bioihbjkbjnl/mcl2 huggingface dataset:
Metabolic, Endocrine and Appetite-related Responses in Healthy, Adolescent Males After Acute and Daily Milk Consumption
Condition: Appetite Regulation
Study type: Interventional

Summary: 
      Comprising two experiments, the investigators assessed the metabolic, endocrine and
      appetite-related responses to acute (1-d, part 1) and daily mid-morning milk consumption
      (28-d, part 2) in adolescent males (15-18 y).
    

Detailed description: 
      The aims of the present study were twofold. Firstly, this study sought to examine the acute
      (1-d) effects of mid-morning milk consumption on subsequent metabolic, endocrine and
      appetite-related responses relative to an isoenergetic and isovolumetric serving of
      fruit-juice (part 1). Considering the putative mechanisms of milk consumption on appetite,
      feeding behavior and metabolism no studies are available that have explored the impact of
      daily milk or dairy food consumption on the above mentioned constructs in children and
      adolescents. This study therefore also aimed to compare the effect of daily (28-d)
      mid-morning milk or fruit-juice consumption on the above mentioned constructs (part 2).

      Eleven adolescents participated in part 1 of this study and completed two trials (milk or
      fruit-juice mid-morning snack) in a randomized crossover design. For part 2, a parallel
      design with two intervention groups was employed. Participants were randomly allocated to
      groups, and received either a milk (n = 10) or an isocaloric and isovolumetric fruit-juice (n
      = 9) mid-morning snack for 28-d. On laboratory visits (for both part 1 and 2) participants
      remained at rest for 180 min. During this time, circulating concentrations of GLP-17-36,
      glucagon, insulin, leptin and blood glucose were determined. Measures of energy expenditure,
      substrate metabolism and subjective appetite were also collected. At 180 min, a homogenous ad
      libitum pasta meal was provided. For the remainder of the study day, subsequent energy intake
      was recorded utilizing a combined weighed self-reported food record and 24-h dietary recall
      technique.
    

Intervention name(s): milk; orange fruit-juice
Intervention type(s): Other; Other
Intervention description(s): small serving (217 mL) of british semi-skimmed milk; small serving (217 mL) of orange juice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Dairy; appetite; feeding behaviour
Effectiveness of Buspirone and Motivational Enhancement Therapy for the Treatment of Marijuana Dependence - 1
Condition: Marijuana Abuse; Mood Disorders
MeSH terms: Marijuana Abuse; Mood Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the effectiveness of a combination of buspirone and motivational
      interviewing therapy in the treatment of marijuana dependence.
    

Detailed description: 
      Marijuana dependence is one of the most common substance-related disorders in the United
      States. Despite its prevalence, there is a lack of clinical research addressing treatments
      for marijuana dependence. Research has shown that marijuana abuse is associated with
      affective disorders. This may be caused by repeated use for relief from anxiety. The use of
      an anxiolytic agent, a drug that relieves anxiety, may help treat marijuana dependence.
      Motivational enhancement therapy has been shown to reduce marijuana use. Therefore, it is
      likely that buspirone, which is an anxiolytic agent, combined with motivational enhancement
      therapy will prove beneficial in treating marijuana dependence. This study will assess the
      effectiveness of a combination of buspirone and motivational interviewing in the treatment of
      marijuana dependence.

      This double-blind study will last a total of 16 weeks. Participants will be randomly assigned
      to receive either buspirone or placebo for a period of 12 weeks. There will be one follow-up
      appointment 4 weeks post-intervention. Baseline assessments will include a physical exam and
      urine and blood tests. Study visits will occur weekly throughout treatment in order to
      monitor compliance, assess adverse affects, and obtain substance use data. Mood assessment
      scales, marijuana craving questionnaires, and a withdrawal symptom checklist will be used to
      gather the data. Urine drug screens will be collected weekly to test for marijuana use. In
      addition to this, the presence of opioids, cocaine, amphetamines, and benzodiazepines will be
      tested at baseline, Weeks 6 and 12, and at follow-up. A 10-day supply of medication will be
      dispensed to participants each week. Meetings for motivational enhancement therapy will last
      30 to 90 minutes each and will occur at baseline, Week 2, and Week 4. Participants' perceived
      quality of life will be measured at baseline and Weeks 6 and 12 to determine the effect of
      buspirone.
    

Intervention name(s): Buspirone
Intervention type(s): Drug
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Marijuana; Mood Disorder
A Common Polymorphism of the SRD5A2 Gene is Not Associated With Male-to-Female and Female-to-Male Transsexualism
Condition: Transsexualism
Study type: Observational

Summary: 
      Genetic variations, i.e. polymorphisms, may be associated with gender dysphoria, e.g.
      transsexualism. This study aims to identify such variations.
    

Detailed description: 
      Context: Early developmental exposure of the brain to sex steroids may play a role in the
      etiology of transsexualism.

      Objective: To assess the association between transsexualism and allele and genotype
      frequencies of the steroid 5-alpha reductase (SRD5A2) Val89Leu polymorphism.

      Design and Patients: We performed a case-control study of 100 male-to-female (MtF)
      transsexuals, 47 female-to-male (FtM) transsexuals, 755 male controls, and 915 female
      controls. DNA was extracted from buccal swabs and genotypes were determined by polymerase
      chain reaction.

      Results: SRD5A2 Val89Leu allele frequencies (SRD5A2 V: 137/200 [69%] and SRD5A2 L: 63/200
      [31%] vs. SRD5A2 V: 1065/1510 [71%] and SRD5A2 L: 445/1510 [29%], respectively; p=0.6; Odds
      Ratio [OR] 1.10; 95% Confidence Interval [CI] 0.76-1.58) and genotype distributions (SRD5A2
      V/V+V/L: 92/100 [92%] and L/L 8/100 [8%] vs. SRD5A2 V/V+V/L: 683/755 [91%] and L/L 72/755
      [9%], respectively, p=0.7; OR 0.82; 95% CI 0.24-2.84) were not significantly different
      between MtF transsexuals and male controls. SRD5A2 Val89Leu allele frequencies (SRD5A2 V:
      70/94 [74%] and SRD5A2 L: 24/94 [26%] vs. SRD5A2 V: 1253/1830 [69%] and SRD5A2 L: 573/1830
      [31%], respectively; p=0.3; OR 0.75; 95% CI 0.45-1.26) and genotype distributions (SRD5A2
      V/V+V/L: 44/47 [93%] and L/L 3/47 [7%] vs. SRD5A2 V/V+V/L: 823/915 [90%] and L/L 92/915
      [10%], respectively, p=0.6; OR 0.61; 95% CI 0.11-3.32) were also not significantly different
      between FtM transsexuals and female controls. Of note, there was no gender-specific genotype
      distribution among controls.

      Conclusions: The SRD5A2 Val89Leu polymorphism is not associated with transsexualism and is no
      candidate gene of this condition.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Female-to-male transsexuals and male-to-female transsexuals
IP Peru, Bioavailability of Iron From Potatoes
Condition: Iron-deficiency; Iron Deficiency Anemia; Iron Deficiency (Without Anemia)
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      To combat iron deficiency in Low and Middle-Income Countries, sustainable food-based
      solutions have to be implemented to serve populations, not only individuals. One solution is
      the introduction of iron biofortified staple crops on market level. Before market level
      introduction, the bioavailability of iron in the new biofortified Irish Potato (IP) breed
      needs to be assessed. In this study the investigator compares the fractional and total iron
      absorption after extrinsic stable isotope labelling of the new biofortified high iron IP
      variety and a normal market level IP variety. The study is conducted in Peruvian women of
      reproductive age with marginal iron status.
    

Detailed description: 
      The 40 women enrolled will consume test meals consisting of 500g steamed and mashed high iron
      Irish potatoes labelled with Fe-58 daily for a period of 10 days and will then switch to the
      test meals consisting of 400g steamed and mashed control sweet potatoes labelled with Fe-57
      for a period of 10 days. The order of test meal type is random. A baseline blood sample will
      be taken on the first meal feeding day prior to consumption of any test meals, study day 15
      (before switching to the other test meal IP variety), on study day 26 (14 days after
      completion of the first test meal period) and on Day 40 (14 days after completion of the
      second test meal period). Erythrocyte incorporation of the stable isotope labels will be
      measured in these blood samples using an ICPMS and will be used to calculate fractional and
      total iron absorption from the two different type of test meals.
    

Intervention name(s): High Fe IP meal labelled with Fe-58; Control OFSP meal labelled with Fe-57
Intervention type(s): Other; Other
Intervention description(s): 500 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days; 500 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each woman consumes both high-iron Irish potato and a regular Irish potato variety.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Biofortification; Staple crops; Stable isotope studies
Extension Study for Participants of MACI00206 Study of MACI® for the Treatment of Symptomatic Articular Cartilage Defects of the Knee
Condition: Articular Cartilage Defects
MeSH terms: Cartilage Diseases
Study type: Observational

Summary: 
      To examine the 5-year efficacy and safety of MACI implant, compared with arthroscopic
      microfracture, in participants who received study treatment in the SUMMIT study for treatment
      of symptomatic articular cartilage defects of the knee.
    

Detailed description: 
      This study was an open-label, multicenter extension to the SUMMIT study designed to examine
      the 5-year efficacy and safety of MACI compared to arthroscopic microfracture in the
      treatment of articular cartilage defects of the knee in participants who received study
      treatment in the SUMMIT study. Follow-up to 2 years post-study treatment was completed as
      part of the SUMMIT study. Follow-up from 3 to 5 years post-study treatment in SUMMIT was
      completed in this extension study.

      All 144 participants who received study treatment in the SUMMIT study were eligible for
      enrollment into this extension study. Participants had until the end of the visit window for
      the last visit of this extension study (ie, Week 260 + 6 weeks) to consent to enter this
      extension study.

      Efficacy and safety assessments were performed at scheduled visits 3, 4, and 5 years
      following treatment in SUMMIT (ie, at Weeks 156, 208, and 260 postarthrotomy for patients
      treated with MACI implant or at Weeks 156, 208, and 260 postarthroscopy for patients treated
      with microfracture).
    

Intervention name(s): autologous cultured chondrocytes on porcine collagen membrane; Microfracture
Intervention type(s): Biological; Procedure
Intervention description(s): Implantation received in the previous MACI00206 study; Arthroscopic Microfracture treatment received in the previous MACI00206 study
Other intervention name(s): MACI; matrix applied characterized autologous cultured chondrocytes
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Randomized and received study treatment (MACI or microfracture) in the SUMMIT study.
      
Keywords: Cartilage legions; Symptomatic focal cartilage defects; Microfracture; MACI; Autologous chondrocyte
An Exploratory Study To Look At The Effect Of Two Investigational Drugs On Body Fat And Inflammation
Condition: Hypercholesterolemia; Dyslipidaemias; Obesity
MeSH terms: Hypercholesterolemia; Dyslipidemias; Inflammation
Study type: Observational

Summary: 
      The investigational drugs administered in this study activate proteins called PPARs. Data in
      the scientific literature on PPARs, as well as animal data and early clinical data generated
      by GSK with these drugs, suggest that activation of PPARs may cause the body to increase its
      use of fatty acids for energy, and lead to a reduction in body fat. There are also data to
      suggest a role for PPARs in regulating lipid (e.g., cholesterol) levels and inflammation.
      These and other activities of PPARs are being further explored in this clinical study.
    


Intervention name(s): GW501516; GW590735
Intervention type(s): Drug; Drug
Other intervention name(s): GW501516
Keywords: cholesterol; inflammation; fat
Glucagon-like Peptide 1 Agonist Exenatide for Improved Glucose Control and Cardiac Function in Patients With Aortocoronary Bypass
Condition: Coronary Artery Disease; Decreased Left Ventricular Function
MeSH terms: Coronary Artery Disease; Ventricular Dysfunction, Left
Study type: Interventional
Phase: Phase 3

Summary: 
      GLP-1 has not only beneficial effects on glucose metabolism but also direct positive effects
      on cardiac function and metabolism in both experimental models and in patients with type 2
      diabetes mellitus. Clinical data on the effects of GLP-1 agonists on cardiac function and
      glucose control in patients undergoing cardiac surgery are not known. Based on the results of
      experimental studies there is a potential for exenatide to positively influence both cardiac
      function and glucose metabolism in cardiac surgery patients with and without type 2 diabetes
      mellitus. The primary endpoint of this study is to examine whether pre- and peri-operative
      administration of exenatide affects perioperative hemodynamics, echocardiographic parameters,
      necessity of antiarrhythmic and inotropic treatment and glucose control in patients with
      coronary atherosclerosis and decreased left ventricular function undergoing elective coronary
      artery bypass grafting operation (CABG). In addition, safety and tolerability of
      peri-operative administration of exenatide in these patients will be examined as a secondary
      study objective.
    


Intervention name(s): Exenatide
Intervention type(s): Drug
Intervention description(s): Perioperative continuous i.v. administration of exenatide lasting for 72 hours - 40 ng/min for initial 30 min, 20 ng/min for remaining 71.5 hours
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study to Evaluate Safety and Imunogenicity of Double Viral Vaccine (MR) for Measles and Rubella
Condition: Rubella; Measles
MeSH terms: Measles; Rubella
Study type: Interventional
Phase: Phase 1

Summary: 
      Measles and rubella are highly contagious acute viral diseases. As per WHO, several evidences
      demonstrate the benefit for providing the universal access to vaccines containing measles and
      rubella antigens, mainly due to, respectively, mortality in children and malformations in
      fetuses. This is a Phase I, open study, non-controlled, to evaluate the safety, tolerability
      and imunogenicity of double viral vaccine anti-measles and rubella (MR), which is developed
      and produced at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil,
      for use in human beings. 30 eligible volunteers, between 18-49 years old, will be vaccinated
      and monitored for local and systemic adverse events and titration of antibodies. The study
      will last 20 months in total.
    

Detailed description: 
      This is a Phase I, open study, non-controlled, to evaluate the safety, tolerability and
      imunogenicity of double viral vaccine anti-measles and rubella (MR), which is developed and
      produced at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for
      use in human beings. 30 eligible volunteers, between 18-49 years old, will be vaccinated and
      monitored for local and systemic adverse events and titration of antibodies. The study will
      last 20 months in total.
    

Intervention name(s): Double viral (MR) vaccine
Intervention type(s): Biological
Intervention description(s): Measles and Rubella vaccine, as single arm
Other intervention name(s): Measles and Rubella vaccine; MR Vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Double; Viral; Vaccine; Measles; Rubella; Safety; Efficacy; Imunogenicity
A Ph1 Study in Healthy Male Japanese and Caucasian After Single and Multiple Doses of D5884(Omega-3-carboxylic Acids)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety, tolerability and pharmacokinetics of D5884
      following administration of single and multiple doses in healthy male Japanese subjects.
    

Detailed description: 
      This is a Phase 1, single-centre study that plans to enrol 3 cohorts in 3 study arms (Study
      Arms A, B and C). Study Arms A and B will be comprised of cohorts of healthy male Japanese
      subjects in randomised, single-blind, placebo-controlled, single and multiple dose parallel
      studies and Study Arm C will be comprised of a cohort of healthy male Caucasian subjects in a
      single and multiple dose open-label study.

      Two dose levels, 2 and 4 g D5884, will be investigated in healthy male Japanese subjects. Up
      to 18 healthy male Japanese subjects aged 20 to 45 years, inclusive, will be enrolled in 2
      cohorts (Study Arms A and B) and up to 6 healthy male Caucasian subjects will be enrolled in
      a 3rd cohort (Study Arm C). Each subject will participate in 1 cohort only.

      Following a screening period of a maximum of 42 days, subjects will reside at the study
      facility for 18 nights starting from the day before dosing (Day -1) to Day 18 (day of
      discharge). The follow-up period after dosing will be 8 (±2) days after last dose. Dose
      administration in all 3 study arms will be done in the following sequence: a single dose of
      D5884 or placebo will be administered; this will be followed by a 2-day washout period; after
      the washout period, multiple doses of D5884 or placebo will be administered, once daily for
      14 consecutive days. The 1st cohort (Study Arm A) will receive 2 g D5884 (n=6) or placebo
      (n=3), the 2nd cohort (Study Arm B) will receive 4 g D5884 (n=6) or placebo (n=3) and the 3rd
      cohort (Study Arm C) will receive 4 g D5884 (n=6).

      The PK analysis included all evaluable PK data appropriate for the evaluation of interest
      (eg, with no major protocol deviations or violations thought to significantly affect the PK
      of the drug) from all subjects who received D5884.
    

Intervention name(s): D5884; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1st cohort: Dose 1(2g) D5884(n=6) in Japanese 2nd cohort: Dose 2(4g) D5884(n=6) in Japanese 3rd cohort: Dose 2(4g) D5884(n=6) in Caucasian; st cohort: Dose 1(2g) D5884(n=3) in Japanese
nd cohort: Dose 2(4g) D5884(n=3) in Japanese
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Safety; Tolerability; Pharmacokinetics; Pharmacodynamics; D5884; Japanese; Caucasian
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
Condition: Primary Biliary Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Ursodeoxycholic acid (UDCA) has been the only treatment for primary biliary cirrhosis (PBC)
      approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in
      patients with PBC improves serum liver biochemistries and survival free of liver
      transplantation However, about 40% of patients do not respond to UDCA optimally as assessed
      by known criteria for biochemical response. Those patients represent the group in need for
      additional therapies, having increased risk of disease progression and decreased survival
      free of liver transplantation. Both lab research and some clinical studies suggest that
      fenofibrate could improve cholestasis in multiple ways including reduce of bile acid
      synthesis, increase of biliary secretion and anti-inflammation effect. Here we start a
      random, open and parallel clinical research to explore the effect of fenofibrate in the PBC
      treatment.
    


Intervention name(s): Fenofibrate; UDCA
Intervention type(s): Drug; Drug
Intervention description(s): Fenofibrate 200mg/day; UDCA 13-15mg/kg/day
Intervention MeSH terms: Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PBC; UDCA; Fenofibrate