Kornimate/medical-research-clean huggingface dataset:
efficacy trial of a vaccine to prevent herpes zoster in adults over 40 years of age

Conditions: Herpes Zoster

Summary: varicella-zoster virus (vzv) is a herpesvirus that causes two distinct clinical syndromes.primary infection is manifested as varicella (chickenpox), whereas reactivation of latent vzv results in a localized eruption known as herpes zoster. more than 99.6% of people 40 years of age orolder had evidence of previous vzv infection. this study plans to have 30000 adults 40 years of age or older involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated varicella-zoster virus vaccine. the investigational vaccines are produced by changchun changsheng biotechnology co. ltd. the incidence of herpes zoster and the severity, and duration of the associated pain and discomfort were measured after the vaccination. and the safety of the varicella-zoster virus vaccine is also evaluated.


Eligibility criteria:
inclusion criteria: * healthy volunteers aged over 40 years (male or female). * able to comply with all clinical trial protocol requirements and willing to complete all the visit plan process during the whole clinical trial observation period. * able to understand the content of informed consent and willing to sign the informed consent. * able to complete the diary card independently. * for females only (40-49 years), a negative urine pregnancy test and willing to practice continuous effective contraception during the study. * axillary temperature ≤37.0°c. exclusion criteria: * prior history of herpes zoster. * prior history of vaccination with herpes zoster vaccine or chickenpox vaccine. * history of allergic disease likely to be exacerbated by any component of the vaccine. * taking immunoglobulins and/or any blood products within the last 3 months or will receive these products during the study period. * taking certain pharmaceuticals to be like salicylate kind, including aspirin, and difluorosalicylic, or going to take these medicine during the study period. * participation in another research study involving receipt of an investigational product in the last 30 days. * prior administration of attenuated vaccine in last 28 days. * prior administration of subunit vaccine, inactivated vaccine or allergic therapy in last 14 days. * history of serious disease and the participation in the clinical trial is likely to increase the disease risk and interfere with the observation of clinical trial index. * taking immunosuppressive therapy in last 6 months. * any autoimmune disease or immunodeficient state, autoimmune disease or immunodeficient disease. * active tuberculosis patient. * acute or chronic infections at the vaccination day (axillary temperature\>37.0°c). * coagulation disorders (coagulation factor deficiency, coagulopathy or platelet disorder) diagnosed by doctors, or obvious bruises or blood coagulation noticed. * woman who is breast-feeding. * any other conditions may compromise the safety or availability of participants in the judgment of the investigator.
the role of pain-related fear in sexual pain

Conditions: Sexual Pain Disorders

Summary: the purpose of this study is the evaluate the extent to which an intervention aimed at reducing pain-related fear affects sexual function and pain sensitivity compared to usual care.

the overarching goal of this work is to identify the mechanisms underpinning sexual pain in women. women with sexual pain exhibit higher vaginal pain sensitivity and lower levels of sexual desire and arousal compared to pain-free women. as a result of pain, sexual intercourse is avoided. previous work in this area has examined a wide variety of interventions for sexual pain but has not examined how vaginal pain sensitivity and resulting sexual dysfunction may be mediated by pain-related fear. the study team proposes that a standardized exposure intervention that directly targets pain-related fear will in turn reduce vaginal pain sensitivity and translate to clinically meaningful changes in sexual function. the study team will assign women with sexual pain to receive a home-based, patient-controlled exposure intervention or standardized home-based home program. the specific aims of this proposal are: 1) to evaluate the extent to which pain-related fear mediates vaginal pain sensitivity in women with sexual pain; 2) to evaluate the extent to which graded exposure translates to changes in sexual function and partner dynamics. the completion of this work will provide us with a better understanding of the mechanisms underpinning sexual pain and specifically, how pain-related fear influences vaginal pain sensitivity and sexual function.

Eligibility criteria:
inclusion criteria: * females with sexual pain \>= 6 months * appropriate to use vaginal dilators * the ability to read english and understand the informed consent form and screening questions * the ability and willingness to follow all requirements of the study including following all directions and completion of daily pain reports * signed informed consent * are sexually active (have had intercourse at least twice in the last 30 days) * pain-related fear of intercourse greater than 50 on the numerical fear rating scale exclusion criteria: * physical, psychological and medical issues, encountered during routine care that are felt insufficient for trial participation (physician discretion), such as poor mental status or neurological deficit limiting participation physically or cognitively (mini-mental state exam less than 20). * women with sexual pain who are not sexually active (have not had intercourse at least twice in the last 30 days) * participants who use narcotic pain medication * participants diagnosed with a major depressive disorder * participants who exhibit signs and symptoms of infection, malignancy, or other conditions identified by a member of the study team that may be contraindications to the use of dilators * unable to readily access computer with internet for reporting on daily fear levels and dilator size * pain-related fear of intercourse less than 50 on the numerical fear rating scale * women who are pregnant * participants who report a history of sexual abuse or trauma.
a study to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis c virus (hcv) infection and cirrhosis

Conditions: Chronic Hepatitis C Infection; Compensated Cirrhosis

Summary: the purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis c virus (hcv) infection and cirrhosis.

this was a multicenter study evaluating the efficacy and safety of ombitasvir/ paritaprevir/ritonavir and dasabuvir administered for 12 weeks in hcv genotype 1b (gt1b)-infected, treatment-naïve and previous pegylated interferon (pegifn)/ ribavirin (rbv) treatment-experienced adults with compensated cirrhosis. the duration of the study was up to 36 weeks (not including a screening period of up to 42 days) and consisted of a 12-week treatment period and a 24-week post-treatment period for all participants who received study drugs.

Eligibility criteria:
inclusion criteria: 1. chronic hcv genotype 1-infection prior to study enrollment. chronic hcv-infection is defined as the following: * positive for anti-hcv antibody (ab) or hcv rna \> 1,000 iu/ml at least 6 months before screening, and positive for hcv rna and anti-hcv ab at the time of screening; or * hcv rna \> 1,000 iu/ml at the time of screening with a liver biopsy consistent with chronic hcv-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis c disease). 2. screening laboratory result indicating hcv genotype 1b-infection. 3. compensated cirrhosis defined as a child-pugh score of 5 or 6 at screening. exclusion criteria: 1. women who are pregnant or breastfeeding. 2. positive test result for hepatitis b surface antigen (hbsag) or positive human immunodeficiency virus (hiv) antibody (confirmed by western blot). 3. any current or past clinical evidence of child-pugh b or c classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy. 4. confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (ct) scan or magnetic resonance imaging (mri) within 3 months prior to screening or on an ultrasound performed at screening (a positive ultrasound result will be confirmed with ct scan or mri.) 5. use of contraindicated medications within 2 weeks of dosing 6. screening laboratory analyses showing any of the following abnormal laboratory results: * calculated creatinine clearance (using cockcroft-gault method) \< 30 ml/min * albumin \< 2.8 g/dl * international normalized ratio (inr) \> 1.8. participants with a known inherited blood disorder and inr \> 1.8 may be enrolled with permission of the abbvie study designated physician. * hemoglobin \< 10 g/dl * platelets \< 25,000 cells per mm3 * total bilirubin \> 3.0 mg/dl

Keywords: hepatitis c chronic hepatitis c compensated cirrhosis cirrhotic hepatitis c genotype 1b hepatitis c virus interferon-free child pugh a ribavirin-free
a study to assess the effect of multiple doses of itraconazole, gemfibrozil, or carbamazepine on bms-986278 in healthy participants

Conditions: Healthy Participants

Summary: this is a study in healthy participants designed to assess the effect of multiple doses of itraconazole, gemfibrozil, or carbamazepine on the drug levels of a single-dose of bms-986278.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 18.0 kilograms per meter squared (kg/m\^2) through 32.0 kg/m\^2, inclusive. bmi = weight (kg)/(height \[m\])2. * body weight ≥ 50 kg for males and ≥ 45 kg for females. exclusion criteria: * any significant acute or chronic medical illness. * any gastrointestinal disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. note: appendectomy is allowed. * any major surgery within 4 weeks of study intervention administration. other protocol-defined inclusion/exclusion criteria apply.

Keywords: bms-986278 itraconazole gemfibrozil carbamazepine idiopathic pulmonary fibrosis drug interaction
endobronchial ultrasound vs mediastinoscopy in nsclc

Conditions: Non-small Cell Lung Cancer

Summary: proper staging of lung cancer is of paramount concern when determining a treatment regime. currently the assessment of surgical candidacy is performed with the staging process, mainly the mediastinoscopy. a mediastinoscopy has the ability to access samples of the paratracheal lymph node stations (levels 2r, 2l, 3, 4r, 4l), as well as the anterior subcarinal lymph node station (level 7). in comparison, the ebus-tbna technique is a real-time procedure that has the potential to access the same paratracheal and subcarinal lymph node stations associated with the mediastinoscopy, but also extending out to the hilar lymph nodes (levels 10 and 11). because of the possibility of extended sampling range and a reduction in procedural invasiveness, ebus-tbna may represent a more efficient patient centered alternative to mediastinoscopy in the staging of lung cancer patients. additionally, patients who are have lymph nodes in the n2 region frequently undergo chemotherapy and/or radiotherapy prior to surgery. assessment of the lymph nodes after chemo/radiation is done using ct scans, as re-mediastinoscopy is a technically difficult procedure. these patients may benefit from ebus-tbna.


Eligibility criteria:
inclusion criteria: a) age 18 years or older b) patients with confirmed or suspected non-small cell lung cancer who require a mediastinoscopy as part of their staging investigations of the mediastinum to determine suitability for lung cancer resection will be considered for the trial. c) patients with undiagnosed enlarged lymph nodes in the mediastinum suspicious for lung cancer in which a tissue diagnosis is required. exclusion criteria: a) patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy or a mediastinoscopy or who are not suitable for definitive surgical resection by thoracotomy will be excluded. b) patients who have verified stage iv disease or who are not appropriate for lung cancer resection by virtue of direct invasion of mediastinal structures or large parts of the chest wall. c) known small cell lung cancer. d) patients where there is a high clinical suspicion of lymphoma. e) inability to give informed consent.

Keywords: non-small cell lung cancer nsclc ebus endobronchial ultrasound mediastinoscopy
audit of lung cancer screening practice in chest physicians: an update

Conditions: Lung Cancer Screening

Summary: the investigators will conduct nationally representative survey in chest physicians in egypt in 2016-2017. self-administered questionnaire will be used to assess the physicians' knowledge of lung cancer screening guidelines, beliefs about the effectiveness of screening tests, and ordering of screening chest radiography, low-dose spiral computed tomography, or sputum cytology in the past 12 months.

although current practice guidelines do not recommend screening asymptomatic patients for lung cancer, physicians may still order lung cancer screening tests. no recent national survey of health care professionals has focused on lung cancer screening

Eligibility criteria:
inclusion criteria: * physicians practising in egypt (chest physicians, general practitioners, and general internists) exclusion criteria: * other nationalities * other specialities

Keywords: audit lung cancer screening practice egypt
mdr ez pass and precision flexible reamer

Conditions: Anterior Cruciate Ligament Injury; Rotator Cuff Tear

Summary: the objective of this study is to confirm the safety and performance on the ezpass suture passer instrumentation and the precision flexible reamer instrumentation. ultimately, clinical performance will be assessed through survey questions that evaluate the safety and performance of these instruments.

the primary objective of the study is to assess performance, clinical benefits and safety of the ezpass suture passer and the precision flexible reamer instrumentation. performance and clinical benefits will be assessed through an operative survey conducted immediately following intraoperative surgery. safety will be assessed by recording and analyzing the incidence and frequency of complications, adverse events, and intra-operative revisions.

Eligibility criteria:
inclusion criteria * ez pass suture passer: - intended as an open or arthroscopic instrument utilized in conjunction with a nitinol wire or nylon monofilament to aid in passing suture through soft tissue. * precision flexible reamer: * this device is a hand held, or hand-manipulated device, intended to be used in acl and pcl reconstruction surgeries and is intended for medical purposes to manipulate tissue, or for use with other devices in these surgeries. exclusion criteria * ez pass suture passer: - any use other than the approved uses indicated in the instructions for use (ifu). * precision flexible reamer: * any use other than the approved uses indicated in the instructions for use (ifu).
bone marrow aspirate concentrate (bmac)treatment for knee osteoarthritis

Conditions: Osteo Arthritis Knee

Summary: the purpose of this study is to investigate the safety and effectiveness of bone marrow aspirate concentrate (bmac) in patients with moderate to severe osteoarthritis of the knee. bmac provides a rich source of mesenchymal stem cells (mscs) and is a stem cell-based therapy that has been reported to preserve or improve the structure of joints. the angel system is the device used in this study to concentrate bone marrow from the patient and is intended to separate a mixture of blood and bone marrow and collect plasma rich platelets preoperative to a surgical procedure. the goal of this study is to identify whether bmac can be an effective and safe treatment for patients with osteoarthritis of the knee.

this is a pilot open-label, non-randomized, single institution study of bmac administration in patient's with moderate to severe osteoarthritis of the knee who will undergo total knee replacement. several weeks prior to total knee replacement, patients will have a sample of bone marrow taken from their pelvic region and concentrated using an investigational device called the arthrex angel concentrated platelet rich plasma (cprp) system also known as the angel system. the concentrated bone marrow will be immediately delivered back to the patient arthroscopically to the knee of interest. blood and tissues samples will be collected at scheduled visits for molecular and histological analysis. adverse events will be monitored throughout the trial. assessment of healing will be performed by physical exam and standardized questionnaires related to the health of the patient.

Eligibility criteria:
inclusion criteria: 1. kellgren lawrence radiographic grade iv 2. need for a total knee arthroscopy by the patients primary care provider/or orthopedist. 3. persistent pain in target knee that is unresponsive to standard of care including acetametaphine, non-steroidal anti-inflammatory drugs, physical therapy and/or intraarticular corticosteroids and/or hyaluronic acid preparations. 4. males or females aged 45-75. exclusion criteria: -

Keywords: moderate to severe knee osteoarthritis total knee replacement bone marrow stem cell-based therapy arthroscopy
prediction of lymph node status in stage t1 esophageal squamous cell carcinoma（renmin-237）

Conditions: Esophageal Squamous Cell Carcinoma

Summary: accurate assessment of lymph node status in superficial esophageal squamous cell carcinoma is of great significance for preventing undertreatment and overtreatment. however, the accuracy of the commonly used preoperative imaging methods for evaluating lymph node status is not high, and it is urgent to develop a prediction model that can predict the risk of individual lymph node metastasis to assist in clinical decision-making. in this context, investigators intend to retrospectively collect the clinical and pathological data of 300 patients with superficial esophageal squamous cell carcinoma, construct a lymph node metastasis risk prediction model. in addition, investigators are also preparing to prospectively collect tissue samples from 30 patients with superficial esophageal squamous cell carcinoma to further explore the mechanism of lymph node metastasis.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with esophageal cancer in renmin hospital of wuhan university from 2013 to 2022. 2. histopathological diagnosis was squamous cell carcinoma. 3. t1nxm0. 4. received endoscopic resection or esophagectomy. exclusion criteria: 1. patients who received neoadjuvant therapy. 2. positive surgical margin. 3. prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured. 4. lack of complete histopathological information.

Keywords: superficial esophageal squamous cell carcinoma lymph node metastasis prediction model tumor- infiltrating immune cells
efficacy and safety of bgg492 in the treatment of migraine

Conditions: Migraine

Summary: this study will assess the efficacy and safety of bgg492 used to treat migraine pain.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe migraine for at least 1 year * at least 1 migraine episode, but not more 15 migraine days per month * past use of triptans * migraine onset before 50 years of age exclusion criteria: * diagnosis of basilar, ophthalmoplegic or hemiplegic migraine. * more than 6 non-migraine headaches per month * patients receiving migraine prophylaxis treatment * patients receiving regular treatment with psychoactive drugs * smokers * patients with a very high or low body weight other protocol-defined inclusion/exclusion criteria may apply

Keywords: migraine headache
efficacy and safety of repaglinide combined with insulin in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this trial is to compare oral anti-diabetic drug (oad) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately controlled on the current oad therapy.


Eligibility criteria:
inclusion criteria: * hba1c between 7.5 % and 13.0% (both inclusive) * fasting c-peptide above or equal to 0.33 nmol/l * bmi (body mass index) between 25 and 32 kg/m2 (both inclusive) exclusion criteria: * medical history of treatment with insulin within the last 6 months * impaired renal function, defined as serum creatinine above to 1.7 mg/dl (150 µmol/l)
chronic hepatitis c and insulin resistance

Conditions: Hepatitis C; Insulin Resistance

Summary: chronic hepatitis c (chc) is among the commonest chronic infectious disease in australia with \>200,000 exposed persons. amongst non-infectious chronic conditions- type 2 diabetes, obesity and heart disease are extremely common. this study will examine the relationship between insulin resistance, fat deposition in the liver, muscle and abdomen, and liver injury due to chc


Eligibility criteria:
inclusion criteria: * caucasian male * age: 25-55 years * chronic hepatitis c (pcr positive) and fibrosis ≤ f2 (if liver biopsy done) * genotypes 1 or 3 * due to commence antiviral therapy * bmi \< 30 exclusion criteria: * cirrhosis or f3 fibrosis on liver biopsy (if done) * \> 20 g etoh per day * type 2 diabetes (need an ogtt if fasting bgl\> 5.7) * concurrent hiv * other cause of liver disease

Keywords: insulin resistance liver fat muscle fat abdominal fat cytokines
study on the measurement of retinal blood flow in children

Conditions: Myopia

Summary: in order to provide reference for clinical application, the normal values of retinal blood flow parameters in chinese healthy children were measured by oct-angiography. meanwhile, the repeatability and consistency of retinal blood flow parameters measured by oct-angiography in children were further analyzed, and the correlation of retinal blood flow parameters with eye axis, choroidal thickness, age and diopter was analyzed, so as to provide basis for clinical diagnosis of children's ophthalmopathy. objective to study the effect of short-term optical defocusing on retinal blood flow parameters, and analyze the correlation between the changes of posterior segment parameters before and after short-term optical defocusing, so as to provide the basis for the possible compensation mechanism of posterior segment optical defocusing, and further understand the possible physiological mechanism of myopia.


Eligibility criteria:
inclusion criteria: 1. the subjects should be 6-18 years old, with parents' consent and be able to abide by the experimental rules; 2. uncorrected visual acuity or spectacle corrected visual acuity ≥ 1.0, and each eye can fix the target; 3. equivalent spherical lens range + 0.50d \~ - 6.00d, binocular spherical lens anisometropia ≤ 1d, anisometropia ≤ 1.5d; 4. frame glasses can be worn for patients with ametropia, and hard contact lenses can not be worn for at least 4 weeks, and anisometropia can not be worn for 2 weeks 5. intraocular pressure in the normal range (9mmhg-21mmhg) exclusion criteria: 1. patients with history of ocular trauma and surgery; 2. patients with ocular organic lesions or systemic diseases; 3. patients with dry eye; 4. patients in the treatment period using drugs (such as atropine eye drops); 5. patients with poor cooperation or unqualified image quality