Kornimate/medical-research-clean huggingface dataset:
prophesys 2: an observational study on predictors of response in treatment-naïve patients with chronic hepatitis c treated with pegasys (peginterferon alfa-2a) or peginterferon-alfa-2b

Conditions: Hepatitis C, Chronic

Summary: this observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis c initiated on treatment with pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. target sample size is \<2000.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * chronic hepatitis c * informed consent to data collection exclusion criteria: * co-infection with hiv or hbv * previous treatment with peginterferon and/or ribavirin
intraoperative imaging of thoracic malignancies with indocyanine green

Conditions: Lung Neoplasms

Summary: our specific aim is to determine if indocyanine green (icg) administered intraoperatively and imaged using our camera will aid in the identification of a suspected lung nodule.

according to the world health organization, lung cancer is the most common cause of cancer-related death in men and women, and is responsible for 1.3 million deaths worldwide annually as of 2004. surgery remains the best option for patients presenting with operable stage i or ii cancers, however the five year survival rate for these candidates remains at a dismal 53% for stage i and 32% for stage ii1. the high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. by ensuring a negative margin through near-infrared imagery with a safe non-toxic contrast agent it would be possible for the investigators to improve the rates of recurrence free patients and thus overall survival. this study is a small pilot/feasibility study to determine if the investigators camera system can be effective at identifying malignancies in lung cancer patients.

Eligibility criteria:
inclusion criteria: 1. adult patients over 18 years of age 2. patients presenting with a lung nodule or mass presumed to be resectable stage i, ii, or iiia non-small call lung cancer on pre-operative assessment 3. good operative candidate as determined by a thoracic oncology multidisciplinary team 4. subject capable of giving informed consent and participating in the process of consent exclusion criteria: 1. pregnant women as determined by urinary or serum beta hcg within 72 hours of surgery 2. subjects with a history of iodide allergies 3. at-risk patient populations * homeless patients * patients with drug or alcohol dependence * children and neonates * patients unable to participate in the consent process

Keywords: imaging indocyanine green lung cancer lung neoplasms preliminary study
validation of peptest™ for the detection of reflux in cough

Conditions: Cough

Summary: chronic cough is a common presenting problem which has a significant impact on quality of life. gastro-oesophageal reflux (gor) is a common cause of chronic cough and reflux of stomach contents into the airways has been implicated in the pathogenesis of a number of respiratory diseases. clinical history in patients with suspected reflux can aid in the diagnosis but traditional investigations for gor including 24hr oesophageal ph monitoring or endoscopy are not reliable diagnostic tools since the reflux may be non acidic. the detection of pepsin in the sputum, saliva or bronchial biopsy has been found to be an accurate marker of reflux into the airways. pepsin is solely produced by parietal cells in the stomach. the presence of pepsin in the upper airways therefore indicates reflux. studies have demonstrated that pepsin was frequently found in laryngeal biopsies and sputum of patients with signs and symptoms of airways reflux and that nissen fundoplication resulted in a decrease in pepsin detection alongside an improvement in symptoms. the peptest™ lateral flow device has been shown to be effective in the detection of pepsin in sputum and saliva of patients with chronic cough and gastro-oesophageal reflux. the investigators have detected pepsin in expectorated saliva during episodes of cough, apparently supporting a diagnosis of airways reflux. critics, however, have suggested that the act coughing itself is responsible for the reflux. this study aims to identify if cough induced by inhaled citric acid in healthy adult volunteers leads to detectable pepsin in expectorated saliva.


Eligibility criteria:
inclusion criteria: * a negative score for airway reflux (harq score \<13). * provision of informed consent. exclusion criteria: * participants with a positive score for airway reflux (harq score \>13). * chronic respiratory disease. * acute gastro-respiratory illness at the time of the study. * participants who will be physically unable to undergo sputum collection or cough induction. * those who are unwilling to undergo cough challenge and induction of cough. * smoking or consumption of food, caffeinated or carbonated beverages for 30 minutes prior to sample collection.

Keywords: cough reflux pepsin peptest
self-management intervention for children with chronic medical complexity: pilot feasibility trial

Conditions: Children With Medical Complexity

Summary: the investigators have developed a tool to facilitate self-management for children with medical complexity (complex, multisystem chronic diseases) called mychildcmc (my child's complex medical condition). mychildcmc is an online, phone application (app) that engages parents daily in ongoing monitoring of common, crosscutting acute symptoms, including respiratory distress, inadequate feeding/fluid intake, fever, altered mental status, pain, and seizure status. the mychildcmc app also guides parents to recognize early warning signs for health deteriorations to avoid acute events (i.e., ed visits and/or hospitalizations). parent comments during the development of the mychildcmc application revealed that the tool had potential in helping them manage their child's chronic conditions. this study will be the first to explore if online home monitoring using online technology is feasible, scalable, and can lead to improved cmc outcomes. this pilot trial for the mychildcmc app was designed to determine preliminary impact by comparing outcomes (child qol, child emergency department and hospital admissions, and parent/caregiver satisfaction with care) between the intervention and control groups. if successful, our approach will be a model for improving cmc care and reducing costs for families and children with medical complexity. future mychildcmc trials will integrate care coordination and a more robust alert system to help facilitate care and follow-up for patients.

aim: investigators will assess the impact of the mychildcmc app by comparing the following outcomes for the child and caregiver: 1. child quality of life (qol) 2. child emergency department (ed) and hospital admissions 3. number of hospital days 4. parent/caregiver satisfaction with care

Eligibility criteria:
participant inclusion criteria: children with complex medical conditions\* ages 1 through 20 years with their primary caregiver (primary person caring for the child) who: * have been seen at primary children's hospital within 365 days, * own a smartphone or a tablet computer with internet access, and * are english speaking \*physician diagnosis was used to determine cmc diagnosis exclusion criteria: * critically ill children in imminent death * non-english speakers

Keywords: medical complexity multiple chronic conditions children
spatial analysis of host-parasite interactions in cutaneous leishmaniasis in ethiopia

Conditions: Cutaneous Leishmaniases

Summary: cutaneous leishmaniasis manifestations range from self-healing localized skin ulcers/nodules to diffusely spread chronic lesions. knowledge on the host-parasite interactions underpinning the different clinical presentations is scarce, in particular for l. aethiopica infections where disease can be extremely severe. our aim is to define differences in skin immune responses and parasite virulence in cl patients at single cell/parasite level and how it underpins the different clinical presentations (localised, mucocutaneous and diffuse), by producing the first spatially-resolved 'ecological' map of the lesions.

specific objectives: 1. to profile the full heterogeneity in skin and lesion immunity (single cell rnaseq), and the cellular microenvironment surrounding infected and non-infected macrophages (digital spatial profiling). 2. to study the genomic diversity of l. aethiopica and identify features associated with the different clinical presentations (whole genome sequencing). 3. to understand how parasites respond to the microenvironmental conditions and define parasite survival niches (digital spatial profiling). 4. study metabolic determinants of skin immunity (e.g. lipid metabolism, bioenergetics, short-chain fatty acids) in the context of key structural features of the skin landscape known to influence local metabolism and immune response (e.g. adipose tissue, follicles, microvasculature) (spatialomx). 5. to investigate the association between patient outcomes and the above host/parasite factors at baseline.

Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent * clinically confirmed cl diagnosis * between 12 and 50 years of age exclusion criteria: * difficult or too painful sampling zone (see skin biopsy procedure below) * (primary) lesion size \< 1 cm * already receiving cl treatment or received cl treatment in the last 3 months (excluding traditional medicine) * known major comorbidity at time of diagnosis (e.g. vl, hiv, tb, malaria, severe intestinal helminth infection) * medical history of vl * severely underweight (bmi\<16) * known pregnancy * use of immunosuppressive medication in the last month * known excessive alcohol use (between \>10 intakes/day and \>10 intakes/week) * history of hypersensitivity to local anaesthetics * presence of keloids/hypertrophic scars

Keywords: leishmania leishmaniasis cutaneous leishmaniasis neglected tropical disease immunoparasitology
effect of schroth exercises combined with laser acupuncture therapy in adolescent idiopathic scoliosis

Conditions: Adolescent Idiopathic Scoliosis; Laser Acupuncture

Summary: the goal of this clinical trial\] is to explore the clinical effect of laser acupuncture combined with schroth training on adolescent idiopathic scoliosis (ais) . the main question\[s\] it aims to answer are: * the effects of schroth exercises on cobb angles, angle of trunk rotation, spinal mobility, gait parameters and clinical efficacy in patients with ais. * laser acupuncture combined with schroth method on cobb angles, angle of trunk rotation, spinal mobility, gait parameters and clinical efficacy in patients with ais. participants will received schroth exercise therapy and laser acupuncture therapy (mls laser). if there is a comparison group: researchers will compare received schroth exercise therapy to see the effects of schroth exercises and laser acupuncture combined with schroth method on cobb angles, angle of trunk rotation, spinal mobility, gait parameters and clinical efficacy in patients with ais

in this study, the standard control, control group receipts schroth exercise therapy, while trial group receives schroth exercise therapy and laser therapy. the design of the individual schroth exercise is carried out according to the c urve patterns of the schroth classification. the schroth classification criteria includes four curve patterns that are determined with reference to the location of the curves, the importance of lumbar and thoracic prominences, and the effect of the scoliosis on the pelvis. laser therapy was performed w ith a dual wavelength, high power ir laser (multiwave locked system (mls®) laser, mphi, asa srl, vicenza, italy) and the laser acupuncture points include du2, gb30, du9, sp6, lr8, du6, du4, du12. laser puncture acupuncture points had been identified according to traditional chinese medicine (tcm) and treated with handpiece optical group following the detailed treatment parameters: 900hz, fpw mode, 60 s per point, 29.12j, spot size 3 cm2, energy density 27j/cm2. all treatments are performed five times in a week for 4 consecutive weeks.

Eligibility criteria:
inclusion criteria: * adolescent idiopathic scoliosis patients without history of traumas * positive adam's forward bend test, cobb angle\>10° exclusion criteria: * functional scoliosis and other structural scoliosis * previous history of scoliosis surgery * wearing braces and being treated in other ways * unable to complete psse training actions as required * complicated with serious heart, liver, kidney and other systemic diseases
evaluation of different modelling techniques on child anxiety (rct)

Conditions: Anxiety

Summary: a huge number of children suffer from anxiety during their dental treatment especially those who did not receive any type of behavior management during their first dental visit. this will result in a more complicated treatment sessions for the children, dentist and the parents. fear and anxiety control is the key to change the resistant nature of the anxious patients and also allow them to receive the proper treatment they require. from the point of view that there is no difference between the techniques effectiveness, evaluation of two modelling techniques (live modelling and filmed modelling versus no modelling) for children anxious behavior management during the dental treatment will be performed.

i. diagnosis: 1. history taking \[personal, medical and dental\]. 2. clinical examination using mirror and probe. 3. radiographic examination to make sure that the caries is simple. 4. preoperative photograph is taken. ii. interventions to each group 1. group a: live modelling technique 1. in the 1st dental visit the operator will start by measuring the behavior of the child by frankl behavior rating scale. 2. a cooperative patient will be the model for the child. 3. in the 2nd dental visit the pulse oximetry device will be installed on the child's finger and another form of frankl behavior rating scale is filled. 4. the treatment is performed as follows: i. place topical anesthesia. ii. place anesthetic injection. iii. cavity preparation. iv. filling material placement. v. finishing of the filling. e. the child will be asked to complete a facial image scale 2. group b: video modelling technique (1) in the 1st dental visit the operator will start by measuring the behavior of the child by frankl behavior rating scale. 1. a recorded film will be shown to the child. 2. in the 2nd dental visit the pulse oximetry device will be installed on the child's finger and another form of frankl behavior rating scale is filled. 3. the treatment is performed as follows: i. place topical anesthesia. ii. place anesthetic injection. iii. cavity preparation. iv. filling material placement. v. finishing of the filling. d. the child will be asked to complete a facial image scale. 3. group c: no modelling 1. in the 1st dental visit the operator will start by measuring the behavior of the child by frankl behavior rating scale. 2. in the 2nd dental visit the pulse oximetry device will be installed on the child's finger and another form to frankl behavior rating scale. 3. the treatment is performed as follows: i. place topical anesthesia. ii. place anesthetic injection. iii. cavity preparation. iv. filling material places. v. finishing of the filling. d. the child will be asked to complete a facial image scale.

Eligibility criteria:
inclusion criteria: 1. english articles 2. in vivo study (rct) 3. medically free children 4. age group 5-6 years old exclusion criteria: 1. medically compromised children 2. adult patients
novel method for diagnosing lateral patellar compression syndrome using x-ray: a retrospective case-control study

Conditions: Lateral Patellar Compression Syndrome

Summary: this study evaluates whether the patellar axial radiograph of lateral patellar curvature angle （lpca）with knee flexion at 30 ° can be used as a new diagnostic surrogate of lateral patellar compression syndrome（lpcs）. we believe that the new index lpca has high sensitivity and specificity in initial diagnosis of lpcs using axial patellar radiograph with knee flexion at 30 ° , and has high application value.

background: a well-established reference is lacking for diagnosing lateral patellar compression syndrome (lpcs), and this diagnosis currently depends on clinicians' subjective judgment and several examination results. x-rays are primarily used to diagnose lpcs, but they have low detection rates of patellar tilt using the congruence angle (ca) and patellar tilting angle (pta). purpose: to investigate whether patellar axial radiography of the lateral patellar curvature angle (lpca) of knee in 30° flexion can diagnose lpcs. methods: we enrolled 87 patients between 2016 and 2019 and divided them as per diagnosis into three groups of 29 each: lpcs, patellar dislocation (pd, control), and meniscus tear (mt, negative control) groups. a senior radiologist and the chief physician of sports medicine examined their patellar axial radiographs of the knee in 30° flexion using a computer imaging system, measuring lpca, pta, and ca. univariate analysis of variance and kruskal-wallis h test were used to compare measurement data with normal distribution and non-normal distribution, respectively. bonferroni correction was used to analyze different indicators for different groups. the area under the curve (auc) was calculated to verify the value of lpca in initial diagnosis of lpcs.

Eligibility criteria:
inclusion criteria: * patients were diagnosed as lpcs ，mt and pd respectively exclusion criteria: * patients with ligament injury, malunion of patella fracture, free bodies in the joint, surgical contraindications, and with both knees affected.

Keywords: lateral patellar compression syndrome lateral patellar curvature angle patellar axial radiographs the area under the curve
immune response after booster vaccination in hiv - infected patients who received rabies primary vaccination

Conditions: HIV; Rabies

Summary: booster rabies vaccination in hiv - infected patients who have ever received rabies primary vaccination could improve their immune response to this kind of vaccine.

the investigators have learned from the previous studies that some hiv-infected patients especially those with low cd4+ t-lymphocyte count had poor antibody response to rabies vaccination. because of the role of the memory b cell, the investigators hypothesized that primary rabies immunization in hiv-infected patients could rise rapid anamnestic antibody response to ones after booster vaccination in case of re-exposure of rabies occur despite of their immunocompromised state.

Eligibility criteria:
inclusion criteria: * hiv infected patients 18-60 years of age * ever received primary rabies immunization exclusion criteria: * currently have any active opportunistic infections * have received blood or blood product within previous 3 months * history of allergy to vaccine or any vaccine components * currently received anti-malarial drugs

Keywords: hiv booster rabies immune response
patient journey in advanced gynecologic cancers

Conditions: Genital Neoplasms, Female; Uterine Cervical Neoplasms; Endometrial Carcinoma

Summary: this is a mixed-methods survey study including a 2-phased sequential-explanatory design. this study is to understand the patient journey in conventional therapy for newly diagnosed stage iii or iv cc or ec in china, including ①patients' treatment decision making factors and treatment experiences and ② patients' unmet needs during post-treatment surveillance.

this is a mixed-methods survey study including a 2-phased sequential-explanatory design: phase 1, qualitative interview will be done first to explore the treatment decision factors, treatment experiences and unmet needs during post treatment surveillance, to provide components and inform the quantitative data collection. phase 2, quantitative survey to collect data on a larger scale and allow a statistical generation of the qualitative findings.

Eligibility criteria:
inclusion criteria: * age 18 or older * newly diagnosed stage iii or iv cc or ec * completed their initial conventional therapies which must include at least chemotherapy, radiotherapy or a combination between dec. 2022 to dec. 2024 and the therapies were within 6 months after diagnosis. * told by their physician that their disease is stable. * patients must have informed consent form (icf) signed for the study. exclusion criteria: * previously treated with targeted biologic therapy anti-pd-1, anti-pd-l1, or anti pd-l2 agent or with an agent directed to another stimulatory or co-inhibitory t-cell receptor. * previously participated in or participating in a clinical trial. * patients who received another line of therapy after initial therapy. * unable or unwilling to provide informed consent. * not fluent in local language. * indicates or exhibits hearing difficulties, which would make a conversation challenging.
cytokine removal by crrt in pediatric sepsis

Conditions: Sepsis

Summary: this pilot study will compare the effect of diffusive versus convective continuous renal replacement therapy (crrt) in children with sepsis who require crrt. the hypothesis for the study is that convective forms of crrt provide enhanced clearance of cytokines and improved clinical responses as compared to a diffusive crrt modality.

the purpose of this study is to test the hypothesis that convective forms of continuous renal replacement therapy (crrt) provides enhanced clearance of cytokines compared to a diffusive crrt modality. also, we plan to test the hypothesis that patients who receive convective crrt modalities demonstrate improved clinical responses to patients who receive a diffusive crrt modality.

Eligibility criteria:
inclusion criteria: * patients with documented sepsis or suspected sirs * patients initiating crrt * age 1 to 21 years exclusion criteria: * patients on ecmo * patients receiving concomitant plasma exchange * cardiopulmonary bypass procedure within 96 hours of crrt * patients with new onset acute leukemia * patients with active autoimmune disease * ungrafted stem cell transplant recipients

Keywords: continuous renal replacement therapy (crrt) sepsis convection diffusion
expanded access for immu-132

Conditions: Metastatic Triple-Negative Breast Carcinoma

Summary: this is an expanded access program (eap) for eligible participants designed to provide access to immu-132.


Eligibility criteria:
inclusion criteria: - exclusion criteria: -
what is an important change in the short physical performance battery (sppb)?

Conditions: Respiratory Tract Diseases; Lung Diseases

Summary: the purpose of this study is to determine the important change in the short physical performance battery (sppb) when used in patients with lung disease. the sppb is a simple physical test that measures balance and the functioning of the legs. it has been widely used in healthy elderly populations and predicts hospital admission and the onset of disability. the sppb has not previously been used in patients with lung disease, and it is not clear what change in this test is considered meaningful and worthwhile by patients or doctors (the minimal clinically important difference: mid). knowing what the mid for the sppb will allow researchers and doctors to evaluate the effectiveness of current and new treatments, and to detect improvement or deterioration in the condition of patients.


Eligibility criteria:
inclusion criteria: * all patients entering pulmonary rehabilitation exclusion criteria: * any patient in whom mobility and lower limb function have been significantly affected by a neuromuscular cause, severe peripheral vascular disease or amputation. * any patient whom the chief investigator feels it is unsafe to exercise (e.g. unstable cardiac disease).

Keywords: rehabilitation [e02.831] exercise [g11.427.394.380] health education [i02.233.332] [c08] [c08.381]