Kornimate/medical-research-clean huggingface dataset:
effect of a decision aid on decision making for the treatment of pelvic organ prolapse

Conditions: Decisional Conflict

Summary: pelvic organ prolapse is a common condition that affects millions of women every year. there are many options for treatment and it can be difficult to make a decision as how best to proceed. previous studies have shown that decisional aids (das) may improve knowledge, physician-patient communication, decisional conflict, and patient satisfaction. however, no study has evaluated the role of a decisional aid among women presenting for evaluation and management of prolapse. we would like to determine if a decision aid for prolapse decreases the amount of decisional conflict women face when choosing a plan of care. we hypothesize that there will be a difference in the level/amount of decisional conflict between women who receive a da and those who do not. specifically, we anticipate that women randomized to receiving standard counseling and a da with have less decisional conflict than the cohort receiving standard counseling alone.

women scheduled for the evaluation and management of pelvic organ prolapse at hartford hospital will be contacted via telephone prior to the initial consultation visit to ascertain interest for this study. if they are interested, they will be randomized to one of two groups: those that receive a da and those that do not. this study requires you to answer some questions about the information packet you received in the mail. we routinely send a packet to all of our new patients. half of the participants received a decision aid to supplement their information packet and the other half received our routine informational packet. you will be asked to complete a set of 2 questionnaires. it will take less than 10 minutes to complete these questions. all data will be extracted and used by only the investigators on this study. the data will be stored on a restricted-access network drive and results will be reported in aggregate and no personal health history will be disclosed. our primary outcome for this analysis is decisional conflict differences in those who receive a da and those who do not.

Eligibility criteria:
inclusion criteria: * female * ≥18 years old * scheduled for consultation visit for pelvic organ prolapse of any type (cystocele, rectocele, enterocele, uterine prolapse, and/or uterovaginal prolapse) exclusion criteria: * \<18 years old * non-english speaking * any patient who declines, or expresses unwillingness to being contacted for participation in the study * planned concomitant non-gynecologic procedure * established patient in the practice
study of cutaneous disease accompanied with pruritus in pediatrics

Conditions: Pruritus

Summary: to assess the safety of long-term use of cetirizine dry syrup in children with various type of cutaneous disease accompanied on pruritus.


Eligibility criteria:
inclusion criteria: * chronic urticaria * eczema \& dermatitis group * atopic dermatitis * prurigo group: acute prurigo, prurigo subacuta, chronic prurigo * pruritus cutaneous: systemic pruritus cutaneous, topical pruritus cutaneous * giving informed consent * children who have 2 grades or more pruritus score when assessed by the investigator or sub-investigator with the criteria for the diurnal or nocturnal pruritus score in the patient diary. * children with a pruritus severity of "2.mild" or severer on the first day of the treatment period. exclusion criteria: * have a history of drug hypersensitivity * are pregnant, lactating or possibly pregnant female children. * have asthma that requires the treatment with corticosteroid. * cannot avoid the use of external steroid classified into "strong", "strongest" or "very strong". * have pruritus only on face and head. * have inappropriate complication of dermal disorder that may influence on the evaluation of the study drug. * are undergoing specific desensitization therapy or immunomodulation therapy or phototherapy.

Keywords: cetirizine various type of cutaneous disease accompanied with pruritus pediatrics
microbiome and exacerbations in neutrophilic asthma

Conditions: Asthma; Microbiome; Exacerbation

Summary: neutrophilic asthma (na) is the least known severe asthma phenotype. it is associated with more exacerbations, worse control and impaired lung function. one of its possible etiologies is bronchial infections. the study of bronchial microbiology and its relationship with exacerbations is a new line of research. objectives: 1) to analyze bronchial microbiome in patients with an and non-neutrophilic (ann), with frequent exacerbations and without exacerbations. 2) to relate the presence of bronchial infections with differences in the microbiome. 3) correlate the characteristics of the microbiome with other evidence used in exacerbations. methods: prospective study involving 40 non-smoking asthmatics without bronchiectasis (20 with an and 20 with ann). of these, 10 in each group will have frequent exacerbations (\>2 rounds of systemic steroids in the last year, of \>3 days each) and 10 non- frequent exacerbations. an will be defined as \>65% neutrophils in stable phase sputum. all patients will have two stable visits in which clinical variables, asthma control, lung function and induced sputum samples will be collected (for analysis of bronchial inflammatory cell count and for the study of the microbiome by 16 subunit rrna). specific immunoglobulin a (iga) for chlamydia pneumoniae will be determined. in exacerbations, sputum samples will be collected for culture and nasopharyngeal smears for the study of major respiratory viruses and bacteria by multiple polymerase chain reaction.

see above

Eligibility criteria:
inclusion criteria: * age between 18 -80 * confirmed diagnose of asthma * severe persistent asthma exclusion criteria: * respiratory infection during the previous month * other significant lung disease
noal (hpmc) in combination with oxymetazoline in patients with allergic rhinitis

Conditions: Allergic Rhinitis

Summary: allergic rhinitis is treated with a variety of systemic and locally applied drugs. the effectiveness of the intranasally applied formulations is diminished by the cleaning mechanisms of the nose, rhinorrhea in particular. slowing down of the clearance of the nasal mucosa and prolonging the contact time of locally applied drugs with the nasal mucosa would improve their efficacy. one method is creating dosage forms containing mucoadhesive polymers. we have demonstrated that a mucoadhesive solution containing hpmc enhances the clinical efficacy of oxymetazoline. however, the industrial development of fixed combinations of pharmaceutical compound and mucoadhesive carrier requires substantial investments, escalating manifold if different pharmaceutical compounds have to be rendered mucoadhesive. noal is a cellulose derivative powder, which forms a gel layer on contact with the mucosal surface of the nose blocking the contact of the pollen grains with the nasal mucosa in seasonal allergic rhinitis. however, there is another potential benefit of applying noal (hpmc) along with other commercially available drugs for local treatment of rhinitis, as the formation of a gel layer can substantially delay their clearance from the nose and thus increase their effectiveness. this hypothesis needs to be substantiated clinically.

the main objective of the trial is to test the synergy between hpmc and oxymetazoline (both applied nasally) on the increase of peak nasal inspiratory flow in patients suffering from moderately severe / severe persistent allergic rhinitis. the design of the trial is parallel-groups, double blind, randomized, placebo controlled, single centre study. forty patients are randomly assigned to receive either oxymetazoline followed by hpmc (group a) or oxymetazoline followed by placebo (group b). each patient is followed up for 15 days. day 1 is the screening and inclusion visit. data will then be collected on day 8 \& 15. patients will fill in diaries their everyday symptoms, adverse events and applied medications.

Eligibility criteria:
inclusion criteria: * male or female patients * age ≥ 18 and ≤ 50 years * moderately severe / severe persistent allergic rhinitis * positive skin prick test for perennial aero-allergens * active symptoms with prominent congestion at the time of inclusion exclusion criteria: * subjects with pollen sensitization during the respective pollen season * subjects with arterial hypertension, arrhythmia or evidence of heart ischemia * subjects with other serious chronic comorbidities and bad therapeutic control * subjects with nasal polyposis * flu-like episode during the past 30 days * subjects unable to give informed consent * subjects with any of the contra-indications of oxymetazoline or noal * pregnant or lactating women

Keywords: allergic rhinitis congestion mucoadhesive treatment nasal decongestant
standard treatment compliance of participants, effectiveness and prognosis in acute respiratory distress syndrome

Conditions: Respiratory Failure; Acute Respiratory Distress Syndrome

Summary: the acute respiratory distress syndrome (ards) is one of common clinical critically diseases. in the united states, the incidence of ards reaches 31%, which is one of the main causes of death in patients. there is no unified treatment process for ards currently and the treatment measures are not yet standardized, so the standardization of ards treatment processes is needed to reduce mortality in patients. following the evidence-based medicine principles and six-step treatment standards of ards, this study uses the method of multi-center randomized controlled clinical trials to evaluate the standardized treatment process of ards, which provides the basis for the standardized treatment of ards.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * admitted to the icu * according to the diagnostic criteria of ards berlin definition，admit patients with severe ards exclusion criteria: * age \<18 years old * be expected to die within 24 hours * end-stage malignancies * be participating in other studies, which may affect the results of this study * dni (do not intubation) and dnr (do not recovery) patients * family members do not agree to sign an informed consent

Keywords: mechanical ventilation ards ventilator strategy outcome
an efficacy, safety, and tolerability study of tmc435 in treatment-naive, genotype 1 hepatitis c-infected patients

Conditions: Hepatitis C

Summary: the purpose of this study is to investigate the effectiveness and safety of tmc435 compared with placebo in participants who are infected with genotype 1 hepatitis c virus who have never received treatment before. participants will also receive peginterferon alpha-2a and ribavirin as part of their treatment.

this is a randomized, double-blind (neither physician nor participants know the name of the assigned drug), placebo-controlled study of tmc435 in participants who are infected with genotype 1 hepatitis c virus (hcv), who have never received treatment for hcv infection before. participants in this study will also receive two other drugs for their hcv infection called peginterferon alpha-2a (pegifn alpha-2a) and ribavirin (rbv). the purpose of the study is to investigate if tmc435 is superior to placebo in reducing plasma levels of hcv ribonucleic acid (rna) to an undetectable level 12 weeks after the end of treatment. for the first 12 weeks, participants will take either tmc435 or placebo, plus pegifnα-2a and rbv. for the next 12 weeks, participants will take pegifn alpha-2a and rbv only. after that, some participants will continue to take pegifn alpha-2a and rbv for up to 24 additional weeks and some will stop taking pegifn alpha-2a and rbv depending on response-guided treatment criteria. the study doctor will inform each participant about how to take their study medication and when they should stop taking it. after a participant stops taking study medication, they will continue to come to the doctor's office for study visits until a total of 72 weeks after they enroll in the study. the total duration of the study is 78 weeks (including screening). participants will be monitored for safety throughout the study.

Eligibility criteria:
inclusion criteria: * genotype 1 hepatitis c infection (confirmed at screening) * patient has not received any prior treatment for hepatitis c * patient must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis c infection * must agree to use 2 forms of effective contraception throughout study (both males and females) exclusion criteria: * infection with hiv or non genotype 1 hepatitis c * liver disease not related to hepatitic c infection * hepatic decompensation * significant laboratory abnormalities or other active diseases * pregnant or planning to become pregnant

Keywords: hepatitis c tmc435 hcv hep c genotype 1
hepatic steatosis and chronic hepatitis b virus

Conditions: Chronic Hepatitis

Summary: this study aims to evaluate the prevalence and severity of hepatic steatosis in chb and investigate the relationship between hepatic steatosis and viral load, liver biochemistry, liver fibrosis, and inflammation in chb

this hospital-based cohort study will be conducted on 80 adult hepatitis b surface antigen (hbsag) carriers presented to the tropical medicine and gastroenterology outpatient clinic, at sohag university hospital exclusion criteria patients with serological evidence of hcv. hbv patients who had received or are currently under anti-viral therapy. alcohol consumption. decompensated liver disease. patients with hcc. patients are known to have another chronic liver disease (e.g. autoimmune hepatitis, primary biliary cirrhosis, wilson's disease, haemochromatosis, or drug-induced chronic hepatitis). patients with contraindications to liver biopsy such as uncooperative patients, prothrombin time (pt) \>4 seconds more than control, inr greater than 1.6, platelets count \<100.000/mm3after taking informed written consent, the participants will be subjected to: clinical evaluation: medical history and physical examination. laboratory investigations: complete blood count. prothrombin time and concentration. liver function tests anti-hcv. hbeag. hbv dna. abdominal ultrasonography ultrasound-guided percutaneous liver biopsy

Eligibility criteria:
inclusion criteria: hepatitis b surface antigen (hbsag) carriers presented to the tropical medicine and gastroenterology outpatient clinic, at sohag university hospital exclusion criteria: patients with serological evidence of hcv. hbv patients who had received or are currently under anti-viral therapy. alcohol consumption. decompensated liver disease. patients with hcc. patients are known to have another chronic liver disease (e.g. autoimmune hepatitis, primary biliary cirrhosis, wilson's disease, haemochromatosis, or drug-induced chronic hepatitis). patients with contraindications to liver biopsy such as uncooperative patients, prothrombin time (pt) \>4 seconds more than control, inr greater than 1.6, platelets count \<100.000/mm3.

Keywords: hbv steatosis
montelukast as prophylaxis for upper respiratory tract infections in children: a randomised, double-blind, placebo-controlled study

Conditions: Upper Respiratory Tract Infection

Summary: viral upper respiratory tract infection (uri) is one of the most common diseases among toddlers and pre-school children.complete and effective prevention measures for uri are currently unavailable. montelukast (singulair ) is a selective leukotriene-receptor antagonist that inhibits the cysteinyl leukotriene 1 receptor. it is well tolerated and safe even in young children. montelukast is an effective treatment for asthma (and allergic rhinitis from 1 year of age. infections with viruses causing uri such as influenza a, rhinovirus and respiratory syncitial virus increases leukotriens levels in nasal secretions. therefore, one may postulate that leukotriens inhibitors may reduce symptoms during uri. however the effect of montelukast as a treatment for non-specific cough was not properly studied and there are no studies on the effect of montelukast as prevention for uri. hypothesis: prophylactic treatment with montelukast will reduce the incidence and severity of upper respiratory infection in children.


Eligibility criteria:
inclusion criteria: * children 1 to 5 years old without significant health problem. exclusion criteria: * a previous history of wheezing (requiring treatment with bronchodilators in the last 3 month or more than one treatment in the last year) * hospital admission due to reactive air way disease * prophylactic use of montelukast or steroids * chronic cardiac or respiratory disease * presence of acute respiratory tract infection within the 7 days before consideration for the study * history of allergic rhinitis * children who are receiving chronic medications of any kind * known allergy to montelukast * inability to get an informed consent from a legal guardian.

Keywords: montelukast upper respiratory tract infection leukotriene children
ai-driven early warning system for perioperative risks in acute hemorrhagic stroke

Conditions: Acute Hemorrhagic Stroke

Summary: acute hemorrhagic cerebrovascular disease is a life-threatening condition characterized by sudden onset, rapid progression, multiple complications, poor prognosis, and high mortality. it presents a significant public health burden. during surgical interventions, precise risk stratification and effective perioperative management are crucial to mitigating intraoperative and postoperative complications, optimizing disease diagnosis, guiding severity assessment, and refining anesthesia strategies. continuous real-time evaluation and dynamic perioperative adjustments are essential to minimize the influence of institutional variability and individual clinician-dependent decision-making. by harnessing big data-driven, evidence-based medical approaches, clinicians can enhance diagnostic accuracy and therapeutic precision, addressing a critical challenge in reducing morbidity and mortality in this patient population. this study aims to develop a comprehensive multimodal perioperative database and leverage large language models (llms) for the efficient extraction of structured demographic and clinical data throughout the perioperative course. by integrating real-time hemodynamic monitoring parameters, the investigators seek to elucidate the relationship between perioperative hemodynamic patterns and the incidence of postoperative complications affecting major organ systems, including the brain, heart, kidneys, and lungs. the ultimate goal is to construct a multimodal fusion early-warning model capable of real-time, simultaneous prediction of multiple perioperative complications. this ai-driven platform will function as a risk stratification and alert system for organ-specific perioperative complications in patients with acute hemorrhagic cerebrovascular disease. by providing evidence-based insights for optimized perioperative management-encompassing early warning mechanisms, diagnostic support, and individualized therapeutic strategies-the system aims to improve clinical outcomes, reduce perioperative morbidity, and lower overall mortality.


Eligibility criteria:
inclusion criteria: * patients aged 18 to 80 years. * diagnosis confirmed by preoperative imaging (ct or mri) of one of the following conditions: * intracranial aneurysm * arteriovenous malformation (avm) * hemorrhagic moyamoya disease * cavernous malformation * spontaneous intracerebral hemorrhage * undergoing surgery within seven days of symptom onset. exclusion criteria: * patients who decline to provide informed consent. * patients enrolled in conflicting clinical studies.

Keywords: perioperative complications artificial intelligence in medicine acute hemorrhagic stroke
patient-ventilator asynchrony in patients with brain injury

Conditions: Brain Injuries; Mechanical Ventilation

Summary: mechanical ventilation is an important support strategy for critically ill patients. it could improve gas exchange, reduce the work of breathing, and improve patient comfort. however, patient-ventilator asynchrony, which defined as a mismatch between the patient and ventilator may obfuscate these goals. studies have shown that a high incidence of asynchrony (asynchrony index \> 10%) is associated with prolonged mechanical ventilation and icu length of stay and high mortality. so far, there have been only a few studies on the epidemiology of asynchrony in brain-injured patients. investigators conduct a prospective observational study among brain-injured patients to determine the prevalence, risk factors and outcomes of patient-ventilator asynchrony. esophageal pressure monitoring, a surrogate for pleural pressure, combined with airway pressure and flow waveforms is used to detect patient-ventilator asynchrony.


Eligibility criteria:
inclusion criteria: * 1) \]older than 18 years 2) with brain injury in the icu 3) mechanical ventilated for at least 72 hours exclusion criteria: * 1) icu length of stay less than 24 hours 2) enrolled in another trial

Keywords: brain-injured patients, patient-ventilator asychrony
study of immune globulin intravenous (human) gc5107 in subjects with primary humoral immunodeficiency

Conditions: Immunologic Deficiency Syndromes

Summary: the purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of immune globulin intravenous (human) gc5107 in subjects with primary humoral immunodeficiency (phid).

this was a prospective, open-label, single-arm, historically controlled, multicenter phase 3 study measuring the safety, efficacy and pharmacokinetics and tolerability of gc5107 in subjects with primary humoral immunodeficiency disease (phid). subjects received intravenous infusions of the investigational product at the same dose and interval as used for their previous immunoglobulin intravenous (ivig) maintenance therapy. gc5107 was administered every 21 or 28 days for a period of 12 months.

Eligibility criteria:
inclusion criteria: * subject with a confirmed clinical diagnosis of a primary humoral immunodeficiency disease as defined by iuis (international union of immunological societies) and require treatment with igiv. documented agammaglobulinemia or hypogammaglobulinemia * male or female, ages 2 to 70 years * the subject has received 300-900 mg/kg of a licensed igiv therapy at 21 or 28 day intervals for at least 3 months prior to this study * at least 2 documented igg trough levels of ≥ 500 mg/dl are obtained at two infusion cycles (21 or 28 days) within 12 months prior to study enrollment exclusion criteria: * subject has secondary immunodeficiency * subject was newly diagnosed with phid and has not yet been treated with immunoglobulin * subject has been diagnosed with dysgammaglobulinemia or isolated igg subclass deficiency or isolated iga deficiency with known anti-iga antibodies * history of severe reaction or hypersensitivity to igiv or other injectable form of igg * subject has a lifetime history of at least one thrombotic event including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction * subject has received blood products other than human albumin or human immunoglobulin within 12 months prior to enrollment
effect of hypnotherapy in irritable bowel syndrome (ibs)

Conditions: Irritable Bowel Syndrome

Summary: in this trial, the effects of two psychological interventions - i.e. hypnotherapy and relaxation training - are compared with care as usual in ibs treatment. the investigators hypothesized that hypnotherapy is most effective in reducing complaints in ibs.


Eligibility criteria:
inclusion criteria: * irritable bowel syndrome (rome ii) * presence of complaints \< 12 months exclusion criteria: * gastrointestinal disorders, other than ibs * previous psychotherapeutic treatment for ibs * severe psychological comorbidity

Keywords: symptoms psychological status hypnotherapy relaxation training