Kornimate/medical-research-clean huggingface dataset:
skull bon variations in patient with congenital unilatral choanal atresia

Conditions: Atresia

Summary: identify skull bone associated anomalies in patients with cngenital unilatral choanal atresia

choanal atresia is a rare congenital disorder caused by a failure to develop the posterior nasal cavity (choana), resulting in a missing opening between the nasopharynx and the nasal cavities.it is the most common congenital anatomical abnormality of the nasal cavities with incidence ratio approximately 1/5000-7000 live births generally, choanal atresia may affect one or both choanae, although most studies show that the unilateral form is more common than the bilateral one,and the incidence is higher in females than in males children with unilateral choanal atresia are subject to unilateral breathing usually have late unilateral nasal obstruction, persistent ipsilateral rhinorrhea, and recurrent rhinosiusitis previous studies have shown that the ratio of bone to membranous atresia is 9:1; although a detailed review of ct findings with histopathological studies showed that mixed-wall atresia is the most common and is present in 71% of cases, while in 29% of cases we found a pure bone wall computer tomography (ct) is presently the golden standard in diagnostics of nasal cavity diseases; thus, it can be applied successfully as a tool for assessing anatomical structures

Eligibility criteria:
inclusion criteria: * clinical diagnosis of congenital unilateral choanal atresia exclusion criteria: patients with severe craniofacial syndromes
fatty acids omega -3 diet supplementation efficiency and safety evaluation in anorexia nervosa

Conditions: Anorexia Nervosa

Summary: the purpose of this study is to determine whether omega -3 fatty acids are effective and safe in treating anorexia nervosa.

10-week, randomized, placebo-controlled, parallel-group study to compare the efficacy and safety of omega-3 fatty acids with placebo in the treatment of anorexia nervosa. patients will be randomly assigned to blinded study treatment. double-blind treatment will be preceded by a medication washout period of 1-28 days if necessary. some patients may be taking anti-depressants or anti-psychotics, e.g. fluoxetine, prior to admission to the study. in such case the wash out period will depend on the medical treatment (dependent on the drug given) given prior to qualification to the study. patient will be treated as inpatients during 10 weeks of the study. the study will recruit female inpatients with anorexia nervosa (aged 12 to 19 years), with dsm-iv and icd-10 diagnosis of anorexia nervosa.bmi below 5 percentile and eat-26 score \> 30 is required at both screening and randomization.

Eligibility criteria:
inclusion criteria: * anorexia nervosa (dsm iv,icd-10) * female * age 12-19 * written informed consent given by patient and his parents exclusion criteria: * lack of informed consent

Keywords: omega-3 fatty acids anorexia nervosa efficacy safety
a study to evaluate the safety and pharmacokinetics of radprotect® in healthy volunteers

Conditions: Acute Radiation Syndrome

Summary: this is a phase 1, non-randomized, sequential-cohort, dose escalation, open-label study designed to evaluate the safety and tolerability of radprotect® in healthy volunteers. this study is to be conducted at two clinical centers and in conformity with good clinical practice (gcp).


Eligibility criteria:
inclusion criteria: * each subject must be willing and able to provide written informed consent for the study * healthy volunteer subjects of both genders, aged 18-64 years old, and any race/ethnicity * subjects with normal blood pressure (between ranges of 120-140/60-80 mmhg) at screening and baseline * subjects with a body mass index (bmi) 18-30 kg/m2 * men or woman of childbearing potential using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) during screening, while receiving the investigational drug, and for 60 days after stopping the investigational drug * female subjects of childbearing potential must have a negative urine pregnancy test at screening * subjects with physiological examination and laboratory values within normal limits (cbc/differential, blood chemistry, iron, total iron binding capacity (tibc), urinalysis, ecg and vital signs) * subjects with the ability to comprehend and complete the telephone visits, screening, and site visits * subjects must be able to adhere to dose and visit schedules * subjects who agree to abstain from taking unauthorized medications or supplements or participating in any other clinical trial or experimental treatment during this trial. exclusion criteria: * subjects with any allergic reaction or sensitivity to glutamate acid, polyethylene glycol, or any component of the test article product * subjects who consume \> five alcoholic beverages per week * subjects who are pregnant or lactating * subjects who have blood (or urine) levels outside the normal range for any hepatic, renal, hematologic, lipid or coagulation parameters measured. * subjects on hormone replacement therapy within the past three months * subjects in any other clinical trial or experimental treatment in the past three months * subjects with a history of diabetes (type 1 or type 2 diabetes mellitus) or other endocrine disorders, hypertension, hypotension or systolic blood pressure below 80 mmhg, prior cerebrovascular accident or seizure disorder, cardiovascular, hepatic or renal disease, active cancer, hematologic disorder, thromboembolic disease, or hiv infection.

Keywords: acute radiation syndrome ars amifostine radio-protectants
microtransplantation for advanced and relapsed solid tumors

Conditions: Solid Tumors

Summary: in this study, we will apply micro transplantation to the field of solid tumors to study the efficacy and safety of radiotherapy and chemotherapy combined with micro transplantation in the treatment of advanced / relapsed solid tumors.

the eligible patients are assigned to the experimental group (microtransplantation group, mst group) or the control group (ct) according to the availability of suitable donors. in mst group, peripheral blood hematopoietic stem cells from hla mismatched donors mobilized with granulocyte colony stimulating factor are infused after conventional chemotherapy and/or radiotherapy ; the ct group only received conventional chemotherapy and/or radiotherapy. according to the patient's past medical history, current tumor assessment results, and the latest cancer treatment guidelines, the individualized chemotherapy and / or radiotherapy plan for the patient is formulated after discussion by more than 3 oncologists. after each course of treatment, the efficacy and safety are evaluated. for the patients who are evaluated to be effective or stable (sd) after the first treatment, the second treatment of the same scheme will be given. those who reach the disease control level will continue to be treated for 4 courses, with an interval of 28 days. the patients who failed to achieve the improvement of sd after two cycles of chemotherapy will be withdrawn from the study. patients are allowed to receive any treatment, including symptomatic support treatment, after the end of treatment or withdrawal from the study.

Eligibility criteria:
inclusion criteria: * patients are 18-80 years old, regardless of gender or race; * advanced / relapsed solid tumors (small cell lung cancer, ovarian cancer, cervical cancer, gastric and colorectal cancer, sarcoma, head and neck tumor, etc.) are confirmed by clinical or histopathological diagnosis; * more than two kinds of tumors are allowed; * karnofsky score ≥ 60, ecog physical status ≤ 2; * sensitive to chemotherapy or radiotherapy; * there are measurable lesions; * there are suitable hematopoietic stem cell donors exclusion criteria: * have no suitable donor or donor refused * patient refused to accept donor cells

Keywords: microtransplantation
evaluate durvalumab and tremelimumab +/- lenvatinib in combination with tace in patients with locoregional hcc

Conditions: Hepatocellular Carcinoma

Summary: a global study to evaluate transarterial chemoembolization (tace) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma

this is a phase iii, parallel, randomized, open-label, sponsor-blinded, 3-arm, multicenter, international study assessing the efficacy and safety of durvalumab + tremelimumab + tace with or without lenvatinib compared with tace alone in participants with locoregional hcc not amenable to curative therapy (eg, surgical resection, transplantation, or ablation).

Eligibility criteria:
inclusion criteria: * no evidence of extrahepatic disease * disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to tace * child pugh score class a * eastern cooperative oncology group (ecog) performance status of 0 or 1 at enrollment * measurable disease by modified response criteria in solid tumors (mrecist) criteria * adequate organ and marrow function exclusion criteria: * history of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardia arrhythmia * history of hepatic encephalopathy * major portal vein thrombosis visible on baseline imaging * uncontrolled arterial hypertension * co-infection with hbv and hdv

Keywords: hepatocellular carcinoma locoregional hcc durvalumab tremelimumab lenvatinib tace liver cancer
incentive spirometer and inspiratory muscle trainer

Conditions: Parkinson Disease

Summary: patients suffering from parkinsonism have respiratory function abnormalities. this study compared the effects of incentive spirometer and inspiratory muscle trainer on pulmonary functions in patients with parkinsonism.

the participants were recruited according to the inclusion and exclusion criteria. participants were divided into two groups - incentive spirometer and inspiratory muscle trainer. these trainings were performed for 6 weeks duration. several outcome measures related to pulmonary function tests were measured before and after the intervention.

Eligibility criteria:
inclusion criteria: * patients diagnosed as having parkinsonism disease by the neuro physician. * duration of parkinson's disease ≥ 5 years. * patients with the age of 65 to 80 years. * hoen and yahr classification within 1 to 3. * both males and females were included. * patients who were able to comprehend the commands. * patients who were willing to participate. exclusion criteria: * patients having any cardiovascular and pulmonary disorders. * history of smoking currently or in the past. * psychological impairment. * insufficient verbal/intellectual understanding. * patients with unstable vital parameters. * those unable to perform pulmonary function tests (pft) because of anatomical abnormalities or clinical signs of dementia.

Keywords: parkinson disease incentive spirometer inspiratory muscle trainer pulmonary functions
evaluation of one-stop strategy of evar and pci

Conditions: Coronary Artery Disease; Aortic Atherosclerotic Disease

Summary: the study is designed to evaluate the safety and effectiveness of the "one-stop" endovascular intervention strategy for patients with concomitant coronary artery disease and aortic atherosclerotic disease. it is a registration study, which will consecutively enroll at least 50 patients with at least 30 subjects receiving one-stop strategy.

it is a registration study, at least 50 patients will be consecutively enrolled and then be allocated into one-stop strategy group or staging strategy group with at least 30 subjects receiving one-stop strategy. in one stop strategy group, percutaneous coronary intervention (pci) will be performed on the same operating table immediately after the endovascular aortic repair (evar). in staging strategy group, pci will be performed several days after evar. the safety and effectiveness will be assessed between the two groups untill 1 year after the operation. the economic index will be evaluated.

Eligibility criteria:
inclusion criteria: * aged from 18 years to 75years, male or female; * aortic atherosclerotic disease with the indication of evar; * coronary heart disease with the indication of pci; * provided informed consent. exclusion criteria: * acute aortic dissection * acute coronary syndrome * dysfunction of coagulation system * patients with gastrointestinal hemorrhage * known allergy to contrasts or antiplatelet drugs * renal dysfunction (gfr≤60ml/min) * patient with multi-branch coronary preferred cabg

Keywords: coronary artery disease aortic atherosclerotic disease one-stop percutaneous coronary intervention endovascular aortic repair
pharmacokinetic study of an acute gout regimen

Conditions: Pharmacokinetics

Summary: this study aims to characterize the pharmacokinetic profile of colchicine after a regimen of 1.8 mg over two hours. a secondary goal is to evaluate the safety and tolerability of this regimen in healthy volunteers. to this end, all study subjects will be monitored for adverse effects throughout the entire study period.

this study aims to characterize the pharmacokinetic profile of colchicine and its three main metabolites, after a regimen of 1.8 mg over two hours. after a fast of at least 10 hours, fifteen healthy non-smoking, non-obese, non-pregnant adult volunteers between the ages of 18 and 55 will be given colchicine 1.2 mg (2 x 0.6 mg) orally followed by an additional single 0.6mg dose one hour later. fasting will continue for 4 hours after the first dose at which time a standardized meal will be served. blood will be drawn from all participants at times sufficient to adequately define the pharmacokinetics of colchicine and its 3 major metabolites, 2, 3 and 10 demethylcolchicine. a further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. to this end, subjects will be monitored throughout participation in the study for adverse reactions to the study drug and/or procedures. seated and standing blood pressure and pulse will be measured prior to the first dose and 0.5, 1, 2, 4, and 12 hours post-dose. twelve-lead electrocardiograms will be obtained at the same time points. all adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Eligibility criteria:
inclusion criteria: * healthy adults 18-55 years of age, non smoking and non-pregnant (postmenopausal, surgically sterile or using effective contraceptive measures) weighing at least 55kg and within 15% of ideal body weight. exclusion criteria: * recent participation (within 30 days) in other research studies * recent significant blood donation * pregnant or lactating * test positive at screening for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or hepatitis c virus (hcv) * recent (2-year) history or evidence of alcoholism or drug abuse * history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease * subjects who have used any drugs or substances known to inhibit or induce cytochrome (cyp) p450 enzymes and/or p-glycoprotein (p-gp) within 30 days prior to the first dose and throughout the study

Keywords: healthy blood levels
prevalence of chondromalacia patella among adolescent dancers - correlation between symptoms and sonography findings

Conditions: Chondromalacia; Cartilage Diseases

Summary: comparing the physical and sonographic findings of dancers with chondromalacia patella to non-dancers athletes.

a cross sectional study in which comparing of dancers to non-dancers athletes will be carried. specifically, chondromalacia patella will be studied and compared between dancers with and without knee injuries and non-dancers athletes. study will include detailed function and pain questionnaires, physical findings and sonographic study of the knee joint.

Eligibility criteria:
group a - dancers with knee injury: inclusion criteria: 1. min. 3 hours of classic ballet dancing per week 2. at least 4 years of dancing practice 3. reported knee pain during the last 6 months exclusion criteria: 1. injury other than knee joint group b - dancers without knee injury: inclusion criteria: 1. min. 3 hours of classic ballet dancing per week 2. at least 4 years of dancing practice 3. reported no musculoskeletal injury during the last 6 months exclusion criteria: 1. none group c - non-dancers athletes: inclusion criteria: 1. main physical activity is other than dancing exclusion criteria: 1. reported no musculoskeletal injury during the last 6 months

Keywords: chondromalacia patellae (cmp) patella
long-covid in patients post rehabilitation treatment and reintegration into everyday life

Conditions: Long COVID

Summary: the aim of the first study is to investigate how often a long covid syndrome occurs after an inpatient rehabilitation due to previous hospitalization because of after acute covid and whether there might be a connection with the severity during acute illness. 3 clusters of acute cases have been identified to be studied with regard to the long-term symptoms 1. mild course (medication, oxygen) 2. moderate course (ips-imc with niv but without intubation) 3. severe course (intubation) the aim of the second study is to use a catamnestic survey and subsequent evaluation of the information to gain an insight into the existing functional deficits relevant to everyday life and restriction of the ability to participate in the workplace after rehabilitation treatment. the assessment of functional deficits is carried out in relation to: 1. deficits in everyday skills (adls) 2. restrictions in the ability to participate in the profession.

all patients who had been infected with walenstadtberg after acute covid infection were included. patients were hospitalized for inpatient rehabilitation in the period from 01.04.2020 to 30.06.2022. a written follow-up survey was carried out with regard to a possible persistent long covid symptoms and possible persistent deficits in everyday skills and restrictions in the ability to participate in the profession. there are 2 cohort studies.

Eligibility criteria:
inclusion criteria: * \>18 years of age * treated at a rehabilitation facility after being hospitilized for covid-19 infection * complete questionnaire * written consent to use collected data exclusion criteria: * \< 18 years * incomplete questionnaire
study of glycogen storage disease and associated disorders

Conditions: Glycogen Storage Disease

Summary: glycogen, is the storage form of glucose. it is usually formed from sugar and stored in the liver. when tissues, such as muscle, need glucose for fuel the stored glycogen is converted into glucose with the help of enzymes produced in the body. glycogen storage disease (gsd) refers to a group of conditions characterized by abnormal storage of glycogen due to the absence of particular enzymes needed in the process of storing and using glycogen. this study addresses the related metabolic abnormalities of glycogen storage disease (gsd). as patients with disorders of glycogen metabolism are followed it becomes apparent that the condition is much more complex than initially thought. researchers believe that patients suffering from glycogen storage disorders should be followed and monitored for other heritable metabolic disorders. this study will attempt to determine the frequency of associated disorders in patients with gsd. in addition, the study will look at the current management of these patients to see if the prognosis and course of the disease is changed.

this study addresses the related metabolic abnormalities of the glycogeneses. as more older individuals with glycogen storage disease are followed and studied, it becomes apparent that when individuals with glycogenosis are viewed from a longitudinal perspective, the condition is much more complex and diverse in its related conditions than one would have reason to believe, even in hindsight. it is relevant to follow these individuals, searching for abnormalities not only with glycogen storage disease in mind, but also because other heritable metabolic disorders, including cystinosis and cystic fibrosis, reflect the accumulation of associated disorders with age which often have no apparent direct association with gsd.

Eligibility criteria:
patients age 20 or older, male or female.

Keywords: electrooculography electroretinogram fluorescein angiogram glycogen storage disease
safety, tolerability, and pharmacodynamic profile of oral 2101 in secondary raynaud's disease

Conditions: Raynaud's Disease

Summary: to investigate the severity of secondary raynaud's disease-related attacks during the 14 days 2101 dosing period.

1. number and cumulative duration of raynaud's attacks. 2. adverse events and changes in vital signs. 3. slx-2101 pharmacokinetic parameters derived after dosing on day 1 and day maximum plasma concentration (cmax), area under the plasma concentration-time curve (auc0-4), time to cmax (tmax), and accumulation ratio

Eligibility criteria:
inclusion criteria: * male and female ages 18 and 65 y.o. * bmi body weight within a body mass index range of 17 - 30 kg/m2 (inclusive). exclusion criteria: * hypersensitivity to the active substance of slx-2101or to any of the excipients. * past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety, or affect the pharmacokinetic and pharmacodynamic evaluations