Kornimate/medical-research-clean huggingface dataset:
evaluation of auto-epap for management of upper airway obstruction during non-invasive ventilation

Conditions: Obstructive Sleep Apnea; Obesity Hypoventilation Syndrome (OHS); Chronic Obstructive Pulmonary Disease (COPD); Neuromuscular Diseases (NMD)

Summary: to evaluate the safety and effectiveness of the automatic expiratory positive airway pressure (auto-epap) feature versus manual expiratory positive airway pressure (epap) in the vivo 45 ls ventilator.


Eligibility criteria:
inclusion criteria: 1. subject has the ability to provide written informed consent. 2. subject is ≥ 18 years old. 3. subject has documented respiratory failure (e.g. sleep hypoventilation with historical transcutaneous carbon dioxide (ptco2) increase ≥ 10mmhg) and/or daytime hypercapnia (\>45 mmhg). 4. subject is currently using non-invasive positive pressure ventilation (niv) for 1 month. 5. subject has a previously documented apnea-hypopnea index (ahi) ≥ 5/hr. 6. subject's expiratory positive airway pressure (epap) settings were recently (≤ 12 months) reviewed. exclusion criteria: 1. subject is not compliant on niv (e.g., \< 4 hr./night). 2. subject is pregnant. 3. subject is on oxygen therapy ≥ 5 l/min. 4. subject has an invasive interface (e.g. tracheostomy). 5. subject has had an acute exacerbation within the last 3 months that resulted in a hospitalization. 6. subject is acutely ill, medically complicated, or who are medically unstable. 7. subject in whom niv therapy is otherwise medically contraindicated. 8. subject has had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days. 9. subjects with untreated, non-obstructive sleep apnea (osa) sleep disorders, including but not limited to: insomnia, periodic limb movement syndrome, or restless leg syndrome. 10. subjects who have the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, cerebrospinal fluid leak, or recent cranial surgery or trauma. 11. subject does not comprehend english. 12. subject is unable or unwilling to provide written informed consent. 13. subject is physically and/or mentally unable to comply with the protocol. 14. subject is not suitable to participate in the trial for any other reason in the opinion of the investigator.

Keywords: sleep apnea non-invasive ventilation (niv) respiratory failure polysomnography apnea-hypopnea index (ahi) expiratory positive airway pressure (epap)
fluarix/ flulaval/ fluarix quadrivalent/ flulaval quadrivalent vaccine pregnancy registry

Conditions: Influenza

Summary: the purpose of this pregnancy registry study is to detect and describe abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with any of glaxosmithkline (gsk) biologicals' seasonal inactivated influenza vaccines (siivs): fluarix, flulaval, fluarix quadrivalent and flulaval quadrivalent.

this study is a transition of existing ongoing pregnancy registries for fluarix/ flulaval/fluarix quadrivalent/ flulaval quadrivalent into one post-authorization safety study (pass). pregnancy outcome data will be collected using questionnaires within 2 months of the estimated date of delivery (edd) and approximately 6 months and 12 months after the edd (for all live births) to ascertain the presence of birth defects not diagnosed before, from q2 2014 to q2 2019. the intent of the registry is to prospectively collect data such as vaccination with gsk siivs during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy.

Eligibility criteria:
inclusion criteria: a subject will be included in the registry if all of the following criteria are met: * exposure to gsk siivs occurs during pregnancy or within 28 days preceding conception. * subject is a us resident. * a hcp is identified (name, address and phone number). * subject can be identified (by gsk or hcp). data from registered subjects will be included in the analyses if the following criterion is met: • pregnancy is ongoing and the outcome is unknown at the time of initial report. exclusion criteria: data from registered subjects will not be included in the analyses if the following criterion is met: • outcome of pregnancy is known at the time of initial report. types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus.

Keywords: fluarix quadrivalent fluarix flulaval flulaval quadrivalent pregnancy registry pregnancy outcome
safety study of cdp7657 in healthy volunteers and patients with systemic lupus erythematosus (sle)

Conditions: Immune System Diseases; Autoimmune Diseases; Lupus Erythematosus, Systemic; Skin and Connective Tissue Diseases; Connective Tissue Disease

Summary: to evaluate safety, tolerability, pharmacokinetics and immunogenicity of cdp7657


Eligibility criteria:
inclusion criteria: * healthy volunteers and subjects with sle exclusion criteria: * severe neuropsychiatric or severe renal sle * history of chronic, recurrent, or recent severe infection * significant hematologic abnormalities * history of cancer, heart failure, renal disease, liver disease or other serious illness

Keywords: lupus sle
influence of vitamin d deficiency on the development of autism

Conditions: Autism

Summary: the investigators wish to study the effect of vitamin d on the development of autism in children. the investigators will also investigate the environmental and genetic influences on the level of vitamin d in children with autism.


Eligibility criteria:
inclusion criteria: * autistic children * healthy children * children with add exclusion criteria: * all others
effects of kinesiotaping with and without active release technique in patients with carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: the goal of this study is to compare the effects of kinesiotaping and active release technique in patients with cts to see which method is better for improving pain, grip strength, range of motion and functional disability.

carpal tunnel syndrome (cts) is a common nerve entrapment condition that causes pain, numbness, tingling and weakness in the hand and wrist. people suffering from cts complain of pain, decreased rom, loss of grip strength and in severe cases, disability. this happens when there is an increased pressure within the wrist on a nerve called "median nerve". this nerve provides sensations to the thumb, index, middle and half of the ring finger. people who are most susceptible to cts are computer/keyboard workers. high force, extreme wrist motions, vibrations are causes. other factors like genetics and pregnancy can also cause cts. there are a lot of treatment options for cts such as use of orthotics, steroidal injections, surgery and physical therapy. the aim of this study will be to determine the effects of kinesiotaping with and without active release technique on pain, grip strength, functional disability and range of motion in patients with carpal tunnel syndrome.

Eligibility criteria:
inclusion criteria: * patients having symptoms for less than 1 year. * age above 18 years. * patients having positive tinel and phalen test. * pain in the median nerve distribution with minimum score of 3 on nprs. ability to read and understand the study instructions and written consent form exclusion criteria: * having any secondary entrapment neuropathy like diabetes, inflammatory arthritis, and hypothyroidism. * pregnancy skin infection on the forearm, cervical radiculopathy or polyneuropathy. * previous history of carpal tunnel decompression surgery. * corticosteroid injection into the carpal tunnel.

Keywords: cts wrist pain disability kinesiotaping active release technique
a study to assess overall survival and treatment patterns for advanced liver cancer participants who received nivolumab therapy

Conditions: Hepatocellular Carcinoma

Summary: a study to describe real-world treatment patterns and overall survival in advanced liver cancer participants who received second or third line nivolumab therapy

the central aims of this study are descriptive and designed to describe the patient demographics, clinical characteristics, treatment patterns, and overall survival in advanced liver cancer participants who received second or third line nivolumab therapy in the real-world setting.

Eligibility criteria:
inclusion criteria: * adult ahcc participants in the flatiron database as defined by: * diagnosed with hcc international classification of diseases (icd)-9 155.x or icd-10 c22.x) * pathology consistent with advanced hcc * age 18 years or older at index * at least two clinic encounters on different days in the flatiron database occurring on or after january 1, 2011 * participants who received second or third line nivolumab monotherapy or combination therapy for ahcc exclusion criteria: * participants with \<1 month of medical data (any clinic visits, medication administrations or oral medication prescriptions) following and including the index date * participants with clinical study drug during prior or post study index periods other protocol-defined inclusion/exclusion criteria could apply
ultrasound guided rhomboid intercostal subserratus plane block vs erector spinae plane block in open nephrectomy

Conditions: Post Operative Pain

Summary: our aim is to measure the efficacy of rhomboid intercostal subserratus plane block and erector spinae plane block in patients undergoing open nephrectomy

open nephrectomy incision is associated with a high incidence of intense immediate postoperative pain and chronic pain the months following surgery. regional anesthesia techniques are commonly recommended for pain management in open nephrectomy as they decrease parenteral opioid requirements and improve patient satisfaction. rhomboid intercostal subserratus plane block (riss) is considered a novel approach for chest wall and upper abdominal analgesia, initially showed promising results, first reported in 2016. erector spinae plane block (esb), was initially described in 2016 for analgesia in thoracic neuropathic pain. it has also been widely used in both adults and children at different levels for different indications. epidural analgesia is the gold standard for perioperative analgesia in open surgery.

Eligibility criteria:
inclusion criteria: 1. type of surgery; open nephrectomy. 2. physical status asa ii, iii. 3. body mass index (bmi): \> 20 kg/ m2 and \< 35 kg/ m2. exclusion criteria: 1. patient refusal. 2. local infection at the puncture site. 3. severe respiratory or cardiac disorders. 4. advanced liver or kidney disease. 5. history of psychological disorders and/or chronic pain. 6. contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy. 7. patients with known sensitivity or contraindication to amide local anesthetics used in the study.

Keywords: rhomboid intercostal block
effects on quality of life following dysport treatment in post-stroke spasticity of the arm

Conditions: Cerebrovascular Accident; Muscle Spasticity

Summary: the main purpose of this study is to assess the effect on quality of life of two cycles of dysport treatment on post-stroke spasticity of the upper limb. the effect of treatment on spasticity and function will also be measured.


Eligibility criteria:
inclusion criteria: * the patient has suffered a stroke, as defined by the world health organisation (who) criteria, at least 6 months previously. * the patient has a hemiparetic arm and meets minimum score requirements on the modified ashworth scale. * the patient has the cognitive and communication ability to participate in the study. exclusion criteria: * patients who have received botulinum toxin treatment within the past 120 days. * contraindication to botulinum toxin treatment. * patients who are receiving oral anti-spasticity medication and who have had a change in dosage of this medication in the month prior to study entry. * patients who have previously been treated with phenol for their upper limb spasticity.
effect of whole-body vibration on tcpo2

Conditions: Diabetes Mellitus, Type 2

Summary: in order to determine the effect of whole body vibration on tcpo2 levels in patients with type 2 diabetes, 40 subjects will undertake whole body vibration exercise three times a week for 12 weeks. tcpo2 will be measured before and after the intervention. a second control group with type 2 diabetes will also have tcpo2 levels measured before and after the 12 weeks of the study.

objective: to determine the effect of whole body vibration exercise on levels of tcpo2 measured in the feet of patients with type 2 diabetes, in order to create recommendations for prevention of diabetic foot. material and methods: controlled open clinical trial consisting in 2 arms, as follows: 1) control group under care for type 2 diabetes, and 2) intervention group, who, in addition to the standard care, will undergo an exercise program of whole body vibration three times a week, with progressive intensity, for a period of 12 weeks. partial pressure of transcutaneous oxygen (tcpo2) will be measured in the feet of the participants at baseline and after 12 weeks, with 40 patients per group. statistical analysis: demographic information of the subjects will be described as arithmetic means, standard deviation, percentages, frequencies. comparison between groups will be done with student t for independent data or mann-whitney u when convenient. baseline and final measurements will be compared. inter and intra group comparisons will be made by repeated measurements. for qualitative values, chi square will be used. multivariate analysis will be performed to control for confounding variables. the level of significance will be a value of 0.05.

Eligibility criteria:
inclusion criteria:• patients with diagnosis of type 2 diabetes less than or equal to six years, under care and having concluded the 4th or 5th medical visit. * non-smokers. * residents of mexico city * both sexes. * 40 to 69 years old. * agreeing to participate through signature of informed consent. * hba1c between 6.0 and 9.0 %. * blood pressure less than or equal to130/80. * total cholesterol ≤ 240 mg/dl, triglycerides ≤300 mg/dl. * stable weight over the last 6 months ( \<10% variation). exclusion criteria:• patients with severe motor handicap and amputations of pelvic members. * with exposed lesions in subcutaneous tissue (ulcers) in the sole of the foot, diabetic foot (wagner 3 or more) or intermittent claudication. * with important alterations in balance. * with a recent surgery. * gravidity. * deep venous thrombosis. * with pacemaker. * recent myocardial ischemia. * orthopedic implants. * recently-placed mammary prosthesis. * exoskeletal prosthesis. * discopathies. * neoplasia in the last 5 years. * history of 2 episodes of severe hypoglycemia in the last year. * chronic kidney disease with creatinine clearance estimated at \<60 ml/min. * severe non-proliferative retinopathy, uncontrolled macular edema. * hepatic failure (child-pugh "c") and/or heart failure (functional class - nyha-: iii-iv). * patients with hemoglobinopathies, severe anemia (≤7.5 g/dl), known hemolytic disease.
moxifloxacin in the prevention of bacteremia after high-dose chemotherapy and transplantation of peripheral stem cells

Conditions: Hodgkin Disease; Non-Hodgkin Lymphoma; Multiple Myeloma; Bacteremia

Summary: this study investigates whether the prophylactic use of moxifloxacin during high-dose chemotherapy followed by autologous stem cell transplantation reduces the incidence of clinically significant bacteremia. further investigations include time to occurrence of fever, duration of fever, overall survival and antibiotic sensitivity of blood isolates.

because fluoroquinolones have broad antimicrobial coverage, bactericidal activity, high tissue concentrations, oral bioavailability and adequate tolerability and safety profiles, they are ideal candidates as antibacterial prophylaxis in cancer patients. randomized trials investigating the effect of an antibiotic prophylaxis on patients with intermediate neutropenia have recently been conducted with levofloxacin. the influence of moxifloxacin on the incidence of bacteremia in patients undergoing autologous hematopoetic stem cell transplantation has not been investigated. moxifloxacin may be another promising alternative, covering a broader spectrum of gram-positive and anaerobic bacteria than first- or secondary generation fluoroquinolones and for instance it is an agent administered only once daily, thus optimizing compliance, a crucial issue in prophylaxis.

Eligibility criteria:
inclusion criteria: * high-dose chemotherapy followed by peripheral autologous stem cell transplantation * underlying disease: hodgkin disease, non-hodgkin-lymphoma, multiple myeloma or solid tumor exclusion criteria: * allogenic stem cell transplantation * aplastic anemia * antibiotic treatment within seven days prior to randomization * signs and symptoms of current infection

Keywords: prophylaxis bacteremia moxifloxacin stem cell transplantation hodgkin disease non-hodgkin lymphoma multiple myeloma solid tumor autologous stem cell transplantation
effect of transcutaneous acupoint electrical stimulation (taes) on postoperative cough in lung cancer

Conditions: Postoperative Cough; Lung Cancer

Summary: observation and exploration of the improvement in cough symptoms in postoperative lung cancer patients with transcutaneous acupoint electrical stimulation (taes), the change in cough symptom score (css) compared to baseline, the change in visual analog scale (vas) score for cough symptoms compared to baseline, the change in total score of leicester cough questionnaire-mandarin chinese version (lcq-mc) compared to baseline, and overall evaluation of treatment effectiveness by patients. a total of 120 postoperative lung cancer patients with cough were strictly selected according to the inclusion/exclusion criteria and treated and followed up according to the research plan requirements. clinical observation forms were completed and clinical data were recorded in the database. statistical analysis was performed on relevant clinical observation indicators to report research results and write related papers.

to obtain sufficient evidence from evidence-based medicine, prospective, random, blind, and controlled clinical trials are adopted to evaluate the effectiveness and safety of teas in treating postoperative cough in lung cancer patients. this study aims to provide a potential non-pharmacological treatment option for postoperative cough patients with lung cancer, improve the quality of life of postoperative lung cancer patients, identify the population that is more likely to benefit from teas treatment and provide a solid scientific basis and guidance for personalized acupuncture treatment for postoperative cough in lung cancer patients.

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years old - surgery performed under general anesthesia for radical resection of lung cancer or lung cancer resection combined with lymph node dissection. * pathological confirmation of primary lung cancer after surgery. * duration of persistent dry cough after lung surgery ≥2 weeks. * consciousness, ability to express opinions clearly, and voluntary signing of informed consent. exclusion criteria: * patients diagnosed with acute respiratory system diseases within 1 month. * patients diagnosed with pneumonia based on chest x-ray. * patients with a history of asthma or tuberculosis. * patients with uncontrolled hyperthyroidism, severe hypertension, heart disease, systemic infection, coagulation disorders (hypercoagulable state or bleeding tendency), or other severe systemic diseases. * patients who have used steroid drugs within the past 3 months. * patients who have taken angiotensin-converting enzyme inhibitors (aceis) within the past 6 months. * patients with surgical incisions, skin allergies, wounds, or infections in the treatment area. * patients who cannot tolerate transcutaneous acupoint electrical stimulation or withdraw during the procedure. * patients with contraindications to transcutaneous electrical stimulation or implanted electrophysiological devices. * patients who are pregnant or breastfeeding.
promoting the psychological health of women with sci: a virtual world intervention

Conditions: Spinal Cord Injuries

Summary: the purpose of this project is to test the efficacy of an internet-based psychological health enhancement program for women with spinal cord injury. the intervention will occur in second life (sl), which is an online virtual word simulator with a group of women with spinal cord injury.


Eligibility criteria:
inclusion criteria: * have a traumatic spinal cord injury * be at least one year post injury * be able to speak and read english (to participate in the group intervention and complete study questionnaires in english). * have access to a phone, an email account, and a computer and high-speed internet connection that meets minimum sl computing requirements. exclusion criteria: * have a cognitive impairment that significantly limits their ability to give informed consent, participate in the intervention, or complete study assessments as determined by an inability to correctly answer questions on a comprehension of consent questionnaire * have a significant visual or hearing impairment that would prohibit their ability to participate in the virtual intervention * report active suicidality * live in institutions. individuals living in community-based group and adult foster homes will be invited to participate.