Kornimate/medical-research-clean huggingface dataset:
feasibility of utilising brushing cytology and dermoscopy for diagnosing penile lesions

Conditions: Penile Cancer

Summary: in an attempt to reduce patient flow into the hospital we are going to assess the use of penile cytological brushings and dermoscopy in diagnosing cancer or non-cancer conditions of the penis.

currently the standard of care pathway for all patients suspected of having penile cancer involves the need for a penile biopsy under local (la) or general anaesthetic (ga). we hope to assess the feasibility of cytololgical brushings and the patient experience of the use of such a technique. additionally, we will make initial comparison on the concordance between cytological brushing and dermoscope photo vs actual biopsy only. importantly for this study, all patients will be offered standard of care: a biopsy under la or ga. the additional procedures of the cytological brushing and dermoscope photo will be done in an out-patient clinic setting (with no anaesthetic). if it can be shown that the inclusion of the cytological brushing and dermoscope photo have comparative results over current standard of care histological biopsy, this will provide sufficient evidence to expand this study to acquire more data.

Eligibility criteria:
inclusion criteria: 1. all patients requiring either diagnostic biopsy or wle (wide local excision) of a lesion of the penis 2. age \> 18 years 3. written informed consent provided by the patient 4. subject has been scheduled for surgical intervention, with a biopsy procedure being a part of the surgical plan exclusion criteria: 1. subject is unfit for surgery upon surgeon's assessment. 2. unable to provide consent 3. those with terminal disease 4. those with palpable lymph nodes 5. other coincident cancers 6. previous radiotherapy treatment to the penis, bladder, prostate, anus 7. subject is deprived of liberty or under guardianship 8. subject is not able to follow and understand the procedures of the study due to mental state or other reasons

Keywords: penile cancer hpv cytology testing
prostate cancer stereotactic radiotherapy

Conditions: Prostate Neoplasms; Toxicity Due to Radiotherapy

Summary: primary purpose of the study is to develop a stereotactic radiation treatment (rt) to prostate cancer which minimizes treatment related toxicity. movement of the prostate during a radiation therapy will be monitored by temporary implanted electromagnetic transmitter. this data will be used to define prostate marginals (ptv) for stereotactic treatment. radiation toxicity to rectum will be reduced by using a rectum fixation during a treatment. study group i (20 patients) will be treated 39 x 2 gy and study group ii (20 patients) with 20 x 3 gy fractionation schedules. with the data collected from these groups treatment marginals to prostate will be defined and used to treat group iii (40 patients) with 5 x 7.25 gy. second purpose of this study is to assess if diffusion-weighted magnetic resonance imaging could be used to evaluate radiation treatment response in intermediate prostate cancer. androgen deprivation therapy is not allowed in this study.

new local prostate cancer patients needing external radiotherapy are included into three radiation dose groups; group i will be treated normal dosing (39 x 2 gy) and study group ii with hypofractionated dosing (20 x 3 gy) and group iii extreme hypofractionated dosing. primary goal is to develop safe and effective curative radiotherapy for these patients second aim is to study diffusion-weighted magnetic resonance image (dw mri) in radiation treatment response in intermediate prostate cancer. patients are followed by mri, psa, bone scans and quality of life questionaries.

Eligibility criteria:
inclusion criteria: * biopsy-proven prostate cancer * one or two risk factors for intermediate prostate cancer: * gleason score 7 * t2b-t2c * psa 10-20 microg/l * no need for androgen deprivation therapy * eligible fo mri * radical radiotherapy exclusion criteria: * locally advanced or metastatic prostate cancer * previous radiotherapy to pelvic reason * other severe disease * previous cancer within 5 years * severe urinary symptoms at the start of the study (over 20) * wide cavity after transurethral resection of prostate (turp)

Keywords: prostate neoplasms urogenital neoplasms genital neoplasms, male radiation therapy prostate specific antigen dw-mri, diffusion weighted mri intra-fractional movement hypofractionated radiotherapy stereotactic toxicity due to radiotherapy quality of life
breathe-easy: hayfever care for patients with seasonal allergic rhinitis

Conditions: Hayfever; Allergy Pollen; Allergic Rhinitis

Summary: this waitlist-controlled trial aims to evaluate the therapeutic effectiveness of hayfever care by assessing disease-specific symptoms over a 4-week period. additionally, the study examines the tolerability and safety of the solution.


Eligibility criteria:
inclusion criteria: * mild to moderate symptoms during the hayfever season * generally healthy individuals without chronic illnesses * willingness to comply with study requirements, including completing symptom diaries. exclusion criteria: * history of anaphylaxis or severe hayfever symptoms requiring emergency treatment. * pregnant or breastfeeding * history of substance abuse or excessive alcohol consumption. * use of systemic corticosteroids, immunotherapy

Keywords: breathe-easy hayfever care
cardiac pathologies in standard thoracic ct imaging

Conditions: Coronary Artery Disease

Summary: modern high-end ct scanners with faster scan acquisition times now allow for routine assessment of cardiac pathologies, which could result in numerous incidental cardiac findings on standard thoracic ct angiography (cta) scans. the capact-study aims to assesses the presence, management and possible clinical impact of incidental cardiac pathologies which are becoming visible on standard thoracic ct scans performed on new high-end scanners.

a known disadvantage of constantly improving diagnostic imaging is the detection of incidental findings. computed tomography (ct) scanner technology is ever improving in both temporal and spatial resolution. recently developed advanced reconstruction algorithms and dedicated post-processing software reduce image noise thereby improving image quality. equipped with these advancements, modern ct scanners accomplish well defined imaging of cardiovascular structures. these technical improvements have enabled cardiac assessment on routine standard (non-ecg triggered) thoracic ct scans. if thoracic radiologists are able to assess the heart and coronary arteries on a standard thoracic ct, this could result in an extensive amount of incidental cardiac findings. herein lies the potential for large scale reporting of incidental cardiac findings and, consequently, a huge influx of new 'patients' for downstream testing and potential (over-)treatment. coronary artery disease (cad) is a known comorbidity for multiple diseases, for example presence of cad could require a different treatment strategy in lung cancer and worsen prognosis \[khakoo et al\]. in patients with diabetes mellitus (dm), the incidence of cad is four times higher compared with the general population, and the risk of a cardiovascular event is two- to four-fold higher \[kannel et al. + aktas et al.\]. therefore, the discussion on management and treatment of these patients with incidental cardiac findings on chest ct evidently is important. unfortunately, to date no consensus has been reached on the management and reporting of these findings. the capact study (cardiac pathologies on standard thoracic ct) has been developed to evaluate the visibility and management of incidental cardiac pathologies on a ultra-high pitch thoracic ct-scan with help of the cad-rads classification.

Eligibility criteria:
inclusion criteria: - standard non-ecg triggered thoracic ct scanning. exclusion criteria: * iodine allergy * renal insufficiency (gfr \< 30ml/min) * pregnancy * age \< 18 years

Keywords: multidetector computed tomography incidental cardiac findings thoracic high-pitch computed tomography management guidelines
comparison of the computer controlled and conventional local anesthesia techniques in primary molar extraction in children aged 5 to 9 years old

Conditions: Computer-controlled Intraligamentary Anaesthesia; Inferior Alveolar Nerve Block; Pain Perception; Anesthesia Effectiveness

Summary: the goal of this clinical trial is to assess pain perception, child stress level and compare the effectiveness between periodontal ligament anesthesia using computer-controlled local anesthetic delivery system and the conventional inferior alveolar nerve block during extraction of the primary molars. the main questions it aims to answer are: is there a difference in pain perception, child stress level and anesthesia effectiveness between the cc-ila system and the traditional syringe when administering ianb in pediatric patients undergoing primary molar extractions. researchers will compare cc-ila system to traditional syringe when administering ianb to see if there a difference in pain perception, child stress level and anesthesia effectiveness. participants will: have their lower first primary molar extracted by receiving either periodontal ligament anesthesia using computer-controlled local anesthetic delivery system or the conventional inferior alveolar nerve bock. pain perception during the anesthesia process was measured using both objective criteria through the sound-eye-motor scale and subjective assessment using wong-baker faces pain rating scale. salivary cortisol level will be used to determine child stress level. the efficacy of anesthesia at various stages of the extraction procedure was evaluated using the sound-eye-motor scale.


Eligibility criteria:
inclusion criteria: * healthy children (asa i). * ranging in age from 5-9. * cooperative (frankle ++). * with mandibular first primary molars earmarked for removal owing to factors such as: extensive caries, crown damage, periapical lesions and unsuccessful pulp treatment. exclusion criteria: * mobile teeth (grade iii). * ankylosed teeth. * teeth with root resorption (more than 1\\3). * patients with facial cellulitis and when there is a need for supplemental anesthesia
a study of evaluating the safety and efficacy of atg-010 in relapsed/refractory diffuse large b-cell lymphoma

Conditions: Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Summary: this is an open-label, single arm, and registered study of atg-010 in patients with relapsed/refractory diffuse large b-cell lymphoma.

this is an open-label, single arm, and registered study. about 60 patients with relapsed/refractory dlbcl plan to be enrolled in about 10 study sites of the study. it is planned that at least 50% (\~30 patients) will have the gcb subtype of dlbcl. enrolled patients will be treated with a fixed dose, 60 mg of atg-010, orally, twice weekly, each 4 week (28-day) a cycle. patients should remain on the study treatment of atg-010, until either pd or occurrence of unacceptable toxicity.

Eligibility criteria:
inclusion criteria: 1. the patient must provide informed consent form (icf) prior to the first screening procedure. 2. age ≥18 years. 3. ecog performance status of ≤ 2. 4. patients should have estimated life expectancy of \>3 months at study entry. 5. previously treated, pathologically confirmed de novo dlbcl, or dlbcl transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). 6. patients must have received at least 2 but no more than 5 previous systemic regimens for the treatment of their de novo or transformed dlbcl. 7. documented clinical or radiographic evidence of progressive dlbcl prior to dosing. 8. patients must have measurable disease per the revised criteria for response assessment of lymphoma (cheson, 2014). 9. patients must not be eligible for high-dose chemotherapy with autologous stem cell transplantation rescue. exclusion criteria: 1. patients who are pregnant or lactating. 2. dlbcl with mucosa-associated lymphoid tissue (malt) lymphoma, composite lymphoma (hodgkin's lymphoma +nhl), or dlbcl transformed from diseases other than indolent nhl or richter's. 3. primary mediastinal (thymic) large b-cell lymphoma. 4. known central nervous system lymphoma or meningeal involvement. 5. patients whose most recent systemic anticancer therapy include radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy other than glucocorticoids \< 6 weeks prior to first dose of study drug. 6. patients who have not recovered to grade ≤ 1 clinically significant adverse events, or to their baseline, from their most recent systemic anti-dlbcl therapy. 7. patients with active graft-versus-host disease after allogeneic stem cell transplantation. at least 4 months must have elapsed since completion of allogeneic stem cell transplantation. 8. major surgery within 2 weeks of first dose of study treatment of atg-010. 9. any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety. 10. active hepatitis b virus or hepatitis c virus infection. 11. known human immunodeficiency virus infection.
contrast-enhanced mri in detecting benign and malignant liver lesions

Conditions: Hepatocellular Carcinoma; Liver and Intrahepatic Bile Duct Disorder; Metastatic Malignant Neoplasm in the Liver; Primary Malignant Liver Neoplasm

Summary: this clinical trial studies contrast-enhanced magnetic resonance imaging (mri) in detecting nonmalignant and malignant liver lesions. diagnostic procedures, such as mri, may help find and diagnose nonmalignant and malignant liver lesions. contrast agents, such as gadoxetate disodium and gadobutrol, may help doctors to see mri images more clearly.

primary objectives: i. to compare the specificity of contrast enhanced mri using a liver specific agent eovist (gadoxetate disodium) versus the combined use of eovist and an intravascular-extracellular agent gadavist (gadobutrol) for the radiologic detection and characterization of liver lesions via clinical stability and follow up imaging. outline: patients receive gadoxetate disodium intravenously (iv) over 1 minute and undergo mri. patients then receive gadobutrol iv over 1 minute at the 20 minute mark during mri.

Eligibility criteria:
inclusion criteria: * patients with the most recent abdominal magnetic resonance (mr) study obtained within 3 months +/- 1 week * patients with renal function (estimated glomerular filtration rate \[egfr\] \>= 30) * any disease type exclusion criteria: * pregnant women * patients with impaired renal function (egfr \< 30) * patients with surgical implants and/or metallic foreign bodies non-compatible with the mr magnet * patients with contraindications to the use of intravenous contrast such as allergic type reactions
comparison of two naloxone infusion rates on the postoperative recovery of patients undergoing spine fusion surgery

Conditions: Pain, Postoperative; Postoperative Nausea and Vomiting; Scoliosis

Summary: there will be two groups in this study: one group will be given the standard infusion of naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the other group will receive a higher dose. the trial is designed to determine if a higher dose of naloxone infusion will reduce side effects from opioid therapy in patients who have undergone spine fusion for scoliosis.

currently, patients undergoing spinal fusion for scoliosis are routinely given patient controlled analgesia (pca) for pain control postoperatively. pca therapy is typically combined with an ultra low dose naloxone infusion because of the established benefit of reduced pruritis and nausea. the investigators hypothesize that using a higher dose naloxone infusion may lead to further improvement in pruritis and nausea and may improve gi function. improvement in bowel function could lead to faster initiation of oral intake as well as transition to oral pain medication and even decreased length of stay.

Eligibility criteria:
inclusion criteria: * idiopathic scoliosis requiring spine fusion surgery * age 10-21 years exclusion criteria: * inability to understand pca instructions * allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine * chronic opioid therapy \> 2 months * non-english speaking

Keywords: narcotic antagonists naloxone infusion postoperative pruritis patient controlled analgesia pediatric children
understanding and improving diabetes care for ethnic minorities

Conditions: Diabetes Mellitus, Type 2

Summary: in this study, we are testing the effectiveness of an intervention known as "coached care" to improve health outcomes and quality of care of patients being treated for type 2 diabetes, particularly patients in underserved populations. the intervention involves training members of minority communities who have diabetes to be "coaches", teaching minority patients the skills needed to participate effectively in care during office visits, as they present for those visits. coaches follow patients for 9 routine consecutive visits, reinforcing participation skills before and between their routine office visits.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes * at least one hemoglobin a1c value greater than 7.5% in the year prior to recruitment. exclusion criteria: * age above 80 years * patients with dementia or other serious mental health problems that would prevent them from participating in the intervention. * patients with other serious medical problems that would prevent them from participating in the intervention.

Keywords: healthcare disparities
a multi-component alcohol and sex risk intervention for college students

Conditions: College Drinking

Summary: hazardous alcohol use, sexually transmitted infections, and sexual violence are interrelated and highly prevalent public health concerns in college student populations. the current study seeks to develop a tri-pronged sex-positive intervention that addresses risky alcohol use, unsafe sex, and sexual violence for college men and women (ages 18-24). the study involves a small randomized pilot trial to demonstrate the feasibility and acceptability of the recruitment methods and research design. preliminary evidence of intervention efficacy will also be evaluated.


Eligibility criteria:
inclusion criteria: * must be student at the site university exclusion criteria: * students who have participated in relevant site specific studies will be excluded
interactive intention-driven upper-limb training robotic system

Conditions: Stroke

Summary: the goal of this study is to determine robotic hand system is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in subjects after stroke.

this study will investigate the recovery in hand and upper limb functions when the physical training is assisted by an exoskeleton robotic hand system. subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). all subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour. during the training, you will be asked to do the hand open and hand grasp by electromyography-driven robotic control strategy. there will be evaluations on the upper limb motor functions before and after the 20-session of training and follow up session by clinical assessments on functional recovery.

Eligibility criteria:
inclusion criteria: * subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). all subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour. exclusion criteria: * excessive spasticity of the affected arm * participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.

Keywords: stroke hand upper extremity robotics
tools to improve parental recognition of developmental deficits in children

Conditions: Malnutrition; Child Development

Summary: in this study, we aim to improve child nutrition by increasing parents' awareness of their children's physical growth. we use a cluster-randomized trial design to evaluate two interventions that provide parents with regular information on their children's physical development and growth: 1) distribution of full-sized growth charts for measurement of child height within households; and 2) organization of community-based meetings, during which children's height and weight are measured by trained project staff.

the target population for the study will be children between the ages of 6 and 18 months at baseline living in small-scale farming households in chipata district, zambia. as part of a cluster-randomized trial titled "food constraints, yield uncertainty and 'ganyu' labor" funded by iza-dfid (pi: g fink), 3,100 farming households in approximately 180 rural villages in eastern province are currently enrolled in a two-year study, which aims at assessing the effect of food loan programs on agricultural productivity. the study described here uses the "food constraints" population as a sampling frame; all households enrolled in the "food constraints" program that have a child between 6 and 18 months are invited to participate in this add-on trial. we anticipate that there will be around 600 eligible households recruited for this study. study duration is about 18 months. selected households will be visited for study enrollment and a short baseline assessment in september 2014, at which time the two interventions will also be rolled out. final impact of the interventions will be assessed one year later, in september 2015.

Eligibility criteria:
inclusion criteria: * all households with a child between the ages of 6 and 18 months at baseline exclusion criteria: * none
multidisciplinary evaluation of elderly patients with digestive cancer (epodig-g)

Conditions: Digestive System Disease; Neoplasms

Summary: this is a monocentric, comparative, open-label, randomized parallel group study enrolling elderly subjects hospitalized in strasbourg europe cancerology institute (icans), starting chemotherapy or targeted therapy for the treatment of digestive cancer.

at the icans an epodig-g program, consisting in a coordination of supportive care that are existing in the institute, is proposed to elderly patients with digestive cancer. the purpose of this study is to evaluate the impact of this early multidisciplinary geriatric program (epodig-g), when it is initiated before therapeutic treatment.

Eligibility criteria:
inclusion criteria: * patients must be ≥ 75 years old * performance status 0, 1 or 2 * diagnostic of digestive cancer, all stages (adjuvant or metastatic), with an indication for chemotherapy treatment or targeted therapy * patients previously treated with one or several lines of chemotherapy for this digestive cancer are eligible * estimated life expectancy ≥ 3 months * patients able to speak, read and understand french * signed informed consent from the patient * patients must have a social security coverage exclusion criteria: * history of differentiated neuroendocrine tumors grade 1 or 2 (pancreas, small intestine) * history of another treated cancer during the last five years * history of major surgery and/or curative radiation therapy during the last 4 weeks before inclusion * patients unable to submit to medical follow-up for geographical, social or psychological reasons * patients placed under guardianship

Keywords: digestive cancer supportive care gastrointestinal cancer