Kornimate/medical-research-clean huggingface dataset:
physiotherapy applications in upper extremity lipedema

Conditions: Lipedema

Summary: lipedema which causes excessive accumulation of fat in the subcutaneous tissue, is a rare, progressive disease. this disease generally affects women, following puberty or early adulthood and usually results in the slow increase of the circumference of the legs and/or arms, bilaterally. in a typical presentation of lipedema, the enlargement of the lower extremities is disproportionately greater than that of the trunk and upper extremities when first described in 1940, lipedema was thought to exclusively affect the lower extremities. however, as the disease has been recognized over the years, lipedema has been reported to affect the upper extremities. upper extremity lipedema, with no involvement of the lower extremities is an extremely rare incident.

due to the hypertrophy in adipose tissue, the link between lymphatic dysfunction and the progression to lipo-lymphedema, lipedema is conservatively treated with physiotherapy, manual lymph drainage and compression, also known as complex decongestive physiotherapy. furthermore, the consensus of the international society of lymphology has stated that intermittent pneumatic compression is an optional treatment which may be applied as an adjuvant therapy to complex decongestive physiotherapy. all participants included in the study were included in a treatment protocol consisting of complex decongestive physiotherapy and intermittent pneumatic compression. the perometer was used in the measurement of upper extremity volume and circumference before and after treatment.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-65, * having a diagnosis of upper extremity lipedema * being willing to participate in the study exclusion criteria: * accompanying diagnosis of lymphedema, * deep vein thrombosis * disease which causes edema in the upper extremities

Keywords: upper extremity lipedema lymphatic drainage
a study of the safety and efficacy of infliximab(remicade ) in pediatric patients with moderately to severelyactive ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of the study is to evaluate the effectiveness and safety of infliximab (remicade) in children with moderately to severely active ulcerative colitis.

ulcerative colitis (uc) is a disorder involving the lining of the colon. a substance called "tumor necrosis factor" (tnf) naturally occurs in the body. tnf is thought to play an important role in the development of ulcerative colitis by causing some of the damage that is seen in the colon. "antibodies" are normally made in the body and help fight off infection. infliximab is an antibody that is made in a scientific laboratory, using parts of both mouse and human antibodies. it has been designed to attach to tnf, making it difficult for tnf to do any damage. this study will be done at centers in north america and europe. each child will first have a clinic visit (screening visit) to have some tests done to make sure the child is the type of patient who should be in this study. at the 2nd visit (week 0), the child will have the first treatment with infliximab. all children in the study will receive 5 mg/kg infliximab 3 times (at weeks 0, 2 and 6) over the first 6 weeks of the study. if the child's symptoms do not improve by the 8th week, the child will receive no further infusions, but will return for safety evaluations. if the child's symptoms do improve, the child will be randomly assigned (like the flip of a coin) to either 5 mg/kg infliximab every 8 weeks through week 46 or 5 mg/kg infliximab every 12 weeks through week 42. if the child gets worse after being randomly assigned, the amount of infliximab may be increased or the infliximab may be given more frequently. a final infusion will be given at either week 42 or week 46. there will be a safety evaluation at week 54 and a visit at week 62 to get a blood sample. patients will receive 5 mg/kg of infliximab at weeks 0, 2 and 6 and then 5mg/kg infliximab either every 8 weeks or 12 weeks until weeks 42 or 46. infliximab is given as an intravenous infusion over 2 hours.

Eligibility criteria:
inclusion criteria: * have moderately to severely active ulcerative colitis * diagnosed with ulcerative colitis for 2 weeks before screening * male patients who are sexually active and female patients who are sexually active or of childbearing potential must use adequate birth control while participation in the study and for 6 months after the last infusion. exclusion criteria: * history of latent or active tb * have had a live viral or bacterial vaccination within 3 months before screening * have or have had serious infections within 3 months before screening * prior treatment with infliximab

Keywords: ulcerative colitis inflammatory bowel disease children
educational tools for pregnant women with diabetes mellitus.

Conditions: Diabetes Mellitus; Pregnancy Complications

Summary: a randomized controlled trial evaluating whether a patient-centered virtual educational tool based on small videos focusing on optimization of mental health, diet, physical activity, self-adjustment of insulin dose and use of diabetes technology in addition to usual individual face-to-face education, will improve glycemic control and pregnancy outcome ij women with pre-existing diabetes mellitus compared to women receiving usual individual face-to-face education alone.

etos-dm is a national rct evaluating the effect of combined virtual patient-centered education based on a tool of small videos accessible via smartphones in addition to usual individual face-to-face education during pregnancy or to routine individual face-to-face education only. the small educational videos covering topics as food choices, physical activity, self-adjustment of insulin dose insulin pump settings during pregnancy, use of cgm during pregnancy, mental health among others,each of 1-4 minutes duration, will be developed in collaboration with user representatives (women with pre-existing diabetes who are or have recently been pregnant) and relevant health care professionals. . the inclusion period of the etos-dm study starts on september 1st 2023 and ends on august 31st 2025. pregnant women with pre-existing diabetes will be randomized before 14 gestational weeks. the women in the intervention group will have free, unlimited access to approximately 10 educational videos. the use of these virtual educational videos will be monitored and the women's own experience with the videos will be explored. the women will be followed during pregnancy, delivery until one month after delivery. both groups of women follow usual local care and local face-to-face education which is allowed to change during the study period. stratification will be performed for diabetes center, for diabetes type and, in women with type 1 diabetes, use of mdi or insulin pump.

Eligibility criteria:
inclusion criteria: * women, age ≥ 18 years * type 1 diabetes, type 2 diabetes or other types of pre-existing diabetes (e.g., maturity onset diabetes of the young (mody)) * pregnant with one or more intrauterine singleton living foetus(es) (5 to 13 completed gestational weeks) at inclusion confirmed by an ultrasound scan) exclusion criteria: * a diagnosis with severe mental or psychiatric barriers or a concurrent disease based on the decision of the investigator * no proficiency in danish to understand oral and written information to secure independent observations, women can be randomized in the etos-dm study only once.
effect of methylprednisolone on immune signaling in hip-arthroplasty patients

Conditions: Osteoarthrosis

Summary: the study evaluates the pathophysiological effects of a single dose methylprednisolone administered prior to total hip-arthroplasty (tha) surgery. the investigators examine the effect on immune signaling and recovery after surgery. half of participants will receive intravenous solu-medrol 125 mg, while the other half will receive placebo. the investigators hypothesize that the group receiving methylprednisolone will experience a positive modulation of the immune response and an enhanced recovery.

the anti-inflammatory effects of glucocorticoids are well known. the beneficial effects on postoperative pain, postoperative nausea and vomiting are well-documented. hip-arthroplasty surgery and the inflammatory stress response in general affect the potential of recovery. the basic physiological mechanisms behind restoration of recovery after surgery are still unresolved. the many different immune cells involved in the complex signal response enables wound healing and recovery, and the individual immune signal pattern might be able to predict recovery. the effects of glucocorticoids on this immune signal pattern is unknown and calls for further investigation. the study is to be considered as exploratory. this study is embedded in a primary study registrated as: nct02445898 for further details please view the eudract registration: eudract nr.: 2015-000102-19

Eligibility criteria:
inclusion criteria: * osteoarthrosis * undergoing total unilateral hip-arthroplasty surgery * speak and understand danish * have given informed content exclusion criteria: * revision or bilateral hip-arthroplasty surgery * general anaesthesia * allergy or intolerance towards methylprednisolone * local or systemic infection * permanent systemic treatment with steroids within 30 days peroperatively * insulin-dependent diabetes * atrial fibrillation * neurological disease incl. parkinsons * daily use of hypnotics or sedatives * alcohol abuse \>35 units per week * active treatment of ulcer within 3 months preoperatively * cancer disease * autoimmune disease incl. rheumatoid arthritis * pregnant or breast feeding women * menopause \<1 year

Keywords: glucocorticoids immune signaling recovery hip arthroplasty, total
beta amyloid pet imaging for alzheimer disease with [18f]-fluselenamyl

Conditions: Alzheimer Disease

Summary: the purpose of this research study is to determine the safety of a radiotracer 18f-fluselenamyl using positron emission tomography (pet) imaging.

the investigators will first complete whole-body pet dosimetry studies in healthy adult normal volunteers to calculate the actual radiation dose of each human organ and determine the allowable dose for a human subject when receiving a single dose for a pet scan. second, imaging of the brain and neck will be completed in a wide range of ages of healthy adult normal control participants and participants with mild cognitive impairment, both male and females to characterize 18f-fluselenamyl uptake in the brain, its binding to beta-amyloid plaques, and radiolabeled metabolite will be completed. amyloid is a protein related to dementia of alzheimer's disease. 11c-pib pet imaging and mri of the brain will also be completed in the same participants and the data will be compared with 18f-fluselenmayl. 11c-pib and 18f-fluselenamyl both bind to beta-amyloid plaques. finally, a comparison of the normal control participants to patients with alzheimer's disease will be completed.

Eligibility criteria:
inclusion criteria: * male or female, any race * age ≥ 18 years * healthy volunteers or volunteers with alzheimer's disease exclusion criteria: * has hypersensitivity to 18f-fluselenamyl or any of its excipients ; * has hypersensitivity to 11c-pib or any of its excipients ; * incapable of providing written informed consent or lacking a legally authorized representative (lar) to provide informed consent ; * unwilling or unable to undergo pet scans tracer injections ; * unwilling or unable to undergo mri (aim 2 and aim 3) * any condition that, in the investigator's opinion, could increase the risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., renal or liver failure, advanced cancer); * women who are currently pregnant or breast-feeding; * current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the u.s. code of federal regulations (cfr) title 21 section 361.1.
mfolfiri combine with nimotuzumab second line chemotherapy for squamous-cell carcinoma of the esophagus

Conditions: Advanced Esophageal Carcinoma

Summary: there are few studies about 2nd line treatment in advanced esophageal carcinoma (aec), some showed that irinotecan may be effective. the investigators previous study has shown the efficacy and safety of paclitaxel/cisplatin as 1st line treatment, so in this phase ii study, the investigators would like to observe the efficacy and safety of nimotuzumab plus irinotecan/5fu/leucovorin as 2nd line treatment if aec after failure to 1st treatment of ptx/ddp.


Eligibility criteria:
inclusion criteria: * histologically confirmed esophageal squamous carcinoma,failed to 1st line treatment of paclitaxel/cisplatin * age 18 to 75 years old * measurable disease according to the recist criteria(diameter of the lesion should be more than 10mm by spiral ct or mri, more than 20mm by common ct, the date of image should be less than 15 days before enrollment) * life expectancy of ≥3 month * karnofsky performance status ≥80 * wbc\>3,500/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, hb\>9g/dl，bilirubin level \< 1.0 times uln，serum creatinine \<1.0 times uln，alt and ast\<2.5 times uln ，akp \< 2.5 times uln ，(≤5 times uln in patients with liver metastases)(within 7 days before enrollment) * no sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever\>38℃； * normal ecg/cardiac function * good compliance * having signed informed consent exclusion criteria: * more than 1 previous systemic therapy for metastatic esophageal squamous carcinoma * known hypersensitivity to study drugs * tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung * no measurable lesions, eg. pleural fluid and ascites * only with other previous malignancy within 5 year, except non-melanoma skin cancer * heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months only brain or bone metastasis * chronic diarrhea * mentally abnormal or disable cognition,including cns metastasis * pregnancy or lactation period
the efficacy and safety of diluted oral phosphate enema versus intravenous sodium glycerophosphate in the treatment of hypophosphatemia in icu patients

Conditions: Acute Hypophosphatemia

Summary: the goal of this clinical trial is to study the efficacy and safety of diluted phosphate enema in treating hypophosphatemia in adults in critical care unit in comparison to intravenous sodium glycero-phosphate as the current standard of care. the main question it aims to answer is: can the investigators rely on phosphate enemas as an effective and safe treatment option for hypophosphatemia in critically ill adults, in the era of global shortage of parenteral nutrition solutions and the absence of defined guidelines for treatment of acute hypophosphatemia in those population.

a randomized controlled trial - non inferiority trial of 2 groups, eligible participants will be randomly assigned to one of two groups (intervention group will receive diluted oral phosphate enema as the repletion strategy, while control group will receive the standard of care: intravenous sodium glycerophosphate) for the purpose of treatment of hypophosphatemia in critically ill patients. dose calculation: as per hospital protocol and scientific reference(crook, 2009) 0.32 mmol per kg for mild hypophosphatemia 0.64 mmol per kg for moderate hypophosphatemia all participants will be reassessed the next day after the intervention and followed up for the occurrence of any side effects, then participants will be followed up again the day after. (assessment of serum phosphate and sodium along with occurrence of diarrhea or any other side effects).

Eligibility criteria:
inclusion criteria: * critically ill patients with mild (2-2.4 mg/dl) to moderate (1.5-1.9 mg/dl) hypophosphatemia. * serum phosphorus level less than 2.5mg/dl - between 1.5 - 2.5mg/dl * patients 18 years or older exclusion criteria: * severe hypophosphatemia * serum phosphorus level less than 1.5 mg/dl * patients on non-peroral status * ileus (as paralytic ileus, post-operative) * any problem in gut integrity as (intestinal obstruction, severe malabsorption, severe diarrhea) * any form of ischemic gut (as mesenteric ischemia, mesenteric gastric occlusion, arterial venous insufficiency) * hemodynamically unstable patients * severe hypocalcemia or hypercalcemia at the beginning of the study (when iv phosphate is deemed inappropriate at the discretion of attending physician)
a safety and efficacy study of two japanese encephalitis vaccines chimerivaxtm-je and je-vax

Conditions: Japanese Encephalitis

Summary: the purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between chimerivax™-je and je-vax® to the respective homologous virus strain and several wild types strains after completion of vaccination course.


Eligibility criteria:
inclusion criteria: * written informed consent obtained. * aged ≥18 to \<49 years. * in good general health. * available for the study duration, including all planned follow-up visits. * females must have negative pregnancy test and be using adequate form of contraception exclusion criteria: * clinically significant abnormalities on laboratory and vital sign assessments. * anaphylaxis or other serious adverse reactions * administration of another vaccine within 30 days of study treatment period. * physical examination indicating any significant medical condition. * intention to travel out of the area prior to the study visit on day 56. * seropositive to hepatitis c virus (hcv) or human immunodeficiency virus (hiv) or positive for hepatitis b surface antigen. * pregnancy. * excessive alcohol consumption, drug abuse. * involvement in another clinical study within 60 days preceding the screening visit and during study treatment period.

Keywords: japanese encephalitis chimerivax™-je je-vax®
impact of alarm reduction on delirium in icu

Conditions: Delirium

Summary: delirium is an acute and fluctuating disturbance of consciousness and can occur in 80% of critically ill patients. delirium is more frequent in mecanically ventilated patients and is associated with longer hospital stay, increased cognitive impairment and mortality. on the occasion of the change of the monitors in the icu ward, allowing a total withdrawal of alarms in patients room, this study evaluates the prevalence of delirium before and after the alarm withdrawal. during the first period the patients will be monitored as usual, and during the second period patients will be monitored without alarms ringing in patients room. delirium will be screened with a validated, clinical tool.


Eligibility criteria:
inclusion criteria: * age\>18 years, admission to icu exclusion criteria: * length of stay in icu\<24 hours, moribund patient, deafness, dementia, psychiatric pathology, delirium at admission, acute neurological pathology at admission (stroke, epilepsy, neuro-infection), hepatic encephalopathy, admission for cardiac arrest, admission for voluntary drug intoxication, pregnancy
nodify xl2 classifier clinical utility study in low to moderate risk lung nodules

Conditions: Nodule Solitary Pulmonary; Non-small Cell Carcinoma

Summary: this study evaluates the how addition of the nodify xl2 test result impacts the clinical management of newly identified solid lung nodules assessed as low to moderate risk of cancer.

a multicenter, randomized controlled study with a blinded control arm. open label arm is observational for lung nodule management. the clinical trial will evaluate the clinical utility of the nodify xl2 integrated classifier when used in the clinical management of newly identified solid lung nodules assessed as \< 50% risk of cancer by mayo risk prediction algorithm.

Eligibility criteria:
inclusion criteria: 1. subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements 2. subject is \> 40 years of age at the time of the discovery of the lung nodule of concern 3. subject's lung nodule of concern meets the following: * was incidentally identified or detected during lung cancer screening * is a solid nodule * has maximal dimension of \> 8mm and \< 30mm 4. the first ct scan identifying the lung nodule of concern was performed within 60 days of subject enrollment 5. the pre-test risk of cancer as determined by the mayo risk prediction algorithm is 65% or less exclusion criteria: 1. nodule work-up at the time of subject enrollment indicating any prior attempted or completed diagnostic biopsy procedure or blood-based testing for the lung nodule of concern 2. nodule of concern is part-solid or ground glass opacity (ggo) 3. prior diagnosis of lung cancer 4. any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer 5. administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment 6. concurrent participation in any unrelated clinical trial that may impact or alter the management of the subject's nodule of concern 7. any illness or factor that will inhibit compliance with study participation
efficacy of glycerol, two topical steroids, and a topical immune modulator against skin irritation

Conditions: Dermatitis, Contact; Dermatitis, Occupational

Summary: the purpose of this study is to compare the efficacy of glycerol ointment, triamcinolone acetonide ointment, clobetasol ointment and tacrolimus ointment on irritated skin in a cumulative skin irritation test model using healthy volunteers.

irritant contact dermatitis (icd) is a frequent cause of hand eczema and occupational skin disease. one way to study icd is to expose healthy volunteer skin to chemicals and evaluate the skin response. because different chemicals act differently on the skin, the use of different skin irritants may provide more information than relying on one irritant only. in this study the two commonly used irritants sodium lauryl sulphate and nonanoic acid are exposed to the skin in a cumulative wash test. treatment of icd has classically involved topical steroids and/or emollients. however, the outcome is variable with some patients being very refractory to this regimen. this study was designed to investigate the relative efficacy of the steroids triamcinolone acetonide and clobetasol, the topical immune modulator tacrolimus, a 20% glycerol ointment compared with an inert ointment vehicle on experimentally induced irritated skin.

Eligibility criteria:
inclusion criteria: * caucasian * normal skin on both volar forearms * oral and written informed consent exclusion criteria: * pregnant, lactating women * no safe anticonceptive method used * intake of systemic immunosuppressants (e.g. prednisolone) * endocrine, immune, or liver disorders * known allergy towards drugs applied to the skin

Keywords: irritant contact dermatitis experimental contact dermatitis treatment efficacy topical steroids topical immune modulators glycerol