Kornimate/medical-research-clean huggingface dataset:
non invasive biomarkers to identify subjects at risk for preterm delivery

Conditions: Preterm Birth

Summary: the goal of this study is to identify a non-invasive predictor or predictors that will increase the clinician's ability to identify patients with preterm labor (ptl) at risk for preterm delivery (ptd). through these studies we also hope to reveal potential therapeutic targets in the prevention of prevention of preterm births. the study hypothesis is that we can identify non-invasive predictors of ptl at risk for ptd.

study design this is a prospective study involving a cohort of pregnant subjects with pre-term labor. maternal blood and cervical/vaginal fluid will be collected from consenting subjects with preterm labor. repeat sampling of cervical fluid will occur as often as weekly until the time of delivery. relevant clinical and demographic data will be recorded. levels of prostaglandins (pg's), lipocalin-type prostaglandin d2 synthase (l-pgds) and cytokines will be determined using elisa. dna will also be extracted from maternal blood for snp analysis of cytokine genes. at the time of delivery, cord blood and placenta samples will be collected if logistically possible (during regular laboratory hours). to determine fetal levels of pg's, l-pgds and cytokines in cord blood will be analyzed using elisa. placental samples will be used for in vitro studies aimed at investigating the placental regulatory pathways of cytokine and pg production. placental samples will also be processed and embedded in paraffin for use in immunohistochemical studies in order to localize the expression of pg's and cytokines. clinical delivery data will also be recorded. gender of subjects. only female subjects will be included. age of subjects. the age of subjects will be restricted to 18-45 years. inclusion criteria. women with a diagnosis of preterm labor will be included in this study. preterm labor will be diagnosed as six or more contractions per hour associated with one of the following: 1. cervical dilation \>= 2 cm 2. cervical effacement \> 80% 3. documented changes in dilation or effacement or cervical length less than 2.5 cm by ultrasound with or without contractions. exclusion criteria. multiple pregnancy, fetal anomalies, abruptio placenta, preeclampsia, cervical dilation greater than 4 cm, clinical signs of infection and vaginal bleeding. subject capacity. all subjects included in this study will have the capacity to give informed consent.

Eligibility criteria:
inclusion criteria: * women with a diagnosis of preterm labor. exclusion criteria: * multiple pregnancy, fetal anomalies, abruptio placenta, preeclampsia, cervical dilation greater than 4 cm, clinical signs of infection and vaginal bleeding

Keywords: non invasive biomarkers preterm delivery
local compression seroma diminution objective (clodis)

Conditions: Breast Cancer; Mastectomy; Seroma

Summary: this study evaluates the impact of local compression by chest bandage on the number of seroma punctures in patients treated by mastectomy with or without lymphadectomy. half of the participants will have local compression by chest bandage in addition to seroma punctures while the other half will only have punctures.

the most common complication induced by mastectomy is seroma formation. this seroma is a serolymphatic effusion that is created in the days following surgery. iterative puncture is the only treatment for seroma mentioned in the literature. a retrospective study in the investigator's establishment on 1800 patients determined that a second puncture greater than 250ml is predictive of a chronicisation of punctures. the research hypothesis is that by applying local compression by chest bandaging with the urgo® k2 kit, the "dead space" created by surgery would be removed. this would help resorb the seroma and reduce the number of punctures.

Eligibility criteria:
inclusion criteria: * patient followed for histologically proven breast cancer treated by total mastectomy, whether or not dissociated from the sentinel node technique, with or without axillary curing. * patient with a second seroma puncture with a volume greater than or equal to 250 ml. * neo adjuvant chemotherapy authorized. * absence of known metastases. * patient has given written consent. exclusion criteria: * mastectomy with immediate reconstruction. * partial mastectomy. * concurrent bilateral mastectomy. * delay in healing observed at inclusion. * patient under legal protection. * chronic respiratory failure. * patient with a pacemaker. * personality disorders and known progressive psychiatric pathology. * inability to submit to trial follow-up
nonacog alfa prophylaxis and treatment of bleeding episodes in previously treated patients with hemophilia b

Conditions: Hemophilia B

Summary: nonacog alfa is indicated for the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with hemophilia b. the current single country, multi-centric, open label, non-randomized clinical trial is a post-approval study to fulfill the central drugs standard control organization (cdsco) request for supplementary information relating to the use of nonacog alfa in indian subjects with hemophilia b.


Eligibility criteria:
inclusion criteria: 1. male subjects ≥12 years to ≤65 years with a diagnosis of congenital moderately-severe to severe hemophilia b (fix activity ≤2%). 2. documented history of at least 50 exposure days (eds) to fix-containing products. 3. evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative, parent(s)/legal guardian) has been informed of all pertinent aspects of the study. for minors under the age of legal consent in india, assent of the participating child needs to be documented for the age range 12 to 18 in addition to the parental informed consent. exclusion criteria: 1. prior history of inhibitor to fix or positive inhibitor testing (≥0.6 bu/ml) during screening. clinical signs or symptoms of decreased response to fix. 2. known hypersensitivity to the active substance or any of the excipients. 3. known allergic reaction to hamster proteins. 4. presence of any bleeding disorder in addition to hemophilia b. 5. participation in other studies involving investigational drug(s) (phases 1-4) within 30 days before the current study begins and/or during study participation. 6. planned surgery within 6 months from the start of the study. 7. unsuitable to participate in study for any other reason as assessed by the investigator; including any disorder, except for conditions associated with hemophilia b, which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol. 8. subjects (or a legally acceptable representative) is not able to understand study documents and study procedure. 9. immunocompromised subjects due to human immunodeficiency virus (hiv) infection (defined as viral load above or equal to 100,000 copies/ml; and for hiv+ subjects: cluster of differentiation 4 positive (cd4+) lymphocyte count below or equal to 200/μl). hiv status and cd4+ lymphocyte count results may be obtained at screening or from available medical records; results must be not older than 6 months prior to screening. 10. subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, subjects who have been previously enrolled into the study, or subjects who are pfizer employees directly involved in the conduct of the study. 11. planned use of any non-study medication for treatment of hemophilia (eg, other factor replacement agents, bypassing agents, or non-factor treatments \[such as anti-tissue factor pathway inhibitors\]).
neoadjuvant database

Conditions: Neoadjuvant Treatment in Breast Cancer

Summary: the neoadj database base contains data collected during the regular clinical patient management (sociodemographic, clinical, pathological, radiological, biological, disease evolution...). this database allows easy access to information in a centralized and structured way. this cohort is used to gather insights for research purposes. all data collected come from medical files of patients managed at centre georges francois leclerc, dijon, france.


Eligibility criteria:
inclusion criteria: * women followed for breast cancer in georges francois leclerc center * neoadjuvant chemotherapy * age \>= 18 exclusion criteria: * males * metastatic breast cancer

Keywords: cancer; breast, neoadjuvant
neurological consequences of perinatal listeriosis infection

Conditions: Perinatal Listeriosis

Summary: the purpose of the study is to determine whether perinatal listeriosis is associated with long-term neurological consequences, and to evaluate the respective contribution of perinatal sepsis, of prematurity and of the known neurological tropism of the involved pathogen, listeria monocytogenes.

perinatal listeriosis is defined by the occurrence of maternal listeriosis at birth and/or of early-onset listeriosis in the neonate (defined by the positive culture of any sample of maternal or neonatal origin). neurological involvement is defined by the presence of inflammation of the cerebrospinal fluid of positive culture or the cerebro-spinal fluid. evaluation is performed at the age of 5 years, and includes wppsi evaluation of the intelligence quotient (iq), nepsy evaluation of the executive functions and clinical evaluation checking for any motor, sensorial or other focal deficiency among 90 cases and 270 controls matched for gestational age.

Eligibility criteria:
inclusion criteria: * children from the monalisa cohort (culture proven-maternal listeriosis) * or children from the epipage cohort (control group) * written consent from the parent(s) or legal representative exclusion criteria: * children whose parents or legal representative would deny their consent

Keywords: perinatal listeriosis neurological impairment sepsis prematurity neurotropism listeria monocytogenes intellectual quotient
prevalence of vitamin d deficiency in pregnant women and their fetus in north jordan

Conditions: Vitamin D Deficiency

Summary: in jordan, there are few data about the prevalence of hypovitaminosis d in pregnant women and their newborns and factors that affect their levels. hence, in this study, investigators will : 1. determine vitamin d levels among newborns born in north jordan 2. determine vitamin d levels among pregnant women in north jordan 3. study the association between maternal and infants levels of vitamin d 4. explore the association between maternal and fetal characteristics and maternal and/or fetal vitamin d level 5. study the effect of low fetal vitamin d on newborn anthropometry 6. study the effect of maternal vitamin d supplement use during pregnancy in raising cord serum vitamin d levels

this is a cross-sectional study that will be carried out at king abdullah university hospital (kauh). after being approved by the institutional review board (irb) of kauh, written informed consents will be obtained from the newborns' mothers. 5 ml of venous blood will be obtained from pregnant women at the time of admission and 3 ml of venous blood will be obtained from the umbilical cord veins of the newborns immediately after their delivery. the quantitative measurement of 25ohd in serum will be performed using eliza. investigators will determine the means, medians and standard deviations of 25ohd levels among pregnant women and infants in jordan. in addition, investigators will study the association between maternal and infants levels of 25ohd. moreover, investigators will investigate the association between maternal level of vitamin d and elective maternal variables including vitamin d supplements during and before pregnancy, sun exposure, age, weight, parity, bmi, \& maternal medical problems. in addition, investigators will study the effect of low fetal vitamin d on newborn anthropometry. finally, investigators will study the effect of maternal vitamin d supplements use during pregnancy in raising cord serum vitamin d levels

Eligibility criteria:
inclusion criteria: all pregnant women who attend to labour ward with singleton alive pregnancies exclusion criteria: women with multiple pregnancies or with dead fetuses
a 52-week international, multicenter trial with a long -term extension to evaluate saxagliptin with dapagliflozin in combination with metformin compared to glimepiride in combination with metformin in type 2 diabetes who have inadequate glycemic control on metformin alone

Conditions: Diabetes

Summary: this clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better glycemic control, as measured by hba1c, over a treatment period of 52 weeks, compared to the addition of glimepiride to metformin in subjects with type 2 diabetes mellitus who have inadequate glycemic control on metformin alone. we will compare the change from baseline in hba1c achieved with saxagliptin, in co-administration with dapagliflozin, added to current background therapy with metformin compared to glimepiride added to current background therapy with metformin ≥1500 mg at week 52.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * subjects must be willing and able to give signed and dated written informed consent * patients with type 2 diabetes mellitus (t2dm) with inadequate glycemic control * subjects should have been taking the same daily dose of metformin ≥ 1500 mg * fasting plasma glucose ≤ 270 mg/dl (≤15 mmol/l) * males and females, aged ≥18 years old at time of screening visit * women of childbearing potential (wocbp) must have a negative serum or urine pregnancy test * wocbp and males must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug exclusion criteria: * clinical diagnosis of type i diabetes * history of diabetic ketoacidosis * cardiovascular/vascular diseases within 3 months of the enrollment * renal disease * hepatic diseases * history of, or currently, acute or chronic pancreatitis * hematological and oncological disease/conditions * patients who have contraindications to therapy being studied * patients on weight loss program(s) * replacement or chronic systemic corticosteroid therapy
a safety and efficacy follow-up study with levetiracetam in children (4-17 years old) suffering from absence seizures

Conditions: Absence Seizures

Summary: this long-term open label follow-up trial gave pediatric subjects suffering from typical absences in cae or jae the opportunity to continue levetiracetam treatment after participation in the pilot study (study n162) or the double-blind study (study n163). safety and efficacy data were obtained.


Eligibility criteria:
inclusion criteria: * male/female 4-17 years old having participated in study n162 or in study n163 * suffering from typical absences with 3 hz spike-wave discharges, with or without tonic-clonic seizures, in cae or jae * expected reasonable benefit (efficacy and tolerability) of levetiracetam long term administration exclusion criteria: * allergy/intolerance to pyrrolidine derivatives and/or excipients * use of \> 2 concomitant antiepileptic treatment or valproate, ethosuximide or lamotrigine

Keywords: levetiracetam keppra
perioperative management of patients with coronary stents undergoing noncardiac surgery

Conditions: Acute Coronary Syndrome; Coronary Stent Occlusion; Surgery

Summary: the purpose of this study is to evaluate and monitor perioperative management of patients with coronary stents undergoing noncardiac surgery. objectives: * to describe the incidence and severity of adverse cardiovascular events in patients with coronary stents undergoing noncardiac surgery with admission. * to assess the following-up of the guidelines about the perioperative management of antiplatelet therapy in these patients. * to assess the relationship between the incidence of cardiac or neurovascular events, as well as bleeding complications with the perioperative management of antiplatelet therapy. * number of participants with adverse events as a measure of safety

(not desired)

Eligibility criteria:
inclusion criteria: * \> 18 years old, with coronary stents * american society of anaesthesia physical status ii-v * noncardiac surgery wiht admission * informed consent exclusion criteria: * \< 18 years old * american society of anaesthesia physical status i * ambulatory surgery * pregnancy * obstetric anaesthesia * endoscopic procedures * cardiac surgery * not informed consent

Keywords: coronary stent bms stent des stent date of stent implantation cardiac event neurovascular event bleeding transfusion
a call center during hae attacks (sos hae)

Conditions: Hereditary Angioedema

Summary: this clinical trial aims to compare morbidity and cost associated with acute attacks of hereditary angioedema in patients with an intervention based on a support after a phone call to the call center (sos hae) from a group of patients does not change their practice.

investigators propose a study to determine whether a call center for an acute attack of hae associated with intervention recommendations based on systematic early treatment (self-administration at home or by a caregiver) would reduce the morbidity and the socioeconomic impact.

Eligibility criteria:
inclusion criteria: * patients with an hereditary angioedema followed in a reference center for bradykinin angioedema (créak) * patient's age ≥ 18 years * consent to the participation in the study * affiliated to social security exclusion criteria: * pregnant woman * recent history of myocardial infarction * recent history of stroke * allergy to icatibant or c1 inhibitor concentrate

Keywords: hereditary angioedema emergency medical service health care coast telephone
dose-escalation study of safety of pbcar19b in participants with cd19-expressing malignancies

Conditions: CD19 Expressing Malignancies; Hematologic Malignancy

Summary: this is a phase 1, nonrandomized, open-label, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of pbcar19b in adult study participants with cd-19 expressing malignancies.


Eligibility criteria:
inclusion criteria: * relapsed or refractory cd19+ expressing malignancies * at least 2 prior regimens per standard of care exclusion criteria: * no history of active cns involvement
a new glucose meter with alternative site testing

Conditions: Diabetes Mellitus

Summary: the purpose of the study was to evaluate the performance of the blood glucose monitoring system when used with samples taken from the palm and forearm for alternative site testing (ast).

the blood glucose monitoring system may be used for alternative site testing. the blood glucose results obtained by subjects with samples taken from the palm and forearm were compared with fingerstick capillary blood glucose results obtained from subjects by an hcp. product labeling was evaluated for comprehension of performing alternative site testing as well as for additional meter features. user feedback about the system and its features was obtained.

Eligibility criteria:
inclusion criteria: * have type 1 or type 2 diabetes * be \>18\<76 years of age at time of consent, with approximately 50% (+10%) being less than 55 years of age * be willing to complete all study procedures * be routinely testing their blood sugar at home (at least once per day) * be able to speak, read, and understand english and understand the informed consent document * be able to read the labeling instructions exclusion criteria: * minors \ 75 years of age * pregnancy * physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the bgms * disorders in the fingertip lancing areas * acute or chronic infections, particularly skin infections * infection with a blood borne pathogen * taking prescription anti-coagulants or having clotting problems that may prolong bleeding. taking aspirin daily (81mg or 325 mg) is not reason for exclusion. * hemophilia or any other bleeding disorder * having a condition which, in the opinion of the principal investigator or designee, would put the person at risk or seriously compromise the integrity of the study * working for a competitive medical device company
a double-blind study to evaluate the safety of glutamic acid decarboxylase gene transfer in parkinson's participants

Conditions: Parkinson Disease

Summary: the objective of this clinical trial is to evaluate the safety and tolerability of adeno-associated virus (aav)-mediated delivery of glutamic acid decarboxylase (gad) gene transfer into the subthalamic nuclei (stn) of participants with parkinson's disease.

the planned length of participation in the study for each participant will be approximately 7 months. this includes a screening period of up to 40 days, randomization and surgery, and a follow-up period of 26 weeks.

Eligibility criteria:
inclusion criteria: * confirmed parkinson's disease * levodopa responsiveness for at least 12 months * updrs part 3 score of ≥25 points in the "off" state exclusion criteria: * past history of brain surgery to treat parkinson's disease * any history of cerebral insult or central nervous system infection * atypical parkinson's disease * focal or lateralized neurologic deficits * evidence of significant medical or psychiatric disorders * cognitive impairment as defined by montreal cognitive assessment (moca)≤20 * beck depression inventory-ii score of ≥ 20