Kornimate/medical-research-clean huggingface dataset:
a registry study of palmoplantar pustulosis (ppp) treatment patterns, disease burden and treatment outcomes in japan

Conditions: Palmoplantar Pustulosis

Summary: the purpose of this study is to describe the treatment patterns of participants receiving systemic treatment for of palmoplantar pustulosis (ppp) in japan.

this is a retrospective study where the historical data on ppp therapy will also be used prior to visit 1 (baseline).

Eligibility criteria:
inclusion criteria: * must have a confirmed diagnosis of palmoplantar pustulosis (ppp) in accordance with local clinical practice * has previously been prescribed treatment for ppp * a decision has been made by the treating physician and the participant to commence treatment with a systemic ppp therapy, having been deemed to have an inadequate response to previous therapy (new users are defined as those participants to commence treatment on baseline visit date. existing users are defined as those who commenced treatment prior to the baseline visit since 01 november 2019.) * must sign a participation agreement/informed consent form allowing data collection and source data verification in accordance with local requirements exclusion criteria: * are receiving, or have received within the past 3 months, anti-inflammatory or analgesic systemic therapy such as oral corticosteroid, disease modifying antirheumatic drug (dmards), non-steroidal anti-inflammatory drugs, opioids, phosphodiesterase 4 (pde4) inhibitor, or biologics for any other indication (for example, psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and asthma) * received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the start of the study or the first data collection time point * participation in an investigational study * participation in another observational study for guselkumab (including a post marketing surveillance study) * if the only treatment they have received for ppp has been antibiotics
study of hydroxychloroquine in patients with x-linked alport syndrome in china (chxlas)

Conditions: Alport Syndrome, X-Linked

Summary: this phase 2 randomized controlled trial will study the safety, tolerability, and efficacy of hydroxychloroquine in qualified patients with alport syndrome. the trial will be open-label, randomized, controlled and will enroll up to 50 patients.

this phase 2 randomized controlled trial will study the safety, tolerability, and efficacy of hydroxychloroquine in qualified patients with alport syndrome. the trial will be open-label, randomized, controlled and will enroll up to 50 patients. patients in the phase 2 cohort will be randomized 1:1 to either hydroxychloroquine cohort or comparator cohort. all patients in the study will follow the same visit and assessment schedule. following randomization on day 1, patients will be scheduled to be assessed during treatment at weeks 4, 12, and 24. patients will not receive study drug during a 24-week withdrawal period between weeks 25 and 48. patients will also be scheduled to be assessed at an in person follow up visit at week 36, and 48.

Eligibility criteria:
inclusion criteria: * male or female; * age 3-18 years old; * diagnosis of alport syndrome by genetic testing (documented mutation in a gene associated with alport syndrome, including col4a3, col4a4, or col4a5) or histologic assessment using electron microscopy; * screening egfr ≥ 90 ml/min/1.73 m2; * ace inhibitor and/or arb, the dosing regimen should be stable for at least 4 weeks prior to screening; * no antirheumatic drugs such as hydroxychloroquine have been used; * willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures; exclusion criteria: * causes of chronic kidney disease aside from alport syndrome (including but not limited to other heritable disorders leading to chronic kidney disease, diabetic nephropathy, hypertensive nephropathy, lupus nephritis, iga nephropathy); * prior exposure to hydroxychloroquine; * ongoing chronic hemodialysis or peritoneal dialysis therapy; * renal transplant recipient; * any clinically significant illness within 4 weeks before screening or surgical or medical condition (other than alport syndrome) that could interfere with the subject's study compliance; confound the study results; impact subject safety; or significantly alter the absorption, distribution, metabolism, or excretion of drugs; * participation in other interventional clinical studies; * known hypersensitivity to any component of the study drug.

Keywords: alport syndrome hydroxychloroquine treatment
influence of sulindac and probiotics on the development of pouch adenomas in patients with familial adenomatous polyposis

Conditions: Adenomatous Polyposis Coli

Summary: the purpose of this study is to determine whether sulindac and vsl#3 - inulin, either combined or alone, are effective in treating or preventing adenoma development in the ileal anal pouch in patients with familial adenomatous polyposis.


Eligibility criteria:
inclusion criteria: * clinically or genetically proven familial adenomatous polyposis * restorative proctocolectomy with ileal pouch anal anastomosis exclusion criteria: * chronic or acute renal or hepatic disease * history of oesophageal, gastric or duodenal ulcers * known hypersensitivity to sulindac * daily use during the last three months of: * aspirin * non-steroidal anti-inflammatory agents * probiotics
prosthetic device in children with upper congenital limb deficiency

Conditions: Upper Limb Deformities, Congenital

Summary: this is a study being performed to evaluate the safety and effectiveness of 3d printed myoelectric prosthetic devices in children with a congenital upper limb deficiency.

the purpose of this study is to learn more about whether myoelectric prosthetic devices would be beneficial and useful for children. the study protocol specifies 4 study visits over the course of a year at the following intervals: baseline, 3 month, 6 month, 12 months. in following the protocol, each study visit will use the assessment of capacity for myoelectric control (acmc) functional testing. the study participants will also complete several parent-child reported health related quality of life and musculoskeletal questionnaires. specifically, the pediatric outcomes data collection instrument (podci), the pediatric quality of life inventory (pedsql), and the children's hand-use experience questionnaire (cheq) will be used to measure efficacy of the myoelectric devices..

Eligibility criteria:
inclusion criteria: * children between the ages of 6 to 17 with congenital/infant upper limb deficiency identified by limbitless solutions will be referred to ohsu for evaluation and selection. * all approved and consented subjects will receive a limbitless 3d printed myoelectric device as delivered by established protocol. * preference will be given to children with long term previous experience with limbitless solutions' bionic systems. exclusion criteria: * non english-speaking children and families. due to the entirely volunteer nature of this project, the investigators are unable to hire appropriate translation services or create translated forms and surveys in other languages currently. * shoulder or wrist disarticulation will be excluded.
maternal serum alpha-fetoprotein level may predict the presence of morbid adherent placenta

Conditions: Placenta Accreta

Summary: the aim of the study is to compare between alpha-fetoproteine as a biological marker and between ultrasound and doppler in prediction of morbid adherent placenta.

in pregnant women withe previous cesarean section, placenta previa and ultrasonographic finding of an abnormally adherent placenta dose maternal serum alpha-fetoprotein predict prenataly the presence of morbid adherent placenta accurately?

Eligibility criteria:
inclusion criteria: * pregnant women with history of scarred uterus * plcenta previa covering the scar of previous caesarean section as diagnosed by 2du/s * gestational age from 28wks to full term exclusion criteria: * pregnant women with fetus with congenital anomalies * pregnant women with ovarian swelling * pregnant women with medical disease
retinal vascular changes in primary open angle glaucoma patients

Conditions: Primary Open Angle Glaucoma

Summary: the study aims to detect ischemic changes in macula using oct angiography in primary open angle glaucoma patients correlating with glaucoma staging system ii by visual field.

our study will be designed as " prospective non-randomized case - control study" the study will include 100 eyes of 100 participants 50 eyes of normal subjects , non-glaucomatous subjects 50 eyes of 50 patients with poag to detect ischemic changes in macula using oct angiography correlating with glaucoma staging system ii by visual field.

Eligibility criteria:
inclusion criteria: * (\> 18 years old) exclusion criteria: * patients with cataract * retinal disorders including: amd , macular degeneration , retinal detachment , retinitis pigmentosa , etc . * corneal opacites * any ocular surgeries * patients with systemic disease. * patient refusal
the impact on therapeutic effect and tolerance of treatment for patients with hepatocellular carcinoma in transcatheter arterial chemoembolization (tace) of dexamethasone application: a random, double-blind, controlled, clinical trial.

Conditions: HepatoCellular Carcinoma

Summary: the current random, double-blind, controlled, clinical trial was designed to evaluate the impact on therapeutic effect and tolerance of treatment for patients with hepatocelluclar carcinoma in transcatheter arterial chemoembolization (tace) of dexamethasone application.


Eligibility criteria:
inclusion criteria: * older than 18 years old; * ecog ps\<3; * proven hepatocellular carcinoma according patological examination or easl/aasld diagnostic criteria; * meeting at least 1/4: 1) multiple nodules, 2) single tumor but not suitable for resection, 3) vascular invasion exists, 4) distant metastasis excluding cns and bone * not previous treated for tumor; * child-pugh a or b; * at least one measurable lesion according mrecist; * cannot afford sorafenib; * the lab test could meet: neutrophil count≥1.5×109/l; hemoglobin≥80g/l; platelet count≥60×109/l; serum albumin≥28g/l; total bilirubin\<3-times upper limit of normal; alt\<5-times upper limit of normal; ast\<5-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; pt≤upper limit of normal plus 6 seconds; inr≤2.3 * sign up consent; * unrolled by other clinical trials about hepatocellular carcinoma. exclusion criteria: * cannot tolerate tace; * cns or bone metastasis exits; * known history of other malignancy; * be allergic to related drugs; * underwent organ transplantation before; * be treated before (interferon included); * known history of hiv infection; * known history of drug or alcohol abuse; * have gi hemorrage or cardiac/brain vascular events within 30 days; * pregnancy;
community based strategies to reduce maternal mortality in northern nigeria

Conditions: Maternal Mortality

Summary: the objective of this cluster randomized controlled trial is to assess the impact of several community-based interventions that address the key factors underlying the high maternal mortality, as well as neonatal mortality and morbidity in northern nigeria. the interventions, include: 1. a voluntary health worker program (vhw) 2. the vhw program with provision of a safe birth kit 3. the vhw program with community folk media activities.


Eligibility criteria:
inclusion criteria: * women of reproductive age who live in the study clusters who provide consent. exclusion criteria: * eligible women who do not consent.

Keywords: pregnancy maternal mortality neonatal mortality community intervention voluntary health worker safe birth kit maternal child health
observational study of ctdna in resectable and borderline resectable pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to collect information about treatment recommendations based on ctdna testing and whether treatment changes based on ctdna information result in better outcomes for patients with pancreatic cancer.


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. resectable or borderline resectable pancreatic adenocarcinoma per ncnn guidelines 3. no prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer. 4. ecog performance status ≤ 1 5. clinically eligible for chemotherapy 6. able to tolerate collection of up to 20 ml of blood via venipuncture for research blood draw 7. has residual ffpe specimen available for submission to natera 8. able to read, understand and provide written informed consent 9. willing and able to comply with the study requirements exclusion criteria: 1. pregnant or breastfeeding 2. radiologic evidence of distant metastases 3. prior history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer 4. prior initiation of chemotherapy, radiation therapy, or surgery for pancreatic cancer 5. neuropathy \> grade 2 6. history of bone marrow or organ transplant 7. blood transfusion within 1 month of enrollment 8. medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder 9. serious medical condition that may adversely affect ability to participate in the study
oral/intramuscular b12 to treat cobalamin deficiency

Conditions: Vitamin B 12 Deficiency

Summary: objective: to determine the effectiveness of oral versus intramuscular cobalamin (vitamin b12) by restore cobalamin parameter in blood at 8, 26 and 52 weeks in ≥ 65 aged patients with cobalamin deficiency. design: noninferiority randomised controlled trial, pragmatic and multi-center in the primary healthcare setting (madrid region). participants: ≥ 65 aged patients with cobalamin deficiency. patients give inform consent. number of patients: 320 (160 each arm). assignment: randomized simple (automatic system). variables. main outcome variable: cobalamin level standardization (yes/no). secondary outcome variables: adverse events. adherence measurement of treatment. health related quality of life questionnaire (euroqol-5d). satisfaction and preferences. other variables: gender. age. live alone. vegetarian diet. alcohols consume. clinic variables (symptoms and physical examination) and blood parameters. drugs consume. causes of all losses and withdrawals. number of patients (age and gender) who declined to participate. all data (excluding patient identification data) will be record in an electronic database. intervention group: oral optovite® b12 1000 gammas. control group: idem intramuscular. analysis: descriptive analysis (screening phase). baseline comparison of the two intervention groups. effect of cobalamin (main outcome variable). security. quality of life. adherence measurement of treatment.

variables. main outcome variable: cobalamin level standardization (yes/no). secondary outcome variables: adverse events. adherence measurement of treatment. health related quality of life questionnaire (euroqol-5d). satisfaction and preferences. other variables: gender. age. live alone. vegetarian diet. alcohols consume. clinic variables (symptoms and physical examination) and blood parameters. drugs consume. causes of all losses and withdrawals. number of patients (age and gender) who declined to participate. all data (excluding patient identification data) will be record in an electronic database. intervention group: oral optovite® b12 1000 gammas. control group: idem intramuscular. analysis: descriptive analysis (screening phase). baseline comparison of the two intervention groups. effect of cobalamin (main outcome variable). security. quality of life. adherence measurement of treatment.

Eligibility criteria:
inclusion criteria: * ≥ 65 aged patients with cobalamin deficiency. * patients give inform consent. exclusion criteria: * treatment with b12 (1 last year) * neurologic or psychiatric pathologies * folic acid \< 2.3ng/ml ...

Keywords: primary health care vitamin b 12 deficiency
thrombin generation parameters and bleeding in patients treated with anticoagulants for cancer associated thrombosis

Conditions: Cancer; Pulmonary Embolism; Thrombosis

Summary: pulmonary embolism, the second leading cause of death in cancer patients, is effectively treated with anticoagulants. in patients with cancer-associated thrombosis (cat), the use of anticoagulants is associated with 10 to 15% of bleeding in the first 6 months. most of the guidelines propose to integrate the bleeding risk in the choice of therapies. thrombin generation assay (tga) reflects an overall hemostatic response and could be a useful biomarker. proven on the thrombotic side in the cat population, useful in the assessment of the bleeding risk of hemophiliac patients, the tga is emerging as a tool. the investigators to measure tga in cancer patients included prospectively, having recently developed a cat and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment.

pulmonary embolism, the second leading cause of death in cancer patients, is effectively treated with anticoagulants. in patients with cancer-associated thrombosis (cat), the use of anticoagulants is associated with 10 to 15% of bleeding in the first 6 months. most of the guidelines propose to integrate the bleeding risk in the choice of therapies. existing models for predicting anticoagulant associated bleeding risk applied to the cat patients are not very predictive (auc\<0.60). thrombin generation assay (tga) reflects an overall hemostatic response and could be a useful biomarker. proven on the thrombotic side in the cat population, useful in the assessment of the bleeding risk of hemophiliac patients, the tga is emerging as a tool. the investigators wish to measure tga in cancer patients included prospectively, having recently developed a cat and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment.

Eligibility criteria:
inclusion criteria: * patients with active cancer, as defined by current french recommendations (mahé i et al rev mal respir 2021) * presenting acute proximal deep vein thrombosis of the lower limb (dvt) and/or proximal pulmonary embolism (pe), confirmed by objective tests (doppler ultrasound in the event of dvt; lung scintigraphy or ct scan in the event of pe) * no contraindication for anticoagulant treatment at a curative dose at the time of inclusion exclusion criteria: * patients participating in a therapeutic clinical trial with blinded therapy will be excluded. * patients already on anticoagulant at a curative dose for valvular or rhythmic embolic disease or a history of venous thromboembolic disease * hematological malignancies * patients with a contraindication to anticoagulant treatment on inclusion * patient whose relay by doac has already been carried out.

Keywords: cancer thrombosis anticoagulant associated bleeding
effectiveness of a guided mobile app intervention for depression and anxiety in university students (promes-u study)

Conditions: Depressive Symptoms; Anxiety

Summary: background: symptoms of depression and anxiety are prevalent among spanish university students. minimally guided online interventions have shown promise in reducing symptomatology and preventing increased mental distress. there is a need to evaluate the effectiveness of guided preventive mental health interventions for depression and anxiety in university students. methods: two-arm multicenter randomized controlled trial (rct), addressed to undergraduate students from 6 public universities with symptoms of depression and/or anxiety. students will be evaluated through an online survey assessing mental health problems, use of mental health services, sociodemographic variables, self-perceived health, childhood and adolescent adversities, recent stressful events, social networks, personality and university experiences. a total of 600 students will be randomly assigned to: intervention group (guided e-health prevention intervention) or control group (treatment as usual with self-monitoring). the intervention, in app format, is based on principles of cognitive behavioral therapy, includes weekly feedback based on content and participation from a psychologist and self-monitoring. assessments will take place post-intervention (up to 6 weeks), at 6 months and 12 months after randomization. the primary outcome will be the reduction of depressive or anxiety symptoms post-intervention, assessed with the patient health questionnaire-9 (phq-9), the generalized anxiety disorder-7 (gad-7) and the patient health questionnaire-anxiety and depression scale (phq-ads). secondary outcomes of the rct will be mental wellbeing, academic stress, comorbid symptoms, and adherence. analyses will be conducted on an intention-to-treat and per protocol basis. discussion: the results of the promes-u rct will provide valuable information on a guided preventive online intervention that could be delivered in the campus context. in addition, results will provide information on the positive impact of the intervention on other relevant factors involved in mental health among university students.


Eligibility criteria:
inclusion criteria: * eligible participants are all undergraduate students at the 6 participating universities and students followed in the promes-u observational study * having 18 years of age or more * having literacy in spanish * having access to a smartphone (android or apple) * with mild or moderate depression and/or anxiety symptoms screened (i.e., depression (5≤ (phq-9) ≤14); and/or anxiety (5≤ gad-7 ≤14). exclusion criteria: * moderately severe or severe depression and/or anxiety (i.e., phq-9≥15 and/or gad-7≥15) * high suicide risk * a history of severe psychiatric disorder (e.g., bipolar, psychosis) * being on mental health treatment (i.e., medication, psychotherapy or other intervention) students with high suicide risk will receive a clinical alert recommending them to visit a specialist and a list of available mental health resources.
copd msa 3 regions: epidemiology and risk factors of copd in rural environment (bm3r)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the agricultural environment presents a unique profile in terms of epidemiology of pulmonary diseases. certainly due to persistent exposure to organic particles, the prevalence of copd is higher in farmers than in the general population, despite less smoking. it is likely that the risk of copd depends on several factors, such as the type of farm, local conditions and the region where the farm is located. it is important to diagnose copd at an early stage in order to initiate appropriate therapy, and implement secondary prevention with a view to limiting deterioration of respiratory function and reducing complications. in this context, the aims of bm3r project were: (1) to study the epidemiology of copd in a large representative sample of french farmers, in order to identify the types of farming, working conditions and regions that are associated with the presence of copd; and (2) to develop a score to identify patients at risk and optimise diagnosis of copd in the context of a screening programme.


Eligibility criteria:
inclusion criteria: * \> 40 years old and \< 75 years old * affiliated to the msa exclusion criteria: * copd known