Kornimate/medical-research-clean huggingface dataset:
dose ranging trial to determine the safety and efficacy of ema401 in patients with phn

Conditions: Neuralgia, Postherpetic

Summary: the study is a randomized, double blind, placebo-controlled, parallel-group comparison (two dose levels of ema401 versus a placebo group), of safety and efficacy in patients with postherpetic neuralgia.

screening period (up to four weeks) to confirm eligibility for the study which will be determined by screening tests, physical examination/medical history and fulfillment of eligibility criteria including assessment of pain. study period (14 weeks) approximately 360 eligible male and female patients will receive double-blind treatment for 14 weeks. patients will be randomized in a 1:1:1 ratio to treatment with ema401 100 mg bid, 300 mg bid or placebo. patients will attend the study site at the end of the baseline visit and end of weeks 1, 3, 5, 7, 9, 11, 13, and 14 for on-study assessments.

Eligibility criteria:
inclusion criteria: * be diagnosed as suffering from phn defined as pain in the region of the rash persisting for more than six months after onset of herpes zoster rash. * be assessed as suffering from moderate to severe pain across the screening period. the assessment of moderate and severe pain will be made using an algorithm proprietary to spinifex. the investigator/site staff will be informed immediately as to whether the patient is eligible or ineligible on the epro website based on the patient entering all relevant pain scores in the ediary device. * women of child bearing potential (wocbp) must have a negative urine pregnancy test at the screening visit (visit 1) and within 72 hours prior to administration of ip. exclusion criteria: * patients taking any topical treatment for their phn at the time of screening visit 2 will be excluded, including lidocaine plaster, capsaicin patch, and any other topical preparations of these or any other topical medications (e.g., aspirin, non-steroidal anti-inflammatory drugs (nsaids)) for their phn. * have a blood pressure reading, after resting for at least five minutes, outside a systolic blood pressure range of 84-151 mmhg or a diastolic blood pressure \> 95 mmhg. if the blood pressure is outside of the range, a repeat measurement can be taken after the patient has rested. the repeat measurement should be used as the screening value. * have serum aspartate transaminase (ast) or alanine transaminase (alt) levels \> 1.5 x the upper limit of normal or have total bilirubin concentrations \> 1.5 x the upper limit of normal at screening (visit 1). * patients who have a known diagnosis of diabetes and are stable on medication with a hemoglobin a1c \> 8%. those who do not have a known diagnosis of diabetes with a hemoglobin a1c \> 7%. * have active herpes zoster upon physical examination at screening (visit 1) or during the study. * known history of, or positive laboratory result for hepatitis b virus (hbv), hepatitis c virus (hcv) or human immunodeficiency virus (hiv) infection as defined by being seropositive for hepatitis b surface antigen (hbsag), hcv antibodies or hiv antibodies respectively.
effectiveness of intensive rehabilitation on shoulder function after proximal humerus fracture

Conditions: Fracture of Proximal Humerus

Summary: the fracture of the proximal humerus represents 4% of the fractures encountered in clinics and it must be treated surgically. thus, the aim of the surgical treatment is to maintain bone alignment, articular congruity, vascularization of the humeral head and provide a painless shoulder with satisfactory function. the objective of this study is to demonstrate the potential benefits of an early rehabilitation program on shoulder function.


Eligibility criteria:
inclusion criteria: * male or female over 18 years * unstable fracture of the proximal humerus * two-part and three-part fractures according to the neer classification * closed fracture * time between trauma and surgery less than or equal to 7 days * signing of consent form exclusion criteria: * stable fracture of the proximal humerus (not requiring surgery) * four-part fracture on the neer classification * fracture-dislocation or fracture involving the articular surface * isolated fracture of the large or small tuberosity * pathological fracture * fracture associated with neuro-vascular lesions * bilateral fractures * fracture associated with long bones fracture * polytrauma * previous history of fracture or surgery to the ipsilateral proximal humerus * severe copd * severe neuromuscular disorders (parkinson, hemiparesis, myasthenia gravis, muscular dystrophy, etc. ...) * remote location of patient's home which makes it difficult to come to facility for follow-up visits * any medical condition making it impossible for the patient to perform the exercise program (alzheimer, dementia, etc. ...) * man or woman incapacitated sign consent form * any other condition which prevents the assessor from fully monitoring the patient during study.

Keywords: humerus fracture locked plate
a study to evaluate the efficacy of eplerenone compared with losartan for the treatment of patients with mild to moderate hypertension

Conditions: Hypertension

Summary: the purpose this study is to compare the efficacy of eplereonone and losartan in patients with mild to moderate hypertension.

this phase 2 study epla-0501-072 (a6141012) was conducted beginning 02 april 2003 and was prematurely terminated due to poor enrollment on 12 september 2003. there were no statistical analyses of efficacy conducted because the numbers of patients enrolled were insufficient for inferential analysis due to the poor enrollment. there were no serious adverse events or deaths reported during the study.

Eligibility criteria:
inclusion criteria: * history of mild to moderate hypertension, or newly diagnosed hypertension, defined as sedbp ≥90 mmhg and \<110 mmhg and sesbp \<180 mmhg * withdrawal of all previous antihypertensives prior to the single-blind placebo run-in period and the double-blind treatment period exclusion criteria: * secondary hypertension (e.g., renal, renovascular, or adrenocortical disease, pheochromocytoma, cushing's syndrome, primary aldosteronism, iatrogenic), severe hypertension, or malignant hypertension * the patient cannot withdraw from antihypertensives by any route including diuretics, alpha-blockers, betablockers, calcium channel blockers, ace-i, arb, or other medications affecting blood pressure; patients who have stable angina and have not had their nitrate dosage changed within the past three months (i.e., on a stable maintenance dose) are eligible for this study; sildenafil citrate, theophylline, or papaverine must not be taken within 24 hours prior to a clinic visit
a study to test the efficacy of the hbv vaccine and to look at the prevalence of hbv infection

Conditions: Hepatitis b Virus

Summary: the prevalence of hepatitis b core antigen in the thai population is about 70 %, no data of isolated hepatitis b core antigen is reported. hepatitis b core antigen is observed in 10%-20% of individuals from low endemic areas of hbv infection. however, this prevalence of isolated antihbc would be higher in endemic area of hbv infection. there is conflicting data of occult hbv infection in hiv infected patients. in thailand, perinatal transmission is the main route of transmission which is different from developed countries. therefore, isolated antihbc in thai people has longer duration than low prevalence regions. moreover, hbv genotype c and b is common in this region. if the hbv vaccination could eliminate an occult hbv infection in these individuals, the liver related mortality might be reduced. the prevalence and clinical importance of isolated antihbc in thai have not been investigated yet. there is also limited data of hbv vaccine response in this setting.

the prevalence of the hepatitis b core antigen (anti-hbc)in the thai population is about 70 %. no data of isolated anti-hbc is reported. anti-hbc antigen is observed in 10%-20% of individuals from low endemic areas of hbv infection. the prevalence of isolated antihbc antigen is expected to be higher in endemic areas of hbv infection. there is conflicting data of occult hbv infection in hiv-infected patients. in thailand, perinatal transmission is the main route of hbv transmission, different from developed countries. therefore, isolated anti-hbc in thai people has longer duration than low prevalence regions. moreover, hbv genotype c and b is common in this region. hbv genotype c is correlated with more cirrhosis and hepatoma than genotype b. a study from taiwan demonstrated that hbv dna \> 100,000 copies/ml is correlated with cirrhosis and hepatoma. sustained reduction of hbv replication lowers the risk of hepatoma in hbv related cirrhosis. if the hbv vaccination could eliminate an occult hbv infection in these individuals, the liver related mortality will be reduced. the prevalence and its clinical importance of isolated anti-hbc in the thai population has not been investigated yet. there is also limited data of hbv vaccine response in this setting.

Eligibility criteria:
inclusion criteria: * hiv-infected adults followed at hiv-nat and hiv-nat affiliated hospitals and un-infected hiv adults followed at chulalongkorn hospital and blood bank * antihbc positive without hbsag and antihbs * written inform consent exclusion criteria: * patients receiving, or with an anticipated need to receive, any concomitant medications with the potential to decrease the response to hbv vaccine such as long term steroid user, chemotherapy, cancer

Keywords: isolated hbc hbv vaccine response occult hbv in isolated antihbc compared hiv to non hiv
36 versus 42 hour time interval from ovulation to intrauterine insemination

Conditions: Infertility

Summary: the purpose of this study is to prove that a higher clinical pregnancy rate can be achieved with a 42 to 44 hour time interval between ovulation trigger and intrauterine insemination than a 36 to 38 hour time interval in stimulated cycles utilizing gonadotropins and gnrh antagonists.


Eligibility criteria:
inclusion criteria: 1. patients who can be monitored for follicle growth and hormone measurements on the day of ovulation trigger, or one day before. 2. patients who have no more than 4 follicles of 14 mm or more 3. patients who have no more than 6 follicles of 10 mm or more exclusion criteria: 1. patients who cannot give informed consent to language or comprehension barriers 2. patients who are deemed to be at high risk for high order multiple gestations 3. patients who cannot be monitored on the day of hcg administration or one day before
a study to assess s-217622 in participants with mild and moderate hepatic impairment and healthy control participants

Conditions: Hepatic Impairment

Summary: the objective of this study is to assess the pharmacokinetics (pk), safety, and tolerability of s-217622 in participants with mild and moderate hepatic impairment compared with control participants with normal hepatic function.


Eligibility criteria:
inclusion criteria: * body weight ≥50 kilograms (kg) and body mass index (bmi) within the range of ≥18.5 to \<38.0 kilogram-meter squared (kg/m\^2) at the screening visit. participants with hepatic impairment * a diagnosis of clinically stable hepatic disease for at least 1 month prior to the screening visit, confirmed by medical history or previous confirmation of hepatic cirrhosis by liver biopsy or medical imaging technique (including laparoscopy, computerized tomography \[ct\] scan, magnetic resonance imaging \[mri\], or ultrasonography). * mild or moderate hepatic impairment based on the child-pugh classification score at the screening visit to determine eligibility: 1. mild (class a) hepatic impairment (child-pugh classification score 5 to 6) 2. moderate (class b) hepatic impairment (child-pugh classification score 7 to 9) * a stable medication regimen is required, defined as not starting new drug(s) or changing dosage(s) within 14 days prior to administration of study intervention through the follow-up/early termination visit. healthy participants * matched to each participant with moderate (and mild when possible) hepatic impairment with respect to sex, age (± 5 years), and bmi (± 10%). exclusion criteria: * history or presence of/significant history of or current cardiovascular, respiratory, renal, gastrointestinal (gi), endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data. * history of gi surgery including but not limited to gastric resection and/or intestinal resection that resulted in a clinically significant abnormality in gi function. * lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. * breast cancer within the past 10 years. * participant with poor venous access. other inclusion and exclusion criteria may apply.
influence of propranolol on conditioned pain modulation

Conditions: Healthy Subjects

Summary: an extensive amount of studies indicate that conditioned pain modulation (cpm) test paradigms can be of use to evaluate the efficacy of the endogenous pain inhibition pathway in healthy controls and pain patients. a number of studies indicate that the autonomic nervous system (ans) responds to painful stimulation by parasympathetic activity withdrawal and up-regulation of sympathetic activity (flight-or-fight mode), but it remains unknown whether these responses predict individual pain susceptibility or cpm efficacy and whether different pain modalities evoke different physiological stress responses, i.e. do individuals with low pain tolerance exhibit more vigorous ans responses when subjected to controlled acute pain stimuli, and do high ans responsiveness to pain coincide with altered psychophysical pain levels/cpm efficacy. this study aims to investigate the effect of ans responsiveness on cpm paradigms and to investigate if an exogenous, pharmaceutically induced decrease in the sympathetic drive of the ans will yield decreased cpm efficacy.


Eligibility criteria:
inclusion criteria: * healthy subjects exclusion criteria: * drug addiction defined as the use of cannabis, opioids or other drugs * previous history of neurologic, musculoskeletal, mental illnesses or a chronic pain condition * lack of ability to cooperate * current use of medications that may affect the trial, e.g., analgesics, anti-inflammatory drugs * consumption of alcohol, caffeine, nicotine or painkillers the morning and until termination of the study on the study day * recent history of acute pain affecting the lower limb * participation in other pain trials throughout the study period * known diagnosis of cardio vascular diseases (low blood pressure, heart conditions) * asthma * decreased function of liver and kidneys * diabetes
safety, tolerance and immunogenicity of eucorvac-19 for the prevention of covid-19 in healthy adults

Conditions: COVID-19

Summary: phase i/ii study to determine safety, tolerance and immunogenicity of eucorvac-19, a recombinant protein vaccine, for the prevention of covid-19 in healthy adults


Eligibility criteria:
inclusion criteria: 1. individuals who voluntarily decide to participate in this study and provide written informed consent * healthy male and female adult at the age of 19 to 50 years (part a) * healthy male and female adult at the age of 19 to 75 years (part b) 2. individuals who are available for all visit procedures including telephone visits during the study period exclusion criteria: 1. covid-19 positive based on rt-pcr using upper respiratory tract or lower respiratory tract sampling or covid-19 antibody positive 2. history of sars-cov, mers-cov or sars-cov-2 infection 3. history of vaccination against sars-cov, mers-cov or sars-cov-2 4. immune system disorders including immunodeficiency disease 5. clinically significant abnormalities in clinical laboratory test, ecgs and chest x-ray during screening in the opinion of the investigator 6. fever within 3 days prior to screening or serious acute or chronic infection within 7 days prior to screening requiring systemic antibiotics or antivirals 7. evidence or history of serious acute, chronic, or progressive disease which, in the opinion of the investigator, makes the individual ineligible for the study 8. history of severe allergic reactions or severe hypersensitivity reactions to the ip or any of its components 9. history of therapy that might affect immunity: treatment with immunosuppresants or immune modifying drugs, anticancer therapy, or radiotherapy within 3 months prior to screening 10. women of childbearing potential who do not agree to use medically allowed methods of contraception or to be heterosexually inactive until 60 days after the last dose of the ip 11. pregnant or breastfeeding woman 12. treatment with other ips within 6 months prior to participation in this study 13. other reasons including medical reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator
the effect of heart rate variability biofeedback training on health of intrapartum women

Conditions: Mental Stress

Summary: in this study, the investigators examined the efficacy of heart rate variability biofeedback on physical and mental health problems in childbirth women.

in this study, the investigators examined the efficacy of heart rate variability biofeedback on physical and mental health problems in childbirth women. the following validated self-report measures were administered before and at five days after the intervention, perceived stress scale-10, beck anxiety inventory, and edinburgh postnatal depression scale.

Eligibility criteria:
inclusion criteria: * woman * aged 20 years or more * able to understand and write chinese * singleton birth * having a full-term and healthy newborn exclusion criteria: * suicidal ideations * psychosis * medical or obstetric complications
clinical effects of ozone therapy in cervical disc hernia

Conditions: Pain, Neck

Summary: the aim of the study is to evaluate the clinical effects of ozone-oxygen therapy as therapeutic substance for nucleolysis application in the patients with cervical disc hernia who had chronic pain and weakness on the neck, shoulders and arms

this is a retrospective, single-center study that is going to be conducted from november 2013 to may 2016 on patients visiting the pain clinic of the hospital who were treated with ozone-oxygen therapy for cervical discogenic or radicular pain. data collected from medical record forms and electronic medical record system of the hospital were used in the retrospective analysis of medical data with regard to age, gender, complications. a resident who has not involved in the study interviewed each patient by telephone on the follow up to collect the related information.

Eligibility criteria:
inclusion criteria: * continuous radicular pain radiating to the upper limb, with a duration ≥8 weeks and an intensity \>4/10 as rated by the patient on a visual analog scale (vas) * resistant to appropriate conservative treatment combining antiinflammatory drugs, and confirmed by imaging with ct or mri of a herniated disc putting pressure on a nerve root consistent with the clinical pain. exclusion criteria: * history of surgery at the cervical spine, contraindication to percutaneous chemonucleolysis (coagulopathy or infection), imaging results that did not support the clinical results, the presence of a herniated disc excluded or calcified on imaging, possible interference with pain evaluation due to any medical condition or treatment, involvement of incomplete data collection

Keywords: ozone therapy percutaneous treatment oswestry disability index (odi) visual analog scale (vas) neuropathic pain questionnaire (dn-4) cervical
laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments for stage ii-iii pelvic organ prolapse.

Conditions: Pelvic Organ Prolapse

Summary: the international continence society defines post-hysterectomy vault prolapse (phvp) as descent of the vaginal cuff scar below a point that is 2 cm less than the total vaginal length above the plane of the hymen. the incidence of phvp has been reported to affect up to 43% of hysterectomies. the risk of prolapse following hysterectomy is 5.5 times more common in women whose initial hysterectomy was for pelvic organ prolapse as opposed to other reasons. techniques available to manage phvp aim to ultimately suspend the vaginal vault. approaches include vaginal, e.g. uterosacral ligament suspension, sacrospinous ligament fixation, open procedures and more recently laparoscopic, e.g. sacrocolpopexy and uterosacral plication. data published so far do not allow to draw a firm conclusion about the best treatment to prevent phvp for women undergoing hysterectomy for stage ii-iii pelvic organ prolapse. considering this scenario, in the current study the investigators aim to evaluate short and long-term outcomes after total laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments versus vaginal hysterectomy with mccall culdoplasty for the treatment of stage ii-iii pelvic organ prolapse.


Eligibility criteria:
inclusion criteria: * stage ii-iii pelvic organ prolapse * bilateral preservation of the ovaries * sexually active women exclusion criteria: * smoking * body mass index \> 30 * strenuous activity (frequent heavy lifting) * other gynecological and non-gynecological (chronic endocrine, metabolic, autoimmune, neoplastic diseases) comorbidities * pharmacological and/or nonpharmacological treatment (including pelvic floor exercises) in the six months preceding the surgery or during the study period

Keywords: laparoscopy hysterectomy uterosacral ligaments suspension mccall culdoplasty post-hysterectomy vault prolapse
cognitive behavioral therapy for treatment of adult attention deficit hyperactivity disorder

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: this study will determine the efficacy of cognitive behavioral therapy in treating adults with attention deficit hyperactivity disorder.

attention deficit hyperactivity disorder (adhd), previously believed to be a disorder of childhood, affects as many as 5 percent of adults. adults with adhd are at high risk for academic and occupational underachievement, relationship difficulties, and reduced quality of life. this study will determine whether cognitive behavioral therapy (cbt) is more effective than adhd education and relaxation techniques in treating adults with adhd. participants will be randomly assigned to receive 12 to 15 weekly sessions of either cbt or training in which they will learn relaxation techniques and receive detailed information about adhd. questionnaires will be used to assess participants' adhd symptoms at study entry and at study completion. the study is being conducted at massachusetts general hospital in boston and requires 5 assessment visits and 12 weekly therapy visits. participants must be able to travel to boston on a weekly basis in order to participate in the study. study hypothesis: cbt is a more efficacious treatment for adult adhd than education and relaxation techniques.

Eligibility criteria:
inclusion criteria: * diagnosis of adult adhd of at least mild clinical severity (cgi score of 3 or greater) * stable on medications for adult adhd for at least 2 months * between 18 and 65 years old * be able to give informed consent and comply with study procedures exclusion criteria: * moderate to severe major depression, clinically significant panic disorder (cgi for depression or panic greater than 4), bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders * active suicidality (ham-d suicidality item rated 3 or 4) * current substance abuse or dependence * iq less than 90 * suicide risk * prior participation in cognitive behavioral therapy for adhd

Keywords: adult adhd add cbt relaxation techniques education