Kornimate/medical-research-clean huggingface dataset:
ramelteon 8 mg tablets specified drug-use survey: - transitional survey from the preceding drug-use survey -

Conditions: Insomnia

Summary: the purpose of this survey is to examine the safety and efficacy of long-term use of ramelteon tablets (rozerem 8 mg tablets) in participants with difficulty falling asleep associated with insomnia in daily medical practice.

this survey was designed to examine the safety and efficacy of long-term use of ramelteon tablets (rozerem 8 mg tablets) in participants with difficulty falling asleep associated with insomnia in daily medical practice.the usual dosage for adults is 8 mg of ramelteon administered orally once daily at bedtime.

Eligibility criteria:
inclusion criteria: -participants with difficulty falling asleep associated with insomnia who have completed a 4-week follow-up in the preceding drug use surveillance and are able to receive continuous administration of rozerem tablets exclusion criteria: * participants with contraindications to rozerem tablets. * participants with previous history of hypersensitivity to ingredients in rozerem tablets. * participants with severe liver dysfunction. * participants taking fluvoxamine maleate

Keywords: pharmacological therapy
her2 expression detection in breast cancer using 99mtc-nm-02

Conditions: Breast Cancer

Summary: a 99mtc-labeled anti-her2-sdab (99mtc-nm-02) will be developed for spect/ct assessment of her2 expression in breast cancer patients. its safety, radiation dosimetry and biodistribution, and the relationship between tumor uptake and her2 immunohistochemistry results will be investigated.

to evaluate the safety, dosimetry and efficacy of 99m-tc labeled anti-her2 single domain antibody (sdab) (product code name: 99mtc-nm-02) spect/ ct imaging of her2 expression in breast cancer and compare it with the existing gold standard " her2 expression detection" by biopsy tissue immunohistochemistry (ihc) and/or fluorescence in situ hybridization (fish) method. it is also to establish a new clinical method of non-invasive her2 expression detection in breast cancer using 99m-tc labeled anti-her2 sdab

Eligibility criteria:
inclusion criteria: 1. adult female, age 18 years or older 2. prior diagnosis of breast cancer 3. willing to participate in this study and given written informed consent 4. ast, alt, bun, cr not more than double the normal values 5. subjects of childbearing potential must be willing to undergo a pregnancy test prior to enrolment exclusion criteria: 1. pregnancy (subjects with a positive pregnancy test at baseline screening period or who are planning to become pregnant during the study period) 2. breastfeeding (subjects in lactation) 3. no biopsy tissue sample can be provided for her2 expression detection 4. subjects with pacemakers 5. hepatitis b virus infection (including carriers) at screening, ie hepatitis b surface antigen (hbsag) positive, or hepatitis c antibody (anti-hcv) positive, or acquired immunodeficiency disease (hiv) infected, or serum syphilis positive person 6. abnormal liver function during baseline screening period : ast or alt\> 2 times the upper limit of normal value (uln), if the marginal increase of a single index is judged as having no clinical significance by the investigator, it can be retested during the screening period. once, if ≤ 2 times uln after retesting, consider enrolling). 7. impaired renal function during screening: serum creatinine or urea nitrogen \> 1.5 times uln. 8. within 4 months prior to the baseline screening period , myocardial infarction or other cardiac events requiring hospitalization (unstable angina, etc.), cerebrovascular accident, transient ischemic attack, acute congestive heart failure or severe arrhythmia (ventricular arrhythmia, atrioventricular block above ii) 9. subjects with pulmonary embolism or deep vein thrombosis 10. various infections that the investigators consider unsuitable for study, including but not limited to patients with various infections requiring further treatment, such as urinary tract infections, respiratory infections, and diabetic foot infections. 11. patients with abnormal thyroid function during baseline screening period (including but not limited to active hyperthyroidism, hypothyroidism or hashimoto's thyroiditis)

Keywords: her2 single domain antibody (sdab) spect/ct imaging
stem cell therapy combined with neuroregen scaffold™ in patients with erectile dysfunction after rectal cancer surgery

Conditions: Rectal Cancer; Erectile Dysfunction

Summary: erectile dysfunction (ed) is one of the commonest complications in men after rectal cancer treatment. the purpose of this study is to assess the safety and efficacy of autologous bone marrow mononuclear cells (bmmcs) or allogeneic human umbilical cord-derived mesenchymal stem cells (huc-mscs) combined with neuroregen scaffold transplantation in men with erectile dysfunction after rectal cancer treatment.


Eligibility criteria:
inclusion criteria: 1. diagnosed with local rectal cancer, which is within 12cm from anus. 2. male, 20-65 years old. 3. iief-5 score\> 21. 4. no obvious abnormal in external genitalia, testis, epididymis and spermatic cord. 5. have a consistent partner who is willing to engage in sexual activity more than twice per month during the study. 6. signed informed consent. 7. recently take no drugs affecting sexual function (such as androgen replacement drugs, pde5i and chinese patent medicine, etc.). exclusion criteria: 1. suffering hypertension or diabetes. 2. in the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery. 3. patient's partner is trying to conceive during the trial period. 4. exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study. 5. geographically inaccessible for follow-up visits required by protocol or want to other treatment.
the association between nephrolithiasis and periodontal status

Conditions: Periodontal Diseases; Nephrolithiasis

Summary: dental calculus is a calcified deposits firmly attached to teeth and implants surfaces. dental calculus is strongly associated with periodontitis and considered to have indirect role in the pathogenesis of periodontal diseases. dental calculus composed primarily of calcium phosphate mineral salts originated in the saliva covered by unmineralized bacterial layer. composition of calculus varies from person to person and influenced by numerous variables such as: age, gender systemic disease and ethnic background. nephrolithiasis (kidney stones) are composed of insoluble salts of constituents of the forming urine. the most two frequent stone types are: calcium oxalate (with a frequency of 15% -35%) and calcium phosphate (5% -20%). the prevalence of kidney stones varies with race, sex, and geographic location. in the united states for men, kidney stone rates vary between 4%-9%, and for women, kidney stone rates range between 2%-4%. previous studies dealt with the connection between sialolithiasis and nephrolithiasis were inconclusive. to the authors' best knowledge no studies were done to examine the associations between nephrolithiasis and dental calculus. thus, the aim of this study is to compare the mineral composition of both dental calculus and nephrolithiasis and determine whether nephrolithiasis composition may be linked to the periodontal status.


Eligibility criteria:
inclusion criteria: * patients diagnosed with nephrolithiasis * over 18 years old exclusion criteria: * pregnant woman, uncontrolled diabetes (hba1c \> 7.5%), patients who received periodontal treatment in the past 6 months, smokers
study to test the safety of an investigational drug given repeatedly to adult men with severe hemophilia

Conditions: Hemophilia

Summary: the purpose of this study is to investigate the safety of a test drug to treat hemophilia in adult men.

the primary objective is to assess the safety of multiple doses of bay1093884.

Eligibility criteria:
inclusion criteria: * participants with hemophilia a and fviii activity \<1% or hemophilia b with fix activity \<2% * participants must be currently without inhibitors or with low titer inhibitors (inhibitor titer \< 5 bethesda units) who are receiving current on demand treatment with any fviii or fix (recombinant or plasma-derived; modified or unmodified) exclusion criteria: * history or at risk of developing diseases related to venous thromboembolic events (e.g., pulmonary embolism, deep vein thrombosis or thrombophlebitis) * history of any other clinically relevant coagulation disorder (particularly disseminated intravascular coagulopathy or combined fviii/factor v deficiency) or platelet disorder * history or at risk of developing cardiac, coronary and/or arterial peripheral atherosclerotic disease and/or arterial thromboembolic events, particularly myocardial infarction, cerebrovascular accident, stroke, transient ischemic attack, congestive heart failure, angina pectoris, treatment for angina pectoris or uncontrolled hypertension * history or at risk for thrombotic microangiopathy

Keywords: coagulation factor viii (fviii) coagulation factor ix (fix) anti-tissue factor pathway inhibitor (atfpi) human monoclonal immunoglobulin g2 antibody
mri findings in inguinal hernia

Conditions: Inguinal Hernia; Pain

Summary: mri imaging in clinically evident inguinal hernia is not routinely used. in other painful inguinal conditions (such as sportsmans hernia) inflammatory changes have been detected. the aim of the present study is to determine, whether similar inflammatory changes can be detected with mri scan in inguinal hernia. also, patient questionaires are used preoperatively and postoperatively to determine, if preoperative pain scores can be used as a predictive value for postoperative prolonged pain/neuralgia.


Eligibility criteria:
inclusion criteria: * age \< 50 years * painful inguinal hernia exclusion criteria: * conditions that do not allow the use of mri * conditions that prevent general anesthesia
prospective analysis of "genotype-phenotype" correlations observed in a large cohort of patients with hereditary retinal dystrophies - gephird

Conditions: Hereditary Retinal Dystrophies

Summary: this study will carry out a detailed descriptive analysis of a large population of patients with hereditary retinal dystrophies (hrd): clinical, paraclinical and genetic data. the information drawn from these analyzes will provide a better understanding of the pathophysiology of these rare diseases and this may ultimately impact the medical management of patients (targeted therapy).


Eligibility criteria:
inclusion criteria: * patients hospitalized for suspicion of hereditary retinal dystrophy * benefiting as part of the care of a genetic analysis exclusion criteria: - patient under a measure of legal protection

Keywords: hereditary retinal dystrophies
do benzodiazepines improve the outcome of mechanical physiotherapy for lumbar disk prolapse

Conditions: Pain; Disability; Paresis

Summary: sixty patients were randomized to receive either placebo or diazepam in addition to mechanical physiotherapy and analgesics for the first 7 days of conservative treatment of clinically and radiologically confirmed lumbar disk prolapse


Eligibility criteria:
inclusion criteria: * sciatica without or with neurological deficit attributable to lumbar disc prolapse * ct or mri confirmation of lumbar disc prolapse * informed consent exclusion criteria: * bladder or bowel disturbance * acute (\< 24 h) development of paresis grade 1 or plegia * taken benzodiazepines for more than 2 weeks * history of benzodiazepine intolerance * prior surgery for disc prolapse, or prior trauma to the vertrebral column

Keywords: physiotherapy tuebingen concept benzodiazepines muscle relaxants disc herniation
dorsal nerve block and caudal block in hypospedius repair in children

Conditions: Dorsal Nerve Block in Hypospiudus

Summary: comparison between dorsal nerve block and caudal block effect in post operative pain in hypospedius repair in children randomoized clinical trial

• group a receive caudal block placing the patient into the left lateral decubitus position. povidone iodine was used to sterilize the skin. the sacral hiatus was found by palpating the sacral cornu and a 22-g needle was placed through it. after passing through the sacrococcygeal membrane by using the loss of resistance method, the caudal epidural space was entered. negative aspiration was used to make sure there was no blood or cerebrospinal fluid present and 0.25% bupivacaine was administered at a dose of 0.2 ml/kg. once the procedure was completed, the patient was placed into the supine position. group b us guided dorsal penil block. general anesthesia induction was followed by skin sterilization using 70% alcohol in 2% chlorhexidine. the 5-10 mhz linear probe was placed at the penis root, making it possible to observe the corpus cavernosum, corpus spongiosum, dorsal artery and vein, and the deep penile fascia (buck's fascia) on the transverse plane with gentle penile traction. the in-plane technique was then used to insert a 50-mm block needle toward the dorsal penile section from the lateral part of the penis root. the needle was then advanced from the hyperechoic superficial penis fascia (dartos fascia) and the superficial sheath was passed. after advancing the needle into buck's fascia, the needle was placed lateral to the dorsal artery, at a position between buck's fascia and tunica albuginea. negative aspiration was performed. us was then used to observe the distribution of the anesthetic while half of the total 0.25% bupivacaine dose (0.2 ml/kg) was administered (fig. 1). afterward, the same procedure was also performed on the other side of the penis.

Eligibility criteria:
inclusion criteria: * aged 2-12 years * asa physical status i or ii exclusion criteria: * asthmatic patients * emergency surgery * intellectual disability * neurological diseases with agitation-like symptoms * renal or hepatic disease, * cardiac or respiratory disease * allergy to the study drugs * parent refusal * psychiatric diseases
swiss traumatic birth trial

Conditions: Posttraumatic Stress Disorder; Acute Stress Disorder

Summary: this randomized controlled study aims to investigate the effects of a brief computerized intervention (the computer game "tetris") on intrusive memories and other posttraumatic stress symptoms following an emergency cesarean section (ecs). women who have undergone an emergency cesarian section will be randomly allocated to either the brief computerized intervention plus usual care or an attention placebo control group plus usual care within the first 6 hours following the ecs. women and their infants will be followed up at ≤ 1 week postpartum, 6 weeks postpartum, and 6 months postpartum. it is predicted that women given the brief computerized intervention will develop fewer intrusive memories and less posttraumatic stress symptoms than those who are not. this will inform the development of a simple computerized early intervention to prevent distressing psychological symptoms after a traumatic event, such as an ecs.


Eligibility criteria:
inclusion criteria: women: * had an ecs at ≥ 34 weeks gestation * gave birth to a live baby * answered with a score of ≥ 2 separately for at least two out of four screening questions regarding perceived threat * gave written consent partners: * if the woman agrees to participate * was present at the childbirth * gave written consent exclusion criteria: women: * don't speak french sufficiently well to participate in assessments * have an established intellectual disability or psychotic illness * severe illness of mother or infant (e.g. cancer, cardiovascular disease, severe neurodevelopmental difficulties, malformations) * infant requires intensive care * alcohol abuse and/or illegal drug use during pregnancy partner: - don't speak french sufficiently well to participate in assessments
tap block vs lawi for analgesia post-cesarean section: rct

Conditions: Obstetric Pain; Obstetric Anesthesia Problems

Summary: adequate pain control after cesarean delivery is a significant concern both for parturients and obstetric anesthesiologists. transversus abdominis plane (tap) block and local wound infiltration with anesthetics are alternatives for reducing the severity of pain, total analgesic consumption, and opioid side effects. both the tap block and wound infiltration are superior to placebo; however, it is unknown which provides better analgesia after cesarean delivery because of a scarcity of randomized clinical trials. so, we hypothesized that the tap block would decrease postoperative pain and postoperative cumulative opioid consumption at 24 hours


Eligibility criteria:
inclusion criteria: 1. women who underwent cesarean section under spinal anesthesia. 2. aged ≥19 years and less than 40 years. 3. gestational age ≥ 37 weeks. exclusion criteria: 1. body mass index (bmi) ≥40 kg/m2. 2. history of recent opioid exposure 3. hypersensitivity to any of the drugs used in the study. 4. significant cardiovascular, renal, or hepatic disease

Keywords: transversus abdominis plane vas; visual analogue score wound infiltration cesarean section postoperative pain analgesia
single-ascending dose study of biib054 in healthy participants and early parkinson's disease

Conditions: Parkinson's Disease; Healthy

Summary: the primary objective of the study is to evaluate the safety and tolerability of a range of single biib054 doses, administered as a single intravenous (iv) infusion, in healthy participants and participants with early parkinson's disease (pd). secondary objectives of the study are to assess the serum pharmacokinetics (pk) profile of biib054 after single-dose administration and to evaluate the immunogenicity of biib054 after single-dose administration.

only healthy participants will be enrolled in cohorts 1 through 6. only participants with early pd will be enrolled in cohort 7

Eligibility criteria:
key inclusion criteria: 1. all women of childbearing potential and all men must practice effective contraception during the study and for 6 months after their last dose of study treatment. 2. must have a body mass index from 19 to 32 kg/m2, inclusive. 3. must be in good health as determined by the investigator, based on medical history, physical examination, and 12-lead ecg. for cohort 7 only: 4. diagnosis of idiopathic pd key exclusion criteria: 1. history of cardiovascular disease. 2. subject smokes more than 5 cigarettes or the equivalent in tobacco daily. 3. surgery within 3 months prior to day -1 (other than minor cosmetic surgery and minor dental surgery, as determined by the investigator). 4. history or positive test result for hepatitis c, hepatitis b, or human immunodeficiency virus (hiv). 5. female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: alpha synuclein pd
udff performance evaluation ((ultrason derived fat fraction)

Conditions: Non Alcoholic Fatty Liver Disease

Summary: the purpose of this study is to assess udff performance (compared to mri)


Eligibility criteria:
inclusion criteria: * all patients who had hepatic ultrasound with available udff measurements and hepatic mri (with steatosis quantification sequences) between 01/01/2022 and 31/09/2023 may be included. exclusion criteria: * chronic liver disease with a different etiology other than nafl/nash or mixed (hepatitis b or c, hemochromatosis, autoimmune hepatitis, wilson's disease, cholestasic disease, alpha 1 antitrypsin deficiency), * decompensated cirrhosis (ascites, jaundice, encephalopathy, rupture of esophageal varices), * hepatocellular carcinoma. * opposition to the use of its data
extended release nifedipine treatment as maintenance tocolysis to prevent preterm delivery

Conditions: Preterm Labor

Summary: to evaluate the treatment efficacy and safety usig extended release nifedipine, as maintenance therapy to pregnant women who were hospitalized and treated for preterm labor until 34 weeks' gestation. after the ptl will stop, we will randomize these women for the treatment group and the control (no treatment) group. the main outcome will be preterm delivery before 34 weeks' gestation. the secondary outcome will be the side effects of the medication and the newborn/mother health variables.


Eligibility criteria:
inclusion criteria: * pregnancy week 24-33 * singleton pregnancy * after successful treatment to stop ptl exclusion criteria: * contraindications for nifedipine extended release treatment.

Keywords: nifedipine tocolysis maintenance preterm delivery extended release nifedipine ptl
relationship between serum vitamin d levels and postherpetic neuralgia.

Conditions: Postherpetic Neuralgia

Summary: 1. the correlations of serum vitamin d level, serum calcium level and osteoporosis degree with disease severity, treatment response, incidence of post-herpes zoster(phn) and disease prognosis in herpes zoster(hz) patients were studied. 2. to investigate the role of inflammation-related factors and immune-related factors in the occurrence and development of hz mediated by low vitamin d level.

herpes zoster is a neuropathic disease which induce by the varicella-herpes virus reactivation.and postherpetic neuralgia (phn) is the most common complication. currently,the mechanism of herpes zoster still unclearly even though there had much study about it .vitamin d is an essential vitamin for human body, which has the function of maintaining calcium and phosphorus homeostasis and immune regulation. vitamin d is a natural antiviral substance, and vitamin d deficiency can affect the body's antiviral ability, thereby promoting varicella-zoster virus(vzv) reactivation, and may promote the development of phn through continuous neuroinflammation. therefore, vitamin d level may be related to the occurrence and progression of hz. this study intends to use an observational cohort study design to investigate the correlation of serum vitamin d level and osteoporosis degree with the severity of the herpes zoster disease, although we plan to further explore the role of inflammatory state in this process.

Eligibility criteria:
inclusion criteria: * age ≥18 years. * the patient was diagnosed with herpetic neuralgia and the course of disease was ≤3 months. * can cooperate with the completion of inquiry and scale evaluation. exclusion criteria: * severe spinal disease (fracture, malignancy, acute or chronic infection) confirmed by previous spinal surgery or imaging. * previous history of head trauma. * have autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, leucothrombocytopenia). * suffering from mental disorders, intellectual disability, epilepsy and other diseases. * a history of substance abuse, drug abuse or alcohol abuse. * pregnant or breastfeeding women. * and recent participation in other clinical studies.

Keywords: herpes zoster,post-herpes zoster,vitamin d,