Kornimate/medical-research-clean huggingface dataset:
fluoroquinolone resistance prevalence study

Conditions: Multiple Myeloma

Summary: this is an exploratory study to determine the prevalence of fluoroquinolone resistance in patients receiving dose-intense melphalan with autologous peripheral blood stem cell (pbsc) transplantation in the treatment of multiple myeloma (mm). these data may be used in subsequent studies exploring the use of prophylaxis in this patient population.

the goal of this observational study is to determine the prevalence of fluoroquinolone resistance in patients receiving dose-intense melphalan with autologous peripheral blood stem cell (pbsc) transplantation in the treatment of multiple myeloma (mm). the main question\[s\] it aims to answer are: * what is the prevalence of fluoroquinolone-resistant enterobacterales (fre) in patients undergoing autologous pbsc transplantation with dose-intense melphalan? * does the risk of febrile neutropenia differ in fre carriers compared to non-carriers? participants will be tested for the presence of fre before receiving fluoroquinolone prophylaxis at multiple points during the transplant course, including before chemotherapy mobilization (if used) using fluoroquinolone prophylaxis, at initial transplant hospitalization, at time of hospital discharge, and at or after day 84 after transplantation (day 0 is defined as day of hsc (hematopoietic stem cell) infusion). fre colonization will not be a determining factor in the use of fluoroquinolone prophylaxis during the treatment course. this study will be open at two transplant units: hackensack university medical center (humc) and medstar georgetown university hospital (mguh). estimated number of subjects to be enrolled; * humc: 124 * mguh: 20 anticipated enrollment period: 12-months with monitoring of subjects for 84 days (twelve weeks) after transplantation. data will be analyzed over a three-month period (total study period of 18 months).

Eligibility criteria:
inclusion criteria: * subjects \>18 yrs of age. * diagnosis of multiple myeloma undergoing (first or subsequent) autologous pbsc transplantation. * transplant conditioning with melphalan 200 mg/m2. * pbsc cell dose of \>2x10e6 cd34+ cells/kg. * able to receive fluoroquinolone prophylaxis. * subjects must give consent for enrollment into this study. exclusion criteria: * unwillingness to provide informed consent. * enrollment into a treatment protocol prescribing antibiotic prophylaxis. * a diagnosis other than multiple myeloma. * receiving a conditioning regimen other than melphalan 200 mg/m2. * known light-chain amyloid deposition in any organ.

Keywords: myeloma, plasma-cell fluoroquinolone resistance autologous hematopoietic stem cell transplantation antibiotic prophylaxis gut microbiome febrile neutropenia
a study of how insulin peglispro (ly2605541) and insulin glargine affect the breakdown of fat and sugar in type 1 diabetics

Conditions: Type 1 Diabetes Mellitus

Summary: this is a two-period study of participants with type 1 diabetes mellitus (t1dm). in each period, participants will receive once daily injections of stable dose ly2605541 or insulin glargine for 28 to 35 days followed by procedures to look at how the body uses or stores fats and sugars. participants will continue to use meal time insulin throughout the study. healthy participants will also enroll in the study. they will not receive any study medication.


Eligibility criteria:
inclusion criteria: type 1 diabetics: - t1dm for more than 1 year with hemoglobin a1c (hba1c) of less than 9.5% all participants: * otherwise fit and healthy * non smoker exclusion criteria: type 1 diabetics: * taking medication or supplements other than insulin to control diabetes * suffered a hypoglycemic event in the last 12 months that required hospitalization or have poor awareness of hypoglycemia all participants: - taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids
cystic fibrosis adherence study

Conditions: Cystic Fibrosis

Summary: this study aims to assess the role of some factors which can influence the chest physiotherapy adherence in adult with cystic fibrosis. at first, we are going to try to consider the adherence of chest physiotherapy. then, after dividing the patients into two groups - adherent or not adherent - we will attempt to identify the factors which can influence this adherence. it consists in a short questionnaire that the patient will fill during usual visits. the hypothesis is that the following factors can play a role in adherence of chest physiotherapy: * age * age of diagnostic * sex * fev1 * number of antibiotic course * anxiety/depression * work time * socio-professional category * individual situation * physiotherapy with liberal physiotherapist and transport time * sport practice * family support * feeling of work time burden * feeling of physiotherapy efficiency * feeling of physiotherapy burden


Eligibility criteria:
inclusion criteria: * respiratory symptoms * subnormal respiratory function (fev1 \< 80%) * without lung transplant exclusion criteria: * lung transplantation approach

Keywords: cystic fibrosis adherence to chest physiotherapy
congenital chagas disease: long term follow up of treated children. preliminary report or cardiological evaluation in chagas disease treated children

Conditions: Chagas Disease; Chagas Cardiomyopathy

Summary: chagas disease (cd) could be acquired by contact with the vector, transplacentally and by blood transfusion. the duration and clinical presentation of the initial acute phase of the infection may be variable, but the majority of patients are asymptomatic. the acute phase usually lasts a few months and, if untreated, the acute phase goes on to develop a chronic infection. the chronic phase usually continues for the subject's lifetime, and 30% to 40% of patients will progress to the chronic phase with a cardiac, digestive, neurological, or mixed form at 15 to 30 years after the initial infection. progressive heart failure and sudden death due to ventricular arrhythmias are the main causes of death in patients with chronic chagas heart disease. objective: to evaluate cardiac involvement in children after pharmacological treatment for chagas disease. methods: open exploratory study, blind for cardiological evaluation. population: children treated for chagas disease with at least 6 years after-treatment parasitological (t.cruzi qpcr), serological (iha, eia) and cardiological follow-up. non-infected subjects were included as a control group for final cardiological evaluation. treatment: benznidazole or nifurtimox, standard dose, for 60 days. blood samples were collected at diagnosis, end-of-treatment and every 6-12 months thereafter. electrocardiogram (ecg) was performed at diagnosis and every year after treatment. in this cohort, 24 hours ecg (holter) and speckle-tracking strain echocardiography study were performed at the end of follow-up for this study.


Eligibility criteria:
inclusion criteria: * chagas diseases children treated with benznidazole / or nifurtimox * patients with at least 6 years of after-treatment follow-up. * diagnosis of chagas disease: in infants younger than 8 months by direct observation of t.cruzi using parasitological concentration method (microhematocrit test); in infants older than 9 months 2 reactive serological test (elisa, indirect hemagglutination ). exclusion criteria: * patients with chronic diseases (renal, hepatic, neurological) that at the discretion of the researcher could affect the interpretation of the results. * subjects with congenital heart disease.
cardiovascular prevention for persons with hiv

Conditions: HIV Infection; Cardiovascular Disease Risk

Summary: this study is funded by the american heart association. the goal of this research is to prevent early cardiovascular damage before symptoms develop for persons with hiv infection. evidence suggests that taking low doses of blood pressure and cholesterol medication reduces risk for heart disease in persons who are at increased risk (such as the case with hiv infection). participants who are taking hiv treatment with an 'undetectable' viral load, and who do not need treatment for high blood pressure or cholesterol may be eligible to enroll. participants will take a low dose cholesterol medication (or placebo) and a low dose of a blood pressure medication (or a placebo), and will be seen at 3 study visits over 4 months.


Eligibility criteria:
inclusion criteria: * hiv infection with viral load 'undetectable' while taking antiretroviral therapy * age ≥40 * framingham risk score (frs) ≥5%, or ≥3% with ≥5 years of exposure to antiretroviral therapy exclusion criteria: * known cardiovascular disease or framingham risk score (frs) ≥20% * blood pressure ≥140/90 * ldl cholesterol ≥160 (with frs \<10%), or ≥130 (with frs 10-20%) * currently taking, or has a medication contraindication to take, a 'statin', an ace inhibitor, or an angiotensin receptor blocker medication * cirrhosis or plasma alt/ast levels \>2x upper limit of normal * chronic kidney disease and a creatinine \>2.0mg/dl * triglycerides \>500mg/dl

Keywords: treatment experienced
prophylactic antibiotic in subtalar fusion surgery

Conditions: Surgical Site Infection

Summary: assessment of surgical site infection when using postoperative antibiotic prophylaxis in subtalar fusion surgery 24hours versus 5 days

infection in orthopedic surgery is one of the most dreaded complications. antibiotic prophylaxis should be utilized routinely in foot and ankle surgeries involving bone, utilizing hardware and prosthetic joints. it is appropriate for the antibiotics to be administered within 60 minutes prior to surgery, discontinued within 24 hours after surgery, given prior to tourniquet inflation, and utilized routinely in prolonged foot and ankle surgery cases. narrow spectrum antibiotics covering staphylococcus aureus should be utilized for prophylaxis in patients without a history of resistant infection. according to american society of health system pharmacists (ashp) cefazolin was the most used antibiotic in preoperative prophylaxis, combination of cefazolin with gentamicin was the second common regimen while 3rd generation cephalosporin were 3rd widely used antibiotics. the controversy persists in administration of antibiotics varying from a single dose to 3 doses to 5 days or 14 days. in subtropical country, with a hot and humid climate is a conducive environment for both gram-positive and gram-negative bacterial colonization of skin. therefore, we need studies tailored to our environment in egypt prevention of ssis is critical for the health of patients, economic efficiency, antibiotic resistance considerations in conclusion, in many ways, the topic of prophylactic antibiotics in elective foot and ankle surgery is an unusual one, in that a relative divide exists between empirical science and common practice.

Eligibility criteria:
inclusion criteria: 1. posttraumatic subtallar osteoarthritis 2. adult age 18 up to 60 3. good skin condition healthy exclusion criteria: 1. comorbidities such as diabetes mellitus, autoimmune diseases 2. previous foot surgery 3. wounds near surgical incision 4. skin infection
chagas disease diagnostic - inconclusive serology

Conditions: Parasitemia; Protozoan Infections

Summary: t. cruzi infection affects approximately five million people in brazil. the diagnosis of the chronic phase of infection is performed by indirect serological methods which, nevertheless, leave inconclusive results. one of the direct methods used for t. cruzi identification, blood culture in lit (liver infusion tryptose) medium, presents low sensitivity in that phase of the disease. a negative result does not eliminate the possibility of infection, but a positive test has high absolute diagnostic value, which enables the indication of antiparasitic treatment. molecular diagnosis (pcr) in this phase is promising and can be used as a confirmatory test, particularly when individuals present inconclusive results in conventional serological tests, such as elisa, hai and ifi. this study aimed at improving blood culture sensitivity in lit medium by performing pcr in individuals with positive and inconclusive serology for chagasic infection.


Eligibility criteria:
inclusion criteria: * individuals with positive or inconclusive results in conventional serological tests: elisa, hai and ifi for chagas disease
a trial of shr-4849 in advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the study is being conducted to evaluate the safety, tolerability and efficacy of shr-4849 injection in advanced solid tumors. to explore the reasonable dosage of shr-4849 for advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. subject has provided informed consent prior to initiation of any study-procedures 2. age from 18 to 75 years old at the time of signing the informed consent 3. histologically or cytologically confirmed advanced solid tumors 4. at least one measurable lesion was identified per recist 1.1 5. eastern cooperative oncology group (ecog) performance status of 0-1 6. has a life expectancy of at least 3 months. 7. adequate organ function 8. subjects of both genders of child-bearing potential were required to use highly effective contraception from the time they provided written informed consent until 6 months after the last dose of the trial drug exclusion criteria: 1. subjects with active central nervous system (cns) metastasis. 2. subjects with a history of malignant tumors within 5 years prior to the first dose 3. subjects with uncontrolled cancer pain. 4. subjects with severe cardiovascular disease. 5. subjects with clinically significant hemorrhage 6. subjects with uncontrolled pleural effusion, peritoneal effusion and pericardial effusion 7. subjects highly suspected of interstitial lung disease 8. subjects with serious infection within 4 weeks prior to the first dose 9. known history of human immunodeficiency virus (hiv)，active hepatitis b virus or hepatitis c virus infection. 10. the adverse events of previous antineoplastic therapy did not recover to nci-ctcae≤ grade 1 11. subjects who received anti-cancer treatment within 4 weeks prior to the first dose 12. subjects who received major surgery within 4 weeks prior to the first dose 13. subjects who plan to receive or have received live vaccines within 28 days prior to the first dose. 14. female subjects who were pregnant, lactating, or planned to become pregnant during the study period 15. known allergic to any component of shr-4849 products 16. alcohol abuse, drug abuse, other serious medical conditions (including mental illness) requiring combined treatment, and other conditions that may affect subject safety or data collection. 17. based on the investigator's judgment, subjects with other conditions that may affect study results, interfere with study procedures,
investigating hope and expectations in open-label placebos

Conditions: Pain

Summary: research has shown that placebo effects contribute substantially to clinical outcomes. recent evidence suggests that placebos remain effective even if they are openly described as placebos (so-called open-label placebos). in this study, the investigators examine hope and expectations as components of open-label placebos in an experimental study investigating pain..

a growing body of research has indicated that placebos contribute substantially to clinical outcomes. yet, the implementation of deceptive placebos in clinical practice is incompatible with key principles of openness and patient autonomy. however, recent research suggests that placebos remain effective even if they openly described as placebos (so-called open-label placebos (olp)), hence questioning the necessity of deception in clinical trials. however, research identifying the specific mechanisms underlying olp is lacking. therefore, the current study aims to examine hope and expectations as components of olp in pain. for this purpose, experimentally induced heat pain is examined. first, all participants receive heat pain stimuli and evaluate them. next, participants are randomly assigned to one of four groups: (1) a traditional deceptive placebo (dp) group, which is told that they receive an effective analgesic cream, (2) an olp group inducing hope among the participants that the placebo cream could help them tolerating painful stimuli (olp hope), (3) and olp group raising the expectation that the placebo cream will help participants tolerating heat pain (olp expectation), (4) a control group receiving no cream. finally, participants receive and evaluate heat pain again.

Eligibility criteria:
inclusion criteria: * sufficient german language knowledge * at least 18 years old exclusion criteria: * current mental disorder * current medical disease * studying psychology or medicine * pregnancy or breastfeeding period * intake of drugs * severely visually impaired
immediate effect of ultrasound therapy on bilateral masseter myalgia: randomized single blinded investigational trial

Conditions: Temporomandibular Joint Dysfunction Syndrome

Summary: introduction. temporomandibular disorders (tmd) are a group of conditions that are multifactorial in nature, and it primarily presents with symptoms of pain and decreased functional capacity. therapeutic ultrasound is a method of physical therapy that has shown clinically to provide immediate relief of pain in patients with different musculoskeletal disorders. in this study, for the purpose of immediate management of painful masticatory muscle and tissues, the investigators attempt to understand the mechanism of therapeutic ultrasound by exploring the physiologic changes peripherally and centrally. in addition, the investigators aim to determine if there is a dose response relationship between two different intensities (0.4 w/cm2 and 0.8 w/cm2) and between two sets of duty cycles (50% and 100%). a third purpose is to determine if therapeutic ultrasound applied to the masseter muscle is capable of eliciting segmental effects in the temporalis muscle. methods. a total of 28 adult females with bilateral myalgia according to diagnostic criteria for tmd (dc/tmd) will be recruited for this investigational trial. each subject will be randomly allocated to one of the four ultrasound intervention groups each of which has different settings. using sonicator®740, therapeutic ultrasound intervention will be performed on both masseters for five minutes on each side of the face. a template will be used to confine the borders of the muscle and to determine the sites for the repeated outcome measures. outcome parameters of: self-reported pain scale, pressure pain threshold, electromyographic muscle amplitudes and intraoral muscle temperatures will be measured for masseter and temporalis muscles on each side of the face, and will be assessed at baseline and after intervention on each side.

the "brief summary" above encompasses the detailed description.

Eligibility criteria:
inclusion criteria: * adult females who have bilateral myalgia based on diagnostic criteria for tmd (dc-tmd) criteria and current pain intensity (≥4 out of 10, where 0 is no pain and 10 is the worst pain ever) on both sides. exclusion criteria: * those who have a history or were diagnosed with systemic musculoskeletal disorders or rheumatologic diseases (e.g. fibromyalgia, muscular atrophy). * certain conditions such as neoplasms or fractures. * neuropathies or neurological disorders. * participants who are currently taking muscle relaxants or analgesics. * those who have undergone any form of physical therapy within the last 60 days.

Keywords: therapeutic ultrasound
combination of cryosurgey and nk immunotherapy for recurrent cervical cancer

Conditions: Recurrent Cervical Cancer

Summary: the aim of this study is the safety and efficacy of cryosurgery plus nk immunotherapy to recurrent cervical cancer.

by enrolling patients with recurrent cervical cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and natural killer (nk) cells. the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * body tumor 1-6, the maximum tumor length \< 5 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: cervical cancer cryosurgery nk immunotherapy
controlled study of mk-0431/ono-5435 in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: determine the safety and efficacy of mk-0431/ono-5435 in patients with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus on diet and exercise therapy exclusion criteria: * patients with type 1 diabetes mellitus

Keywords: mk-0431 ono-5435 type 2 diabetes mellitus
adhd/me bibliotherapy study

Conditions: Attention Deficit Hyperactivity Disorder

Summary: attention-deficit/hyperactivity disorder (adhd) is one of the most common neurodevelopmental disorders of childhood. it affects approximately 8% of school aged children and is characterized by persistent symptoms of inattention and/or hyperactivity/impulsivity. typical adhd assessments primarily involve interviewing the parents and gathering rating scales from parents and teachers. feedback regarding diagnosis, clinical conceptualization, and treatment recommendations is usually provided by the clinical staff to the child's parents in the absence of the child. hence, the adhd diagnosis and repercussions of that diagnosis are often left unexplained to the child. research has shown that bibliotherapy is an effective educational tool that can be used to help parents discuss adhd diagnosis and treatment with their child. the aim of this study is to conduct a randomized trial in which tools for parents who are getting their elementary-aged (7 to 10-year-old) children evaluated for adhd are explored. the evaluations (n=60) will be conducted at the center for adhd at cincinnati children's hospital medical center (cchmc) in cincinnati, oh. half of the families (n=30) will be randomly assigned to the intervention group, where they will be provided with the child-focused "adh-me!" book during the feedback session, and the remaining half will not receive it. all participants will receive a booklet with general information about adhd and a list of recommendations from the clinicians. approximately 3 months after their feedback sessions, follow-up surveys will be conducted via telephone to question the parents and children about their adhd knowledge, as well as about whether they had followed up on the clinicians' recommendations. it is hypothesized that providing families with the adh-me! book will increase families' knowledge about adhd and facilitate the family following up on treatment recommendations.


Eligibility criteria:
inclusion criteria: * english speaking * meet adhd criteria based on adhd evaluation exclusion criteria: -