Kornimate/medical-research-clean huggingface dataset:
safety and immunogenicity of an intranasal vaccine for respiratory syncytial virus in seronegative children 6-36 months

Conditions: Respiratory Syncytial Virus (RSV)

Summary: this study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (rsv) and is administered as a nasal spray. specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 6 and 24 months who are seronegative to rsv.


Eligibility criteria:
key inclusion criteria: 1. children aged 6-36 months 2. good health based on history, physical examination, and medical record review, without evidence or suspicion of chronic disease 3. seronegative to rsv, as defined by serum nab titer below the threshold described in the study protocol and operations manual 4. written informed consent provided by parent(s)/guardian(s) key exclusion criteria: 1. known or suspected chronic illness, particularly cardiopulmonary (including asthma or reactive airways disease), genetic or metabolic, hepatic, renal, infectious (including recurrent or chronic sinusitis), or immunodeficiency 2. prior lab-confirmed rsv infection 3. household or close contact (including but not limited to daycare) during the 21 days post-inoculation with anyone \< 6 months old or immunocompromised (applies to first study inoculation) 4. nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes) 5. receipt of immunoglobulins, monoclonal antibodies and/or any blood products, or ribavirin within 6 months prior to study inoculation, or planned use during study period 6. receipt of an investigational rsv vaccine at any time 7. any other condition that, in the judgment of the investigator, would be a risk to subject's safety and/or may interfere with study procedures or interpretation of results

Keywords: live attenuated vaccine safety immunogenicity phase 1 clinical trial pediatric seronegative children
a clinical study to evaluate the efficacy and safety of regend001 cell therapy on idiopathic pulmonary fibrosis (ipf)

Conditions: Idiopathic Pulmonary Fibrosis

Summary: idiopathic pulmonary fibrosis (ipf) is a serious chronic (long term) disease with injury of lung tissues. regend001 is a cell therapy product, made from bronchial basal cells with ability to regenerate lung tissue, is promising to ipf treatment. this is a multi-center, randomized, double-blinded, parallel and placebo-controlled phase ii clinical study to evaluate the efficacy and safety of regend001 in ipf patients.


Eligibility criteria:
inclusion criteria: * male or female, aged between 40 to 75; * subjects diagnosed with ipf according to guidelines for the diagnosis of idiopathic pulmonary fibrosis 2022 edition; * subjects tolerant to bronchofiberscope; * subjects tolerant to test of lung function; * subjects able to voluntarily sign the informed consent and cooperate with the completion of pulmonary function tests; exclusion criteria: * female subject who is pregnant, nursing, or planning to be pregnant in half a year after using this product (or male subjects planning to have a pregnant spouse); * at the time of screening, subject who is positive in each of treponema pallidum antibody (tp-ab), human immunodeficiency virus (hiv) antibody, hepatitis b surface antigen (hbsag), hepatitis c virus (hcv) antibody test, except the following: (1) hepatitis b virus carriers (only hbsag positive, no hepatitis symptoms and signs, all liver function tests are normal); (2) cured hepatitis c patients with negative result in hcv ribonucleic acid (rna) test. * subject with malignant tumors or a history of malignant tumors; * subject with severe anemia, poorly controlled agranulocytosis and thrombocytopenia at screening; * subject at risk of suicide or has a history of mental illness or epilepsy at the time of screening; * subject with severe arrhythmias or atrioventricular block of degree ii or above, shown by 12-lead electrocardiogram (ecg); * subject who participated in other interventional clinical trials in the past 3 months; * subject assessed as inappropriate to participate in this clinical trial by investigators.
gw640385 plus ritonavir and nrtis for 48 weeks in hiv-1 infected adults

Conditions: Infection, Human Immunodeficiency Virus I; HIV Infection

Summary: this is a proof of concept (poc) single arm study of gw640385, a protease inhibitor, in combination with rtv and 2 or more nucleoside reverse transcriptase inhibitors (nrti) backbone. this study has a 48 week duration and is open to both treatment naive and experienced patients who are hiv positive. there are 3 intensive pharmacokinetic (pk) visits.


Eligibility criteria:
inclusion criteria: * hiv-1 infected subjects. * females must be of either non-childbearing potential or have a negative pregnancy test at screening and agree to use a protocol approved method of contraception. * plasma hiv-1 rna (viral load) \>/=1,000 copies/ml at screening. * cd4+ cell count \>/= 200 cells/mm3 at screening. * be able to receive at least two of the following nrtis (3tc, ftc, d4t, ddi or zdv)to build a nucleoside backbone regimen. * willing and able to provide signed and dated written informed consent prior to study entry. exclusion criteria: * active cdc class c disease. * pregnant or breastfeeding women. * protocol-specified laboratory abnormalities at screening. * personal or family history of autoimmune disease. * history or current indication of thyroid dysfunction or current thyroid gland abnormalities.

Keywords: hiv-1 protease inhibitor gw640385 ritonavir rtv
number one overall graft pick? hamstring vs bone-patellar-tendon-bone vs quadriceps tendon

Conditions: Anterior Cruciate Ligament Rupture

Summary: the main purpose of this study is to determine if there is a difference in graft re-injury/failure rates between participants that have had an acl reconstruction with a stg, bptb or qt autograft. additionally, to compare quality of life, patient reported outcomes and functional performance after acl reconstruction with stg, bptb and qt.

the main purpose of this study is to determine if there is a difference in graft re-injury/failure rates between participants that have had an acl reconstruction with a stg, bptb or qt autograft. additionally, to compare quality of life, patient reported outcomes and functional performance after acl reconstruction with stg, bptb and qt. quasi-randomized clinical trial

Eligibility criteria:
inclusion criteria: * - confirmed diagnosis of a complete primary unilateral acl rupture based on all of the following: * history of a traumatic injury episode * physical exam findings of increased anterior translation of the tibia on the femur (lachman test and/or anterior drawer test) * positive pivot shift test * patients must be 14 to \</= 50 years (at time of surgery) * x-rays showing skeletal maturity (i.e. tibial tubercle fused) and no fractures * mri prior to surgery (note: if the radiologist's report states an incomplete or partial acl on mri but the surgeon diagnoses the patient with a complete unilateral tear based on the clinical criteria above, then the patient will be considered eligible. final eligibility will be determined intra-operatively.) exclusion criteria: * - acl rupture on contra-lateral limb * partially torn acl \*final determination made intra-operatively * concomitant medial collateral, lateral collateral, or posterior collateral ligament tears requiring surgical repair \*final determination made intra-operatively * severe chondromalacia (grade iv on the icrs scale) \*final determination made intra-operatively * acl reconstruction using allograft tissue * confirmed connective tissue disorder * unwillingness to be followed for 24 months post-operatively * history of rheumatoid arthritis * pregnancy (at the time of surgery) * psychiatric illness that precludes informed consent * unable to speak, read or understand the english language * major medical illness (life expectancy less than 1 year or unacceptably high operative risk)

Keywords: graft choice hamstring quadriceps tendon
phase ii study of imrt with sib as adjuvant treatment for high risk resected well-differentiated thyroid cancer.

Conditions: Thyroid Neoplasms

Summary: resected well-differentiated thyroid neoplasms with at least one high risk feature will receive adjuvant radiation using imrt with sib. the acute toxicity and locoregional control rate at 2 years will be recorded.

resected well-differentiated thyroid neoplasms with at least one high risk feature will receive adjuvant radiation using imrt with sib. the acute toxicity and locoregional control rate at 2 years will be recorded.

Eligibility criteria:
inclusion criteria: * resected well-differentiated throid cancer with at least one high risk feature for locoregional recurrence exclusion criteria: * medullary or anaplastic thyroid cancer, unresectable

Keywords: thyroid neoplasms intensity modulated radiation radiotherapy
alpha-defensin as a diagnostic means to distinguish between acute bacterial and viral infections

Conditions: Bacterial Infections; Viral Infection

Summary: this study aims to investigate the use of alpha-defensin as a diagnostic means to distinguish between acute bacterial and viral infections.


Eligibility criteria:
inclusion criteria: * children with either bacterial or viral infections exclusion criteria: * all others
evaluation of all'incath in peripheral vasculature percutaneous transluminal angioplasty.

Conditions: Vascular Diseases

Summary: the purpose of this study is to evaluate the clinical safety, performance and benefits (e.g. decrease of procedure time, decrease of radiation time, decrease of the amount of injected contrast, delivery and ease of use) of a novel balloon catheter that combines angiography and angioplasty capabilities.

the purpose of this study is to evaluate the clinical safety, performance and benefits (e.g. decrease of procedure time, decrease of radiation time, decrease of the amount of injected contrast, delivery and ease of use) of a novel balloon catheter that combines angiography and angioplasty capabilities when used per its instructions for use (ifu) during percutaneous transluminal angioplasty procedures in clinical practice.

Eligibility criteria:
inclusion criteria: * ability to provide informed consent * can also be executed by the legal designated representative or the witness * as per the principal investigator's practices as per standard of care, the subject is indicated for pta in the peripheral vasculature, including iliac, femoral, popliteal, and renal arteries, and any treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. * male or female \>18 years old. * life expectancy \>1 year exclusion criteria: * unstable coronary artery disease or any other uncontrolled comorbidity. * myocardial infarction or stroke within two (2) months before baseline evaluation. * previous peripheral bypass or procedure that includes the target vessel. * known, untreated allergy or other contraindications to contrast agents or medications used during or after pta. * non-correctable bleeding diathesis, platelet dysfunction, thrombocytopenia, or any other known coagulopathy. * the use of antiplatelet or anticoagulant therapy is contraindicated. * any planned major surgical or interventional procedure within 30 days after the study procedure. * females who are breast-feeding or child-bearing potential and not using a medically reliable method of contraception (as defined below) for the entire study duration: * medically reliable contraception defined as: oral, injectable, or implantable contraceptives, intrauterine contraceptive devices, or those not using another method deemed by the investigator to be sufficiently reliable. * subjects who are surgically sterilized / hysterectomized or post-menopausal for longer than two (2) years are not considered childbearing potential. * positive pregnancy test result in women of child bearing potential or is breast-feeding. * incapacitated individuals and those with psychiatric disorders that could interfere with the provision of informed consent, completion of tests, therapy, follow-up or general study compliance. * participation in another study with investigational drug or device within the 30 days preceding and during the present study.
clinical evaluation of the cm-1500 in postoperative surgery patients

Conditions: Blood Loss

Summary: the primary objective is to evaluate the the changes in the relative index in post abdominal or pelvic surgery patients on the cardiac monitor model cm-1500.

postoperative hemorrhage incidence can vary depending on the type of surgery, but it can lead to severe clinical complications ranging from mild anemia to fatal hemorrhagic shock. monitoring and detecting these fluid changes postoperatively can be complicated, and standard operating procedures vary. the cardiac monitor, model 1500 (cm-1500), uses a personalized approach by non-invasively and simultaneously monitoring five (5) physiological parameters.

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent * ability and willingness to comply with study procedures and duration requirements * 18 years of age or older * undergoing an abdominal or pelvic surgery within the next 10 days exclusion criteria: * females who are pregnant or breastfeeding * participation in other clinical studies involving experimental drugs or devices * undergone an amputation of the left upper extremity * diagnosed with dextrocardia * subjects who have a pacemaker
markers of defective membrane remodelling in scott-like syndromes

Conditions: Unexplained Isolated Provoked Hemorrhages; Familial Bleeding Disorder; Scott Syndrome

Summary: purpose: identification of the gene(s) involved in plasma membrane remodelling. identification of the circulating markers affected by the defective membrane remodelling in a collection of families with unexplained provoked hemorrhages and evaluation of their prognosis value in the assessment of the hemostatic cellular response.hypothesis: scott syndrome is rare a familial disorder characterized by provoked haemorrages in homozygous-type patients due to isolated membrane remodelling deficiency. membrane remodelling is necessary for cellular hemostatic responses.


Eligibility criteria:
inclusion criteria: * patients with unexplained provoked hemorrhages (surgery, tooth extraction, birth ...), and associated with reduced prothrombin consomption (residual prothrombine in serum \> à 5%). * family members of the patients defined above, with or without unexplained hemorrhages (symptomatic or not). * patient's approval based on detailed information given by the pratician exclusion criteria: * patients with primary hemostasis defect or defective blood coagulation factor(s) possibly explaining the bleeding disorder. * anémia, * patients known to be affected by factor v new york . * patients enrolled in a previous clinical study, the exclusion period of which is not yet completed. - collaboration to the study rejected by the patient * patients that are not registered for medical care social insurance.

Keywords: defective gene(s) in plasma membrane remodelling. scott syndrome, reduced prothrombin consumption, circulating biomakers of scott syndrome
dietary and lifestyle habits during the pandemic of covid-19 in greece

Conditions: Eating Behavior; COVID-19

Summary: the aim of this study was to examine potential changes in children' and adolescents' dietary and lifestyle (physical activity, sedentary behaviour and sleep) habits during the quarantine that was implemented in greece due to covid-19. an online survey in a random sample of families across greece was conducted. parents self-reported their children's and their own dietary and lifestyle habits, as well as information about their sociodemographic status.

since december 2019, the world is facing a new disease (covid-19), which is caused by the coronavirus (sars cov-2). who declared the disease of covid-19 as a pandemic in february 2020. since then, many countries around the world have imposed lockdown (quarantine at home), as the main measure to prevent the spreading of the disease. in greece, the lockdown was officially imposed from march, 23rd, 2020. this unprecedented situation may have caused changes in adults' and children's dietary and lifestyle habits. data were collected via an online survey consisting of 70 questions. study participants were enrolled after signing an informed consent form. the questionnaire self-reported by volunteers (parents of children aged between 2-18 years old). the survey had 3 sections. the first section focused on participants' sociodemographic data (e.g. gender, age, city of residence and socioeconomic level). the second and third sections contained questions about the parents' (section 2) and their children's (section 3) dietary and lifestyle habits before and during quarantine. the scientific community raises concerns about the health implications that will be caused due to the covid-19 lockdown. the results of this study are expected to shed light into children and adolescents, as well as their parents', changes in dietary and lifestyle behaviours and feed the development of effective strategies to prevent the adoption of unhealthy lifestyle behaviours and weight gain in the event of a second wave of covid-19 in the coming months.

Eligibility criteria:
inclusion criteria: 1. parents of children and adolescents, aged 2-18 years. 2. during the lockdown period due to the covid-19 pandemic in greece. 3. parents signed an informed consent form prior to their participation to the study exclusion criteria: 1. parents of children \<24 months old. 2. parents of children \>18 years old. 3. parents not living in greece. 4. parents who did not sign the consent form.

Keywords: eating habits sedentary behavior childhood obesity quarantine covid-19 school closings
behavioral rx & nutrition in pediatric chronic disease

Conditions: Pediatric Obesity

Summary: the objective of this project is to pilot test a behavioral intervention for modifying the diet and physical activity patterns of overweight preschool children through improved parenting and nutritional education(launch). this intervention will be compared to standard of care for preschool overweight in the primary care setting using a randomized clinical trial design (rct. the results of this pilot rct will provide data integral to estimating the effect size for a more definitive rct of the intervention in the future. the primary hypothesis is: h1: launch will result in a significantly greater decrease in bmi z score compared to the standard of care at 12 months post-treatment.


Eligibility criteria:
inclusion criteria: 1. child age between 2- 5 years; 2. child \> 95th percentile bmi for age and sex 12, but not more than 100% above the mean bmi; 3. medical clearance from pediatrician; and 4. at least one parent with a bmi \> 25. - exclusion criteria: 1. non-english speaking; 2. living more than 50 miles from the medical center; 3. a disability/illness that would preclude engagement in at least moderate physical activity; 4. medical condition/medication associated with weight gain; or 5) enrolled in another weight control program.

Keywords: behavioral treatment preschool children obesity treatment
effect of vitamin d on offspring obesity

Conditions: Pediatric Obesity

Summary: the purpose of this study is to observe the effect of lack or excess of vitamin d in the first, second and third trimester on child birth weight, fat content and the secretion of metabolism related hormone, and clinical follow-up their offspring obesity.


Eligibility criteria:
inclusion criteria: * pregnancy women * children * chinese exclusion criteria: -
the difference between the extrafascial injection and the subfascial injection of quadratus lumborum block

Conditions: Postoperative Pain

Summary: quadratus lumborum block can be used for the hip surgery and abdominal surgery postoperative analgesia. but the lower thoracic to the hip dermatome can't be blocked at the same time. the anesthetists used the same method, but had produced the different dermatome were blocked. the investigators hypothesized that this was due to local anesthetics was injected to different locations of the anterior thoracolumbar fascia. if the investigators inject local anesthetics to the anterior layer of thoracolumbar extrafascial, this produced the dermatomal coverage from lower abdominal to hip. a different situation was when the investigators injected local anesthetics to anterior thoracolumbar subfascia, the lower thoracic dermatome were blocked.

quadratus lumborum block can be used for the hip surgery and abdominal surgery postoperative analgesia. but the lower thoracic to the hip dermatomes can't be blocked at the same time. the anesthetists used the same method, but had produced the different dermatomes were blocked. the investigators hypothesized that this was due to local anesthetics was injected to different locations of the anterior thoracolumbar fascia. if the investigators inject local anesthetics to the anterior thoracolumbar extrafascial (between the anterior layer of thoracolumbar fascia and psoas major muscle), this produced the dermatomal coverage from lower abdominal to hip. in this case, the investigators speculated the local anesthetic spread to the lumbar paravertebral space via the fascia and the fascicle of psoas major. a different situation was when the investigators injected local anesthetics to anterior thoracolumbar subfascial (between the anterior layer of thoracolumbar fascia and quadratus lumborum), the lower thoracic dermatomes were blocked. the investigators speculate that the local anesthetic injected subfascial could spread cephalad to lower thoracic paravertebral space posterior to the endothoracic fascia via lateral arcuate ligament. the investigators confirm the hypothesis in the pilot trial. therefore, the investigators need to trial with large sample. the investigators plan to improve the clinical guidance of quadratus lumborum block technology, so that more patients benefit.

Eligibility criteria:
inclusion criteria: * participants undergoing laparoscopic cholecystectomy. asa: i\~ii. bmi: 17\~32. the operation time is less than 2 hours. participants volunteered for the trial. exclusion criteria: * pregnant and lactation women. coagulation disorders. drug allergy. can not communicate normally. bacteremia. emergency surgery. asa: \>iii.

Keywords: quadratus lumborum block anterior thoracolumbar fascia subfascial injection extrafascial injection