bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Administration Strategies of Ticagrelor in Patients With Unstable Angina Pectoris, a Pharmacokinetic / Pharmacodynamic Study
Condition: Unstable Angina Pectoris
MeSH terms: Angina Pectoris; Angina, Unstable
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the differences in pharmacokinetics and
      pharmacodynamics of ticagrelor and its active metabolite depending on the strategy of the
      drug administration in patients with unstable angina pectoris.
    

Detailed description: 
      On the basis of the current guidelines ticagrelor is a recommended antiplatelet agent in
      acute coronary syndromes, including unstable angina pectoris.

      According to the results of the MOJITO study, performed in patients with ST-elevation
      myocardial infarction, the effect of ticagrelor, measured as platelet inhibition, may be
      achieved sooner when crushed tablets are administered. Thus, there may be significant
      differences in pharmacokinetics and pharmacodynamics of ticagrelor if pulverized drug is
      given orally or sublingually when compared with currently used oral administration of
      integral tablets.

      The study is designed as an open-label, single-center, randomized trial of different
      strategies of administration of ticagrelor in patients with unstable angina pectoris. After
      enrollment, the participants will be randomized into three arms, each receiving ticagrelor.
      The drug will be given in: (1) pulverized tablets administered sublingually, (2) pulverized
      tablets administered orally or in (3) integral tablets orally. The time required for
      ticagrelor and its active metabolite AR-C124900XX to reach their maximum serum concentration
      will be measured as the primary outcome of the study. Moreover, further evaluation of other
      parameters including maximum plasma concentration and area under the plasma concentration of
      ticagrelor and its active metabolite will be assessed as secondary outcomes. The platelet
      reactivity will be measured with the Multiplate Analyzer.
    

Intervention name(s): Pulverized ticagrelor sublingually; Pulverized ticagrelor orally; Integral ticagrelor
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pulverized ticagrelor (180 mg) administered sublingually; Pulverized ticagrelor (180 mg) administered orally; Integral ticagrelor (180 mg) administered orally
Other intervention name(s): Brilique; Brilique; Brilique
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gemcitabine, Oxaliplatin and Panitumumab in Kras/B-raf Wild-Type Biliary Track and Gallbladder Cancer
Condition: Biliary Tract Cancer; Gallbladder Cancer
MeSH terms: Biliary Tract Neoplasms; Gallbladder Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine disease response of GEMOX-Panitumumab (GEMOX-P) in
      KRAS/ BRAF wild-type, Stage IV, biliary tract and gallbladder cancer patients who have
      previously not received chemotherapy. This study will also examine the potential toxicities,
      progression-free and overall survival in this population.
    


Intervention name(s): Panitumumab; oxaliplatin; gemcitabine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Day 1 and 15 = 6 mg/kg IV; Days 1 and 15 = 85mg/m2 IV; Days 1 and 15 = 1000 mg/m2 IV
Other intervention name(s): GEMOX-Panitumumab (GEMOX-P)
Intervention MeSH terms: Gemcitabine; Oxaliplatin; Panitumumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Unresectable; metastatic; biliary tract; gallbladder cancer
Serotonin and Everyday Social Interaction
Condition: Social Behaviour
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Rationale: Poor social functioning may contribute to major depressive disorder (MDD). Poor
      serotonin function may also contribute to MDD. Recent research suggests that serotonin plays
      a role in regulating human social behaviour. Therefore it would be intriguing to investigate
      the role of serotonin in regulating the quality of everyday social interactions in a
      population at risk for MDD. Human social behaviour can be reliably assessed in everyday life
      using Ecological Momentary Assessment (EMA).

      Objective: This study aims to investigate how an experimental increase in serotonin
      influences social functioning in healthy adults with a first-degree family member diagnosed
      with MDD. The primary goal is to investigate the role of serotonin in regulating everyday
      social behaviour, measured using EMA. This will be done using oral supplementation with
      tryptophan, the amino acid precursor of serotonin. Secondary goals are to determine how this
      experimental manipulation influences people's feelings as well as their perceptions of
      other's social behaviour following interpersonal events, and social cognitions at the end of
      the day. An exploratory goal is to investigate if these effects are moderated by genes
      thought to be involved in MDD.

      The primary hypothesis to be tested is that tryptophan will reduce quarrelsome behaviour.
    


Intervention name(s): Tryptophan
Intervention type(s): Dietary Supplement
Intervention description(s): Tryptophan and placebo are given in a crossover design, based on randomisation.
Intervention MeSH terms: Tryptophan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effects of Fat and Carbohydrates in Obese Men
Condition: Obesity; Steatosis
MeSH terms: Fatty Liver
Study type: Interventional

Summary: 
      Obesity has become a global epidemic, and treating and preventing obesity appears to be one
      of the world's greatest challenges. The disorder is associated with a wide range of metabolic
      and hormonal changes, including the development of insulin resistance, changes in adipose
      tissue function, increased levels of blood lipids, cardiovascular disease and obesity induced
      fatty liver. Obesity is characterized by inflammation in adipose tissue, altered fat storage
      capacity and increased exchange of lipids between adipose tissue and blood, and increased
      secretion of cytokines from adipose tissue. Cytokines are believed to play a central role in
      the regulation of adipose tissue, the size of adipocytes and other metabolic conditions.

      The hepatic synthesis of lipoproteins and interaction with adipose tissue is essential for
      the body's energy storages. The central role of the liver in energy supply, fat storage and
      normalization of blood values implies the importance of investigating the interaction between
      adipose tissue and liver to increase knowledge about the morbidity of obesity. Central
      obesity and insulin resistance are clear risk factors for the development of fatty liver, but
      the importance of diet is unclear. The common perception is that fatty liver condition can be
      improved by a reduction in dietary fat and cholesterols, but the relationship is unclear, and
      contradictory findings occur in epidemiological studies. It is therefore necessary to better
      understand the impact of the different macro-nutrients.

      The purpose of this study is to determine whether two weight reducing diets with equal
      calorie levels that contain high or low fat differentially affects the adipose tissue
      function, distribution of body fat, as well as tissue, blood and urine levels of inflammatory
      markers, lipids, vitamins, hormones and other substances that may be related to metabolically
      health.
    


Intervention name(s): High fat low carbohydrate diet; Low fat high carbohydrate diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 70E% fat, 20E% protein, 10E% carbohydrates; 20E% fat, 20E% protein, 60E% carbohydrates
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Microsurgical vs Macro Surgical Approach for Grade II Gingival Recessions Employing Laterally Repositioned Flap
Condition: Gingival Recession, Localized
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      This study was conducted to assess the evaluation of micro and Macro surgical approach in the
      treatment of grade II gingival recessions using the laterally repositioned flap
    

Detailed description: 
      In this study total, 30 patients were selected The patients initially received a
      comprehensive periodontal examination and complete plaque control program including oral
      hygiene to eliminate habits related to the aetiology of recession. Scaling, root planning and
      occlusal adjustments were done The patients were randomly assigned and divided into two
      groups. Group A and Group B. Patients with miller class II were treated with a laterally
      repositioned flap to obtain root coverage using conventional macrosurgical approach
      (15patients) and microsurgical approach(15patients)

      The clinical parameters evaluated were height of gingival recession relative clinical
      attachment level which was measured as the distance from a fixed point in a stent to the
      bottom of the pocket and gingival biotype at baseline, 3 months and 6 months period
    

Intervention name(s): root coverage
Intervention type(s): Procedure
Intervention description(s): Group A: After administration of local anaesthesia using ophthalmic microsurgical knives a V-shaped incision was made in the gingival recession area. the gingiva was removed .the adjacent partial thickness pedicle flap was reflected from the donor area .the pedicle flap was then covered over the recipient site. then secured with 6-0 absorbable sling suture without tension. the surgical procedure was done with seilar microscope 40X magnification.
Group B: After administration of local anaesthesia using 15 no blade a V-shaped incision was made in the gingival recession area . gingiva was removed .the adjacent partial thickness pedicle flap was reflected from the donor area .the pedicle flap was then covered over the recipient site. then carefully secured with 4-0 absorbable sling suture
Intervention model: Single Group Assignment
Intervention model description: The patients will be equally divided into two test groups. Group A and Group B after phase I therapy. the group A patients will be treated with laterally repositioned flap to obtain root coverage using microsurgical approach. The group B patients will be treated with laterally repositioned flap to obtain root coverage using macrosurgical approach
Masking: None (Open Label)
Primary purpose: Treatment
Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single centre, open-label, randomised study in four parallel groups of healthy volunteers
    

Detailed description: 
      Single centre, open-label, randomised study in four parallel groups of healthy volunteers:
      Group 1 = 900 mg of eslicarbazepine acetate (ESL, BIA 2-093); Group 2 = 450 mg of
      S-licarbazepine plus 450 mg of R-licarbazepine; Group 3 = 450 mg of S-licarbazepine; Group 4
      = 450 mg of Rlicarbazepine. In each group, the study consisted of a single-dose period (Phase
      A) followed by a repeateddose period of 7 days of duration in which the investigational
      product was administered once daily (Phase B). The repeated-dose phase started 96 h post
      single-dose.
    

Intervention name(s): BIA 2-093; S-licarbazepine; R-licarbazepine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets containing 900 mg; capsules containing 225 mg; capsules containing 225 mg
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY900020 in Healthy Chinese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate three new formulations of LY900020; a fixed dose, combination drug
      developed for people with type 2 diabetes mellitus. The study will be conducted in healthy
      participants to investigate the effect of different tablet formulations on the amount of
      LY900020 in the bloodstream. Side effects and tolerability will be documented. The study will
      last about 10 weeks for each participant, including screening and follow up. Screening is
      required within 28 days prior to entering the study.
    


Intervention name(s): LY900020; Metformin XR; Atorvastatin; Valsartan
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Metformin; Valsartan; Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Test the Efficacy of the HBV Vaccine and to Look at the Prevalence of HBV Infection
Condition: Hepatitis b Virus
MeSH terms: Hepatitis B
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): HBV vaccine
Intervention type(s): Biological
Intervention description(s): HBV vaccine 3 doses at month 0, 1, and 6
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: isolated HBc; HBV vaccine response; occult HBV in isolated antiHBC compared HIV to non HIV
Bone Density in Voluntary Apheresis Blood Donors
Condition: Bone Density
Study type: Interventional

Summary: 
      A longitudinal, randomized, controlled, single-center Phase IV clinical trial will be
      performed to assess changes in bone mineral density (BMD) among voluntary apheresis blood
      donors. The primary outcome measure will be clinically significant decline in BMD at the
      lumbar spine assessed by dual-energy x-ray absorptiometry (DXA).
    

Detailed description: 
      Apheresis blood donation maximizes an individual's donation by selecting specific blood
      components that are used to save patient lives. Dramatic increases in the number of apheresis
      procedures performed each year are apparent both domestically and internationally. Apheresis
      requires the use of citrate anticoagulation, a substance that confers its anticoagulant
      effect through chelation of cations, like calcium. A small number of cross-sectional studies
      have reported that intermittent exposure to citrate through apheresis is associated with
      significant declines in donor bone mineral density (BMD). In contrast, oral potassium citrate
      of much lower dose has been used to treat low bone density with well-documented efficacy. The
      impact of citrate exposure during apheresis, either positive or negative, is important given
      that BMD is a significant risk factor for low trauma fracture, a problem that affects more
      than 2M people in the U.S. annually. It is ultimately unknown what effect repeated apheresis
      has on skeletal health. To address this knowledge gap, we will perform a Phase IV clinical
      trial of apheresis blood donors using a cross-disciplinary, multi-institutional team. As
      apheresis blood donation continues to affect more people, the importance of understanding the
      effects of repeated exposure to citrate on donor skeletal health is essential in protecting
      this precious community resource.
    

Intervention name(s): high frequency voluntary apheresis blood donation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: apheresis; citrate anticoagulation; blood donor; bone
Energy Content and Energy Density of Pre-portioned Entrees
Condition: Obesity
Study type: Interventional

Summary: 
      Pre-portioned entrées are commonly consumed to help control portion size and limit energy
      intake. Few studies, however, have investigated the influence of the characteristics of
      pre-portioned entrées on energy intake. This study investigates how the characteristics of
      solid pre-portioned entrées, specifically, variations in their energy content and energy
      density influence energy intake over a day. The investigators hypothesize that reducing the
      energy content and energy density of compulsory entrées will act independently and add
      together to reduce daily energy intake.
    

Detailed description: 
      This experiment uses a crossover design with repeated measures within subjects. One day a
      week for four weeks, participants are provided with all of their foods and beverages for
      breakfast, lunch, and dinner meals. Across test days, the entrée at each meal is varied in
      both energy content and energy density between a standard level (100%) and a reduced level
      (64% of the standard). Following consumption of a compulsory entrée, a variety of
      unmanipulated foods will be served for ad libitum consumption. The order of experimental
      conditions is counterbalanced across the subjects.
    

Intervention name(s): Energy density (ED), Energy content
Intervention type(s): Other
Intervention description(s): Standard or reduced energy content and energy density of pre-portioned entrees
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: energy content; energy density; energy intake; pre-portioned entrees
LIVE SMART: Smartphone Intervention for Weight Control
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to compare three methods of delivering behavioral weight loss
      treatment.Participants are randomly assigned to one of three 18-month weight loss treatments
      (group, individual, or smartphone treatment). Participants who are assigned to group
      treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6
      months, and then monthly for the final 6 months. Participants who are assigned to individual
      treatment will attend one-on-one sessions with a weight loss counselor every month for 18
      months. Participants who are assigned to smartphone treatment will use a smartphone to learn
      and practice weight loss skills. They will also attend one-on-one sessions with a weight loss
      counselor every month for 18 months. Assessment visits are conducted at baseline, 6, 12, and
      18 months.
    


Intervention name(s): Lifestyle Counseling
Intervention type(s): Behavioral
Intervention description(s): Participants receive instructions for making healthy changes to their diet and physical activity habits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overweight; Obesity; Weight Loss
Noninvasive Treatment of Upper Trapezius Active Trigger Points in College Students With Neck Pain
Condition: Neck Pain; Trigger Point Pain, Myofascial
MeSH terms: Myofascial Pain Syndromes; Neck Pain
Study type: Interventional

Summary: 
      Hyperexcitable myofascial trigger points located within a taut band of skeletal muscle or
      fascia cause referred pain, local tenderness, and autonomic changes. The scientific data
      refer to an immediate improvement in the symptoms of these active points treated with manual
      therapy. Based on these factors, the objective of the study is to determine the effect of the
      combined therapy of the Jones, Chaitow, Lewit technique and pain-free positioning in
      participants with the presence of an active upper trapezius trigger point.
    

Detailed description: 
      The treatment will last a total of 15 minutes accompanied by a baseline assessment and after
      10 minutes of the intervention in 3 experimental groups and a placebo group, of no-pain
      positioning. In addition to basic indices and scales of cervical pain and functionality, it
      is intended to measure flexibility, range of motion, proprioception and cognition through
      software with sensors of the latest technology when it comes to representing reliable results
      in differences between techniques.
    

Intervention name(s): Jones Group (Strain Counterstrain); Lewit Group; Chaitow Group; Placebo Group
Intervention type(s): Other; Other; Other; Other
Intervention description(s): No pain positioning technique with diaphragmatic breathing; Isometric muscular exercise acompained with stretching technique; Isometric muscular exercise acompained with stretching technique and diaphragmatic breathing; No pain positioning of participants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physiotherapy; Rehabilitation; Treatment; Active Trigger Point