Kornimate/medical-research-clean huggingface dataset:
a study to investigate how well ravagalimab (abbv-323) works and how safe it is in participants with moderate to severe ulcerative colitis who failed prior therapy

Conditions: Ulcerative Colitis (UC)

Summary: study m15-722 is a phase 2a study to investigate the efficacy and safety of ravagalimab (abbv-323) in participants with moderate to severe uc who failed prior therapy.


Eligibility criteria:
inclusion criteria: * participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (iec)/institutional review board (irb), prior to the initiation of any screening or study-specific procedures. * diagnosis of uc for at least 3 months prior to baseline. appropriate documentation of biopsy results consistent with the diagnosis of uc in the assessment of the investigator, must be available. * participant meets the following disease activity criteria: active uc with an adapted mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review). * history of inadequate response, loss of response, or intolerance to one or more of the approved biologic therapies: infliximab, adalimumab, golimumab, vedolizumab, and/or tofacitinib (note: if tofacitinib was received in a clinical trial, subject must have received open-label drug). exclusion criteria: * participant having an active, chronic, or recurrent infection that based on investigator's clinical assessment makes the participant an unsuitable candidate for the study. * participant having any malignancy except for successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix. * participant with history of dysplasia of the gastrointestinal tract or evidence of dysplasia in any biopsy performed during the screening endoscopy other than completely removed low-grade dysplastic lesions. * laboratory values not meeting the following criteria : serum aspartate transaminase (ast) and alanine transaminase (alt) \ = 3.0\*10\^9/l.

Keywords: ulcerative colitis (uc) abbv-323 ravagalimab
pws european blood bank for infants and controls from 0 to 48 months

Conditions: Prader-Willi Syndrome

Summary: the present project aims to determine the underlying mechanisms for the switch from failure to thrive to excessive weight gain and hyperphagia with impaired satiety in pws. the primary objective is to describe the evolution of circulating hormones involved in feeding and appetite regulation during the 4 first years of life. the secondary objective is to make this blood bank available for other research projects and particularly the investigation of hormones involved in hypogonadism. over the last ten years, the age at diagnosis in pws has fallen significantly and the majority of cases is now diagnosed during the 1st trimester of life giving the possibility to collect precise clinical data and serum samples at early stages. the investigators of the project are involved in the care of patients with pws and have a devoted clinic and an organized network in their country through clinical networks or patient associations.

the investigators propose to perform a prospective multicentric study, both longitudinal (duration 30 months) and cross-sectional with implementation of a blood bank in link with a multicenter database including clinical data on birth, auxology, endocrine functions and feeding behaviour. the cohort will include 200 infants from 3 to 48 months with pws and 200 controls matched on age recruited in the 6 participating countries. the investigators make the assumption that 3 blood sampling will be necessary during the first year and 6 monthly sampling thereafter. for measuring hormones and neuropeptides (ghrelin, insulin, leptin, pancreatic polypeptide, oxytocin, cortisol, melatonin, orexin a, glp-1 and pyy) involved in feeding and appetite regulation the investigators will use primarily multiplex microplates technics requiring 50-200µl of sample. intragroup and intergroup comparisons will be performed in order to describe the evolution of each hormone with time and to compare data obtained in the pws group with those obtained in the control group.

Eligibility criteria:
inclusion criteria (pws infants cohort) * genetic diagnosis of prader-willi syndrome exclusion criteria (pws infants cohort) * none inclusion criteria (control group) * children hospitalized for a planned surgery for malformation, orthopaedic or visceral surgery exclusion criteria (control group) * children with endocrine disorder
circulating markers in preterm infants with perinatal and neonatal inflammation

Conditions: Sepsis; Necrotizing Enterocolitis; Chorioamnionitis; Feeding Intolerance

Summary: circulating markers to diagnose complications (sepsis, necrotizing enterocolitis) in preterm infants are often inaccurate, partly due to the lack of comprehensive studies with temporal evaluation from birth until a disease onset. the investigators plan to collect weekly blood samples of preterm infants from birth until 4 weeks of age to comprehensively characterize differential protein and epigenetic markers in infants with and without complications (sepsis, necrotizing enterocolitis, chorioamnionitis).

preterm infants (10% incidence worldwide), especially those who do not receive sufficient mother's own milk, are susceptible to infectious diseases including sepsis and necrotizing enterocolitis. infants with history of prenatal inflammation including chorioamnionitis may be at higher risks of acquiring these infectious diseases. limited knowledge is available regarding a comprehensive temporal profile of circulating markers in preterm infants from birth to disease onset. this current study aims to provide a comprehensive temporal profile of circulating markers, via -omic techniques (proteomics and/or epigenetics), during the first 4 weeks of life in preterm infants with various systemic complications. thus, this will elucidate a profile of early markers consistently associated with pathological conditions in the whole study period. depending on the outcome, a subsequent study for validation may be performed. primary objective: to characterize circulating markers associated with the early life complications including chorioamnionitis, los and nec in preterm infants during the first four weeks of life. secondary objective: to characterize how different feeding regimes and diets may affect these markers during the first four weeks of life in preterm infants

Eligibility criteria:
inclusion criteria: * preterm infants born before the complete 32 weeks of gestation * signed parental consent exclusion criteria: * major congenital anomalies or birth defects

Keywords: preterm infants sepsis chorioamnionitis circulating markers
terlipressin administration in patients undergoing major liver resection

Conditions: Liver Resection; Liver Failure

Summary: this study investigates if the administration of terlipressin reduces complications after major liver surgery.

background surgery offers the only potential cure in many patients with primary or metastatic liver cancer. extending the limits and improving safety of liver resection would allow more patients to benefit from surgery and to increase their survival. the prerequisite for successful and safe liver surgery is the optimal regeneration of the remaining hepatic tissue in order to fulfill the metabolic demands of the patient. liver regeneration depends on a correct portal pressure and portal blood flow. in the preliminary results the investigators show an elevation of portal pressure post partial hepatectomy in mice. pharmacologic reduction of such elevated portal pressure using terlipressin, a vasopressin agonist, was associated with improved liver regeneration. objective surgery offers the only potential cure in many patients with primary or metastatic liver cancer. extending the limits and improving safety of liver resection would allow more patients to benefit from surgery and to increase their survival. liver regeneration depends on a correct portal pressure and portal blood flow. pharmacologic reduction of elevated portal pressure using terlipressin, a vasopressin agonist, is potentially associated with improved liver regeneration. aim: to perform a prospective randomized trial comparing terlipressin versus placebo in patients undergoing major hepatic resection. methods

Eligibility criteria:
inclusion criteria: * patients undergoing resection of 3 or more liver segments * minimum age of 18 * any gender * written informed consent exclusion criteria * preoperative renal failure (gfr \< 50ml/min) * severe liver dysfunction (child-turcotte-pugh grade c) * hyponatremia (\<132mmol/l) * severe aortic regurgitation, severe mitral regurgitation, heart failure * symptomatic coronary heart disease * bradycardic arrhythmia (heart rate \< 60/min) * peripheral artery occlusive disease (clinical stadium ii-iv) * dilatative arteriopathy, history of subarachnoidal bleeding * decompensated arterial hypertension (blood pressure \>160/100mmhg despite intensive treatment) * present or suspected acute mesenteric ischemia * septic shock * pregnancy
pharmacokinetics and safety of rifabutin 150 mg once daily versus rifabutin 300 mg thrice weekly

Conditions: HIV; Tuberculosis

Summary: to describe the pharmacokinetics of rifabutin 150 mg once daily versus rifabutin 300 mg thrice weekly in combination with lpv/r 400/100mg based haart in hiv/tb infected patients

the overall aim of the project is to evaluate rifabutin as a replacement for rifampicin, for the combined treatment of tuberculosis and hiv infection. rifabutin represents an alternative to rifampicin for hiv infected patients as its half-life is longer and the enzymatic induction effect appears to be less important on the associated art drugs. this phase ii trial is to determine precisely the pharmacokinetics parameters of rifabutin in combination with lpv/r regimens in thai hiv/tb infected patients, in order to define optimal doses that will be further tested in a larger phase iii trial comparing safety, tolerability and efficacy of rifabutin and rifampicin regimens.

Eligibility criteria:
inclusion criteria: 1. confirmed hiv positive after voluntary counseling and testing 2. aged \>18-60years of age 3. pi-naïve (nnrti intolerance/failure) or pi experience ( tb developed during on salvage regimen) without prior pi mutation 4. any cd4 cell count 5. alt \<5 times uln 6. serum creatinine \<1.4 mg/dl 7. hemaglobin \>7 mg/l 8. tb is diagnosed and planned to receive stable doses of rifabutin containing anti-tb therapy for at least another 4 week period after initiation of art 9. no other active oi (cdc class c event), except oral candidiasis or disseminated mac 10. body weight \>40kg 11. able to provide written informed consent exclusion criteria: 1. current use of steroid (except short course steroid for iris) and other immunosuppressive agents. 2. current use of any prohibited medications related to drug pharmacokinetics. 3. patients with current alcohol or illicit substance use that in the opinion of the site principal investigator would conflict with any aspect of the conduct of the trial. 4. unlikely to be able to remain in follow-up for the protocol defined period. 5. patients with proven or suspected acute hepatitis. patients with chronic viral hepatitis are eligible provided alt, ast \< 5 x uln. 6. karnofsky performance score \<30% 7. tb meningitis and bone/joints ( due to longer period of anti tb drug) 8. pregnancy 9. patient choose to use efavirenz, not lpv/r. however, in art naïve, efv is allowed after intensive pk of lpv/r and rifabutin at week 2-4.

Keywords: pharmacokinetics of rifabutin hiv/tb co-infection resource limited setting auc cmax cmin ctrough
docetaxel followed by capecitabine versus concomitant docetaxel/capecitabine for early stage breast cancer

Conditions: Breast Neoplasms

Summary: the purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

the purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast. induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo. previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome. additionally, we will correlate specific molecular markers in the breast tumors before and after chemotherapy, with response to treatment. expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively. approximately 100 patients will participate at emory winship cancer institute and emory crawford w. long hospital and grady health system in atlanta, georgia.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed breast carcinoma. * early stage breast cancer (stage 1, 2, 3). * no evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes. * 18 years of age or older. * final eligibility for a clinical trial is determined by the health professionals conducting the trial. exclusion criteria: * prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer. * major surgery within 28 days of study entry. * evidence of cns metastases. * final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Keywords: breast cancer early-stage chemotherapy
effect of a fermented milk product with probiotics alone or in combination with fibers on constipation symptoms

Conditions: Healthy; Constipation

Summary: first experimental study (proof of concept) to investigate bowel function parameters on which a fermented milk product with probiotics alone or in association with fibers has a potential effect.


Eligibility criteria:
main eligibility criteria (non-exhaustive list) are defined as: * healthy caucasian subject of both gender, aged from 18 to 69 years * subject with body mass index (bmi) between 18 kg/m2 (bound included) and 30 kg/m2 (bound excluded) * subjects with moderate constipation defined according to rome iii adapted criteria. * subjects without ongoing or diagnosed gastrointestinal disease or complications. * subjects without previous (within one month), ongoing or planned therapy during the study with drugs altering bowel function. * subjects without known gluten intolerance, lactose intolerance or allergy to milk proteins.

Keywords: adults moderate constipation
lap-band ap early experience trial (apex)

Conditions: Obesity, Morbid

Summary: the purpose of this study is to evaluate the lap-band ap system in severely obese patients.

the primary objective of this study was to collect additional information about the safety and effectiveness of the lap-band ap system in a real-life clinical setting. effectiveness was assessed through the collection of weight loss data, as well as other secondary effectiveness measurements. safety was assessed by the incidence and severity of adverse events (aes) related to treatment.

Eligibility criteria:
inclusion criteria: * patient is scheduled to receive the lap-band ap system * willingness to follow protocol requirements, including: the informed consent form (icf), health insurance portability and accountability act (hipaa) forms, follow-up schedule, completion of patient questionnaires. exclusion criteria: * per the lap-band ap system directions for use (dfu)
primary care-hospital embedding: a prospective, multicentric, observational study

Conditions: Heart Failure; Chronic Obstructive Pulmonary Disease; Diabetes Mellitus; Pneumonia; Urinary Tract Infections; Fever of Unknown Origin; Deep Vein Thrombosis; Hypertension

Summary: this is a multicentric, prospective, observational study with two cohorts and adjunctive procedure. it aims at collecting and analyzing data about the function of an innovative hospital-territory integration health service for the management of patients with intermediate urgency, or emergency department "white codes." this service, activated in the participating centers, will be provided in two alternative modalities, one so-called "dual specialty" (cardiology and diabetes specialist outpatient clinic) and a second one more focused on the figure of the specialist in internal medicine. the investigators will monitor the population treated in these centers (presenting complaint, medical history, clinical-radiological data, performed therapies and overall health path) and the degree of satisfaction of the general practitioners who sent their patients there and the degree of satisfaction of the patients themselves. the data collected will also be used to evaluate the effectiveness of the outpatient clinics in terms of reducing improper admissions to the emergency departments and hospitalizations. the two modes of service delivery will be compared. this is an 18-month study, sponsored by our scientific directorate and carried out on a nonprofit basis. the study will enroll 246 patients and 30 healthy volunteer general practitioners. the clinical trial will be conducted in accordance with good clinical practice standards.


Eligibility criteria:
inclusion criteria: * patients sent by general practitioners for outpatient evaluation in the two models * patients able to read and sign the informed consent * patients able to read and fill the questionnaire exclusion criteria: - pregnant women
international registry of accidental hypothermia

Conditions: Accidental Hypothermia

Summary: transient mild hypothermia (core body temperature 35-32°c) is common and usually without consequences for the brain or other organs. however, prolonged severe accidental hypothermia (core body temperature below 28°c) due to accidents is rare, and usually fatal in more than 50% of cases. little is known on its physiopathology, on prognostic factors for rewarming decision or ideal rewarming techniques for better survival. furthermore, complications after successful rewarming are extremely frequent and very often severe or fatal. accidental hypothermia is a frequent problem during the winter months and can be caused by snow sport accidents, near drowning and urban cold exposure. the international hypothermia registry's principle goal is to increase knowledge on accidental hypothermia by creating the largest database on accidental hypothermia which will comprise enough patient data to give a statistical power since the causes of accidental hypothermia and its treatment varies greatly. the international hypothermia registry (ihr) will enable improvement of pre- and in-hospital treatment and rewarming methods, study survival predictors and prevention of post-rewarming complications. by this way, the ihr will permit the establishment of evidence-based diagnosis and treatment guidelines.

the aim of the international hypothermia registry is to improve rescue, treatment and outcome of accidental hypothermia victims. the principal objectives of the international hypothermia registry are: * improving the outcome of accidental hypothermic patients (survival and normal neurologic function); * this outcome is dependent on the presenting status of the patient (temperature, trauma, cardiac arrest, etc.); * the hospital treatment and rewarming method will also influence the outcome, invasive vs. non-invasive rewarming and rewarming rate. * quality control, assessment of hypothermia cases this ihr is mainly prospective but retrospective entries are welcome. there is no data limit on retrospective cases: cases of any year can be entered.

Eligibility criteria:
inclusion criteria: * accidental hypothermia with body core temperatures equal or less than 35°c/95°f; * any cause leading to accidental hypothermia (e.g. mountain, water, urban); * any age, gender, or comorbidities; * any pre-hospital and hospital treatment and rewarming; * any outcome. exclusion criteria: * patient opposition to be part of a study; * essential missing values, e.g. temperature.

Keywords: accidental hypothermia
prospective investigation of pulmonary embolism diagnosis (pioped ii)

Conditions: Lung Diseases; Pulmonary Embolism; Venous Thromboembolism

Summary: to determine the value of contrast enhanced spiral computed tomography (spiral ct) for the diagnosis of acute pulmonary embolism (pe).

background: approximately 600,000 americans sustain pulmonary embolism each year; one-third of these episodes are fatal. unfortunately, pulmonary embolism is underdiagnosed and, therefore, under-treated. a substantial body of evidence suggests that the diagnosis of pulmonary embolism is not made in the majority of patients in whom it causes or contributes to death. in the main, there are two explanations for the failure to diagnose pulmonary embolism: pulmonary embolism may be clinically silent, and there is no definitive, noninvasive diagnostic test. indeed, ventilation perfusion lung scans are nondiagnostic in the majority of patients with suspected acute pulmonary embolism. pulmonary angiography may be used to establish a diagnosis in such patients, but it is underutilized because of a mortality risk around 1 percent. recently, relatively small studies have suggested that contrast enhanced spiral computed tomography (ct) scanning is a useful diagnostic test for pulmonary embolism, with sensitivity as high as 80 percent and specificity as high as 95 percent. spiral ct is widely available and much less invasive than pulmonary angiography. if spiral ct could be established as a useful diagnostic test, pulmonary embolism would be diagnosed more effectively and more patients would receive proper treatment. design narrative: the study evaluates the role of spiral ct scan in the diagnosis of pe by comparison with a composite reference test, including pulmonary angiography, v/q lung scan in patients without prior pe and compression ultrasound of the lower extremities in patients with no prior deep venous thrombosis (dvt).

Eligibility criteria:
\> 18% normal kidney function, no dye allergies, suspected of acute pulmonary embolism