Kornimate/medical-research-clean huggingface dataset:
combined replacement therapy with levothyroxine and liothyronine in thyroidectomized patients

Conditions: Hypothyroidism

Summary: the aim of the study is to evaluate the peripheral tissue response to the combined administration of levothyroxine (lt4) and liothyronine (lt3) in hypothyroid patients with residual thyroid function virtually absent (thyroidectomized). cases will be treated with lt4+lt3, at personalized doses according to clinical guidelines and respecting the circadian rhythmicity of lt3 and the physiological t3/t4 ratio. controls will be treated with lt4 and placebo. treatment duration: 24 weeks. the primary endpoint will be the peripheral effect of thyroid hormones. the secondary endpoints are bone and metabolic modifications, and changes in quality of life. moreover any changes of outcomes related to polymorphisms of genes involved in thyroid hormones metabolism will be evaluated.


Eligibility criteria:
inclusion criteria: * older than 18 years * capable of consent * able to fill in a questionnaire in italian * thyroidectomized * serum thyroglobulin levels below 0.2 ng/ml and antibodies anti-thyroglobulin undetectable (below normal range) * well treated taking stable doses of levothyroxine in tablets, in the previous 3 months exclusion criteria: * tsh suppressive therapy * pregnancy * cardiac arrhythmias * severe liver, kidney or bone diseases * ongoing steroids treatment * ongoing or in the previous 12 months treatment with bone anti-resorptive, amiodarone, colestyramine or iron.

Keywords: thyroid levothyroxine combined therapy
multimodal intervention in allogeneic stem cell transplantation

Conditions: Allogeneic Stem Cell Transplantation; Leukemia

Summary: objective: to evaluate the feasibility and safety of a 4-6 weeks exercise - psycho-educational intervention in patients undergoing allogeneic stem cell transplantation (allo-hcst). the intervention included structured and supervised exercise, relaxation and psycho-educational components. it was hypothesized that the intervention would minimize loss of physical capacity during hospitalization.


Eligibility criteria:
inclusion criteria: * 18-65 yrs * patients undergoing allogeneic stem cell transplantation exclusion criteria: * recent cardiovascular or pulmonary disease * abnormal ekg * psychiatric disorder * motor function, musculoskeletal or neurological disturbances * bony metastasis

Keywords: patients undergoing allogeneic stem cell transplantations
the assessment of copper parameters in wilson disease participants on standard of care treatment

Conditions: Wilson Disease

Summary: this was a 24-month study to assess copper parameters in participants with wilson disease (wd) treated with standard of care (soc) medications. after providing informed consent, participants meeting all inclusion and no exclusion criteria were enrolled into the study as outpatients. the participants' routine clinic visits were scheduled according to the standard clinical practice at the study center and at the discretion of the treating physician at approximate 6-month intervals. at the time of enrollment, participants were receiving soc medications for the treatment of wd, which could include penicillamine, trientine, zinc, or a combination of a copper chelator and zinc. if treatment was interrupted or stopped during the course of the study, participants continued in the study and biological samples and clinical data were continued to be collected for the full 24-month study period. dosing with soc agents was individualized and managed by the treating physician at the study center according to standard clinical practice at the site.


Eligibility criteria:
inclusion criteria: * willing and able to give informed consent for participation in the study. * male or female participants, aged 18 years or older as of signing the informed consent form. * receiving soc medications (penicillamine, trientine, zinc, or copper chelators with zinc) for the treatment of wd at the time of enrollment and for no more than 60 months prior to enrollment. * able to understand and willing to comply with study procedures and requirements, as judged by the investigator. * established diagnosis of wd. * adequate venous access to allow for collection of blood samples. exclusion criteria: * major systemic disease or other illness that would, in the opinion of the investigator, compromise participant safety or interfere with the collection or interpretation of study results. * in the opinion of the investigator, the participant was likely to be non-compliant or uncooperative during the study.
berberine and altered fasting glucose

Conditions: Glucose Metabolism Disorders

Summary: the aim of the study was to evaluate the effectiveness of a food supplement, berberine phytosome, which contributes to the control of blood sugar and the improvement of insulin resistance.


Eligibility criteria:
inclusion criteria: * fasting blood glucose range:100-125 mg/dl exclusion criteria: * diabetes mellitus
overuse injuries in road cyclists, prevalence and prevention

Conditions: Overuse Injuries

Summary: the purpose of this study is to investigate the prevalence of overload injuries to road cyclists in sweden, and if it 's possible to prevent low back pain by a simple exercise program for two months of training .


Eligibility criteria:
inclusion criteria: * planning to ride "vätternrundan 2014" in a subgroup . * cycled "vätternrundan" at least twice in the past or bicycled for exercise at least 800 mil ( the equivalent of two seasons) . * age 18-55 years . * training cycle at least three hours a week or three days a week . exclusion criteria: * do not have access to a computer.
modafinil in treating fatigue in patients with cancer

Conditions: Cognitive/Functional Effects; Depression; Fatigue; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: modafinil may help relieve fatigue and improve quality of life in patients with cancer. purpose: this clinical trial is studying how well modafinil works in treating fatigue in patients with cancer.

objectives: primary * determine the safety of modafinil in cancer patients. * determine the efficacy of this drug, in terms of improving fatigue, in these patients. secondary * determine the efficacy of this drug, in terms of improving mood, cognitive ability, functional status, and quality of life, in these patients. outline: this is a nonrandomized, pilot study. patients receive oral modafinil once daily for 4 weeks in the absence of disease progression or unacceptable toxicity. patients may receive additional modafinil at the discretion of the physician. fatigue, mood, cognition, functional status, and quality of life are assessed at baseline and in weeks 2 and 4. after completion of study treatment, patients are followed at 30 days. projected accrual: a total of 26 patients will be accrued for this study within 9 months.

Eligibility criteria:
disease characteristics: * diagnosis of cancer * brief fatigue inventory score ≥ 4 patient characteristics: age * 18 and over performance status * ecog 1-3 life expectancy * at least 2 months hematopoietic * not specified hepatic * not specified renal * not specified cardiovascular * no history of left ventricular hypertrophy * no history of ischemic ecg changes * no history of chest pain * no history of arrhythmia * no history of other clinically significant manifestations of mitral valve prolapse in association with cns stimulant use other * not pregnant or nursing * negative pregnancy test * thyroid stimulating hormone normal * no known hypersensitivity to modafinil * no history of psychotic disorder and/or active psychosis * no history of any chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation or compliance prior concurrent therapy: biologic therapy * concurrent thalidomide allowed chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified other * concurrent narcotics, phenothiazines, or benzodiazepines allowed * no other concurrent investigational therapy

Keywords: depression cognitive/functional effects fatigue unspecified adult solid tumor, protocol specific
clinical application of image-guided liver surgery

Conditions: Hepatocellular Cancer

Summary: image-guided surgery is a new technology, which is used to create 3-d pictures that generate a map of the liver. this map will allow surgeons to know the exact anatomical location of their instruments, including instances when direct visualization is not possible. this study is designed to determine the safety and feasibility of using image-guided techniques for treatment of liver tumors. the overall goal of this study is to use image-guided surgery for the improvement of the surgeon's ability to remove liver tumors.


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained. * patient must be 18 years or older. * are male or non-pregnant, non-lactating females. liver resection or ablation could be harmful to an unborn child therefore, is not recommended during pregnancy. after informed consent is obtained, women of childbearing potential will be required to have a blood or urine pregnancy test. all consented patients of childbearing potential will be advised to use adequate birth control (oral, implanted, or barrier methods) along with their sexual partners while being considered for liver tumor resection or ablation and at least up to a month following surgery. * patients enrolled in phase i must be candidates for surgical liver resection per a treating surgeon's discretion. patients enrolled in phase 2-3 must be candidates for surgical liver resection of liver mass. patients enrolled in phase 4 must be candidates for surgical ablation, but not candidates for surgical resection. * patients are scheduled clinically for use of the pathfinder explorer liver image guided system which is indicated for open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia. exclusion criteria: * any condition which, in the judgment of the investigator, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study. * mental condition rendering the subject or his/her legal representative unable to understand informed consent to the nature, scope, and possible consequences of the study.

Keywords: image guided liver surgery
comparing 3 imaging systems

Conditions: Diabetic Retinopathy

Summary: the purpose of this study is to evaluate the quality of ocular images captured on 3 different cameras of patients with diabetic retinopathy. the study will determine whether diabetic retinopathy assessment is comparable between the cameras. the research is being done to see if a camera takes higher quality pictures over the other cameras. 60 participants will be enrolled into this study. participants need to have diabetic eye disease. this is a one-time study visit that lasts approximately 1 hour.


Eligibility criteria:
inclusion criteria: * any race * established diagnosis of diabetes. * willing to participate as evidenced by signing the written informed consent. exclusion criteria: * unable to tolerate ophthalmic imaging. * ocular is media not sufficiently clear to obtain technically acceptable ultrawide field images. * history of panretinal laser photocoagulation or vitrectomy (history of anti-vascular endothelial growth factor treatment is not an exclusion criteria). * presences of confounding abnormalities such as age-related macular degeneration, retinal vein occlusion.
discontinuation of levothyroxine therapy for patients with subclinical hypothyroidism

Conditions: Subclinical Hypothyroidism

Summary: the investigators propose the following hypothesis: discontinuation of levothyroxine (lt4) for veterans with subclinical hypothyroidism (sch) will be feasible, acceptable, and safe and will not negatively affect their quality of life (qol). the investigators aim to evaluate the feasibility of lt4 discontinuation among veterans with sch and determine the changes in qol measures, lipids, and adverse events.

this is a pilot, randomized, double-blind, placebo-controlled trial. methodology: the investigators will conduct a double-blind, placebo-controlled clinical trial where eligible veterans diagnosed with sch and on lt4 will be 1:1 randomized to either continue lt4 or change to placebo. the primary outcome is intervention feasibility (willingness to enter the trial, recruitment rate, and completion rate). secondary outcomes are: 1) changes in qol measures (hypothyroid symptom \[hss\] and tiredness scale scores of the thyroid-specific patient-related outcome measure \[thypro\], euroqol 5-dimension self-report questionnaire) measured at baseline, 6-8 weeks and 6 months and 2) changes in lipids assessed at baseline and 6 months, and 3) incidence of adverse events (overt hypothyroidism, hyperthyroidism, atrial fibrillation, fractures, acute myocardial infarction, stroke, acute coronary syndrome, heart failure, mortality).

Eligibility criteria:
inclusion criteria: * veterans * diagnosis of sch exclusion criteria: * thyroid-stimulating hormone (tsh) \> 10 milli-international units per liter (mlu/l) (at any point) * levothyroxine (lt4) dose more than 75 mcg daily * use of antithyroid medications, amiodarone, tyrosine kinase inhibitors or lithium * history of thyroidectomy or radioactive iodine therapy * lt4 suppressive therapy for thyroid cancer, goiter, or inflammation * pregnancy or plans for pregnancy in the next 6 months * an unstable medical condition that would jeopardize safety or interfere with study participation * severe hypothyroidism-related symptoms * strong family history of hypothyroidism * severe dyslipidemia * hospitalization for major illness within the previous 4 weeks * acute coronary artery syndrome, acute myocarditis, or pancarditis with the previous 12 months * grade iv new york heart association heart failure * receiving services from hospice * lack of decision-making capacity * terminal medical condition for which life expectancy would be less than 6 months * not willing to stop lt4 * self-reported non-adherence to lt4 therapy * abnormal tsh at time of screening for participation (assessed during baseline visit)
safety and efficacy of low-dose sirolimus to kaposiform hemangioendothelioma

Conditions: Hemangioma; Kaposiform Hemangioendothelioma

Summary: to evaluate the safety and efficacy of low-dose sirolimus in kaposiform hemangioendothelioma in chinese children by a prospective, randomized open trial.

the clinically commonly used dose of sirolimus for kaposiform hemangioendothelioma is 0.8 mg/m2 administered twice daily, and the blood concentration can be maintained at 10-15 ng/ml according to the pharmacokinetic formula.related research reports that maintaining low blood concentration of sirolimus is effective in the treatment of certain vascular malformations and hemangioma, and complications are less. in the clinical practice, we found that the blood concentration was maintained at 7-10 ng/ml, and the patients still achieved good results and the chance of infections decreased. therefore, this clinical trial was designed.in this trial, two different dosing regimens with corresponding blood concentration were designed to compare the safety and efficacy.in the high concentration group, the sirolimus dosage was adjusted monthly to achieve trough levels between 10 and 15 ng/ml(excluding 10 ng/ml), and it is still used at 0.8 mg/m2 administered twice daily.the low concentration group is 7-10 ng/ml (including 10 ng/ml), and the initial use of sirolimus is 0.7mg/m2 administered twice daily.the dose was adjusted according to the formula after two weeks.the follow-up and evaluation were performed according to a strictly established follow-up schedule after taking the drug.

Eligibility criteria:
inclusion criteria: * kaposiform hemangioendotheliomas with or without kasabach-merritt phenomenon. * 0 - 12 years of age at the time of study entry. * male or female. * consent of parents (or the person having parental authority in families): signed and dated written informed consent. exclusion criteria: * with hematological diseases. * with other solid tumors. * with hypertension, diabetes, adrenal insufficiency, neurological diseases, liver and kidney dysfunction, and cardiopulmonary insufficiency. * with tuberculosis,cytomegalovirus and epstein-barr virus infection before the treatment.

Keywords: kaposiform hemangioendothelioma kasabach-merritt syndrome sirolimus rapamycin
randomized, double-blind, placebo-controlled, safety and tolerability study of iti-214 in patients with heart failure

Conditions: Heart Failure, Systolic

Summary: this is a phase i/ii randomized, double-blind, placebo-controlled, single rising dose study in patients with systolic heart failure to evaluate the safety and tolerability of iti-214.


Eligibility criteria:
inclusion criteria: * nyha class ii-iii heart failure * ejection fraction equal to or below 35% * on stable heart failure drug treatment exclusion criteria: * considered medically inappropriate for study participation
clinical trial to evaluate the safety and efficacy of dwn12088 in patients with ipf

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of dwn12088 in patients with idiopathic pulmonary fibrosis.

this is randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of dwn12088 in patients with idiopathic pulmonary fibrosis.

Eligibility criteria:
inclusion criteria: * male or female patients aged ≥40 years based on the date of the written informed consent form * diagnosis of ipf as defined by american thoracic society/european respiratory society/japanese respiratory society/latin american thoracic association guidelines * in a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ecg, and laboratory evaluation * patients receiving local standard-of-care for ipf, defined as either pirfenidone or nintedanib, at a stable dose for at least 3 months prior to screening, or neither pirfenidone nor nintedanib. if the patients were on pirfenidone or nintedanib previously and have been off for at least 3 months prior to screening, they will be considered as not on any treatment for ipf * meeting all of the following criteria during the screening period: * fvc ≥40% predicted of normal * dlco corrected for hgb ≥25% and ≤80% predicted of normal. * forced expiratory volume in the first second/fvc (fev1/fvc) ratio ≥0.7 based on pre-bronchodilator value exclusion criteria: * acute ipf exacerbation within 6 months prior to screening and/or during the screening period * patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study * female patients who are pregnant or nursing * abnormal ecg findings * use of any investigational drugs for ipf within 4 weeks prior to screening
data collection from the cardiacsense1 and other modalities for developing a system for monitoring of respiratory rate

Conditions: Respiratory Disease

Summary: collect data from the cardiacsense1's sensors and capnograph, for the purpose of developing a wearable system for monitoring of respiratory rate (rr) in patients while at hospital

hospitalized subjects, diagnosed with a respiratory disease or subjects with no known respiratory disease will be will be connected simultaneously to cardiacsense watch and capnograph for a duration of at least 30 minutes and up to 24 hours in order to collect data for the purpose of developing a wearable system for monitoring of respiratory rate (rr) by the cardiacsense watch. the cardiacsense1 is a wrist worn device designed to detect atrial fibrillation. cardiacsense1 senses the radial artery inflation and deflation and together with a ppg sensors give an ultimate performance that is superior to ppg only.

Eligibility criteria:
inclusion criteria: * age of eighteen (18) year and above * diagnosed with respiratory disease/impairment or without any known respiratory disease/impairment * ability and willingness to sign an informed consent form exclusion criteria: * subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study * patients with significant co morbidities (assessed by the clinician at screening only * bmi\>40 * presence of an acute disease process that might interfere with test performance * subjects with ppg snr \<100 indicated by the cardiacsense1 device * women who are pregnant or breastfeeding

Keywords: respiratory rate
inspiratory muscle training combined with general exercise training in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is a frequent disease, with increasing prevalence. pulmonary rehabilitation through general exercise training (get) is a corner stone of copd care. inspiratory muscle training (imt) as a stand-alone therapy decreases dyspnea and improves exercise capacity. whether imt combined with get adds a supplementary benefit in the rehabilitation of copd patients is however uncertain.

prospective, parallel-group, randomized controlled trial 80 copd patients will be randomized into two groups. one group will receive general exercise training combined with inspiratory muscle training, 3 times a week, for a total of 36 sessions. the other group will receive general exercise training combined with shame inspiratory muscle training, 3 times a week, for a total of 36 sessions. we will assess the difference of improvement in exercise capacity between the 2 groups with the 6 minute walking test. we will also assess the difference of improvement in quality of life with st-george's respiratory questionnaire. finally the difference of improvement in maximal inspiratory pressure will be determined. patients and investigators assessing the outcomes will be blinded to group allocation. written informed consent will be obtained from each subject. the data will be treated anonymously.

Eligibility criteria:
inclusion criteria: * copd demonstrated by spirometry using gold criteria * patient referred by a pneumologist to the ambulatory pulmonary rehabilitation program at the riviera-chablais hospital, monthey * patient with maximal inspiratory pressure \< 60 cmh20 * patient older than 40 years exclusion criteria: * orthopaedic or neurological troubles that could slant the 6 minute walking test

Keywords: inspiratory muscle training general exercise training pulmonary rehabilitation chronic obstructive pulmonary disease
treatment of unstable trochanteric fracture: a comparative study between dhs and dhs with trochanteric stabilization plate

Conditions: Trochanteric Fractures

Summary: compare the results in treatment of unstable trochanteric fracture by using dhs and dhs with trochanteric stabilizing plate as regard shaft medialization.neck shaft angle measurment and shaft migration


Eligibility criteria:
inclusion criteria: * pateints with comminution of medial femoral cortex and loss of continuity of lesser trochanter exclusion criteria: * stable trochanteric fracture subtrochanteric extension reverse oblique trochanteric fracture