bioihbjkbjnl/mcl2 huggingface dataset:
Effect of High Cocoa Content Chocolate on Health in Postmenopausal Women.
Condition: Postmenopausal Women
Study type: Interventional

Summary: 
      This is a randomized clinical trial aimed at postmenopausal women aged 50 to 64 years old
      selected in urban primary care centers of two centers (Spain). Its objective is to evaluate
      the effects of the additional intake of high cocoa content chocolate on blood pressure,
      vascular function, body composition, quality of life and cognitive performance.
    

Detailed description: 
      -  Objective: To assess the effect at 6 months of the additional intake of 10 g/day of high
           cocoa content chocolate for 6 months on blood pressure, vascular function, body
           composition, quality of life and cognitive performance in postmenopausal women.

        -  Design and setting: A randomized clinical trial of two parallel groups. Population: 140
           postmenopausal women, 50 to 64 aged will be included, selected by consecutive sampling
           in two primary care centers.

        -  Measurements and intervention: Vascular function (blood pressure, augmentation index and
           Cardio-Ankle Vascular Index), body composition and health-related quality of life will
           be evaluated. The intervention group will receive a daily supplement of high cocoa
           content chocolate for 6 months.
    

Intervention name(s): Intervention group
Intervention type(s): Dietary Supplement
Intervention description(s): 10 g/day of high cocoa content chocolate for six months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Other
Keywords: Cocoa; Vascular function; Body composition; Quality of life; Cognitive performance; Postmenopausal women
Safety Study of Oral BTA9881 to Treat RSV Infection
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Infections; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a placebo-controlled, double-blind, randomised, single dose escalation Phase I
      clinical trial to determine the safety and tolerability of BTA9881 administered orally to
      healthy subjects
    


Intervention name(s): BTA9881; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral escalating doses
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RSV
VAC063C: A Study to Assess Repeat Blood-stage P. Falciparum Infection
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      This is a clinical study to assess the safety of primary, secondary and tertiary blood-stage
      controlled human Plasmodium falciparum malaria infection of healthy malaria-naïve UK adults,
      as well as to evaluate any effect of prior exposure to a blood-stage controlled human malaria
      infection (CHMI) on the parasite multiplication rate.

      As a secondary objective, the immune response to primary, secondary and tertiary P.
      falciparum blood-stage infection, as well as gametocytaemia, will also be assessed.
    

Detailed description: 
      Nine to seventeen healthy adult volunteers, aged between 18 and 50 years, will be recruited
      and receive a blood-stage controlled human malaria infection (CHMI) at the CCVTM, Oxford. Of
      these volunteers, three will be newly recruited, malaria-naïve volunteers, who will receive a
      primary CHMI.

      The remaining volunteers will be invited to be involved in this study, following previous
      participation in the VAC063 study (ClinicalTrials.gov Identifier: NCT02927145). VAC063 was a
      study to assess the safety, immune responses and efficacy of the new malaria vaccine
      RH5.1/AS01. As part of this study, control volunteers, who did not receive a vaccine,
      received a blood-stage CHMI, or "challenge", in order to compare to the vaccinated
      volunteers. Some control (unvaccinated) participants received two challenges and some
      received just one challenge, therefore, in this study, participants who previously took part
      in VAC063 will receive either a third or second malaria challenge.

      Volunteers will be challenged with malaria by administering a small amount of P. falciparum
      infected blood intravenously. Blood will then be taken at regular intervals to measure the
      parasite growth, quantify the sexual parasite forms and assess the immune response to
      primary, secondary or tertiary P. falciparum CHMI.

      When volunteers are diagnosed with malaria, treatment with a standard antimalarial course of
      oral artemether-lumefantrine (Riamet) will be given over 3 days.

      Volunteers who take part in this study will be involved in the trial for approximately 3
      months.
    

Intervention name(s): Blood-stage controlled human P. falciparum malaria infection
Intervention type(s): Biological
Intervention description(s): Volunteers will be challenged with malaria by administering a small amount of P. falciparum infected blood intravenously.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
NATural Ovarian Stimulation
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      To overcome unsuitable effects of controlled ovarian hyperstimulation (COH )while maintaining
      large oocyte availability, investigators elaborated an innovative protocol (NATural Ovarian
      Stimulation) that dissociates E2 production from multiple follicle development.

      The purpose of this prospective, randomized trial is to demonstrate that, in a good prognosis
      IVF-ET population, the physiological E2 environment resulting from NATOS significantly
      improves IVF-ET outcome when compared to the conventional GnRH antagonist protocol.
    

Detailed description: 
      Controlled ovarian hyperstimulation (COH) seeks to improve IVF-ET results by increasing
      per-cycle oocyte and embryo availability. Yet, the coexistence of multiple preovulatory
      follicles engenders compulsory alterations in the endocrine milieu of the follicular phase.
      The most evident of them are the extremely high serum estradiol (E2) levels. The 10 to
      15-fold increase in E2 levels as a result of COH has been shown to provoke unwanted
      consequences in both embryo quality and uterine receptivity.

      Therefore, investigators elaborated an innovative COH protocol (NATural Ovarian Stimulation)
      that aimed at dissociating E2 production from multiple follicle development. To obtain this
      effect, they virtually curtailed endogenous LH production by using GnRH antagonist doses as
      strong and frequent enough to maintain E2 levels around the physiological range during
      standard exogenous FSH-only administration. Given that high E2 levels are commonly reached in
      patients having a normal follicle endowment, NATOS should target this group of good prognosis
      IVF-ET candidates. Indeed, this new COH approach was first tested in a pilot study that
      included 15 good prognosis IVF-ET candidates, aged 25-35 years, who volunteered to undergo
      NATOS. 11 out of 15 patients achieved a pregnancy. These pilot results spurred them to
      conduct a prospective, randomized trial to demonstrate that, in a good prognosis IVF-ET
      population, the physiological E2 environment resulting from NATOS significantly improves
      IVF-ET outcome when compared to the conventional GnRH antagonist protocol.
    

Intervention name(s): Gonal-F®; Cetrotide®; Cetrotide®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 225 to 450 IU/d; from day 2 of menstrual cycle onward; 0.25 mg/day, starting on day 6 of Gonal-F®.; 1.5 mg/day (6 ampoules of 0.25 mg), starting on day 1 (S1) of Gonal-F® treatment until dhCG
Intervention MeSH terms: Cetrorelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Controlled ovarian hyperstimulation; Estradiol; Embryo implantation; Endometrial receptivity; Fertility preservation
Effect of Tai Chi Chuan on Autonomic Nervous Modulation in Aged Subjects
Condition: Healthy Subjects
Study type: Observational

Summary: 
      Since Tai Chi Chuan (TCC) training has been shown to be beneficial to the cardiopulmonary
      function of the subject, TCC might have a beneficial effect on the pulmonary function,
      autonomic nervous modulation, lipid profile, and cytokines production in the aged subjects.
    

Detailed description: 
      Tai Chi Chuan (TCC) is a traditional Oriental conditioning exercise or calisthenics that is
      believed by many people around the world to be good for the health. The frequently claimed
      reason for this merit of TCC is that it can improve the cardiopulmonary function and immunity
      of the subject who practice it continuously. TCC has been shown to delay the decline of
      aerobic power, improve the cardiopulmonary function, balance and strength of the subjects.
      One study has demonstrated that TCC could reduce tension, anxiety, and mood disturbance.
      However, few studies have examined the effect of TCC on the blood lipid profile and immunity
      of the TCC practitioners. Another study reported that 12-week programme of regular TCC
      exercise enhanced functional mobility, personal health expectations, and regulatory T cell
      function. It has also been shown that an appropriate combination of TCC exercise program with
      diabetic medication might improve both glucose metabolism and immunity in type 2 diabetic
      patients. Since TCC training has been shown to be beneficial to the cardiopulmonary function
      of the subject, TCC may also have an effect on the blood lipid profile and immunity of the
      subjects. We hypothesize that TCC might have a beneficial effect on the pulmonary function,
      autonomic nervous modulation, lipid profile, and cytokines production in the aged subjects.
      Thus, the aim of this study was to examine whether or not TCC have these effects in the aged
      subjects.
    

Intervention name(s): Tai Chi Cuan
Intervention type(s): Procedure
Intervention description(s): Tai Chi Cuan training for 3 months
Other intervention name(s): Yang's Tai Chi Cuan
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy aged subjects
      
Biospecimen description: 
      Blood sample obtained from each subject was withdrawn for the quantitative measurements of
      total cholesterol (TC), high-density lipoprotein--cholesterol (HDL-C), high-density
      lipoprotein--cholesterol (LDL-C), triglyceride (TG), fasting blood sugar (FBS), and uric acid
      (UA). The immunoenzymometric assays for the quantitative measurement of tumor necrosis
      factor-α (TNF-α) and interferon-γ (IFN-γ) in the serum were also performed on the blood
      sample from each subject.
    
Keywords: Tai Chi Chuan; Lipid; Cytokine
The Chocolate Study 2.0
Condition: Normal Weight
Study type: Observational

Summary: 
      The purpose of this study is to test how the brain responds when enjoyable foods such as
      chocolate are consumed. The investigators know that eating certain types of foods can make an
      individual want to keep eating even when he or she is full. The chemical in the brain that
      causes this is called dopamine. The investigators can measure this response by looking at
      changes to how an individual's eye responds to light.
    

Detailed description: 
      The overall objective of this study is to determine dopamine (DA) neuromodulation (changes in
      b-wave amplitude as measured by electroretinography (ERG)) in response to consuming a highly
      reinforcing food (chocolate). The investigators hypothesize that orosensory stimulation with
      chocolates with increasing sugar content will increase the beta wave (b-wave) amplitude and
      the increase in the b-wave amplitude will correlate with score changes on the Psychophysical
      Effects Questionnaire (PEQ). This will be accomplished by testing different chocolates
      (extreme dark (90% cocoa), dark (70% cocoa), milk (38% cocoa), and white (0% cocoa)) on
      different days using 1.0 cd∙s/m2 flash luminance energy.
    

Intervention name(s): Chocolate
Intervention type(s): Other
Intervention description(s): Participants will be asked to taste commercially available chocolate varying in sugar, fat and percent cocoa (extreme dark (90%), dark (70%), milk (38%), and white (0%)).
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Community sample
Efficacy of Two Chlorhexidine Solutions to Control the Initial Subgingival Biofilm Formation
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to compare the effect of a suspension containing chlorhexidine and
      alcohol and another one containing clorhexidine with no alcohol in dynamic of the subgingival
      biofilm formation versus a Placebo suspension. The initial subgingival biofilm formation will
      be evaluated by means of Plaque Free Zone (PFZ).
    

Detailed description: 
      This is a double blind, cross over, randomized clinical trial. 35 volunteers will stop
      mechanical supragingival biofilm removal measures for 96h following a complete scaling and
      polishing of the tooth surfaces. During this period they will be asked to rinse for a minute
      a Solution containing chlorhexidine and alcohol or a solution with chlorhexidine alcohol-free
      or placebo. Every 24h the presence of deposits will be registered with special attention to
      the presence of a plaque free zone between the apical border of the deposits and the gingival
      margin. Absence of deposits is scored 0, presence of deposits and plaque free zone =1 and
      presence of deposits and absence of plaque free zone =2 (MALISKA, A. N. et al. Measuring
      early plaque formation clinically. Oral health preventive dentistry, v. 4, p. 273-278, 2006).
      The prevalence of scores and the rate of changes from scores 0 and 1 into 2 will be evaluated
      for significance. Sample size was calculated taking the results from the study o MALISKA, AN
      (2006) as reference.
    

Intervention name(s): 0.12% Clorhexidine with alcohol; placebo; 0.12% Clorhexidine without alcohol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days; Use of placebo every 12 hours for 04 days; Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days
Other intervention name(s): Periogard; No plak; Periogard
Intervention MeSH terms: Ethanol; Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: biofilms; cross over trial; chlorhexidine
Biomarkers and Validation of Selected Outcome Measures (CMTNSmod)
Condition: Charcot-Marie-Tooth Disease, Type IA
MeSH terms: Tooth Diseases; Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Hereditary Sensory and Motor Neuropathy
Study type: Observational

Summary: 
      CMT is a rare disease for which novel treatments are being developed. Evaluation of
      intervention efficacy is hampered by slow progression and lack of sensitive outcome measures.
      Primary goal of the project is to identify and validate RNA and protein derived biomarkers in
      blood of CMT patients for selected outcome measures over 2 years. The investigators expect to
      develop more responsive outcome measures and circulating biomarkers to improve assessment of
      intervention efficacy in forthcoming therapeutic trials.
    

Detailed description: 
      Novel treatments are being developed for CMT. Intervention efficacy evaluation is hampered by
      slow disease progression and lack of sensitive outcome measures. The investigators have
      previously shown that biomarkers from skin identified in a CMT1A rat model can be translated
      to CMT1A patients. Primary goal is to identify circulating biomarkers correlating with
      disease severity and progression. 210 young, adolescent and adult patients affected by
      genetically confirmed CMT1A, will be evaluated with different clinical outcome measures,
      assessing impairment, disability and quality of life: Patients will be re-evaluated at 12
      (n=147) and 24 months (n=103) with the same measures to assess disease progression. A number
      of candidate markers correlating with disease severity have been identified in blood samples
      from the rat model of CMT1A. At 0-12-24 months a blood sample will be drawn from affected
      CMT1A patients. The investigators will purify total mRNA from blood samples, and validate the
      10 strongest regulated markers identified in the rat model via qRTPCR in blood of CMT1A
      patients. Protein biomarkers will also be analysed. Marker expression at baseline and at
      follow up will be correlated with clinical severity and progression. In this translational
      project (rat/human) the investogators expect to develop more responsive outcome measures and
      circulating biomarkers to improve assessment of intervention efficacy in forthcoming
      therapeutic trials.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients suffering from CMT1A disease
      
Biospecimen description: 
      DNA and RNA from blood and skin
    
Keywords: Biomarkers; CMT1A; Charcot-Marie-Tooth disease
Cytochrome P450 2E1 and Iron Overload
Condition: Insulin Resistance; Iron Overload
MeSH terms: Insulin Resistance; Iron Overload
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to determine, in patients presenting hepatic iron overload (genetic
      haemochtomatisis or dysmetabolic iron overload syndrome), the effects of venesection therapy
      on cytochrome P450 2E1 activity by comparing the rates of metabolization of chlorzoxazone
      before and after venesection.
    


Intervention name(s): venesection
Intervention type(s): Procedure
Intervention description(s): Venesection therapy is realised every 7 - 14 days until iron desaturation completion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: insulin resistance; iron overload; phlebotomy; hepatic iron overload
Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
Condition: Varicose Veins
MeSH terms: Varicose Veins
Study type: Interventional
Phase: Phase 3

Summary: 
      Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and
      may cause discomfort. In this study, patients with varicose veins in the legs will be
      participating. The purpose of this research study is to evaluate the safety and effectiveness
      of three different concentrations of an investigational drug, Polidocanol Endovenous
      Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and
      appearance of varicose veins.
    


Intervention name(s): polidocanol injectable foam, 0.125%; polidocanol injectable foam, 0.5%; polidocanol injectable foam, 1.0%; Vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): active placebo for blinding; 0.5% polidocanol foam injection; 1.0% polidocanol foam injection; injection of vehicle comparator
Intervention MeSH terms: Polidocanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: varicose veins
Ciclosporin in the Management of New Erythema Nodosum Leprosum
Condition: Leprosy
MeSH terms: Leprosy; Erythema Nodosum
Study type: Interventional
Phase: Phase 2

Summary: 
      Study 2A: Ciclosporin in the management of new Erythema Nodosum Leprosum

      Objective: A pilot (double blind controlled) study randomizing patients to treatment either
      with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of
      Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).
    

Detailed description: 
      A pilot (double blind controlled) study randomizing patients to treatment either with
      Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in
      the treatment of patients with new acute Type 2 reactions (ENL).
    

Intervention name(s): Ciclosporin; prednisolone
Intervention type(s): Drug; Drug
Intervention description(s): Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks); prednisolone 40mg daily then reducing regimen over 16 weeks
Other intervention name(s): cyclosporin; Cyclosporin A; corticosteroids
Intervention MeSH terms: Cyclosporine; Prednisolone; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Leprosy; ENL; Erythema Nodosum Leprosum; Prednisolone; Ciclosporin
Safety of Desloratadine in Children With Allergy Sensitivity and Chronic Hives, Who Are Poor Metabolizers of Desloratadine (Study P02994)
Condition: Chronic Idiopathic Urticaria; Atopy
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was conducted to evaluate the safety and tolerance of desloratadine after 5 weeks
      of repetitive dosing in children ages 2 to 12 years old with allergic hypersensitivity or
      chronic hives. All of the subjects enrolled in this trial were previously identified in an
      earlier trial to be poor metabolizers of desloratadine.
    


Intervention name(s): desloratadine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): desloratadine syrup: 1.25 mg (2.5 mL) for subjects >=2 to <6 years, 2.5 mg (5 mL) for subjects >=6 to <12 years, orally once daily in the morning for 36 days.; placebo syrup: 2.5 mL for subjects >=2 to <6 years, 5 mL for subjects >=6 to <12 years, orally once daily in the morning for 36 days.
Other intervention name(s): SCH 034117; Clarinex
Intervention MeSH terms: Desloratadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment