Kornimate/medical-research-clean huggingface dataset:
structural description of skin biopsies with dynamic full-field optical coherence tomography on suspected basal cell carcinoma lesions, a pilot study (doctoba)

Conditions: Basal Cell Carcinoma; Tomography, Optical Coherence

Summary: basal cell carcinoma (bcc) are the most frequent skin cancers. their incidence is constantly increasing. bcc diagnosis is first clinically suspected and then confirmed following histological examination of either a skin biopsy or the excisional specimen. surgery is the first-line treatment and some procedures (notably mohs surgery) require extemporaneous histological analysis of the edges to ensure a complete excision. such on-site histopathological examination can be time consuming and associated with decreased sensitivity. skin imaging techniques have already been tested to overcome these limitations and seem promising. although some of them - such as confocal microscopy - are already even used in vivo, there is to date no report of the use of full-field optical coherence tomography for the diagnosis of bcc. the doctoba study intends to describe direct histopathological examination of fresh skin biopsy or excisional specimen with dynamic full-field optical coherence tomography.


Eligibility criteria:
inclusion criteria: - patient \> 18 years of age who received skin biopsy or excision of basal cell carcinoma suspected lesion between start study date and primary completion date exclusion criteria: * inability to perform dynamic full-field optical coherence tomography observation at the moment of skin biopsy * diagnosis of basal cell carcinoma disproved
safety and pregnancy outcomes in thrombocythemia patients exposed to xagrid® (anagrelide hydrochloride) compared to other treatments

Conditions: Thrombocythemia, Essential

Summary: this is an observational safety study being conducted in europe comparing patients taking xagrid to patients taking other cytoreductive treatments. the plan is to enrol at least 750 subjects taking xagrid with up to 3000 subjects taking other cytoreductive therapies. the study will collect follow up data for 5 years for each patient enrolled that will focus on collecting data related to pre-defined events (pdes) and suspected serious adverse reactions (ssars).


Eligibility criteria:
inclusion criteria: * high risk et patients * subjects who can give written informed consent. * subjects taking cytoreductive therapy exclusion criteria: * contraindications listed by the product being used. * patient cannot be participating in another clinical trial.
effect of sodium glucose co transporter 2 inhibitor ( sglt2) on proteinuria in diabetic patients

Conditions: Diabetic Nephropathies

Summary: diabetes mellitus is the leading cause of end stage renal disease. as proven by many studies , controlling proteinuria can delay the progression to end stage renal disease.this work will study the effect of sodium glucose co transporter 2 inhibitor , a new antihyperglycemic drug , on proteinuria and to compare its effect with the effect of classic antiproteinuric drugs as angiotensin converting enzyme inhibitor , aspirin and statins.

diabetic nephropathy involves progressive stages including glomerular hyperfilteration , microalbuminuria , overt proteinuria and a decline in glomerular filteration rate leading to end stage renal disease. despite all the available interventions available for diabetic patients including tight glycemic control , and blood pressure control , using angiotensin converting enzyme inhibitors, angiotensin ii receptor antagonist renal disease remains prevalent and progress in these patients. the newer therapy of diabetes is the use of sodium glucose cotransporter 2 inhibitor as it has the potential of renoprotection in patients with diabetic nephropathy just as acei and arbs to reduce glomerular hyperfilteration .this action may reduce albuminuria.

Eligibility criteria:
inclusion criteria: * adult patients with type 2 diabetes. * controlled diabetes. * patients with proteinuria exclusion criteria: * patients with proteinuria due to other disease. * patients with hba1c \>8%. * patients with uncontrolled hypertension. * patients with chronic liver disease. * patients with type 1 diabetes . * patients already on the same drug ( dapagliflozine). * patients with raised serum creatinine.

Keywords: proteinuria , sglt2 inhibitors , diabetes
mmrf molecular profiling protocol

Conditions: Multiple Myeloma; Plasma Malignancy

Summary: this protocol is now being used as screening for the mydrug study

here we propose an "integrative sequencing approach" utilizing a 1500 gene exome comparative analysis between multiple myeloma or related plasma cell malignancies and normal cells coupled to capture transcriptome sequencing to provide a nearly comprehensive landscape of the genetic alterations for the purpose of identifying informative and/or actionable mutations in patients with multiple myeloma and plasma cell malignancies. the approach will enable the detection of point mutations, insertions/deletions, gene fusions and rearrangements, amplifications/deletions, and outlier expressed genes among other classes of alterations.

Eligibility criteria:
inclusion criteria: 1. patients must have a diagnosis of multiple myeloma or related malignancy 2. patients are undergoing standard of care bone marrow aspirates 3. patients (male or female) from any race or ethnicity must be at least 18 years of age at the time of registration. 4. procedure-specific signed informed consent form prior to initiation of any study-related procedures. exclusion criteria: 1. it is the enrolling study physician's discretion to decide if a patient is not fit enough to undergo a bone marrow aspirate. 2. patients who are incarcerated are not eligible to participate. 3. women who are pregnant 4. patients who have had another malignancy within the last five (5) years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix) where there is a possibility to contaminate the bone marrow aspirate.

Keywords: genetic sequencing relapsed
oral nitrite in patients with pulmonary hypertension and heart failure with preserved ejection fraction

Conditions: Pulmonary Hypertension Secondary; Heart Failure

Summary: the main objective of this study is to determine the clinical efficacy of oral inorganic nitrite verses placebo and the therapeutic response with regards to exercise tolerance in patients with pulmonary hypertension and heart failure with preserved ejection fraction (ph-hfpef).

this is a single-center, 22-week double-blind, randomized placebo-controlled cross-over trial of oral nitrite on exercise capacity and hemodynamic measurements in subjects with ph-hfpef.

Eligibility criteria:
inclusion criteria: age 18 years and older ph-hfpef confirmed diagnosis by rhc: * mean pulmonary arterial pressure (mpap) ≥ 25 mmhg and * pulmonary capillary wedge pressure (pwcp) ≥ 15 mmhg and * transpulmonary gradient (tpg) ≥ 12 mmhg exclusion criteria: * age less than 18 years; * sbp \> 170 or \< 110 mmhg * dbp \>95 or \< 60 mmhg * hemoglobin a1c \> 10 * positive urine pregnancy test or breastfeeding; * ejection fraction (ef) \< 40%; * dementia * end-stage malignancy * major cardiovascular event or procedure within 6 weeks prior to enrollment * severe valvular disease * known chronic psychiatric or medical conditions that may increase the risk associated with study participation in the judgment of the investigator, would make the subject inappropriate for entry into this study; * smoker * hemoglobin \<9 g/dl * serum creatinine \> 3.0 mg/dl * receipt of an investigational product or device, or participation in a drug research study within a period of 15 days; rhc \< 2 weeks from study screening rhc unless clinically indicated
evaluation of a "flash-free" adhesive resin for orthodontic bracket bonding

Conditions: Malocclusion

Summary: the purpose of this study is to compare bonding time, bond survival, amount of adhesive remaining on the tooth surface after bracket debonding, and time required for adhesive remnant cleanup between a new "flash-free" and a conventional adhesive resin for orthodontic bracket bonding.

patients presenting for comprehensive orthodontic treatment with fixed appliances at the university of minnesota, who are willing to participate, will be included in the initial study. selection criteria will include full permanent dentition through the first molars, teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide, and no previous orthodontic treatment with fixed appliances. the patients will have their maxillary incisors, canines, and premolars bonded with ceramic orthodontic brackets pre-coated with a "flash-free" adhesive resin (clarity advanced brackets apc flash-free, 3m unitek, monrovia, ca, usa) on one side and a conventional adhesive resin (clarity advanced brackets apc ii, 3m unitek) on the other side. the side allocation and order of bonding will be randomized for each patient.

Eligibility criteria:
inclusion criteria: * full permanent dentition including incisors, canines, premolars, and first molars * teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide * no previous orthodontic treatment with fixed appliances exclusion criteria: * mental/emotional/developmental disability * cleft lip and/or palate, craniofacial anomaly, or syndrome * obvious oral hygiene issues such as excessive plaque accumulation, gingivitis, and/or pre-existing white spot lesions * prosthodontic or restored substrate extending on the labial surface of maxillary teeth * known allergies to any acrylates contained in the study materials
comparison of three laryngoscopes in difficult laryngoscopy

Conditions: Intubation; Difficult

Summary: tracheal intubation requires alignment of oro-pharyngeal-laryngeal axes. when these three axes are not aligned, intubation becomes difficult. in the researchers' study, the investigators simulated difficult laryngoscopy situation by using a rigid neck collar. this neck collar renders intubation difficult not only by restricting neck movement, but also reducing mouth opening. the investigators compared the performance of macintosh, maccoy and airtraq laryngoscope in simulated difficult laryngoscopy using a rigid neck collar.

airtraq laryngoscope is an optical laryngoscope which allows visualization of vocal cord as a reflected image through multiple lenses and prisms. maccoy laryngoscope is a modification of macintosh laryngoscope. it has a lever which, when pressed, moves its flexible tip. in the investigators' study, the researchers compared the performances of airtraq laryngoscope with maccoy and macintosh laryngoscopes in simulated difficult laryngoscopy using a rigid neck collar. the researchers recruited 120 patients and randomly divided those patients into three equal groups i.e. 30 patients in each group. these three groups are 1-airtraq, 2-maccoy and 3-macintosh. the researchers compared efficacy and safety in these three laryngoscopes. the researchers compared efficacy in terms of time of intubation, ease of intubation, overall success, intubation difficulty score, visualization of vocal cord in terms of pogo (percentage of glottic opening) score. the researchers compared safety in terms of hemodynamic pressor response and airway trauma.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i and ii. * posted for elective surgery requiring general anesthesia and tracheal intubation exclusion criteria: * patients with anticipated difficult airway * obese (body mass index (bmi)\>30) patients * patients with risk of pulmonary aspiration of gastric contents * pregnant patients * patients with airway distortion or trauma.
a study of mabthera (rituximab) in patients with rheumatoid arthritis who have had an inadequate response to a tnf-blocker.

Conditions: Rheumatoid Arthritis

Summary: this single arm study will evaluate the efficacy and safety of mabthera in patients with active rheumatoid arthritis whose current treatment with one or more tnf blocker had produced an inadequate response. patients will receive mabthera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). the anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * diagnosed ra for \>=3 months prior to first administration of study medication; * inadequate response or intolerance to \>=1 anti-tnf therapies, alone or in combination with methotrexate; * if using nsaids, analgesics or oral corticosteroids, must be on a stable dose for \>=2 weeks prior to start of study. exclusion criteria: * other chronic inflammatory diseases; * use of parental corticosteroids within 4 weeks prior to screening; * severe heart failure, or severe, uncontrolled cardiac disease.
evaluation the treatment of nonunion of long bone fracture of lower extremities (femur and tibia) using mononuclear stem cells from the iliac wing within a 3-d tissue engineered scaffold

Conditions: Nonunion of Fracture

Summary: because the rate of non union of long bone in lower extremities specially in tibia in this two last decade due to malnutrition and smoking and other risk factors was increased, so many patient in our country suffer from non union. on the other hand it seems that the use of the mesenchymal stem cells can irritate the union rate. also for better result we used the mesenchymal stem cells with bmp2 in collagenic scaffold. the collagen has a osteoconductive effect and bmp2 and stem cells has a osteoinductive effect therefore this combination is useful in filling the gap in non union site and irritate the union rate. mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure. then the investigators will follow the patient with monthly radiography and evaluate the callus volume and clinical union and any side effect of this treatment. clinical union consider to relief pain in non union site and be stable in examination.


Eligibility criteria:
inclusion criteria: * every patient with non union in the site of long bone fracture * age more than 18 and under 60 years old * fracture having no radiological callus after 6 months and absence of any hypertrophic bone reaction. * no infection in site of surgery * be able and willing to participate in the study * written informed consent exclusion criteria: * evidence of malignancy * pregnancy or breastfeeding * patient positive by serology or pcr for hiv, hepatitis b or c infection the patient with accompanied fracture such as hip fracture that could not weight bearing

Keywords: nonunion mesenchymal stem cell scaffold bmp2 long bone
phase 2a obesity study of oral doses of oleoyl-estrone (mp-101)

Conditions: Obesity

Summary: the purpose of this study is to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day cycles of escalating oral doses of mp 101 in 100 obese adult subjects.


Eligibility criteria:
inclusion criteria: * be a male or female between the ages of 18 and 65 years, inclusive * female subjects must be either surgically sterile or at least 2 years postmenopausal * have a bmi of 27 - 38.9, inclusive * have a stable weight for the past 30 days per subject report * be otherwise healthy and have an acceptable medical history * have negative urinalysis test results for drugs of abuse and alcohol * have the ability to understand the requirements of the study, have provided written informed consent and agree to abide by the study restrictions * exhibit stable behavior patterns with regard to smoking and exercise * subject who has at least one factor of the metabolic syndrome exclusion criteria: * be pregnant or nursing * have taken exclusionary medication in the past 30 days * have any clinically significant abnormal laboratory test as determined by the investigator * have a clinically significant illness during the 30 days before enrollment * have a history of testing positive for hepatitis b virus, hepatitis c virus, or hiv * have a confirmed diagnosis or history of cancer, with the exception of nonmelanoma skin cancer * have a previous diagnosis of diabetes * be otherwise unsuitable for the study, in the opinion of the investigator * have an allergy to safflower seeds or its byproducts (e.g., safflower oil) * have any postmenopausal bleeding within the last 6 months * have been involved in a formal or informal (self-imposed) diet regimen within the last 30 days * currently working night shifts * have a history of known multiple miscarriages
movement visualization in pain management in patients with hemophilic arthropathy.

Conditions: Haemophilia

Summary: background. the recurrence of hemarthrosis in patients with hemophilia favors the development of a progressive, degenerative intra-articular lesion (hemophilic arthropathy). pain is one of the main clinical manifestations of this arthropathy. objective. assess the safety and efficacy of a pain intervention by visualizing movement using an augmented reality mobile application and immersive 360º video, regarding the frequency of bleeding and the improvement in pain perception and quality of life, joint condition , strength and functionality in patients with hemophilic arthropathy. study design. randomized, multicenter, single-blind clinical study. method. 70 patients with hemophilia a and b will be recruited in this study. the patients will be recruited in 5 regions of spain. the 8 dependent variables will be: frequency of bleeding (self-registration), pain (measured with the visual analog scale and pressure algometer, tampa scale of kinesiophobia and pain catastrophizing scale), quality of life (sf-12 scale), anxiety (questionnaire of anxiety status-trait-stai), joint status (hemophilia joint health score scale), muscle strength (dynamometer) and functionality (6-minutes walking test, quick disabilities of the arm, shoulder and hand). three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 6 months. expected results. to observe the efficacy of the visualization of movement in the characteristics of pain, and its implication in the functionality, joint state, muscular strength and the perception of quality of life in patients with hemophilic arthropathy.


Eligibility criteria:
inclusion criteria: * patients diagnosed with hemophilia a and b * patients with a medical diagnosis of hemophilic arthropathy and pain * people over 18 years of age * patients on prophylactic or on-demand treatment regimen with fviii / fix concentrates exclusion criteria: * patients with neurological or cognitive disorders that impede understanding of the questionnaires * pain free patients * amputees, epileptics or patients with severe vision problems * patients who are receiving physiotherapy treatment at the time of the study * patients who have not signed the informed consent document

Keywords: hemophilic arthropathy educative intervention pain quality of life anxiety stress
the effect of taichi on ischemic burden of patients with coronary heart disease complicated with renal insufficiency

Conditions: Coronary Heart Disease (CHD); Renal Insufficiency

Summary: this study focuses on patients with incomplete revascularization combined with renal insufficiency. and since heart and kidney are two organs influence each other, the study take the mechanism of heart and kidney comorbidity and the risk factors of the two organs.as one of the traditional chinese sports, tai chi is an aerobic exercise combineing movements with static postures, which can significantly improve the aerobic endurance of patients with coronary heart disease. in this study, a parallel, randomized controlled study method is used to quantitatively evaluate the myocardial ischemia condition by myocardial perfusion imaging indicators. this study aims to figure out whether the cardiac rehabilitation training program based on tai chi has a positive effect on the patients' myocardial ischemic.


Eligibility criteria:
inclusion criteria: 1. 30-75 years old, all genders; 2. at least two main vessels or their main branch vessels have obvious stenosis (≥50%) according to the coronary angiography; 3. received stent implantation and incomplete revascularization (incomplete revascularization: at least one vessel whose a diameter\> 2.0 mm and at least one lesion with a stenosis\> 50%, after pci); 4. egfr\<60ml/min·1.73m2; 5. willing to be treated and followed-up during the specified time of the study; 6. signed the informed consent approved by the ethics committee exclusion criteria: 1. patients with high-risks according to the exercise rehabilitation risks of patients with heart disease by aacvpr; 2. severe cardiac insufficiency or cardiogenic shock; 3. combined with severe ventricular arrhythmia, icd is required; 4. combined with severe pulmonary hypertension, chronic obstructive pulmonary disease, severe infectious disease, blood system disease, malignant tumor, severe liver damage, etc.; 5. nervous, mental and motor system diseases; 6. unwilling to be followed-up.

Keywords: chd pci tai chi renal insufficiency cardiac rehabilitation
the efficacy of the hiv/aids symptom management manual

Conditions: HIV; Acquired Immunodeficiency Syndrome

Summary: the goals of this research are: 1) to test the efficacy of a self-care symptom management manual by examining whether people who use the manual find it to be useful; 2) to examine symptom and demographic data related to self-care behaviors, symptom control, medication adherence and enhanced quality of life. the university of california, san francisco is the coordinating site for this multi-site international study.

people living with hiv/aids encounter many psychological, physiological, and cognitive symptoms, such as pain, diarrhea, fever, fatigue, depression, and confusion. these symptoms have been found to restrict a person's daily life significantly. self-management of multiple hiv and medication side effects symptoms and maintaining optimal quality of life have, therefore, become major daily tasks for people living with hiv/aids. this study is a randomized controlled trial with a two-group repeated measures design to test the efficacy of the symptom management manual. two groups (experimental and control) will be assessed in a repeated measures design at 3 time points: baseline (time 0), one month (time 1), and two months (time 2). data will be analyzed using longitudinal mixture modeling. comparison(s): hiv-positive patients receiving a symptom management manual and orientation to the manual, compared to hiv-positive patients receiving a nutrition manual and orientation to the manual.

Eligibility criteria:
inclusion criteria: * diagnosed hiv/aids * adult (men and women, transgender) * presence of at least one symptom within the past week * consent * may or may not be pregnant * may or may not be on art * able to use the manual with or without family support exclusion criteria: * documented diagnosis of dementia * unable to understand consent procedure as judged by the person getting consent * self-reporting no symptoms within the past week * self-reports having had experience with a self-care symptom management manual

Keywords: signs and symptoms self care patient compliance quality of life