Kornimate/medical-research-clean huggingface dataset:
effect of intracervical on the pain associated with the insertion of the lng-ius

Conditions: Pain

Summary: this study has the objective to evaluate the effect of injectable intracervical anesthesia in comparison with a non-steroidal anti-inflammatory drug (nsaid) on the pain scores immediately after insertion of the levonorgestrel-releasing intrauterine system (lng-ius) in women without previous vaginal delivery. h0: there is no difference in terms of pain score between the treatments h1: there will be difference in terms of pain score between treatments

objective: to evaluate the effect of injectable intracervical anesthesia in comparison with a non-steroidal anti-inflammatory drug (nsaid) on the pain scores immediately after insertion of the levonorgestrel-releasing intrauterine system (lng-ius) in women without previous vaginal delivery. as secondary objectives, the effects of the interventions on the pain scores assessed 2 and 6 hours after the lng-ius insertion, the level of discomfort associated with the insertion procedure and the ease of insertion of the lng-ius will be evaluated. design: open randomized controlled trial setting: outpatient contraceptive services patients: 100 women who want to use the lng-ius interventions: 100 women will be randomized into two groups: a) use of a nsaid (ibuprofen, 400 mg) 1 hour before the lng-ius insertion; and b) 2% lidocaine intracervical injection. these women will be evaluated immediately after the lng-ius insertion, and then 2 hours and 6 hours after it. main outcome measures: two pain scales will be used (the visual analogue scale and the facial pain scale) in addition to assessing the ease of insertion (as rated by the provider) and the level of discomfort from the procedure (as rated by the patient). multivariate logistic regression will be performed to analyze the predictors associated with moderate/severe pain.

Eligibility criteria:
inclusion criteria: * patients who wanted to use the lng-ius as a contraceptive * age between 18 and 45 years * nulliparity * absence of previous vaginal delivery exclusion criteria: * women in categories 3 and/or 4 for lng-ius use according to the medical eligibility criteria of the world health organization * illicit drug and/or alcohol users * women with allergies or contraindications to nsaids or lidocaine * chronic pelvic pain of any etiology * abnormalities in the cervix (such as fibrosis or isthmus-cervical incompetence) * previous abortion with or without uterine curettage * psychiatric disorders * continued use of medications that could interfere with the pain threshold

Keywords: levonorgestrel-releasing intrauterine system anesthesia pain nulliparous
s0334 analyzing chromosomes in patients with newly diagnosed multiple myeloma or other blood disease

Conditions: Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Precancerous/Nonmalignant Condition

Summary: rationale: studying the chromosomes in samples of bone marrow and blood in the laboratory from patients with cancer or other blood diseases may help doctors learn more about the disease. purpose: this laboratory study is analyzing chromosomes in patients with newly diagnosed multiple myeloma or other blood disease.

objectives: * compare the frequency of deletion 13 as detected by fluorescence in situ hybridization (fish) and conventional cytogenetics in patients with newly diagnosed multiple myeloma (mm) or other monoclonal gammopathies (mg). * examine the prognostic value of specific subsets of chromosome aberrations detected by conventional cytogenetics and fish in relation to event-free and overall survival in these patients. * compare the prognostic value of cytogenetics and fish with other mm and mg prognostic factors in these patients. * correlate the presence of cytogenetic and fish features with clinical pathophysiological, cellular, or other molecular characteristics in these patients. outline: patients receive treatment as directed by the treatment clinical trial on which they are registered. patients undergo bone marrow or blood sample collection periodically for conventional cytogenetic analysis and fluorescence in situ hybridization studies (fish). samples are analyzed for deleted 13q/monosomy 13 and chromosomal abnormalities. projected accrual: a total of 500 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of 1 of the following: * multiple myeloma (mm) * smoldering myeloma * waldenstrom's macroglobulinemia (wm) * monoclonal gammopathy of undetermined significance (mgus) * amyloidosis (al) * newly diagnosed disease * must be currently registered, but have not begun therapy, on 1 of the following southwest oncology group (swog) treatment clinical trials: * swog-s0115 * swog-s0232 * swog-s0340 * all new swog coordinated mm, smoldering myeloma, wm, mgus, or al clinical trials activated on or after the activation date of this research study (swog-s0334) patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: waldenstrom macroglobulinemia monoclonal gammopathy of undetermined significance primary systemic amyloidosis stage i multiple myeloma stage ii multiple myeloma stage iii multiple myeloma
radiopaque hydrogel spacer in patients undergoing radiotherapy for pancreatic cancer

Conditions: Pancreatic Cancer

Summary: an early feasibility study to evaluate feasibility, radiotherapy benefits and safety when using traceit tissue spacer to create space between pancreas and duodenum in patients with localized pancreatic cancer.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old 2. biopsy-confirmed localized pancreatic cancer in the head or neck of the pancreas as defined by the nccn guidelines 3. tumor is clearly delineable from duodenum and no clear evidence of invasion of the duodenum is seen at time of eus performed for either diagnosis or fiducial placement. 4. subject is able to comply with motion management guidelines. 5. radiotherapy or chemoradiotherapy for treatment of the disease is indicated. 6. in investigator's opinion, medically fit to undergo endoscopy for fiducial marker implantation and traceit administration. 7. subjects screening/baseline laboratory testing must meet the following laboratory value criteria: 1. white blood cell count: ≥ 3.0 x 109/l 2. absolute neutrophil count (anc): ≥ 1.5 x 109/l 3. platelets: ≥ 100 x 109/l 4. total bilirubin: ≤ 2.0 times upper limit of normal (uln) 5. ast and alt: ≤ 3.0 times institutional upper normal limit 6. serum creatinine: \< 1.5 times uln e 7. inr: \< 1.5 8. serum pregnancy: negative 9. hemoglobin: ≥ 8.0 g/dl 8. zubrod performance status 0-2 9. subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate institutional review board (irb) of the respective clinical site. 10. life expectancy of at least 9 months exclusion criteria: 1. patients for whom radiotherapy is contraindicated 2. previous thoracic or abdominal radiotherapy 3. any gi abnormality that would interfere with the ability to access the injection site 4. presence of tumor invasion of the duodenum detected on eus at time of biopsy 5. previous whipple procedure or other resection of pancreatic tumor prior to screening 6. active gastroduodenal ulcer or uncontrolled watery diarrhea 7. history of chronic renal failure. 8. documented history of uncontrolled diabetes (i.e., symptomatic hyperglycemia that cannot be medically managed, fasting blood glucose level above 300 mg/dl, and/or frequent swings between hyperglycemia and hypoglycemia) 9. currently enrolled in another investigational drug or device trial that clinically interferes with this study. 10. unable to comply with the study requirements or follow-up schedule. 11. any condition or comorbidity that the investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject. 12. women who are pregnant or breast-feeding; women of child-bearing age must use contraceptives.

Keywords: radiotherapy radiation sbrt
extracorporal photopheresis pilot study

Conditions: Hematological Malignancies

Summary: ecp will be given to the patients \[uvar®xts tm therakos system, johnson \& johnson\] according to the following schedule: starting at day 21 after transplant, if hematologic recovery allowed it: 2 ecp per week the first 2 weeks, and 1 ecp per week during 1 month. total = 8 ecp after transplantation.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years and \< or = 65 years with an hematological malignancy indicated for an allogeneic transplantation after reduced intensity conditioning : * due to the age : for patients between 55 and 65 years. * or for patients between 18 and 55 years of age presenting a risk of increased toxicity for myeloablative conditioning (cardiac, renal or pulmonary pathology) * cml and mps in blastic phase achieving cr, * mm stage ii or iii, relapse after autologous transplant, achieving a response ≥ 30% or on first line if high risk, * nhl in 2nd cr, pr after chemotherapy or autologous transplant, chemo-sensible. * cll in 2nd cr, pr after chemotherapy or autologous transplant, chemo-sensible. * aml in 2nd cr or in first line for high risk criteria, secondary aml. in aml, high risk criteria are defined by : lam 7, leukocytes\>30000/mm3, cytogenetic abnormalities: t(6,9); 11q23, 17p, 11q, 20q, 21q, -5, del(5q), -7/del7q, del 9q and inv 3q, * all in 2nd cr or in first line for high risk criteria defined by cytogenetic abnormalities: 11q23, t(9,22); t(1,19); t(4,11). * mds patients without prior chemotherapy * hla identical sibling donor * performans status \< or = 2 * patients member of a social security company exclusion criteria: * age \ 65 years * pregnant or lactating females * known hiv positivity * active infectious hepatitis, type a, b or c * performance status \> 2 according to who * left ventricular ejection fraction \< 40% and alveolus-capillary diffusion \< 50% * uncontrollable hypertension with medical therapy * creatinine clearance \< 60 ml/min * hypersensitivity or allergy to psoralen (methoxsalen) * disease associated with a photosensitivity * hypersensitivity or allergy to both heparin and citrate products * contra-indication to busulfan, fludarabine, sat or methotrexate * hypersensitivity to ciclosporine, mycophenolate mofetil or mycophenolic acid

Keywords: allogeneic hematopoietic stem cell transplantation extracorporeal photopheresis
a novel approach for transjugular intrahepatic portocaval shunt creation using real-time three dimensional roadmap

Conditions: Portal Hypertension

Summary: tips creation has been widely used to treat the complications associated with portal hypertension. in association with increased operator experience and the ongoing development of imaging modalities, the rate of major complications associated with tips has decreased significantly in the past decades. however, the passage of a curved needle from the hepatic vein into the portal vein still remains a challenging and time-consuming part of the procedure and is associated with puncture-related complications that are potentially fatal.three-dimensional roadmap guidance has been widely applied in various interventions. the aim of the present study is to prospectively assess the feasibility and efficacy of real-time 3d roadmap guidance during tips creation.


Eligibility criteria:
inclusion criteria: cirrhosis complications of portal hypertension requiring tips exclusion criteria: non-cirrhotic portal hypertension complete occlusion of intrahepatic portal vein gastro-renal shunt presence of liver tumor pregnancy other contradictions of tips
pilot study: hypovitaminosis d, hyperparathyroidism and hypomagnesemia in patients with congestive heart failure

Conditions: Congestive Heart Failure; Hypovitaminosis D; Hyperparathyroidism

Summary: people with heart failure may have low magnesium and low vitamin d levels. they may also have abnormally high levels of parathyroid hormones. magnesium and vitamin d are important chemicals that are not routinely measured in blood tests. we are studying how many people with heart failure have low levels of magnesium and vitamin d. we are also studying how many people with heart failure have overactive parathyroid glands and if that is related to their vitamin d levels.

this is a single-encounter crossectional prevalence study in which demographic information, health opinion surveys and labwork are all obtained at one visit. there are no follow up visits, however, if abnormal lab results are discovered, participants will be notified via us mail.

Eligibility criteria:
inclusion criteria: * congestive heart failure exclusion criteria: * pregnant * hospitalized within one month * taking calcium, vitamin d or magnesium supplements * proteinuria \> 1g/24h * creatinine clearance \<35 (mdrd)
lactobacillus kefiri lkf01 (dsm32079) in newborns born by caesarian section

Conditions: Caesarean Section;Stillbirth; Microbial Colonization

Summary: the mode of delivery affects the diversity and colonization pattern of the gut microbiota during the first year of infants' life. probiotics have been observed to positively influence the host's health, but to date few data about the ability of probiotics to modify the gut microbiota composition exist. 40 newborns born by elective caesarian sectional be randomized to a lactobacillus kefiri lkf01 dsm32079 (lkef) supplementation or placebo for 21 days. changes in the gut microbiota composition were detected by using a next generation sequencing technology.


Eligibility criteria:
inclusion criteria: * term newborn * adeguate for gestational age * born by elective cesarean section * otherwise healthy newborn exclusion criteria: * major acute or chronic disease * use of probiotics/antibiotics * gastrointestinal malformation, cystic fibrosis, other genetic diseases * concurrent participation in other clinical trials

Keywords: lactobacillus kefiri lkf01 dsm32079 microbial colonization
a safety and pharmacokinetics study of niraparib plus an androgen receptor-targeted therapy in men with metastatic castration-resistant prostate cancer (bedivere)

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to assess the safety and pharmacokinetics of niraparib when administered in combination with an androgen receptor (ar)-targeted therapy (apalutamide or abiraterone acetate plus prednisone) in adult men with metastatic castration resistant prostate cancer (mcrpc) who may or may not have deoxyribonucleic acid (dna)-repair anomalies.


Eligibility criteria:
inclusion criteria: * histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is be excluded * at least 1 line of prior taxane-based chemotherapy * at least 1 line of prior androgen receptor (ar) targeted therapy * progression of metastatic prostate cancer in the setting of castrate levels of testosterone or history of bilateral orchiectomy at study entry * eastern cooperative oncology group performance status (ecog ps) of lesser than or equal to \[\<=\]1 exclusion criteria: * known brain metastases or history of seizure * prior treatment with a poly (adenosine diphosphate \[adp\] ribose) polymerase (parp) inhibitor * prior platinum-based chemotherapy for the treatment of prostate cancer * known history or current diagnosis of myelodysplastic syndrome (mds)/acute myeloid leukemia (aml) * severe or unstable cardiovascular disease or uncontrolled hypertension * left ventricular ejection fraction (lvef) of lesser than \[\<\] 50 percent (%) as determined by multiple uptake gated acquisition (muga) or echocardiography during screening
safety and efficacy of a novel topical therapy for tinea pedis (athlete's foot)

Conditions: Tinea Pedis

Summary: the purpose of this study is to evaluate the safety and efficacy of a novel topical therapy in patients with laboratory confirmed tinea pedis. during the follow-up period clinical and mycological examinations will be performed.


Eligibility criteria:
inclusion criteria: * otherwise healthy patients with laboratory proven tinea pedis exclusion criteria: * age lower than 18 and higher than 80
effects of play based therapy on attention level of children with down syndrome

Conditions: Down Syndrome

Summary: the aim of the study is to examine the attention level of children with down syndrome receiving play based therapy as compared to children receiving child centered play therapy.


Eligibility criteria:
inclusion criteria: * age: 3-5 years * gender: both male and female * children who are currently taking speech therapy sessions with parental involvement. * medically stable children with no severe ongoing health issues that could interfere with their participation in the study. exclusion criteria: * children with severe sensory impairments * co-morbid neurological conditions that may confound the results * children who received intervention from any other institute

Keywords: play therapy down syndrome attention randomized control trial child development
effect of motivation text messages on diabetes patients

Conditions: Diabetes Mellitus, Type 2

Summary: the investigators will examine the influence of increasing motivation on healthy lifestyle and glycemic control in diabetes patients. participants will be randomized to two groups, the control group gets informational text message and the intervention group gets motivational sms. the patients get a weekly text message and after 26 weeks the hba1c and quality of life will be assessed.

the investigators will examine the influence of increasing motivation on healthy lifestyle and glycemic control in diabetes patients. participants will provide demographic and clinical information, fill human value questionnaires and quality of life questionnaires and decide on personal lifestyle-improvement goals. they will then be randomized to one of two groups: the control group gets informational text message and the intervention group gets motivational text message. the patients get a weekly text message and after 26 weeks we will check the hba1c and quality of life. the text message will be personalized by including personal details acquired by a questionnaire. they will provide demographic and clinical information. in addition, the influence of demographic characters and related dm character on the benefit of the motivational sms will be assessed.

Eligibility criteria:
inclusion criteria: * uncontrolled dm 2 patients (hba1c \> 8%) * know to read (hebrew or arabic) * have a cellular phone * can sign informed consent. exclusion criteria: * a life expectancy of less than one year
molecular diagnosis and prognosis of severe pulmonary infection immunosuppressed hosts

Conditions: Severe Pneumonia; Immunosuppressed Hosts; Diagnosis

Summary: serious pneumonia is a serious inflammation of the lungs caused by various pathogens, resulting in severe bacteraemia or toxemia, which in turn causes blood pressure drop, shock, blurred consciousness, restlessness, delirium and coma, etc., and requires intensive care and treatment in intensive care unit (icu) because of its seriousness. there is an upward trend in the number of clinically immunosuppressed host patients, including long-term use of glucocorticoids for rheumatoid immune diseases and kidney diseases, tumor chemotherapy, organ transplantation, etc. a huge risk for these patients is the diagnosis and treatment of infections, especially lung infections. we have previously observed a significant increase in mortality from severe pneumonia in immunosuppressed patients, and our recent analysis of 204 patients with novel coronavirus pneumonia found that low lymphatic counts, immunosuppression, etc. were independent risk factors for death in patients. early diagnosis and timely treatment are the main means to reduce the mortality rate of severe pneumonia. cd55 is an important complement regulatory protein that inhibits c3 and c5 activation by blocking the formation and accelerating the decay of new c3 and c5 convertases, both of which mediate the downstream action of all three complement activation pathways, and cd55 protects host cells from complement attack. our previous study found that cd55 was significantly elevated in patients with severe pneumonia. therefore, this project proposes "early diagnosis of severe pneumonia based on combination of biomarkers with new generation pathogenesis and early clinical manifestations". it is proposed to validate the predictive effects of recently discovered markers such as cd55, hbp and cd64 on severe pneumonia through prospective single-center clinical studies, explore the establishment of new predictive models for early diagnosis of severe pneumonia, and optimize the diagnosis and treatment strategy of severe pneumonia, and provide new ideas for accurate treatment of severe pneumonia.


Eligibility criteria:
inclusion criteria: * ① age ≥ 18 years, ≤ 75 years, male or female * patients diagnosed with severe pneumonia ③ immunosuppressed patients * patient informed consent exclusion criteria: * ① pregnant women, lactating women and women who are at risk of pregnancy. * patients with malignant neoplasms that have metastasized extensively and are expected to have a short survival period. * patients with obstructive pneumonia and interstitial fibrosis due to lung tumours. * refusal of the patient or the patient's family to participate in the study. * refusal of invasive mechanical ventilation and tracheal intubation by the patient or the patient's family.