Kornimate/medical-research-clean huggingface dataset:
kinesthetic exercises and sine sound waves in cervical spondylosis

Conditions: Cervical Spondylosis

Summary: the goal of this randomized control trial is to determine the effect of kinesthetic exercises and sound waves on pain, rom, shoulder alignment and disability in cervical spondylosis. the main question it aims to answer is: weather sine sound and kinesthetic exercise are effective in management of pain, rom, alignment, and disability in patients that are suffering from cervical spondylosis

cervical spondylosis is a progressive disease defined by degenerative changes affecting the vertebrae, intervertebral disks, facets, and associated ligaments. symptoms of cervical spondylosis manifest as neck pain and neck stiffness and can be accompanied by radicular symptoms when there is compression of neural structures. the degenerative changes are intervertebral disc degeneration, osteophyte formation, and ligamentum flavum and facet hypertrophy. the sine sound waves approach aims to provide orthopaedic spinal treatment through focused vibroacoustic treatment (fvat) and manage the biomechanical aspect of back pain. vibroacoustic therapy has been indicated for patients with a range of musculoskeletal, neurological, and haemodynamic problems demonstrating positive changes in pain, spasticity, movement control, and specifically fatigue and anxiety in those with spinalcord or brain injuries. for neck pain syndromes, the kinesthetic rehabilitation exercises (i. e.,eye-follow exercises, head relocation exercises, eye-head coordination, and gaze stability exercises) are developed to improve or restore somatosensory and sensorimotor function by enhancing tactile afferents cues. kinaesthetic exercises have an added advantage over the conventional exercise programs as it uses an unconscious component of proprioceptive signals for the automatic control of cervical muscle tone and posture. the research include 3 intervention groups group a will be give sine sound waves treatment 6 sessions 3 times a week followed by 6 sessions 2 times a week. group b will be given kinesthetic exercise for 6 weeks. and group c will be given combination of both group a and group b treatments. outcomes, encompassing pain levels, range of motion (rom), and neck disability index (ndi) scores, will be evaluated using the numeric pain rating scale, goniometer, and crom device. data analysis will employ spss version 26. data will be collected at baseline, immediately post-intervention, and at follow-up intervals. statistical analyses will be conducted to assess and compare the effects of the interventions on the primary and secondary outcomes, thereby addressing the research question regarding their relative efficacy.

Eligibility criteria:
inclusion criteria: * neck pain * age 45-60 years * radiography showed degenerative changes exclusion criteria: * cervical myelopathy * whiplash injury * infection involving the c-spine

Keywords: alignment, cervical spondylosis.
lymphocyte-sparing thoracic radiotherapy for esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Cancer

Summary: esophageal squamous cell carcinoma (escc) is one of the most aggressive malignant tumors. although neoadjuvant chemoradiotherapy combined with surgery has significantly improved the survival rate of patients with locally advanced esophageal cancer, approximately half of the patients will experience local regional recurrence or distant metastasis. lymphocytes are crucial immune cells in the human body, playing a key role in combating infections and tumor development. in recent years, an increasing body of research has indicated that lymphocyte depletion is a significant factor associated with poor prognosis in various solid tumors, including esophageal cancer. the lymphocyte depletion caused by radiotherapy has garnered considerable attention from oncologists. however, there is still a lack of prospective clinical research data on lymphocyte protection in thoracic tumors. therefore, this study aims to provide high-level evidence from evidence-based medicine regarding the correlation between lymphocyte depletion and prognosis in esophageal cancer patients, offering more effective strategies and methods to improve the outcomes of neoadjuvant chemoradiotherapy for esophageal cancer.


Eligibility criteria:
inclusion criteria: 1. patients approve and sign written informed consent; 2. pathologically confirmed esophageal squamous cell carcinoma; 3. the age of patients should be more than 18 years, and less than 80 years; 4. kps score of patients should be more than 80 exclusion criteria: 1. diagnosis of metastatic esophageal cancer; 2. patient refuses to receive systemic drug treatment; 3. clinical diagnosis of pleural metastasis or malignant pleural effusion; 4. pregnant or breastfeeding women; 5. severe non-cancerous medical comorbidities that affect the implementation of radiotherapy.

Keywords: esophageal cancer neoadjuvant treatment lymphocyte-sparing radiotherapy prognosis
comparison of atomoxetine versus placebo in children and adolescents with adhd and comorbid odd in germany

Conditions: Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder

Summary: a three-arm, randomized, double-blind, placebo-controlled, phase 4, multicenter study to compare the efficacy and safety of atomoxetine versus placebo in children and adolescents aged 6 through 17 years with attention-deficit/hyperactivity disorder (adhd) and comorbid oppositional defiant disorder (odd) who are treated as outpatients in germany. after an initial 3- to 28-day screening and washout phase, participants will be assigned to double-blind treatment with atomoxetine or placebo. a 2 week up-titration period will be succeeded by a 7 week treatment period at the target dose. the primary efficacy measure will be the swanson, nolan and pelham rating scale revised (snap-iv) odd subscale score.


Eligibility criteria:
inclusion criteria: * male or female outpatients who are at least 6 years of age, and who will not have reached their 18th birthday * diagnosis of adhd and presence of diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria a through c for odd (note: diagnosis for conduct disorder not exclusionary) * normal intelligence * able to swallow capsules exclusion criteria: * weigh less than 20 kilogram (kg) or more than 90 kg at study entry * prior treatment with atomoxetine * history of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3 months * history of severe allergies or multiple adverse drug reactions * cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, qt (measure of the time between the start of the q wave and the end of the t wave in the heart's electrical cycle) prolongation , inherited cardiac disorders
efficacy and safety of venus p-valve to treat rvot stenosis with pulmonary regurgitation

Conditions: Right Ventricular Outflow Tract Stenosis

Summary: a prospective, non-randomized, multi-center clinical study of the venus p-valve for the treatment of rvot stenosis with pulmonary regurgitation after surgery of congenital heart defect.

the aim of this protocol is to assess the efficacy, safety and performance of venus p-valve. patients between 18-60 years with rvot stenosis and moderate to severe pulmonary regurgitation (≥3+) who have undergone trans-annular patch repair of their rvot, cardiac magnetic resonance (cmr) screening right ventricular end-diastolic volume index (rvedvi) between 130-160ml/m2. post-procedure follow-ups will be scheduled at 24 hours, 30 days, 6 months and 12 months.

Eligibility criteria:
inclusion criteria: * rvot stenosis who have undergone transannular patch repair with moderate to severe pulmonary regurgitation * isotopic or cmr criteria of rvedvi≥130ml/m2 and ≤160ml/m2 * age≥18 years and ≤60 years (zhongshan hospital age≥18 years and ≤60 years * body weight≥18 kg * pulmonary annular diameter between 14mm to 31mm * rvot length≥20mm * the subject or his/her legal representative has provided written informed consent * subject will comply with protocol required follow-ups add any of the following conditions: * subject is symptomatic * subject presents with \>30% pulmonary regurgitation fraction as defined by cardiac mri * ≥3+ pulmonary regurgitation by echocardiograms * deteriorating rvef% * progressive tricuspid valve regurgitation (at least moderate degree) * complicated with rvot obstruction (rv systolic pressure\>80mmhg) * persistent arrhythmias exclusion criteria: candidates will be excluded from the study if any of the following conditions are present: * existing pulmonary artery branch stenosis or artificial pulmonary valve * severe chest wall deformity * adhf * active infection or endocarditis requiring antibiotic therapy * leukopenia (wbc\<3000mm3) * acute or chronic anemia (hb\<9g/l) * platelet account \<100,000 cells/mm3 * in the judgment of the investigator, percutaneous introduction and delivery of the valve is not feasible * a known hypersensitivity to aspirin or heparin * positive urine or serum pregnancy test in female subjects * ileofemoral vessel characteristics that would preclude safe placement of introducer sheath

Keywords: venus p-valve
mast cell connect: a registry for patients with mastocytosis

Conditions: Mastocytosis

Summary: the mast cell connect registry is a voluntary, observational database that will capture demographic, socioeconomic, and disease information directly from patients with mastocytosis via a secure web-based tool. no experimental intervention is involved.

mastocytosis is an extremely rare and heterogeneous spectrum of diseases characterized by the buildup of genetically altered mast cells. patients experience a wide range of symptoms and in some cases, mast cell buildup can lead to organ dysfunction and failure. current treatments address disease symptoms and not the underlying cause. to facilitate the development of new therapies for mastocytosis, it is important for the community to support clinical trials and to document the impact of the disease, including disease natural history and the impact on patients, in a systematic way. mast cell connect is a web-based registry that allows mastocytosis patients and caregivers to enter information about the experience of the patient living with mastocytosis directly into an online data collection tool. the mast cell connect registry allows mastocytosis patients and caregivers to enter information about the experience of the patient living with mastocytosis directly into a web-based data collection tool. two forms of data will be collected: responses to surveys administered on the web-based portal, and de-identified data curated from medical reports uploaded by patients or their caregivers.

Eligibility criteria:
inclusion criteria: * any patient with a diagnosis of mastocytosis, including systemic mastocytosis and cutaneous mastocytosis and any subtypes of these diseases, who is willing and able to provide written online informed consent exclusion criteria: * none

Keywords: mastocytosis cutaneous mastocytosis urticaria pigmentosa telangiectasia macularis eruptiva perstans (tmep) diffuse cutaneous mastocytosis solitary cutaneous mastocytosis systemic mastocytosis indolent systemic mastocytosis smoldering systemic mastocytosis aggressive systemic mastocytosis systemic mastocytosis with associated clonal hematologic non-mast cell lineage disease mast cell leukemia
neurostimulation for dysphagia in parkinson's disease

Conditions: Dysphagia; Parkinson Disease; Swallowing Disorder.Other Specified; Brain Diseases

Summary: this study will explore the effects of 3 different neurostimulation methods on swallowing function in patients with dysphagia secondary to parkinson's disease

the aim of this study is to assess 3 novel neuromodulation approaches - namely, pharyngeal stimulation, high frequency (5hz) repetitive transcranial magnetic stimulation and low frequency (1hz) repetitive transcranial magnetic stimulation on swallowing function in patients with dysphagia after parkinson's disease. a total of 66 patients are planned to be recruited, randomised to one of the 3 technologies or a sham treatment. a single treatment will be given and the effects will be assessed with a barium exam called videofluoroscopy within the 1st hour after the treatment. in addition, some measures of brain function will be recorded, before and after the treatments using single pulse transcranial magnetic stimulation.

Eligibility criteria:
inclusion criteria: confirmed parkinson's disease with dysphagia exclusion criteria: contraindications to magnetic stimulation, such as pacemakers, significant neuroleptic medications, pregnancy other causes for dysphagia unable to give informed written consent
frailty in patient undergoing percutaneous left atrial appendage closure.

Conditions: Transcatheter Left Atrial Appendage Closure; Frailty

Summary: to assess the prevalence and severity of frailty in patients undergoing laac, as well as its association to peri-procedural and long-term outcomes and quality of life.

transcatheter left atrial appendage closure (laac) has emerged as an alternative to anticoagulation for preventing thromboembolic events in patients with non-valvular atrial fibrillation and relative or absolute contraindications to oral anticoagulation (oac). procedural safety and success are now excellent with approximately 98% of successful procedures without major complications. laac seems to offer persisting protection against ischemic events in long-term reports, while also decreasing bleeding risk by reducing antithrombotic treatment intensity. however, patients undergoing laac in real-world practice are a high-risk population with a high rate of adverse events, mainly not related to the laac device-procedure. as a prophylactic intervention, the beneficial effects of laac increase over time, as more potential adverse events (ischemic and haemorrhagic) are prevented. thus, it took approximately 5 years to reach cost-effectiveness (favoring laac versus oral anticoagulation) in the pooled data from protect-af and prevail randomized controlled trials. patients that experience early death after laac do not fully benefit from the costly procedure - that can be therefore considered futile. in a recent study, close to 1 on 5 laac recipient had either died or suffered from a major ischemic event within the first year after the procedure highlighting the need for better patient selection before laac. the definition of frailty is nonconsensual and has constantly evolved in the literature. nonetheless, there is a general agreement that frailty is a multidimensional concept involving many domains (such as nutrition, mobility, strength and cognitive) and that frail patients are a high-risk population and vulnerable to stressors and adverse outcomes. thus, considering this global definition, assessing frailty using multidomain scales is more appropriate to discriminate frail to non-frail patients. frailty and its association to adverse events are well-known in transcatheter aortic valve replacement (tavr). despite being performed in a high-risk population, frailty has not yet been studied in laac although it could be a potent indicator for futile or harmful procedures. the implementation of frailty assessment into the routine practice could help identify vulnerable patients who will most likely less benefit from the laac procedure. therefore, in this prospective multicenter trial, the investigators seek to explore frailty and its consequences in laac recipients.

Eligibility criteria:
inclusion criteria: * transcatheter laac with any approved device * age ≥18 years old exclusion criteria: * unable to provide informed consent * severe neuropsychiatric impairment
effects of the d3 antagonist gsk598809 on food reward and reinforcement

Conditions: Substance Dependence

Summary: this novel compound is a new experimental treatment that may help people to stop compulsive overeating. compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. there is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. the purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

this novel compound is being developed for the treatment of substance dependence and potentially other impulse control disorders. this is an fmri study designed to examine the behavioural and physiological effects of a single dose of novel compound on food reward and reinforcement in relation to food seeking behaviour under conditions of fasting, using fmri, neurocognitive and metabolic endpoints in overweight and obese subjects. these main objectives will be evaluated in the principal part of the study, part a. the study will also consist of a follow up period of weight management with a dietician where exploratory objectives are considered, part b. part a, will be a single-blind, randomised, placebo controlled, multi-centre, two-period cross-over study. approximately 24 subjects will be enrolled such that a minimum of 20 subjects complete dosing and critical assessments. all subjects will be required to complete questionnaires, perform a series of behavioural tasks and scanning procedures. safety and tolerability will be assessed by monitoring subjects for adverse events, vital signs, ecgs, movement disorders (eps, akathisia) and laboratory parameters. the pharmacokinetic profile of the compound in this subject population will be determined by blood sampling over a 72 hour period post dosing, in both sessions. part b will consist of 12 weeks weight management directed by a dietician on an outpatient basis. subjects will have fortnightly visits with a dietician and at the end of the 12 weeks complete three questionnaires (tfeq-18r, dbeq and ybocs-be) and have their weight measured to assess weight loss.

Eligibility criteria:
inclusion criteria: * generally healthy * right handed * binge eating episode * use appropriate contraception method * willing to see a dietician * overweight or obese (bmi 27 - 40 kg/m2) exclusion criteria: * pregnant or breast feeding female * recent weight loss or gain * recent use of weight loss drugs * surgery for obesity * abuse alcohol or drugs * cannot do mri scans * smokers * certain emotional problems being treated with medications * medical, surgical or neuropsychiatric illness * ecg abnormality * sudden unexplained death or syncope in first degree relatives

Keywords: food reward fmri obese cognition food addiction behaviour overweight food reinforcement metabolic endpoints
genetic counseling in women at risk for brca1 or brca2 mutations

Conditions: Breast Cancer

Summary: rationale: genetic counseling and using an interactive computer program may help women at risk for breast cancer make medical decisions about treatment. purpose: this randomized clinical trial is studying standard genetic counseling to see how well it works when given together with or without a medical decision-making computer program in women at risk for brca1 or brca2 mutations.

objectives: * evaluate the impact of brca1/brca2 testing among members of hereditary breast-ovarian cancer families. * evaluate the long-term impact of genetic counseling and testing on psychosocial and behavioral outcomes. * evaluate the relative impact of standard genetic counseling (sgc) versus sgc plus the interactive decision-aid (ida) on medical decision-making. * evaluate the relative impact of sgc vs sgc + ida on psychological well-being. * explore the mechanisms by which the sgc + ida intervention impacts on psychosocial and behavioral outcomes. outline: this is a multicenter study. eligible women are asked to participate in a baseline telephone interview over 30 minutes and then invited to a genetic counseling session over 1.5-2 hours that includes information about brca1/2 testing. patients are then offered brca1/2 testing, and the test results (i.e., mutation carrier vs noncarrier) are presented at a subsequent in-person individual genetic counseling session over 1.5-2 hours. patients who tested positive for brca1 or 2 mutation are randomized to 1 of 2 counseling arms. all other patients proceed to follow up. * arm i (standard genetic counseling): no further counselor-initiated contact is scheduled. * arm ii (individualized decision aid): patients are asked to view an interactive computer program that is designed to help the patients make medical decisions based on their breast cancer risk. outcome assessments, including quality of life assessment, are conducted at 2, 6, and 12 months. projected accrual: a total of 950 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * members of hereditary breast/ovarian cancer families (in which there is at least a 10-20% prior probability of a brca1/2 mutation) or who have a first-degree relative with a known brca1 or brca2 mutation * prior diagnosis of breast cancer allowed * must not be undergoing active treatment * patients with prior bilateral mastectomy are eligible for study but not eligible for randomization patient characteristics: * female only * no psychiatric or cognitive disorder that would preclude giving informed consent prior concurrent therapy: * see disease characteristics

Keywords: breast cancer stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer
exploratory study to evaluate qr-010 in subjects with cystic fibrosis δf508 cftr mutation

Conditions: Cystic Fibrosis

Summary: exploratory proof of concept study to determine whether intranasal administration of qr-010 in subjects with cystic fibrosis, homozygous or compound heterozygous for the δf508 mutation, can increase the function of cystic fibrosis transmembrane conductance regulator (cftr).

this is an open-label, multi-center, exploratory study to estimate the effect of intranasal administration of qr-010 on the nasal mucosa in the restoration of cftr function, as measured by nasal potential difference (npd), in the nasal epithelium of adult subjects with cf who are homozygous or compound heterozygous for the δf508 cftr mutation.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cf as defined by iontophoretic pilocarpine sweat chloride test (sweat chloride) of \> 60 mmol/l * nasal potential difference (npd) measurement at screening consistent with cf * confirmation of cftr gene mutations homozygous or compound heterozygous for the δf508 mutation * body mass index (bmi) of ≥ 18 kg/m2 * non-smoking for a minimum of 2 years * stable lung function * fev1 ≥40% of predicted normal for age, gender, and height at screening exclusion criteria: * breast-feeding or pregnant * acute allergy or infection affecting nasal conditions not resolved within 14 days prior screening * use of lumacaftor or ivacaftor * use of any investigational drug or device * hemoptysis

Keywords: cystic fibrosis cf δf508 cftr qr-010 antisense oligonucleotide rna therapy f508del npd nasal potential difference