Kornimate/medical-research-clean huggingface dataset:
acute effects of high intensity training in pregnancy on fetal well-being and blood flow distribution

Conditions: Pregnancy

Summary: pregnant women are recommended to be physically active ≥150 min/week, but \<15% of norwegian women attain this goal. several well-designed studies on lifestyle interventions focusing primarily on exercise training in overweight/obese pregnant women have reported disappointing outcomes with regard to maternal glycemic control, gestational weight gain and infant outcomes. low adherence to the training program was found to be a problem; the participants did not enjoy the exercise program and had difficulties scheduling time to exercise. pregnant women also report that they are not sure what exercises are safe during pregnancy. high intensity interval training (hit), defined as short periods of intense activity separated by low-intensity breaks, has proved to induce superior improvements in insulin sensitivity and fitness compared with continuous moderate intensity training in individuals at increased risk for cardiometabolic diseases. even short-term (6 weeks) hit with brief (15-60 sec) work-bouts and a total time commitment of \<45 min per week, improves insulin sensitivity similar to that attained after 6 months of traditional endurance training. hit is feasible and enjoyable for individuals with low fitness level and with obesity. hit is therefore a highly potent intervention that elicits important changes in a range of clinically relevant health outcomes in reproductive-aged women. this study will investigate fetal responses to a single bout of hit. preliminary data of the investigators suggest that hit does not negatively influence fetal heart rate. others have reported that uterine and umbilical blood flow are not changed during or following acute exercise. however, no previous study has determined the acute effect of hit on uterine blood flow and there are no studies investigating the fetal blood flow distribution in response to exercise. since the relative distribution of blood to the fetal liver is associated with newborn adiposity, fetal blood flow distribution in response to exercise can provide insight about the effect of maternal exercise on offspring health.


Eligibility criteria:
inclusion criteria: * pregnant, gestational week 22-36 * singleton fetus * no known diseases * capable of cycling on an ergometer bike exclusion criteria: * hypertension * gestational diabetes mellitus * any contraindication to exercise training

Keywords: exercise high intensity interval training pregnancy outcome placental circulation fetal blood heart rate, fetal
a phase 1 dose escalation study of av-203, an erbb3 inhibitory antibody, in subjects with advanced solid tumors

Conditions: Solid Tumors

Summary: this is a phase 1, multi-center, open-label, multiple dose, dose escalation study to evaluate the safety, tolerability, dose limiting toxicities (dlts), maximum tolerated dose (mtd) and/or recommended phase 2 dose (rp2d), pharmacokinetic (pk), pharmacodynamics, and preliminary anti-tumor activity of av-203, an erbb3 inhibitory antibody, administered once every 2 weeks via intravenous (iv) infusion in subjects with metastatic or advanced solid tumors. once the rp2d is determined, patients with tumor types of interest will be evaluated in an expansion cohort at the rp2d for safety and anti-tumor activity.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * histologically and/or cytologically confirmed primary diagnosis * metastatic or advanced solid tumor, that has recurred or progressed following standard therapies, or for which no standard therapy exists * must have available tumor tissue or be willing to undergo biopsy prior to enrollment * eastern cooperative oncology group (ecog) performance status of 0 or 1 * blood chemistry and hematology results within defined limits exclusion criteria: * history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent * current central nervous system (cns) or leptomeningeal metastases, or history of cns or leptomeningeal metastases. * significant conduction disturbance, history of a severe arrhythmia, or history of a familial arrhythmia * significant cardiovascular disease * significant thromboembolic or vascular disorders within prior 3 months * any other medical condition or psychiatric condition that, in the opinion of the investigator, might interfere with the subject's participation in the trial or interfere with the interpretation of trial results * known history of positive results for hepatitis c, hepatitis b, or human immunodeficiency virus. * for female subjects, pregnancy or lactation.

Keywords: av203 solid tumors erbb3 monoclonal antibody her3
comedication study assessing mono- and combination therapy with levodopa-carbidopa intestinal gel

Conditions: Parkinson's Disease (PD)

Summary: the purpose of this study is to evaluate treatment of advanced parkinson's disease (pd) patients on levodopa-carbidopa intestinal gel (lcig) monotherapy in a routine clinical setting.

participants with advanced parkinson's disease who have been prescribed lcig for at least 12 months will be entered into the study cohort. clinical data will be collected by retrospective review of the participant's medical records as well as a single study visit for current data. treatment of the participants and follow up will be according to the physician's judgment, regional regulations and the product monograph.

Eligibility criteria:
inclusion criteria: * participants diagnosed with apd and on lcig treatment for at least 12 months * participant must have been on continuous lcig treatment for at least 80% of days in the preceding year * participants must be treated by the same physician (principal investigator or co-investigator) since the initiation of lcig treatment exclusion criteria: * participation in a concurrent or a previous interventional clinical trial during which the participant was on lcig therapy * lack of motivation or insufficient language skills to complete the study questionnaires

Keywords: advanced parkinson's disease levodopa-carbidopa intestinal gel (lcig)
perform = pentaglobin® registry for outcome report and monitoring

Conditions: Severe Bacterial Infection

Summary: international registry on the use of pentaglobin® in patients with severe bacterial infections; multicentric, international registry, non-interventional trial

aim of the pentaglobin® registry of adult critically ill patients with severe infections is primarily to assess the effects of ivigam on the aforementioned outcome parameters and its side effects under real-life conditions based on a prospective, high-quality data documentation * age ≥ 18 years * diagnosis of severe bacterial infection * pentaglobin® use * signed informed consent for data collection exclusion criteria none primary endpoints * comparison apache ii and saps ii predicted mortality vs. observed hospital mortality and * difference in sofa scores, baseline vs. posttreatment (24 h after last application) assessment secondary endpoints * in-hospital mortality total and in subgroups according to baseline igm serum levels (\< 80 mg/dl vs. ≥ 80 mg/dl) and baseline crp (\< 70 mg/l vs. ≥ 70 mg/l) * change in mof score from the day before treatment start till 24 h after last application of pentaglobin * course of laboratory markers (concentration-difference): crp, procalcitonin, il-6, igm, iga, igg before treatment start till 24 h after last application as far as available in the centers * duration of icu stay (days) * duration of hospital stay (days) * time from onset of severe bacterial infection to start of treatment

Eligibility criteria:
inclusion criteria: age ≥ 18 years * diagnosis of severe bacterial infection * pentaglobin® use * signed informed consent for data collection - exclusion criteria: -

Keywords: pentaglobin® use severe bacterial infection
combination of cryosurgey and nk immunotherapy for recurrent tongue cancer

Conditions: Recurrent Tongue Cancer

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

by enrolling patients with recurrent tongue 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: tongue cancer cryosurgery nk immunotherapy
retention of complete denture using rapid prototyping

Conditions: Retention of 3D Printed Dentures

Summary: nineteen patients will be selected from the clinic following the inclusion and exclusion criteria. each one of them will receive two dentures. the first denture will be a conventional complete denture while the second denture will be a complete denture made by rapid prototyping method. for both groups, a preliminary impression will be made \& after pouring the primary impression, self-cured acrylic resin trial denture bases with a wax rim will be constructed on the primary casts for the upper \& lower arches for a jaw relation record. a facebow record will be used to mount the upper cast, while the lower cast will be mounted using a centric relation record. setting of artificial teeth will be performed, then the denture will be tried in patient's mouth. functional impression will be taken during the try in stage which. for the first denture, the functional impression will be poured in normal way to obtain the master cast. then processing will be done in normal way and the denture will be finished and polished and delivered to the patient. but for the second denture construction cbct scanning of the try in with the functional impression will be done to obtain stl file then denture base manufacturing will be done by 3d printing. for group a and group b retention will be measured for the upper denture immediately, with a wash out period one month between the two dentures.

heat processed denture base is the treatment of choice for most of edentulous patients and it is considered as the golden standard and the main comparator for the new techniques. but using heat cured acrylic resin would require many laboratory steps which introduce several errors . meanwhile, the introduction of rapid prototyping method with high accuracy which eliminates some of the laboratory steps was the reason for choosing it to compare it with the conventional method.

Eligibility criteria:
inclusion criteria: 1. age ranging from 40-70 years. 2. cooperative patients. 3. male or female patients exclusion criteria: 1. pathological changes of residual ridges. 2. patients with any systemic diseases. 3. patients with xerostomia. 4. patients with flabby and flat ridges. 5. patients with allergy to resins. 6. patient with sever undercuts, or irregular bony exostosis. -
pilot study of the hwl program

Conditions: Overweight and Obesity

Summary: the goal of the project is to test a remotely delivered, standalone behavioral weight loss intervention designed to help adults initiate the important dietary, physical activity (pa) and behavioral changes necessary to achieve weight loss.

the weight management center currently offers a remotely delivered (smart phone, tablet, computer) program to assist patients with maintaining weight losses already achieved, which includes multi-channel self-monitoring and asynchronous individually recorded feedback from clinical staff. the goal of the presently proposed project is to build on this existing maintenance-focused program to create a remotely delivered, standalone behavioral weight loss intervention designed to help participants initiate the important dietary, physical activity (pa) and behavioral changes necessary to achieve weight loss. we recently developed the home weight loss (hwl) program by repackaging existing clinical educational materials as instructional lifestyle change modules to be delivered remotely for participant weight loss the aim of the proposed project are to pilot test the effects of the hwl program among a sample of overweight and obese adults (n=30). the digital platform currently used in the maintenance program will be used for the hwl program

Eligibility criteria:
inclusion criteria: * aged 18-70 years * bmi = 25.0- 40 kg/m2 * internet access via desktop or laptop computer * valid email address * smart phone ownership * women of childbearing potential must agree to use effective contraception during the study exclusion criteria: * currently dieting (\>10-pound weight loss in past 3 months) * another member of the household is participating in this pilot study * inability to engage in physical activity * inability to read and speak english * diagnosis of diabetes (other than treated by diet alone), * uncontrolled thyroid condition or other endocrine disorder * major depressive disorder or other severe psychiatric disorder (e.g., bipolar disorder) within the past two years * past suicide attempt * current use of prescription or over-the-counter weight loss medications * current/planned pregnancy * drug and/or alcohol abuse * use of steroid medication for more than 10 days in the past three months \*implanted electronic devices

Keywords: telehealth remote weight loss self-monitoring diet physical activity
upfront treatment with chemotherapy and bevacizumab in advanced ovarian cancer

Conditions: Advanced Ovarian Cancer

Summary: our study aims at assessment of response, survival and toxicity of frontline treatment with chemotherapy and bevacizumab in patients having advanced epithelial ovarian cancer.

ovarian cancer is the most lethal gynecologic malignancy and is the fifth most common cause of cancer death in women .the majority of women with ovarian cancer are diagnosed with advanced-stage disease; only 15% of all cases are diagnosed with local disease. risk factors for ovarian cancer include family history, nulliparity, lack of breast feeding, and infertility . the gog-0218 trial demonstrated that the use of bevacizumab in the front-line and maintenance setting improved progression free survival by 3.8 months when compared with conventional every-3-weeks carboplatin and paclitaxel. the icon-7 trial also aimed to compare the progression free survival and overall survival in women who receive bevacizumab with carboplatin/paclitaxel and women receiving carboplatin/paclitaxel alone the final results of icon7 were announced in 2013. overall, the results showed no difference in overall survival between those in the group receiving bevacizumab han those in the group receiving no bevacizumab. however, for high-risk patients, who were most likely to have early disease progression, the results were positive and showed an improvement in overall survival of 4.8 months in the group who received bevacizumab. not only has the best route been intensely debated but the optimal timing of therapy has been and is currently being studied. chemotherapy is usually given either only after primary debulking surgery or as both neoadjuvant chemotherapy before and after interval debulking surgery. recent trials have tried to determine which treatment timing is associated with better outcomes . the aim of the study will be assessment of response, survival and toxicity of frontline treatment with chemotherapy and bevacizumab in patients having advanced epithelial ovarian cancer.

Eligibility criteria:
inclusion criteria: * female patients diagnosed with advanced ovarian cancer by biopsy * age more than 18 years old * routine labs are within normal values ( cbc, renal function tests , liver function tests ) * performance score 0-2 * figo stage ii-iv * not having any contraindication to bevacizumab as : uncontrolled hypertension , bleeding tendency , ischaemic events * chemotherapy naïve. * informed consent exclusion criteria: * patients previously received chemotherapy or radiotherapy to any part of the abdomen or pelvis * patients with uncontrolled infection * patients with clinically significant cardiovascular disease * patients with active bleeding or conditions associated with high risk of bleeding * patients with history of cns disease

Keywords: advanced ovarian cancer upfront treatment bevacizumab
clinical evaluation of insect repellent and insecticide treated nets in lao pdr

Conditions: Malaria; Dengue; Japanese Encephalitis

Summary: rural communities involved in agriculture are often at highest risk of insect-borne diseases in southeast (se) asia. skin-applied insect repellents may prove a useful means of reducing mosquito-borne diseases for those people working outdoors in high risk areas. this trial is evaluating the use of insect repellent (20% diethyltoluamide) to reduce incidence of malaria, japanese encephalitis and dengue. the investigators will recruit up to 1000 households from 100 villages in rural laos. in each house the investigators shall recruit up to 5 individuals. half of households will be randomised to repellent, half to a placebo. all individuals will be provided with insecticide treated bed nets for use at night. all household occupants will be followed for 7 months to record malaria cases by rapid diagnostic test every month. blood spots will be collected at start and end of study to measure japanese encephalitis and dengue. all positive cases will be promptly treated. outcome will be reduction in number of malaria cases (primary outcome) and dengue/japanese encephalitis (secondary outcomes).


Eligibility criteria:
inclusion criteria: * working in agriculture * available for monthly follow-up exclusion criteria: * allergy to repellent * pregnant / breastfeeding

Keywords: mosquito repellent vector control malaria
using preoperative anxiety score to determine the precise dose of butorphanol for sedation

Conditions: Preoperative Anxiety; Precise Dose of Butorphanol

Summary: pre-operative anxiety usually lead to increased anesthetics during the surgery. the precise sedative requirement which can keep adequate sedative state and avoid adverse effects caused by excessive drugs still needs further study. therefore, our purpose was to confirm the sedative effect of butorphanol and to explore the relationship between pre-operative anxiety and intra-operative butorphanol requirement to evaluate the precise sedative requirement which can keep adequate sedation for patients by pre-operative anxiety score.

a total of 142 patients (aged 18-75 years) who were scheduled for elective low limb orthopedic procedures under spinal anesthesia were included in this study. patients were divided into two groups based on pre-operative anxiety score evaluated by the amsterdam pre-operative anxiety and information scale before the surgery. and intramuscular midazolam 0.05mg/kg as a premedication in preoperative room was given to patients before shifting into operation room. patients in each group were randomly divided into butorphanol group and 0.9% saline group. the sedation score, the duration of reaching adequate sedation state and postoperative recovery were recorded.

Eligibility criteria:
inclusion criteria: * asa ⅰ-ⅱ * age 18-75 years * surgical operation of lower extremities in orthopedics * no contraindication of epidural anesthesia exclusion criteria: * with central system disease * with cardiovascular disease * with autonomic nervous system disease * long term use of analgesic drugs ,sedative drugs,and anti-anxiety drugs * language barrier * unwilling to cooperate with the experimenter

Keywords: butorphanol preoperative anxiety sedation recommend dose
placebo and active controlled, double dummy study to prove efficacy of aspirin in treatment of acute low back pain

Conditions: Low Back Pain

Summary: the purpose of this study is to determine the efficacy and safety of 1000 mg aspirin (the study medication) by comparing it to placebo (the control group without active substance) or 400 mg ibuprofen (the control group with an active substance) in treating the symptoms of back pain. the study is designed to develop a treatment method against back pain which will have more advantages for patients than the methods that are currently available.


Eligibility criteria:
inclusion criteria: * ambulatory male or female, 18 to 70 years of age * body mass index ranging in-between 18 and 30 kg/m² * normal blood pressure * patients suffering from low back pain * low back pain, localized below the costal margin and above the inferior gluteal folds, either as acute low back pain, or as chronic or intermittent low back pain exclusion criteria: * hypersensitivity to acetylsalicylic, salicylates, or other non steroidal anti-inflammatory drugs * serious physical illness especially uncontrolled disorders of kidney, liver, lung, heart or brain function, neurological disorders or severe chronic or terminal disease * pregnancy or lactation period * abuse of alcohol or addictive substances

Keywords: back pain acute low back pain
household influenza transmission study

Conditions: Influenza

Summary: the purpose of this study is to determine whether nonpharmaceutical interventions (i.e., handwashing and masks) reduce secondary transmission of influenza in households.

hits is a multi-year project that will prospectively identify laboratory-confirmed influenza infected children. secondary influenza infection will then be examined among members of the child's household and effectiveness of non-pharmaceutical interventions to decrease secondary infection will be assessed. the pediatric influenza-infected index case will be identified by rapid influenza testing and their household will then be enrolled and randomized to one of three study arms: control, hand washing (intervention 1), and hand washing and mask use (intervention 2). following enrollment, at days 0, 3 and 7, all household participants will be tested: the index case will be assessed for influenza viral shedding and household members will be assessed for secondary influenza infection. this study is being conducted at queen sirikit institute for child health in bangkok.

Eligibility criteria:
inclusion criteria: * child, 1 month through 15 years of age * resident of bangkok metropolitan area * outpatient of queen sirikit national institute of child health children's * hospital seen during hits' active study period * positive influenza rapid test result from patient presenting with influenza-like illness * in addition to the index case, consent must be obtained from at least 2 household members ≥1 month of age who plan to sleep inside the house for a period of at least 21 days from the time of enrollment exclusion criteria: * illness onset 48 hours or more before presentation and influenza testing at queen sirikit national institute of child health children's hospital * treatment with influenza antiviral medications since it may decrease secondary attack rate * children who are at high risk for severe influenza disease (e.g., chronic lung disease, renal disease, chemotherapy for cancer, long-term aspirin therapy) * a history of influenza-like illness in another household member that precedes the index case by 7 days or less will lead to exclusion of the household because the source of influenza infection for secondary cases is uncertain. * receipt of influenza vaccine by any household member during the preceding 12 months. * prior participation in hits.

Keywords: handwashing masks infectious disease transmission