Kornimate/medical-research-clean huggingface dataset:
surveillance for early liver injuries caused by yangxue shengfa capsule.

Conditions: Drug-Induced Liver Injury

Summary: this is a prospective registry study to surveil early liver injuries caused by yangxue shengfa capsule (yxsf capsule) through a non-intervention observational way. and attempt to establish a predictive model to screen susceptibilities to yxsf capsule.

the primary objectives of this study include: (i) the detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of yxsf capsule; (ii) the record of overall individuals with demographics, underlying diseases, physical status, medication information, clinical laboratory index, and so on; (iii) the specimen collection of surveiled individuals. (iv) the attempt to establish a predictive model to screen susceptibilities to yxsf capsule.

Eligibility criteria:
inclusion criteria: 1. individuals in accordance with indications for yxsf capsule, including xerasia, itchy scalp, alopecia areata, seborrheic dermatitis and alopecia; 2. the age range of 18 to 70 years； 3. individuals taking yxsf capsule over 2 weeks; 4. abnormalities of serum liver biochemistry achieving one of the criteria as follows: (i) alanine aminotransaminase (alt) or aspartate transaminase (ast) ≥2 folds of upper limit of normal (uln); (ii) total bilirubin (tbil) ≥ 2 uln; (iii) alkaline phosphatase (alp) ≥ 2 uln; 5. individuals can provide informed consent form. exclusion criteria: 1. individuals without indications for yxsf capsule; 2. inconformity to the yxsf capsule drug label; 3. individual taking yxsf capsule less than 2 weeks; 4. individuals taking other hepatotoxic drugs combined with yxsf capsule, simultaneously; 5. inconformity to the diagnostic standard for herb-induced liver injury (the guideline for diagnosis and treatment of herb-induced liver injury, rpgip-2016cn003）.

Keywords: drug-induced liver injury
3-part study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of exs21546

Conditions: Oncology

Summary: a 3-part study to assess safety, tolerability, pk and pd of single (part 1) and multiple (part 2) ascending doses of exs21546, and to evaluate the relative bioavailability of a solid dose formulation compared to a powder for oral suspension (part 3), in healthy male subjects.

part 1 is a randomised, double-blind, placebo-controlled, sad study with a food effect assessment. part 2 is a randomised, double-blind, placebo controlled, mad study over 14 days. in order to explore the potential cyp3a4 inducer effect, midazolam will also be administered in one cohort. part 3 is a 3-period, open label, randomised, sequential study. each subject will receive solid dose formulation and powder for oral suspension in a randomised manner.

Eligibility criteria:
inclusion criteria: * bmi 18.0 to 30.0 kg/m2 * weight ≥60 kg * must adhere to contraception requirements exclusion criteria: * subjects who have received any imp in a clinical research study within the 90 days prior to day 1 * subjects who have previously been administered imp in this study. * evidence of current sars-cov-2 infection * history of any drug or alcohol abuse in the past 2 years * regular alcohol consumption in males \>21 units per week * a confirmed positive alcohol breath test at screening or admission * current smokers and those who have smoked within the last 12 months. a confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission * current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months * subjects with pregnant or lactating partners * positive hepatitis b surface antigen (hbsag), hepatitis c virus antibody (hcv ab) or human immunodeficiency virus (hiv) antibody results * regimen l only: history of sleep apnea * subjects with a history of cholecystectomy or gall stones * serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients * presence or history of clinically significant allergy requiring treatment, as judged by the investigator. hay fever is allowed unless it is active * donation of blood or plasma within the previous 3 months or loss of greater than 400 ml of blood
aromatase inhibitor growth study: letrozole vs. anastrozole

Conditions: Short Stature

Summary: the purpose of the study is to determine if there are differences in the final height or hormone profile of short pubertal boys placed on different forms of aromatase inhibitor now routinely used to increase stature: anastrozole and letrozole. it also should determine if there are differences in the side effect profiles of the two drugs to be used.


Eligibility criteria:
inclusion criteria: * current height less than 5th percentile and/or * predicted adult height (based on bone age) more than 10 cm below target height (mid parental height) * evidence of puberty: physical signs and serum luteinizing hormone \> 0.3 iu/l and testosterone \> 15 ng/dl exclusion criteria: * bone age reading more than 14.0 years * follicle stimulating hormone \> 20 iu/l
buprenorphine in the treatment of osteoarthritis (oa) in the elderly

Conditions: Osteoarthritis

Summary: the primary objective is to compare buprenorphine transdermal delivery system (btds) with standard- treatment in subjects with osteoarthritis (oa).


Eligibility criteria:
inclusion criteria: * either sex aged 65 or above * diagnosis of oa of the hip and/or knee * severe pain requiring step two medication * taking maximum dose of paracetamol exclusion criteria: * painful disease of the joints other than oa * contraindication to buprenorphine, other opioids, patch adhesives or nonsteroidal anti-inflammatory agents (nsaids) * subjects taking cyclooxygenase (cox) ii selective inhibitors

Keywords: oa elderly pain oa of the hips and/or knees
neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel in squamous cell carcinoma of esophagus

Conditions: Squamous Cell Carcinoma of Esophagus

Summary: albumin-bound paclitaxel regimen in advanced nsclc has a better tumor response rate and safety than solvent-based paclitaxel. however, the safety and efficacy is uncertain in neoadjuvant therapy in esophageal cancer. the objective of this single-arm phase ii trial was to evaluate the benefit of neoadjuvant chemotherapy with nanoparticle albumin-bound paclitaxel plus 5-fluorouracil in patients with locally advanced esophageal squamous cell carcinoma.

in the past decade, clinical trials have evaluated the role of neoadjuvant chemotherapy, radiation, or both, for patients with surgically resectable esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. in eastern countries, preoperative chemotherapy followed by radical surgery became one of the treatment strategies for resectable, clinical stage ii or iii esophageal cancer. in an effort to improve the efficacy of systemic chemotherapy, we conducted a prospective study to evaluate the regimen of nanoparticle albumin-bound paclitaxel plus 5-fluorouracil as perioperative therapy for patients with resectable esophageal carcinoma.

Eligibility criteria:
inclusion criteria: * histologically confirmed squamous cell carcinoma of the thoracic esophagus, including the gastroesophageal junction (siewert type i) * locally advanced disease that is technically operable with curative intent (r0) * t3, n0 or t1-3, n+ or t4, nx * no t1-2, n0 * no inoperable t4 (unequivocal organ involvement) * no distant metastasis, including m1a lymph node status * lymph nodes suspicious of m1a status by ct scan, pet scan, or ultrasound must be verified by fine-needle aspiration cytology * no carcinoma of the cervical esophagus * obstructive tumors allowed exclusion criteria: * not suitable to surgery * cervical esophageal carcinoma(distance of incisor tooth\<19cm) * early esophageal carcinoma(stage i) * complete esophageal obstruction，esophageal perforation or hematemesis * other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ * pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives * uncontrolled seizures or psychiatric diseases, loss of control over their own behavior * history of serious allergic or castor oil allergy * patients who are not suitable to participate in the trial according to researchers

Keywords: neoadjuvant chemotherapy nab-paclitaxel carcinoma of esophagus
pre-operative neoadjuvant therapy combined with surgery for treating stage iii hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma Stage III

Summary: the purpose of present study is to evaluate whether per-operative neoadjuvant therapy combined with surgery could improve the 1-year disease-free survival of stage iii hepatocellular carcinoma patients.


Eligibility criteria:
inclusion criteria: * age 18-80 years old, both gender * confirmed diagnosis of stage iii hepatocellular carcinoma(hcc) * fulfill the criteria of surgery * no other severe comorbidity * eastern cooperative oncology group score(ecog) 0-2 * expected survival \> 3months * informed consent obtained. exclusion criteria: * received chemoradiotherapy or other antineoplastic drugs * severe cirrhosis with child-pugh score \>10 * total bilirubin \> 1.5 times upper limit, ast or alt \> 2times upper limit, indocyanine green retention rate after 15 min(icg15) \>=40%; * not fulfill the surgery criteria * received major surgery within 1month * history of other tumor * participate other clinical trial within 1month * drug or alcohol abuse, aids * uncontrollable epileptic seizure or cognitive disorder * severe allergy * other unsuitable conditions.
follow-up of immunogenicity of influenza virus vaccine, adimflu-s (a/h1n1), in healthy volunteers after 6 months

Conditions: Influenza

Summary: in the spring of 2009, a recently emerged novel influenza a (h1n1) virus was first identified in mexico and usa and it has continued to spread globally. the rapid global spread of a novel influenza a (h1n1) 2009 virus prompted the world health organization (who), on 11 june 2009, to declare the first influenza pandemic in 41 years. in taiwan, a clinical study to assess the immunogenicity and safety of influenza virus vaccine, adimflu-s (a/h1n1), in healthy volunteers has already been completed. in the previous study, we found that a single 15 mcg ha dose of the adimflu-s (a/h1n1) vaccine induces a protective immune response in most adults, including those \> 60 years of age (\>70%). our current study aims to follow-up subjects who received influenza virus vaccine, adimflu-s (a/h1n1), six months ago. these subjects' serum samples were tested for anti-hemagglutinin (ha) antibodies by hemagglutination inhibition (hai). the seroconversion is defined as the post-vaccination serum hai titer had at least 1:40 for subjects who had seronegative pre-vaccination or a four-fold or greater increase in hai titers for subjects who had seropositive pre-vaccination serum. the immunogenicity of influenza virus vaccine, adimflu-s (a/h1n1), in adults after half a year will be analyzed and discussed among the subjects with serum hai titer had at least 1:40 at least 3 weeks after adimflu-s (a/h1n1) injection.


Eligibility criteria:
inclusion criteria: * subjects with serum hai titer had at least 1:40 at least 3 weeks after adimflu-s (a/h1n1) injection

Keywords: the immunogenicity of influenza virus vaccine, adimflu-s (a/h1n1), in adults after half a year will be analyzed and discussed.
neural predictors and neural changes associated with cognitive behavior therapy for obssesive compulsive disorder

Conditions: Obsessive-Compulsive Disorder (OCD)

Summary: the goals of the project are 1) to understand what are the neural mechanisms involved in the psychological treatment of obsessive-compulsive disorder (ocd) in children/adolescents and adults, 2) to assess potential differences in the neural mechanisms involved in the psychological treatment of ocd between children/adolescents and adults, and 3) to assess the effectiveness of intensive cbt for children/adolescents and adults with ocd.

obsessive-compulsive disorder (ocd) is a frequent and disabling disorder. cognitive-behavior therapy (cbt) is the best treatment option available for ocd, although it achieves optimum results in less than half of the patients. the investigators will investigate the main neural circuits that predict cbt outcome in ocd and the neural changes associated with cbt in two separate randomized controlled trials (rcts), one in an adult sample and another in a pediatric sample. in this two rcts, ocd participants will be randomized to either intensive cbt (20 sessions in 1 month) by a experienced clinician or a waiting-list control (wlc) and will be assessed (by a blind assessor) and scanned before and after cbt. patients will be offered cbt if they have been randomized to the wlc. at baseline, the investigators will also compare ocd patients with a group of healthy controls (hc). secondary goals of the project include 1) assessing potential differences between children/adolescents and adults in the neural mechanisms involved in cbt for ocd; 2) assess the effectiveness of intensive cbt for children/adolescents and adults.

Eligibility criteria:
inclusion criteria: (same for study 1 and study 2): 1. principal diagnosis of ocd; 2. y-bocs or cybocs ≥ 16). 3. no current psychotropic medication (except benzodiacepines for sleep). 4 ) age between 8 and 17 years (study 1) and between 18 and 60 years (study 2). exclusion criteria: (same for study 1 and study 2 1. current major depression or current/past psychosis, bipolar disorder or substance abuse. 2. developmental disorders (including autistic spectrum disorders). 3. to be pregnant or during breastfeeding 4. current cbt; nt. 5. any severe medical disorder ; 6. any contraindication for neuroimaging

Keywords: obsessive compulsive disorder intensive cognitive-behavioral therapy neuroimaging response prediction response mechanisms functional magnetic resonance imaging
study of collagen membrane in guided bone regeneration

Conditions: Cystectomy; Segmental Growing of Alveolar Tissue; Sinus Lift; Root Amputation and Apicoectomy; Periimplantitis

Summary: the main purpose of this study is to investigate the efficacy of hypro-sorb® f, a bilayered bioabsorbable membrane in inducing bone regeneration in different dental procedures requiring gbr.

guided bone regeneration is a procedure used in dentistry for the reconstruction of osseous defects around teeth, dental implants, and prior to implant placement. the main function of the membrane barrier in gbr is to mechanically prevent the undesirable penetration of epithelial cells and fibroblasts to the bone defect area, creating a secluded space where bone regeneration may occur. resorbable and non-resorbable membranes have been used in gbr. while non resorbable membranes require another surgical procedure for removing the membrane after the healing period, the resorbable membranes have the advantage of transmitting tissue fluids, excluding undesirable cell penetration and sparing an additional unwanted surgical procedure. the aim of this study is to investigate the efficacy of hypro-sorb® f, a bilayered bioabsorbable membrane in inducing bone regeneration in different dental procedures requiring gbr.

Eligibility criteria:
inclusion criteria: * cystectomy * segmental growing of alveolar tissue * lifting of the sinus bottom * root amputation * apicoectomy * filling of the alveolus after resections in prosthetic surgical practice * periimplantitis * maxillofacial surgery exclusion criteria: * inside bone fractures when acrylate adhesives are applied.

Keywords: cystectomy augmentation sinus amputation implant
weighted blanket use to reduce anxiety in oncology patients

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this clinical trial compares the effect of using weighted blankets versus regular blankets during first time infusions (e.g. chemotherapy, targeted therapy etc.) to decrease adverse side effects such as anxiety and distress in cancer (oncology) patients. feeling safe, comforted, and grounded in the world are some of the benefits noted by individuals who use weighted blankets. deep touch pressure (dtp) has been found to reduce symptoms of stress and anxiety and is defined as a sensation one feels when being hugged, squeezed, or held. dtp affects the nervous system by creating a calming effect which may lower stress and increase feelings of well-being. the use of weighted blankets may help to manage anxiety and distress during chemotherapy or immunotherapy infusions.

primary objective: i. to assess the efficacy of weighted blankets on anxiety in patients receiving infusion therapy. secondary objective: i. to assess the efficacy of weighted blankets on distress in patients receiving infusion therapy. outline: patients are randomized to 1 of 2 arms. arm i: patients use a weighted blanket for 30 minutes during the infusion appointment. arm ii: patients use a regular blanket for 30 minutes per standard of care during the infusion appointment.

Eligibility criteria:
inclusion criteria: * age 18 years of age and older * about to begin either targeted or cytotoxic chemotherapy * able to comprehend and sign a consent form * able to read and complete surveys * alert and oriented exclusion criteria: * currently using a weighted blanket at home * non-english speaking * peripheral neuropathy * fibromyalgia * open pressure ulcer * recent surgical flap * claustrophobic * weight 45 kg or less
continuous glucose monitoring (cgm) in long term care (ltc) facilities

Conditions: Diabetes; Hypoglycemia; Aging

Summary: to prospectively determine the burden of hypoglycemia (minutes spent below 70 mg/dl per day, measured by continuous glucose monitor (cgm)) among residents of long term care facilities (ltc) with a diagnosis of type 1 or type 2 diabetes including key clinical subgroups (living in skilled nursing facility (snf) or nursing home (nh), on different hypoglycemic medications). this aim will be achieved by recruiting 300 residents with diabetes in 4 ltc facilities. all participants will undergo masked cgm for 10 days.


Eligibility criteria:
inclusion criteria: * adults \>64 years with diagnosis of type 1 or type 2 diabetes * using glucose-lowering medication or insulin exclusion criteria: * currently taking or planning to take hydroxyurea * patient or health care proxy refuses to sign consent form

Keywords: older adults hypoglycemia continuous glucose monitoring long-term care facilities
tailored internet information supply for patients

Conditions: Headache

Summary: medical expert systems in combination with portal searching meta-search engines are exploited to provide reliable patient-tailored information. a prototype of a web-based information system has been developed and is to be evaluated. its aim is to answer the decisive question whether expert system guided internet meta-search provides a better information supply for patients seeking health information online then this is possible by using ordinary search engines or health portals. the research does neither investigate the influence of ethical nor legal aspects of internet health information supply.


Eligibility criteria:
inclusion criteria: * age between 18 and 75 * suffers at least occasionally from headaches * has internet access * has not obtained a medical diagnosis (concerning this headache) by a physician, yet exclusion criteria: * age under 18 * age over 75 * does never suffer from headaches * has no internet access * has already gotten a medical diagnosis for her/his headaches

Keywords: internet information supply tailoring patient empowerment headaches consumer health information information services information storage and retrieval information systems
hypnosis in virtual reality in patients in protector isolation room for aplasia in clinical hematology.

Conditions: Aplasia

Summary: hematology patients are frequently treated in hospital for aplasia. patients are then placed in protective isolation room. this situation of protective isolation can represent a significant source of stress and anxiety for the patient. hypnosis is already used to treat anxiety in patients with cancer. the purpose of this study is to evaluate the impact of virtual reality medical hypnosis sessions on anxiety and chronic pain of patients hospitalized for aplasia in order to broaden the supportive care proposals in the clinical hematology service of sévigné private hospital.

after verifying the patient's eligibility criteria and obtaining the signed informed consent form, the patient is randomized to the arm receiving hypnosis in virtual reality or to the control arm. the study ends after three consecutive days in protector isolation with one session hypnosis in virtual reality per day.

Eligibility criteria:
inclusion criteria: * patient aged ≥ 18 years. * haematological pathology * patient hospitalized in protective isolation for aplasia defined by a rate of polymorphonuclear neutrophils \<0.5 g / l. * patient having signed his informed consent. * patient with social security coverage. * patient treated and monitored in the center for the duration of the study (maximum 1 month) exclusion criteria: * patient unable to undergo protocol monitoring for psychological, social, family or geographic reasons. * patient deprived of his liberty or under guardianship. * patient with an underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic * patient with a contraindication to the use of virtual reality (psychiatric disorders, unbalanced epilepsy, visual or hearing disorders).

Keywords: aplasia anxiety hypnosis virtual reality protector isolation