Kornimate/medical-research-clean huggingface dataset:
a phase ii clinical trial to evaluate the recombinant vaccine for covid-19 (adenovirus vector)

Conditions: COVID-19

Summary: this is a phase ii, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age. this clinical trial is designed to evaluate the immunogenicity and safety of ad5-ncov which encodes for a full-length spike (s) protein of sars-cov-2.

this is a phase ii, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age,inclusive, who meet all eligibility criteria. this clinical trial is designed to evaluate the immunogenicity and safety of ad5-ncov which encodes for a full-length spike (s) protein of sars-cov-2. 500 subjects will be enrolled, 250 subjects in middle-dose vaccine group, 125 subjects in low-dose and placebo group, respectively. immunogenicity will be tested on days 0, 14, 28 and 6 months after vaccination

Eligibility criteria:
inclusion criteria: * aged between 18 and 60 years. * able to understand the content of informed consent and willing to sign the informed consent * able and willing to complete all the secluded study process during the whole 6 months study follow-up period. * negative in hiv diagnostic test. * negative in serum antibodies (igg and igm) screening of covid-19. * axillary temperature ≤37.0°c. * the bmi index is 18.5-30.0. * general good health as established by medical history and physical examination. exclusion criteria: * family history of seizure, epilepsy, brain or mental disease * subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past. * woman who is pregnant, breast-feeding or positive in β-hcg (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months * any acute fever disease or infections. * history of sars * major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease. * serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc. * hereditary angioneurotic edema or acquired angioneurotic edema * urticaria in last one year * no spleen or functional spleen. * platelet disorder or other bleeding disorder may cause injection contraindication * faint at the sight of needles. * prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months. * prior administration of blood products in last 4 months * prior administration of other research medicines in last 1 month * prior administration of attenuated vaccine in last 1 month * prior administration of inactivated vaccine in last 14 days * current anti-tuberculosis prophylaxis or therapy * according to the judgement of investigator,various medical, psychological, social or other conditions, those could affect the subjects to sign informed consent.

Keywords: covid-19 vaccine ad5-ncov sars-cov-2
a therapist guided internet-delivered treatment for adults with adhd (attention deficit / hyperactivity disorder) - an open effectiveness trial in routine care

Conditions: ADHD; ADHD - Combined Type; ADHD Predominantly Inattentive Type; ADHD, Predominantly Hyperactive - Impulsive

Summary: the primary objective of this study is to explore and evaluate the use and utility of a guided internet-delivered psychological treatment for adults with adhd with a combined focus on: i) evaluating the impact of potential predictors to treatment adherence, treatment response, treatment use and utilty. ii) evaluating the feasibility, clinical benefits and implementation process of the treatment in routine outpatient care. iii) evaluate the cost-effectiveness of the treatment program.

attention deficit hyperactivity disorder (adhd) is a neurodevelopmental disorder characterized by symptoms of inattention and/or hyperactivity/impulsivity that are persistent across time and situations. adhd in adulthood, with estimated prevalence of 2-3%, is associated with challenges that may have severe consequences on daily life functioning. treatments delivered over the internet on smartphones or personal computers may help to increase the availability of effective psychological interventions for a larger group of adults with adhd. the overall aim of this study is to investigate 1) predictors of effect; 2) implementation outcomes; and the 3) cost-benefit of a therapist guided internet-delivered treatment for adults with an adhd diagnosis. the study is an open longitudinal cohort trial in routine care. a total of 200 participants with an adhd diagnosis will be included in the trial, and 15 participants will be interviewed about their experiences with guided internet-delivered treatment. the outcomes are change in primary and secondary symptoms and quality of life, cost-benefit and implementation outcomes of guided internet-delivered treatment for adults with adhd. the investigators will use quantitative statistical procedures and qualitative methods to analyze the data. the results from the study will contribute to the growing research on internet-delivered treatments. the expected results may have a major impact on treatment provision and the further development of treatment options for adults with adhd. moreover, investigating ways to increase adoption, adherence and fidelity in internet-delivered treatment could be of great value when implementing such treatment into routine care.

Eligibility criteria:
inclusion criteria: \| * age ≥18 * a self-reported diagnosis of adhd * access to and ability to use a computer, smartphone and the internet. * speaks, writes and reads norwegian exclusion criteria: * in need of other psychological treatment for mental health illness such as borderline or personality disorder, bipolar disorder, substance abuse or psychosis. * ongoing psychological treatment for adhd or other psychiatric illnesses.
randomized db controlled trial of botulinum toxin a in hemiplegic shoulder pain and spasticity

Conditions: Post-stroke Shoulder Pain and Spasticity

Summary: the purpose of this study is to evaluate whether botulinum toxin type a injected into muscles around the shoulder is effective in treating shoulder pain and improving function in patients with shoulder pain and involuntary muscle tightness after a stroke.

subjects with shoulder pain and spasticity at the shoulder following a stroke resulting in hemiplegia are eligible for participation. following an initial screening visit involving a history and physical examination, subjects will be entered in to the study if they have significant spasticity of shoulder internal rotation/adduction associated with pain rated at least a 4 on the vas for pain. subjects will also be given a cognitive screening in which they will be asked to rate pain in hypothetical situations. shoulder pain is a frequent complication following hemiplegic stroke, and may result in further disability. spasticity is also a complication following stroke . botulinum toxin is used in the treatment of post-stroke spasticity and may also have pain modulating effects. participants in this study will be asked to make total of 6 visits over a period of approximately 13 weeks. eligible subjects will be randomized to 100 to 200 units of botulinum toxin type injected into the pectoralis major at the second visit. if there is significant spasticity for shoulder extension, subjects will also receive injections into the teres major. subjects will be followed up with assessments of pain, functioning, active and passive range of motion and depression following the initial injection. at the 12 weeks post injection visit, the blinding will be broken and subjects initially injected with placebo will be injected with the active drug. this will be done to give all subjects an opportunity to receive the active drug, as well as to assess the effects of any differences with delayed treatment. all subjects will return 4 weeks later to repeat the same assessments above. subjects will be called at one year post study enrollment for repeat pain ratings and for information regarding subsequent treatments. .

Eligibility criteria:
inclusion criteria: * post stroke greater than 2 months * shoulder pain despite pt/ot interventions * weight greater than 88 lbs * stable medically * spasticity exclusion criteria: * myasthenia gravis or other medical conditions that preclude use of botulinum toxin * pregnancy * infection or dermatologic conditions at the injection site

Keywords: stroke shoulder pain spasticity
a comparison of dynamic vision & balance between college athletes & controls

Conditions: Head Injury; Sport Injury; Concussion, Brain

Summary: the purpose of this study is to determine the value of including dynamic vision testing into california state university, northridge (csun) athletics' established concussion protocol. the study's hypotheses are 1) dynamic vision testing will reveal vision impairments right after a person sustains a concussion, 2) these impairments may still be present upon clearance to return to play.

the subjects of interest are csun student-athletes who give consent to participate in the study. dynamic vision will be assessed through the administration of the dynamic visual acuity (dva) test and the gaze stabilization test (gst). additionally, the 6-condition balance error scoring system (bess), which is currently a component of csun's established concussion protocol, will be administered to assess balance impairments. this cluster of tests will be administered three times per athlete: (1) during preseason to establish baseline measures, (2) acutely post-concussion once the athlete subject has been cleared by the team physician for return to exercise, and (3) when cleared to return to sport. the results will be used to evaluate whether or not dynamic vision results have returned to baseline by the time that csun athletics clears the athlete to "return to play."

Eligibility criteria:
inclusion criteria: * california state university northridge athletes * participants are able to give consent to participate in the study * completion of preseason testing for the 6-condition, bess, dva, gst with the research team * sustained a concussion as diagnosed by the medical staff during the 2020-2021 season of play. * sampling of convenience on a volunteer basis exclusion criteria: * athletes with preseason baseline tests on bess or dva that are not within the normative value range for an unimpaired individual. * the initial 6- condition bess score is \>20 errors * the subject is unable to attain a minimum of 85 degrees per second of horizontal head rotation when performing the dva test.
observational study evaluating the potential impact of procalcitonin testing on care of stemcell transplant recipients

Conditions: Multiple Myeloma

Summary: an observational study in evaluating the clinical impact of procalcitonin on the care of stem cell transplant recipient and its performance as an adjunct in the diagnosis and prognostication of infectious processes

the overall goal of this project will be to provide new insights into the use of biomarkers in surveillance for infectious processes in stem cell transplant recipients by evaluating the added impact of procalcitonin testing on detection of infectious processes

Eligibility criteria:
inclusion criteria: * patients age 18-95 years with multiple myeloma (mm) undergoing stem cell transplantation exclusion criteria: * none
study evaluating bazedoxifene/conjugated estrogens combinations in healthy postmenopausal women

Conditions: Menopause

Summary: bazedoxifene/conjugated estrogens (bza/ce) is an investigational drug that is being developed for treatment of menopause. the purpose of this trial is to compare a new manufacturing process for making bza/ce to the current process by assessing the way it is absorbed into the blood.


Eligibility criteria:
inclusion criteria: * postmenopausal women aged 35 to 70 years * body mass index (bmi) in the range of 18.0 to 35.0 kg/m2 and body weight greater than or equal to 50 kg * healthy as determined by the investigator on the basis of medical history, physical examination, breast and gynecologic examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ecg). exclusion criteria: * any clinically important active condition of gynecologic, cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. * history or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies. * history of any clinically important drug allergy to conjugated estrogens (ce) or selective estrogen receptor modulators (serms).

Keywords: postmenopausal
paclitaxel and carboplatin in treating patients with persistent or recurrent stage iii or stage iv uterine cancer

Conditions: Sarcoma

Summary: rationale: drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving more than one drug (combination chemotherapy) may kill more tumor cells. purpose: this phase ii trial is studying how well giving paclitaxel together with carboplatin works in treating patients with persistent or recurrent stage iii or stage iv uterine cancer.

objectives: * determine the antitumor activity of paclitaxel and carboplatin in patients with persistent or recurrent stage iii or iv uterine carcinosarcoma. * determine the nature and degree of toxicity of this regimen in these patients. outline: this is a non-randomized, multicenter study. patients receive paclitaxel iv over 3 hours followed by carboplatin iv over 30 minutes on day 1. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years. projected accrual: approximately 14-47 patients will be accrued for this study within 20 months.

Eligibility criteria:
disease characteristics: * histologically confirmed uterine carcinosarcoma (mixed mesodermal tumor) * stage iii or iv disease * persistent or recurrent disease * documented disease progression * measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral ct scan * at least 1 target lesion * tumors within a previously irradiated field are not considered target lesions unless there is documented disease progression * ineligible for any higher priority gynecology oncology group (gog) protocol (i.e., any active gog phase iii protocol for the same patient population) patient characteristics: age * 18 and over performance status * gog 0-2 life expectancy * not specified hematopoietic * platelet count ≥ 100,000/mm\^3 * absolute neutrophil count ≥ 1,500/mm\^3 hepatic * bilirubin ≤ 1.5 times upper limit of normal (uln) * sgot ≤ 2.5 times uln * alkaline phosphatase ≤ 2.5 times uln renal * creatinine ≤ 1.5 times uln other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no active infection requiring antibiotics * no other invasive malignancy within the past 5 years except nonmelanoma skin cancer * no sensory or motor neuropathy \> grade 1 prior concurrent therapy: biologic therapy * not specified chemotherapy * no prior cytotoxic chemotherapy for uterine sarcoma endocrine therapy * at least 1 week since prior hormonal therapy for uterine sarcoma * concurrent hormone replacement therapy allowed radiotherapy * see disease characteristics surgery * not specified other * recovered from all prior therapy * no prior anticancer therapy that would preclude study therapy

Keywords: recurrent uterine sarcoma stage iii uterine sarcoma stage iv uterine sarcoma uterine carcinosarcoma
screening for fabry disease in a pediatric population at risk

Conditions: Chronic Pain in the Extremities; Chronic Abdominal Pain; Fabry Disease

Summary: the purpose of this study is to assess the frequency of fabry disease in children with chronic abdominal pain or chronic pain in the extremities


Eligibility criteria:
inclusion criteria: * age below 18 years * one of the following criteria: * diagnosis or suspicion of a rheumatological disorder with recurrent complaints for more than 6 months * chronic, recurrent abdominal pain for more than 6 months * planned blood sample for routine diagnostics * written informed consent exclusion criteria: - patient and/or the patient's parent(s) or legal guardian(s) are unable to understand the nature, scope, and possible consequences of the screening.
a phase iii study of abatacept in japanese subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to demonstrate the safety of chronic use of abatacept in japanese subjects with rheumatoid arthritis (ra) having completed clinical studies im101-071, im101-034, and also disease modifying anti-rheumatic drugs (dmards) failures with mtx intolerance.


Eligibility criteria:
inclusion criteria * the participants who completed the 169 days, full study period of phase ii (im101-071) and were not administered other biologics between completion of im101-071 and registration of this long-term study. * the participants of the phase i study (im101-034), who received abatacept, except participants who were withdrawn from the study due to safety problems related to abatacept. * new subjects with mtx intolerance: rheumatoid arthritis (ra) patients to whom mtx cannot be administered for safety reasons and who present an inadequate response to disease-modifying antirheumatic drugs (dmards;excluding mtx) or biologics (new subjects with mtx intolerance: ra patients who present an inadequate response to dmards). exclusion criteria * women of childbearing potential (wocbp) who were unwilling or unable to use an acceptable method of contraception. * participants who have received non approved or investigational biologics (other than abatacept from previous or ongoing studies in japan) at registration. * participants who have received treatment with any investigational drug within 56 days before registration or five half-lives (whichever is the longest). * participants currently receiving treatment with leflunomide, mycophenolate mofetil, calcineurine inhibitors such as cyclosporine and tacrolimus, d-penicillamine, cyclophosphamide, or immunoadsorption columns. * the participants who completed phase ii (im101-071) are not applicable in the following instances at time of registration: with active vasculitis, symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, breast cancer, or a history of cancer within the last 5 years, evidence of active or latent bacterial , viral infections, any serious or chronic, at risk of tuberculosis (tb), with any opportunistic infections, laboratory values of hemoglobin \ 2 times upper limit of normal (uln), serum alanine transaminase or aspartate aminotransferase \> 2 times uln.
post-marketing surveillance of the safety, tolerability and efficacy of vytorin (ezetimibe + simvastatin) tablet among filipino patients (study p05647)

Conditions: Hypercholesterolemia

Summary: this study aims to establish the safety, tolerability, and efficacy of vytorin (r) (ezetimibe + simvastatin) (sch 465981) on a select population of filipinos with hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * outpatient men or women, age 18 years and above * patients with primary (heterozygous familial and non-familial) hypercholesterolemia exclusion criteria: * known hypersensitivity to ezetimibe and simvastatin * moderate to severe hepatic insufficiency * persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal * pregnancy or lactation * concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine
emollient therapy for severe acute malnutrition

Conditions: Child Malnutrition; Malnutrition in Children; Malnutrition

Summary: the investigators hypothesize that the absorption of topically applied efa-containing emollient (sso) into the skin and thence into the bloodstream in children with sam will improve skin barrier function and accelerate weight gain and clinical rehabilitation beyond that possible through normal standard-of-care

a child with sam, in addition to wasting will often present with infection, hypothermia, dehydration and electrolyte imbalance - complications attributable, at least in part, to compromised skin barrier function. essential fatty acid (efa)-containing emollients such as sunflower seed oil (sso) have been shown to augment skin barrier function, reduce transepidermal water loss (tewl) and risk of bloodstream infection and mortality, and promote weight gain in preterm infants. recent research from rural bangladesh showed very low levels of efas in young children in the general population. it is believed that efa levels will be further depleted in children with sam. so the investigators aim to demonstrate the feasibility of topical applications of sso to children with sam, and to measure clinical impact of emollient therapy with sso on skin barrier function, skin condition, efa levels in blood, weight gain, co-morbidities (e.g., pneumonia, sepsis), and time to complete acute rehabilitation from sam, in addition to the benefits of normal standard-of-care.

Eligibility criteria:
inclusion criteria: * parent or legal guardian is willing and able to provide written informed consent for the subject to take part in the trial and comply with an inpatient stay of at least 10 days. * children aged 2-24 months inclusive diagnosed with sam (weight-for-length z score \<-3 or bilateral pedal edema) admitted in the dhaka hospital of icddr,b, dhaka, bangladesh * willing to suspend usual home skin care treatments for the duration of study exclusion criteria: * consent refusal * life threatening health conditions such as septic shock and altered consciousness on admission; congenital problems (congenital heart disease or known metabolic disorders, chromosomal abnormalities, renal failure, etc.); any known chronic disease including tuberculosis, hiv infection * history of drug or other allergy or any condition that may complicate the interpretation of safety or efficacy such as dermatitis which, in the opinion of the investigator, contraindicates participation in the trial, or know hypersensitivity to sso * the child is in care (no longer looked after by their parent or legal guardian) * participation in another study