Kornimate/medical-research-clean huggingface dataset:
prospective cohort study of germline variant carriers with brca1 or brca2

Conditions: BRCA1 And/or BRCA2 Variant Carriers; Ovarian Carcinoma; Fallopian Tube Carcinoma; Peritoneal Carcinoma

Summary: to determine the incidence and risk factors in the development of ovarian, fallopian tube, and peritoneal cancers in japanese women carrying breast cancer susceptibility gene (brca)1/2 variants.

1. to estimate the incidence of ovarian, fallopian tube and peritoneal cancers in women carrying brca1/2 variants. 2. to investigate risk factors concerning the development of ovarian, fallopian tube, and peritoneal cancers (loci of brca1/2 genetic variants, modifier genes, genetic polymorphism, hormones, and lifestyle habits.) in women carrying brca1/2 variants. 3. to estimate the detection rates of occult cancer based on histopathological evaluations, using risk-reducing salpingo-oophorectomy (rrso). 4. to examine the risk-reducing effect of rrso on the development of ovarian, fallopian tube, and peritoneal cancers in women carrying brca1/2 variants, and compare with those not undergoing rrso. 5. to identify clinicopathological features in women carrying brca1/2 variants who had undergone rrso. 6. to identify the appropriate interval or degree of surveillance.

Eligibility criteria:
inclusion criteria: 1. women carrying brca1/2 variants (those with either brca1 or brca2 variants, or those carrying both variants) and women carrying a variant of uncertain significance (vus). 2. women who have received sufficient genetic counseling at any medical institution, prior to enrollment to the study. 3. women who provide consent should be 20 years of age or older. 4. women who provide written consent. exclusion criteria: 1. women without ovarian or fallopian tube cancer at the time of informed consent. 2. women previously diagnosed with ovarian, fallopian tube, or peritoneal cancer, and not excluding those with a personal history of breast cancer development. 3. other individuals considered inappropriate for involvement in this study by the investigator.
prognosis of anxiety in intensive care unit

Conditions: Anxiety

Summary: anxiety is commonly considered as an epiphenomenon of the cognitive and emotional response to a threat. anxiety is a consequence of the reciprocal interaction between stress and the neuroendocrine, autonomic and immune systems. a systematic and circumstantial assessment of anxiety in critically ill patients has never been done. our hypothesis is that high levels of anxiety at icu admission are associated with death or the occurrence of one or more organ failure during the first 7 days, and that anxiety should be considered as a "warning sign" in critically ill patients.

multicentre prospective study. demographic data, diagnosis, severity scores and vital signs will be assessed at admission. within the first 12 hours, and at day 4 and day 7, anxiety will be assessed by the stai scale, geriatric anxiety inventory (gai) scale, and a specific questionnaire assessing anxiety in the intensive care (reax). visual analogue scale (vas) scoring for anxiety, starvation, thirst, pain and dyspnoea will be collected daily. anxiety and depression will be evaluated by the hospital anxiety and depression scale (hads) on day 7. patients will be assessed by psychologists or trained doctors, the team in charge of the patient will not be aware of the result of this evaluation. clinical and biological data regarding the hemodynamic, neurological, respiratory and renal status will be collected from admission to day 7, as well as parameters required for computing the sequential organ failure assessment (sofa) score.

Eligibility criteria:
inclusion criteria: * all adult patients admitted to the icu * patient without delirium at admission (assessed using the cam-icu score) exclusion criteria: * severe hearing impairment or poor understanding of french language * history of serious psychiatric illness * comatose or sedated patient at admission * diagnosis of voluntary self-poisoning, or polytrauma at admission

Keywords: anxiety level of anxiety delirium agitation tools for measuring anxiety neuroendocrine system
type 2 diabetes controlled eating experiment

Conditions: Type 2 Diabetes Mellitus

Summary: a short-term feeding study in type 2 diabetics manipulating the fat and caloric values of meals to assess both compensation and glucose control, both covertly and overtly.


Eligibility criteria:
inclusion criteria: type 2 diabetic, age 18+, informed consent, able to eat 3 meals/day 1 day/week at clinic exclusion criteria: non-diabetic, type 1 diabetic
tolerance and efficiency of an intrabuccal biological film to enhance oral dryness sensation: the "predelfi" clinical pilot study

Conditions: Sicca Syndrome; Xerostomia

Summary: xerostomia affects at least a quarter of the population. this prevalence is increased in postmenopausal women and people over 65 years of age. associated with age are systemic diseases such as sjögren's syndrome, diabetes, parkinson's disease or cancer. it handicaps the patient in his social life, but also in terms of his well-being by the consequences it generates in the oral cavity. this dryness may be the consequence of taking certain medications, head and neck radiotherapy, but also being a symptom of an underlying pathology whose screening will allow early treatment and avoid complications. today, no single therapeutic solution is enough and patients are waiting for new therapeutic innovations in this area. this study proposes to evaluate the tolerance of an adhesive film containing prebiotics by comparing it to a placebo control film.

the purpose of this study is to evaluate the tolerance of an adhesive film containing prebiotics on the improvement of signs and symptoms related to dry mouth by comparing it to a placebo film. the primary endpoint is the assessment of tolerability assessed using a visual analogue scale (vas) from 0 to 100 at the end of the 1-month period of both treatment periods (d30 and d90). in this study, the efficacy and tolerance of the adhesive film containing prebiotics will be analyzed. each participant in this study will receive two galenic forms of the medical device whose allocation order was previously defined by a randomization list.

Eligibility criteria:
inclusion criteria: * men or women aged 18 or over * complaining of xerostomia and validated by a standardized question * with hyposialia diagnosed by the measurement of stimulated salivary flow (dss) and unstimulated (dns) * patient having signed a consent * registered with social security exclusion criteria: * the patient having known sensitivity to any of the products or components of the biofilms (milk protein, soy derivatives, sodium alginate, vegetable glycerin, caramel and beta carotene) * allergic to birch and / or peanut * having an ethyl intoxication (\> 2 glasses of wine / day), smoking (\> 10 cigarettes / day) * unable to complete self-assessment questionnaires or to follow study protocol procedures (unable to read and / or write). * participant in another clinical study at the time of inclusion or having participated in the 30 days preceding recruitment in this study * having a life-threatening condition for the duration of the study * treated with sialogogues (pilocarpine hydrochloride) within 30 days prior to inclusion * using salivary substitutes * protected persons within the law (articles l1121-5 to l1121-8)

Keywords: natural film prebiotics
descriptive study in patients treated with vimovo™, including registration of the physicians' prescribing patterns

Conditions: Osteoarthritis; Rheumatoid Arthritis; Ankylosing Spondylitis

Summary: the most common pain-relievers used by patients with rheumatic disorders are called non-steroidal anti-inflammatory drugs (nsaids). these drugs are effective and well documented, but they can cause ulcers and gastrointestinal side effects. vimovo™ is a tablet containing naproxen (nsaid) and a gastroprotective agent called esomeprazole. patients with rheumatic disorders, who are at risk for developing gastrointestinal side effects, and where lower doses of naproxen or other nsaid treatment is not considered sufficient, could use this tablet. the regulatory authorities in many european countries have approved the use of vimovo™, but they would like to understand how various factors influence the doctors' decision to prescribe the tablet and what is characterizing the patients receiving it. the aim of the study is to answer these questions.

european study in patients with osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis at gastrointestinal risk: a retrospective, non-interventional study of vimovo™ prescribing patterns

Eligibility criteria:
inclusion criteria: * diagnosis of arthritic disorder (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis) risk for developing gastrointestinal ulcer already prescribed vimovo exclusion criteria: * participation in any interventional drug study at the time vimovo™ was prescribed * patients started on vimovo during the first 3 months after country-specific launch date * patients started on vimovo after the study site is initiated (in order to avoid influence on prescribing decision and recruitment)

Keywords: vimovo™ treated patients and prescribing patterns risk of gastrointestinal side effects
epidemiological and clinical-pathological factors of philadelphia-negative myeloproliferative neoplasms in ecuador

Conditions: Myeloproliferative Neoplasm; Myeloproliferative Syndrome; Myeloproliferative Neoplasm, Unclassifiable; Myeloproliferative Disorders; Myeloproliferative Disease, Not Classified

Summary: the goal of this observational study is to evaluate the epidemiological and clinical-pathological features of philadelphia-negative myeloproliferative neoplasms through data from medical records

the investigators are proposing a study that provides descriptive understanding of patients with philadelphia-negative myeloproliferative neoplasms in ecuador. the primary objective of this pilot study is to lay the foundations for the development of a multicenter registry of philadelphia-negative myeloproliferative neoplasms, which will provide high-quality real data and serve as a basis for the application to future projects and elaboration of public policies in the medium and long term.

Eligibility criteria:
inclusion criteria: * 18 years and older * patients with confirmed diagnosis of philadelphia-negative myeloproliferative neoplasms exclusion criteria: * patients with translocation t(9;22)(q34:q11.2) with subsequent formation of the bcr-abl1 fusion gene determined by cytogenetics or fluorescence in situ hybridization (fish) * absence of the histopathological report in the clinical history and the corresponding plaque, except in the case of polycythemia vera that does not require them for diagnosis, according to the 2022 who classification

Keywords: myeloproliferative neoplasm
b195: effect of diet-induced energy deficit and body fat reduction on inflammatory markers in obese subjects

Conditions: Obesity

Summary: aim: to dissociate the effects on plasma concentrations of the inflammatory marker c-reactive protein of a negative energy balance and a reduction in body fat stores. secondly to compare crp with fibrinogen and interleukin-6 (il-6).

background: previous epidemiological studies have associated elevated levels of acute phase proteins, mainly c-reactive protein, with cardiovascular diseases (cvd) and cardiac death. levels of several cy-tokines and acute phase proteins as crp, haptoglobin and fibrinogen have been found associated with elevated body fat and the risk of diseases associated to the metabolic syndrome. method: thirty-six otherwise healthy obese subjects (bmi: 34.23.2 kg/m2, age: 43.410.5 y) participated in a 20-week controlled dietary intervention divided into 4 periods. weight reduction was induced by an 8-week low caloric diet (lcd) (3.4 mj/d) followed by a 4-week weight stable maintenance program (m1). subsequently, they underwent another 4-week lcd (4.2 mj/d) followed by a final 4-week weight stable maintenance diet (m2). blood samples and anthropometrical measures were assessed at baseline and after each of the four periods (8, 12, 16 and 20 weeks).

Eligibility criteria:
inclusion criteria: * 41 participants (20 men, 21 women) were included in the study. they were between 24-62y, healthy, non-athletic, weight stabile (\< 3 kg in last 2 mo) but overweight to obese (bmi: 28-40 kg/m2). exclusion criteria: * evidence of metabolic or systemic diseases other than obesity. frequent use of medication, a systolic blood pressure \>165 mmhg and diastolic blood pressure \>95 mmhg.

Keywords: weight loss obesity energy restriction
tramadol versus fentanyl for post-operative analgesia in newborn infants

Conditions: Pain; Neonatal Infections; Analgesia

Summary: in newborn infants submitted to surgical procedures, tramadol may provide an effective analgesia and decrease the time on mechanical ventilation support and the time to achieve full enteral feeding.


Eligibility criteria:
inclusion criteria: * infant 0-28 days of life with indication of large or medium surgical procedure (definition according to the american college of cardiology, american heart association - 2002) exclusion criteria: * death or hospital discharge until 72 hours after surgical procedure * new surgery until 72 hours after the studied surgical procedure * proved bacterial infection before surgery * ambiguous genitalia * chromosomal syndromes

Keywords: pain analgesia newborn infant opioids side-effects intensive care postoperative
surgical versus nonoperative treatment of metastatic epidural spinal cord compression

Conditions: Metastatic Epidural Spinal Cord Compression

Summary: the aim of this trial is to evaluate the differences in pain relief, neurological function, quality of life and survival in patients with metastatic epidural spinal cord compression (mescc) who are managed with a combination of surgery and radiotherapy versus radiotherapy alone. further we shall evaluate cost-effectiveness of the two treatment approaches.


Eligibility criteria:
inclusion criteria: * single symptomatic metastatic epidural spinal compression at any level confirmed by mri * age 18 and more * able and willing to give written informed consent to participate in the study * able to read and write english on an elementary level exclusion criteria: * multiple symptomatic spinal metastases * radiosensitive tumors * radioresistant tumors * primary cancer site in cns or spine * poor life expectancy (\< 3 months) * patients with a tumor that has compressed only the cauda equina or spinal roots * has a recent history of substance abuse * is a prisoner * currently involved in another study * has a disease or condition that would preclude accurate evaluation

Keywords: spine neoplasm metastasis treatment, surgical treatment, nonoperative quality of life
multi-center study assessing the safety and efficacy of de-117 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension

Conditions: Open-angle Glaucoma or Ocular Hypertension

Summary: the purpose of this study is to investigate the safety and efficacy of four concentrations of de-117 ophthalmic solution.

this is a 28-day randomized, observer-masked, placebo-and active-controlled, parallel-group, multi-center, study investigating the safety and efficacy of four concentrations of de-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) and placebo (vehicle of de-117) in subjects with primary open-angle glaucoma or ocular hypertension.

Eligibility criteria:
main inclusion criteria: * current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes * qualifying intraocular pressure in at least one eye at baseline * qualifying corrected etdrs visual acuity in each eye * qualifying central cornea thickness in each eye main exclusion criteria: * closed/barely open anterior chamber angle or a history of acute angle closure in either eye * diagnosis of primary open-angle glaucoma or ocular hypertension due to etiology known to be non-responsive to conventional drug therapy * evidence of advanced glaucoma, visual field defect or progressive visual field loss that that do not meet the study criteria * history of ocular surgery specifically intended to lower iop * history of any ocular or systemic abnormality or condition that may put the subject at significant risk, may confound study results, or may interfere significantly with the subject's participation in the study * intended or current use of any ocular medications other than study medications during the study * use of contact lenses within one week prior to baseline (day 1) until end of treatment * known allergy or sensitivity to any components of the study medications * use of steroids (systemic) within 30 days prior to visit 1 (screening) * anticipate the need to initiate or modify an existing chronic therapy that could substantially affect iop or the study outcomes during the study period * females who are pregnant, nursing or planning a pregnancy

Keywords: santen eye glaucoma ocular hypertension
forced air versus endovascular warming in polytrauma patients

Conditions: Polytrauma; Hypothermia

Summary: trauma is the leading cause of death in young adults, bleeding and infection are major concomitant problems. we test the hypothesis that fast, perioperative warming with an endovascular catheter versus forced air warming may improve patient outcome (primary outcome: combined perioperative morbidity, secondary outcome: bleeding, infection).

trauma is the leading cause of death in young adults and a major cause of morbidity and mortality at all ages. the acute problem is often uncontrollable bleeding. subsequently, infection becomes a leading cause of morbidity. polytrauma patients are at high risk for accidental hypothermia. mild perioperative hypothermia causes a coagulopathy that significantly augments blood loss and increases allogeneic transfusion requirements. hypothermia also impairs numerous immune functions - even slight decreases in core temperature triple the risk of surgical wound infection. endovascular temperature management system alsius® (icy, alsius corporation: irvine,california,usa) has been approved in europe and united states for the past 10 years and has been used in thousands of patients mainly for the indication of therapeutic cooling and subsequently rewarming of patients. a major potential advantage of this system is that heat is directly added to the thermal core, thus bypassing the heat sink and insulating effects of peripheral tissues. the efficacy of this system is sufficient to allow rapid rewarming in hypothermic trauma victims, even those undergoing major surgery. we therefore propose to test the hypothesis that polytrauma patients rewarmed with the alsius® system will have better patient outcome (combined perioperative morbidity) than those warmed conventionally with forced-air.

Eligibility criteria:
inclusion criteria: we will evaluate patients admitted to the emergency department for polytrauma. patients will be eligible for the study when they: 1. are between 18 and 70 years old 2. have a glasgow coma score ≥ 9 3. an iss (injury severity score) ≥16; and 4. have a severity characterisation of trauma (ascot) score predicting mortality ranging from 2 to 50% (www.sfar.org/scores2/ascot2.html). exclusion criteria: patients will be excluded if they are: 1. \<150cm in height 2. known to have a vena cava filter 3. known to have a history of coagulopathy including anti-coagulant medications; or 4. known to be pregnant.

Keywords: polytrauma hypothermia wound infection blood loss combined perioperative morbidity
early versus late bcg vaccination in hiv-1 exposed infants in uganda in uganda

Conditions: Severe Illness; Septicaemia; Diarrhoea; Lower Respiratory Infection

Summary: bcg vaccination may have non-specific effects (nse) i.e., additional benefits on childhood morbidity and mortality that are separate the vaccine's effect on the incidence of disseminated tuberculosis. though the available literature is mostly from observational study designs, and is fraught with controversy, bcg vaccination at birth, in a high risk population of hiv exposed children, may protect infants against serious infections other than tb. yet, other studies indicate that giving bcg later in infancy, when the immune system is more mature, may offer even greater protection. the appropriate timing of bcg vaccination could therefore be up for revision. this study will therefore compare bcg vaccination at birth with bcg vaccination at 14 weeks of age in hiv exposed (he) babies. methods: this is an individually randomized clinical trial in 4,500 hiv exposed infants. the intervention is an intra-dermal administration of 0.05 ml of bcg vaccine within 24 hours of birth while the comparator will be an intra-dermal administration of 0.05ml of bcg vaccine at 14 weeks of age. the main study outcomes include: 1. severe illness in the first 14 weeks of life, 2. innate and adaptive immune responses to mycobacterial, non-mycobacterial antigens and tlr-agonists 3. severe illness in the first 14-52 weeks and 0-52 weeks of life. the study will be carried in two health centers and one district hospital in uganda. implications: a well-timed bcg vaccination could have important additional benefits in he infants. this trial could inform the development of programmatically appropriate timing of bcg vaccination for he infants.


Eligibility criteria:
inclusion criteria: a baby born at a participating study clinic will be included if s/he: 1. has a mother with a positive hiv test (elisa or rapid test) 2. is receiving peri-exposure prophylaxis as part of the standard/national guidelines in uganda 3. has a mother that is of legal age for participation in clinical research studies in uganda or is an emancipated minor 4. has a mother/caregiver that resides within the study area, is not intending to move out of the area in the next 4 months and is likely to be traceable for up to 12 months 5. has a mother/caregiver that gives informed consent to random assignment to either of the two trial arms 6. has a mother that has received antiretroviral therapy (art) for at least 4 weeks exclusion criteria: a new-born child will be excluded if she/he has: 1. an identified serious congenital malformation(s) 2. severe illness requiring hospitalization 3. a birth weight \< 2.0 kg 4. a mother participating in another clinical trial on the day of enrolment or a mother who will participate in another clinical trial within the next month. 5. a mother or other household member with symptoms and signs of tuberculosis on the day of enrolment 6. a severely ill mother with (a) condition(s) requiring hospitalization 7. a baby with an apgar score at 5 minutes \<7 8. a twin or triplet