Kornimate/medical-research-clean huggingface dataset:
at-risk for type 1 diabetes extension study (tn-10 extension)

Conditions: Diabetes Mellitus, Type 1

Summary: this study was an extension of the nih-sponsored at-risk (tn-10) type 1 diabetes study (nct 01030861). teplizumab-treated and placebo-treated participants in the nih trial who developed clinical type 1 diabetes after the conclusion of that trial, were eligible to enroll and receive teplizumab treatment within one year of diagnosis of clinical type 1 diabetes.

the study was a single-arm, multicenter, open-label clinical trial. all participants received a 12-day course of teplizumab given through daily iv infusion and were followed for 78 weeks. the purpose of this study was to evaluate the safety and tolerability of teplizumab treatment, administered intravenously (iv) to participants in the nih-sponsored trial who have developed type 1 diabetes and were able to start teplizumab treatment within 1 year of diagnosis of type 1 diabetes. whether teplizumab treatment reduced the loss of insulin-producing pancreatic beta cells were evaluated.

Eligibility criteria:
inclusion criteria: 1. previous participant in the tn-10 study 2. participant had received a diagnosis of type 1 diabetes after the conclusion of the tn-10 study, according to the criteria from the american diabetes association (ada). 3. participant was able to initiate teplizumab treatment required in this study within 1 year of type 1 diabetes diagnosis. 4. participant was willing to forego other forms of experimental treatment during the entire study. 5. participant and/or guardian had given informed consent and assent as applicable. exclusion criteria: 1. had an active infection and/or fever. 2. had a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv). 3. an individual who had a medical, psychological or social condition that, in the opinion of the principal investigator, would interfere with safe and proper completion of the trial.

Keywords: recent-onset type 1 diabetes teplizumab t1d stage 3 type 1 diabetes new onset type 1 diabetes
feasibility study incorporating lung function imaging into radiation therapy for lung cancer patients

Conditions: Lung Neoplasms; Lung Cancer

Summary: the proposed study is in the field of thoracic radiation oncology where radiation therapy is used to treat lung cancer. the primary objective of the early phase clinical trial will be to evaluate the safety of performing functional avoidance radiation therapy for lung cancer patients using 4d computed tomography (4dct) ventilation imaging.

this study plans to learn more about radiation therapy. radiation therapy is one of the main treatments used to treat lung cancer. one of the known side effects of this radiation therapy is scarring of the lungs and reduced lung function that can result in shortness of breath. at this time the radiation treatment plan does not take into account differences in lung function between one part of the lung and another. studies have shown that lung function can vary substantially throughout the lungs. this study aims to plan the radiation therapy to be away from the highest functioning portions of lungs while still delivering the intended radiation dose to the tumor. this study will allow researchers to determine whether taking lung function information into account when designing radiation treatment plans can protect lung function after radiation therapy.

Eligibility criteria:
inclusion criteria: 1. diagnosis of pathologically confirmed lung cancer by tumor biopsy and/or fine-need aspiration 2. lung cancer patients that will undergo definitive radiation therapy defined as 45-75 gy as part of standard of care for their disease 3. 18 years of age or older 4. signed informed consent 5. planned curative intent chemotherapy, delivered concurrently or sequentially in combination with radiotherapy 6. the patient's 4dct-ventilation image meets image heterogeneity criteria exclusion criteria: 1. patients receiving stereotactic body radiation therapy 2. patient receiving palliative radiation therapy (defined as less than 45 gy)

Keywords: lung cancer radiation therapy 4dct-ventilation imaging
retracting the esophagus during af ablation

Conditions: Atrial Fibrillation; Esophageal Fistula; Cardiac Arrhythmia

Summary: this study is designed to determine the outcome and effect of implementation of esophageal stylet as a strategy to minimize the risk of esophageal injury during the atrial fibrillation catheter ablation procedure.

there is a clear potential to produce transmural esophageal injury during catheter ablation for af when employing a lesion set targeting the posterior left atrial wall and pulmonary vein (pv) antra using contemporary large-tip or irrigated-tip catheter ablation systems when endocardial target sites are in close proximity to the esophagus. it is very likely that a movement by the esophageal stylet of only 2 to 3 centimeters from the midline can safely protect the esophagus from thermal injury and will mimic the natural migration of the esophagus itself. the stylet proposes to safely facilitate lateral esophageal movement in a manner consistent with the esophagus's own natural migration in order to displace and maintain the esophagus's position away from potential damage resulting from a cardiac ablation procedure in the left atrium or coronary sinus. the esophageal stylet is a thin rigid tube, which will be inserted inside a commonly used nasogastric tube placed inside the esophagus during the ablation. we will use this stylet to move the esophagus away from the site of the ablation about 1-2 centimeters. other common procedures, such as (trans-esophageal echocardiogram), move the esophagus twice this distance with a low risk.

Eligibility criteria:
inclusion criteria: 1. age 18 or above for the patient or legal representative to provide informed consent. 2. documented paroxysmal or persistent atrial fibrillation by a cardiologist and ekg finding. 3. the patient will undergo atrial fibrillation catheter ablation as a treatment plan. exclusion criteria: 1. bleeding disorder. 2. dysphagia to solid and liquid or any documented esophageal masses or cancer. 3. esophageal varices, diverticulum, esophageal web, upper gi bleeding, or hiatal hernia.

Keywords: esophageal stylet esosure atrial fibrillation catheter ablation mechanical esophageal displacement
clinical efficacy and safety of metformin versus apple cider vinegar (acv) in prediabetics

Conditions: PreDiabetes

Summary: the goal of this clinical trial is to compare efficacy and safety of metformin versus apple cider vinegar in prediabetics . the main question\[s\] it aims to answer are: * efficacy of metformin versus apple cider vinegar in prediabetics * safety of metformin versus apple cider vinegar in prediabetics researchers will compare group of prediabetics taking metformin with group of prediabetics taking apple cider vinegar to see if there is difference in safety and efficacy..


Eligibility criteria:
inclusion criteria: * males and female * 17-40 years age * body mass index (bmi) overweight and obese * fbs (100-125 mg/dl) * hba1c 5.7% to 6.4% exclusion criteria: * concomitant medical problems as established diabetes, hepatic or renal insufficiencies etc. * known allergy or intolerance to metformin or apple cider vinegar

Keywords: prediabetes metformin hcl apple cider vinegar
omadacycline vs. moxifloxacin for the treatment of community-acquired bacterial pneumonia

Conditions: Community-acquired Pneumonia; Bacterial Pneumonia

Summary: the purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.


Eligibility criteria:
inclusion criteria: * male or female subjects, age 18 or older who have signed the informed consent form * must have a qualifying community-acquired bacterial pneumonia * subjects must not be pregnant or nursing at the time of enrollment * must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug exclusion criteria: * known or suspected hospital-acquired pneumonia * confirmed or suspected sars-cov-2 infection * evidence of significant immunological disease * has a life expectancy of less than or equal to 3 months or any concomitant condition that is likely to interfere with evaluation of the response of the infection under study, determination of aes, or completion of the expected course of treatment * has a history of contraindications, hypersensitivity, or allergic reaction to any tetracycline or fluoroquinolone antibiotic * has received an investigational drug within the past 30 days
evaluation of the asthma management program to promote activity for students in schools (asthma-pass)

Conditions: Asthma in Children

Summary: physical activity (pa) is an important component of asthma management in children. studies show that pa is associated with decreased severity of asthma symptoms, as well as improved disease control and quality of life. however, urban minority children with asthma face barriers to pa on multiple levels.the goal of this research project is to evaluate whether a multifaceted school-based intervention that addresses key barriers to physical activity reduces asthma morbidity among urban schoolchildren with asthma.

investigators will conduct a cluster-randomized controlled trial with 416 children ages 5-11 years with persistent or uncontrolled asthma from 26 bronx schools. schools will be randomly assigned to either (1) the asthma-pass intervention or an asthma management (am) comparison group. both groups will participate in an existing classroom-based daily activity program. enrollment will occur over 4 consecutive school years with 6-8 schools joining the study each year. the investigators will assess the effectiveness of asthma-pass in reducing asthma morbidity, and improving pa as well as additional clinical and functional outcomes. the investigators will also identify potential mediators and moderators of the intervention effect. they will evaluate the process of intervention implementation by applying the re-aim framework.

Eligibility criteria:
inclusion criteria: * physician-diagnosed asthma (based on parent report with validation from the child's physician). * mild persistent or more severe asthma, or asthma that is uncontrolled despite therapy * attending kindergarten through 5th grade in bronx elementary schools * parent is able to speak and understand either english or spanish. * consent from the primary caregiver, caregiver permission for child participation as well as assent from the child (for age 7 and above). exclusion criteria: * no access to a phone to conduct follow-up surveys. * family plans to leave the school or city in less than 6 months. * the child has other significant medical conditions, such as congenital heart disease, cystic fibrosis, or other chronic lung disease. * child is unable to participate in routine pe classes as per physician-completed sports participation form. * children in foster care or other situations in which consent cannot be obtained from a guardian. * child is a participant in a concurrent asthma intervention study.
comparison of clinical outcome among vaccinated and unvaccinated coronavirus disease patients in critical care unit.

Conditions: Coronavirus Infections; Critical Illness

Summary: corona virus disease has been a pandemic since its beginning. the problem has scaled to break health care system of multiple countries. one of the prime strategy of preventing this disease has been large mass scale vaccination campaign ongoing worldwide. no vaccine has been proven to 100 percent effective in preventing the infection with coronavirus disease so far. the investigators are conducting a study comparing outcome among vaccinated and unvaccinated population admitted to critical care unit of civil services hospital, kathmandu , nepal .

coronavirus disease has been a pandemic since its beginning. the problem has scaled up and health care system of multiple countries have reached to a breaking point . one of the prime strategy of preventing this disease has been large mass scale vaccination campaign ongoing worldwide. no vaccine has been proven to 100 percent effective in preventing the infection with coronavirus disease so far. the investigators are conducting a study comparing difference in outcome with regard to mortality and length of critical care unit stay among vaccinated and unvaccinated population admitted to critical care unit of civil services hospital , kathmandu , nepal. since different groups of population received different vaccine according to age profession and other factors investigators are trying to study the effectiveness of vaccine with regards to type of vaccine.

Eligibility criteria:
inclusion criteria: patients proven to have covid 19 infection patients more than 18 years of age patients admitted to critical care unit exclusion criteria: * patient below 18 years of age patients who do not have covid 19 infection
enriched music-supported therapy to restore motor deficits after stroke

Conditions: Stroke

Summary: music-supported therapy (mst) is a rehabilitation technique to improve the upper extremity motor function of stroke patients through playing musical instruments. a modified version of the mst protocol has been created (hereafter, referred as enriched mst, emst) to include (i) a home-based self-training program using an app for electronic tablets and (ii) weekly group sessions of musical playing strengthening the motivational and emotional components of music playing. a randomised controlled trial will be conducted to test the effectiveness of this enriched mst (emst) protocol in improving motor functions, cognition, emotional well-being and quality of life when compared to a program of home-based exercises utilizing the graded repetitive arm supplementary program (grasp). sixty stroke patients will be recruited and randomly allocated to an emst group (n=30) or a control grasp intervention group (n=30). patients will be evaluated before and after a 10-week intervention, as well as at 3-month follow-up. the primary outcome of the study is the functionality of the paretic upper limb measured with the action research arm test. secondary outcomes include other motor and cognitive functions, emotional well-being and quality of life measures as well as self-regulation and self-efficacy outcomes. we hypothesize that patients treated with emst will show larger improvements in their motor and cognitive functions, emotional well-being and quality of life than patients treated with a home-based grasp intervention.


Eligibility criteria:
inclusion criteria: * presence of mild-to-moderate paresis of the upper extremity after a stroke (having a score between 1 and 4 in the medical research council scale for muscle strength at the distal muscles of the upper extremity); * more than 6 months post-stroke; * completion of formal rehabilitation programs. exclusion criteria: * major language or cognitive deficits affecting comprehension (mini-mental state examination \< 24); * neurological or psychiatric co-morbidity; * other musculoskeletal condition affecting upper extremity motor function (e.g. fracture or arthritis).

Keywords: stroke rehabilitation music therapy
uterine tourniquet at open myomectomy

Conditions: Myomectomy; Uterine Leiomyoma

Summary: the aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss at open myomectomy.

single tourniquet is applied to uterine isthmus to occlude uterine arteries. triple tourniquet is applied to both infundibulopelvic ligaments and uterine isthmus.

Eligibility criteria:
inclusion criteria: * uterine myoma \>12 weeks exclusion criteria: * pedunculated myoma, broad ligament myoma * hb\<10.5 g /dl

Keywords: hemorrhage leiomyoma myofibroma uterine myomectomy tourniquet
surgical face mask effects in patients with covid-19

Conditions: Covid19

Summary: the use of personal protective equipment is mandatory for healthcare workers caring patient with covid-19. to maximise the reduction of virus spread during clinical procedures involving the presence of healthcare workers, it is also recommended to patients to wear surgical facemask. routine clinical procedures include cardio-pulmonary and strengthening exercises. during these exercises, the wearing of a face mask may be difficult to tolerate by patients, especially since they experience breathing difficulties due to the illness. therefore, this study aims to verify the effects of the surgical facemask on breathing difficulties and exercise performance during a 1-minute sit to stand test.


Eligibility criteria:
inclusion criteria: * hospitalized for covid-19 * no need of supplemental oxygen during the procedure exclusion criteria: * altered state of consciousness * respiratory co-morbidities * neurological or orthopedic co-morbidities susceptible to alter the reliability of the sit-to-stand test * having required high flow nasal cannula or non-invasive ventilation during the hospital stay

Keywords: sit-to-stand test surgical facemask dyspnea
key aspects of medical practice in patients with haemophilia a

Conditions: Joint Disease

Summary: the kappa project has the aim to create an international database in which information about clinical features, therapeutic management, burden of illness and costs of severe and moderate haemophilia a patients from different countries and sites is collected. the aim of this project is to analyse the influence of such different characteristics on medical, psychosocial and economic outcomes in patients over the long-term.

1000 patients with hemophilia a will be enrolled using a webbased registry. key quality factors that will be registered are : hemophilia joint health score (hjhs), annual bleed rate, quality of life (eq5d), as well as dosing of replacement therapy.

Eligibility criteria:
inclusion criteria: or forms. * severe haemophilia a (factor viii\<1%) * moderate (factor viii\<5%) * signed informed consent exclusion criteria: * not fullfilling inclusion criteria

Keywords: haemophilia, joint disease, quality of life
ultrasound-guided pectoral nerve blocks, thoracic erector spinae plane block and serratus anterior plane block for breast surgery

Conditions: Ultrasound; Pectoral Nerve Blocks; Thoracic Erector Spinae Plane Block; Serratus Anterior Plane Block; Breast Surgery

Summary: the study will compare ultrasound-guided pectoral nerve block, erector spinae plane block, and serratus anterior plane block for pain management following elective breast surgeries

adequate acute postoperative pain control is important for patients undergoing breast surgery because the pain may be severe and longlasting. surgical incision at the breast and axillary areas is associated with significant pain, with high incidence of acute pain progressing to chronic pain in 25% to 60% of patients. post-mastectomy pain managed with opioids often lead to side effects of nausea and vomiting. regional anesthetic techniques are used in the current management of pain associated with breast surgeries .they attenuate surgical stress response , intraoperative consumption of opioid, prevent central sensitization and diminish postoperative pain. the efficacy of fascial plane blocks like pectoral nerve block (pecs), serratus anterior plane block (sap), and erector spinae plane block (esp) has been proven in previous studies. these blocks require deposition of local anesthetic in an inter-fascial plane through which peripheral nerves travel. the pectoral nerve block relies upon the deposition the local anesthetic at the inter-fascial planes among the pectoralis major, minor, and serratus anterior muscles: it blocks the pectoral, the intercostobrachial, the intercostals iii and vi, and the long thoracic nerves. erector spinae plane block is another interfacial plane block. it involves deposition of local anesthetic between erector spinae muscle and transverse process of t5 vertebrae and targets both dorsal and ventral rami of thoracic spinal nerves. serratus anterior plane block involves the injection of local anesthetic in 1 of the 2 fascial planes, superficial and deep to serratus anterior muscle at the level of the fifth rib in midaxillary line. the sap block targets the lateral cutaneous branches of the thoracic intercostal nerves. the deep sap block was found to have similar analgesic efficacy and technically easier and safer to perform as compared to the superficial sap block.

Eligibility criteria:
inclusion criteria: • age from 21 to 65 years old female, american society of anesthesiologists (asa) physical status i or ii, who will undergo breast surgeries under general anesthesia. exclusion criteria: * patient refusal to participate in research. * body mass index (bmi) ≥35 kg/m2. * sensitivity to the intervention drugs. * coagulation abnormalities. * psychiatric disorder and communication difficulties. * chronic neurological disease. * any skin infection at the needle puncture site. * chest wall deformity
natural history of human papillomavirus (hpv) infections in mid-adult women (whim)

Conditions: Papillomavirus Infections

Summary: the purpose of this study is to determine rates of oral and genital human papillomavirus (hpv) infections, and look at risk factors for hpv infection in healthy mid-adult women.

the investigators propose a longitudinal study of 500 women in order to determine rates and risk factors for hpv infections in 30-50 year old women. participants will be followed for 6 months and will be asked to complete online questionnaires on their health, sexual behavior, hpv vaccinations, and cervical cancer screening. the investigators will ask participants to self-collect monthly vaginal swab samples and self-collect 2 oral swab samples. women will also be asked to provide 2 blood samples. all swab samples will be tested for type-specific hpv deoxyribonucleic acid (dna) using a polymerase chain reaction (pcr)-based assay, blood samples will be tested for hpv antibodies.

Eligibility criteria:
inclusion criteria: * affiliated with the university of washington (student, staff, faculty) * willing to self-collect vaginal samples at home for hpv testing * able to provide informed consent exclusion criteria: * pregnant * have had hysterectomy * serious medical condition which prevents completion of activities of daily living

Keywords: hpv cervical cancer
the effect of aromatherapy on covid-19-induced anxiety

Conditions: Stress; Covid19; Anxiety

Summary: the purpose of this study is to assess the potential for a non-invasive sensory based intervention to reduce the stress associated with a covid-19 diagnosis.

after being informed about the study, participants who provide consent will be randomized to one of two groups. participants will receive one of two aromas to inhale with one being active and the other a control comparison.

Eligibility criteria:
inclusion criteria: * otherwise healthy * documented covid-19 exposure, suspected infection, or diagnosed infection * has been tested for or diagnosed with covid-19 * adults age 18-65 living in the us * understands and agrees to comply with study procedures * provides informed consent exclusion criteria: * smoker in household * pregnant or may become pregnant * difficulty breathing * pain or pressure in the chest * confusion * hospitalization * asthma, copd, or other respiratory condition * demonstrated inability to comply with study procedures * has participated in an interventional clinical study within 31 days prior to enrollment

Keywords: aromatherapy essential oils environmental health