Kornimate/medical-research-clean huggingface dataset:
sitaxsentan efficacy and safety trial with a randomized prospective assessment of adding sildenafil (sr-paas)

Conditions: Pulmonary Arterial Hypertension; Pulmonary Hypertension

Summary: this protocol is for subjects with pulmonary arterial hypertension and is the first of 3 studies forming the sitaxsentan efficacy and safety trial with randomized prospective assessment of adding sildenafil (sr-paas) program.


Eligibility criteria:
inclusion criteria: * current diagnosis of symptomatic pulmonary arterial hypertension (pah) classified by one of the following: idiopathic arterial hypertension (ipah), primary pulmonary hypertension (pph), familial pulmonary arterial hypertension (fpah) or pulmonary arterial hypertension (pah) associated with connective tissue diseases. has who functional class iii symptoms. exclusion criteria: * previous exposure to an endothelin receptor antagonist (etra) such as sitaxsentan, bosentan or ambrisentan.

Keywords: sitaxsentan endothelin receptor antagonist
study of magrolimab (hu5f9-g4) in combination with avelumab in solid tumor participants and checkpoint-inhibitor-naive ovarian cancer participants who progress within 6 months of prior platinum chemotherapy

Conditions: Ovarian Cancer

Summary: the primary objectives of this study are to investigate the safety and tolerability of magrolimab in combination with avelumab in participants with advanced solid tumors and to confirm the safety and tolerability of this combination and evaluate the anti-tumor activity in participants with checkpoint inhibitor-naive ovarian cancer, fallopian tube cancer, and primary peritoneal carcinoma who have previously progressed within 1-6 months of receiving platinum chemotherapy.


Eligibility criteria:
key inclusion criteria: * safety run-in cohort: pathologically confirmed advanced solid tumors. * ovarian cancer expansion cohort: histologically or cytologically confirmed, epithelial ovarian, fallopian tube, or peritoneal cancer. * checkpoint inhibitor naive participants. * willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy. * adequate performance status. adequate hematological, liver, and kidney functions. * availability of pre-treatment tumor tissue to evaluate programmed cell death-ligand 1(pd-l1) expression. key exclusion criteria: * individuals with symptomatic or untreated central nervous system (cns) metastases. * prior treatment with cluster of differentiation 47 (cd47) or signal regulatory protein alpha (sirpα) targeting agents. * known active or chronic hepatitis b or c infection or human immunodeficiency virus (hiv). * red blood cell transfusion dependence. * prior organ transplantation requiring immunosuppression or active autoimmune disease. * significant medical diseases and/or history of uncontrolled intercurrent illness or other serious medical condition. * pregnancy or active breast feeding. note: other protocol defined inclusion/exclusion criteria may apply.
a study of eptinezumab in participants with migraine and medication overuse headache

Conditions: Migraine; Medication Overuse Headache

Summary: medication overuse headache (moh) is a type of headache caused by excessive use of acute headache or migraine medications (medications used to treat a headache or migraine once it begins). treatment of moh usually involves reducing the dose of or discontinuing acute medications. eptinezumab is a medication used for the preventive treatment of migraine in adults. the main goals of this trial are to learn whether eptinezumab helps reduce the number of days with migraine, the number of days with headache, and acute medication use in adults who have migraine and moh.

the total study duration from screening visit to safety follow-up visit is approximately 36 weeks and includes a screening period (4 weeks), a placebo-controlled period (12 weeks), an open-label period (12 weeks), and a safety follow-up period (8 weeks).

Eligibility criteria:
inclusion criteria: * the participant has a diagnosis of migraine or moh as defined by ihs ichd-3 guidelines confirmed at the screening visit. * the participant has ≥8 migraine days per month for each month within the past 3 months prior to the screening visit. * the participant has ≥15 headache days per month for each month within the past 3 months prior to the screening visit. * the participant has had an onset of migraine diagnosis at ≤50 years of age. exclusion criteria: * the participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome). * the participant has a diagnosis of acute or active temporomandibular disorders. * the participant has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration). * the participant has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6 months prior to the screening visit. * the participant has a history of clinically significant cardiovascular disease including uncontrolled hypertension, vascular ischaemia, or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism). other inclusion and exclusion criteria may apply.

Keywords: eptinezumab migraine medication overuse headache brief educational intervention
use of ipro™2 in real life diabetes management of type 2 patients in india

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the india ipro2 study is to demonstrate that ipro2 continuous glucose monitoring system (cgms) evaluation enables health care professional (hcp)s treating patients in india with type 2 diabetes to get a better understanding of their patient's metabolic fluctuations, and support appropriate therapeutic intervention.

the study will be designed to demonstrate the value of ipro2 in real-world diabetes management in type 2 patients in india. it will be an interventional post-market, prospective, multi-center study with a data review performed after 30 subjects have completed the trial. during the course of the study, patients will undergo two ipro2 evaluations: * first ipro2 test (visit 1 \[application\] \& 2 \[removal\]) * second ipro2 test (visit 3 \[application\] \& 4 \[removal\]) patient and hcp questionnaires will be administered at visit 1, 2, 3, 4 and 5. these questionnaires aim to assess the impact of an ipro2 evaluation on the physicians understanding of their patient's metabolic fluctuations and its support of therapeutic interventions. they will also investigate the subjects understanding (both pre \& post ipro2 evaluation) of the concept of glycemic variability and the importance of compliance to hcp recommendations.

Eligibility criteria:
inclusion criteria: 1. subject is \> 18 years to ≤ 70 years of age 2. subject has been diagnosed with type 2 diabetes mellitus for at least 1 year and is currently being treated with an oral anti-hyperglycemic medication and/or insulin 3. subject's a1c \> 8.0% to ≤ 10% conducted in the last 4 weeks 4. subject, or legal representative, has signed the study patient informed consent form (pic) 5. subject is willing to comply with the study procedures exclusion criteria: 1. subject is unable to tolerate tape adhesive in the area of sensor placement 2. subject is pregnant, or is expecting to become pregnant during the course of the trial per investigator discretion. 3. subject has no experience with smbg and blood glucose meter use 4. subject has undergone an ipro evaluation during the past 6 months 5. subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, staphylococcus infection) 6. subject is actively participating or planning to actively participate in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks 7. subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator 8. subject has unresolved alcohol or drug addiction

Keywords: type 2
optimal temperature control in body contouring procedures

Conditions: Hypothermia; Postoperative Pain; Postoperative Nausea; Postoperative Complications; Postoperative Shivering; Postoperative Hemorrhage

Summary: the goal of this clinical trial is to compare different strategies for normothermia prevention in patients undergoing body contouring and other aesthetic plastic surgery procedures. the main question(s) it aims to answer are: * do active measures have an impact on preventing hypothermia in patients undergoing cosmetic procedures? * does an active normothermia prevention protocol have any impact in the clinical setting? four different protocols will be used for patient peroperative preparation for normothermia.

participants will receive either of four different protocols for normothermia: group 1 (control) involved patients with standard temperature management according to regular institutional protocol, without preoperative or intraoperative thermal protection measures. group 2 (passive thermal protection measures) had patients who underwent one-hour preoperative warming with hot air at 38°c (100.4°f), the operating room (or) temperature was maintained at a minimum of 21°c (69.8°f), aseptic/antiseptic solutions along with infiltration fluid were all warmed to 38°c (100.4°f), and surgical fields were kept as dry as possible. in group 3 (active thermal protection measures), patients received the same measures as group 2, adding continuous intraoperative temperature protection, using a thermal convection blanket by water flow (blanketrol®) at 40°c (104°f). group 4 (active thermal protection measures) included patients with the same measures as group 2, adding permanent intraoperative thermal protection measures with conductive fabric electric warming device (hotdog®) at 40°c (104°f).

Eligibility criteria:
inclusion criteria: * patients undergoing body contouring procedures (liposuction or liposculpture), either individually or combined with a maximum of two other major aesthetic procedures involving face, breast, or dermolipectomy. * healthy patients without underlying comorbidities (classified as asa≤ii) exclusion criteria: * women with bmi \>30 kg/m² * men with bmi \>32 kg/m² * patients after massive weight loss * smokers

Keywords: normothermia body contouring warming blankets safety high-definition liposuction
lactocare baby drops in infants colic

Conditions: Infant Colic

Summary: the objective of this study is to determine an efficacy of the combination of l. rhamnosus 19070-2 (floraactivetm) and l. reuteri dsm 122460 (floraactivetm) in decreasing cry/fuss in infants aged 4 through 12 weeks with ic. the active group of infants will receive lactobacilli with vitamin d3 while the control group will receive vitamin d3 2 times daily as oil suspension for 28 days. duration of infant fuss/cry will be measured at baseline and at the end of intervention to define a difference between the groups

there is accumulating interest in role of lactobacilli in decreasing cry and fuss in infant colic, the condition that affects around 1 of 4-5 infants. the interest for dietary supplementation has been evoked by a line of earlier studies, indicating that infants with colic had an increased number of gas-forming e.coli in the intestines and potential interference between lactobacilli and e.coli. systematic review of evidence, based on the 6 randomized controlled dietary studies, conducted in italy, poland, australia, canada, and finland, has concluded of the decrease of the mean time cry of infant by -55 minutes a day after the 3 weeks dietary course with lactobacilli . in the mentioned studies most commonly used lactobacilli were l. reuteri, however, the effect of combination of l. reuteri with other lactobacilli remains unknown.

Eligibility criteria:
inclusion criteria: 1. informed consent form signed by both parents. 2. gender: males and females; 3. age: 4 -12 weeks; 4. infant colic, defined as cry/fussing lasting \> 3 h, occurring \> 3 d for 7 days; 5. gestational age 37-42 weeks; 6. birth weight 2,500-4,200 g; 7. stated availability throughout the study period; 8. sated availability of mobile phone or phone with answering machine. exclusion criteria: 1. any formula feeding in any amount; 2. failure to thrive (weight gain less than 100 grams per week as averaged from the birth weight to the weight at entry); 3. current maternal smoking; 4. known moderate or severe disease of any systems (neural, skeletal, muscular, cutaneous, gastrointestinal, respiratory, genital, urinary, immune); 5. present intake of antibiotics by infant or mother; 6. present intake of prebiotics or probiotics by infant or mother; 7. difficulty of parents to comprehend study requirements as judged by the physician; 8. suspected parental alcohol or drug addiction as judged by the physician.
routine versus selective midtrimester ultrasound in a poorly resourced setting: a cluster randomised controlled trial

Conditions: Fetal Congenital Abnormalities; Prolonged Pregnancy; Multiple Pregnancy

Summary: it is debatable whether routine ultrasound scanning of pregnancies at about 20 weeks of pregnancy has substantive benefits for mothers and babies. few studies have addressed this issue in poorly resourced settings. this trial will attempt to determine the benefits, if any, of a policy of routine ultrasound scanning of normal pregnancies versus a policy of no routine (only selective) scanning. this will be done by recruiting about 900 women in south africa, and randomly allocating about half to routine scanning and half to selective scanning groups, and following up their pregnancies.

routine ultrasound scanning in the second trimester of pregnancy has few substantive benefits, according to the results of number of randomised trials, mostly performed in industrialised countries. while ultrasound did not seem to prevent fetal death, it was associated with improved detection of multiple pregnancies, improved detection of congenital abnormalities and reduced need for postterm labour induction. only one trial, from cape town, has investigated the benefits of a policy of routine second trimester ultrasound scanning in an under-resourced setting. this will be cluster randomised controlled trial, performed in the krugersdorp area of south africa, where most health service users are african, working class and dependent on government health facilities. about 900 low-risk pregnant women at less than 24 weeks gestation will be recruited, and randomised, in clusters, to either routine scanning or no scanning with recourse to selective scanning if clinically indicated. women will be followed up for maternal, fetal and neonatal outcome, and for indices of health service utilisation. important outcome measures will be need for subsequent ultrasound,detection of multiple pregnancy, detection of congenital abnormalities, postterm pregnancy induction, still birth,and neonatal morbidity and mortality. data analysis will compare outcomes according to whether routine ultrasound scanning was or was not done, using standard statistical methods.

Eligibility criteria:
inclusion criteria: * pregnancy, 24 weeks pregnant or less, willing to participate exclusion criteria: * high risk pregnancy condition, e.g. poor past obstetric history, hypertensive disease, previous caesarean section
us promybetaapp2.0: a study to learn more about the medication usage and patient reported outcomes via the mybetaapp in medical care of patients with multiple sclerosis treated with betaseron using betaconnect autoinjector

Conditions: Multiple Sclerosis

Summary: in this study researchers want to learn more about the medication usage behavior among multiple sclerosis (ms) patients treated with betaseron using the mybetaapp. multiple sclerosis (ms) is a disease in which the covering called "myelin" around the nerves of the central nervous system degenerate. ms is a lifelong disease therefore requiring continuous treatment to delay the disease progression and reduce the rate of relapse (the return of signs and symptoms of). betaseron is an approved medicine used to reduce the relapse in patients with ms. it is injected into the tissue under the skin using betaconnect autoinjector, which automatically captures injection data including injection date, time, speed, and depth and uploads the data into paired mybetaapp. this allows patients to organize and track their progress and share the injection information with their physicians. the medication usage behavior to be collected in this study includes the elements to what extent * taking medication matches the presciber's recommendation (adherence, compliance), * treatment for the prescribed duration (persistence) is continued and * injections were missed. among ms patients treated with betaferon using the mybetaapp the study will also collect information on the health-related quality of life , treatment satisfaction and satisfaction with treatment support.


Eligibility criteria:
inclusion criteria: * aged ≥18 years * treated with betaseron using the betaconnect autoinjector * registered with mybetaapp * provided electronic informed consent exclusion criteria: - there are no exclusion criteria for participation in this study

Keywords: ms
indocyanine green fluorescence angiography (icg-fa) in revisional bariatric surgery

Conditions: Obesity; Bariatric Surgery

Summary: this study will compare different doses of a green fluorescent product that is administered during weight loss surgery in order to observe where blood vessels are located. there is uncertainty around the optimal dose of this product for patients with obesity, so this study will aim to study if the dose in the minimal range recommended by international guidelines is sufficient for most patients or if higher doses are needed with increasing body mass index.


Eligibility criteria:
inclusion criteria: * diagnosis of obesity with a bmi ≥ 30 kg/m² * scheduled for revisional bariatric surgery exclusion criteria: * allergy to iodides. * anticoagulation with products containing sodium bisulfite (due to the risk of icg-fa inactivation). * use of radioactive iodine studies within the past 7 days. * pregnant, breastfeeding, or planning to become pregnant within the next year (due to unknown teratogenic or fertility effects of icg-fa). * history of liver disease or laboratory findings suggestive of moderate to severe hepatic disease: total bilirubin \>1.5 times the upper limit of normal (uln), or any elevation of aspartate aminotransferase (ast) above uln. * participants who withdraw their consent to participate in the study (elimination criterion).

Keywords: bariatric surgery indocyanine green vascular weight loss surgery intraoperative complications postoperative complications
somatostatin analogues with perioperative antibiotics versus prolonged antibiotics

Conditions: Pancreatic Diseases

Summary: researchers are trying to determine how the length of antibiotic treatment in addition to octreotide after pancreatic surgery affects the amount of time subjects are hospitalized as well as how many subjects develop pancreatic fistulas.


Eligibility criteria:
inclusion criteria * patients undergoing a whipple procedure for various diagnoses (neuroendocrine tumors, adenocarcinoma, benign cystic neoplasms, duodenal and ampullary malignancies, etc) who are deemed intermediate-high risk as per our institutional protocol as shown above. * patients \> 18 years of age exclusion criteria * negligible and low risk patients * all patients undergoing arterial resection. * age \<18 years * currently pregnant
adverse childhood experiences, adaptation and breast cancer

Conditions: Adverse Childhood Experiences; Cancer, Breast; Attachment Styles; Resilience, Psychological; Quality of Life; Epigenesis, Genetic

Summary: adverse childhood experiences (aces) have long been linked to mental health problems in adulthood. in the case of cancer, no study has considered that such an anteriority could make patients more vulnerable emotionally, even though the presence of reactionary disorders such as stress, anxiety or depression are characteristic of such a pathology. activated during periods of stress and therefore during the illness, even the attachment system is mobilized and must be considered to allow more understanding of the illness experience. the attachment style can be seen here as an individual dimension that plays a role in the emotional regulation and resilience of patients. it is also particularly solicited during the remission phase, a complex and singular period of cancer disease that confronts patients with an ambivalence of hope and fear. the fear of recurrence is a concern that the cancer may return or progress in the same organ or in another part of the body. this is a determining factor in the occurrence of anxiety-depressive disorders. finally, several studies have shown a strong association between depression/anxiety and cancer-related fatigue (crf) after treatment, especially during the remission phase. aces leave physiological and epigenetic impact that can nowadays be easily evaluated, thus providing additional evidence between adversity, physiological and epigenetic vulnerability and the ability to adapt to life's challenges such as cancer. life history changes are mediated by changes in cellular mechanisms affecting genome expression. it is currently widely demonstrated that aces increases epigenetic modifications. the interest of this project is therefore to highlight the psychological consequences related to the occurrence of cancer in the developmental history (in terms of adversities) of patients who have completed adjuvant chemotherapy for breast cancer, taking into account the patients' previous attachments, resilience, fear of recurrence and perceived fatigue in order to consider their interactions and their effects on their psychological health and ultimately on their quality of life.


Eligibility criteria:
inclusion criteria: * have had breast cancer * be considered in remission * be over 18 years of age * literate (able to understand the information and complete the questionnaire independently) * agree to participate in the project and sign the informed consent form exclusion criteria: * be a person subject to a legal protection measure * be a protected adult, under guardianship or curators * be undergoing oncological treatment * have a lack of autonomy making it impossible to complete the questionnaire online * have had or have begun psychotherapeutic treatment

Keywords: breast cancer aces quality of life