bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Study to Investigate the Effect of Water-soluble Tomato Extract on TMAO
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      To determine the effect of 4 weeks daily consumption of Fruitflow on changes in plasma levels
      of fasting Trimethylamine N-oxide concentrations (TMAO)
    

Detailed description: 
      Tomatoes contain a range of polyphenols that are of low bioavailability and reach the colon.
      Data from animal studies suggest that certain polyphenols are extensively metabolized by the
      gut microbiota which may impact bioactivity including TMA/TMAO production. It was previously
      shown that a polyphenol-rich cranberry extract attenuated diet-induced metabolic syndrome in
      mice in a gut microbiota-dependent manner. In another mouse study the polyphenol resveratrol
      attenuated TMAO-induced atherosclerosis by decreasing TMAO levels and increasing hepatic bile
      acid neosynthesis via gut microbiota remodelling. However, human studies on polyphenol effect
      on TMAO levels and the gut microbiome are sparse. In a recent study TMAO serum levels were
      reduced in healthy subjects upon supplementation with a grape pomace polyphenolic extract.

      This clinical study will provide new insight into the effect of tomato extract on TMAO levels
      and the gut microbiota composition and thus potential new mechanisms responsible for the
      cardiovascular protective effects.
    

Intervention name(s): FruitFlow; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 300mg tomato extract; Maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, cross-over
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: gut microbiome; carciovascular risk factor
Evaluation of iMmune Function in Post-surgical and AuToimmune HYpoparathyroidism (EMPATHY)
Condition: Hypoparathyroidism; Hypoparathyroidism Postprocedural; Hypoparathyroidism Due to Impaired Parathormone Secretion
MeSH terms: Hypoparathyroidism
Study type: Observational

Summary: 
      This is an observational pilot study for the evaluation of immune function, infectious
      diseases, psychometric status and quality of life in patients with hypoparathyroidism
      compared to healthy controls.
    

Detailed description: 
      This is an observational pilot study for the evaluation of immune function, infectious
      diseases, psychometric status and quality of life in patients with hypoparathyroidism
      compared to healthy controls.

      All patients with Hypoparathyroidism will be on established conventional therapy with calcium
      supplements and calcitriol. According to guidelines, possible confounding factors (i.e.
      Vitamin D, serum magnesium levels) will be evaluated at screening visit. Age-, sex- and BMI-
      matched healthy controls will be enrolled.

      Patients and controls will undergo a screening visit (V0) and a baseline visit (V1) in the
      following month.

      The primary outcome will be the immune profiling of patients with hypoparathyroidism compared
      to healthy controls by the quantification of peripheral blood mononuclear cells (PBMC)
      subpopulations assessed by flow cytometry.

      Secondary Outcome Measures will be:

      Functional evaluation of PBMC cytokine secretion assessed by flow cytometry

      Evaluation of calcium signaling components expression compared to healthy controls

      Evaluation of PTHR1 expression in immune cells compared to healthy controls

      Evaluation of inflammatory cytokines production compared to healthy controls.

      Evaluation of quality of life compared to healthy controls. Quality of life will be measured
      by Short Form (SF)-36-Item Health Survey total score, SF-36-Item Health Survey physical
      component summary score and SF-36-Item Health Survey mental component summary score.

      Evaluation of infectious diseases frequencies and severity compared to healthy controls.
      Infectious diseases will be evaluated by an adaptation of Infectious Diseases Questionnaire
      (GNC).

      Psychometric evaluation by self-administered questionnaires: Beck depression Index, Middlesex
      Hospital Questionnaire.

      Sleep disturbances evaluation by The Pittsburgh Sleep Quality Index (PSQI) self reported
      questionnaire.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        20 patients with post-surgical or autoimmune hypoparathyroidism and 20 age-, sex- and BMI-
        matched controls, referring to our center for diagnostic procedures for suspected other
        endocrinopathies, not affected by hypoparathyroidism
      
Keywords: parathormone; hypoparathyroidism; parathyroid; hypocalcemia; immunity; immune function; quality of life; sleep disturbances; parathyroid hormone
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 811 in Subjects With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, immunogenicity, and clinical
      effects of AMG 811 following single subcutaneous dose administration in subjects with
      moderate to severe psoriasis.
    


Intervention name(s): AMG 811 or Placebo
Intervention type(s): Drug
Intervention description(s): Single dose subcutaneous administration of AMG 811 or placebo to adult subjects with psoriasis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: AMGEN; PSORIASIS; SAFETY
Monthly Itraconazole Versus Classic Homeopathy for Treatment of Recurrent Vulvovaginal Candidiasis (RVVC)
Condition: Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Study type: Interventional

Summary: 
      A prospective study to evaluate the efficacy of classic homeopathic therapy compared to
      maintenance itraconazole therapy with and without additional exogenous lactobacillus for
      treatment of recurrent Candida vaginitis.
    

Detailed description: 
      Objective:

      Antimycotics effectively treat sporadic and recurrent vulvovaginal candidiasis (RVVC).
      Classic homeopathy (CH) is also used to treat this condition. We compared the efficacy of CH
      and itraconazole in reducing the frequency of RVVC episodes.

      Design:

      Single-centre, prospective, randomized.

      Sample:

      One-hundred-and-fifty patients with a history of RVVC and an acute episode of VVC.

      Methods:

      Women were randomised into 3 groups: itraconazole with lactobacilli (group 1), itraconazole
      without lactobacilli (group 2) and CH (group 3). Itraconazole treatment of acute infection
      was followed by a 6-months maintenance regimen with monthly single-day itraconazole (200 mg
      bid). Thereafter, patients were followed without treatment for 6 months. Women in group 1
      were given additional vaginal lactobacilli for six days per month. CH treatment was performed
      for 12 months.
    

Intervention name(s): itraconazole; lactobacillus gasseri; classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid); Lactobacillus vaginal tablets monthly given through 6 days; CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000.
Intervention MeSH terms: Iron; Itraconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent vulvovaginal candidiasis; itraconazole; classic homeopathy
Randomized Placebo-controlled Pilot Trial of Prebiotics+Glutamine in HIV Infection
Condition: HIV
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A rapid and almost complete loss of CD4+ T cells from the gut associated lymphoid tissue
      (GALT) occurs early in HIV infection, with a permanent damage in the intestinal barrier,
      changes in gut microbiota, increased bacterial translocation and persistent immune
      activation, changes that are not restored after the initiation of antiretroviral therapy. The
      investigators hypothesize than an intervention targetting the enterocyte barrier and the gut
      microbiota might modify the gastrointestinal tract towards a bifidogenic microbiota and
      improve markers of bacterial translocation, inflammation, immune activation and endothelial
      dysfunction.
    

Detailed description: 
      This is a randomized placebo-controlled clinical trial to evaluate the safety and
      effectiveness to modify gut microbiota, bacterial translocation, immune activation and
      markers of endothelial dysfunction of a dietary supplement (prebiotics + glutamine) during a
      period of six weeks. The study will enroll four cohorts: 1) HIV-infected, treatment naive
      individuals; 2) HIV-infected subjects, currently on ART, with >350 CD4+ T-cells/uL; 3)
      HIV-infected subjects, currently on ART, with <350 CD4+ T-cells/uL; 4) HIV negative healthy
      controls.
    

Intervention name(s): Prebiotics+Glutamine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Prebiotics are nondigestible food ingredients, generally oligosaccharides, that modify intestinal microbiota balance by stimulating the growth of beneficial bacteria.
Glutamine is a non-essential amino acid that can be metabolized by epithelial cells, enhancing barrier function.; Maltodextrin, 20 g.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HIV; immunoactivation; bacterial translocation; prebiotics; glutamine; microbiota
Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated With AA4500 for Peyronies Disease
Condition: Peyronie's Disease
MeSH terms: Penile Induration
Study type: Observational

Summary: 
      This a Phase 4 non-treatment, long-term follow-up study of subjects who received AA4500 in a
      12-month double blind placebo-controlled study (AUX CC 803 or AUX-CC-804) or in a 9-month
      open label study (AUX-CC-802 or AUX-CC-806) sponsored by Auxilium Pharmaceuticals, Inc. After
      participation in one of the aforementioned studies, subjects will be followed yearly for up
      to 4 consecutive long-term follow-up visits with at least 6 months between consecutive visits
    

Detailed description: 
      At each long-term follow-up visit, subjects will be assessed for adverse events relative to
      their previous long-term follow-up assessment. Blood samples for the determination of
      antibodies to AUX-I and AUX-II and neutralizing antibodies to AUX-I and AUX-II will be
      collected at each long-term follow-up visit.

      At each long-term follow-up visit, a flaccid penile examination will be performed and a
      curvature deformity measurement (with the penis in the erect state) will be recorded.
      Subjects will also be asked to complete the Peyronie's Disease Questionnaire (PDQ) and the
      International Index of Erectile Function (IIEF) questionnaire. At each visit, medical,
      surgical, or other treatments for Peyronie's disease since the last assessment will also be
      collected and recorded.
    

Intervention name(s): Subjects Previously Treated with AA4500
Intervention type(s): Drug
Intervention description(s): no treatment to be administered - observational only
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Up to 750 subjects who received AA4500 and completed at least the first or last follow-up
        visit in one of the Auxilium-sponsored studies (AUX-CC-802, AUX-CC-803, AUX-CC-804, or
        AUX-CC-806).
      
Biospecimen description: 
      Blood samples for the determination of antibodies to AUX-I and AUX-II and neutralizing
      antibodies to AUX-I and AUX-II will be collected at each long-term follow-up visit.
    
Keywords: curvature; bend
Reversal of Residual Neuromuscular Blockade at Train-of-four Ratio 0.3 With Sugammadex and Neostigmine
Condition: Neuromuscular Blockade
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to estimate the optimal dose of sugammadex and neostigmine reversal
      of a vecuronium-induced residual neuromuscular block at train-of-four ratio 0.3.
    

Detailed description: 
      Sugammadex is a modified γ-cyclodextrin compound that reverses the neuromuscular blockade
      produced by steroidal nondepolarizing muscle relaxants such as rocuronium,vecuronium and
      pipecuronium by encapsulating them, making them unavailable to interact with the nicotinic
      acetylcholine receptors at the neuromuscular junction.However, residual neuromuscular blocks
      between reappearance of T4 and train-of-four ratio (TOFR)=0.5 are more frequent in clinical
      practice compared with profound or deep blocks and have not been investigated for sugammadex
      previously.

      Unlike neostigmine, sugammadex is efficacious in reversing profound (no responses to either
      train-of-four (TOF) or posttetanic count stimulation) or deep (posttetanic count of 1 or 2)
      neuromuscular block (NMB) in doses of 16 and 4 mg/kg, respectively. However, shallow
      neuromuscular blocks are more frequent in clinical practice compared with profound or deep
      blocks and have not been investigated for sugammadex previously.
    

Intervention name(s): Sugammadex; Neostigmine; Saline 0.9%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of either :
Sugammadex 0.125 mg/kg (sugammadex 0.125) Sugammadex 0.25 mg/kg (sugammadex 0.25) Sugammadex 0.5 mg/kg (sugammadex 0.5) Sugammadex 1.0 mg/kg (sugammadex 1.0) Sugammadex 2.0 mg/kg (sugammadex 2.0); At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of either :
Neostigmine 10 µg/kg (Neostigmine 10) Neostigmine 25 µg/kg (Neostigmine 25) Neostigmine 40 µg/kg (Neostigmine 40) Neostigmine 55 µg/kg (Neostigmine 55) Neostigmine 70 µg/kg (Neostigmine 70)
Atropine will be administered with Neostigmine at a half dose of Neostigmine administered through an intravenous line with brisk flow.; At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of saline 0.9%.
Other intervention name(s): Bridion; Org 25969; Prostigmin; Placebo
Intervention MeSH terms: Neostigmine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        people scheduled for elective surgery
      
Keywords: sugammadex neostigmine
Alcohol Consumption Relation With Nutritional Knowledge and Body Weight
Condition: Binge Drinking
MeSH terms: Body Weight; Binge Drinking; Alcohol Drinking
Study type: Observational

Summary: 
      The increase of overweight and obesity in young Italian people, nowadays showed by several
      epidemiological data, has been related to the misuse of alcohol and to a lack in nutritional
      knowledge.

      Thus the aim of our study was to investigate if different nutritional knowledge from could
      affect body composition and drinking habits of a cohort of local young people.

      104 healthy subjects (56 males and 54 females) were recruited using oral advertisements among
      the students of 18-19 years-old belonging to the Istituto Agrario and the Istituto
      alberghiero Raineri-Marcora of Piacenza. The subjects were asked to complete a questionnaire
      on alcohol consumption and another one related to nutritional knowledge. Then anthropometric
      data were measured: height, weight, waist and hips circumferences, waist-hips ratio and
      skinfolds were evaluated for each subject and body fat mass was calculated.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        104 healthy subjects (56 males and 54 females)
Study to Compare Safety and Tolerability of AKST1210 Column at 2 Blood Flow Rates in Subjects With ESRD on Hemodialysis
Condition: End-Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      This study is to evaluate the safety and tolerability of the AKST1210 column at blood-flow
      rates greater than 250 mL/min in subjects with end-stage renal disease (ESRD) undergoing
      hemodialysis (HD). The study will assess the safety, tolerability, and impact on HD
      parameters when the AKST1210 column is used at a blood-flow of up to 450 mL/min.
    

Detailed description: 
      This is an open-label study in approximately 12 to 15 subjects between 40 and 75 years of age
      with ESRD on HD. The objective of this study is to explore the safety and tolerability of the
      AKST1210 column at blood-flow rates greater than 250 mL/min in subjects with ESRD undergoing
      HD. The proposed study will assess the safety, tolerability, and impact on HD parameters when
      the AKST1210 column is used at a blood-flow rates of up to 450 mL/min. Each participant, per
      the protocol, will be sequentially treated to each column and blood-flow rate combination.

      The incidence of IDH events will be one factor used to determine column size/blood-flow rate
      escalation/de-escalation as well as discontinuation from the study. The planned duration of
      subject participation is approximately 12 weeks.
    

Intervention name(s): AKST1210 S-15 at 250 mL/min; AKST1210 S-15 at 450 mL/min; AKST1210 S-25 at 250 mL/min; AKST1210 S-25 at 450 mL/min; AKST1210 S-35 at 250 mL/min; AKST1210 S-35 at 450 mL/min
Intervention type(s): Device; Device; Device; Device; Device; Device
Intervention description(s): Procedure: Hemodialysis, AKST1210 column size 150mL and blood-flow rate at 250mL/min; Procedure: Hemodialysis, AKST1210 column size 150mL and blood-flow rate at 450mL/min; Procedure: Hemodialysis, AKST1210 column size 250mL and blood-flow rate at 250mL/min; Procedure: Hemodialysis, AKST1210 column size 250mL and blood-flow rate at 450mL/min; Procedure: Hemodialysis, AKST1210 column size 350mL and blood-flow rate at 250mL/min; Procedure: Hemodialysis, AKST1210 column size 350mL and blood-flow rate at 450mL/min
Other intervention name(s): S-15 at 250 mL/min; S-15 up to 450 mL/min; S-25 at 250 mL/min; S-25 at 450 mL/min; S-35 at 250 mL/min; S-35 at 450 mL/min
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
Condition: HIV Infections
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if it is safe and effective to give an anti-HIV drug
      combination of indinavir (IDV) plus stavudine (d4T) plus lamivudine (3TC) to HIV-infected
      children. IDV will be given either as a powder mixed into applesauce or as capsules given on
      an empty stomach.
    

Detailed description: 
      In this multicenter, open-label study patients receive a combined drug regimen of indinavir,
      stavudine, and lamivudine over 48 weeks. Patients are evaluated at Weeks 0, 2, 4, every 4
      weeks until Week 24, and every 8 weeks thereafter until study completion. [AS PER AMENDMENT
      4/27/99: The study has been extended for an additional 48 weeks for a total of 96 weeks.]
    

Intervention name(s): Indinavir sulfate; Lamivudine; Stavudine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lamivudine; Stavudine; Indinavir
Primary purpose: Treatment
Keywords: Dose-Response Relationship, Drug; Drug Therapy, Combination; Stavudine; HIV Protease Inhibitors; Lamivudine; Indinavir; RNA, Viral; Reverse Transcriptase Inhibitors; Viral Load
A Blinded, Dose Ascending Study to Assess the Pharmacokinetics, Safety and Tollerability of Repeat Inhaled Doses of Nebulised GW870086X in Healthy Adult Male Volunteers.
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomised, double-blind, placebo-controlled, dose ascending, 3-way crossover
      study in healthy adult male volunteers. The primary objective of the study is to assess the
      pharmacokinetics of 14 days dosing of GW870086X administered via nebules formulation. The
      secondary objective is to assess the safety and tolerability of repeat doses of nebulised
      GW870086X.
    

Detailed description: 
      GW870086X is a potent glucocorticoid agonist in human in vitro functional assays that is
      under development as an inhaled treatment for asthma in children. This study will determine
      the PK characteristics and assess the safety and tolerability of the nebules formulation of
      GW870086X in healthy volunteers after 14 days of dosing.

      This is the first clinical study that will be assessing the nebules formulation. The purpose
      of this study is to ensure that the doses that have been selected have a good safety profile
      in line with what has been found in the previous DPI formulation studies, and to assess the
      PK profile after single (Day 1) and repeat dose (Day 14) to select appropriate doses for
      future studies with the nebules formulation. This study will also provide additional safety
      cover with the nebules formulation given over a longer duration than studied previously with
      the DPI formulation before moving into the paediatric programme. This study is designed to
      give at least 5-fold cover for the highest dose to be studied in future paediatric
      programmes. During this study cortisol production will be assessed by measuring 24 hour
      cortisol profile in serum and urine as well as performing an ACTH stimulation test. Two doses
      (5mg and 8.75mg) have been selected. These doses are 5 and 10 times higher than the
      anticipated maximum clinical dose. The doses have been selected to ensure sufficient safety
      cover in future paediatric studies as well as to confirm the absence of significant adrenal
      inhibition at doses that would be expected to cause complete inhibition of cortisol
      production with traditional steroids.
    

Intervention name(s): GW870086X; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5mg and 8.75mg GW870086X once daily for 14 days in separate traetment periods.; placebo will be randomly inserted into one of the treatment periods following the treatment sequences outlined in the protocol.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: ACTH stimulation test; Pharmacokinetics; Nebules; Cortisol