Kornimate/medical-research-clean huggingface dataset:
the effect of acupuncture on nerve pain caused by taxane (chemotherapy) treatment

Conditions: Breast Cancer; Taxane-Induced Peripheral Neuropathy

Summary: some people experience a side effect while they are receiving taxane called taxane-induced peripheral neuropathy (tipn). tipn is pain in the arms and legs due to nerve damage caused by cancer treatment and may interfere with quality of life. the purpose of this study is to learn if acupuncture can prevent tipn from getting worse. acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body. we will compare real acupuncture (ra) to placebo (sham) acupuncture (sa). sa is done like ra, but will use different needles and target different sites or places on the body than ra. we are comparing ra to sa to learn whether ra can prevent tipn from getting worse while receiving taxane.

the study will include two phases. the first phase is the screening phase, in which patients with early stage breast cancer undergoing taxane therapy will consent and receive tipn screening each week till they develop grade 1 or higher by ctcae criteria. the patients with tipn grade 1 or higher will then be consented to the intervention phase, in which patients will be randomized to receive either weekly real or sham acupuncture treatment using a standardized, semi-fixed protocol developed in our preliminary studies to improve tipn pain. the participant may also participate in part 2 of the study if they begin to experience tipn but do not participate in part 1.

Eligibility criteria:
inclusion criteria: screening phase: * english or spanish-proficient men and women aged ≥18 years * histological diagnoses of invasive carcinoma of the breast * plan to receive curative intent chemotherapy regimen containing 12 weeks weekly paclitaxel or nab-paclitaxel as standard of care intervention phase: * tipn grade ≥1 based on the nci common terminology criteria for adverse events (ctcae) version 5.0, developed while receiving taxane * ≥ 4 4 weeks of either weekly paclitaxel or nab-paclitaxel, or paclitaxel or abraxane with dosing every 2-3 weeks planned, as standard of care and at treating physician's discretion * willing to adhere to requirement that no new pain medication or dose changes be taken throughout the first 12 weeks of the study period * willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments exclusion criteria: screening phase: * pre-existing peripheral neuropathy within 28 days of screening consent * currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine intervention phase: * currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine * use of acupuncture for symptom management within 28 days of intervention consent

Keywords: acupuncture peripheral neuropathy 22-197
effects of nonintubated thoracoscopic lobectomy on lung protection

Conditions: Non-small Cell Lung Cancer; Lung Function Decreased; Tracheal Intubation Morbidity

Summary: a novel nonintubated thoracoscopic technique is promising to enhance recovery after thoracic surgery. however, the effects of nonintubated technique on specific organ protection in not clear yet. in this randomized trial, the effect of nonintubated technique on lung function protection will be evaluated via pao2/fio2 ratio, oxidative stress and inflammatory cytokines serially in lung cancer patients undergoing thoracoscopic lobectomy.

lung cancer is the leading cause of cancer-related death worldwide. its incidence is increasingly arising recently. for early-stage non-small cell lung cancer, surgery is the standard treatment that offers best chance of survival. for thoracoscopic lung cancer surgery, tracheal intubation with one-lung ventilation is regarded the standard anesthetic management to establish a safe operating environment. however, complications associated with intubated general anesthesia are not negligible. a novel nonintubated thoracoscopic technique is developing and applied in a variety of thoracic diseases. a previous study showed that nonintubated thoracoscopic lobectomy was feasible and safe in lung cancer patients. furthermore, nonintubated techniques was also associated with a faster recovery of oral intake, less postoperative complications and shorter hospital stay. the effects of nonintubated thoracoscopic technique on specific organ protection is not clear yet. the aim of this investigation is to explore the effects of nonintubated thoracoscopic lobectomy on lung function protection in lung cancer patients, comparing with the standard intubated patients as a control. the investigators are going to enrol 82 lung cancer patients and randomize them equally to complete thoracoscopic lobectomy with lymphadenectomy either with a nonintubated technique (n=41) or an intubated technique (n=41). the assessment of lung function will be obtained from serial blood gas analyses using pao2/fio2 ratio. additionally, oxidative stress and inflammatory cytokines will be measured from serial blood samples including 8-isoprostane, malondialdehyde, tumor necrosis factor-α, interleukin-6, interleukin-10, s100-β and neuron specific enolase.

Eligibility criteria:
inclusion criteria * adults (\> 20 year-old), lung cancer patients undergoing thoracoscopic lobectomy exclusion criteria * obesity (bmi \> 26 kg/m2) * previous ipsilateral thoracic surgery * severe ventilatory insufficiency (oxygen/bipap user) * poor cardiopulmonary function (preop forced expiratory volume at one second (fev1) \<60%, preop left ventricular ejection fraction \< 50%) * autoimmune disease requiring chronic steroids * patients with difficult airway management, pregnant women

Keywords: thoracoscopic surgery,airway management,anesthesia
a clinical trial of prax-222 in pediatric participants with early onset scn2a developmental and epileptic encephalopathy

Conditions: SCN2A-DEE; Epilepsy

Summary: the goal of this trial is to learn about the effect of prax-222 in pediatric participants with early onset scn2a developmental and epileptic encephalopathy (dee), aged 2 to 18 years.


Eligibility criteria:
inclusion criteria: * has onset of seizures prior to 3 months of age. * has a minimum weight of at least 10 kg at screening. * has a documented scn2a variant through genetic testing obtained via a laboratory accredited per clinical laboratory improvement amendments (clia) or college of american pathologists (cap) or equivalent. * additional inclusion criteria apply and will be assessed by the study team exclusion criteria: * has any clinically significant or known pathogenic genetic variant other than in the scn2a gene, or a genetic variant that may explain or contribute to the participant's epilepsy and/or developmental disorder. * is taking more than 2 sodium channel blocking anti-seizure medications * additional exclusion criteria apply and will be assessed by the study team

Keywords: antisense oligonucleotide nav1.2 voltage-gated sodium channel voltage-gated sodium channel blockers scn2a variant pediatric epilepsy developmental and epileptic encephalopathy dee
sonographic venous doppler imaging in end-stage renal disease

Conditions: Emergent Dialysis; Venous Doppler Ultrasound

Summary: patients with end-stage renal disease (esrd) may visit to emergency services for urgent hemodialysis or other reasons. hemodialysis application in emergency conditions is generally not as optimal as in dialysis units. it takes time to provide suitable conditions (personnel and equipment), the length of stay of patients in the emergency services is prolonged, and this may cause disruption of patient care in these areas where rapid patient care is provided. therefore, the management of esrd patients continues to be one of the serious problems faced by emergency physicians. sonographic evaluation of the venous system (vena cava inferior, hepatic, portal and renal vein) may be an alternative diagnostic method for need for urgent hemodialysis. hereby, patients who don't need hemodialysis safely can be discharged from emergency services. studies conducted so far have generally been based on predicting cardiorenal aki and renal poor outcomes and have been designed in general icu conditions. in this study, the researchers aimed to determine the diagnostic value of sonographic venous doppler imaging the need for urgent hemodialysis in esrd patients in the emergency services.


Eligibility criteria:
inclusion criteria: * patients with end-stage renal disease exclusion criteria: * who are pregnant, * with cirrhosis and liver malignancy, * who do not give consent for the study, * arrest presentation * unable to scan in the first six hours
moving on after breast cancer plus- for breast cancer survivors

Conditions: Breast Cancer Female; Depression

Summary: breast cancer (bc) ranks second among all the types of cancer and is equally common in developing as well as developed countries. breast cancer is most common type of cancer worldwide and its diagnosis as well as early treatment is associated with distress. the aim of this study is to explore the feasibility of integrating a 'moving on after breast cancer (abc)' manual developed by service user (dr a saleem) with cognitive behavior therapyfor pakistani women who are breast cancer (bc) survivors attending primary care and oncology services in pakistan b) refine the moving on abc plus so as to develop a culturally appropriate therapeutic programme to be tested in a future definitive randomized controlled trial.

according to an estimate of world health organization (2000) cancer was responsible for 12% of all the deaths from all causes worldwide and rate of cancer is expected to increase 50% by the year 2020. in pakistan every ninth women has a chance of developing breast cancer, which is highest rate in asia. the estimated incidence rate of breast cancer in pakistan is 50/100,000. despite the high association of distress with breast cancer, data on prevalence of depression in women with breast cancer especially in low income countries is limited . the proposed project consists of two phases: 1) phase 1: integration of the two existing interventions moving on abc and the cognitive behavior therapy and the refinement of the integrated intervention. 2) phase 2: randomized control trial (rct). sample size of phase ii will be comprised of 50 patients. patients will be divided into two groups. one group will receive group moving on abc plus intervention and other group will receive routine care. the total sample size of the effectiveness trial 354.

Eligibility criteria:
inclusion criteria: * female * breast cancer (stage i to stage iv) * has completed primary treatment for breast cancer * score of 10 or above on phq - 9 or gad - 7 * age 18 and above exclusion criteria: * already diagnosed with any psychiatric illness * already taking psychiatric medicines * severe cognitive impairment (not able to give consent to take part in intervention)

Keywords: breast cancer depression moving on abc plus pakistan
ig nextgen 10% in patients with primary immune deficiency (pid)

Conditions: Primary Immune Deficiency (PID)

Summary: this study aims to assess the safety, tolerability and pharmacokinetics of ig nextgen 10% in patients with primary immune deficiency currently being treated with intragam p. eligible patients will switch from 3 to 4 weekly intravenous intragam p therapy to receive seven cycles of ig nextgen 10% treatment administered intravenously at three- to four-weekly intervals. patients will be monitored on the study for up to 36 weeks.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of pid * = or \>6 month use of intragam p at three- or four-weekly intervals * = or \>6 month history of igg trough levels of ≥ 5 g/l exclusion criteria: * newly diagnosed pid within six months prior to screening * known selective iga deficiency or antibodies to iga * immunosuppressive treatment other than topical and/ or inhaled steroids and/ or low dose oral steroids * protein-losing enteropathies, or kidney diseases * history of malignancies of lymphoid cells * any of the following laboratory results at screening: * serum creatinine \> 1.5 times the upper normal limit (unl) * ast or alt concentration \> 2.5 times the unl * albumin \< 25 g/l

Keywords: pid ivig intragamp
corneal specular microscopy in infectious and noninfectious uveitis

Conditions: Uveitis

Summary: the purpose of this study is to determine whether some endothelium morphologic variables are different between infectious and noninfectious uveitis group using a noncontact specular microscopy device.


Eligibility criteria:
inclusion criteria: * patients with infectious and noninfectious uveitis in any activity level and presence of keratic precipitates. exclusion criteria: * patients with previous ocular surgery, trauma, contact lens history, corneal dystrophy, corneal edema and high intraocular pressure * any other anterior segment disorders affecting the corneal endothelium.

Keywords: keratic precipitates
mi-thos® transcatheter mitral valve replacement study

Conditions: Mitral Valve Regurgitation

Summary: to evaluate the safety and performance of the mi-thos® mitral heart valve with the mi-thos® transcatheter delivery system.

the mi-thos® study is an multicenter, single-arm, prospective, safety and performance clinical study.

Eligibility criteria:
inclusion criteria: * severe mitral valve regurgitation ≥ 3+; * high surgical risk fot open mitral valve surgery; * age ≥ 65 years old; * life expectancy \> 12 months; * as assessed by multidisciplinary cardiac team, patients who are not eligible for surgery; * patients sign an informed consent form. exclusion criteria: * previous cardiac mitral valve surgery; * active infections requiring antibiotic therapy; * clinically significant untreated coronary artery disease (cad); * pulmonary hypertension （pulmonary systolic pressure \> 70 mmhg）; * patients with severe right heart failure; * left ventricular ejection fraction \<25%; * diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis; * dialysis patient; * patients with severe coagulopathy; * patients with contraindications to anticoagulant drugs; * patients with stroke or transient ischemic within 30 days; * echocardiography found any intracardiac mass, left ventricle or atrial thrombus; * patients who require surgery or interventional therapy for other valvular lesions; * patients with severe macrovascular disease requiring surgical treatment; * patients with more than 70% of carotid stenosis; * to be allergic to contrast agents, nickel-titanium memory alloys or bovine-derived products; * patients with severe neurological disorders affecting cognitive ability; * patients with severe thoracic deformities.
rapid evaluation of pandemic h1n1 influenza vaccine in adults receiving seasonal influenza vaccine

Conditions: Influenza; H1N1 2009 Influenza

Summary: the purpose of this study is to assess the safety and effectiveness (immune response) to a licensed h1n12009 influenza vaccine in adults when given at the same time or prior to the seasonal influenza vaccine. the study will enroll 300 adults (ages 20-59 years). participants will be randomized into 2 groups. one group will receive one dose of a licensed h1n1 vaccine and one dose of the seasonal influenza vaccine at the same time; the second group will receive the seasonal influenza vaccine 3 weeks after receiving the licensed h1n12009 influenza vaccine. study procedures include: medical history, blood samples and completing a memory aid. participants will be involved in study related procedures for approximately 3-6 weeks depending upon the group assignment.

the objectives of this study are two-fold: 1. to evaluate the safety and immunogenicity of h1n12009 influenza vaccine in a convenience sample of adults, soon after the pandemic vaccine becomes available so as to inform the subsequent use of vaccine in public programs. 2. to evaluate the compatibility of co-administered h1n12009 pandemic vaccine and seasonal tiv vaccine in the same group of subjects, as the option of co-administration would be useful for public programs.

Eligibility criteria:
inclusion criteria: * written informed consent * adults 20-59 years of age exclusion criteria: * allergies to eggs, thimerosal, gentamicin sulphate, neomycin * life-threatening reaction to previous flu vaccine * bleeding disorder * pregnancy * receipt of blood or blood products in past 3 months * chronic illness * compromised immune system * previous lab-confirmed h1n12009 infection * receipt of h1n12009 vaccine * receipt of seasonal influenza vaccine since march 2009

Keywords: vaccine h1n1 influenza h1n1 influenza vaccine influenza vaccine seasonal influenza
bio-connekt wound dressing for treatment of chronic leg wounds: a pilot study

Conditions: Skin Ulcer

Summary: the purpose of this study is to assess the performance of the bio-connekt™ wound dressing and compare its performance with the standard of care at nfrmc wound therapy services, for the treatment of chronic foot/leg ulcers (dfu/vlu) in a prospective single center open one-arm clinical study.


Eligibility criteria:
inclusion criteria: 1. a full thickness diabetic foot ulcer with a viable wound bed free of necrotic material (grade 1 on wagner scale) or a venous leg ulcer confirmed with duplex ultrasound 2. the ulcer has been diagnosed/present for greater than 4 weeks duration. 3. three or fewer ulcers separated by \> 3.0 cm distance 4. post-debridement, the ulcer size must be \> 5 sq cm 5. ankle / brachial index is between 0.7 to 1.2 and or one of the following must be present: 1. transcutaneous partial pressure oxygen (tcpo2) \> 30 mmhg at the ankle 2. toe pressure of \>40mm hg or a doppler waveform consistent with adequate flow in the foot (biphasic or triphasic) 6. at least 18 years old 7. able and willing to read and sign a voluntary written informed consent 8. able and willing to attend scheduled follow-up visits and study related exams exclusion criteria: 1. greater than 30% reduction in wound size (dfu) or 20% reduction in vlu during first week of observation by the investigator 2. ulcer with exposed tendon or bone 3. gross clinical infection at the study ulcer site including cellulitis and osteomyelitis 4. ulcer of a non-diabetic/non-venous pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers) 5. known severe anemia 6. known serum albumin \< 2.5 7. renal failure requiring dialysis 8. rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, hiv 9. severe liver disease as defined by the treating physician or patient's primary care physician 10. malignancy at or near the ulcer site 11. any condition judged by the investigator that would cause the study to be detrimental to the patient 12. presence of a hematology, clinical, chemistry or other test obtained within 7 days of screening that is outside the normal range for the laboratory and is determined to be clinically significant by the investigator 13. received another investigational device or drug within 30 days of day 0. 14. radiation therapy, chemotherapy or immunosuppressive therapy within 30 days of enrollment 15. received another allograft, autograft or xenograft within 30 days of the day 0/ 16. known allergy to equine derived tissue 17. alcohol or drug abuse, defined as current medical treatment for substance abuse 18. pregnant or nursing women

Keywords: diabetic foot ulcer (dfu) venous leg ulcer (vlu)
efficacy/safety of antibiotic steroid combination in prevention of postoperative inflammation in cataract surgery

Conditions: Inflammation Following Cataract Surgery

Summary: efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

study of 15 +-1 day, double-masked, randomized, two arms, parallel groups to confirm the efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

Eligibility criteria:
inclusion criteria: * patients having cataract surgery exclusion criteria: * uncontrolled glaucoma or intraocular hypertension; * use of any ocular anti-infectious drugs or any topical or systemic ocular nsaids during the study but study drugs; * a history of chronic or recurrent ocular inflammatory disease; * uncontrolled diabetes mellitus and diabetic retinopathy ; * patients with sight in a single eye; * iris atrophy in the eye to be operated; * pregnant or lactating women, or women of childbearing potential who are not using proper birth-control methods; * known or suspected allergy or hypersensitivity to any component of study medication; * a history or any other evidence of severe systemic disease

Keywords: prevention of post inflammation in cataract surgery
ropustin for refractory aplastic anaemia after radiotherapy - a single-centre, prospective, open-label, single-arm study

Conditions: Aplastic Anemia

Summary: to investigate the efficacy and safety of roprostin in the treatment of refractory aa after radiotherapy.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years, male or female. 2. diagnosis consistent with refractory aa after radiotherapy. refractory is defined as patients who have failed to respond to at least an adequate amount of supportive therapy, cyclosporine or povidone tpo-ra for 3 months . 3. at least one of the following conditions was met at enrolment: haemoglobin \<90 g/l. platelets \<30 x 10\^9/l, neutrophils \<1.0 x 10\^9/l. 4. baseline liver and renal function is less than two times the normal value. 5. no active infection. 6. agreed to sign the consent form. 7. eastern cooperative oncology group (ecog) score of 0-2. exclusion criteria: 1. other causes of whole blood cytopenia, such as myelodysplastic syndromes (mds). 2. presence of cytogenetic evidence of clonal haematological bone marrow disorders (mds, aml). 3. pnh clones ≥50%. 4. hematopoietic stem cell transplantation (hsct) prior to enrolment. 5. prior treatment with atg. 6. infection or bleeding uncontrolled by standard therapy. 7. allergy to roprostin. 8. active hiv, hcv or hbv infection or cirrhosis or portal hypertension. 9. any concomitant malignancy, localised basal cell carcinoma of the skin within 5 years. 10. previous history of thromboembolic events, heart attack or stroke (including antiphospholipid antibody syndrome) and current use of anticoagulants. 11. pregnant or lactating (breastfeeding) women. 12. participation in another clinical trial within 3 months.

Keywords: after radiotherapy and chemotherapy romiplostim