Kornimate/medical-research-clean huggingface dataset:
diagnosing perineal tears, does different assessment methods affect the midwife's clinical judgement of perineal tears?

Conditions: Obstetric Perineal Rupture

Summary: this study aims to compare different midwife practitioners assessments of perineal tears.

perineal injuries are one of the traumas most frequently suffered by women during delivery.countries report wide variations in trauma rates, and within countries further variations exists among institutions and also among professional groups of caregivers.visual and digital examination of the wound has been and is the most common way to assess and classify a perineal tear. however resent studies indicate that many tears diagnosed with this method are misclassified.the suggested reasons for this, apart from the fact that bleeding and tissue oedema make the diagnose difficult, is that many healthcare providers have too little training in perineal assessment and basic anatomy. in this prospective randomised trial consenting women will be randomised in to the common visual and digital assessment of the perineal tear by to different midwives, blinded to each others assessment or visual and digital assessment and measuring of the tear with a small soft ruler, peri-rule also by two different midwives.

Eligibility criteria:
inclusion criteria: * spontaneous vaginal birth * women over 18 years of age * healthy child * written consent signed by participant * spontaneous tear in perineum that involves the perineal skin exclusion criteria: * bleeding from tears that demand suturing immediately. * bleeding that affected the general condition negatively * complex tears that branched out in two or more different directions * women delivered instrumentally forceps or ventouse * women delivered with cesarian section * women who sustain episiotomy

Keywords: obstetric perineal tear perineal injury diagnosis
relative bioavailability of phase ii and phase iii formulations of azd0530

Conditions: Healthy

Summary: the aim of the study is to compare how different formulations of azd0530 are absorbed by the body. as for all clinical trials, safety and tolerability of the drug will be evaluated.


Eligibility criteria:
inclusion criteria: * female subjects must be of non- child-bearing potential * body mass index between 19 and 30 kg/m2 and weigh between 50-100 kg exclusion criteria: * presence of any clinically significant illness * abnormal vital signs * history of any conditions that may put the subject at risk by participating in the study * participation in another clinical study.

Keywords: healthy volunteers relative bioavailability
erlotinib for hepatocellular carcinoma chemoprevention

Conditions: Cirrhosis, Liver

Summary: this phase iia trial studies long-term low-dose erlotinib hydrochloride treatment to assess its efficacy and safety to prevent development of hepatocellular carcinoma in patients with liver cirrhosis.


Eligibility criteria:
inclusion criteria: * adults (≥ 18 years-old) * clinically and/or histologically diagnosed cirrhosis * no active hepatic decompensation * no prior history of hcc * adequate hematologic, hepatic, and renal function, karnofsky performance status score ≥70 * both sexes and all racial/ethnic groups will be considered exclusion criteria: * prior treatment with epidermal growth factor receptor (egfr) inhibitors * uncontrolled intercurrent, use of cyp3a4 modulators * failed biopsy * erlotinib treatment \<4 weeks or \<80% of planned regimen at the end of week 4 * hcc development during the study

Keywords: hepatocellular carcinoma chemoprevention
an open-label, long-term study with al-4943a ophthalmic solution, 0.2% in patients with allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: the objective of this study is to assess safety and efficacy of long-term use of al-4943a (olopatadine hydrochloride ophthalmic solution, 0.2%) in patients with allergic conjunctivitis.


Eligibility criteria:
inclusion criteria: * subjects must provide written consent. * subjects must have a diagnosis of allergic conjunctivitis. * other protocol-defined inclusion criteria may apply. exclusion criteria: * itching and/or hyperemia associated with diseases other than allergic conjunctivitis. * retinal detachment, diabetic retinopathy, or any progressive disease in posterior segment of the eye. * known history of ocular infection. * contact lens wear during study. * pregnant, nursing. * participation in another clinical study within 30 days of informed consent. * other protocol-defined exclusion criteria may apply.
study of inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone in patients with chronic asthma (0476-386)

Conditions: Asthma

Summary: this study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma.

during this study, all patients will receive mometasone (powder, 220 mcg once-daily, for approximately 6 weeks). in a crossover manner, eligible patients will also receive montelukast (powder, 1 mg once-daily, for approximately 2 weeks) followed by placebo; or will receive placebo followed by montelukast. the order of when each of these 2 treatments are added to the mometasone will be randomized.

Eligibility criteria:
inclusion criteria: * patient has decreased breathing capacity (when not taking asthma medicine) that improves after taking a fast-acting asthma inhaler * within one month of the first study visit, patient has been treated with a fast-acting asthma inhaler, and may be treated with a corticosteroid inhaler or an inhaler that combines a corticosteroid plus a bronchodilator exclusion criteria: * patient is hypersensitive to inhaled beta-agonists, corticosteroids, leukotriene antagonists, or any of their components * has required an oral corticosteroid rescue for worsening asthma during the screening period
vaginal preparation and azithromycin to reduce post cesarean infections

Conditions: Infection; Obstetric Labor Complications; Endometritis; Cesarean Delivery Affecting Fetus; Wounds Injuries

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Eligibility criteria:
inclusion criteria: * full term pregnancy * undergoing labored, non-emergent cesarean section * patient in labor exclusion criteria: azithromycin contraindicated: * known hypersensitivity to azithromycin, erythromycin, macrolides or ketolide medications. * liver dysfunction * prescription medications which may interact with azithromycin, such as nelfinavir or warfarin * a history of a cardiac dysrhythmia (irregular heartbeats) * known hypersensitivity to iodine * patients carrying fetuses with known congenital anomalies * immunodeficiency * patients who are not in labor at the time of delivery * non-english speaking subjects or subjects with language barriers
complementary food supplements for reducing childhood undernutrition

Conditions: Stunting; Wasting

Summary: the purpose of this study is to test the impact on child growth of three specially formulated complementary food supplements vs. plumpy'doz, a previously tested, commercially available complementary food, and vs. a control group that receives no food. all groups will receive nutrition education related to infant and young child feeding. this will be a cluster-randomised trial in children 6-18 months old in rural rangpur and gaibandha in bangladesh.

childhood stunting and growth faltering is highly prevalent in south asia. among other strategies, adequate complementary feeding practices and provision of complementary foods that are appropriate and fill the nutrient gap by providing macro and micronutrients essential for growth are important means to reduce the global burden of undernutrition and related morbidity and mortality. we propose to evaluate the impact of three complementary food supplement products that are fortified with micronutrients in a rural, remote setting in bangladesh, where high rates of childhood undernutrition persist on child growth, health, and development. the three foods being tested are an enhanced wheat-soy blend (wsb++) developed by wfp, and locally developed chickpea-based and a rice-based complementary food supplements. we will assess the impact of feeding these daily against the non-fed controls, hypothesizing that the children fed these foods show increased length for age z scores (laz) and weight for length age z scores (wlz) of \>0.21 and decreased prevalence of stunting and wasting by \>10%. we expect that the impact of the three foods will be equivalent/ non-inferior to that of plumpy'doz.

Eligibility criteria:
inclusion criteria: * infants 6 months of age

Keywords: complementary food supplements stunting wasting growth bangladesh infant feeding
evaluation the association of microbiome between respiratory tract samples and stool samples in pneumonic patients accompanied by respiratory failure

Conditions: Microbiota; Pneumonia, Bacterial; Respiratory Failure; Lower Resp Tract Infection

Summary: a prospective observational study. enrolled participants admitted to icu due to pneumonia and respiratory failure need mechanical ventilator support. investigators collected the residual specimens, such as sputum from endotrachea aspiration, bronchoalveolar lavage fluid in those participants as the usual care in the icu. those residual samples were sent to extract rna and sequence by using high-throughput sequencing (next-generation sequencing) method. investigators will compared the microbiome feature between lower respiratory tract and stool specimens in those participants diagnosed as pneumonia with respiratory failure.


Eligibility criteria:
inclusion criteria: * adults aged than 40 years old * diagnosed as pneumonia * respiratory failure with mechanical ventilator support exclusion criteria: * less than 40 years old * has been treated with antibiotics more than 7 days within two weeks before enrolling into study * suspected or active pulmonary tuberculosis infection

Keywords: microbiota respiratory failure pneumonia lower respiratory tract infection
investigational biomarkers for neurological immune-related adverse events

Conditions: Neurological Disease

Summary: neurological immune-related adverse events (n-iraes) are an emerging group of disorders of patients with cancer treated with immune checkpoint inhibitors, presenting with heterogeneous clinical manifestations and of uncertain outcome. novel genetic, inflammatory, and neurogenerative biomarkers could be associated with distinct phenotypes and different outcomes. to test this hypothesis, the study will provide: a phenotypic characterization and outcome assessment of patients with n-iraes; the analysis of biomarkers of genetic predisposition (hla and other immunity-related genes), inflammation (serum and cerebrospinal fluid \[csf\] cytokines and autoantibodies, peripheral blood and csf lymphocytes and other immune cells, neuroimaging), neurodegeneration (serum and csf neurofilaments, neuroimaging) and their correlation with clinical features and outcome.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of n-iraes exclusion criteria: * presence of an alternative diagnosis explaining the neurological syndrome

Keywords: biomarkers autoimmunity immunotherapy side-effects immune checkpoint inhibitors neuroimmunology
efficacy of botulinum toxin type a in patients with bladder pain syndrome/intersticial cystitis and hunners' lesions

Conditions: Interstitial Cystitis

Summary: the etiology of bladder pain syndrome is unknown. therefore the management is directed to pain relief, as bladder pain is believed to drive both voiding frequency and nocturia. botulinum toxin a has been shown to decrease noxious input. several studies showed efficacy of botox for treatment of painful bladder. the aim of this study is to evaluate the efficacy of botulinum toxin in patients who are suffering bladder pain syndrome with hunner lesions during cystoscopy.


Eligibility criteria:
inclusion criteria: * longer than 6 months of bladder pain syndrome/interstitial cystitis with hunner lesion(s) during cystoscopy exclusion criteria: * pregnancy * neurologic diseases * urinary tract infections * bladder outlet obstruction * previous pelvic radiotherapy

Keywords: interstitial cystitis bladder pain syndrome intratrigonal injection botulinum toxin
analysis of retinal nerve fiber layer and macular thickness after congenital cataract surgery

Conditions: Congenital Cataract

Summary: congenital cataract is the main cause of form deprivation amblyopia in children. current studies confirm that form deprivation amblyopia affects the retinal nerve fiber layer. however, there are different opinions about the effect of amblyopia on the optic nerve fiber thickness around the optic disc at home and abroad. investigators have performed "cataract extraction with iol implantation" on children with bilateral and unilateral congenital cataract. investigators used oct biometry to measure children's the retinal nerve fiber layer (rnflt) and macular thickness (cmt) before and after surgery. investigators dynamically observed changes in rnfl and cmt to explore the retinal mechanism of form deprivation amblyopia and help guide the clinical correct understanding of postoperative follow-up time.

this prospective study reviewed children with cc who were undergoing cataract extraction with iol implantation at the eye hospital of wenzhou medical university, hangzhou, china. bilateral and unilateral cc children were placed in study group, while age-matched normal children were included as controls. children who were uncooperative to complete the preoperative and postoperative examinations were excluded. all eyes were divided into 4 groups. group 1: form deprivation amblyopia of unilateral cc, group 2: unaffected eyes of unilateral cc, group 3: form deprivation amblyopia of bilateral cc, group 4: normal eyes of normal children. the preoperative and postoperative data including sex, age at surgery, 7 position of rnflt and cmt were collected. all surgeries were performed by the same surgeon (y.e.z.) under general anesthesia. investigators used oct biometry to measure participants' the retinal nerve fiber layer (rnflt) and macular thickness (cmt) before surgery and 1 week, 1 month, 3 months, and 6 months and 1 year after surgery, and compared with age-matched normal children.

Eligibility criteria:
inclusion criteria: * congenital cataract exclusion criteria: * incooperative to complete the preoperative and postoperative examinations

Keywords: rnflt
safety surveillance of vaxigriptetra® and efluelda® influenza vaccines in europe during the influenza season 2022/23

Conditions: Influenza (Healthy Volunteers)

Summary: this is an enhanced passive safety surveillance conducted in routine clinical care setting. spontaneously reported adrs will be collected by study staff following routine vaccination. the primary objective of this surveillance is to estimate the vaccinee reporting rate (rr) of suspected adverse drug reactions (adrs) occurring within 7 days following routine vaccination with vaxigriptetra® and efluelda®, respectively, during the northern hemisphere (nh) influenza season 2022/23. the secondary objectives of the study are: * to estimate the vaccinee reporting rate of suspected adrs occurring within 7 days following routine vaccination with vaxigriptetra® and efluelda®, respectively, according to the pre-defined age groups (not applicable for efluelda®) * to estimate the vaccinee reporting rate of serious suspected adrs after vaccination with vaxigriptetra® and efluelda®, respectively, at any time following vaccination, within the epss

study duration per participant 2 months (including 6 weeks for vc distribution + 2 weeks for vaccinee reporting) following the first vaccination

Eligibility criteria:
inclusion criteria: * there are no formal inclusion criteria. individuals who approach the site for vaccination and agree to receive a vaccination card will be included and vaccinated with the respective vaccine brand according to the country of their location, * recommendations for the individual vaccines as well as national recommendations exclusion criteria: * none
reinforcing exercise in substance abusing patients

Conditions: Substance Abuse; Contingency Management; Exercise

Summary: this study will evaluate the efficacy of an exercise-based contingency management (cm) intervention. a total of 120 substance abusing patients in intensive outpatient treatment will be randomly assigned to one of two conditions: (a) standard care plus cm for completing goal-related activities not related to exercising (e.g., improving work, family, or transportation issues), or (b) standard care plus cm for completing exercise-related activities. compared to those receiving goal-related cm activity contracting, it is expected that those in the exercise cm condition will participate in more physical activities and develop greater strength and flexibility, decrease drug use, reduce hiv risk behaviors, lessen depressive symptoms, and improve health indices.


Eligibility criteria:
inclusion criteria: * age 18-65 years * english speaking * in substance abuse treatment * written permission from a physician (or their designated health care professional, e.g., nurse, physicians assistant) to participate in the study and an exercise program. exclusion criteria: * inability to comprehend the study * in recovery for pathological gambling * contraindication for exercising
nerve blocks vs local injections for post-op pain prevention in laparoscopic cholecystectomy in children

Conditions: Laparoscopic Cholecystectomy

Summary: the objective of this study is to compare transversus abdominis plane (tap) blocks to local wound infiltration (lwi) in terms of postoperative pain control in pediatric patients undergoing elective laparoscopic cholecystectomy. our hypothesis is that tap blocks will be superior to lwi for postoperative pain control resulting in decreased use of opioid / narcotic pain medication and decreased pain scored in the immediate 24-hour postoperative period. the rationale is that determining the effect of analgesia in this pediatric population is important to optimize clinical care.

in this study, patients ages 8 through 17 years scheduled for elective laparoscopic cholecystectomy will be invited to participate. those having da vinci cholecystectomy procedures will also be eligible. the da vinci system is a minimally invasive option utilizing robotic technology. once randomized, the patient will undergo either ultrasound guided bilateral tap blocks or lwi at the beginning of the surgical procedure. prospective data regarding pain scores, use of opioid medication, and nausea and vomiting episodes will be collected for both groups. due to the nature of the study, it will not be possible to blind the investigators to the randomly selected method of injecting local anesthesia; however the personnel involved in the post-anesthetic and post-operative assessment will be blinded to the intervention, as well as the subjects themselves.

Eligibility criteria:
inclusion criteria: 1. 8-17 yrs of age at date of enrollment. 2. elective laparoscopic or da vinci cholecystectomy scheduled for any diagnostic reason. exclusion criteria: 1. chronic pain or chronic use of narcotic or other prescription pain medications. 2. use of pain medication within 24 hours before surgery 3. prior major abdominal surgery 4. evidence of acute inflammation 5. patients with acute cholecystitis 6. bleeding / coagulation disorder 7. seizure disorder 8. renal dysfunction 9. infection at injection sites for tap block or trocar placement 10. contraindication to lwi or tap block procedure, as determined by surgeon or anesthesiologist performing the procedure (including, but not limited to, previous incision distorting anatomy or inability to visualize anatomical planes) 11. any known allergy to medications used in this study 12. patient unable to verbalize pain score or independently assess pain level 13. unstable patient in need of emergent intervention at surgeon discretion 14. patients who are known to be pregnant 15. patients who are currently prisoners 16. children in custody of the state 17. subjects will a bmi \>/= 50 18. investigator discretion for any other reason

Keywords: pediatric post-operative pain prevention anesthesia, infiltration nerve blockade
evaluation of the safety and efficacy of insulin glargine + glulisine or insulin regular + nph insulin (isophane insulin) use in type 2 diabetes mellitus patients with moderate renal failure.

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: \>to obtain an estimation for both treatment groups of the proportion of patients that reach the target of hba1c \<= 7% without confirmed nocturnal hypoglycaemia in each treatment group. secondary objectives: * glycemic control, measured by hba1c and fpg (fasting plasma glucose) at baseline and after each period of treatment. * incidence of confirmed symptomatic and nocturnal hypoglycemia. * incidence of confirmed severe hypoglycemia (\ weight variation for each period of treatment. * creatinine clearance at baseline and after each period of treatment. * overall safety: incidence of adverse events.


Eligibility criteria:
inclusion criteria: * type 2 diabetes and renal failure in use of nph regular insulin or fast-acting analog and hba1c \>= 8%. * albuminuria or microalbuminuria diabetic retinopathy. * creatinine clearance \ 30 ml/min/1,73 m2 exclusion criteria: * hypersensibility to insulin glargine or any other component of the insulin formulation. * use of investigational medications during the last 12 months or use of any investigational insulin preparation during the last 4 months. * history of diabetic ketoacidosis or positive gad antibodies. * advanced retinopathy needing laser therapy. * diagnosed advanced neuropathy * severe hepatic disease or active hepatitis. * cardiac failure class iii or iv (nyha). * patients on hemodialysis. * diagnosed cancer. * active infection. * current therapy with steroids. * patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.