Kornimate/medical-research-clean huggingface dataset:
study of dose adjustment from levothyroxine to a new levothyroxine sodium test formulation

Conditions: Hypothyroidism

Summary: the purpose of this study is to investigate the effect of switching participants taking levothyroxine to a new sodium formulation.

the drug being tested in this study is a new sodium formulation of levothyroxine. levothyroxine (l-thyroxine christiaens®) is used in the treatment of hypothyroidism. this study will investigate the effect of switching subjects taking levothyroxine to a new levothyroxine sodium formulation. the results of this study will be used to provide instructions to general practitioners and endocrinologists assisting patients on levothyroxine hormone substitution in performing the switch to the new formulation. the study will enroll approximately 90 patients. patients receiving the same daily dose of l-thyroxine christiaens® during the past 6 weeks and with serum thyroid stimulating hormone (tsh) levels between 0.4-2.5 mu/l will be switched to the equivalent daily dose of the new formulation of levothyroxine. after the switch, patients will be followed up after 2 (± 2 weeks) and 4 months (± 4 weeks). all participants will be asked to take a daily dose at the same time each day throughout the study. this study will be conducted in belgium. participants will make 3 to 4 visits to the clinic.

Eligibility criteria:
inclusion criteria: 1. (near) total thyroidectomised patients. 2. aged 18 years and older. 3. stabilised on the same daily dose of l-thyroxine christiaens® during the last 6 weeks before inclusion in the study. 4. written informed consent given. 5. able and willing to comply with protocol requirements and to complete the study. exclusion criteria: 1. history of graves' disease or positive tsh-receptor antibodies. 2. history of thyroid cancer requiring tsh suppression. 3. medical procedures or treatments planned that could influence the thyroid hormone state of the patients during this trial. 4. use of levothyroxine containing medicines provided by other brands to treat hypothyroidism. 5. pregnant or planning pregnancy. female patients of childbearing potential need to apply highly effective methods of birth control. 6. participation in another trial in the past 6 weeks. 7. exclusion criteria during the study are the occurrence of any serious adverse reaction, any laboratory or clinically relevant change in patient status, any change in smoking status, use of drugs non-authorized by the physician (to avoid relevant drug interactions) and lack of patient compliance with the study drug. (or events not considered as exclusion criteria but to be documented in the case report form, as a possible explanation for change in lab parameters and/or dose switch).

Keywords: drug therapy
questionnaire regarding the effect of wearing face masks on oral health

Conditions: Dry Mouth; Halitosis

Summary: during the current covid-19 pandemic, the use of face masks is recommended / mandatory to prevent infection. patients and students have reported to experience limitations in their oral health-related quality of life, especially with regard to the occurrence of dry mouth and halitosis, while wearing face masks. scientific studies regarding the effects of face masks have so far focused exclusively on medical staff. studies among the general population are not yet available, but are of interest as dry mouth is a risk factor for dental diseases (e.g., caries, erosion). therefore, the present study aims at performing a questionnaire survey regarding self-perceived dry mouth and halitosis and the use of face masks (type, wearing time).


Eligibility criteria:
inclusion criteria: * patients, visitors, and staff members of the university medical center goettingen exclusion criteria: * n/a
infectivity of norovirus in groundwater-human challenge study

Conditions: Healthy

Summary: norwalk virus and related "norwalk-like viruses" are the most common cause of outbreaks of stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the united states. these viruses are sometimes found in drinking water, ice, shellfish and in other foods. they can be spread easily from contact with water, food, objects or hands that have even small amounts of feces from someone who was sick. the purpose of this research study is to see how long norwalk virus can survive in water and still be able to cause sickness. when this is determined the researchers will be able to recommend risk levels for norovirus contaminated waters. another purpose for this study is to see how a person's body's immune cells respond to norwalk virus in the body. during this study volunteers will receive a dose of norwalk virus in water that may make them sick.


Eligibility criteria:
inclusion criteria: * normal healthy volunteer * must be within 33% of normal body mass index exclusion criteria: * have a job in which they handle food * work in a child care, elderly care center or if they live with young children or anyone who has a weak immune system * are not willing or able to wash their hands every time after they go to the bathroom, or before and after they prepare or handle food for up to eight days after they take the virus * are over the age of 50 * are pregnant * have tested positive for the hiv virus

Keywords: norovirus gastroenteritis clinical trial stomach flu
clinical comparison of patients with transthyretin cardiac amyloidosis and patients with heart failure with reduced ejection fraction

Conditions: Transthyretin Amyloid Cardiomyopathy; Heart Failure

Summary: clinical comparison of patients with transthyretin cardiac amyloidosis and patients with heart failure with reduced ejection fraction


Eligibility criteria:
inclusion criteria: * age \>65 * attrwt diagnosis for patients, either with dpd-scintigraphy or myocardiac biopsy * informed consent exclusion criteria: * alder \<65 * no attrwt diagnosis

Keywords: heart failure echocardiography
glycaemic load and pre-meal insulin doses in type 1 diabetes patients

Conditions: Type 1 Diabetes

Summary: the aim of this study is to compare the feasibility and the efficacy on short-term glucose control of pre-meal insulin doses adjustment made on the bases of the glycemic load or of the carbohydrates content of the meal in patients with type 1 diabetes mellitus treated with insulin pump


Eligibility criteria:
inclusion criteria: * type 1 diabetes treated by insulin pump exclusion criteria: * preganncy * hba1c \> 9% * any serious acute or chronic illness a part diabetes
relation between vasovagal tendency and smoking among university students

Conditions: Vasovagal Syncope; Smoke Inhalation

Summary: almost everyone is aware these days is aware about the risk of smoking. still many people start this habit specially in early life and during college year. we aim to investigate in this study if there is a drive to smoke in people with vasovagal tendency to improve their symptoms, even if not aware of this. vasovoagal symptoms are common and include dizziness, smoking, sweating, abdominal pain, fatigue and syncope. some studies have shown correlation between smoking and a positive tilt table test which is indicative of vasovagal tendency. by collecting the information regarding smoking habit and vasovagal symptoms analysis can be done to see if there is correlation between these two factors

methods a questionnaire will be conducted among university students to investigate the tendency toward vasovagal symptoms and also smoking habits. statistical correlation will be subsequently conducted to see if there is correlation between those two problems (vasovagal symptoms and smoking) study criteria inclusion benefit to the patient: there is no direct benefit for participation in the study. the information obtained may help in the future to find factors that increase smoking and being aware of these factors may help in controlling the habit of smoking.

Eligibility criteria:
inclusion criteria: * college students who agree to participate in the questionnaire exclusion criteria: * unable or does not consent to fill the form
radial, sequential compression device deep venous thrombosis detection study

Conditions: Deep Venous Thrombosis

Summary: the purpose of this study is to evaluate the effectiveness of a new leg compression device in preventing post-surgical deep vein thrombosis (blood clot) that can occur after major and complex spine surgery. the investigators aim to show that this new compression device is no worse than the standard sequential compression device (scd) at preventing dvt and may be able to detect deep vein thrombosis in patients who are not typically screened for this diagnosis after surgery. this new device may be able to capture an important post-surgical complication while providing a more comfortable treatment option.

compression therapy of the leg is a proven and well-established modality to prevent deep vein thrombosis in immobilized and post-surgical patients. the investigators aim to compare a new sequential compression for the leg that utilizes a servo motor for compression as opposed to a traditional pneumatic motor that is typically used in the hospital and after surgery. pneumatic sequential compression devices are cumbersome, expensive and not mobile. this new compression device was developed to provide a cheaper, mobile device that can be worn by the patient after surgery and while at home during ambulation. the addition of the servo motor and fine sensors may also be able to detect sub-clinical dvt's that contribute to post-surgical pulmonary embolus and post-surgical complications. the investigators aim to learn how this new device performs in the subset of patients undergoing complex spine surgery, the incidence of post-surgical dvt with this new device compared to traditional scd and if this new device is capable of detecting sub-clinical post-surgical dvt.

Eligibility criteria:
inclusion criteria: * patients scheduled for complex spine surgery at stanford hospital exclusion criteria: * pregnancy * non-decisional capacity * incarcerated persons * any hereditary or acquired coagulopathy
investigation of quality of life in adolescent idiopathic scoliosis

Conditions: Adolescent Idiopathic Scoliosis

Summary: the aim of our study is to identify independent predictors of quality of life in ais.

adolescent idiopathic scoliosis (ais) is the lateral and horizontal deformity of the columna vertebralis which occurs idiopathically in adolescence ages. the aim of this study is to identify independent predictors of quality of life in ais

Eligibility criteria:
inclusion criteria: * volunteered for the study participants were diagnosed with adolescent idiopathic scoliosis, * between ages 10-18 * cobb angle between 10-30 degrees * lenke curve type 1 exclusion criteria: * non-idiopathic scoliosis, * who had exercise contraindications * who had previous spinal surgery * who had orthotic treatment for scoliosis before * who had exercise contraindications * who had another neuromuscular * who had cardiopulmonary and rheumateulogical problem
effect of amr101 (ethyl icosapentate) on triglyceride (tg) levels in patients on statins with high tg levels (≥ 200 and < 500 mg/dl)

Conditions: Hypertriglyceridemia

Summary: the primary objective is to determine the efficacy of amr101 (ethyl icosapentate) compared to placebo in lowering high fasting triglyceride levels in patients with high risk for cardiovascular disease and fasting triglyceride levels ≥ 200 and \< 500 mg/dl.


Eligibility criteria:
inclusion criteria: * men and women, ages \>18 * fasting triglyceride ≥200 mg/dl and \<500 mg/dl * ldl-c (low density lipoprotein - cholesterol) ≥40 mg/dl and \<100 mg/dl * high risk for coronary heart disease * on stable dose of statin (atorvastatin, rosuvastatin or simvastatin) * provide written informed consent and authorization for protected health information disclosure exclusion criteria: * women who are pregnant or lactating, or planning to become pregnant * use of non-statin lipid-altering drugs which cannot be stopped including fibrates, niacin, fish oil and other products containing omega-3 fatty acids or other dietary supplements with potential lipid-altering effects * history of bariatric surgery or currently on weight loss drugs * uncontrolled hypertension (bp \> 160/100) * hiv infection or on treatment with hiv-protease inhibitors, cyclophosphamide,or isotretinoin * consumption of more than 2 alcoholic beverages per day * history of cancers (except if been disease free for \>5 years or history was basal or squamous cell skin cancer) * participation in another clinical trial involving an investigational agent in the last 30 days * other parameters will be assessed at the study center to ensure eligibility for this study.

Keywords: hypertriglyceridemia omega-3 fatty acids statin triglycerides lipids epa docosahexaenoic acid fish fatty acids fibrates niacin lipid atorvastatin lovaza simvastatin lovastatin pravastatin fluvastatin rosuvastatin trilipix vytorin simcor niaspan ezetimibe zetia ethyl-epa ethyl icosapentate crestor zocor lipitor ldl hdl cholesterol dyslipidemia vascepa icosapent ethyl
oncologic and functional outcome and quality of life in patients treated for laryngeal cancer

Conditions: Laryngeal Cancer

Summary: the goal of this observational study is to learn about oncologic and functional outcome and investigate quality of life in patients treated for laryngeal cancer.

adult (\>=18 years of age) patients treated by surgery and/or radiation therapy are enrolled retrospectively. the main question it aims to answer is: is voice after total laryngectomy with voice prosthesis better than voice after open partial horizzontal laryngectomy? subjective and objective scales and parameters are used.

Eligibility criteria:
inclusion criteria: * patients treated for laryngeal cancer diagnosed by histopathologic examination exclusion criteria: * patients lost at follow up * age \< 18 years
circumcision and urinary tract infections in boys with posterior urethral valves

Conditions: Posterior Urethral Valves

Summary: children with posterior urethral valves (puv) are at risk of presenting febrile urinary tract infections (uti). circumcision has been shown to decrease the number of febrile utis in healthy children. the effect of circumcision on the number of utis in boys with puv has not yet been studied. through a prospective randomised trial of children with posterior urethral valves the investigators wish to determine the effect of circumcision on the risk of presenting febrile utis. one group will be on antibiotic prophylaxis alone and the other will be on antibiotic prophylaxis plus circumcision performed at the time of valve resection. both groups will be followed for two years, with clinical examination at 1, 3, 6, 12, 18 and 24 months. a dmsa scan will be performed at 1-2 and 24 months and biological renal function will also be monitored. the relative risk of presenting a febrile uti in each group will be determined. clinical, radiological and antenatal data concerning each child will be analysed. at 24 months follow-up, an "impact on family scale" survey (iofs) will be proposed parents.

after diagnosis of posterior urethral valves, children will be randomised either to antibioprophylaxis alone or antibioprophylaxis plus circumcision. circumcision will be performed at the time of valve resection. children will undergo a cystogram between 1 and 4 months to control valve resection. they will be followed for two years and the number of febrile utis in each group will be compared. the diagnosis of febrile uti will be confirmed by urethral catheterisation or suprapubic aspiration. a dmsa scan will be performed at the beginning and end of the study to determine whether children who have presented febrile utis show deterioration of their dmsa as compared to those who did not present febrile utis. at 24 months follow-up, "impact on family scale" survey (iofs) whose main objective is to evaluate the impact of family support for a child with posterior urethral valves will be proposed parents.

Eligibility criteria:
inclusion criteria: * male * aged 0 to 28 days * diagnosed with posterior urethral valves within the 28 first day of life * holders of parental authority affiliated to french national health insurance * informed consent signed by holders of parental authority exclusion criteria: * boys with hypospadias or epispadias or any other anomaly rendering circumcision impossible * concomitant participation to another clinical trial

Keywords: posterior urethral valves febrile urinary tract infection circumcision antibioprophylaxis impact on family
chidamide, azacitidine combined with gm regimen for relapsed and refractory dlbcl patients

Conditions: Diffuse Large B-Cell Lymphoma

Summary: to evaluate the efficacy and safety of cagm regimen in r/r dlbcl patients and to provide a safe and more effective approach for r/r dlbcl patients.

the study will start with an initial 2 cycles of induction therapy with cagm containing chidamide, azacitidine, obinutuzumab and mitoxantrone liposome, orelabrutinib and rituximab，following imaging examinations to evaluate response rates. for patients feasible to car-t/asct, sequential car-t/asct treatment was given. for patients who were unable to undergo car-t/asct, 4 cycles of cagm immunochemotherapy were carried out. efficacy and safety of cagm regimen in r/r dlbcl will be evaluated.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. at least one measurable lesion，measurable lymph nodes or masses of at least 15 millimeter (mm). 3. histopathologically confirmed dlbcl. 4. diseases refractory to first-line treatment (including cd20 monoclonal antibody and anthracycline) or relapsed after the last treatment. 5. life expectancy \> 3 months. 6. appropriate organ function: cardiac function: cardiac ejection fraction ≥50%; liver function: alanine aminotransferase and aspartate aminotransferase ≤3 times the upper limit of normal; renal function: serum creatinine clearance ≥30 ml/min; lung function: spo2\>91% without oxygen; 7. adequate bone marrow reserve: hemoglobin ≥8 g/dl; platelet count ≥75×10\^9/l; absolute neutrophil value ≥1.0×10\^9/l; platelet count ≥50×10\^9/l, absolute neutrophil value ≥0.75×10\^9/l if there is bone marrow invasion. 8. the patient has the ability to understand and is willing to provide written informed consent. 9. agreement to practice birth control from the time of enrollment until the follow-up period of the study. exclusion criteria: 1. severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine \> 3 times the upper limit of normal); 2. structural heart disease, leading to clinical symptoms or abnormal cardiac function (nyha ≥ grade 2); 3. uncontrolled active infection; 4. concurrent presence of other tumors requiring treatment or intervention; 5. current or expected need for systemic corticosteroid therapy; 6. pregnant or lactating women. 7. other psychological conditions that prevent patients from participating in the research or signing the informed consent. 8. in the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or does not meet the requirements for participation in the study.
development of a questionnaire to evaluate patient expectations for breast reconstruction in women with breast cancer or other conditions

Conditions: Breast Cancer

Summary: rationale: a questionnaire that evaluates a patient's expectations about breast reconstruction surgery may help doctors improve patient education before surgery and increase patient satisfaction after surgery. purpose: this clinical trial is developing a questionnaire to evaluate patient expectations for breast reconstruction in women with breast cancer or other conditions.

objectives: * develop and validate a questionnaire to evaluate preoperative expectations about breast reconstruction in women with breast cancer or other conditions. * determine variations in expectations related to patient characteristics. * develop educational modules to help patients understand realistic outcomes. * identify patient groups at risk for dissatisfaction. outline: this is a 3-part study. * part 1 (first 80 patients): both preoperative and postoperative patients (50 patients total) undergo an interview by a research study assistant about their expectations for breast reconstructive surgery. some of these patients will also complete a pilot version of a questionnaire about their expectations for breast reconstructive surgery (30 patients total). * part 2 (next 200 patients): preoperative patients complete questionnaires (the preliminary questionnaire developed after part 1 and the mskcc breast-q \[reconstruction module\]) about their expectations for breast reconstructive surgery after patient education about breast reconstructive surgery. some of these patients (100 patients) also complete the brief cope addressing emotional expression and emotional processing styles of coping, impact of events scale, and life orientation test-revised (lot-r) questionnaires. * part 3 (final 200 patients): preoperative patients complete a questionnaire (final questionnaire developed after part 2) about their expectations for breast reconstructive surgery after patient education about breast reconstruction and once after surgery. patients also complete the breast reconstruction outcomes questionnaire (mskcc breast-q) once before surgery (after patient education) and once after surgery measuring patient satisfaction and quality of life. a small group of patients complete the body image scale (bis) and the lot-r addressing body image, sexuality, personal well-being, and lifestyle.

Eligibility criteria:
inclusion criteria: * female. * age \> or = to 18 to 75 years. * patients who are presenting for consultation about breast reconstruction exclusion criteria: * inability to speak or understanding english * inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability. * prior breast reconstruction surgery.

Keywords: recurrent breast cancer stage ia breast cancer stage ib breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer