Kornimate/medical-research-clean huggingface dataset:
campath maintenance in chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: this is a study designed to test whether giving campath (also known as alemtuzumab) on a maintenance schedule will prolong the time until the patient requires chemotherapy.

this is an open-label, single arm, proof-of-principle study of campath (also known as alemtuzumab) maintenance therapy administered subcutaneously at varying intervals for up to 1 year. ongoing prophylactic anti-infectives will be provided. patients will be assessed for response every 2 months and for quality of life every 3 months while on treatment. patients achieving a presumptive complete response will receive no further treatment but will be followed for response. non-responding patients, with confirmed progressing disease following a minimum of 8 doses will be discontinued from treatment and followed for survival. responding patients or patients with stable disease will undergo confirmatory assessment 2 months following their end-of-treatment assessment. if remission has occurred, patients will be followed off treatment until documented disease progression.

Eligibility criteria:
inclusion criteria: * enrollment in this study is open to patients 18 years of age with confirmed chronic lymphocytic leukemia, a clinical response of stable disease or better to previous treatment, and an eastern cooperative oncology group performance status of 0-2 exclusion criteria: * treatment failure in more than 3 prior regimens * active secondary malignancy * central nervous system involvement with cll * history of significant allergic reaction to antibody therapies that required discontinuation of the antibody therapy * history of hiv positivity * hepatitis c virus (hcv) positivity based upon core antigen testing * active infection, requiring treatment with antibiotic, antiviral, or antifungal agents * pregnancy or lactation * other severe, concurrent diseases or mental disorders

Keywords: leukemia
testing brca 1/2 mutation using next generation sequencing

Conditions: Breast Neoplasms; Breast Cancer

Summary: testing brca 1/2 mutation is important for patients with breast cancer, and sanger sequencing is a standard method to identify brca 1/2 mutation. next generation sequencing (ngs) is a high-throughput parallel sequencing that can provide genetic information with high accuracy. ngs is a faster and cost-effective method to detect gene mutations compared to sanger sequencing. in this study, we evaluated the clinical role of ngs testing for brca 1/2 compared to sanger sequencing.


Eligibility criteria:
inclusion criteria: * age \> 18 * breast or ovarian cancer history in 2nd degree family members * male breast cancer * bilateral breast cancer * patient with breast cancer under 40 year of age * simultaneous breast and ovarian cancer * patients with epithelial ovarian cancer * breast cancer with other simultaneous extramammary malignancy exclusion criteria: -patients who do not agree with testing brca 1/2 mutation

Keywords: breast neoplasms, brca1, sanger, ngs, next generation sequencing
tandem autologous- nonmyeloablative allogeneic transplant for newly diagnosed multiple myeloma (trapianto tandem autologo-allogenico non mieloablativo nel mieloma alla diagnosi)

Conditions: Multiple Myeloma

Summary: to evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years


Eligibility criteria:
inclusion criteria: * durie-salmon stage iia-iiib multiple myeloma * age \> 18 and ≤ 65 years * previously untreated myeloma * presence of a sibling (potential donor) * bilirubins \< twice normal;alat and asat \< four times normal * left ventricular ejection fraction \> 40% * creatinine clearances \> 40 ml/min * pulmonary dysfunction with diffusing capacity for carbon monoxide (dlco) \> 40% and/or need for continuous oxygen supplementation * karnofsky performance status \> 60% * patients must give written informed consent exclusion criteria: * age \> 65 years * previously treated myeloma * absence of a sibling (genetic randomisation cannot be applied) * karnofsky performance status score \< 60% * hiv-infection * pregnancy * refusal to use contraceptive techniques during and for 12 months following treatment * patients unable to give written informed consent * ps. informed consent is obtained from each patient according to the institutional review boards of the participating centers. the study is conducted according to the declaration of helsinki.

Keywords: multiple myeloma - nonmyeloablative transplantation - autologous transplant - graft versus myeloma newly diagnosed multiple myeloma tandem auto-allo transplant overall survival event free survival disease response
epidural analgesia and troubles of fetal cardiaq rythm : effect of the systemic transfer of ropivacaine and sufentanil

Conditions: Fetal Cardiac Rhythm Abnormalities

Summary: the aim of the investigators study is to demonstrate the association between fetal cardiac rhythm abnormalies after epidural analgesia and the maternal systemic transfer of ropivacaine and/or sufentanil.


Eligibility criteria:
inclusion criteria: * 18 years old or more * nulliparous _ one fetus * head first * spontaneous labor * epidural analgesia * no fetal cardiac rhythm abnormalies before the epidural analgesia * no active management of labor during 30 minutes after the epidural analgesia induction * at term * signature of the consent form exclusion criteria: * pathological pregnancy * low maternal blood pressure during the 30 minutes after the epidural analgesia * uterin contraction which last for 5 minutes or more * more than 6 uterin contractions during a 10 minutes period * ropivacaine contraindication * sufentanil contraindication

Keywords: epidural analgesia fetal cardiac rythm ropivacaine sufentanil
herniorrhaphy for postoperative pain

Conditions: Hernia, Inguinal

Summary: subjects receive either cpl-01, positive control, or negative control after herniorrhaphy and are then followed.


Eligibility criteria:
inclusion criteria: * able to sign informed consent * scheduled to have inguinal hernia repair * be a reasonably healthy adult 18 - 75 years of age * body mass index ≤ 39 kg/m2 * if biologically female, not pregnant or planning to become pregnant * if biologically male, using acceptable birth control * be willing and able to complete study procedures exclusion criteria: * previously inguinal herniorrhaphy * concurrent painful condition that may require analgesic treatment * history or clinical manifestation of significant medical, neuropsychiatric, or other condition, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation * clinically significant existing arrhythmia, bundle branch block or abnormal ecg, myocardial infarction, or coronary arterial bypass graft surgery within the prior 12 months * history of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency. * impaired liver function (e.g., alanine aminotransferase \[alt\] \> 3 × upper limit of normal \[uln\] or total bilirubin \> 2 × uln), active hepatic disease, or cirrhosis. * impaired renal function (e.g., creatinine \> 1.5 × uln). * malignancy in the past year * known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
scleroderma registry & repository at the hospital for special surgery

Conditions: Scleroderma

Summary: the overall objective of the scleroderma registry is to support and promote the basic science and clinical research of this complex rheumatic disease at the hospital for special surgery (hss). the registry facilitates our understanding of the clinical features, pathobiology, genetics of scleroderma. this will ultimately lead to a potential treatment for this currently untreatable condition.

what will be asked of you: * completion of 2 health questionnaires * donation of research bloods. this is optional, but encouraged (if possible). * we also encourage patients who come for initial visits to return so follow-up data can be collected. benefits to patients: * the hss scleroderma registry gives patients the opportunity to participate in observational research with the goal of improving the lives of patients in the future. * by donating research bloods and providing clinical information, patients will help generate new knowledge about scleroderma that can guide the treatment and care of patients afflicted with this rare disease. * patients will also receive a comprehensive, medical evaluation from an hss physician who specializes in treating scleroderma. he or she will provide guidance on treatment options and recommendations for current or upcoming clinical trials. * physicians will also make patients aware of the resources available to them, including support groups and educational programs.

Eligibility criteria:
inclusion criteria: * individuals older than 18 years of age with scleroderma exclusion criteria: * individuals younger than 18 years of age * individuals older than 18 years of age without scleroderma

Keywords: scleroderma scleroderma registry hospital for special surgery scleroderma
does boredom affect mechanical pain thresholds

Conditions: Pain Threshold; Healthy

Summary: the purpose of this study is to investigate if the feeling of boredom could influence mechanical pain thresholds.

participants will be randomized into 3 different groups watching different short video-clips (2.30 min). the boredom group will watch a boring video about ploughing, the distraction control group will watch a positively valenced video, the control group will just wait for 2.30 min, without any instructions about what to think about. pressure pain thresholds will be measured with an algometer before and after the video-clip interventions.

Eligibility criteria:
inclusion criteria: * no pain at the test session * swedish fluency. exclusion criteria: * pain anywhere in the body during the test session * known neurological disease.

Keywords: pain thresholds pain boredom
immune checkpoint inhibitor therapy- induced endocrinopathy

Conditions: Endocrinopathy

Summary: to review cases from ntuh who developed endocrinopathy and metabolic diseases after immunotherapy, and statistically analyzed their age, clinical presentation, image findings, treatment and its response.

immune checkpoint blockade-based immunotherapy is a new modality of cancer treatment with a unique mechanism that has gained increased numbers of indication and is now used in several cancer types. however, immune-related adverse events (iraes) emerge as a new entity of diseases involving one or multiple organ systems. iraes could result in interruption of immunotherapy, morbidities of patients or even death. among various manifestations of iraes, endocrinopathy and metabolic diseases are rare but important, and require prompt diagnosis and treatment to avoid life-threatening conditions. thus, we intend to review cases from ntuh who developed endocrinopathy and metabolic diseases after immunotherapy, and statistically analyzed their age, clinical presentation, image findings, treatment and its response. we will also review literatures to evaluate the difference and similarity from previous diagnostic and treatment experience.

Eligibility criteria:
inclusion criteria: * patients who receive immunotherapy in ntuh and develop endocrinopathy after therapy exclusion criteria: * patients less than 20 years old. patients who are pregnant
comparison of the airway clearance efficacy of electro flo 5000 and the g5 flimm-fighter in patients with cf

Conditions: Cystic Fibrosis

Summary: it is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the electroflo 500 and the g5 flimm-fighter) for airway clearance (ac) in cf patients with mild to moderate lung disease, who have stable lung health and perform ac at home as part of their routine therapeutic regimen.

the investigators hope to enroll 25 patients with cystic fibrosis (with daily sputum production) in this study. it is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the electroflo 500 and the g5 flimm-fighter) for airway clearance (ac) in cf patients with mild to moderate lung disease, who have stable lung health and perform ac at home as part of their routine therapeutic regimen.

Eligibility criteria:
inclusion criteria: 1. diagnosis of cf established by standard criteria (sweat chloride \> 60 mmol/l and/or two alleles affected by gene mutations know to be associated with cf). 2. age older than 8 years. 3. known to consistently produce sputum. 4. currently on a home therapeutic regimen that includes some form of ac performed at least 1 time daily. 5. fev1 \> 30%-predicted, and with stable lung function exclusion criteria: 1. hospitalization for cf pulmonary complications in the 1 months preceding enrollment. 2. hemoptysis \> 60 cc in a single episode in the 4 weeks preceding enrollment. 3. chronic chest pain. 4. participation in another interventional clinical trial in the previous 30 days.
a study in adults with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to compare the effectiveness and safety of ly2963016 versus lantus when taken once daily in combination with insulin lispro before meals three times a day.


Eligibility criteria:
inclusion criteria: * have type 1 diabetes mellitus based on the disease diagnostic criteria \[world health organization (who) classification\] * have duration of diabetes greater than or equal to one year * have hemoglobin a1c (hba1c) less than or equal to 11.0% * on basal-bolus insulin therapy for at least 1 year \[basal insulin must be once daily (qd) injection of human insulin isophane suspension (nph), lantus, or detemir and combined with mealtime injections of human regular insulin, or insulin analog lispro, aspart or glulisine\] * have a body mass index (bmi) of less than or equal to 35 kilograms/square meter (kg/m²) exclusion criteria: * have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study * have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months before entering the study * have known hypersensitivity or allergy to any of the study insulins (insulin glargine or insulin lispro) or to excipients of the study insulins * have significant renal, cardiac, gastrointestinal or liver disease * have active cancer or cancer within the past 5 years

Keywords: diabetes type 1 diabetes diabetes mellitus
effect of cervical traction on balance in cervical radiculopathy

Conditions: Cervical Radiculopathy; Balance Disorders

Summary: a randomized clinical trial aiming to assess the effect of cervical traction, using different loads, on balance parameters among patients with common cervical radiculopathy. authors hypothesized that as cervical traction alleviate radicular pain and improve function it may also improve patient balance parameters. three different loads of traction are compared main outcome measures are balance parameters (clinical and stabilometric). patients are followed for during six months.

a randomized clinical trial was designed to assess the effect of cervical intermittent traction on balance parameters among patients diagnosed with common cervical neuropathy. the diagnosis is confirmed or made by a physical medicine and rehabilitation physician with 15 y of experience treating musculoskeletal disorders especially cervical neuropathy. enrolled patients are randomly assigned to one of three groups (a, b and c). patients are treated with 2 kg load intermittent cervical traction (a), 8 kg (b) and 12 kg (c). patients in the three groups are treated additionnally with 12 rehabilitation sessions. patients are assessed at baseline, at the end of the treatment (1 month), and at 3 and 6 months. outcomes are mainly clinical balance assessment and stabilometry, and secondary, epidemiological parameters, pain intensity (vas), cervical spine rom and proprioception, grip strength, cervical spinal muscle strength, functional status (ndi), the psychological distress (had), and quality of life all parameters are assessed at the three follow-up points.

Eligibility criteria:
inclusion criteria: * cr evolving for at least 3 months well tolerated manual cervical traction test. exclusion criteria: * rehabilitation or chiropractic treatment for head or neck pain within the previous 3 months. * neurological and/or rheumatic diseases involving the cervical spine or which may result in impaired balance. * surgery or traumatic damage to the cervical spine. * ear, nose and throat pathology and ophthalmological disorders causing a balance disorder. * diabetes at the stage of neurovegetative complications * cardiac arrhythmia * neurological impairments (balance disorders, motor and/or sensory deficits). * severe osteoporosis or long-term treatment with corticosteroids .
prognosis value of pro-adrenomedullin in acute exacerbations of copd in er

Conditions: Pulmonary Disease, Chronic Obstructive Patients Admitted in Emergency Department for Acute Exacerbation

Summary: the purpose of this study is to determine whether pro-adrenomedullin (mr proadm)in addition to clinical evaluation is effective to predict outcome of acute exacerbations of copd patients visiting the emergency room(er).

acute exacerbation of copd (aecopd)are usual and frequent cause of admission in emergency room (er). no validated clinical or biological predictor of evolution are available. the main objective is to determine the prognosis value of mr proadm in addition to the clinical risk stratification for ae copd patients in er. patients presenting with a aecopd diagnosis in er will have a blood sample collected and freezed at their admission. mr proadm will be assessed at the end of the study. clinicians in charge of patients will not have the result during the management of their patients. this study implies no change in the patients' management. data related to the patients'demographic,current exacerbation and basic copd characteristics will be collected.

Eligibility criteria:
inclusion criteria: * patients \> 40 years old * acute exacerbation of copd exclusion criteria: * medico social conditions not allowing home discharge * other causes of dyspnea: pneumothorax, pulmonary embolism, pulmonary oedema, lung cancer * pneumonia on chest ray * acute respiratory distress requiring immediate icu transfer

Keywords: aecopd mr proadm biomarkers er outcome
vaccination against covid-19 in chronic kidney disease

Conditions: Chronic Kidney Disease Stage 5 on Dialysis; Chronic Kidney Disease Stage 5 With Transplant; Vaccine Response Impaired

Summary: this is a prospective, multi-center, observational study that will enroll patients receiving dialysis (hemodialysis or peritoneal dialysis) or patients with kidney transplantation who will be vaccinated against covid-19.

patients on dialysis and kidney transplant patients infected with sars-cov-2 (severe acute respiratory syndrome coronavirus type 2) have an increased risk to develop a more severe course of disease or die from covid-19 (coronavirus disease 2019). sars-cov-2 vaccination can increase protection against covid-19. kidney transplant patients and patients requiring dialysis suffer from an acquired immune deficiency. due to the dysfunctional immune response, the general vaccine response in dialysis patients and kidney transplant patients is in many cases insufficient. until now, the vaccination response in dialysis patients and kidney-transplanted patients is unpredictable. verification of vaccine response can provide important information on how to treat and protect these patients from a covid-19. therefore, there is a medical need to monitor vaccine protection after sars-cov-2 vaccination in clinical practice. in this observational study, data of the sars-cov-2 vaccination response collected in clinical routine will be analyzed from these patients. based on this observational study, the investigators aim to get first evidence whether and to what extent vaccination against covid-19 causes a vaccine response in immunocompromised patients with kidney disease.

Eligibility criteria:
inclusion criteria: * receiving dialysis (hemodialysis or peritoneal dialysis) * capable of giving consent * age 18 or older exclusion criteria: - non-capable of giving consent

Keywords: sars-cov-2 vaccination dialysis kidney transplantation
impact of biosynthetic mesh on paraesophageal hernia repair

Conditions: Hiatal Hernia

Summary: the aim of this study is to find out if using a certain kind of mesh can reduce the chances of hiatal hernias coming back after anti-reflux surgery. participants undergoing antireflux surgery will be assigned to one of two groups, a group that has surgery with mesh, or a group that has surgery without mesh.


Eligibility criteria:
inclusion criteria: * documented diagnosis of gastroesophageal reflux disease * adults aged 18 years or older * english speaking * subject is planned to undergo surgery for reflux disease exclusion criteria: * physician deems the subject is unable to complete the study due to documented dementia. * subject is undergoing emergent surgery. * pregnancy * patient has known allergy to tetracycline hydrochloride or kanamycin sulfate
impact of a novel patient educational booklet on colonoscopy quality

Conditions: Colon Cancer; Colonoscopy

Summary: background: achievement of colonoscopy outcomes depends on high-quality bowel preparation by patients; yet inadequate preparation is common. objective: to develop and test an educational booklet to improve bowel preparation quality. design: "before-and-after" study followed by randomized controlled trial. setting: veteran affairs medical center. patients: patients undergoing outpatient colonoscopy measurements: the investigators first performed cognitive interviews to identify knowledge and belief barriers to high-quality colonoscopy preparation. the investigators then created a patient educational booklet addressing patient barriers to improve preparatory behaviors. the investigators tested the booklet in 2 sequential studies: (1) controlled "before-and-after" study in patients undergoing colonoscopy during 2 consecutive months: 1 without and 1 with the booklet; (2) randomized controlled trial. the outcome in both studies was bowel preparation quality measured on a 6-point likert scale (\>5="good"). in each study the investigators compared the proportion achieving a "good" preparation between groups and performed logistic regression to measure the effect of the booklet on preparation quality while adjusting for the purgative received. limitations: unknown impact on polyp yield and cancer reduction.


Eligibility criteria:
inclusion criteria: * any patient scheduled to undergo outpatient colonoscopic crc screening or surveillance in vagla exclusion criteria: * in patient admissions

Keywords: quality improvement colonoscopy screening colon cancer polyp detection rates colonoscopy completion rates scope withdrawal time reduce costs through improving bowel prep quality