Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of levomilnacipran er (f2695 sr) in adults with fatigue associated with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of the study is to evaluate the efficacy, safety and tolerability of levomilnacipran er for the treatment of fatigue associated with major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: * men and women, 18-65 years old * currently meet diagnostic and statistical manual of mental disorders, fourth edition-text revision (dsm-iv-tr) criteria for major depressive disorder * the patient's current depressive episode must be at least 4 weeks in duration exclusion criteria: * women who are pregnant, women who will be breastfeeding during the study, and women of child-bearing potential who are not practicing a reliable method of birth control * patients with a history of meeting dsm-iv-tr criteria for: 1. any manic or hypomanic episode; 2. schizophrenia or any other psychotic disorder; 3. obsessive-compulsive disorder. * patients who are considered a suicide risk

Keywords: depression fatigue major depressive disorder
a prospective multicenter clinical study： intraconary near-infrared spectroscopy and optical coherence tomography for evaluating coronary vulnerable plaque in patients with diabetes

Conditions: Relationship Between Target Vascular Lipid Content and Long Term Prognosis in Diabetic Patients with Coronary Heart Disease

Summary: to evaluate the correlation between maxlcbi4mm/fctmin(a new index of lipid plaque based on nirs-oct technology) and fiber cap thickness , and the prognosis of patients, providing a new quantitative index for early, accurate and comprehensive identification of vulnerable plaques, and exploring preventive measures for adverse events such as cardiac death and recurrent myocardial infarction caused by vulnerable plaques, so as to improve the long-term prognosis of patients.


Eligibility criteria:
inclusion criteria: * 1: aged 18-80 years, gender is not limited 2: patients with diabetes who require interventional therapy (diabetes definition: active treatment with insulin or oral hypoglycemic agents at admission). for patients with diabetes who are treated with diet only, abnormal fasting blood sugar (\>7 mmol/l), blood sugar \>11.1 mmol/l at any time, or abnormal glucose tolerance tests based on world health organization standards need to be recorded. 3: endoscopic imaging examination or interventional therapy under the guidance of endoscopic imaging is required 4: be able to understand the purpose of clinical research, voluntarily participate can complete the observation as required and sign the informed consent form 5: at least 2 coronary arteries (including suspected criminal coronary arteries) are suitable for nirs-oct imaging 6: stenosis with non-target lesions \> 50% exclusion criteria: * 1: severe coagulation dysfunction (aptt greater than 3 times the upper limit of the normal range) 2: severe hemodynamic disorder or shock that cannot be corrected 3: patients with renal impairment（egfr\<30 ml/min/1.73m2） 4: severe symptoms of heart failure (nyha iii and above) or left ventricular ejection fraction \<30% 5: the presence or suspected presence of infective endocarditis or systemic active infection 6: patients with refractory ventricular arrhythmias who have previously undergone coronary bypass transplantation (cabg) or plan to undergo cabg during the study 7: patients with serious concurrent diseases such as advanced cancer have a life expectancy of less than 24 months 8: pregnant or lactating women, have a family plan within 24 months or are unwilling to take effective contraceptive measures 9: the target vessel has severe calcification or severe tortuosity, which cannot be examined by oct 10: have participated in other clinical trials or are participating in other drug/device clinical trials within 3 months prior to enrollment and have not met the primary endpoint 11: investigators believe that those who are unnecessary for oct or not suitable for inclusion in this trial. 12: there are multiple lesions in the same blood vessel, and the non-target lesion distance requiring treatment vascular segment is less than 5mm
effect of oral contraceptives after administration of semaglutide in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this clinical trial is conducted in europe. the purpose of the trial is to investigate the influence on the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of an oral contraceptive combination drug after multiple administration of semaglutide in female subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * informed consent obtained by a physician before any trial-related activities * postmenopausal women: a. with at least 12 months of spontaneous amenorrhoea with serum follicle stimulating hormone (fsh) above 40 miu/ml and oestrogen deficiency (estradiol levels less than 30 pg/ml, or a negative gestagen test) or b. bilateral oophorectomy (surgical removal of both ovaries) * type 2 diabetes treated with either diet and exercise alone or with metformin (monotherapy) having a glycosylated haemoglobin (hba1c) of 6.5 -10% (both inclusive) * stable treatment of diabetes, either diet and exercise only or a stable dose level of metformin, for at least 3 months * bmi (body mass index) between 18.5 - 35.0 kg/m\^2 (both inclusive) exclusion criteria: * known or suspected hypersensitivity to trial products or related products * previous participation in this trial. participation is defined as being dosed with either drug * treatment with antidiabetic drug other than metformin within the last 3 months * use of hormone replacement therapy within 4 weeks prior to starting dosing with the trial product * presence or history of cancer or any clinically significant diseases or disorders, considered by the physician to have influence on the results of this trial * subjects who are known to have hepatitis * positive human immunodeficiency virus (hiv) antibodies * uncontrolled treated/untreated hypertension (systolic blood pressure above 160 mmhg and/or diastolic blood pressure above 100 mmhg) * history of alcoholism or drug abuse during the last 3 months * history of chronic or idiopathic acute pancreatitis * family or personal history of multiple endocrine neoplasia type 2 (men2), or family history of medullary thyroid cancer (fmtc) * personal history of non-familial medullary thyroid carcinoma * subjects who are considered at increased risk of thrombosis formation, such as deep vein thrombosis, pulmonary embolism, infarction or apoplexy (as judged by the trial physician) and subjects who are smokers * blood or plasma donation within the last 3 months prior to first dosing * participation in any other trial investigating other products or involving blood sampling within the last 3 months prior to first dosing * inability or unwillingness to perform self-injection (with placebo medium) at trial start
a phase 1 study to investigate the food effect of lumacaftor in combination with ivacaftor

Conditions: Cystic Fibrosis

Summary: this study is designed to investigate the effect of food on the relative bioavailability of 2 different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet formulations.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects as defined in the protocol * subjects who weigh \>50 kg at screening exclusion criteria: * history of any illness or condition that might confound the results of the study or pose an additional risk to the subject upon administration of study drug - positive for hepatitis b,c, or hiv * standard 12-lead ecg demonstrating qtc \>450 msec for male subjects and \>480 msec for female subjects at the screening visit * abnormal renal function as defined in the protocol at screening * forced expiratory volume in 1 second (fev1) \<80% predicted at the screening visit * blood donation (of approximately 1 pint \[500 ml\] or more) within 56 days before the first dose of study drug * treatment with an investigational drug or device within 30 days or 5 half-lives preceding the first dose of study drug
vitamin d on prevention and treatment of covid-19

Conditions: Patients Infected With COVID-19

Summary: the new outbreak of the sars-cov-2 coronavirus is causing an important pandemic affecting a large number of people all-over the world. vitamin d is a hormone precursor produced by our own body with the help of sunlight which has an important role on adaptive immunity and cellular differentiation, maturation and proliferation of several immune cells. reduced levels of vitamin d in calves were positioned as the main cause of bovine coronavirus infection in the past. therefore, it seems plausible that the use of vitamin d as a nutritional ergogenic aid could be a potential intervention to fight against covid-19 infected patients which remain asymptomatic or which have non-severe and severe symptoms. this study aims to investigate whether the use of vitamin d as an immune modulator agent induces significant improvements of health status and outcomes in non-severe symptomatic patients infected with covid-19 as well as preventing covid-19 health deterioration. we hypothesize that vitamin d will significantly improve hard endpoints related to covid-19 deleterious consequences compared with a usual care control group.


Eligibility criteria:
inclusion criteria: * non-severe symptomatic patients who present cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia or alternative signs of respiratory infections. exclusion criteria: * patients presenting severe respiratory and/or multisystemic symptoms compatible with advanced covid-19 and intercurrent acute or severe chronic diseases (i.e. active cancer).
the effect of surgical interventions to assist orthodontic movement of impacted maxillary canines

Conditions: Impaction of Tooth

Summary: impacted canine causes many problems for patients, such as absorption and damages to the adjacent teeth roots, as well as aesthetic problems. correction of this problem requires a lengthy time. therefore, many methods have been suggested to accelerate the movement of impacted canines with the help of surgical procedures.


Eligibility criteria:
inclusion criteria: 1. palatal or mid-alveolar impacted canine. 2. there is no previous orthodontic treatment. 3. healthy periodontal tissues and good oral health (i.e., plaque index is less or equal to 1 according to loe and silness(1963)). 4. no consumption of any drug that may interfere with the tooth movement (cortisone, nsaids, ...). 5. mild or no crowding in the upper jaw. 6. no history of previous trauma to the maxillofacial region or surgical interventions. exclusion criteria: 1. any systemic diseases that would affect tooth movement 2. antidepressant prevents oral surgery 3. any congenital syndromes or cleft lip and palate cases 4. bad oral health 5. previous orthodontic treatment
safety and efficacy of neuromultivit in treatment of vertebrogenic radiculopathy

Conditions: Vertebrogenic Radiculopathy L5, S1

Summary: the purpose of the study is to assess the efficacy and safety of neuromultivit (solution for injections) in treatment of vertebrogenic radiculopathy l5, s1 in comparison with standard therapy. the patients are randomised into two groups: standard therapy group and standard therapy plus neuromultivit group.

group 1 (50 patients) receive neuromultivit (2 ml per day, i.m.) for 7 days, then -neuromultivit (2 ml per day, i.m.) every other day for 10 days and standard therapy for 20 days. group 2 (50 patients) receive only standard therapy for 20 days. standard therapy involves: * voltaren (100 mg prolonged-released film-coated tablets once daily) for 20 days * sirdalud (2 mg tablets three times a day) for 20 days

Eligibility criteria:
inclusion criteria: * diagnosed vertebrogenic radiculopathy l5, s1 * radicular pain syndrome * changes in the low back ct and mri scans * minimum 40 mm intensity of spontaneous back pain, rated on the va scale * 1 month exacerbation phase; nonuse of any b-group vitamins before the trial * negative urine pregnancy test; patient informed consent exclusion criteria: * tumors, inflammatory infections, any neurological diseases, imitating the symptoms of radiculopathy * concomitant life-threatening medical conditions * simultaneous administration of acetylsalicylic acid, levodopa, prednisolone; any psychiatric diseases * epilepsy, alcohol and drug addiction * pregnancy and breast-feeding * any condition preventing ct and mri tests, including obesity and special devices * participation in any other clinical study 1 month before enrollment.
out-of pocket payments with lymphedema in france

Conditions: Primary Lymphedema Secondary Lymphedema

Summary: lymphedema is a frequent and chronic condition posing a high burden on patients. clinical guidelines emphasize the role of compression therapy by prescription medical devices. even in a mandatory publicly funded health insurance system, out-of-pocket payments (oopp) may exist due to the price and reimbursement setting processes. oopp may threaten the equity of care and drive patients to forgo care. our aim was to analyze the distributive effects of oopp for lymphedema patients in france. a prospective, multicenter study will be conducted in france in 2014 on patients with lymphedema. household ability to pay will be specified by net income and oopp will be assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices, nursing care, biological tests, imaging, physiotherapy and transportations). both mandatory and voluntary health insurance reimbursements will be considered. we will combine concentration curves and concentration indices to assess the distributive effects.


Eligibility criteria:
inclusion criteria: * patient aged over six years, with primary or secondary lymphedema, regardless of the severity of the disease; * patient treated in one of the centres participating in the study; * patient (and her legal representative for minors) who gave her written consent \[or did not refuse to participate, according to local law\] ; * patient with internet access and an active email address. exclusion criteria: * patients with concomitant chronic venous insufficiency; * patient not covered by any health care insurance scheme; * people protected under the law.
psychological response and readiness associated with ocd of the knee

Conditions: Osteochondritis Dissecans Knee; Psychological Stress

Summary: this study primarily aims to determine whether patients diagnosed with osteochondritis dissecans (ocd) of the knee experience psychological stress due to their diagnosis and treatment plan. secondarily, this study aims to determine whether knee ocd patients experience a change in stress and depression as they progress through their standard-of-care treatment plan, and whether they have impaired psychological readiness for return to sport.

young athletes with poor psychological responses to injury and recovery may be at risk for suboptimal rehabilitation and return to sports. the issues of psychological readiness and fear/anxiety of reinjury are well documented in the treatment of acl injuries in young athletes. to the investigative team's knowledge, no studies have examined the psychological response and psychological readiness to return to sports in pediatric and adolescent patients undergoing treatment for osteochondritis dissecans (ocd) of the knee. ocd is a focal, idiopathic alteration of subchondral bone with risk for instability and disruption of adjacent articular cartilage that may result in premature osteoarthritis. it generally affects a young population between 6 and 19 years of age, with highest prevalence between the ages of 12 and 19 years of age. this condition can be treated both conservatively and surgically depending on the age of the patient, size of the lesion, severity and instability of the bone \& cartilage, and previous treatment. the unclear etiology of this condition, the delayed / prolonged pre-diagnosis symptoms, varied treatment options, and unpredictable healing timelines are all factors that families and patients find frustrating about this condition. the investigators of this study believe that this leads to higher than normal psychological stress at the time of diagnosis and throughout treatment of this condition. improved understanding of the psychological stress and readiness to return to sport in the treatment of knee ocd can help patients, their families, and clinicians alike. awareness can help clinicians provide the appropriate outreach and counseling for patients at risk for increased psychological stress. improved psychological states and readiness can improve both physical and mental well-being.

Eligibility criteria:
inclusion criteria: * between the ages 11-19 * diagnosis of knee ocd confirmed by x-ray or mri exclusion criteria: * had previous surgical treatment for their knee ocd lesion * received knee ocd non-operative treatment on the ipsilateral side for \>6 months and taken out of sports/physical activities * guardian not comfortable with child completing survey * is not fluent in english
effects of self-conditioning techniques in promoting weight loss in patients with obesity. a randomized controlled trial

Conditions: Obesity

Summary: the investigators hypothesized that hypnosis is an alternative technique that could be applied to help patients with obesity to lose weight. the possibility that a self-conditioning technique (self-hypnosis) added to traditional approach (diet, exercise and behavioral recommendations) will be effective in determining weight loss with respect to the traditional approach in subjects with a body mass index (bmi) between 35 and 50 kg/m2 will be studied.

obesity is a serious health concern. most lifestyle interventions fail over time; indeed, overeating often involves loss of control and compulsive behaviors. hypnosis could increase the ability to control emotional impulses. self-conditioning techniques borrowed from hypnosis (self-hypnosis) increase self-control and self-management of emotions. recent hypnosis techniques with a rapid-induction phase allow the trained patients to go into self-hypnosis in a few minutes and to repeat the experience in complete autonomy, employing a short time of the day only.

Eligibility criteria:
inclusion criteria: * able to give written informed consent * bmi between 35 and 50 kg/m2 * age 20-70 years exclusion criteria: * current or previous mental disorders and/or on any psychotropic drug * insulin treatment * candidates for bariatric surgery * current (or discontinued for less than 6 months) treatment with anti-obesity drugs * patients at risk of heart failure, edema, ascites (heart diseases, chronic liver diseases, nephrotic syndrome, renal failure) * patients with untreated or uncompensated thyroid diseases
the study of biodistribution and dosimetry of 99mtc-glycopeptide(99mtc-gp) in patients with breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the biodistribution and dosimetry of single dose of 99mtc-glycopeptide (99mtc-gp, 20-25 mci) in 3 different doses of gp (5, 10and 20 mg)in patients with breast cancer at pre-chemotherapy.

cohorts of 3 will be treated each at different dose levels and images will be taken at 4 time points. for dosimetry estimates, there will be a 20-24 hr time point post-administration of 99mtc-gp for the first 3 patients. if the biodistribution and dosimetry can be adequately quantified without the 20-24 hr scan in 3 patients, then we will eliminate that 4th scan for all other patients. urine and blood samples will be collected at 5 time points, and an additional blood and urine sample will be collected for dosimetry analysis at 30\~60 min.

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed stage i-iv breast cancer (tumor size * 2cm in imaging examinations) who are scheduled to start systemic therapy. * patients must have histological diagnosis of invasive breast cancer. * extent of disease will be determined by physical examination and conventional radiological studies. * must be age 18 or older. * ecog performance status 0-2. * patients with history of prior malignancies must be disease-free for at least 5 years of study entry. * normal hematological function: wbc \> 3000/ul, absolute neutrophil count \> 1500/ul, platelets \> 100,000/ul, and hgb \> 10 gms (transfusion to achieve hgb \> 10 gms is acceptable). * serum total bilirubin \< 1.5 mg/dl and sgpt \< 1.5 x normal. * adequate kidney function (creatinine \< 1.5 mg/dl). exclusion criteria: * patients who received previous chemotherapy for the newly diagnosed breast cancer. * no evidence of primary breast lesion (e.g. t0, tx). * pregnant women or sexually active women of childbearing potential who are not practicing adequate contraception are excluded. * patients with myocardial infarction within 6 months of study entry; unstable angina pectoris; uncontrolled congestive heart failure; uncontrolled arrhythmia are excluded. * patients with history of hypersensitivity/allergy to chitosan/chitin related shellfish foods.
effect of tecar in treating stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: stress urinary incontinence (sui) is the defined as a leakage of urine with physical exertion, most commonly from coughing, laughing, or sneezing. it has a profound psychosocial impact not only to patients but also on their families and caregivers, resulting in loss of self stem, sexual dysfunction.because of the higher incidence of stress urinary incontinence that reach 30% of women during childbearing period, 50% in elderly women, and its social embarrassing condition causing socio-psychological problems, disability and dependency with higher economic impact and based on tecar therapy had better recovery of muscle strength and function in addition to there is no study has evaluated the impact of tecar treatment on stress urinary incontinence, our study aim to assess the effectiveness of tecar in treatment of such cases to decrease time of treatment and provide good results to patients.


Eligibility criteria:
inclusion criteria:participants aged between30 to 50 year and bmi not exceed 30 kg/cm2. all subjects complain from mild sui due to hypermobility of bladder neck and weakness of pelvic floor exercise - exclusion criteria: * those with neurological diseases, diabetic neuropathy, congenital urologic disease, bladder cancer and neurogenic bladder, detrusor hyperactivity and bladder or urethra previous surgery

Keywords: stress urinary incontinence, tecar