bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Performance Characteristics of Capsule Endoscopy With PillCam UGI Capsule Compared to Standard Endoscopy
Condition: Barrett Esophagus
MeSH terms: Barrett Esophagus
Study type: Observational

Summary: 
      This study is to examine the benefits of newly designed capsule with enhanced frame rate and
      wide angle compared to standard endoscopy, which may help enhance detecting esophageal
      diseases that otherwise may have been out of vision in the standard endoscopy, ultimately
      decreasing healthcare costs.
    

Detailed description: 
      This is a pilot, single center, prospective, tandem study. All veteran patients with
      Barrett's esophagus scheduled for an upper EGD at Veterans Affairs Medical Center (Kansas
      City, MO, USA) for check-up of BE will be asked to swallow the pillcam prior to an EGD. A
      member of the research team will approach a potential subject to discuss participation in the
      study, including background of the proposed study, inclusion and exclusion criteria, benefits
      and risks of the procedures and follow-up. If this is of interest to the subject, the
      informed consent form is discussed and presented. The subject must sign the consent form
      prior to enrollment. This form will have prior approval of the study site's Institutional
      Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the
      study

      Eligible subjects at the participating institution who meet the inclusion criteria for this
      study will be offered the opportunity to participate in this clinical trial. To ensure that
      subjects are approached for potential study participation without bias, a Subject Screening
      Log will be maintained. This Log will track the basic demographic information of each subject
      approached for clinical trial inclusion and the resulting reason for exclusion from the
      clinical study if applicable.

      The duration of the study is expected to be approximately 12 months. Enrollment of Study
      patients will cease when approximately 20 patients have been enrolled.
    

Intervention name(s): Pill cam; EGD
Intervention type(s): Device; Other
Intervention description(s): Patient is asked to swallow the esophageal capsule.; Patient will undergo standard EGD
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a pilot, single center, prospective, tandem study. All veteran patients with
        Barrett's esophagus scheduled for an upper EGD at Veterans Affairs Medical Center (Kansas
        City, MO, USA) for check-up of BE will be asked to swallow the pillcam prior to an EGD.
Optimal Time to Start Antiretroviral Therapy in HIV-infected Adults With Cryptococcal Meningitis
Condition: Cryptococcal Meningitis; HIV Infections
MeSH terms: Meningitis, Cryptococcal; Meningitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this randomized clinical trial is to compare early versus standard timing of
      initiation of antiretroviral therapy (ART) with respect to clearance of Cryptococcus
      neoformans from cerebrospinal fluid (CSF) among HIV-infected adults with Cryptococcal
      Meningitis.

      The investigators hypothesize that early ART mediates more rapid clearance of C. neoformans
      from CSF, as manifested by a greater rate of decrease in C. neoformans colony forming units
      (CFUs) during the first 28 days after initiating antifungal treatment.

      Secondary hypotheses are that recovery of pathogen specific cellular immunity directed at C.
      neoformans, as manifested by increases in the number and function of C. neoformans-specific
      peripheral blood mononuclear cells is associated with 1) ART and 2) pathogen clearance. In
      addition, patients randomized to the intervention arm will have more rapid clearance of
      antigen levels in CSF and serum and will have a lower incidence of grade 3 and 4 Adverse
      events.
    


Intervention name(s): Early antiretroviral therapy
Intervention type(s): Other
Intervention description(s): The intervention is early initiation of antiretroviral therapy after diagnosis of Cryptococcal meningitis.
In the intervention/experimental arm, triple-drug highly active antiretroviral therapy regimens will be initiated within 7 days of diagnosis of Cryptococcal meningitis.
Intervention MeSH terms: Anti-Retroviral Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1; Africa; Botswana; Highly active antiretroviral therapy; treatment naive
Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol (THC) and the Ability to Drive in Chronic or Occasional Cannabis Users
Condition: Occasional (1-2 Joints Per Week) and Chronic (1-2 Joints Per Day) Cannabis Users
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      Study of the effects of smoked cannabis consumption on performance on a driving simulator and
      reaction time. The study aims to explore the relationship between concentrations of cannabis
      in the blood, driving performance and reaction time.
    

Detailed description: 
      This study will examine:

        -  The relationship between THC blood levels and driving performance measured on a York
           Driving simulator

        -  The relationship between THC blood levels and reaction times as measured on the
           psychomotor vigilance test (PVT)

        -  the pharmacokinetics of THC in occasional and chronic cannabis consumers

        -  Determine the minimum blood concentration level of THC and 11-OH-THC, below which no
           effect of cannabis is observed

        -  Determine whether the polymorphism of CYP2C9 (* 3) is associated with the AUC, Cmax, and
           higher THC T1/2

        -  Determine if the polymorphism of CYP2C9 (* 3) is associated with different
           pharmacodynamic effects at a given THC level on performance measured by driving
           simulation
    

Intervention name(s): Cannabis (THC) in cigarettes of 30mg, 10mg and placebo
Intervention type(s): Drug
Intervention description(s): Smoked THC containing cigarettes. Randomly allocated dosage 30mg, 10mg et placebo.
Both chronic and occasional cannabis consuming volunteers will be allocated to smoking a cigarette containing (1) no THC (placebo), (2) a joint containing 1% THC (10 mg THC, i.e. low-dose) and (3) a joint containing 3% (30 mg THC) mixed with 1 g tobacco.
Each cigarette will be followed by 24 hours testing in laboratory conditions. Each period is separated by 7 days (3 testing periods over 3 weeks). Each volunteer will undergo performance testing (driving simulator and PVT) before administration of the substance (T0).
Blood samples and repeat performance testing will be carried out at 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: delta-9-tetrahydrocannabinol, volunteers, cannabis users
The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      Ayurved Siriraj Prasaplai is a Thai traditional herbal drug for pain treatment. Mostly it was
      used for antipain during menstruation or dysmenorrhea. This drug has been described by
      alternative medical doctor for treatment of primary dysmenorrhea for more than 10 years and
      showed clinical satisfied response. From review about this agent, it does not have clinical
      trial to prove its efficacy. So the author produce this research to study in efficacy of
      Ayurved Siriraj Prasaplai.
    

Detailed description: 
      The participants were allocated in the study by block randomization and double blind. In
      experiment-group was treated with Ayurved Siriraj Prasaplai and control-group was treated
      with placebo (non-active agent). Both of drug was made in the same appearance of capsule
      (size and color). The participants have to start the drug when they have menstruation after
      that the dosage is 2 capsules for 3 times per day (after-meal) continue to 3 days. The
      participant have to record pain score (minimal/maximal/mean score) and multidimensional score
      in daily card, side effect and satisfaction. If the participant couldn't tolerate the pain,
      they could break the pain with mefenamic acid. They have record number of mefenamic acid
      which they used too. This study evaluate in only one cycle. After complete record, the
      participant come back to investigator for sending the report.
    

Intervention name(s): Ayurved Siriraj Prasaplai with or without mefenamic acid; Placebo with or without mefenamic acid
Intervention type(s): Drug; Drug
Intervention description(s): Prasaplai in capsule, 2 cap three times a day for 3 days. Mefenamic acid 500 mg prn for severe pain (as rescue medication); Placebo in capsule (physically identical appearance as Prasaplai) 2 cap three times a day for 3 days. Mefenamic acid 500 mg prn for severe pain, every 6 hours (rescue medication)
Other intervention name(s): Ponstan; Ponstan
Intervention MeSH terms: Mefenamic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ayurved Siriraj Prasaplai; primary dysmenorrhea
Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers
      will assess changes in the immune response that occur as a result of treatment with
      rituximab.
    

Detailed description: 
      Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers
      will assess changes in the immune response that occur after treatment with rituximab.
    

Intervention name(s): rituximab
Intervention type(s): Drug
Intervention description(s): treatment with rituximab
Other intervention name(s): rituxan
Intervention MeSH terms: Rituximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: active disease despite concomitant methotrexate
Vestibular Dysfunction In Adult Patients With Panic Disorder With or Without Agoraphobia
Condition: Anxiety Disorder; Panic Disorder
MeSH terms: Anxiety Disorders; Panic Disorder
Study type: Interventional

Summary: 
      OBJECTIVES: I. Determine whether the prevalence of abnormalities on clinical vestibular
      (balance) tests is higher in panic disorder with agoraphobia than in uncomplicated panic
      disorder and nonpanic anxiety disorder.

      II. Determine whether the prevalence of abnormalities on audiological tests of cochlear or
      brainstem function is elevated in panic disorder without agoraphobia or nonpanic anxiety
      disorder.

      III. Determine whether symptom patterns can be identified that are indicative of vestibular
      abnormalities in panic disorder.

      IV. Determine whether vestibular dysfunction can be induced by psychosomatic mechanisms.
    

Detailed description: 
      PROTOCOL OUTLINE: Patients are stratified by otoneurological function (panic disorder without
      agoraphobia, panic disorder with agoraphobia, anxiety disorder without panic or
      agoraphobia-like avoidance, and normal controls).

      Patients undergo a psychiatric interview and a structured interview focused on anxiety
      disorders. Physical evaluation is completed.

      A vestibular evaluation consisting of posturography, rotational testing, and ocular motor
      screening battery, and positional and caloric testing is completed on all patients. Patients
      then complete an audiological test battery consisting of basic audiological analysis, speech
      recognition scores, immittance testing, brainstem evoked response, and determination of
      binaural masking level differences.

      Control patients also complete a hyperventilation-rotational test.
    

Intervention name(s): Clinical vestibular tests
Intervention type(s): Procedure
Primary purpose: Diagnostic
Keywords: anxiety disorder; disease-related problem/condition; neurologic and psychiatric disorders; panic disorder; rare disease
Evaluation of an Intervention Based on Cell Phones
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of the study was to assess the effect of an individualized intervention based on cell
      phones to improve glycemic control in patients with type 2 diabetes attending Epidemiology
      Research Unit in Cuernavaca, Morelos. Mexico
    

Detailed description: 
      In this study before randomization, the participants received workshops on diet, physical
      activity, glycemic index of foods.

      Bandura´s theoretical model was used in the voice messages sent to the intervention group.
    

Intervention name(s): Voice messages
Intervention type(s): Behavioral
Intervention description(s): Voice messages reinforced with self-efficacy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cellular phones; Type 2 diabetes; Glycated hemoglobin; glycemic control
D-Stress Baltimore: School-based Mindfulness Instruction
Condition: Coping; Stress Disorders, Post-Traumatic; Mental Health Wellness 1
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Effective strategies to ameliorate the negative effects of stressful urban living are greatly
      needed. D-Stress Baltimore (DSB) is an evidence-based mindfulness-based instructional program
      of stress-reduction techniques, found to reduce mental health problems across many adult
      populations.

      The investigators propose to conduct a randomized controlled trial of the 12-week
      school-based DSB program compared with a 12-week school-based health education control
      program at Elev8 schools among 5th-8th graders to assess if DSB program is beneficial for
      mental health and behavioral problems among public middle-school students.
    

Detailed description: 
      Urban youth in Baltimore City are under significant and inevitable stresses, including
      violent neighborhoods, failing schools, and interpersonal conflict. Effective strategies to
      ameliorate the negative effects of stressful urban living are greatly needed.

      D-Stress Baltimore (DSB) is an evidence-based mindfulness-based instructional program of
      stress-reduction techniques which has been found to be beneficial for adults in decreasing
      anxiety and depression, improving positive emotions, and reducing anger.

      The investigators propose to conduct a randomized controlled trial of the 12-week
      school-based DSB program compared with a 12-week school-based health education control
      program at Elev8 schools among 5th-8th graders. The investigators hypothesize that the
      D-Stress Baltimore Program will reduce negative emotions, including hostility, and improve
      coping.
    

Intervention name(s): Mindfulness Instruction; Health Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Age-appropriate instruction on mindfulness concepts and practices, adapted from the mindfulness-based stress reduction (MBSR) program. Classes are 45-90 minutes each and held weekly for 12 weeks.; Age-appropriate health education concepts and topics. Classes are 45-90 minutes each and held weekly for 12 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: mindfulness; intervention; african american; youth; stress; poverty
The Effect of Long-term Momordica Charantia Supplementation on Blood Glucose Levels
Condition: Glucose, High Blood; Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      The study is a parallel, double blind, controlled trial in which study participants will
      receive a 12-week intervention with 3.6 g/d dried bitter-gourd supplements or a reference
      intervention with 3.6 g/d dried cucumber supplements. Research subjects will come to the
      research facility for a test day on four occasions, with an interval of 4 weeks. The main
      study parameter is fasting levels of plasma glucose.
    

Detailed description: 
      Bitter gourd (BG) (Momordica charantia) is a highly nutritive vegetable from the cucumber
      family. The objective is to assess the impact of 12-weeks of BG supplementation on blood
      glucose levels in subjects with impaired fasting glucose levels. In a previous trial
      (Bitter-Zoet NL70259.081.19) the short-term effects of BG (4 weeks) were studied, but no
      effect was observed. In the current trial a different BG cultivar is chosen, the intervention
      period is prolonged, the dosage per day is higher and study subjects with slightly higher
      fasting blood glucose levels will be included. The study is a parallel, double blind,
      controlled trial in which study participants will receive a 12-week intervention with 3.6 g/d
      dried bitter-gourd supplements or a reference intervention with 3.6 g/d dried cucumber
      supplements. Research subjects will come to the research facility for a test day on four
      occasions, with an interval of 4 weeks. The main study parameter is fasting levels of plasma
      glucose. Secondary outcome measures are glucose tolerance, HbA1c, insulin and HOMA-IR and
      HOMA-B levels.
    

Intervention name(s): Bitter-gourd; Cucumber
Intervention type(s): Other; Other
Intervention description(s): 12-week intervention of 3.6 grams of dried bitter-gourd supplements; 12-week intervention of 3.6 grams of cucumber supplements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: bitter gourd; pre-diabetes; fasting blood glucose
Marine n-3 Polyunsaturated Fatty Acids in Pre- and Postmenopausal Women
Condition: Postmenopause; Premenopause
Study type: Interventional

Summary: 
      The study is a randomised placebo controlled double-blinded clinical trial where a group of
      healthy pre- and postmenopausal women is randomised to the intake of fish oil capsules or
      placebo oil capsules for 12 weeks. Anthropometric measurements(weight, height,blood pressure)
      blood samples and adipose tissue biopsies will be taken in order to illustrate the effect of
      marine n-3 PUFAs (fish oil) on the concentration of circulating female hormones and to
      investigate what impact menopause might have on the ability to incorporate marine n-3 PUFAs
      into tissues.
    


Intervention name(s): marine n-3 polyunsaturated fatty acids; thistle oil; marine n-3 polyunsaturated fatty acids; Thistle oil
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Four capsules daily containing 2.2 g marine n-3 polyunsaturated fatty acids in total; four capsules a day; Four capsules daily, 2.2 g marine n-3 PUFAs in total; Four capsules daily
Other intervention name(s): Fish oil; Fish oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: n-3 PUFAs; menopause; adipose tissue; estrogens; Incorporation of fishoil in pre- and postmenopausal women; Marine n-3 PUFAs influence on female hormones in blood
Efficacy and Safety of Intraarticular Injections of Hyalgan in the Treatment of Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the efficacy and safety of Hyalgan, at a dose of 20mg/2ml administered as 5
      intraarticular injections at weekly intervals, for the sustained relief of pain and
      amelioration of joint dysfunction in patients of OA of the knee.
    


Intervention name(s): Hyalgan; sterile normal saline
Intervention type(s): Device; Device
Intervention description(s): Patients will receive intraarticular injection of 20mg /2ml /syringe Hyalgan® once a week for 5 consecutive weeks.; Patients will receive intraarticular injection of sterile normal saline once a week for 5 consecutive weeks.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Osteoarthritis; Hyalgan
Comparing Minimal Invasive Surgery en Conventional Total Knee Arthroplasty
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized clinical trial comparing minimal invasive operating technique to conventional
      operating technique for placement of total knee prosthesis.

      Clinical evaluations, patient questionnaires, X-rays and CT scans were done to compare these
      two techniques.
    

Detailed description: 
      Study executed with 3 centers and 69 patients.
    

Intervention name(s): surgery method using CR TKP
Intervention type(s): Procedure
Intervention description(s): Operation through minimal invasive surgery or standard open surgery
Other intervention name(s): Cruciate retaining (CR total knee prosthesis (TKP) Stryker
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of fixed combination of
      valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone,
      and placebo in reducing blood pressure. The study will investigate the dose response
      relationship for the combinations, monotherapies, and placebo.
    


Intervention name(s): Valsartan + amlodipine 40/2.5 mg; Valsartan + amlodipine 40/5 mg; Valsartan + amlodipine 80/2.5 mg; Valsartan + amlodipine 80/5 mg; Valsartan 40 mg; Valsartan 80 mg; Amlodipine 2.5 mg; Amlodipine 5 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily; Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily; Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily; Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily; Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily; Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily; Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily; Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily; 4 tablet and 2 capsule placebos taken once daily
Intervention MeSH terms: Amlodipine; Valsartan
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension, Valsartan, Amlodipine, high blood pressure