Kornimate/medical-research-clean huggingface dataset:
performance of ellume·lab group a strep test versus culture for the rapid detection of group a streptococcus in participants with acute pharyngitis

Conditions: Group A Streptococcal Infection

Summary: participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days. enrolment visit (day 1) assessments for all participants will include the collection of throat swabs, testing by staff at the site using the ellume·lab group a strep test and testing for group a streptococcus by a central laboratory using bacterial culture and polymerase chain reaction (pcr). all participants will be followed up with a phone assessment of adverse events between days 2-14.


Eligibility criteria:
inclusion criteria: * male and female participants aged 3 years of age or older * must currently be presenting with symptoms characteristic of pharyngitis, possibly group a strep, including: * acute onset of sore throat; * fever ≥ 37.8° c (100° f) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° c or feeling feverish within 24 hours of presentation and; * at least one of the following: * red and swollen/inflamed tonsils (or fossae); * pharyngeal or tonsillar exudate; o cervical lymphadenopathy * ≤ 14 days from onset of signs and symptoms of pharyngitis * parent/legal guardian of participants \< 18 years of age capable and willing to give informed consent * participants ≥18 years of age capable and willing to give informed consent exclusion criteria: * participants \< 3 years of age * participants undergoing treatment with antibiotics, or those who have undergone treatment with antibiotics for current episode of pharyngitis * currently enrolled in another clinical trial or used any investigational device within 30 days preceding informed consent * participants 18 years of age or older unable to understand english and consent to participation * parent/legal guardian of participants \< 18 years of age unable to understand english and consent to participation of child * prior enrollment in this clinical validation study
long-term observational study in hiv subjects exposed to egrifta®

Conditions: HIV

Summary: the purpose of this observational, 10-year, prospective cohort study is to assess the potential safety concerns of long-term exposure to egrifta® in hiv-infected subjects with abdominal lipohypertrophy compared with a similar group of subjects not exposed to egrifta®.


Eligibility criteria:
inclusion criteria: all of the following inclusion criteria must be fulfilled: 1. subject has given written informed consent; 2. subject is an adult man or woman ≥ 18 years old; 3. subject has hiv infection; 4. subject has physical evidence of excess abdominal fat, as determined by the examining study physician. 5. subject has completed standard of care assessments (mammography, cervical pap smear, colonoscopy and blood work for hiv-1 rna, cd4 cell count, renal, hepatic, and hematology, psa test, fasting blood glucose, lipid panel ) prior to being enrolled onto the study. exclusion criteria: exclusion criteria 1 through 4 are based on the contraindications for egrifta®. 1. disruption of the hypothalamic-pituitary axis, including conditions such as hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma; 2. active malignancy (newly diagnosed or recurrent) 3. known hypersensitivity to tesamorelin and/or mannitol 4. pregnancy or lactation 5. use of egrifta® within 6 months prior to baseline 6. failure to complete any standard of care assessments listed in section 5.2.1

Keywords: hiv with lipohypertrophy
effects of beclometasone dipropionate/formoterol fumarate via next(haler) in a real-world study on asthma control

Conditions: Asthma

Summary: the goal of asthma management is to achieve and maintain optimal asthma control. the newton study assesses the evolution over time of patient reported outcomes (pros) in asthmatic patients, not adequately controlled with ongoing treatments and initiating therapy with extrafine beclometasone dipropionate/formoterol fumarate (bdp/ff) via nexthaler.


Eligibility criteria:
inclusion criteria: 1. male or female patients aged ≥18 years; 2. patients enrolled on the same day as the first prescription with bdp/ff nexthaler® 100/6 micrograms, or having ongoing treatment with bdp/ff nexthaler® 100/6 micrograms started within the previous 14 days (maximum), as per local standard clinical practice. 3. not adequately controlled asthmatic patients (according to clinician's judgement) when bdp/ff nexthaler® 100/6 micrograms was prescribed; 4. patients not treated with extrafine formulations during the 6 months before starting the treatment with bdp/ff nexthaler®; 5. written informed consent to participate in the study and for the processing of personal data. exclusion criteria: 1. recent (i.e. within the last 6 months) history of life-threatening asthma exacerbations; 2. diagnosis of chronic obstructive pulmonary disease (copd); 3. asthmatic patients on treatment with biologic agents (e.g. monoclonal antibodies) and/or extemporary or fixed triple combinations (e.g. long-acting β2 agonist (laba)/long-acting muscarinic antagonist (lama)/inhaled corticosteroid (ics) at any dose regimen; 4. patients with uncontrolled/clinically significant diseases (according to clinician's judgement) or inability to understand and fill in study questionnaires; 5. concomitant participation in experimental clinical studies/investigations or participation in experimental clinical studies/investigations within 3 months prior to enrolment into the present study.

Keywords: control pros
bioequivalence of two products (norditropin® versus nutropin aq®) in healthy adult volunteers

Conditions: Growth Disorder; Healthy

Summary: this trial is conducted in europe and united states of america (usa). the aim of this trial is to examine the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of norditropin® versus nutropin aq® in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: * no previous exposure to recombinant human gh (growth hormone)or igf-i (insulin-like growth factor-i) * body mass index (bmi) 18.0-27.0 kg/m\^2 (both inclusive) * considered generally healthy upon completion of medical history, physical examination, vital signs, screening laboratory results, and electrocardiogram (ecg), as judged by the investigator exclusion criteria: * the receipt of any investigational medicinal product within 1 month prior to this trial * current or previous treatment with recombinant human growth hormone or igf-i * female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures as required by local law) for the duration of the trial * known presence or history of malignancy * diabetes mellitus * use of pharmacologic doses of glucocorticoids * use of anabolic steroids * history of drug or alcohol abuse
a study of ly3039478 in participants with advanced or metastatic solid tumors

Conditions: Solid Tumor; Breast Cancer; Colon Cancer; Cholangiocarcinoma; Soft Tissue Sarcoma

Summary: the main purpose of this study is to evaluate the safety of the study drug known as ly3039478 in combination with other anticancer agents in participants with advanced or metastatic solid tumors.


Eligibility criteria:
inclusion criteria: * for all parts: the participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their advanced or metastatic cancer. * for dose escalation for all combinations: the participant must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced or metastatic. * for part a dose confirmation: all participants must have histological evidence of advanced or metastatic soft tissue sarcoma or breast cancer. breast cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to notch pathway. * for part b dose confirmation: all participants must have histological evidence of advanced or metastatic colon cancer or soft tissue sarcoma. colon cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to notch pathway. * for part c dose confirmation: all participants must have histological evidence of advanced or metastatic breast cancer and prescreened mutations, amplification, or gene/protein expression alterations related to notch pathway. * for part d dose confirmation: all participants must have histological evidence of cholangiocarcinoma and prescreened mutations, amplification, or gene/protein expression alterations related to notch pathway. participants must not have received \>1 line of prior systemic therapy for metastatic or resectable disease (that is, participants may have received adjuvant gemcitabine and then later gemcitabine/cisplatin for recurrent metastatic disease). * for part e dose confirmation: all participants must have histological evidence of locally advanced or metastatic triple negative breast cancer (tnbc) and prescreened mutations, amplification, or gene/protein expression alterations related to notch pathway. participants must not have received \>2 lines of systemic treatment for advanced or metastatic tnbc. * have adequate organ function. * have a performance status of ≤1 on the eastern cooperative oncology group (ecog) scale. * have discontinued all previous therapies for cancer. exclusion criteria: * have current acute leukemia. * have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease.

Keywords: notch inhibitor
a novel target delineation scheme in high-grade glioma patients: a randomized single-blind clinical trial

Conditions: Radiation Toxicity; MRI Simulated Positioning; High Grade Glioma; Progression-free Survival; Overall Survival

Summary: the main question it aims to answer are: 1. whether the new target delineation scheme can improve progression-free survival 2. whether it can reduce the incidence of radiation complications in high-grade glioma patients. participants in trial group will be performed radiotherapy of new target delineation method after the completion of the operation within 4-6 weeks., while participants in the control group be performed radiotherapy of eortc(european organisation for research and treatment of cancer) target delineation method.temozolomide 75 mg / ( m² · d ) will be given to both groups of patients during radiotherapy. after radiotherapy, its dose changes to 150 \~ 200 mg / ( m² · d ) for 5 days and stopped for 23 days as a cycle. there are 6 cycles in total.


Eligibility criteria:
inclusion criteria: 1. high-grade glioma (2021 who grade iii or iv) 2. age between 18-65 years old, karnofsky performance status (kps) score ≥ 70 3. result of pregnancy test being negative within 7 days before enrollment, only applicable to women with reproductive potential 4. the patient voluntarily joined this study and signed an informed consent form 5. willing to return for follow-up 6. willing to provide tissue and blood samples for this research 7. surgical treatment was completed without any postoperative complications (such as consciousness disorders, hematomas, lung infection and cardiac insufficiency) 8. radiotherapy within 4-6 weeks after surgery 9. no contraindications for taking temozolomide exclusion criteria: 1. low-grade glioma(2021 who grade i or ii) 2. had or having other type of malignant cancers 3. not having been performed gross total resection of tumor 4. severe active comorbidities, systemic diseases or other serious comorbidities that would render the patient unsuitable for participation in this study or seriously interfere with the appropriate evaluation of the safety and toxicity of the prescribed regimen in the judgment of the investigator, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, or mental illness； 5. baseline mri indicates a previous or recent risk of cerebral hemorrhage or hernia; 6. pregnancy or lactation, or pregnancy or childbirth during the expected trial period(from pre-screening or screening visits until 120 days after the last trial treatment) 7. unable to perform brain magnetic resonance imaging; 8. allergic to ct contrast agent, unable to perform enhanced ct examination; 9. remote transfer; 10. medical contraindications for receiving radiation therapy, such as active systemic lupus or scleroderma
low dose one-day tc99m protocol with a high-efficiency cardiac dedicated gamma camera for detection of coronary disease

Conditions: Chest Pain

Summary: a prospective single clinical trial to validate the use of a low-dose (\~5msv) tc-99m protocol with a high-efficiency cardiac dedicated camera (dynamic single photon emission computed tomography; d-spect) to detect myocardial perfusion abnormalities during myocardial perfusion imaging.

as above

Eligibility criteria:
inclusion criteria: 1. patient is referred to myocardial perfusion d-spect for clinical indications. 2. written informed consent is obtained by a study investigator. exclusion criteria: 1. patient is diagnosed as having uncontrolled congestive cardiac failure or cardiogenic shock. 2. patient is diagnosed as having uncontrolled hypertension with resting blood pressure \> 220 mm hg systolic or 110 mm hg diastolic. 3. patient pregnancy (known or suspected). 4. lack of written informed consent 5. prisoner status 6. minors under the age of 18 as coronary artery disease is generally an adult disease

Keywords: myocardial perfusion low radiation dose single photon emission computed tomography
safety and efficacy of oc-1 therapy in patients with r/r t-all/ll

Conditions: T-cell Acute Lymphoblastic Leukemia; Lymphoblastic T-Cell Lymphoma

Summary: first in humans, exploratory, open-label, single-arm, multicentre, non-competitive, dose escalation study to assess the safety and efficacy of cd1a-car t therapy in patients with relapsed/refractory (r/r) t-cell acute lymphoblastic leukemia/lymphoma (t-all/ll)


Eligibility criteria:
inclusion criteria: 1. children older than 2 years or adults, male and female in both groups. 2. patients cd1a antigen blast expression ≥20% at inclusion, either immunophenotypically (flow cytometry) or histologically confirmed. 3. r/r cd1a-positive t-all/ll patients, including morphologic or mrd-detectable (≥1x10-4) bone marrow and/or extramedullary relapses after 2 therapy lines: 1. relapse after allogeneic haematopoietic stem cell transplantation (allo-hsct) 2. primary refractoriness, defined as either morphologic persistence or detectable mrd (≥1x10-4) after two standard therapy lines, making the patient not candidate for allo-hsct. 3. refractory first relapse. 4. second or further relapse. 4. patient without reproductive capacity or else, commitment to the use of a highly effective method of contraception during the study. exclusion criteria: 1. limiting organ dysfunction, such as uncontrolled cardiac (e.g., depressed left ventricular ejection fraction (lvef), \<45%), pulmonary, liver, renal or cns dysfunction. 2. allo-hsct within a timeframe \<3 months, or requiring continued immunosuppressive treatment for graft versus host disease (gvhd). 3. uncontrolled epilepsy or underlying central nervous system (cns) severe disease. 4. active bacterial, fungal or viral infection not controlled by adequate treatment. 5. known hiv, active hepatitis b (hbv), or hepatitis c virus (hcv) infection. 6. women who are pregnant (positive urine/blood pregnancy test) or lactating.

Keywords: car-t-based therapies cd1a
effect of spirulina compared to amlodipine on cardiac iron overload in children with beta thalassemia

Conditions: Beta Thalassemia Major

Summary: the aim of this study is to evaluate the effect of spirulina compared to amlodipine on cardiac iron overload and cardiac functions in multi-transfused children with beta thalassemia major

the aim of this study is to evaluate the effect of spirulina compared to amlodipine on cardiac iron overload using magnetic resonance imaging and cardiac functions in multi-transfused children with beta thalassemia major

Eligibility criteria:
inclusion criteria: * patients on regular blood transfusions. * iron overload with no perspective of changing the chelation therapy in the following three months exclusion criteria: * formal contraindication to magnetic resonance examinations * implantable cardiac device * advanced cardiomyopathy or conduction block * other types of hemolytic anemias
the effect of home-based telerehabilitation in individuals with stroke

Conditions: Stroke

Summary: stroke is a clinical picture that develops due to occlusion or rupture of cerebral vessels and results in loss of cerebral functions. stroke individuals face some limitations in managing daily activities such as walking, dressing, feeding and showering. personal, environmental, and societal limitations have led to the development of new treatment strategies, such as telerehabilitation(tr), to meet the needs of stroke individuals and their caregivers. in this study, patients will be randomized and divided into 2 groups in order to examine the effects of two different tr methods on physical parameters and activities of daily living in stroke patients. baseline assessments will be made for both groups to determine functionality, activities of daily living, fall activity, quality of life, and level of fatigue. for 8 weeks, the tr group will do their exercises with exercise videos prepared on the system 3 times a week. the control group, on the other hand, will do their exercises with exercise brochures on the system 3 times a week for 8 weeks. after 8 weeks, assessments will be repeated. with telerehabilitation to be applied to individuals with stroke, it is aimed to increase functional capacity, independence in daily living activities and quality of life, and reduce the number of falls and fatigue levels.


Eligibility criteria:
inclusion criteria: * diagnosed with stroke at least 1 year ago by a neurologist * modified rankin score ≤3 * have an internet infrastructure that can be accessed at home * not participated in a standardized physiotherapy program in the past 3 months exclusion criteria: * presence of blurred or low vision problems * hearing and speech impairment at a level that will affect participation in the system * epilepsy * presence of pregnancy * having any cognitive problems that prevent using the system

Keywords: telerehabilitation home-based physiotherapy
the effects of perioperative pecs block during robotic breast surgery and breast reconstruction

Conditions: Breast Neoplasm

Summary: pectoral nerve blocks (pecs blok) are used in postoperative analgesia after breast surgery in nowadays. many studies shows that pectoral nerve blocks is effective for reducing pain and postoperative opioid consumption undergoing mastectomy. this study was planned to evaluate the efficacy of intraoperative pecs block for postoperative analgesia after robot breast surgery and immediate breast reconstruction.

sixty patients were randomly allocated into two groups by computerised process, each including 30 patients. pecs group (p) received general anesthesia and pectoral nerve block(pecs block) with 025% ropivacaine after surgical resection of breast by operator. control group(c) only received general anesthesia. a patient -controlled analgesia(pca) device provides fentanyl for postoperative pain control. the primary outcome measures total dose of fentanyl consumption during the postoperative 24 hours, and secondary outcome measures pain scores at rest and movement.

Eligibility criteria:
inclusion criteria: 1. 20years or older 2. scheduled for robot-assisted nipple-sparing mastectomy with immediate gel implant or tissue expander breast reconstruction 3. american society of anesthesiologists(asa) physical status i and iii exclusion criteria: 1. emergency operation 2. reoperation 3. patients with local anesthetic allergy 4. patients with coagulopathy 5. patients on anticoagulants 6. patients who cannot use patient controlled analgesia(pca) 7. patients with morbid obesity \[body mass index (bmi) \>35 kg/m2\] 8. patients with history of uncontrolled hypertension (diastolic bp \>110mmhg) or dm 9. patients with history of heart failure (unstable angina, congestive heart failure) 10. patients with history of liver failure, renal failure, allergic to medicine 11. patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia) 12. patients with history of uncontrolled psychiatric disease (ptsd, anxiety, depression) 13. patients who cannot read the consent form (examples: illiterate, foreigner) 14. patients who withdraw the consent

Keywords: breast neoplasms
randomized trial comparing irrisept to saline irrigation for infection prevention

Conditions: Gustilo-Anderson Type III Open Tibia Fracture

Summary: early debridement and definitive fixation, at the initial operative setting, historically led to no difference in the infection rates for gustilo-anderson type iii open tibia fractures. however, lenarz et al. reported that delaying definitive fixation in open tibia fractures could decrease the deep infection rate. at the university of missouri, the investigators found that staged procedures, including initial debridement-temporary fixation and delayed definitive fixation, did not statistically decrease the rate of deep infection in gustilo-anderson type iii fractures, prompting the study that is being proposed here. antibiotic cement coated intramedullary nails have been used in management of infected long bone fractures. since external fixation and staged debridement did not decrease type iii open tibia infection rate, the investigators wanted to consider using antibiotic cement coated nails to deliver antibiotics locally in the acute open fracture setting to prophylactically decrease associated infection rate. additionally, irrisept is a wound irrigant that has been used to lower infection rates in different wound settings. to the investigators' knowledge, there are no robust data showing its effectiveness at lowering infection rates in open tibia fracture management. the purpose of this study is to determine the effects of irrisept and antibiotic nails on lowering deep infection rates in type iii open tibia fractures.


Eligibility criteria:
inclusion criteria: 1. adult, 18 or over 2. gustilo-anderson type iii open tibia fracture 3. able to obtain informed consent from patient exclusion criteria: 1. minor, under 18 2. pregnancy 3. prisoner 4. allergic to chlorhexidine gluconate 5. allergic to vancomycin or tobramycin 6. patient's tibia is unable to accommodate the smallest antibiotic nail 7. unable to provide informed consent