Kornimate/medical-research-clean huggingface dataset:
clinical outcome of a patented pharmaceutical composition (kt-110) to treat alcohol use disorder while avoiding major side effects

Conditions: Alcohol Use Disorder

Summary: double-blind randomised, parallel-group, three-arm, multicentre, placebo-controlled study the primary objective is to demonstrate the superiority of the combination of periactine® (cyproheptadine 8 mg/day or 12 mg/day) and alpress® (prazosin 5 mg/day or 10 mg/day) over placebo on the reduction of the total alcohol consumption (tac), in alcohol-dependent patients. 180 patients will be randomised into the two treatment groups (n=60 in the low-dose group and n=60 in the high-dose group) and the placebo group (n=60).


Eligibility criteria:
inclusion criteria: * severe alcohol use disorder * high-risk alcohol consumption exclusion criteria: * patient with orthostatic hypotension * patient with hypotension * history of uncontrolled hypertension * patient at risk for urinary retention associated with urethroprostatic disorders * patient with a clinically-active malignancy * patient with a confirmed cirrhosis * history of bronchial asthma * history of uncontrolled hyperthyroidism * history of cardiovascular disease not under control * severe psychiatric disorder * history of alcohol withdrawal syndrome
standard versus high dose ed-initiated buprenorphine induction

Conditions: Opioid Use Disorder

Summary: this study is a multisite double-blind, double-dummy, randomized clinical trial enrolling ed patients with untreated moderate to severe opioid use disorder (oud) to compare standard dose induction (sdi) and high dose induction (hdi) on rates of participation in oud treatment within 10 days post randomization, and opioid withdrawal symptoms, opioid craving, and use of illicit and non-prescribed drugs.

this study will recruit, train, and provide resources to approximately 4 ed systems throughout the u.s. to recruit ed patients presenting with oud not receiving medications for opioid use disorder (moud) as part of an rct to compare sdi (zubsolv 5.7/1.4 mg buprenorphine/naloxone\* plus 2 placebo tablets) with hdi (three zubsolv 5.7/1.4 mg\* buprenorphine/naloxone tablets) to evaluate rate of participation in oud treatment within 10 days post-randomization and differences in outcomes of tolerability, opioid withdrawal symptoms, craving, and use of illicit drugs.

Eligibility criteria:
inclusion criteria: all patients enrolled into the study must: 1. be 18-65 years of age. 2. be treated in the ed during study screening hours. 3. meet dsm-5 diagnostic criteria for moderate to severe oud. 4. have a clinical opiate withdrawal scale (cows) score of ≥8 at enrollment (including 2 objective signs of withdrawal at enrollment). 5. have a urine toxicology test that is positive for opioids. 6. be able to speak english sufficiently to understand the study procedures and provide written informed consent to participate in the study. exclusion criteria: all patients enrolled into the study must not: 1. have a medical or psychiatric condition that requires hospitalization at the time of index ed visit. 2. have a known hypersensitivity reaction to buprenorphine/naloxone 3. be actively suicidal or severely cognitively impaired precluding informed consent. 4. require ongoing prescription for opioid analgesics. 5. have a physical exam or reported history consistent with severe liver failure 6. have a positive urine test for methadone and reported use in the past 72 hours 7. be a prisoner or in police custody at the time of index ed visit. 8. be unwilling to follow study procedures (e.g., unwilling to provide permission to contact referral provider/program or unavailable for the follow-up assessments) 9. have prior enrollment in the current study. 10. receiving moud treatment within the past 7 days. 11. be pregnant as determined by human gonadotropin (hcg) testing at the index ed visit 12. have a respiratory rate \<8 or oxygen saturation \<93% 13. be a participant in any other clinical trial in which medications are being delivered or the use of an investigational drug or device within the last 30 days

Keywords: buprenorphine substance use disorder treatment
randomized double blinding controlled study on" jia wei xiao yao jiaonang" treating mild to moderate major depressive disorder

Conditions: Depressive Disorder

Summary: this is a randomized, double-blind multi centric clinic study. both of therapist and patient are blind. there are 180 patients from 3 hospitals included, who meet dsm-iv criteria for major depressive disorder, the score of hamd-item\>20，\<35；and meet the criteria for tcm syndrome of "liver qi stagnation and transformation of stagnant qi into fire". patients are randomized to jwxy and sertraline treatment groups, receiving oral sertraline (start with 50 mg/day for one week then continue with 50 mg/day) plus placebo of jwxyjn; or oral jwxyjn plus placebo of sertraline daily for 2 months. the symptoms of depression and anxiety are measured with hamd and hama tests at baseline and at 2，4，8 weeks; and lft, bun, cr are assessed at baseline and end of program. then data will be analyzed with spss software to determine the efficacy and safety of jwxyjn comparing to sertraline in the treatment of mild to moderate major depressive disorder.


Eligibility criteria:
inclusion criteria: * patients 18 years or older. * a diagnosis of mdd, single episode or recurrent, according to dsm-iv * meets dsm-iv criteria for major depressive disorder. * factor score from the 24-item hamilton depression rating scale (ham-d) \>20,\<35 * patients must be able to provide written informed consent exclusion criteria: * patients with a current (or within 6 months prior to the screening visit) axis i disorder of post traumatic stress disorder, eating disorder, obsessive compulsive disorder. * patients with a history of schizophrenia, schizoaffective disorder or bipolar i or ii disorder (with a history of hypomanic or manic episodes). * patients who meet dsm-iv criteria for substance abuse (alcohol or drugs) within 3 months prior to screening visit or substance dependence within 6 months prior to the screening visit. * patients who meet criteria for any of the following dsm-iv mdd specifiers: \[a\] with catatonic features; \[b\] with postpartum onset; \[c\] with seasonal pattern \[d\] with psychotic features. * patients who are receiving formal psychotherapy or have had psychotherapy within the 12 weeks prior to the screening visit.

Keywords: efficacy, safety, jwxyjn
effect of hip abductors versus knee extensor strengthening in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this study will try to answer the following question: would strengthening of hip abductors be equal to, or more effective than, knee extensors strengthening in improving pain, function and knee extensors isometric strength in patients with knee osteoarthritis

a total of 70 patients with knee osteoarthritis will be recruited all patients who will participate in the study will be referred by orthopedists. patients with knee osteoarthritis will be included with age ranges from 50-70. they will be randomized into 2 groups; hip abductors strengthening (has) group a will receive hip abductors strengthening exercises, and knee extensors strengthening (kes) group will receive quadriceps strengthening exercise. all patients who will meet the study criteria will get a complete knowledge of the objectives and procedures of the study. inclusion criteria: 1. patients with knee osteoarthritis grade ii- iii kellgren- lawrence scores 2. their age is 50-70\[wang et al.,2019\]. 3. body mass index (bmi) 25-30. exclusion criteria: 1. patients who had surgical intervention in the knee and/or hip. 2. fracture in the lower limbs. 3. malignancy 4. any associated ligamentous injuries in knee or ankle. 5. spinal cord injury. 6. hormonal imbalance or on hormonal therapy 7. knee injection within the last 6 months prior to the study. outcome parameters including quadriceps muscle strength, the arabic version of western ontario and mcmaster universities arthritis index questionnaire total score and 3 subscales and timed up and go test score

Eligibility criteria:
inclusion criteria: 1. patients with knee oa grade ii- iii kellgren- lawrence scores 2. their age is 50-70\[wang et al.,2019\]. 3. body mass index (bmi) 25-30. exclusion criteria: 1. patients who had surgical intervention in the knee and/or hip. 2. fracture in the lower limbs. 3. malignancy 4. any associated ligamentous injuries in knee or ankle. 5. spinal cord injury. 6. hormonal imbalance or on hormonal therapy 7. knee injection within the last 6 months prior to the study.

Keywords: knee osteoarthritis and hip abductors and quadriceps
sonographic features of normal soft tissues of the feet

Conditions: Foot Disease; Healthy

Summary: the purpose of this study is to study normal sonographic(ultrasound)anatomy of the soft tissues of the foot in normal volunteers.

to study normal sonographic anatomy of soft tissues of the foot \[which include extensor retinaculum, sinus tarsi, ligaments and tendons, spring ligament and their attachments to underlying bones\] in asymptomatic individuals/volunteers.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * no disease or abnormality of the feet exclusion criteria: * abnormality of the feet

Keywords: anatomy foot sonography medical
long-term extension study evaluating extended release ropinirole xl (formerly referred to as ropinirole cr) in patients who already completed either study 167 or 164

Conditions: Parkinson Disease

Summary: the purpose of this study is to obtain information on the long-term safety, tolerability, and therapeutic benefit of extended release ropinirole xl, and to provide a mechanism for patients who participated in either study 167 or study 164 to continue receiving ropinirole xl if they chose to do so.


Eligibility criteria:
inclusion criteria: * males or non-pregnant/non-breast feeding females * at least 30 years of age * diagnosis of idiopathic parkinson''s disease (hoehn \& yahr criteria) * completed either study 167 or study 164 exclusion criteria: * presence of uncontrolled psychiatric, hematological, renal, hepatic,endocrinological, neurological, cardiovascular disease or active malignancy * dizziness or fainting due to orthostatic hypotension on standing * significant sleep disorder * drug abuse or alcoholism

Keywords: ropinirole ir efficacy safety open-label long term safety; requip ropinirole xl ropinirole cr parkinson's disease
study to evaluate the safety and immunogenicity of fluarix™ 2006/2007 in adults aged 18 years or above

Conditions: Influenza

Summary: vaccination is currently the most effective mean of controlling influenza and preventing its complications and mortality in persons at risk. because of the variable nature of influenza viruses, the composition of influenza vaccines changes almost every year, to target the 3 main circulating strains. each year the influenza vaccine formulation may thus be different and clinical studies are mandated to ensure that the immunogenicity and safety of the vaccine formulated from the three annual circulating strains are similar to what was observed during the previous years. this study is designed to test the immunogenicity and reactogenicity of the fluarix™ vaccine containing the influenza strains recommended for the 2006-2007 season.


Eligibility criteria:
inclusion criteria: * a male or female aged 18 years or above at the time of the vaccination; * healthy subjects or with well-controlled chronic diseases; * if the subject is female, she must be of non-childbearing potential exclusion criteria: * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study. * administration of an influenza vaccine within 6 months preceding the study start. * administration of an influenza vaccine other than the study vaccine during the entire study * clinically or virologically confirmed influenza infection within 6 months preceding the study start * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute disease at the time of enrolment. * acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * not stabilized or clinically serious chronic underlying disease * lactating female. * history of chronic alcohol consumption and/or drug abuse. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Keywords: influenza, vaccine prophylaxis of influenza
computer-assisted cognitive rehabilitation (cacr), placebo cacr and psycho-stimulants in the treatment of adhd

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: current research aimed to compare the efficacy of computer-assisted cognitive rehabilitation (cacr), stimulant drugs and placebo cacr on executive functions and clinical symptoms of children with attention deficit/hyperactivity disorder (adhd).

the investigators administered a randomized controlled trial (rct) through random assignment of adhd subjects in to three different groups to compare the effects of cacr, immediate-release methylphenidate, and a placebo cacr (i.e. some computerized tasks assumed not having any therapeutic effects) on the functioning of children with adhd.

Eligibility criteria:
inclusion criteria: * adhd diagnosis * age between 7 and 12 * iq \> 85 exclusion criteria: * sever co-morbid disorder * seizure * iq \< 85 * disability * sever medical condition

Keywords: adhd
combination trial of intravenous paracetamol - morphine for treating acute renal colic in emergency setting: an optimum treatment

Conditions: Renal Colic

Summary: this randomized, placebo-controlled trial evaluated the analgesic efficacy and safety of intravenous morphine-paracetamol combination and morphine-dexketoprofen combination morphine for the optimum treatment of renal colic. combination of iv morphine and paracetamol is as effective and rapid as combination of iv morphine and iv dexketoprophen for optimum treating of renal colic.


Eligibility criteria:
inclusion criteria: renal colic patients - exclusion criteria: not renal colic patients -
a study to evaluate the efficacy and safety of hcp1004 in chronic low-back pain patients

Conditions: Chronic Low-back Pain

Summary: a randomized, double-blind, active-controlled, non-inferiority, multicenter phase iii study to evaluate the efficacy and safety of hcp1004 as compared to rld2401 in chronic low-back pain patients


Eligibility criteria:
inclusion criteria: 1. chronic low back pain ≥3 months in duration 2. quebec task force in spinal disorders class 1 or 2 3. male or female ≥ 19 years of age with following criteria: * ≥ 50 years * 19\~ 49 years with history of gastric or duodenal ulcers within the past 5 years * low back pain disease condition expected to require daily nsaids therapy for at least 12 weeks 4. vas ≥ 40 (at visit 2) (if there are any treatment history to affect the efficacy evaluation of low back pain, vas after washout period have to meet the criteria; 20% over baseline vas or change from baseline vas ≥10) exclusion criteria: 1. diagnosed with certain serious diseases that may be secondary causes of low back pain (e.g., tumors, infectious diseases, gout, etc.) 2. clinically significant neurological disease or low back pain due to trauma (e.g. spinal fracture) within the past 6 months 3. invasive procedures (using corticosteroids) in the lumbar region within the past 3 months or surgical intervention within the past 6 months or need to such interventions during the study 4. history of non-drug treatment of the lumbar region (e.g., physical therapy) for the purpose of alleviating low back pain within 7 days prior to the screening visit. 5. active gastritis, inflammatory bowel syndrome, peptic ulcer or any history of gastrointestinal bleeding duodenal ulceration within the past 3 months 6. patients with history of platelet-related disease or bleeding disorder within the past 6 months or who are taking anti-coagulants 7. patients with ischemic heart disease or severe cerebrovascular disease within the past 6 months 8. bronchial asthma or uncontrolled diabete mellitus or hypertension 9. use of peptic ulcer treatment (h2-blockers, ppi, pcab series or misoprostol), psychotropic drugs, narcotic analgesics or systemic corticosteroids within past 4 weeks 10. severe renal dysfunction (creatinine clearance ≥ 30ml/min ) or severe liver dysfunction (ast or ast ≥ 3 x unl) 11. history of malignant tumors within past 5 years 12. positive to pregnancy test, nursing mother, intention on pregnancy 13. considered by investigator as not appropriate to participate in the study with other reason
a phase i, observer-blind, placebo-controlled study of the chiron vaccine hiv p24/mf59 administered to healthy hiv-seronegative adults

Conditions: HIV Infections; HIV Seronegativity

Summary: to evaluate the safety and tolerability of the chiron vaccine human immunodeficiency virus (hiv) p24(25 or 50 micrograms)/mf59 in healthy hiv-1 seronegative adults. to evaluate the immunogenicity of the hiv p24(50 micrograms)/mf59 vaccine.

this study evaluates the safety and immunogenicity of the chiron vaccine hiv p24/mf59. in part a, 15 volunteers are randomly assigned to receive either hiv p24/mf59 or a placebo at 0, 1, and 6 months. 10 volunteers receive the vaccine and 5 volunteers receive the placebo. if no serious adverse events are observed within 1 week after the first injection in these first 15 patients, part b is initiated. in part b, 25 volunteers are randomly assigned to receive hiv p24/mf59 or a placebo at 0, 1, and 6 months. 20 volunteers receive the vaccine and 5 volunteers receive the placebo.

Eligibility criteria:
inclusion criteria volunteers must have: * good health as determined by medical history, physical examination, and clinical judgment. * negative serology for hiv infection as determined by licensed hiv elisa test performed within 6 weeks prior to first immunization. * in vitro epstein-barr virus-immortalized cell line from peripheral blood can be established (required for selected part b volunteers only). exclusion criteria co-existing condition: volunteers with the following symptoms or conditions are excluded: * significant acute systemic infection. * occupational or other responsibilities that would prevent completion of participation in the study. * any condition that might interfere with the evaluation of the study objectives. volunteers with the following prior conditions are excluded: * history of immunodeficiency, autoimmune disease, or any serious chronic illness. * evidence of psychiatric or medical history or substance abuse that would adversely affect the volunteer's ability to participate in the trial. * history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components. 1. immunosuppressive medications. * live, attenuated vaccine within 60 days of study entry. note: * medically indicated subunit or killed vaccines (e.g., influenza or pneumococcal) are not exclusionary but should be given at least 4 weeks before or after hiv immunizations to avoid potential confusion of adverse reactions. * experimental agents within 30 days of study entry. * hiv vaccine or mf59 adjuvant. blood products or immunoglobulins in the past 3 months. engaging in high-risk behavior within 6 months of study entry, i.e.: * injection drug use, sexual intercourse without a condom with 4 or more partners or with known iv drug user or hiv+ partner, or newly acquired sexually-transmitted disease.

Keywords: reference values placebos aids vaccines hiv core protein p24 hiv seronegativity mf59 oil emulsion
spectabrain: screening patients with brain tumors for efficient clinical trial access

Conditions: Brain Neoplasms

Summary: the spectabrain protocol describes a structure for screening patients with brain tumors to efficiently allocate eligible patients in relevant therapeutic biomarker-driven clinical trials. efficiency is promoted through the creation of a clinical database of brain tumor patients and the respective human biological material biobank for molecular characterization. the main objectives are to: * allocate patients to clinical trials according to the clinical characteristics and molecular profile of their tumor; * identify or validate new molecularly defined subgroups of tumors; * investigate the prevalence of novel biomarkers to plan future clinical trials; * enable exploratory/future research; * facilitate establishment of quality-assured and validated tests for central nervous system (cns) tumor biomarkers;


Eligibility criteria:
inclusion criteria: * pathologically confirmed newly diagnosed primary cns tumors, with a focus on diffuse gliomas of grades ii, iii and iv, meningiomas from patients who are candidates for pharmacotherapy, and rare cns tumors; * availability of adequate human biological material (hbm): ffpe tissue sample from the primary and/or recurrent tumor and/or metastasis, obtained at the time of surgery or biopsy; minimal amount requested is detailed in the hbm guidelines. inclusion of samples taken at any recurrence diagnosed during follow-up is strongly encouraged but optional; * at least three months life expectancy; * written informed consent according to ich/gcp and national/local regulations; * absence of exclusion criteria, such as active hepatitis b/c or hiv, second malignancies, severe organ dysfunction, or other comorbidities that will prevent inclusion into clinical trials.

Keywords: brain tumor biomarkers screening
phase 3 study of khk7580

Conditions: Secondary Hyperparathyroidism

Summary: this long-term study is designed to evaluate safety and efficacy of khk7580 orally administered once daily for 52 weeks for patients with secondary hyperparathyroidism receiving hemodialysis.


Eligibility criteria:
inclusion criteria: * personally submitted written voluntary informed consent to participate in the study * stable chronic renal disease treated with hemodialysis 3 times weekly for at least 12 weeks before screening * intact pth level of \> 240 pg/ml at screening (except subjects receiving cinacalcet hydrochloride at screening) exclusion criteria: * change in dose or dosing regimen of cinacalcet hydrochloride or activated vitamin d drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening; * parathyroidectomy and/or parathyroid intervention within 24 weeks before screening; * severe heart disease; * severe hepatic dysfunction; * uncontrolled hypertension and/or diabetes; * treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening; * primary hyperparathyroidism; * other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.