Kornimate/medical-research-clean huggingface dataset:
double-blind trial to investigate efficacy and tolerance of ambroxol lozenges 20 mg in sore throat

Conditions: Pharyngitis

Summary: the aim of this trial is to investigate the efficacy and tolerance of ambroxol lozenges 20 mg in the treatment of sore throat in patients with acute viral pharyngitis.

male and female ambulant patients complaining of a sore throat caused by acute viral pharyngitis. every patient may be included in the trial only once. a total of 250 male and female ambulant patients between the ages of 18 and 65 years will be enrolled. approximately 8 centers will be recruited each enrolling approximately 30-32 patients. study hypothesis: the two-sided test hypothesis, that the results of the active treatment group with 20 mg ambroxol and the placebo group do not differ with regard to the primary endpoint (null hypothesis (h0) will be tested against the alternative (h1) that they are not equal. comparison(s): primary endpoint: indication of pain on the vrs (pi)-verbal rating scale (pain intensity)-in the first 3 hours (the patient rates his/her pain on a six-point verbal rating scale). secondary endpoint (s): 1. patient's assessment of effectiveness and tolerance. the patient assesses the effectiveness and the tolerance of the test medicine for treating his sore throat at the end of the first and second day of treatment, by means of a verbal rating scale. 2. participating doctors assessment of tolerance.

Eligibility criteria:
1. patients having a sore throat with acute viral pharyngitis. 2. female and male ambulant patients between the ages of 18 and 65. 3. the throat pain intensity is rated at least severe on the vrs (pi). 4. written informed consent is given by the patient. 5. compliance by the patient seems guaranteed. 1. patients with symptoms of primarily bacterial pharyngitis or bacterial secondary infection (clinical findings; inter alia assessment of exudate). 2. first indication of symptoms of acute pharyngitis (e.g., sore throat) occurred more than 3 days ago already. 3. counting of white blood cell in blood routine examination exceeds 10?109/l. 4. patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks. 5. broncho-motor disorders or concomitant diseases with relatively large quantities of secretion (danger of secretion blockage). 6. known hypersensitivity to ambroxol or to auxiliary substances contained in the tablet. 7. previous and/or existing tumour condition. 8. pregnancy and/or breast-feeding. 9. alcohol, and/or drug abuse. 10. simultaneous participation in another clinical trial.
saphenous nerve block versus platelet rich plasma for chronic knee osteoarthritis

Conditions: Chronic Knee Joint Osteoarthritis

Summary: knee osteoarthritis, as a progressive disease is one of the most common causes of pain, motor disorder and disability in the elderly. by increasing age, the cartilage is eroded and endures degenerative changes due to physiological and biomechanical changes as well as metabolic effects and trauma . non-surgical interventions for pain control of knee osteoarthritis include weight loss, exercise, changes in daily activities, physiotherapy, nonsteroidal anti-inflammatory drugs (nsaids) and analgesics .however ,the intra-articular injection is recently recommended by many studies such as corticosteroids, hyaluronic acid, growth hormone, dextrose ,and platelet rich plasma. intra-articular injection of platelets are activated and undergo degranulation, releasing a range of growth factors, including transforming growth factor beta (tgf-β), platelet-derived growth factor (pdgf), insulin-like growth factor, vascular endothelial growth factors, epidermal growth factors and basic fibroblast growth factor 2. these growth factors are thought to activate a variety of signaling pathways, which promote healing of bone and soft tissue.also,some minimally invasive therapeutic options have been effective in pain relieve in ka, such as ultrasound-guided saphenous nerve block .

the aim of this study is to compare the efficacy of ultrasound guided saphenous nerve block versus platelet rich plasma injection in the management of chronic pain in patients with knee oa. this study will be conducted to evaluate which modality is more effective.

Eligibility criteria:
inclusion criteria: * patients who are not competent to understand the study protocol * radiographic evidence of oa of knee of 2nd degree. * chronic pain for at least 6 months prior to study entry (day 0). * pain relief not achieved with conservative therapies during the last 6 months exclusion criteria: * patient refusal. * bleeding disorders. * coagulation disorders. * local skin infection * current other problem in the affected extremity . * psychiatric disorders affecting co-operation of the patient . * previous chronic opioid use. * intra articular knee injection within previous three months. * history of traumatic arthropathy. * history of neuropathic arthropathy. * allergy or hypersensitivity to any of the study medication. * any condition that could interfere with the interpretation of the outcome assessments. * pregnancy * lactating women. * low back pain due to central cause.
coronary revascularization versus conservative therapy in patients with treated critical limb ischemia

Conditions: Obstructive Coronary Artery Disease

Summary: the objective of the incorporate trial is to evaluate whether an intentional invasive strategy with ischemia targeted, reasonably complete coronary revascularization and optimal medical therapy is superior as compared to a primary conservative approach and optimal medical therapy alone in terms of spontaneous myocardial infarct-free and overall survival in patients with severe peripheral artery disease, underwent peripheral artery revascularization due to critical limb ischemia. the incorporate trial is designed to be non-blinded, open-label, prospective 1:1 randomized controlled multicentric trial.


Eligibility criteria:
inclusion criteria: * patients, undergoing successful peripheral revascularization (percutaneous or surgical) due to critical limb ischemia will be screened, and enrolled if informed consent form is signed and none of the following exclusion criteria is met. exclusion criteria: * contraindication for double antiplatelet therapy for at least one month; * contraindication for guideline-conform longterm antiplatelet/anticoagulation regime after pci; * heart failure with ejection fraction below 35%; * significant valvular heart disease with indication for surgical or percutaneous repair; * any concomitant disease with a life expectancy less than 2 years; * severe renal dysfunction with glomerular filtration rate below 30 ml/min/1.73m2; * ongoing sepsis. patients, who cannot be enrolled for any reasons will enter a prospective registry.

Keywords: critical limb ischemia coronary artery disease fractional flow reserve-guided coronary revascularization
influence of age on amyloid load in alzheimer's disease and in atypical focal cortical alzheimer's disease

Conditions: Alzheimer's Disease; Posterior Cortical Atrophy; Logopenic Progressive Aphasia

Summary: the first objective is to asses influence of age on amyloid load measured by pet imaging using pittsburgh b compound (pib) radio-tracer, in alzheimer's disease(ad). this will allow the determination of brains age-specific deterioration factors by comparing early onset ad (eoad), late onset ad (load)and atypical focal cortical ad (pca and lpa). the amount of brain lesions in ad patients is estimated by: 1. measuring the rate of cortical brain atrophy, 2. fdg imaging of glucose metabolism reflecting neuronal activity, and 3. for patients who benefited from a lumbar puncture; cortical-spinal fluid (csf) amounts of amyloïd and tau proteins are measured.

literature data suggests there are different types of ad depending on their age of onset, called eoad and load. these two categories are distinguished by the localization of brain atrophy : severe and 'posterior' in eoad and more 'anterior' in load. neuro-pathologic data suggests some atypical focal cortical atrophy, characterized by a respect of episodic memory, may be classified within eoad. pib-based pet imaging allows the in-vivo visualization and quantification of amyloïd load. we want to answer the question whether the amount of amyloïd protein may be lower in load than eoad in patients showing the same level of dementia, and thus identify ageing-specific cognitive disorders and understand witch factors influence etio-pathology of typical and atypical alzheimer's disease.

Eligibility criteria:
inclusion criteria: * ad patients: clinical dementia rating between 0.5 and 2 free and cued recall test (grober and buschke) cued-recall \< 18/48 and total recall \< 40/48 * atypical ad : i visual-spatial disorder and respect of episodic memory progressive evolution, balint syndrome ii progressive language disorder constituted of logopenic aphasia respect of episodic memory * controls: age over 30 mmse over or equal to 27 normal neuropsychiatric state for age and education level exclusion criteria: * for every patients : psychiatric disorders age under18 absence of social security counter indication to mri supposed or actual alcoholism or drug addiction pregnancy

Keywords: pib imaging, brain atrophy cognitive impairment pet imaging alzheimer's disease amyloid protein
study to evaluate acdn-01 in abca4-related stargardt retinopathy (stellar)

Conditions: Stargardt Disease; Cone Rod Dystrophy; Juvenile Macular Degeneration; Stargardt Disease 1

Summary: this study is an open-label, single ascending dose clinical trial in participants who have abca4-related retinopathies. this is the first-in-human clinical trial in which acdn-01 will be evaluated for safety, tolerability, and preliminary efficacy following a single subretinal injection of acdn-01.

this is an open-label, single ascending dose study of acdn-01 in adult participants with abca4-related retinopathy. the study is designed to evaluate the safety, tolerability, and evidence of biological effect of sad levels (low, medium, and high) of acdn-01 when delivered subretinally. participants will be followed on study for 2 years for the primary safety and preliminary efficacy endpoints, after which they will continue in the study in a 3-year long-term follow-up period, for a total study duration of 5 years.

Eligibility criteria:
key inclusion criteria: * presence of mutations in the abca4 gene * abca4 retinopathy phenotype (stargardt disease type 1 or cone-rod dystrophy) * area of atrophy located in the macula of the study eye * bcva of 20/80 (0.6 logmar) or worse key exclusion criteria: * the presence of pathogenic or likely pathogenic mutations in other genes known to cause cone-rod dystrophy or stargardt maculopathy * retinal disease other than abca4-related retinopathy * presence of a medical condition (systemic or ophthalmic), psychiatric condition, including substance abuse disorder, or physical examination or laboratory finding that may in the opinion of the principal investigator and sponsor preclude adherence to the scheduled study visits, safe participation in the study, or affect the results of the study.

Keywords: abca4 abca4-related retinopathy stargardt disease stargardt macular dystrophy cone rod dystrophy gene editing rna gene therapy exon editing ird inherited retinal disease inherited retinal dystrophy inherited retinal degeneration
survey of satisfaction on traditional chinese medicine jing-guan-fang (jgf) for covid-19 prevention

Conditions: Corona Virus Infection

Summary: the retrospective observation study, the first line to care cavid-19

the satisfaction of using nature herbal medicine for frontline medical staffs to prevent covid-19: a retrospective clinical study. the medical frontline staffs have the high risk to be infected during working. the stress and load were acuminated, especially when they got the similar symptoms as covid-19. nhm has been used to early prevention for thousands of years9-12. it was well accept to take nhm for early prevention in many asia-pacific countries. although many nhm remedies of covid-19 treatment or prevention were reported, but the related study were lacking. to understand the pressure and the satisfaction of frontline medical staffs after taking jgf for early prevention we conducted this retrospective clinical study to explore the relationship in different groups.

Eligibility criteria:
inclusion criteria: * the person first-line medical staff in hospital * the inspection personnel in airport * self-quarantine at home. * self-quarantine at office. exclusion criteria: * no willing to participate * allergy to herbal medicine * severe illness evaluated by physician

Keywords: natural herbal medicine chinese medicine
anger expression, self-focus and coronary heart disease risk factors

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease

Summary: to identify behavioral factors underlying the development of cardiovascular risk in young adults.

background: the continued number of observations relating the type a behavior pattern to coronary heart disease underscores the importance of developing a careful theoretical basis that may account for the virulent components of a coronary-prone personality. cardia or coronary heart disease risk development in young adults is a prospective, epidemiological study of coronary heart disease risk factors in cohorts of black and white men and women, 18 to 30 years of age. design narrative: from each of the baseline tape-recorded type a/b structured interviews administered in cardia, eighteen questions were scored for self-references, perceived pressure, anger experience, and anger expression. the anger measures were related to other measures of anger-in and hostility in order to establish their validity. the interrelationships of these factors were assessed separately for each of the socioeconomic status (ses) categories. a major focus of the analyses was to describe ses differences in how pressure was perceived and how anger was experienced and expressed. the study also assessed how these factors were related to data already collected on psychosocial risk factors and primary risk factors including blood pressure, serum cholesterol, and cigarette smoking. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
oxycodone/naloxone prolonged release (oxn pr) compared to placebo to demonstrate improvement in symptoms of restless legs syndrome (rls) in subjects with moderate to severe idiopathic rls with daytime symptoms

Conditions: Moderate to Severe Idiopathic RLS With Daytime Symptoms

Summary: the primary objective for the 12-week titration-/maintenance period is: to demonstrate superior efficacy of oxn pr compared to pla in the improvement of symptom severity of rls.

a randomised, double-blind, placebo-controlled, parallel-group, multicenter study to demonstrate improvement of symptoms of rls in subjects with moderate to severe idiopathic rls with daytime symptoms who take oxycodone/naloxone prolonged release (oxn pr) compared to subjects taking placebo (pla).

Eligibility criteria:
inclusion criteria: * moderate to severe idiopathic rls with daytime symptoms exclusion criteria: * females who are pregnant or lactating. * subjects with evidence of significant structural abnormalities of the gastrointestinal tract. * subjects with evidence of impaired liver/kidney function upon entry into the study
a study to describe the breast cancer patient population, treatment, and results in indian patients receiving combinations of the medicines called palbociclib for advanced breast cancer

Conditions: Breast Cancer; Breast Carcinoma; Breast Neoplasms; Breast Tumors; Cancer of Breast

Summary: the purpose of this clinical study is to describe the patient population, breast cancer treatment, and breast cancer treatment results of adult female patients who have received palbociclib combination treatments for advanced or metastatic breast cancer in india. there are two groups of patients this study will describe. the first group of patients will have received palbociclib in combination with aromatase inhibitor (as prescribed by the physician) for the treatment of postmenopausal women with hr+/her2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease. the second group of patients will have received palbociclib for the treatment of hormone receptor hr+/her2- advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy.


Eligibility criteria:
inclusion criteria: * hr+/her2- breast cancer diagnosis with confirmed metastatic or advanced disease * received palbociclib with aromatase inhibitor (as prescribed by the physician) as initial endocrine therapy in postmenopausal metastatic breast cancer (mbc) patients or with fulvestrant in patients who have progressed on prior endocrine therapy * patients on leutinizing hormone releasing hormone (lhrh) agonists for ovarian function suppression in pre- or perimenopausal stage only if prescribed palbociclib with fulvestrant * no prior or current enrolment in an interventional clinical trial for advanced/metastatic breast cancer * minimum of 3 months of follow up data since palbociclib with fulvestrant initiation, or minimum of 6 months of follow up data since palbociclib with aromatase inhibitor initiation exclusion criteria: * cancers other than breast cancer * male breast cancer * visceral crisis

Keywords: hormone receptor positive / human epidermal growth factor 2 negative (hr+/her2-) advanced breast cancer metastatic breast cancer palbociclib aromatase inhibitor fulvestrant
e-health literacy in athletes

Conditions: Athletic Injuries

Summary: e-health literacy in athletes is very important. the aim of this study was to determine the level of e-health literacy in athletes and to examine the relationship between age, gender, sports branches and injury sites.


Eligibility criteria:
inclusion criteria: * volunteering to participate in the training, * being an athlete for at least 2 years. exclusion criteria: * having any vision and hearing problems
efficacy of the use of vaginal balls for the improvement of urinary incontinence and sexual function in women.

Conditions: Urinary Incontinence; Stress Urinary Incontinence; Sexual Dysfunction

Summary: asess if adding vaginal spheres treatment to the conventional pelvic floor muscle trainning (pfmt) produces a greater decrease in the severity of the stress urinary incontinence or a greater perceived quality of life related to incontinence.

the intervention group will perform the pelvic floor muscle trainning (pfmt) plus the use of vaginal spheres, while the control group will perform the pfmt treatment only, daily at home. the study will be conducted on women with stress urinary incontinence. the intervention will last four months and will consist of a monthly session with the physiotherapist, doing a total of 4 sessions and the final assessment.

Eligibility criteria:
inclusion criteria: * women aged 18 or over * suffer from stress urinary incontinence or mixed urinary incontinence. * understand spanish to be able to self-complete the questionnaires (validated in spanish). exclusion criteria: * not giving informed consent. * women with faecal incontinence. * women with grade iii-iv prolapse. * women with pathology that can affect the neuro-muscular response. * women with incontinence that is not of functional origin. * women who have perineal pain that makes it impossible to apply the spheres. * women with an open vagina of more than 2.5 cm opening * being pregnant. * not being committed to complying with a minimum of 80% of the treatment. * having previously started other pelvic physiotherapy treatments

Keywords: vaginal spheres physiotherapy pelvic floor muscle trainning
german registry of alzheimer's disease treated with transcranial pulse stimulation

Conditions: Alzheimer Disease

Summary: this study will primarily investigate the safety and secondarily the effect and applicability of transcranial pulse wave stimulation (tps) for the treatment of alzheimer's disease in the context of a pmcf study (post-market clinical follow-up). the multicenter, prospective data collection should help to optimize the stimulation protocol, as well as to record frequent to occasional adverse effects of the product and cognitive, affective and subjective scores.

this study will primarily investigate the safety and secondarily the effect and applicability of transcranial pulse wave stimulation (tps) for the treatment of alzheimer's disease in the context of a pmcf study (post-market clinical follow-up). the multicenter, prospective data collection should help to optimize the stimulation protocol, as well as to record frequent to occasional adverse effects of the product and cognitive, affective and subjective scores. adverse effects and adverse events without a clear causal relationship will be documented in terms of frequency and severity. furthermore, the progression of improvement in alzheimer's symptoms as a result of tps treatment is summarized in various neuropsychological scales.

Eligibility criteria:
inclusion criteria: i. age = 18 to 85 ii. n\>=100, clinical alzheimer's syndrome, defined by a gradually progressive change in memory function (for severity using the mmse as a screening tool) and impairment of activities of daily living for more than six months iii. mri scan, in vivo evidence from csf and/or pet using the nia-aa criteria, which categorize the underlying pathological processes based on biomarkers, should be added if possible, but are optional. these biomarkers are categorized as ß-amyloid deposition, pathological tau and neurodegeneration \[at(n)\], which can be detected on imaging and in biofluids. if possible, patients with alzheimer's disease (ad) or alzheimer's continuum should be included. iv. tps treatment in a center of a neurological or psychiatric specialist and performed under supervision of a specialist exclusion criteria: i. relevant intracerebral pathologies not related to alzheimer's disease, such as vascular encephalopathy fazekas grade 3, tumors, vascular malformations, pregnancy, metal implants, caa according to boston criteria, z.n. or during antibody therapy ii. blood coagulation disorders or oral anticoagulation iii. epilepsy iv. medical conditions leading to non-compliance with the protocol

Keywords: alzheimer disease transcranial pulse wave stimulation (tps)
effect of designed physical training after selective dorsal rhizotomy on motor function of ambulant children with spastic diplegia

Conditions: Cerebral Palsy

Summary: the management of cerebral palsy is complex and requires a multidisciplinary approach. selective dorsal rhizotomy is a neurosurgical technique that aims to reduce spasticity in the lower limbs and improve motor function.

the current study is designed to assess the effectiveness of selective dorsal rhizotomy on motor function in ambulant children with spastic diplegia. therefore, a convenient sample of ambulant children with spastic diplegia will be allocated to two groups of equal numbers (control and experimental)

Eligibility criteria:
inclusion criteria: * cp, spastic diplegia * 4-8 years of age * the ability to walk with or without assistive devices typically on level ii-iii on gross motor function classification system * at least six months after the last botulinum toxin a injection in the lower extremities * average intelligent quotient according to medical records for active participation * good trunk control with good antigravity strength of lower extremity on clinical examination. exclusionary criteria * ankle clonus; exaggerated deep tendon reflex in the legs * babinski sign * structural non-reducible deformities or musculoskeletal surgery in the lower extremities in the past 12 months * moderate to severe signs of dystonia, athetosis or ataxia.

Keywords: standard orthotic management selective dorsal rhizotomy bilateral cerebral palsy functional balance energy cost of walking functional capacity selective voluntary motor control: