Kornimate/medical-research-clean huggingface dataset:
a study of tq-b3525 on tolerance and pharmacokinetics

Conditions: Relapsed or Refractory Lymphoma or Advanced Cancer

Summary: to study the pharmacokinetic characteristics of tq-b3525 in the human body, recommend a reasonable regimen for subsequent research.


Eligibility criteria:
inclusion criteria: * relapsed or refractory lymphoma or advanced solid tumor that diagnosed pathologically or cytologically diagnosed * ecog ps≤1 * adequate blood cell counts, kidney function and liver function * patients should participate in the study voluntarily and sign informed consent exclusion criteria: * patients with immunodeficiency, including hiv positive or other acquired, congenital immunodeficiency disease, or organ transplant history * hypertension (systolic bp ≥150 mmhg, diastolic bp ≥90 mmhg) still uncontrollable by one medication * hepatitis b virus patients with active replication (dna\> 500 cps / ml), hepatitis c
sonographic characteristics of tumor indices in patients with cervical cancer during chemo-radiotherpy

Conditions: Cancer

Summary: cervical tumors are characterized by vascular changes (in terms of quantity, volume and flows) in the tumor. due to a good access to the cervix through the vagina, these parameters can be assessed using a three dimensional supersonic. sonographic characteristics of tumor indices measures before and after oncological treatments may shed light on the patient's prognosis.

no editional information. see above

Eligibility criteria:
inclusion criteria: * cervical cancer patients intended to undergo chemotherapy or radiation, or both exclusion criteria: * no exclusions

Keywords: cervical tumors,vascular changes,sonographic characteristics
french translation and validation of the peyronie's disease questionnaire

Conditions: Peyronie Disease

Summary: this study is a prospective cohort dedicated to peyronie's disease. the aim is to validate the french translation of the peyronie's disease questionnaire. the primary endpoint is the response rate to the questionnaire.


Eligibility criteria:
inclusion criteria: * adult patient with peyronie's disease clinically diagnosed during a consultation, with palpation of at least one plaque exclusion criteria: * patient refusing to participate * patient with difficulties in understanding the french language. * protected persons referred to in articles l.1121-6 to l.1121-8 of the public health code
ultrasonographic comparison of gastric volume after three modes of positive facemask during induction of anaesthesia

Conditions: Positive-Pressure Respiration; Respiratory Aspiration of Gastric Content

Summary: this study is designed to evaluate the occurrence of gastric insufflation and the critical volume of the stomach after three different modes of positive pressure ventilation during induction (manual-controlled, volume-controlled and pressure-controlled ventilation)

aspiration of gastric contents can be a serious perioperative complication, which can be related to facemask positive pressure ventilation with unprotected airway. even with low peak airway pressure (\<15 cm h2o) gastric insufflation may occur. since gastric content and volume assessment is a new point-of-care ultrasound recommended application, the cross-sectional antra area will be measured using ultrasonography before, continuously during facemask ventilation and after intubation.

Eligibility criteria:
inclusion criteria: * asa status i and ii exclusion criteria: * pregnant woman obese patient (bmi\>30kgm-2) oropharyngeal or facial anomalies anticipated difficult mask ventilation upper respiratory tract infection history of gastric surgery patient refusal
a study to determine the risk of cancer in rheumatoid arthritis (ra) patients who use abatacept and other biologic agents

Conditions: Rheumatoid Arthritis

Summary: an observational study to determine the risk of cancer associated with the use of abatacept and other biologic agents among rheumatoid arthritis patients


Eligibility criteria:
inclusion criteria: * ra patients will be identified using algorithms that require ≥ 1 rheumatologist (physician specialty code: 66) diagnosis codes for ra (at least one of the following icd9 diagnosis codes: 714.0, 714.2, 714.81) at any time before the first claim for a specific drug (index date) during the study period and ≥1 physician (affiliated with physician evaluation \& management codes, listed in the appendix 2) diagnosis codes within 12 months before the first claim for a specific drug use. the index date is defined as the date of the first claim for a specific drug use, and the baseline period is defined as 12 months prior to specific drug use * naive users of biologics, including abatacept, anti-tnfs (i.e. etanercept, adalimumab, certolizumab, golimumab, infliximab), rituximab, and tocilizumab, will be defined specific to each drug as no claim for that therapy in any time prior to the index date * eligible subjects, including cancer patients in seer and non-cancer beneficiaries from 5% sample, must have been continuously enrolled in medicare parts a, b and d and not c at their index date and during baseline exclusion criteria: * patients diagnosed with any cancer (ignoring non-melanoma skin cancer, which is not captured within seer) before the use of biologics under study. cancer cases will be identified based on the records in seer * patients who were younger than 18 years on the index date * patients with claims for other types of auto-immune diseases (e.g. psoriatic arthritis, systemic lupus erythematosus) during baseline * month or year of diagnosis of malignancy in seer was unknown * cancer cases who were identified by death certificate or autopsy only in seer other protocol defined inclusion/exclusion criteria could apply
can mobility technicians provide value to hospitalized patients?

Conditions: Hip Fractures; Lower Extremity Fracture; Lung Transplant

Summary: the specific aim of this study is to determine the impact of the addition of a dedicated mobility technician to the care team on specialty specific outcomes for patients recovering from surgical treatment for a hip or lower extremity long bone fracture or a lung transplant. the practice of post-operative early ambulation has been shown to improve outcomes by promoting enhanced recovery after surgery in a variety of patients. to that end, vumc is establishing a "culture of mobility". to do so, additional personnel are being hired to help ambulate patients with traumatic hip and femur fractures, other fractures of the lower extremity long bones, as well as those post-lung transplant or readmitted post-lung transplant based upon the best available evidence supporting mobility programs. the added personnel are needed as the currently available resources have insufficient bandwidth to ensure complete early ambulation for all patients. the relative effectiveness of adding a dedicated resource is assumed. although the literature suggests adding person-hours increases the amount of mobility achieved, there is an opportunity to evaluate whether this is really the case. the goal of this study is to evaluate the impact of adding the mobility technician to the existing care team. the mobility technician will be assisting patients who could benefit from early ambulation after surgery. we hypothesize that by adding this staffing resource, more patients will get the appropriate level of usual care. specifically, we expect that adding the resource increases the proportion of those patients who are receiving the prescribed amount of early ambulation post-surgery, with subsequent improvements in functional independence at discharge, and decreases length of stay since patients achieve readiness for discharge sooner.


Eligibility criteria:
inclusion criteria: * all traumatic fractures of the hip or a lower extremity long bone * post-lung transplant patient * patient readmitted following a lung transplant exclusion criteria: * non-traumatic joint replacements * patients with ankle fractures * pre-lung transplant patients * patients readmitted to the orthopedics unit following a traumatic injury

Keywords: patient mobility ambulation
weekly paclitaxel plus gemcitabine as second-line in small cell lung cancer

Conditions: Lung Cancer

Summary: as a single agent, paclitaxel has a response rate of 33% and 25-29% in sclc patients with sensitive relapse and with resistant relapse, respectively. as a single agent, gemcitabine also has a response rate 16% and 6-13% in sclc patients with sensitive relapse and with resistant relapse, respectively. because of single-agent activity, different mechanism of action, non-overlapping toxicities, and beneficial pharmacologic interaction, paclitaxel and gemcitabine combinations are attractive for testing in clinical trials.

the treatment consists of paclitaxel 80 mg/m2 and gemcitabine 1,000 mg/m2 given intravenously on days 1 and 8 of a 21-day cycle. patients receive treatment every 3 weeks till disease progression

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed sclc 2. clinically diagnosed metastatic or recurrent sclc according to sixth edition of the ajcc cancer staging manual 3. at least 18 years old 4. ecog performance status 0-2 5. disease status must be that of measurable disease defined as recist:lesions that can be accurately measured in at least one dimension \> 10 mm with chest x-ray, spiral ct scan or physical examination 6. progression during or after prior first line chemotherapy or chemoradiotherapy. 7. before study entry, a minimum of 21 days must have elapsed since any prior chemotherapy or radiation 8. no prior radiotherapy to measurable lesion(s) but previous surgery and/or chest radiotherapy for the primary lesion is allowed 9. adequate major organ function including the following:hematologic function: wbc ≥ 3,500/mm3 or absolute neutrophil count (anc) ≥ 1,500/mm3, platelet count ≥ 100,000/mm3hepatic function: bilirubin ≤ 1.5 x unl , ast/alt levels ≤ 2.5 x unlrenal function: serum creatinine ≤ 1.5mg/dl 10. patients should sign an informed consent 11. if female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device \[iud\], birth control pills, or barrier device) during and for 3 months after trial. if male, use of an approved contraceptive method during the study and 3 months afterwards. females with childbearing potential must have a urine negative hcg test within 7 days prior to the study registration. exclusion criteria: 1. mi within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia 2. serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complication of study therapy 3. other malignancy with the past 5 years except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer 4. pregnant or nursing women 5. psychiatric disorder that would preclude compliance. 6. major surgery other than biopsy within the past two weeks.

Keywords: small cell lung cancer second-line therapy
cicatrix in the treatment of recent post-surgical scars

Conditions: Post-surgical Scars

Summary: the purpose of the study is to assess the efficacy of cicatrix (asian gotu kola or pennywort) usage in the treatment of recent post-surgical scars. the duration of this double-blind placebo controlled phase 3 clinical trial will be 4 weeks. the estimated number of persons to be recruited and randomized for the study is 90.


Eligibility criteria:
inclusion criteria: * recent (less than 48 hours) post-surgical wound exclusion criteria: * post-surgical wound with sepsis * usage of steroids within 30 days * malignant neoplastic conditions * alcoholism * handicap and/or psychiatric condition preventing treatment accomplishment.

Keywords: post-surgical scars asian gotu kola asian pennywort
pharmacokinetics of anidulafungin on intensive care unit (icu)

Conditions: Invasive Candidiasis; Critically Ill

Summary: the objective of this study is to determine whether pharmacokinetic parameters of anidulafungin correlate with disease severity and plasma protein levels in critically ill patients.

one of the risk factors for mortality of patients with candidemia is inadequate antifungal therapy. the first days in the intensive care unit (icu), patients are unstable and it can be questioned whether therapeutic levels of anidulafungin are reached after a standard loading scheme. at this moment there are several clues that the pk of anidulafungin in critically ill patients is different, but an overall picture is lacking. for the investigation of the correlation of the pharmacokinetics of anidulafungin and the disease severity a full pharmacokinetic profile will be obtained. predictive scoring systems will be used to assess disease severity.

Eligibility criteria:
inclusion criteria: * treatment with anidulafungin * at least 18 years of age * invasive candidiasis * admitted to an intensive care unit exclusion criteria: * allergic to anidulafungin or its excipients * contra-indication stated in spc * neutropenia

Keywords: candidiasis invasive fungal disease critically ill anidulafungin pharmacokinetics
a clinical trial to evaluate the immunogenicity and safety of sipv in a "2+1"sequential schedule with bopv in infants

Conditions: Poliomyelitis

Summary: the purpose of this phrase iii clinical trial is to evaluate the immunogenicity and safety of sabin inactivated poliovirus vaccine (vero cell) in a '2+1'sequential schedule with bivalent oral poliovirus vaccine in 2-month-old infants

his study is a randomized, double-blind, active-controlled phrase iii clinical trial. the purpose of this study is to evaluate the immunogenicity and safety of sipv manufactured by sinovac biotech co., ltd in a '2+1' sequential schedule with bopv in 2-month-old infants. 240 infants aged between 60-90 days will be randomly assigned into experimental group or control group in the ratio 1:1. the experimental group received sipv-sipv-bopv vaccination schedule at one month doses interval (i.e., month 0, 1, 2), and the control group received wipv-wipv-bopv vaccination schedule at one month doses interval (i.e., month 0, 1, 2). the control wipv was manufactured by sanofi pasteur s.a.

Eligibility criteria:
inclusion criteria: * healthy volunteer between 60-90 days old; * healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators; * proven legal identity; * participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment; * complying with the requirement of the study protocol; exclusion criteria: * prior vaccination with poliovirus vaccine; * history of allergy to any vaccine, or any ingredient, excipients and gentamycin sulfate of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc; * congenital malformation, developmental disorders, genetic defects, or severe malnutrition; * autoimmune disease or immunodeficiency/immunosuppressive; * severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness; * diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders; * any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) prior to study entry; * blood product prior to study entry; * any other investigational medicine(s) within 30 days prior to study entry; * any live attenuated vaccine within 14 days prior to study entry; * any subunit vaccine or inactivated vaccine within 7 days prior to study entry; * acute disease or acute stage of chronic disease within 7 days prior to study entry; * axillary temperature \> 37.0 °c; * any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;

Keywords: sabin strain inactivated poliovirus vaccine poliomyelitis safety immunogenicity infant sequential schedule
the effect of pneumoperitoneum on intracranial pressure in pediatric laparoscopic surgery: ultrasonographic measurement of optic nerve sheath diameter

Conditions: Intracranial Pressure

Summary: the pneumoperitoneum during laparoscopic surgery in pediatrics has the potential to cause an increase of intracranial pressure (icp). previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (onsd) correlate with signs of increased icp. therefore, this study aims to confirm the increased icp by ultrasonographic measurement of onsd during laparoscopic surgery in pediatric patients.


Eligibility criteria:
inclusion criteria: 1. pediatric patients (under 9 yrs) scheduled for undergoing laparoscopic surgery under general anesthesia exclusion criteria: 1. patients with previous history of neurologic disease or neurosurgery, ocular disease or ocular surgery

Keywords: pneumoperitoneum pediatric laparoscopy optic nerve sheath diameter intracranial pressure
effects of the swedish internet-based individualised active communication education (i-ace) in ftu

Conditions: Hearing Impairment

Summary: hearing impairment affects the ability to communicate, which can adversely affect both mental and physical health. the most common used rehabilitation method in hearing impairment is hearing aid fitting. even with optimally fitted hearing aids, many struggle to hear in situations with difficult listening conditions. active communication education (ace) is an interactive group rehabilitation programme aiming to help those with hearing loss communicate more effectively using communication strategies to cope better in everyday life. an individualised active communication education (i-ace) distributed digitally could enable those unable to get to the hearing care facility, or don't want to join the group sessions to benefit from the programme. this project aims to investigate the effects of the swedish digital version of the i-ace in first time hearing aid users.


Eligibility criteria:
inclusion criteria: * adults \>20 years old who have been fitted with hearing aids for the first time (first time users) 6 - 12 months prior. * computer experience and access to computer, tablet and/or smartphone with internet access. * access to bankid or equivalent. exclusion criteria: * those who have participated in active communication education prior.
changing health and lifestyle behaviors of offspring following maternal bariatric surgery

Conditions: Obesity, Childhood

Summary: this is the phase 2 pilot/feasibility randomized controlled trial of halo (health and lifestyle behaviors in offspring), a parent-led behavioral intervention targeting a high-risk pediatric population (i.e., residing offspring ages 6-12; body mass index \> the 70th and \< 120% of the 95th percentiles of mothers with severe obesity) that is uniquely well-timed, when mothers are highly engaged in behavior change and losing weight during the first year following bariatric surgery.


Eligibility criteria:
inclusion criteria: * female caregivers with a biological child (either sex) aged 6-12 years * caregiver is 3-12 months post undergoing a non-device based bariatric surgical procedure * caregiver is able to read, write, and speak in english * child has a bmi \> the 70th and \< 120% of the 95th percentile * child not currently engaged in weight management (behavioral, pharmacologic) * child has no chronic medical conditions or developmental disabilities * child resides in her home \> 75% of the time * child is willing to participate exclusion criteria: * female caregiver is not pregnant at time of enrollment * must not live \>75 miles from cincinnati children's hospital main campus. * child bmi is \> 120% of the 95th percentile
empower pd - feasibility of an interdisciplinary clinic for people with parkinson's disease

Conditions: Parkinson Disease

Summary: this study is a nonrandomized, pilot study of an interdisciplinary, patient-centric model of health care delivery in a "boot camp" style structured clinic for people diagnosed with parkinson's disease (pwpd). 20 participants will attend a three session empower pd clinic and a two month follow up interview. the primary objective is to assess feasibility and acceptability of the newly developed clinic intervention as well as individual perception of experience and barriers.

this study is a nonrandomized, pilot study of an interdisciplinary, patient-centric model of health care delivery in a "boot camp" style structured clinic for people diagnosed with parkinson's disease (pwpd). 20 participants will attend a three session empower pd clinic and a two month follow up interview. participants will receive a comprehensive assessment by each member of an interdisciplinary team including physical therapy, speech therapy, nutrition, social work or psychology, and pharmacy. participants will return the following week for a half day educational symposium. this is a group format and they will receive a session from each of the disciplines covering topics such as exercise, nutrition, communication, socialization, sleep hygiene, medication management, and coping. the final clinic session will be a one hour 1:1 meeting where individualized recommendations will be provided. a participant identified caregiver is invited/allowed to accompany the participant throughout the assessment and educational process whenever possible however, no information or questionnaires are being collected from them. the primary objective is to assess feasibility and acceptability of the newly developed clinic intervention as well as individual perception of experience and barriers with data derived from a program survey and semi-structured interview completed two months after clinic completion. secondary objectives will test patient response to clinic intervention related to self-reported outcome measures (sros) including patient centered outcome questionnaire pd, pd knowledge, quality of life, fatigue, confidence with balance, and self-efficacy for exercise.

Eligibility criteria:
inclusion criteria: * a diagnosis of idiopathic parkinson disease * living in the community (not institutionalized) exclusion criteria: * a diagnosis of atypical parkinsonism * institutionalized (living in a nursing home setting)

Keywords: patient-centric care interdisciplinary care parkinson disease education