least a 6-month history of ad * chronic pruritus related to ad for at least 3 months * moderate to severe itch associated with mild to moderate ad * female of childbearing potential must agree to use a highly effective contraceptive method during the study and until at least 4 weeks after the last study drug administration exclusion criteria: * history of skin disease or presence of skin condition that would interfere with the study assessments * clearly defined etiology for pruritus other than ad, including but not limited to: urticaria, psoriasis, or other non-atopic dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, uncontrolled hyperthyroidism, and infection * presence of any acute skin condition other than ad which may risk inducing a pruritus flare/worsening during the course of the study, including but not limited to: impetigo, active herpes simplex infection, or allergic contact dermatitis * subject is \>65 years of age and has developed pruritus at age of ≥50 years * history of cancer or lymphoproliferative disease within 5 years with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix * known history of, or active, parasitic infection, including skin parasites such as scabies within 12 months prior to screening * known history of chronic infectious disease (e.g. hepatitis b, hepatitis c, or human immunodeficiency virus \[hiv\]) * known history of clinically significant drug or alcohol abuse in the last year * previous participation in a blu-5937 trial

Keywords: blu-5937 chronic pruritus atopic dermatitis p2x3 receptor antagonist
oxygen consumption in critically ill children

Conditions: Extracorporeal Membrane Oxygenation

Summary: the investigators propose to examine the relationship between do2 and vo2 in critically ill patients requiring an extracorporeal membrane oxygenation (ecmo) machine. this machine can provide complete support of heart and lung function. in so doing, the investigators will be able to avoid physiologic coupling by increasing do2 mechanically, by increasing blood flow through the ecmo circuit. null hypothesis: increased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is not associated with an increase in oxygen consumption. alternate hypothesis: increased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is associated with an increase in oxygen consumption.


Eligibility criteria:
inclusion criteria: * patients in the critical care unit on veno-arterial ecmo. * hemodynamic stability established, as adjudged by the treating ccu staff physician. * informed consent by parent or legal guardian. * approval by treating ccu staff physician to approach parents/guardians for consent process at any given time. exclusion criteria: * patients in the critical care unit on veno-venous (vv) ecmo. * inability to tolerate study period without red cell transfusion. * presence of a large leak around the endotracheal tube (\> 10% tidal volume). * patients requiring \> 70 % fio2 at the time of potential enrollment. * parent or legal guardian refuse consent.

Keywords: pediatric ecmo extracorporeal blood flow vo2
a trial to evaluate the impact of lung-protective intervention in patients undergoing esophageal cancer surgery

Conditions: Acute Lung Injury

Summary: the purpose of this trial is to determine whether low tidal volume during intraoperative one-lung ventilation could decrease the incidence rate of postoperative acute lung injury compared to "normal" tidal volume.

large tidal volume are known risk factor of acute lung injury.mechanical ventilation with low tidal volume has been shown to attenuate lung injuries in critically ill patients.esophagectomy surgery need a relatively long time of one-lung ventilation. a normal tidal volume of two-lung ventilation should be a large one when exerted to one lung. we hypothesized that low tidal volume ventilation during one-lung ventilation could decrease incidence rate of postoperative acute lung injury and mortality.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of esophageal carcinoma and planned for esophagectomy * indication for one-lung ventilation * informed consent * asa i\~ii exclusion criteria: * nyha iii\~iv * severe copd * pulmonary fibrosis * any new pulmonary infiltrate on chest radiograph * preoperative acute infection suspected * altered liver function( child-pugh class b or moe) * acute or chronic renal failure * preoperative corticosteroid treatment during month before inclusion

Keywords: esophagectomy acute lung injury protective ventilation
evaluating the prognostic impact of anti-β1ar antibodies and anti-l-cac antibodies in patients with dilated cardiomyopathy

Conditions: Dilated Cardiomyopathy (DCM)

Summary: background of the study the etiology of dilated cardiomyopathy (dcm) is complex and involves a variety of genetic, environmental, and immunologic factors. autoimmune reactions (especially anti-cardiac autoantibodies) play an important role in the development of dcm. in recent years, several clinical studies have suggested that anti-β1ar and anti-l-cac antibodies are associated with cardiovascular death, ventricular tachycardia, and sudden death in patients with dcm, which is of great value in the prognostic evaluation of dcm. however, most of these studies are single-center studies with small sample sizes and non-uniform testing methods. in this study, we will use a multicenter, prospective cohort study to follow up dcm patients in china for a period of 3 years, to further accurately assess the clinical predictive value of anti-β1ar antibody and anti-l-cac antibody on the prognosis of dcm patients, and to provide epidemiological information as well as targeted therapeutic targets for dcm. aims of the study a multicenter, prospective cohort study of anti-β1ar and anti-l-cac antibodies for prognostic assessment of dcm patients, enrolling 1,000 dcm patients, to further accurately assess the prognostic value of the anti-aha assay for dcm patients, and to provide targets for targeted treatment of dcm.


Eligibility criteria:
inclusion criteria: 1. age 18-75, any gender 2. diagnosed with dilated cardiomyopathy 3. subjects or their legal guardians are fully informed of the nature and risks of the study, participate voluntarily, and sign an informed consent form. exclusion criteria: 1. serious uncontrolled infection at enrolment ("uncontrolled" is defined as signs and symptoms of infection that persist without improvement despite antimicrobial or other treatment) 2. uncontrolled active bleeding at enrollment 3. pregnancy or breastfeeding 4. combination of serious diseases affecting survival, such as tumors, with a life expectancy of less than one year 5. previous heart transplant or implantation of a cardiac assist device 6. patients with poor compliance who are unable to complete the full course of the study 7. other conditions (e.g., overstimulation, sensitivity, cognitive impairment, mental illness, or substance abuse/addiction) that, in the judgment of the investigator, may increase the risk to the subject or interfere with the clinical study and judgment of the results.
subaxial cervical traumatic injuries

Conditions: Cervical Injury Spine

Summary: the aim of this study is to assess the mid-term outcomes of treating subaxial cervical traumatic injury cases admitted to the trauma unit of assiut university hospital.

injuries to the subaxial cervical spine can be bony, discoligamentous or a combination of both. cervical spine trauma is common resulting from high energy trauma such as falling from height and motor vehicle accident . the subaxial cervical spine is a common site of cervical injury with more than 50 % of injuries being located between c5 and c7 mri is superior to ct scans for evaluating the spinal cord, nerve roots, disc, and ligamentous structures in the cervical spine there are a couple of classification systems that have been devised the first is the subaxial injury classification system (slic). this classification stratifies the type of fracture, the competency of the dlc, and the patient's neurologic status with numerical values to determine the course of treatment. a second classification system is the ao spine subaxial cervical spine injury classification. the ao spine scics classifies injuries based on 4 parameters: injury morphology, facet involvement, neurological status, and case-specific modifiers patients with fractures deemed unstable or neurologic compromise should undergo decompression and stabilization. intervention within 24 hours of injury leads to better improvement in asia scores . although we receive and treat a large number of patients with various subaxial cervical traumatic injuries in assiut university hospital each year, there is uncertainty about the midterm outcome of the treatment we provide. in this study, the investigators will assess the mid-term outcomes of all patients with subaxial cervical traumatic injuries who complete a minimum one year follow up regardless of the neurological status or treatment type used.

Eligibility criteria:
inclusion criteria: * all patients presenting with subaxial cervical spine traumatic injuries with and without cervical cord injury who complete a minimum of one year follow up exclusion criteria: * patients who refuse to participate in the study patients with pathological fractures
stretching vs foam-rolling

Conditions: Muscle Relaxation

Summary: the study aims to compare the acute effects of the aplication of foam-rolling and stretching over the hamstrings flexibility. the secondary objective is to determine which time can permit the obtention of better results.


Eligibility criteria:
exclusion criteria: * pregnant women * musculoskeletal disorder in the last 3 months * surgical interventions in lower limbs in the last 6 months * psychological or nervous alterations * uncomprehension of the indications.