bioihbjkbjnl/mcl2 huggingface dataset:
Calcium Metabolism in Asian Adolescents
Condition: Bone Mineralization; Adolescent Development
Study type: Interventional

Summary: 
      Maximizing calcium retention by the skeleton within the genetic potential is a key strategy
      to prevent osteoporosis. It has been shown that calcium retention varies between blacks and
      whites and between gender within race. This study is designed to study the relationship
      between calcium intakes and calcium retention in Asian adolescent girls and boys. It is
      hypothesized that calcium intakes which maximize calcium retention will be lower in Asians
      than for whites studies under the same conditions. In addition it is thought that the
      differences between races in the physiological mechanisms involved in calcium metabolism will
      result in a lower calcium intake required to observe a plateau in calcium retention. This is
      turn could be translated into lower calcium requirements in Asians relative to Caucasians for
      achieving optimal peak bone mass.
    

Detailed description: 
      Adolescent Asian boys and girls will consume a controlled diet for two three-week periods.
      The basal diet will contain 600 mg/d calcium and will be supplemented with beverages
      fortified with calcium citrate malate to achieve a range of intakes from 600-2100 mg Ca/d.
      Each participant will be studied on one of four combinations of a lower and a higher calcium
      intake within that range in a cross-over design.
    

Intervention name(s): Beverage containing calcium citrate malate; Beverage fortified with calcium citrate malate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Beverages containing a lower amount of calcium (0-400 mg/d) will be supplemented to a basal diet containing 600 mg/d Ca. The controlled diet will be consumed for 21 consecutive days.; Beverages containing a higher amount of calcium (500-1300 mg/d) will be supplemented to a basal diet containing 600 mg/d Ca. The controlled diet will be consumed for 21 consecutive days.
Intervention MeSH terms: Calcium, Dietary; Citric Acid; Sodium Citrate; Calcium; Calcium citrate malate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: calcium; bone; bone density; adolescence
Chagas Disease Diagnostic - Inconclusive Serology
Condition: Parasitemia; Protozoan Infections
MeSH terms: Chagas Disease; Parasitemia; Protozoan Infections
Study type: Interventional

Summary: 
      T. cruzi infection affects approximately five million people in Brazil. The diagnosis of the
      chronic phase of infection is performed by indirect serological methods which, nevertheless,
      leave inconclusive results. One of the direct methods used for T. cruzi identification, blood
      culture in LIT (liver infusion tryptose) medium, presents low sensitivity in that phase of
      the disease. A negative result does not eliminate the possibility of infection, but a
      positive test has high absolute diagnostic value, which enables the indication of
      antiparasitic treatment. Molecular diagnosis (PCR) in this phase is promising and can be used
      as a confirmatory test, particularly when individuals present inconclusive results in
      conventional serological tests, such as ELISA, HAI and IFI. This study aimed at improving
      blood culture sensitivity in LIT medium by performing PCR in individuals with positive and
      inconclusive serology for chagasic infection.
    


Intervention name(s): chagas disease diagnostic
Intervention type(s): Other
Intervention model: Parallel Assignment
Masking: None (Open Label)
Study of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Children and Adolescents in Taiwan
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to describe the immunogenicity and safety of the new formulation of
      Quadrivalent Influenza Vaccine (QIV) for the 2013-2014 season in the Northern Hemisphere (NH)
      in subjects aged 9 to 17 years in Taiwan

      Primary Objective:

        -  To describe the immunogenicity of the QIV (split-virion, inactivated) NH seasonal
           formulation

      Secondary Objective:

        -  To describe the safety of the QIV (split-virion, inactivated) NH seasonal formulation
    

Detailed description: 
      Study participants will be vaccinated with one dose of the QIV (split-virion, inactivated) NH
      2013-2014 formulation by the intramuscular route or deep subcutaneous. Immunogenicity will be
      assessed at baseline (Day 0) and 21 days after injection; they will also be followed-up for
      safety for 21 days after injection.
    

Intervention name(s): Quadrivalent Influenza Vaccine (split virion, inactivated)
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Quadrivalent Inactivated Influenza Vaccine
Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to assess the effect of continuous levodopa infusion on autonomic
      nervous system in patients with Parkinson's Disease (PD), blood pressure regulation and
      sweating. The investigators' hypothesis is that levodopa infusion may alleviate hyperhidrosis
      and orthostatic hypotension.
    

Detailed description: 
      Parkinson's disease (PD) is one of the most common neurodegenerative disorders with
      increasing prevalence because of aging population. The main symptoms include rigidity,
      hypokinesia, tremor and impaired balance, but the disease also causes autonomic dysfunction.
      Motor fluctuations are common treatment related problems in PD, around 50-70% of patients
      treated with levodopa finally develop motor fluctuations. Continuous duodenal levodopa
      infusion has been effective in the treatment of motor dysfunction in advanced PD. However,
      little is known of its effects on autonomic nervous system.
    

Intervention name(s): Levodopa infusion
Intervention type(s): Drug
Intervention description(s): Naso-duodenal infusion line is inserted in fluoroscopy control. Levodopa infusion is then tested approximately 5 days. If patient responds favorably to the treatment, PEG-infusion line is inserted in gastroscopy control and patient is followed in hospital for 2 to 4 days to ensure stability of the infusion line. The dosage is individually adjusted, starting dose is estimated from earlier oral levodopa dose.
Other intervention name(s): Duodopa
Intervention MeSH terms: Levodopa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's disease; Autonomic nervous system; Levodopa infusion
Effect of Lofexidine and Oral THC on Marijuana Withdrawal and Relapse
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the interaction between marijuana and two
      potential treatment medications: lofexidine and oral THC, with the direct goal of using this
      information to improve marijuana treatment outcome.
    

Detailed description: 
      Only a small percentage of dependent-marijuana smokers who are seeking treatment for their
      marijuana use is able to achieve sustained abstinence. The objective of this study is to
      investigate the interaction between marijuana and two potential treatment medications:
      lofexidine and oral THC, with the direct goal of using this information to improve marijuana
      treatment outcome. In mice, the α2-receptor agonist, clonidine, reversed symptoms of
      cannabinoid withdrawal (Lichtman et al., 2001). The purpose of this study is to determine if
      lofexidine, an α2-receptor agonist with a more favorable side-effect profile than clonidine,
      decreases symptoms of marijuana withdrawal and thus decreases marijuana relapse, as compared
      to placebo. Oral THC is FDA-approved for appetite enhancement. Lofexidine, which is currently
      not FDA-approved, is used in Europe to treat symptoms of heroin withdrawal, and to treat
      hypertension. For the purposes of this model, relapse is defined to a return to marijuana use
      after a period of abstinence. We have shown that oral THC reduces symptoms of marijuana
      withdrawal at doses that produce minimal intoxication (Haney et al., 2004). Thus, the effects
      of oral THC alone and in combination with lofexidine will be determined. The study will
      utilize an inpatient/outpatient, counter-balanced design, with each participant maintained on
      each of four medication conditions for 8 days each: placebo, lofexidine, oral THC, and oral
      THC combined with lofexidine. During the inpatient study phases, participants will have the
      opportunity to self-administer placebo or active marijuana 6 times per day. Outpatient phases
      are for medication clearance so no medications will be administered. This study will provide
      important information of the effect of these potential treatment medications on both
      marijuana withdrawal symptoms, and on subsequent marijuana self-administration.
    

Intervention name(s): Lofexidine; dronabinol; Marijuana
Intervention type(s): Drug; Drug; Drug
Intervention description(s): alpha 2 adrenergic agonist, hypothesized to decrease noradrenergic activity; cannabinoid agonist hypothesized to decrease MJ withdrawal; marijuana intoxication, withdrawal and relapse assessed
Other intervention name(s): Britlofex; THC; cannabis
Intervention MeSH terms: Lofexidine; Dronabinol
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Lofexidine; Oral THC; Cannabinoids
The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine
Condition: Fascicular Block; Motor Activity; Pain, Postoperative; Latency Period
MeSH terms: Bundle-Branch Block; Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether different clonidine concentration on
      axillary brachial plexus block with 1,5% lidocaine for upper limb surgery may influence the
      sensory and motor block onset time and duration, postoperative analgesia duration,
      postoperative pain intensity
    

Detailed description: 
      Brachial plexus blocks are frequently used in surgical procedures involving the upper limb
      because they facilitate surgical anaesthesia, muscle relaxation and post-operative
      analgesics.

      Various drugs are used to supplement local anaesthetics during brachial plexus block. Many
      studies in the literature show that clonidine, which is an alpha-2 agonist, prolongs the
      length of anesthesia and post-operative analgesia.4,5 However, clonidine's side effects-such
      as hypotension, bradycardia and sedation can limit its use.

      There are no studies comparing different clonidine concentrations on the axillary brachial
      block, so the hypothesis of the present study was that different clonidine concentrations and
      LA volumes may influence the anaesthesia and analgesia quality on this type of regional
      block.
    

Intervention name(s): high Clonidine concentration; low clonidine concentration; Lidocaine; Lidocaine 40 ml
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Clonidine 1 ml - 150 mcg on 20 ml de lidocaine 1,5% on axillary brachial plexus block for upper limb surgery; Clonidine 1 ml - 150 mcg on 40 ml of lidocaine 1,5% - single injection on axillary brachial plexus block for upper limb; Lidocaine 1,5% 20 ml 300 mg for single injection on axillary brachial plexus block for upper lim surgery; Lidocaine 40 ml 1,5% 600 mg single injection for axillary brachial plexus block for upper limb surgery
Intervention MeSH terms: Lidocaine; Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: brachial plexus; lidocaine; alfa 2 adrenergic receptor clonidine; orthopedic procedure
Adiponectin, Leptin, h-CRP Values in Obese Children - Important Markers for Metabolic Syndrome?
Condition: Obesity, Metabolically Benign
MeSH terms: Metabolic Syndrome; Obesity, Metabolically Benign
Study type: Observational

Summary: 
      Obesity is a chronic inflammatory disorder in which leptin, adiponectin and C reactive
      protein (CRP) play an important role. This study aimed to investigate the relationship
      between markers of adiposity like leptin, adiponectin and high sensitive C reactive protein
      (hsCRP) in obese children, and to determine whether these adipokines are significant markers
      in defining metabolic syndrome in pediatric population
    

Detailed description: 
      The idea that adipose tissue is just a form of energy storage has changed dramatically in
      recent years. Currently, adipose tissue is considered to be a true endocrine gland that
      fulfills multiple roles in regulating different biological functions. Communication between
      adipose tissue and the rest of the systems is accomplished through bioactive mediators
      (adipokines) Adipokines control energy homeostasis and are involved in metabolic, endocrine
      and immunological processes.This study aimed to investigate the relationship between markers
      of adiposity like leptin, adiponectin and high sensitive C reactive protein (hsCRP) in obese
      children, and to determine whether these adipokines are significant markers in defining
      metabolic syndrome in pediatric population.The current retrospective observational study was
      conducted at the "Louis Turcanu" Emergency Hospital Timisoara over a period of one year, from
      July 2013 and June 2014. All inborn patient files were analyzed as anonymised limited data
      sets from archived records of the Endocrinology, Diabetology and Cardiology department.
    

Intervention name(s): MetS+; MetS-
Intervention type(s): Other; Other
Intervention description(s): Data processing from Patient Medical Files; Data processing from Patient Medical Files
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All children admitted to the Endocrinology, Diabetology and Cardiology Department who met
        the Inclusion Criteria
      
Keywords: adipokines, metabolic syndrome, obese children
Evaluate the Intestinal Microbiome in Patients With Erosive Gastroesophageal Reflux Disease and in Asymptomatic Healthy Controls
Condition: Gastroesophageal Reflux Disease With Esophagitis
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Esophagitis
Study type: Observational

Summary: 
      . In this study, we investigated intestinal microbiomes, in individuals with Gastroesophageal
      Reflux Disease and healthy individuals, using metagenomic techniques.
    

Detailed description: 
      Background: The pathophysiology of Gastroesophageal Reflux Disease (GERD) involves several
      mechanisms. Intestinal dysbiosis may influence factors involved in the pathophysiology of
      Gastroesophageal Reflux Disease, such as changes in gastrointestinal motor patterns and
      increased intraabdominal pressure due to increased fermentation of non-digestible
      carbohydrates. However, few studies have focused on assessment of gut microbiome in the GERD.
      In this study, we investigated intestinal microbiomes, in individuals with Gastroesophageal
      Reflux Disease and healthy individuals, using metagenomic techniques.

      Methods: We performed a study comprising fecal samples of 22 adults, aged 18-60 years: 11
      with erosive esophagitis (eight male and three female) and 11 healthy controls (ten male and
      one female). Microbiome DNA was extracted from stool samples, and polymerase chain reaction
      amplification was performed using primers for the V4 region of the 16S rRNA gene (16S
      ribosomal ribonucleic acid). The amplicons were sequenced using the Ion Torrent™ Personal
      Genome Machine™ platform, and data were analyzed using QIIME™ software version 1.8
      (Quantitative Insights Into Microbial Ecology).
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        : We performed a study comprising fecal samples of 22 adults, aged 18-60 years: 11 with
        erosive esophagitis (eight male and three female) and 11 healthy controls (ten male and one
        female).
      
Biospecimen description: 
      Microbiome DNA was extracted from stool samples, and PCR amplification was performed using
      primers for the V4 region of the 16S rRNA gene. The amplicons were sequenced using the Ion
      PGM Torrent platform, and data were analyzed using QIIME™ software version 1.8 (Quantitative
      Insights Into Microbial Ecology).
    
Keywords: Gastroesophageal Reflux; intestinal microbiome
Impact of Anthropometrics Data and of Physical Activity Level in Closed kineTic Chain Upper Extremity Stability Test
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate impact of anthropometric criteria to CKCUEST score.
    


Intervention name(s): Closed Kinetic Chain Upper Extremity Stability Test
Intervention type(s): Diagnostic Test
Intervention description(s): Each patient receive the same intervention, the CKCUEST. The CKCUEST is a functional test which assess shoulder's stability. Patient is in push-up position, with 91 cm between his hands. His body is straight and his foots are squeeze. patient has to touch his hand with his other one and returns in the initial position. Then, patient repeats this movement with his other hand, etc, during 15 secondes. The CKCUEST score is the movement's number performed.
Intervention model: Single Group Assignment
Intervention model description: This study is a monocentric interventional prospective study
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: CKCUEST; Physical activity; rehabilitation
PERmixon® in LUTS Evaluation Study (PERLES)
Condition: Benign Prostatic Hyperplasia (BPH)
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to support the efficacy of Permixon 160 mg b.i.d. in treating
      subjects with symptomatic Benign Prostatic Hyperplasia (BPH), compared to placebo, using
      Tamsulosine LP 0.4 mg as a reference treatment.
    


Intervention name(s): Permixon® 160 mg; Tamsulosine LP; Placebo matching Permixon® 160 mg; Placebo matching Tamsulosine LP
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral administration - 160 mg twice daily.; Oral administration - 0.4 mg daily.; Oral administration - twice daily.; Oral administration - daily.
Intervention MeSH terms: Saw palmetto extract; Tamsulosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 50-mg Tablets Relative to One 100-mg Tablet
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of a 100-mg tapentadol (CG5503)
      dose administered as two 50-mg ER, TRF tablets relative to one 100-mg ER TRF tablet in
      healthy Japanese male participants.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single-center,
      randomized (the study drug is assigned by chance), 2-way crossover study (participants may
      receive different interventions sequentially during the trial). All participants will receive
      a single 100-mg dose of tapentadol (CG5503) during 2 periods, in randomized order, as two
      50-mg TRF tablets and one 100-mg TRF tablet. All participants will be randomly assigned to 1
      of 2 possible treatment sequences and receive both of the following treatments, 1 in each
      period:

      Treatment A: two tapentadol (CG5503) ER 50-mg TRF tablets, administered as a single oral dose
      under fasted condition Treatment B: one tapentadol (CG5503) ER 100-mg TRF tablet,
      administered as a single oral dose under fasted condition Each period will be separated by 7
      - 14 days
    

Intervention name(s): tapentadol (CG5503) ER 100-mg TRF; tapentadol (CG5503) ER 50-mg TRF
Intervention type(s): Drug; Drug
Intervention description(s): 100mg TRF single oral dose; 100 mg TRF single oral dose
Intervention MeSH terms: Tapentadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: tapentadol; NUCYNTA; CG5503; R331333; pharmacokinetics; healthy volunteer
Clinical Study of New Urine Collection Bag for Infants.
Condition: Urinary Tract Infection
MeSH terms: Urinary Tract Infections
Study type: Interventional

Summary: 
      To determine whether a new urine collection bag for infants produces a reliable urine sample
      for culturing in respect of contamination rate with skin bacteria.
    


Intervention name(s): Urine collection bag for infants
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Adding Chickpeas to the American Diet on Fecal Microbiota Composition and Markers of Inflammation
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      This prospective study will assess the effects of adding legumes, especially chick peas, to
      the diet of healthy adults on the commensal bacteria from feces of human subjects and
      resulting self-reported GI symptoms as well as markers of immune function.
    

Detailed description: 
      Short-term active feeding study:

      The investigators will provide various chickpea products to participants for a 14 day
      chickpea enhanced diet. Subjects will receive specific meal plan instructions for the
      consumption of 5 servings/week of chickpeas. Chickpea products will be sourced from
      commercial providers. While participants will be told to substitute chickpea products for
      other diet ingredients, the subjects will be free to choose what to substitute according to
      their preferences. Subjects will keep daily food records and will be told that chickpea
      consumption will be monitored in their fecal samples (qPCR). Fecal samples will be collected
      before the start (Day 1), during (Day 7-9) and at the end (Day 14) of the intervention using
      a stool collection kit (Sigma). Participants will complete our GI health questionnaire on a
      weekly basis to determine tolerance to increased chickpea intake. An open ended questionnaire
      will be administered after participants have completed the short-term study protocol to
      assess any issues with compliance to chickpea intake. All individuals that increased their
      chickpea intake from their usual diet by at least 3 servings/week will be included in the
      analysis.
    

Intervention name(s): Chickpea Enhanced Diet (Short term)
Intervention type(s): Other
Intervention description(s): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.
Stool Samples collected at Day 1, Day 9, and Day 14.
Other intervention name(s): Go'Bonzo's
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Gut Microbiota