Kornimate/medical-research-clean huggingface dataset:
the ibd&me randomized controlled trial

Conditions: Inflammatory Bowel Diseases

Summary: navigating the risk-benefit profiles of the various biologic options approved for inflammatory bowel disease (ibd) can be challenging for patients who are considering biologic therapies as a treatment option. thus, there is a need for simple and efficient tools that elicit individual preferences and support the patient-provider interaction. the principal objective of this study is to assess the impact of an online decision aid called ibd\&me on patient perceptions of shared-decision making as compared to a standardized education arm.

context: navigating the risk-benefit profiles of the various biologic options approved for inflammatory bowel disease (ibd) can be challenging for patients who are considering biologic therapies as a treatment option. thus, there is a need for simple and efficient tools that elicit individual preferences and support the patient-provider interaction. objective: the principal objective of this study is to assess the impact of an online decision aid called ibd\&me on patient perceptions of shared-decision making as compared to a standardized education arm. hypothesis: ibd\&me, through optimizing shared-decision making (sdm) and improving the patient-provider interaction, will provide incremental benefits beyond those provided by high-quality educational material without an sdm tool. design: pragmatic multicenter randomized controlled trial in ibd outpatient care 1. intervention: ibd\&me is an online, freely available tool that allows patients to explore decision-making around biologic therapies for ibd at their own pace 2. control arm: standardized, high-quality educational material from the crohn's \& colitis foundation

Eligibility criteria:
inclusion criteria: * 18 years of age or older * have ulcerative colitis (uc), crohn's disease (cd), indeterminate colitis, or inflammatory bowel disease unclassified (ibd-u) * have experienced ibd related symptoms in the 30 days before screening * considering discussing biologic therapies for controlling his or her ibd at the next clinic visit * have an ibd-related visit scheduled at least 7 days and no later than 3 months following screening exclusion criteria: * does not speak english * does not have access to the internet
personalized interactive laser therapy of port wine stain

Conditions: Port Wine Stain

Summary: lasers are being used to treat port wine stains (pws), but the laser doesn't always work. only about 10% of pws can be completely cleared. the research team believes that the investigators can improve the response of pws to laser therapy by using a computer program that the principal investigator of this study (dr. shafirstein phd) has developed. the purpose of this study is to test the validity of this computer program. personalized interactive laser therapy (pilt) could significantly improve clinical outcomes of laser treatment of pws.


Eligibility criteria:
inclusion criteria: * diagnosed with a pws * at least one visible pws measuring greater than or equal to 15 mm in diameter. * information provided regarding alternative treatment methods, includig no treatment. * reading, understanding, and signing of an informed consent document. * children age 7 years or older has read, understood, and signed an assent document. * agreement to participate in the study. * agreement to return to at least 1 follow-up evaluation and treatment within 1 year after first treatment. * zubrod performance status of 0 or 1 at screening. exclusion criteria: * inability or unwillingness of subject to participate in the study. * inability or unwillingness of one parent or legal guardian of the subject to sign written informed consent document. * subject can not return to at least 1 follow-up visit within 1 year, after the first treatment.

Keywords: diagnosis port wine stain pws
us ovulation inhibition study in obese women

Conditions: Contraception

Summary: birth control patch study


Eligibility criteria:
inclusion criteria: * female subject requesting contraception * age: 18 - 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent * normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months) * history of regular cyclic menstrual periods * willingness to use non-hormonal methods of contraception during the entire study. exclusion criteria: * pregnancy or lactation (less than 3 menstrual cycles since delivery, abortion, or lactation before start of treatment) * hypersensitivity to any ingredient of the study drug * significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape * any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug (e.g., known skin disease with suspected alteration of dermal absorption or poor adherence of the patch such as psoriasis) * any disease or condition that may worsen under hormonal treatment.

Keywords: pregnancy prevention female contraception patch
a study of ro6811135 in patients with type 2 diabetes who are inadequately controlled with metformin

Conditions: Diabetes Mellitus Type 2

Summary: this multi-center, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety and tolerability of ro6811135 in type 2 diabetic patients treated with a stable dose of metformin.


Eligibility criteria:
inclusion criteria: * adults between the age of 18 and 65 * have been diagnosed with diabetes for at least 3 months and treated with a stable dose of metformin for at least 8 weeks * hemoglobin a1c between 7.2 and 10.5% * fasting plasma glucose less than 250 mg/dl * c-peptide greater than 1.5 ng/ml * body mass index (bmi) between 27 and 44 exclusion criteria: * pregnant or lactating women * type 1 diabetes * had undergone weight loss surgery or weight loss procedure involving the gastrointestinal tract, such as gastric bypass, gastric stapling, or gastric banding * uncontrolled hypertension or other significant cardiovascular disease as determined by investigator * significant kidney or liver disease as determined by the investigator
combined cbm for social anxiety in turkey

Conditions: Phobia, Social

Summary: in this study, it was examined whether or not combined attentional and interpretational bias modifications with university students who display social anxiety symptoms may lead to a decrease in social anxiety-related complaints. the study was conducted with 84 participants who were university students displaying social anxiety symptoms. the participants were randomly assigned into two conditions; cognitive bias modification group (e) and placebo-control group (c). participants in group-e were subjected to attentional and interpretational bias modifications twice a week, eight sessions in total. participants in group-c were subjected to a similar process, but without any modification. the levels of social anxiety, anxiety, depression, nonfunctional thinking of the participants were evaluated three times; just before the first session, just after the last session and two months after the last session. in addition, levels of attentional and interpretational bias of the participants were evaluated twice, just before the first session and just after the last session.

a 2 (group: experimental, control) × 3 (time: pretest, posttest, follow-up) experimental design was employed. all participants were presented with informed consent form beforehand, and also verbally informed about the procedure. they were assigned to experimental (e) or attention placebo control (c) groups for 2 sessions per week, 8 sessions in total. before the first session (pretest) and after the last session (posttest), participants were asked to answer self-report questionnaires, and their attentional and interpretational biases were assessed. and finally, participants were asked only to answer to the same questionnaires for the follow up measurements after two months. chi square test and independent t-test for dependent variables were run beforehand to check if participants were equally distributed to bias modification group-e and group-c. no statistically significant difference between group-e and group-c was observed with regards to gender distribution, social anxiety, anxiety, depression, dysfunctional thoughts, automatic thoughts, and attentional and interpretational biases. to see the effect of 8 sessions of manipulation on attentional and interpretational bias (independent variable) created a significant difference between experimental and control groups, 2 (group: experimental \[e\] and control \[c\]) × 3 (time: pre \[t1\] / post \[t2\] / follow-up \[t3\]) mixed anova was conducted for each dependent variable in self-report measurements, and 2 (group: experimental \[e\] and control \[c\]) × 2 (time: pre \[t1\] / post \[t2\]) mixed anova were conducted for attentional and interpretational biases.

Eligibility criteria:
inclusion criteria: * scoring above 68 on the liebowitz social anxiety scale exclusion criteria: * having any psychiatric disorder * receiving a psychiatric/psychological treatment
effect of goal-directed crystalloid versus colloid administration on major postoperative morbidity

Conditions: Postoperative Complications

Summary: a trial in which patients having open abdominal surgery are randomized to receive either crystalloids or colloids intraoperatively, guided by esophageal doppler. the investigators test the primary hypothesis that goal-directed colloid administration during elective abdominal surgery decreases a composite of postoperative complications within 30 days of surgery.

patients will be given 5-7 ml/kg of crystalloid (lactated ringer's) in the immediate preoperative period, which will be followed by 4 ml/kg/h crystalloid for maintenance normalized to ideal body weight \[men: ideal body weight (in kilograms) = 52 kg + 1.9 kg for every 2.5 cm over 150 cm; women: ideal body weight (in kilograms) = 49 kg + 1.7 kg for every 2.5 cm over 150 cm\]. they will then be randomly assigned to additional volume replacement, guided by esophageal doppler, to either lactated ringer's solution of voluven starch.

Eligibility criteria:
inclusion criteria: * asa physical status 1-3 * body mass index \< 35 * moderate risk elective abdominal surgical procedures scheduled to take ≥ two hours done under general anesthesia. exclusion criteria: * cardiac insufficiency (ef\<35%) * coronary disease with angina (nyha iv) * severe chronic obstructive pulmonary disease * coagulopathies * symptoms of infection or sepsis * renal insufficiency (creatinine clearance \<30ml/min or renal replacement therapy) * asa physical status \> 3.

Keywords: iv fluid recovery goal directed fluid replacement improved patient recovery
the effect of combined spinal-epidural analgesia on the success of external cephalic version (ecv) for breech position

Conditions: Pregnancy; Breech Presentation

Summary: we aim to answer the clinical question: does combined spinal-epidural analgesia improve the success rate of external cephalic version? we hypothesize that neuraxial analgesia (spinal or epidural analgesia) during version for breech presentation increases successful fetal rotation and decreases the incidence of cesarean delivery for malpresentation.

at term 2 to 3% of singleton pregnancies are in breech presentation. many of these deliveries are managed by cesarean delivery due to higher neonatal morbidity associated with vaginal breech delivery. cesarean delivery, the safer option for the baby, however, is associated with a higher incidence of maternal complications for both the current and subsequent pregnancies. external cephalic version is a procedure commonly used to attempt to manually rotate the fetus into vertex position. this facilitates vaginal delivery and thus avoids higher maternal and/or neonatal complications. obstetricians perform versions after 36 weeks gestational age with a reportable success rate of 30-80%. the most common technique involves external manipulation of the fetal position preceded by pharmacologic uterine relaxation. pain relief is most commonly provided in the form of intravenous opioids such as fentanyl. a more efficacious form of analgesia is the use of neuraxial opioids and local anesthetics (neuraxial analgesia), a technique commonly used for labor and delivery analgesia. although the use of neuraxial analgesia and anesthesia techniques improve maternal pain and satisfaction, there is conflicting evidence if they improve the success rate of version procedures. the american college of obstetricians and gynecologists (acog) has stated, "currently there is not enough evidence to make a recommendation favoring or opposing anesthesia during ecv (external cephalic version) attempts." we propose to conduct a prospective, single blinded, randomized clinical trial to assess the impact of combined spinal-epidural analgesia on the success rate of external version for breech fetal position and the subsequent incidence of vaginal vs. cesarean delivery as a secondary outcome.

Eligibility criteria:
inclusion criteria: * 18-55 years of age * female * pregnant * breech presentation * greater than 36 weeks gestation * version procedure exclusion criteria: * under 18 or over 55 years of age

Keywords: pregnancy 37 weeks gestation breech presentation version procedure pain control neuraxial analgesia
safety and efficacy of exosomes overexpressing cd24 in two doses for patients with moderate or severe covid-19

Conditions: Covid19

Summary: this is a phase ii randomized, single-blind dose study to evaluate the safety and efficacy of exosomes overexpressing cd24 of two doses, dose 1 - 10\^9 exosome particles (per dose) versus dose 2 - 10\^10 exosome particles (per dose), to prevent clinical deterioration in patients with moderate or severe covid-19 infection.

the study population will include patients with moderate or severe covid-19 and laboratory markers predictive of the cytokine storm, who have provided an informed consent. 90 patients will be randomized in a 1:1 ratio to receive either 109 exosome particles (45 patients) or 1010 exosome particles (45 patients). the exosomes will be diluted in normal saline for inhalation via mouthpiece nebulization, administered once daily (qd) for 5 days. study treatments will be given as an add-on to the standard of care. following the 5 days of treatment, patients will remain in follow-up for 23 additional days. in case of hospital discharge before the full follow-up planned, the patient will be required to return to the site for completion of all study assessments.

Eligibility criteria:
inclusion criteria: 1. a covid-19 diagnosis confirmed with a sars-cov-2 infection positive polymerase chain reaction (pcr) within 30 days of screening. 2. age 18-80 years. 3. severity of disease according to the following criteria (at least one clinical parameter and one laboratory parameter are required): a. clinical and imaging-based evaluation i. respiratory rate \> 23/min and \ 25% within 24-48 hours or a severe deterioration compared to imaging at admission. b. evidence of an exacerbated inflammatory process i. ldh \> 300 u/l or what is the upper limit for normal per age ii. crp \>25 mg/l iii. ferritin \>500 ng/ml iv. lymphocytes \ 500ng/ml 4. willing and able to sign an informed consent. exclusion criteria: 1. any concomitant illness that, based on the judgment of the investigator might affect the interpretation or the results of the study (i.e., immunodeficiency). 2. mechanically-ventilated patient or patient who will probably require icu admission or mechanical ventilation within 24 hours from enrolment, according to the investigator's judgment. 3. previous complete or partial vaccination for sars-cov-2. 4. pregnancy \[positive urine pregnancy test (women of childbearing potential only)\] or breastfeeding. 5. participation in any other interventional study in the last 30 days 6. active cancer.
online study of colorectal cancer and prostate cancer screening decision making

Conditions: Colorectal Cancer; Colon Cancer; Prostate Cancer

Summary: participants will be recruited from the united states and australia to take an online survey about colon cancer screening or prostate cancer screening. individuals selected for both the prostate cancer survey and the colon cancer study will be randomized to take one of three survey types - balance sheet, rating and ranking or conjoint analysis. these surveys will help participants clarify their values and opinions about screening options for colon cancer or prostate cancer. participants' responses to the online survey are measured at one point in time - the time at which the participant takes the survey.

this study will compare effect of a conjoint analysis based values clarification exercise, ranking and rating, and a balance sheet on screening test preferences for colorectal cancer screening and prostate cancer screening using online surveys. recruitment will be conducted through survey sampling international (ssi), an online survey research firm. participants will be randomized to one of three arms to take online surveys. patients will complete either a conjoint analysis task, in which they will be asked to make a series of choices between hypothetical screening testing strategies with different attributes; a rating and ranking task for these same attributes; or they will make a choice after viewing a balance sheet of attributes.

Eligibility criteria:
inclusion criteria: * colorectal cancer * men and women, ages 50-75, who can speak and read english. * prostate cancer screening * men, ages 50-75, who can speak and read english. exclusion criteria: * colorectal cancer * individuals with a previous personal or family history of colon cancer, personal history of polyps, or inflammatory bowel disease will be excluded. * prostate cancer * individuals with a previous personal or family history of prostate cancer will be excluded

Keywords: colon prostate cancer
inflammatory response to paramyxovirus infection in an ex-vivo model of bronchial epithelial cells in allogeneic hsct recipients

Conditions: Stem Cell Transplantation

Summary: introduction. chronic graft-versus-host-disease (gvhd) is the main late noninfectious complication after allogeneic hematopoietic stem cell transplantation (hsct) that can affect several organs. bronchiolitis obliterans syndrome (bos) is recognized as pulmonary chronic gvhd. a diagnosis of a lower respiratory tract infection in the first 100 days following transplant has been associated to the development of bos. one hypothesis is that the first stage driving to bos is a previous aggression of bronchial epithelial cells by various factors such as chemotherapy and radiotherapy. thereafter, data suggest that viral infections, in particular parainfluenza viruses could be a trigger for bos. the alloimmune reaction activated by the respiratory virus could lead to the fibrosis process. our hypothesis is that the bronchial epithelium of allogeneic hsct recipients has phenotypic specificities that are associated with a specific response to the viral respiratory infections (in particular paramyxovirus) leading to the development of bos. main objective. to characterize and compare the inflammatory response after infection with parainfluenza 3 virus in an ex-vivo model of bronchial epithelial cells obtained from allogeneic hsct recipients and controls. objective secondary. to characterize the phenotypic specificities of allogeneic hsct recipients' bronchial epithelium. methodology, and experimental plan. prospective, monocentric research. bronchial biopsies obtained from patients, will be completely differentiated after 21 days of culture. epithelial cells will be infected by the virus strain parainfluenza 3. transcriptome of the cells from both allogeneic hsct patients and controls, infected and non-infected will be analyzed 48 hours after infection.


Eligibility criteria:
inclusion criteria: * allogeneic hsct patients \[case\] * requirement of ng bronchial fibroscopy with bronchial biopsies for the exploration of fev1 decline \[case\] * non allogeneic hsct patients \[control\] * .requirement of bronchial fibroscopy for exploration of a lung mass or of interstitial lung disease, requiring bronchial biopsies \[control\] exclusion criteria: * minor or major patients protected * radiotherapy or chemotherapy \[control group\] * respiratory infection * history of smoking \>= 15 packs/yr
dose escalation study with cabazitaxel in combination with daily prednisolone in patients with hormone refractory prostate cancer

Conditions: Prostate Cancer

Summary: primary objective: * to assess the tolerability at global doses secondary objectives: * safety * pharmacokinetics * efficacy

the duration of screening within 28 days, treatment 3 weeks/cycle and follow-up 30 days after the last cabazitaxel administration.

Eligibility criteria:
inclusion criteria : i 01. diagnosis of histologically or cytologically proven prostate adenocarcinoma, that is refractory to hormone therapy (received prior castration by orchiectomy and/or internal medicine, and documented progression of disease or relapse) who has previously been treated with docetaxel. i 02. signed informed consent prior to beginning protocol specific procedures. i 03. patients with psa \>20 ng/ml at screening. exclusion criteria: e 01. age \ 74 e 02. ecog performance status ≥2. e 03. prior surgery ≤4 weeks of registration in the study. e 04. active secondary cancer including prior malignancy from which the patient has been disease-free for ≤5 years (however, adequately treated superficial basal cell skin cancer before 4 weeks prior to registration can be eligible to the study) e 05. inadequate organ function including: neutrophils \ 1.5 mg/dl. total bilirubin \>1.5 times the upper normal limits of the institutional norms alt/ast \>1.5 times the upper normal limits of the institutional norms e 06. previous treatment with \<225 mg/m2 cumulative dose of taxotere® (or docetaxel). the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.