Kornimate/medical-research-clean huggingface dataset:
study in allergic adults to support the development of immunological assays

Conditions: Immunologic Tests

Summary: the purpose of this study is to develop and characterize immunological assays on blood samples.

this is a clinical study in which there is no vaccine administered. it is designed for research purposes such as developing immunological assays.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes can and will comply with the requirements of the protocol. * written informed consent obtained from the subject. * healthy subjects (except the condition studied in the allergy group). * a male or female between, and including 18 and 45 years of age at the time of study start. * subject presenting moderate to severe clinical symptoms of allergy within the week before enrolment (only for allergy group). * subjects suffering from seasonal allergy to birch pollen previously documented by a medical history (only for allergy group). * a positive skin prick test response realised and/or a positive test for specific ige against birch within the last 5 years (only for allergy group). exclusion criteria: * any known or clinical signs of anaemia or any condition that would preclude the drawing of blood as described in the protocol. * receipt of blood products 120 days prior to study visit. * receipt of immunoglobulin 120 days prior to study visit. * use of any investigational or non-registered product within 30 days preceding the study visit. * concurrently participating in another clinical study, at the time of the study visit, in which the subject has been or will be exposed to an investigational or a non-investigational product. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history. * any confirmed or suspected autoimmune or inflammatory disorders. * administration of systemic or inhaled anti-inflammatory medications and, in particular, inhaled corticoid-steroids and cromoglycates within 30 days preceding the study visit. purely local medications such as intranasal steroids or systemic symptomatic medications such as antihistamines and beta agonists are allowed. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the study visit. * pregnant or lactating female. * any past or current birch-specific immunotherapy (only for allergy group). * any allergic disease as established by medical history before study start (only for control group). * family history of allergic diseases in the first degree family members (only for control group).

Keywords: immunological assay birch allergy
examination of the pancreas in new-onset diabetes

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and then screen this cohort for pancreatic cancer

compared to the general population, subjects \>50 years of age with new-onset diabetes (dm) are 8-times more likely to have pancreatic cancer (pac). the likelihood of pac in new-onset dm is further increased in those who have weight loss or elevated ca19-9. in this study patients with newly diagnosed diabetes will be prospectively identified. those with weight loss and/or elevated pancreatic cancer marker (ca 19-9) will undergo pancreatic imaging. all subjects will be followed up to 24 months. if successful in identifying surgically removable pac, this study will fundamentally change our practice and will be a major breakthrough in pac treatment and research.

Eligibility criteria:
patient characteristics: --suspected or definite new-onset diabetes based on recent blood sugar and hemoglobin a1c values * no acute illness or steroid therapy * no prior pancreas surgery

Keywords: pancreatic cancer new-onset diabetic diabetes
is exercise program added to corticosteroid injection effective on pain and performance in plantar fasciitis?

Conditions: Plantar Fascitis

Summary: plantar fasciitis (pf) involves the degeneration of the medial calcaneal tuberosity and nearby perifascial tissues in the heel. it is the leading cause of heel pain, typically resulting from repetitive strain on the plantar fascia, causing structural damage. key risk factors for pf include an increased body mass index in active individuals and a greater range of plantar flexion motion. treatment options for pf vary, and there is no clear consensus on the most effective approach. conservative treatments may include rest, stretching exercises for the plantar fascia and achilles tendon, strengthening exercises for foot intrinsic muscles, nonsteroidal anti-inflammatory drugs (nsaids), orthotics, heel pads, dorsiflexion night splints, and corticosteroid injections. these treatments may be used individually or in combination. corticosteroid injections are the most frequently used invasive treatment. however, there has been limited research examining the effects of corticosteroid injections combined with exercises targeting intrinsic foot muscle strength on functionality and walking distance. the objective of this study was to evaluate the impact of an exercise program added to corticosteroid injections on pain relief and functional performance in individuals with pf.


Eligibility criteria:
inclusion criteria: * those over the age of 18 * those who have pain in the plantar region for 1 month and this pain is 5 or more according to vas, * those who describe pain on the first step of the morning, * those with plantar fascia tenderness on palpation, * patients who will be in harmony with the physician and physiotherapist in exercise and follow-up throughout the entire study period. exclusion criteria: * cases with fracture, entrapment neuropathy and rupture, * those with neurological and systemic diseases, * those with a body mass index (bmi) of more than 40, * conditions with a local contraindication to corticosteroid, * participants who have situations that may prevent their safety, execution or interpretation of the results during the continuation of the training and applied of the test protocol.

Keywords: foot foot disease plantar fasciitis exercise steroid
catheter biofilm microbiome in infected neonatal catheters.

Conditions: Catheter-associated Bloodstream Infections (CLABSI)

Summary: percutaneously inserted central catheters (piccs) are special tubes that are inserted into blood vessels of premature babies (neonates) to give them nutrition and medications. sometimes these tubes get infected and they need to be removed. also, the babies need to be given medications to treat these infections (antibiotics). picc infections in neonates are a serious problem and we need to find new ways of detecting infections early so that we can treat them promptly to avoid complications. the purpose of this study is to understand what causes tube infections in neonates and to develop a test to detect tube infections early to avoid complications.

catheter-associated bloodstream infections (clabsis) are a significant component of healthcare-associated infections (hai),which are associated with significant mortality, morbidity and healthcare costs. neonates are at higher risk for clabsis than children or adults and clabsis are seen more commonly in neonatal than pediatric or adult intensive care units. neonates, who develop clabsis, are not only at serious risk for mortality but also long term neurodevelopmental impairment. clabsis are often caused by organisms colonizing the skin and the most frequently isolated organisms are cons, s. aureus and candida. the catheter biofilm microbiome, to our knowledge has not been investigated before. evaluation of biofilm microbial signatures and microbial dna load is a novel strategy that may permit earlier diagnosis of clabsis. earlier detection may enable earlier targeted therapy such as antimicrobial lock solutions and may facilitate preservation of catheters in this vulnerable population. catheter microbial dna signatures or load may be useful biomarkers to not only predict or diagnose infections but to monitor antibiotic therapy and to confirm resolution of infection. we will study 15 percutaneously inserted central catheters (picc) each from neonates with clabsis and those without. we will evaluate the bacterial microbiome by profiling v3-5 region of the 16s rdna, by pcr and pyrosequencing. we will correlate the catheter biofilm microbiome with catheter tip cultures and the skin microbiome at the catheter entry site. we aim to identify microbial signatures that predispose to dissemination of infection from catheter biofilms leading to clabsis. further, we will quantify microbial dna load in blood from the catheters at the time of removal, by real-time pcr of the bacterial 16s rdna.

Eligibility criteria:
inclusion criteria: * neonates with a percutaneously inserted central catheters (neo picc) who may or may not develop clabsis exclusion criteria: * infants with known immunodeficiency syndrome

Keywords: neonatal intensive care units (nicus) nicus neonates clabsi microbiome dna signature catheter infections
type 2 diabetes patients switched from sulfonylurea with metformin to glyburide/metformin combination tablet

Conditions: Type 2 Diabetes Mellitus

Summary: to evaluate the efficacy and safety of type 2 diabetes patients switched from sulfonylurea co-administered with metformin to glyburide/metformin combination tablet. it is expected that safety and efficacy of glucomet® is not inferior to co-administration of sulfonylurea and metformin.


Eligibility criteria:
inclusion criteria: * male or female age between 20 to 75 years and were diagnosed with type-2 dm for a minimum of 4 months before baseline. * maintain stable dose of sulfonylurea and metformin co-administered 4 months before baseline. * consider suitable to switch from current therapeutic dose to one of the eight testing regimens. * fpg of 80-200mg/dl at screening visit * 6.5% ≦ hba1c ≦ 9% at screening visit, and change of hba1c ≦ 1% within 12 weeks before screening visit. * the body index must be between 18.5 and 35 kg/m2 at screening visit. * sign and date the informed consent form exclusion criteria: * renal disease or renal dysfunction (e.g. serum creatinine \> 1.5mg/dl) * currently significant gi disorder (such as peptic ulcer or diarrhea requiring chronic medical treatment) or which may interfere with absorption of the study drugs. * history or concurrent liver disease or hepatic impairment (total bilirubin above upper normal limit, alt or ast above 2.5 times of upper normal limit at screening visit.) * acute or chronic metabolic acidosis, including lactic acidosis, diabetic ketoacidosis, with or without coma. * history of cardiovascular collapse (shock) or congestive heart failure (function class iii to iv). * history of stroke, myocardial infarction, coronary revascularization, or arrhythmia that requires medical treatment, within past 6 months. * having proliferative retinopathy. * current acute infection, including systemic infection with fever and/or sepsis, or pulmonary infection, cellulitis, etc. * having been treated with insulin during past 6 months, or treated with acarbose or glitazones with change of daily dose past 4 months. * seriously dehydrated. * history of alcoholism (all the time or short-term heavy drinking) or drug abuse, or taking other investigational drug. * pregnant or breast feeding women or planning a pregnancy. * having a surgery within 4 weeks prior to entering the study or a history of cancer within five years. * known hypersensitive to glyburide or metformin hydrochloride. * any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.

Keywords: change from baseline of hba1c after 16 weeks of treatment change from baseline of fpg after 16 weeks of treatment change from baseline of diabetes self-care scale by patient on drug administration after 16 weeks of treatment
vaccine-related pain in infants

Conditions: Pain

Summary: this is a randomized double-blind controlled study and was performed to compare effects of rapid injection without aspiration and 10-second manual pressure before injection on pain severity and crying time in 4-6-month-old infants given the vaccine dtap/ipv/hib. the study population included all the infants presenting for dtap/ipv/hib to two family health centers between april and august in 2015. the study sample included 128 infants based on confidence interval of 95% and statistical power of 80%. the sample was divided into four groups; i.e. manual pressure, rapid injection without aspiration, manual pressure combined with rapid injection without aspiration and control groups. there were 32 infants in each group. gender was adjusted in all groups. stratified and block randomizations were used.

study design: this is an experimental, double-blind, randomized controlled trial. study population and study sample: the study was conducted in two family health centers of cankiri public health directorate, turkey, between april and august in 2015. the study population included infants aged 4-6 months and presenting to the family health centers for the second and third doses of dtap/ipv/hib. the study sample comprised of 128 infants based on confidence interval of 95% and statistical power of 80%. analysis made at the end of the study showed a statistical power of 0.83 based on confidence interval of 95%. outcome measures pain severity: video recordings obtained were evaluated by two pain specialists separately by using neonatal infant pain scale. the specialists were blinded to the groups to eliminate possible mistakes in observations and the possibility of taking sides and to avoid bias. the scores assigned by the specialists were used to determine pain scores before, during and after vaccine injections. crying time: video recordings taken were watched by the same researcher and crying time before, during and after vaccine injections was calculated for each infant. physiological changes (heart rate and oxygen saturation): the probe of pulse oximetry was attached to the foot not injected vaccine to measure oxygen saturation and heart rate before, during and after the injections in each child.

Eligibility criteria:
inclusion criteria: * healthy infants who were aged 4-6 months, had the percentiles of 3p - 97p, were born at term and were not given any analgesics before immunization and whose mothers gave written informed consent were included. exclusion criteria: * infants whose percentiles were below 3p and above 97p and who had acute infectious diseases, underwent topical anesthesia and/or took analgesics were excluded from the study.

Keywords: pain management vaccination manual pressure needle aspiration
observational study for the evaluation of the clinical performance and safety profile of the galaxy fixation™ system and orthofix implantable devices: galaxy study

Conditions: Fractures of the Long Bones; Vertically Stable Pelvic Fractures; Vertically Unstable Pelvic Fractures

Summary: the galaxy fixationtm system and orthofix implantable devices study intends to evaluate the clinical performance and safety profile of the study medical/investigational devices in the standard clinical practice. the study will be conducted in three sites located in italy considered reference sites for the treatment of adults and paediatric patients with fractures of the long bones, vertically stable pelvic fractures, or vertically unstable pelvic fractures as a treatment adjunct, where the usage of galaxy fixation™ system and orthofix implantable devices were part of the normal clinical practice. the participant investigators will retrospectively include a maximum of 118 patients in which galaxy fixationtm system and orthofix implantable devices were used. no diagnostic or therapeutic intervention outside routine clinical practice will be applied.


Eligibility criteria:
inclusion criteria: 1. the patient directly or indirectly (through a respondent) expressed his willingness to participate in the study by signing and dating informed consent. 2. patient who had a regular indication for the following surgical intervention with the galaxy fixation™ system and orthofix implantable devices according to manufacturer's ifus: * fractures of the long bones or; * vertically stable pelvic fractures or vertically unstable pelvic fractures as a treatment adjunct. 3. patients equal or older than 29 days. 4. patients who had a regular indication for external fixation according to the investigator criteria. 5. patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study exclusion criteria: 1. the patient is participating in other clinical studies or did he/she participate in the 3 months before signing the informed consent in other clinical studies. 2. the patient needed the application of or had already in-situ concomitant devices that couldn't be safely removed (except for permitted concomitant devices). 3. the patient was treated with more than one galaxy fixation™ system or non orthofix implantable devices. 4. patient who had mental or physiological conditions who are unwilling or incapable of following postoperative care instructions. 5. patient who had previous infections in the fracture area. 6. patients who had malignancy in the fracture area. 7. patients who had neuromuscular deficit or any other conditions that could influence the healing process. 8. patients who had suspected or documented metal sensitivity reactions as it could result in a treatment failure in the intended population
clinical study on the combination of xiaoyu zhitong formula and lymphatic drainage technique to improve the symptoms of knee pain and swelling in cold dampness obstruction type

Conditions: Knee Osteoarthritis (OA)

Summary: this research project applies a combination of blood stasis relieving and pain relieving formula and lymphatic drainage technique to treat patients with cold dampness obstruction type knee joint pain. the improvement of knee joint pain scores and activity function as well as the degree of soft tissue swelling changes are observed before and after receiving this therapy providing certain ideas for the comprehensive treatment optimization and prognosis judgment of cold dampness obstruction type knee joint pain.


Eligibility criteria:
1. inclusion criteria: * a. patients who meet the diagnostic criteria for knee osteoarthritis in the "guidelines for diagnosis and treatment of osteoarthritis" (2007 edition) of the chinese medical association orthopedic branch and also meet the diagnostic criteria for wind cold dampness syndrome of knee joint obstruction; * b. age range: 25-70 years old; * c.1 week ≤ disease duration ≤ 2 years; * d. if other treatments have already been received and there is a washout period of more than 14 days; * e. voluntarily participate in the study and sign an informed consent form. 2. exclusion criteria: * a. patients with bleeding tendencies severe skin damage or skin diseases in certain areas; * b. suspected or diagnosed with tumors; * c. patients with severe heart lung brain diseases tuberculosis osteomyelitis and osteoporosis; * d. patients with mental illnesses; * e. pregnant or planned pregnant women and lactating women; * f. have participated in other clinical studies within the past 3 months; * g. the researchers believe that they are not suitable to participate in this clinical study due to other reasons.

Keywords: knee osteoarthritis pain swelling of soft tissues
screening for neurodevelopmental disorders in siblings of children with autism diagnosed in tertiary centers

Conditions: Autism Spectrum Disorder; Siblings; Neurodevelopmental Disorders

Summary: in this study, a selective and multi-stages screening for neurodevelopmental disorders (ndd) in siblings of children with a confirmed asd is done. the main aims are to estimate the prevalence of ndd among siblings and to evaluate the feasibility and acceptability of a standardized screening procedure.

although ndd are frequent among siblings of children with asd, their developmental screening is not yet sufficiently organized in routine practice. the needs and the characteristics of these siblings have yet to be better understood in order to define their developmental surveillance.

Eligibility criteria:
inclusion criteria: * step 1: brothers or sisters (including stepsisters and brothers); aged between 2 and 16 years; living in occitanie; informed and express consent of parents ; affiliated to social security. * step 2: step 1 positive screening or parental concerns for child's development ; parental signed informed consent. exclusion criteria: * parents (or child) refusal to participate; adopted brother or sister. do not speak french

Keywords: siblings screening autism spectrum disorder neurodevelopmental disorders
ed50 of dexmedetomidine to prevent emergence agitation in children

Conditions: Agitation

Summary: there are several recommended doses of dexmedetomidine for prevention of emergence agitation in children. in this study, the investigators examine ed50 in prevention of emergence agitation after tonsillectomy or adenoidectomy in children.

to investigate ed50, dixon's up and down method will be used.

Eligibility criteria:
inclusion criteria: * tonsillectomy or adenoidectomy exclusion criteria: * recent uri
intravenous ascorbic acid administration in hysterectomy

Conditions: Abdominal Hysterectomy

Summary: vitamin c or ascorbic acid has known role in tissue repair. due to it's properties(water_soluble), vitamin c is not stored in the body and when depleted, the bleeding tendency will increase due to dysfunctional connective tissues production in vessel wall and it has some important functions in platelets.

in this randomized clinical trial, 1000 mg vitamin c will administrate intravenously a day before surgery and during surgery in patients who undergo abdominal hysterectomy.

Eligibility criteria:
inclusion criteria: * to be 18 years and older * no smoking * no history of bleeding disorder * no history of favism * no history of uterus, ovary, cervical cancer exclusion criteria: * need to injection of vasopressor drugs * surgeon disagreement

Keywords: vitamin c hysterectomy bleeding wound healing abdominal surgeries