bioihbjkbjnl/mcl2 huggingface dataset:
Influence of Food on the Bioavailability of Telmisartan/Amlodipine Fixed Dose Combination in Healthy Japanese Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the relative bioavailability and pharmacokinetics of the fixed-dose
      combination tablets (telmisartan 40 mg/amlodipine 5 mg and telmisartan 80 mg/amlodipine 5 mg)
      in the fed condition compared with those of the same fixed-dose combination in the fasting
      condition in healthy Japanese male volunteers.
    


Intervention name(s): Telmisartan/Amlodipine low dose; Telmisartan/Amlodipine high dose; Japanese meal
Intervention type(s): Drug; Drug; Other
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Association Between Attention Deficit Hyperactivity Disorder and Bulimia Nervosa in Outpatients With Eating Disorders
Condition: Bulimia Nervosa; Eating Disorders; ADHD
MeSH terms: Hyperkinesis; Bulimia; Attention Deficit Disorder with Hyperactivity; Feeding and Eating Disorders; Bulimia Nervosa
Study type: Observational

Summary: 
      To understand whether a relationship exists between eating disorders and ADHD, we seek to
      clarify the prevalence of ADHD in individuals with eating disorders. To this end, we will
      estimate the prevalence of ADHD, and other neuropsychiatric disorders, in outpatients with
      history of an eating disorder diagnosis. Secondarily, we will identify patterns of cognitive
      deficits in outpatients with history of an eating disorder diagnosis. We will also examine
      whether ADHD in this population is associated with functional and familial correlates
      associated with ADHD.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Male and female outpatients between, and including, 18 and 55 years of age with a history
        of eating disorder diagnosis.
      
Keywords: Bulimia Nervosa; Eating Disorder NOS; Attention Deficit Hyperactivity Disorder; ADHD
An Exploratory Study of the Effects of a Single Dose of QAX576 (an Interleukin-13 Monoclonal Antibody) on Simulated Hayfever
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate whether a single dose QAX576 (an interleukin-13 monoclonal
      antibody) gives protection against a model of hayfever
    


Intervention name(s): QAX576; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergic rhinitis, adults, monoclonal antibody, interleukin-13.
Salivary Flow Promoted by Sugar-Free Chewing Gum
Condition: Saliva Altered
Study type: Interventional

Summary: 
      This was a double-blind, single center in vivo salivary flow rate study. The objective was to
      compare a marketed sugar-free chewing gum to a clinically-tested sugar-free reference chewing
      gum, with regards to their ability to promote salivary flow during a 20-minute chew period in
      healthy human adult subjects. Two sugar-free chewing gums were randomly assigned and
      distributed in a cross-over fashion to study subjects over two test period visits. The
      primary response being measured was salivary flow promoted by sugar-free chewing gums during
      the 20-minute chewing period.
    

Detailed description: 
      These procedures were conducted in accordance with proposed guidelines for current good
      clinical practices. Informed consent was obtained in compliance with FDA regulations (21 CFR
      50). Each subject read, understood, signed, and received a signed copy of the most current
      IRB approved informed consent document prior to any study-related procedures being performed.
      The test and control gums were provided by the Sponsor. One serving size of each gum type was
      placed in a labeled, small high barrier foil bag to ensure that the subjects and the site
      personnel received the gum in a blinded manner. During each of the test visits, subjects: 1)
      provided a non-stimulated saliva sample to ensure continued qualification, 2) received their
      assigned chewing gum, and 3) provided stimulated saliva over a timed 20-minute chewing
      period. The primary response being measured was the salivary flow promoted by each chewing
      gum.
    

Intervention name(s): Mastication
Intervention type(s): Behavioral
Intervention description(s): Chewing sugar-free gum for 20 min
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: prospectively planned, double-blind, single center cross-over study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: "salivary flow rate", saliva
Serum Caspase 3, Annexin a2 and Soluble Fas Levels and Endometriosis
Condition: Endometriosis; Apoptotic Pathway Deregulation
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      The study population will comprise of 90 women age varying between 15-55 years, those are
      candidate for laparoscopic surgery due to definition of >4 cm endometrioma or any other
      benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound
      examination, chronic pelvic pain, infertility. The blood samples will be drawn for analysis
      of serum biomarkers.
    

Detailed description: 
      The participants will be accepted for the study between 1st of August 2016 to 30th June 2017.
      2 cc blood samples will be drawn from the antecubital vein for serum analysis of caspase 3,
      annexin a2 and soluble fas levels before the operations. The patients will divide into three
      groups. The group 1 will comprise of 30 patients with benign ovarian cysts such as mature
      teratoma or simple serous cysts on ultrasound examination. The group 2 will comprise of 30
      patients with diagnosis of stage 1-2 endometriosis in guidance with the revised American
      Society for Reproductive Medicine classification. The group 3 will comprise of 30 patients
      with diagnosis of stage 3-4 endometriosis in guidance with the revised American Society for
      Reproductive Medicine classification. The blood samples will be kept in -80 C degree after
      centrifuge till at the end of the study.The relation between serum caspase 3, annexin a2 and
      soluble fas levels and severity of endometriosis will be analysed.
    

Intervention name(s): Blood sample
Intervention type(s): Other
Intervention description(s): 2 cc blood samples will be drawn from antecubital vein
Other intervention name(s): Serum caspase 3, annexin a2 and soluble fas levels
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will comprise of women age varying between 15-55 years, those are
        candidate for laparoscopic surgery due to definition of >4 cm endometrioma or any other
        benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound
        examination, chronic pelvic pain, infertility.
      
Biospecimen description: 
      Serum analysis
Effect of Yoga on Mood and Quality of Life in Patients With Refractory Epilepsy
Condition: Depression; Anxiety
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Study type: Interventional

Summary: 
      The purpose of this study is to learn if a structured yoga program can reduce anxiety,
      improve depression, and improve quality of life in patients with medication resistant
      epilepsy (MRE).
    


Intervention name(s): Yoga
Intervention type(s): Other
Intervention description(s): Restorative Yoga
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Epilepsy
A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the extent to which Lu AF11167 enters the
      bloodstream following tablet intake and the influence of food on uptake in healthy men and
      women
    

Detailed description: 
      This study will be split into Part A and Part B. Part A will happen first and will look at
      new tablet formulations of the test medicine compared to a previously known formulation
      (reference tablet). The results from Part A of the study will be used to decide which
      formulation will be tested in Part B of the study. Part B of the study will look at the food
      effect, variability between participants, and absolute bioavailability of the test medicine
      i.e. how much of the test medicine is taken up by the body when dosed by mouth compared to
      when dosed once by injection directly into the vein. Safety and tolerability will be assessed
      throughout the study.
    

Intervention name(s): Lu AF11167; [14C]-Lu AF11167; Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lu AF11167 - 2 mg modified release tablets (reference formulation), up to 5 prototype MR tablet formulations (test formulations); single iv microdose administered as a 15 minutes infusion; Single oral dose
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Dose Finding Trial of BM32 in Subjects Suffering From Grass Pollen Allergy
Condition: Grass Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate the dose response of immunotherapy against grass pollen allergy using
      the recombinant grass pollen vaccine BM32. Efficacy will be analyzed by:

        -  skin prick testing

        -  grass pollen inhalation challenge

        -  antibody responses. In addition, the safety of subcutaneous application of BM32 will be
           evaluated.
    


Intervention name(s): BM32; BM32; BM32; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Subcutaneous injection of 10 micrograms each of the BM32 components adsorbed on 0.3 mg of aluminum hydroxide every 4 week for a total of 3 injections; Subcutaneous injection of 20 micrograms of each of the BM32 components adsorbed on 0.6 mg of aluminum hydroxide every 4 weeks for a total of 3 injections; Subcutaneous injection of 40 micrograms of each of the BM32 components adsorbed on 1.2 mg of aluminum hydroxide every 4 weeks until a total of 3 injections; Subcutaneous injection of 1.2 mg of aluminum hydroxide suspension every 4 weeks until 3 injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: grass pollen allergy; immunotherapy; recombinant vaccine
The Therapeutic Effect of Dau-Di-Wu-Gong in Patient With Ankle Fracture
Condition: Ankle Fractures
MeSH terms: Fractures, Bone; Ankle Fractures
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Ankle fracture is one of most common bone fracture in Taiwan, although ankle fracture can be
      treated by surgical operation, local edema, pain and wound poor healing always is noted,
      according to the investigator's knowledge, no good therapeutic methods to treat mention-above
      symptoms until now. Helminthostachys zeylanica(L.)Hook, also called Dau-Di-U-Gon has
      anti-inflammation, calm down heat and detoxication, and anti-edema. People in Taiwan often
      uses Helminthostachys zeylanica(L.)Hook to treat bone and tendon pain, and its Ugonin
      component of Helminthostachys zeylanica(L.)Hook also is proved that has analgesia and
      ant-inflammation. Therefore, the purpose of the present study was to design a randomized,
      double-blind, controlled study to evaluate functional recovery effect of Helminthostachys
      zeylanica(L.)Hook after surgical operation in patients with ankle fracture.
    

Detailed description: 
      the purpose of the present study was to design a randomized, double-blind, controlled study
      to evaluate functional recovery effect of Helminthostachys zeylanica(L.)Hook after surgical
      operation in patients with ankle fracture. The primary outcome measure was the scores change
      of American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot scale, and tape
      (figure-of-eight) methods. Secondary outcome measure was the level changes of bone metabolism
      in peripheral blood, four diagnostic method, and the changes of ankle X-ray findings.
    

Intervention name(s): Helminthostachys zeylanica(L.)Hook; Starch
Intervention type(s): Drug; Drug
Intervention description(s): Extract of Helminthostachys zeylanica(L.)Hook, 1gm/time, 3 times daily; Starch in capsule, 1gm/time, 3 times daily
Other intervention name(s): Dao-Di-Wu-Gong; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatment group and Control group
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ankle fracture; Helminthostachys zeylanica(L.)Hook; Clinical trials; Functional recovery
HIV, Abuse, and Psychiatric Disorders Among Youth
Condition: HIV Infections
MeSH terms: Mental Disorders; Problem Behavior
Study type: Interventional
Phase: Phase 1

Summary: 
      One subgroup of adolescents at particular risk for HIV is those with psychiatric disorders.
      Furthermore, those with histories of sexual abuse have been found to have riskier attitudes,
      poorer sexual communication skills, and less consistent condom use than non-abused peers.
      This study implemented and evaluated interventions for adolescents in intensive psychiatric
      treatment settings, particularly those with histories of sexual abuse. It is hypothesized
      that those participating in the intervention that addresses affect management and cognitive
      monitoring strategies will show fewer HIV-risk related behaviors and attitudes at posttest
      than peers in an information-based intervention.
    


Intervention name(s): group intervention; group intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 13-session intervention; 2-session intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV prevention; HIV seronegativity
AZD2066 Cocktail Study
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The aims of this study are to examine the effect of repeated doses of AZD2066 and of
      caffeine, bupropion, tolbutamide, omeprazole, metoprolol and midazolam on the blood
      concentrations of each other
    


Intervention name(s): AZD2066; Caffeine; Tolbutamide; Omeprazole Tablet, 20 mg; Midazolam Tablet, 7.5 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 12 doses, Given as capsule, 2 mg & 8 mg; 2 doses, Given as Tablet, 2x50 mg; 2 doses, Given as Tablet, half of 500 mg; 2 doses, Given as Tablet, 20 mg; 2 doses, Given as Tablet, 7.5 mg
Other intervention name(s): Pharmapac/ProPlus®; Actavis /generic; AstraZeneca/Losec® MUPS®; Roche/generic
Intervention MeSH terms: Tolbutamide; Midazolam; Caffeine; Omeprazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Chronic Pain; AZD2066
Osteosarcopenia and Exercise
Condition: Sarcopenia; Osteoporosis, Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Sarcopenia
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of combination of aerobic and resistive
      exercise on activities of daily living and risk of fall in osteosarcopenic patients
    

Detailed description: 
      After being informed about the study and potential risk, all patients giving written informed
      consent will undergo study entry.

      to begin with: assessment with bioelectrical body composition analyzer and first exercise and
      assessment clinical scales

      1th month: assessment with bioelectrical body composition analyzer and assessment clinical
      scales 3th month: assessment with bioelectrical body composition analyzer and assessment
      clinical scales
    

Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): the combination of aerobic and resistive exercise, three time a week
Intervention model: Single Group Assignment
Intervention model description: Female and male patients over 70 years of age followed-up from osteoporosis outpatient clinic
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aerobic exercise; resistive exercise; balance; falling; physical performance; osteosarcopenia
Aquacel Versus Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage
Condition: Abscess; Cellulitis
MeSH terms: Abscess; Cellulitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study compares Aquacel against routine Iodoform packing for packing abscess cavities
      after incision and drainage. It is hypothesized that Aquacel will produce speedier healing of
      the abscess.
    

Detailed description: 
      The large increase in the incidence of skin and soft tissue infections cause by methicillin
      resistant staphylococcus aureus (MRSA) has produced a corresponding increase in the number of
      ED patients presenting with abscesses that require incision and drainage. This study compares
      Aquacel against routine Iodoform packing for packing abscess cavities after incision and
      drainage. It is hypothesized that Aquacel will produce speedier healing of the abscess. More
      effective abscess healing will reduce the need for oral antibiotic coverage, which will in
      turn reduce the potential for drug resistance caused by indiscriminate use of oral
      antibiotics.
    

Intervention name(s): Type of dressing - Iodoform; Type of dressing - Aquacel
Intervention type(s): Device; Device
Intervention description(s): Dressing for packing a cutaneous abscess; Aquacel dressing
Other intervention name(s): Iodoform; Aquacel
Intervention MeSH terms: Carboxymethylcellulose Sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Aquacel vs. Iodoform Gauze
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: abscess; MRSA; Aquacel dressing; Iodoform dressing
Auricular Acupuncture for Treatment of Preoperative Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      In this prospective nonrandomized study the investigators are going to investigate whether
      auricular acupuncture with indwelling fixed needles is feasible for treatment of preoperative
      anxiety.

      Patients, scheduled for ambulatory gynecologic surgery, will be asked, if they wish to
      receive auricular acupuncture (AA) against preoperative anxiety. The patients who will not
      wish AA, will be asked to take part in questioning (State-Trait-Anxiety-Inventory (STAI)
      questionnaire) and will form the control group. The preoperative anxiety using STAI, as well
      as the duration and quality of sleep on the night before surgery, the incidence of side
      effects, blood pressure and heart rate will be the outcome measures in this study.
    


Intervention name(s): Auricular acupuncture
Intervention type(s): Device
Intervention description(s): Five ear acupuncture points: MA-IC, MA-TF1, MA-SC, MA-AT1 and MA-TG will be needled bilaterally in patients, who will wish to receive AA. Indwelling fixed "New Pyonex" needles (length: 1.5 mm, diameter: 0.22 mm; Seirin Corp., Shizuoka City, Japan) will be used for AA.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study is an open-label, randomized, comparative, multicenter clinical trial. The purpose
      of this study is to assess the efficacy of ABX203, a new chronic hepatitis B therapeutic
      vaccine administered as an adjunct therapy to nucleos(t)ide analogs (NUCs), in maintaining
      control of Hepatitis B disease after cessation of treatment with NUCs in subjects with HBeAg
      negative chronic Hepatitis B.
    


Intervention name(s): ABX203 therapeutic Hepatitis B vaccine treatment arm
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Clinical Efficacy of a Dentifrice Containing 5% Fluoro Calcium Phosphosilicate to a Dentifrice Containing Calcium Sodium Phosphosilicate on Dentinal Hypersensitivity
Condition: Dentinal Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Aim of this study was to assess and compare the efficacy of a dentifrice containing 5% fluoro
      calcium phosphosilicate and dentifrice containing calcium sodium phosphosilicate on Dentinal
      Hypersensitivity (DH) compared to a placebo over a period of 6 weeks.
    

Detailed description: 
      A total of 131 subjects were divided into 3 groups randomly. Group I was given the dentifrice
      containing 5% fluoro calcium phosphosilicate ,Group II was given the dentifrice containing
      calcium sodium phosphosilicate and group III was given placebo. Sensitivity scores (VAS
      score) were recorded at baseline, 2 weeks, 6 weeks.
    

Intervention name(s): 5% fluorocalcium phosphosilicate dentifrice; Calcium sodium phosphosilicate; Placebo dentrifice
Intervention type(s): Other; Other; Other
Intervention description(s): dentifrice containing 5% fluorocalcium phosphosilicate and VAS score assessed at Baseline, 2 weeks, 6 weeks.; Calcium sodium phosphosilicatand VAS score assessed at Baseline, 2weeks, 6 weeks.; placebo dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks.
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dentinal hypersensitivity; visual analog scale