Kornimate/medical-research-clean huggingface dataset:
a pharmaco-epidemiological study of short patients born small for gestational age (sga), treated with saizen® (recombinant somatropin)

Conditions: Infant, Small for Gestational Age

Summary: this one-arm, multi-centric, non-randomized, observational, open label, prospective study was designed to study short subjects born sga, by pediatricians, endocrinologists or physicians in private, mixed private and hospital practice treated with saizen.

the term "small for gestational age" (sga) is a pathological medical condition known since about two decades supported by two consensus conferences of 2001. it inhibits the height and/or weight of the child at birth without prejudging the mechanisms that alter these. this study will be carried out by hospital pediatricians, endocrinologists or physicians in private, mixed private and hospital practice in metropolitan france. subjects will be monitored by doctors in accordance with the normal scope of follow-up of pathology until their final growth and until they reach adult height and/or until the treatment is discontinued. the participating doctors will include all the short sga subjects coming for consultation or the follow-up (for less than 12 months) of their treatment by saizen in this study. the inclusions will take place over a period of 21 months. objectives primary objective: * to describe the characteristics of short children born sga (sga subjects) treated with saizen secondary objectives: * to describe the terms and conditions for the prescription of saizen in terms of dosage, duration of treatment, reason for discontinuation and compliance * to describe the effects of saizen on growth and final height * to describe the tolerance of saizen. for each subject and during each visit, the participating doctor will complete an electronic data collection form.

Eligibility criteria:
inclusion criteria: * short children born sga requiring treatment with saizen, new to growth hormone treatment or being treated with growth hormones for less than 12 months of inclusion * subjects whose parents have given their written consent for participation in this study exclusion criteria: * contra-indication in the treatment with saizen

Keywords: infant, low birth weight infant, low birth height infant, small for gestational age
normothermiс cardiopulmonary bypass increases cerebral oxygenation during valve surgery

Conditions: Heart Valve Diseases

Summary: the aim of our study was to evaluate the effect of different temperature regimens of cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during surgical correction of acquired heart diseases.

our aim was to evaluate the effect of hypothermic and normothermic regimens of cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during valve surgery

Eligibility criteria:
inclusion criteria: * requirement of surgical correction of two or more valves

Keywords: perfusion cardiopulmonary bypass hypothermia cerebral oxygenation
octagam 5% versus comparator post marketing trial

Conditions: Primary Immune Deficiency Disorder

Summary: study design: this is a 2 arm non-interventional trial that will compare the occurrence of adverse drug reactions between octagam 5% and other marketed ivig infusion treatments.

this post marketing study is a prospective, 2-armed, multicenter, non-interventional study. patients will either be administered the brand of igiv therapy ordered by their prescribing physician, or for patients issued unspecified or generic prescriptions of igiv therapy, octagam® 5% or another brand of igiv therapy will be provided by the investigator according to federal, state and local regulations and good clinical practice (gcp) guidelines. the primary objective is to assess and evaluate the safety profile of octagam® 5% during or after administration under routine clinical use for all labeled indications, with a special emphasis on the occurrence of tees. the incidence of tees in patients receiving octagam® 5% will be compared with the incidence rate in a matching concurrent control group of patients receiving other igivs for routine clinical use.

Eligibility criteria:
inclusion criteria: 1. male and female patients aged 18 years. 2. patients with confirmed diagnosis of primary humoral immunodeficiency (pi) as stated by the world health organization and requiring immunoglobulinreplacement therapy due to hypogammaglobulinemia or agammaglobulinemia. 3. patients on regular treatment (every 3 to 4 weeks) with low dose igiv (1 g/kg) for a period of at least 6 months without changing the brand. exclusion criteria: 1. patients with a history of tees within the previous 24 months. 2. patients with a regular treatment frequency of more than once every 3 to 4 weeks.

Keywords: primary immune deficiency syndrome primary immunodeficiency disease (pidd) pid
prevention of hypothermia during caesarean section: continuous core temperature monitoring with zero-heat-flux

Conditions: Inadvertent Perioperative Hypothermia

Summary: nowadays, caesarean sections account for about 7% of all surgical procedures worldwide. over 30% of the patients undergoing a caesarean section experience a fall of the body core temperature under 36°c during the procedure. following a retrospective cohort design, this study aims to examine the magnitude of hypothermia in the parturient and newborn population as well as the impact and efficiency of forced-air warming on preventing it. the researchers plan to conduct a retrospective analysis of the caesarean section treatment protocol at our institution over a period of 5 months including approximately 300 patients who underwent both elective and emergency caesarean sections.

this research seeks to address the necessity of standardizing the use of forced-air warming and monitoring the maternal temperature during caesarean sections. we will also examine the impact of the maternal hypothermia on the newborn temperatures at the time of partus and also 2 hours after birth. the key research question of this study is whether the use of forced-air warming will significantly lower the hypothermia rates and account for a faster temperature recovery in our parturient patients. a major contribution of our research is that it provides modern high-resolution, continuous and user-error free thermometry. this is achieved through zero-heat-flux technology and automatically recorded by data-loggers. also, the heterogeneity of our study population, which has not been attended in previous studies, corresponds to the clinical reality of the most obstetric clinics. this research could provide new information about the necessity of standardizing the use of forced-air warming and monitoring the maternal temperature during caesarean sections, in the concept of bonding the babies to the mother's chest immediately after birth, and derive practical implications on the efficiency of intraoperative warming for the standard clinical routine of the majority of the obstetric clinics.

Eligibility criteria:
inclusion criteria: included will be all caesarean section deliveries under spinal anaesthesia at our facility in the period from 01.04.2019 to 31.08.2019 exclusion criteria: * different anaesthesia procedure (e.g. intubation anaesthesia, peridural anaesthesia etc.), * american society of anesthesiologists (asa) classification iii or higher, * bmi( body mass index) \>45 kg·m-2, * patients with incomplete documentation, * estimated perioperative blood loss \> 500ml, * other perioperative complications (ex. insufficient analgesia and change of anaesthesia procedure).

Keywords: cesarean section c-section hypothermia spinal anesthesia caesarean section zero heat flux technology active warming
reduction of blood recirculation in veno-venous ecmo

Conditions: Extracorporeal Membrane Oxygenation; Acute Respiratory Distress Syndrome

Summary: blood which recirculates through the circuit of a veno-venous extracorporeal membrane oxygenation (v-v ecmo) does not contribute to the systemic oxygenation of a patient on v-v ecmo and is called the recirculation fraction (rf). theoretically, the optimization of ecmo blood flow is possible using rf measurements. a prospective, observational study will be performed measuring the rf of total ecmo blood flow in patients with acute respiratory distress syndrome (ards) on v-v ecmo with an ultrasound dilution technique. ecmo blood flow will be optimized by reducing ecmo blood flow in accordance with the measured rf as long as systemic oxygenation is not compromised.

based on data from the 'blood recirculation and vvecmo' trial (clinicaltrials.gov id: nct03200314) (i.e. an expected frequency of successful blood flow reduction of 66.7%), using a one-sample chi square test, a two-sided type-1 error of 5%, a power of 80%, a total of 68 patients is needed to show that the proportion of patients with a secure ecmo blood flow reduction is greater than 50%. presumably, 136 patients have to be included into the trial to study 68 patients with a relevant rf since not all patients on v-v ecmo suffer from a high rf.

Eligibility criteria:
patients aged 18 years or older requiring veno-venous ecmo for treatment of refractory hypoxemia in ards.
exercise training for the treatment of generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to compare the effects of 6 weeks of endurance or strength training and a wait list comparison condition on symptoms of generalized anxiety disorder (gad).


Eligibility criteria:
inclusion criteria: * women aged 18-39 years * principal diagnosis of generalized anxiety disorder according to dsm-iv diagnostic criteria (comorbidities will be acceptable as long as generalized anxiety disorder is the principal diagnosis) exclusion criteria: * a score of less than 45 on the penn state worry questionnaire * a score of less than 7 on the generalized anxiety disorder section of the psychiatric diagnostic screening questionnaire * expending greater than 250 kilocalories per kilogram body weight per week as measured by a 7-day physical activity recall questionnaire * engaging in greater than 6 exercise bouts in the month prior to recruitment * pregnancy * any medical contraindications (cardiovascular or musculoskeletal) to exercise training according to american college of sports medicine guidelines

Keywords: generalized anxiety disorder exercise training strength training mental health
local infiltration analgesia in total knee arthroplasty

Conditions: Total Knee Arthroplasty; Analgesia

Summary: 40 patients asa i-iii, undergoing total knee arthroplasty were randomly assigned, into one of two groups, namely group lia (n=20), where local infiltration analgesia would be administered intraoperatively; and group sham lia (n=20), where sham injections of normal saline would be administered. all patients received a standardized multimodal approach, including pregabalin, adductor canal peripheral nervous blockade, spinal anaesthesia, paracetamol, and pca with morphine. morphine consumption during the first 24 hours postoperatively was measured and additionally the investigators recorded: time of morphine first dose administration, nrs scores in static and dynamic conditions in 6 hours, 12 hours, 18 hours and 24 hours postoperatively, complications, patient satisfaction and duration of hospitalization.


Eligibility criteria:
inclusion criteria: * physical status according to american society of anesthesiologists (asa) i-iii * patients scheduled for total knee arthroplasty exclusion criteria: * contraindication for central and/or peripheral nervous blockade * reoperation on previous total knee arthroplasty * history of allergic or other adverse reactions on the agents used in the study * chronic opioid or gabapentinoid use * serious psychiatric, mental and cognitive disorders * language barrier * difficulty in understanding or using a patient controlled analgesia device
individually based psychosocial rehabilitation for older people with serious mental illness (smi)

Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Major Depression

Summary: the major goal of this project is to adapt an existing group-based psychosocial program to enhance community functioning in older people with serious mental illness (smi). the focus of the adaptation is designing and evaluating an individually based rehabilitative program for older people with smi who either cannot or choose not to access a group program.


Eligibility criteria:
inclusion criteria: 1. age 50+; 2. ability to provide voluntary informed consent or assent, with formal consent by a legal guardian; 3. axis i disorder of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression; 4. functional impairment based on new hampshire state eligibility criteria for services to people with smi; 5. enrollment in treatment for at least three months. exclusion criteria: 1. residence in a nursing home or assisted living facility; 2. terminal illness expected to result in death within one year or less; 3. diagnosis of dementia, or significant cognitive impairment as indicated by a mini mental status evaluation (mmse) score \<24; 4. current active substance abuse or dependence; 5. past participation in hopes-g

Keywords: older persons with smi
chronic obstructive pulmonary disease and health coaching

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this study is to determine the effect of the health coaching approach applied to patients with chronic obstructive pulmonary disease on the perceived social support of the patients. research hypotheses: h0: health coaching approach has no effect on perceived social support in patients with copd. h1: health coaching approach has an effect on perceived social support in patients with copd.

the current study is in the design of a single-blind randomized controlled trial. patients were randomized into intervention group (n:34) and control group (n=34). coaching interview will be held once a week for 6-8 weeks with the patients in the coaching group. coaching sessions will be based on the social support the patient receives from family and friends. both the coaching group and the control group will be given information about copd. this information will be given face to face first. later, the booklet of the training given will be delivered to the patients via message. the data was collected using the socio-demographic information form,copd assessment test (cat), and multidimensional scale of perceived social support (mspss). data analysis will be done with spss package program

Eligibility criteria:
inclusion criteria: * over 40 years old, * diagnosed with copd for at least 6 months, * without stage iii and iv heart failure, * without any cancer diagnosis, * no communication problems (such as those who do not have problems in expressing - themselves, no hearing problems), * not diagnosed with cognitive and mental dysfunction (such as alzheimer's, dementia, bipolar disorder, major depression) * patients who agree to participate in the study will be formed. exclusion criteria: * with any cancer * with stage iv heart failure * patients requiring clinical follow-up due to acute copd exacerbation

Keywords: chronic obstructive pulmonary disease health coaching social support symptom management
immunogenicity and safety study of glaxosmithkline (gsk) biologicals' influenza vaccine when administered in children who previously participated in study 115345

Conditions: Influenza

Summary: the purpose of this study is to assess the safety and immunogenicity of gsk biologicals' investigational vaccine gsk2321138a in children who previously participated in study 115345 (flu d-qiv-004 pri) (nct01439360).


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that parent(s)/lar(s) can and will comply with the requirements of the protocol. * children, male or female who received a 2-dose vaccination in the study 115345 (nct01439360). * written informed consent obtained from the parent(s)/lar(s) of the subject. * subjects in stable health as determined by medical history and clinical examination before entering into the study. exclusion criteria: * child in care. * use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * since the start of study 115345 (nct01439360), receipt of any seasonal influenza vaccine other than the study vaccines of study 115345 or planned administration of any influenza vaccine other than the study vaccine during the study. * administration of any vaccine not foreseen by the study protocol within 4 weeks preceding the first dose of study vaccine or planned use until visit 2. * laboratory confirmed influenza infection outside of the 115345 (nct01439360) study. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to enrolment in the study or planned administration during the study period. inhaled and topical steroids are allowed. * administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * any contraindication to intramuscular injection. * acute disease and/or fever at the time of enrollment: * fever is defined as temperature ≥ 37.5°c by any route. * subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. * any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.

Keywords: gsk biologicals quadrivalent influenza vaccine influenza children safety immunogenicity
polyethylene glycol interferon alfa-2b (peg intron) versus interferon alfa-2b (intron^® a) in the treatment of newly diagnosed chronic myelogenous leukemia (cml) (c98026)

Conditions: Chronic Myelogenous Leukemia

Summary: the primary purpose of this study is to compare the efficacy of polyethylene glycol (peg; pegylated) interferon alfa-2b (peg intron, c98026) versus interferon alfa-2b (intron® a) in the treatment of participants with newly diagnosed cml.


Eligibility criteria:
inclusion criteria * has chronic phase cml diagnosed within 3 months prior to study enrollment * has chronic phase cml positive for ph\^1 as confirmed by cytogenetic studies, performed by a central laboratory * has platelet count \>/= 50,000/microl * has hemoglobin \>/= 9.0 g/dl * has wbc count \>/=2000/microl but \</= 50,000/microl * has adequate hepatic and renal function, as defined by the following parameters obtained within 14 days prior to initiation of study treatment * serum glutamic oxaloacetic transaminase (sgot) \<2 times upper limit of laboratory normal (uln) * serum glutamic pyruvic transaminase sgpt \<2 times upper uln * serum bilirubin \<2 times uln * serum creatinine \<2.0 mg/dl * is fully recovered from any prior major surgery and must be at least 4 weeks postoperative * has eastern cooperative oncology group performance status of 0-2 * has signed a written, voluntary informed consent before study entry, is willing to participate in this study, and is willing to complete all follow-up assessments exclusion criteria: * has accelerated phase cml as defined by any of the following criteria. * peripheral blood myeloblasts \>/=15% * peripheral blood basophils \>/= 20% * peripheral blood myeloblasts plus promyelocytes \>/=30% * platelets \<100,000/microl, unrelated to therapy * has blastic phase cml (30% myeloblasts in peripheral blood or bone marrow) * is a candidate for and is planning to receive allogeneic, syngeneic, or autologous bone marrow transplantation within the next 12 months * has received prior treatment for their cml, except for hydroxyurea (collection of stem cells without using high dose chemotherapy for mobilization is acceptable) * has severe cardiovascular disease (i. e., arrhythmias requiring chronic treatment, congestive heart failure \[new york heart association (nyha) class iii or iv\], or symptomatic ischemic heart disease) * has a history of a neuropsychiatric disorder requiring hospitalization * has thyroid dysfunction not responsive to therapy * has uncontrolled diabetes mellitus * has a history of seropositivity for human immunodeficiency virus * has active and/or uncontrolled infection, including active hepatitis * has a medical condition requiring chronic systemic corticosteroids * has a history of prior malignancies within the last 5 years, except for surgically cured non-melanoma skin cancer, or cervical carcinoma in situ * has received any experimental therapy within 30 days prior to enrollment in this study * is known to be actively abusing alcohol or drugs * is pregnant, nursing, or of reproductive potential and is not practicing an effective means of contraception
effect of glp-1 on insulin biosynthesis and turnover rates

Conditions: Type 2 Diabetes

Summary: the gut hormone glucagon like peptide-1 (glp-1) has been shown to have important effects on maintaining the function and health of the insulin producing beta cells. this hormone is known to increase the production rate of new insulin as well as increase the release of insulin into the blood.

we will measure the rate of new insulin production in subjects with type 2 diabetes compared to non diabetic subjects. we hypothesize that subjects with type 2 diabetes make less insulin in response to glp-1 compared to non diabetic subjects.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * non diabetic exclusion criteria: * currently taking medication such as thiazolidinediones, metformin, exenatide, or sitagliptin * chronic condition such as chronic heart failure chf), coronary artery disease (cad), or chronic renal failure (crf) * anemia

Keywords: type 2 diabetes insulin biosynthesis non diabetic control
endometrium microbiome alterations in cesarean section diverticula before and after transvaginal repair surgery

Conditions: Cesarean Section Complications

Summary: the study compares the microbiome differences in the endometrium between normal people and patients with uterine diverticula after cesarean section and aims to discover the essential microbes and their metabolites that highly associate with the repair of myometrium through metagenomics and metabolomics. it verifies that flora disorder in the endometrium is the important cause of poor uterine repair after cesarean section. then these patients with uterine diverticula receive the transvaginal repair surgery. through the follow-up with them, we gain the microbiome differences of the endometrium before and after the surgery and show the validity of transvaginal repair surgery in the level of microbiome and metabolism.


Eligibility criteria:
inclusion criteria: have one cesarean delivery, have intermenstrual spotting after the cesarean section or residual muscle thickness was less than 3.0 mm at the preoperative stage underwent magnetic resonance imaging and transvaginalultrasound to evaluate the size of the defect and the residual muscle thickness before surgery have vaginal repair of cesarean section diverticula write consent for operation. exclusion criteria: have a history of endocrine disorders have coagulation disorders use of intrauterine devices have sub-mucous myoma have endometrial diseases have endometrial cysts, uterine fibroids, and adenomyosis