bioihbjkbjnl/mcl2 huggingface dataset:
Smoking Treatment of Prisoners
Condition: Tobacco Use Cessation; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy of a 10-week smoking cessation therapy
      combined with NicoDerm CQ for smoking cessation among female prisoners.
    

Detailed description: 
      This is a randomized controlled trial utilizing a wait-list control group to examine 10-week
      group therapy and nicotine replacement compared to wait-list for smoking cessation among
      female prisoners.
    

Intervention name(s): 10-week smoking cessation group therapy combined with NicoDerm CQ
Intervention type(s): Behavioral
Intervention MeSH terms: Nicotine
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nicotine dependence
The Effectiveness of the Manual Therapy on Infant Colic (MT-IF)
Condition: Infant Colic
MeSH terms: Colic
Study type: Interventional

Summary: 
      The main goal of this study is to get to know if applying manual therapy will reduce the
      infant colic symptoms for to improve quality of life of babies and parents.
    

Detailed description: 
      Background:

      Infant colic is one of the most common disorders in the first year of baby´s life. It is
      estimated to affect between 10 to 40 % of healthy born children in their first year of life.
      To determine the effectiveness of a protocol manual therapy in the treatment of colic, using
      the Infant Colic Severity Questionnaire, we analyzed two intervention groups: experimental in
      which children received the protocol manual therapy and counseling to parents and the Control
      group, in which parents received advice only.

      Objectives:

      To assess the effectiveness of visceral manual therapy to improve the symptoms on infant
      colic.
    

Intervention name(s): VISCERAL MANUAL THERAPY-ADVICES; ADVICES
Intervention type(s): Other; Other
Intervention description(s): The subjects of this group will receive an amount of two sessions of visceral manual therapy that will be applied within two weeks. In the first session will be applied procedures in the most superficial body structures. And, in the second session will be applied procedures in the most deep body structures.; Advices for parents to improve the management of infant colic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infant Colic; Manual Therapy; Effectiveness
Effectiveness of Written Dietary Advice on Lipoproteins - a Pragmatic Randomized Controlled Trial
Condition: Cholesterol, LDL
Study type: Interventional

Summary: 
      This study investigates the effect of detailed, written dietary advice for improving blood
      lipids, in a primary care setting. n=222 participants will be randomized to Active
      Intervention or Control Group. After 3 weeks' intervention, participants will receive written
      feedback on the effect on their blood lipids. After 6 months, another blood sample is drawn
      and participants will receive further written feedback.
    

Detailed description: 
      The Active Intervention Group will receive detailed dietary advice based on current evidence
      for food choices that improve LDL cholesterol levels. The information will contain
      motivational strategies, e.g. "It's great that you want to improve your blood lipids! What
      are your three main reasons that you want to improve your blood lipids? What food choices
      suit you? How low can you go?" Participants will receive a table of ten suggested healthy
      food choices and be instructed to mark for each day a certain food change has been made.

      The Control Group will receive similar advice and motivational strategies, with the one
      difference being the dietary advice, that will focus on Triglycerides instead of LDL
      cholesterol.
    

Intervention name(s): Written advice LDL Cholesterol; Written advice Triglycerides
Intervention type(s): Other; Other
Intervention description(s): One A4 paper with written information on both sides; One A4 paper with written information on both sides
Other intervention name(s): Active Intervention; Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two identical parallel groups
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: cholesterol; LDL cholesterol; Triglycerides; Diet; Food; Lipoproteins
Serum Hepcidin in Pregnant Women and the Association With Pregnancy Outcome
Condition: Anemia
Study type: Observational

Summary: 
      Hepcidin production is normally upregulated by iron stores, and in obesity has been shown to
      be overexpressed and correlated with low iron status. The increased hepcidin may restrain the
      iron release from the cells by affecting the expression of ferroportin, which probably
      associates with the development of diabetes complication. Firstly, investigator examines the
      difference of serum hepcidin and iron parameters between obese and non-obese pregnant women;
      secondly, the correlation between serum hepcidin and adverse maternal and neonatal outcomes
      in pregnant women will be tested.
    

Detailed description: 
      This is a mono-center, observational, controlled study with 2 parallel groups (obese versus
      non-obese pregnant women). The study will be conducted at the University Hospital of Basel,
      Department of Obstetrics and Antenatal Care. A total of N=188 healthy pregnant women
      (expected 40% with BMI ≥ 30 kg/m2) will be recruited in the first trimester in our
      outpatients' department in order to have a total of 169 evaluable women, considering a
      drop-out rate of 10%. Serum hepcidin, iron and hematological parameters will be measured at
      11-14, 24-28, 32-36 weeks of gestation and at labor. The blood pressure, weight, weight gain,
      BMI and smoking status will be examined at all visits. Blood samples will be measured in the
      University Hospital of Basel, Department of Laboratory Medicine. Recruitment will begin in
      January 2019.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        188 singleton pregnancies will be recruited in the first trimester at the University
        Hospital of Basel, Department of Obstetrics and Antenatal Care.
      
Biospecimen description: 
      Hematological and serum iron parameters will be determined using routine laboratory
      methodology. Blood samples are collected by venipuncture. All blood measurements will be
      conducted at the University Hospital of Basel, Department of Laboratory Medicine.

      Hb, RBC, HCT, MCV, MCHC, MRC, HRC and CHr are measured using a hematology analyzer. Mean
      corpuscular hemoglobin is automatically calculated from Hb and RBC. Ferritin is assessed by
      chemiluminescence immunoassay and CRP is assessed by immunoturbidimetry. Soluble transferrin
      receptors and serum hepcidin are measured with an ELISA.
Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting
Condition: HIV Infections; Streptococcus Pneumoniae
MeSH terms: Pneumonia; Pneumonia, Pneumococcal
Study type: Interventional
Phase: Phase 3

Summary: 
      Purpose: To study the immune response of the newly licensed pneumococcal conjugate vaccine
      (PCV) in comparison to the pneumococcal polysaccharide vaccine (PPV) to determine if a
      significantly better immunologic response to boosting can be elicited in patients previously
      vaccinated with PPV.
    


Intervention name(s): pneumococcal conjugate vaccine; pneumococcal polysaccharide vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Prevnar is manufactured as a liquid preparation. Each 0.5 mL dose is formulated to contain:
2 μg of each saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 μg of serotype 6B per dose (16 μg total saccharide); approximately 20 μg of CRM197 carrier protein; and 0.125 mg of aluminum per 0.5 mL dose as aluminum phosphate adjuvant. After shaking, the vaccine is a homogeneous, white suspension.; PNEUMOVAX 23 is manufactured according to methods developed by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25 μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.
Other intervention name(s): PCV; PPV
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: pneumococcal conjugate vaccine; polysaccharide vaccine; PPV; PCV; Streptococcus pneumoniae; Prevnar; Pneumovax; HIV
Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to collect confirmatory clinical data to support 6 or 7 days
      wear of EWIS (Extended Wear Infusion Set).
    

Detailed description: 
      This study is a multi-center, non-randomized, prospective single arm study with Type 1
      patients with diabetes on insulin pump therapy with Continuous Glucose Monitoring (CGM). A
      total of up to 300 subjects age 18-80 will be enrolled at up to 20 investigational centers in
      the US. Each subject will wear their own MiniMed™ 670G insulin system. Each subject will be
      given 12 infusion sets to wear (each infusion set for at least 174 hours, or until infusion
      set failure if this occurs before 174 hours). Subjects will change insulin reservoirs at
      least every 174 hours. The time of infusion set insertion will be taken from Daily Log.
      Subjects can expect to participate for approximately 12-16 weeks.
    

Intervention name(s): Extended Infusion Set
Intervention type(s): Device
Intervention description(s): Each subject is asked to wear each Extended Wear Infusion Set for at least 174 hours.
Other intervention name(s): Extended Wear Infusion Set
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan in Adolescents With Symptomatic Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetic profile of vonoprazan
      in adolescent participants with symptomatic gastroesophageal reflux disease (GERD).
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): Vonoprazan
Intervention type(s): Drug
Intervention description(s): Oral Tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vonoprazan; Gastroesophageal Reflux; GERD; Adolescents; Pharmacokinetics
Dose-Response Study of Probiotic Bacteria BB-12 and CRL-431 in Healthy Young Adults
Condition: Cardiovascular Disease; Constipation
MeSH terms: Cardiovascular Diseases; Constipation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study was to investigate the dose-response effect of increasing doses of
      Bifidobacterium animalis ssp lactis (BB-12) and Lactobacillus paracasei ssp paracasei
      (CRL-431) on the immune response, blood lipids, gut microflora, recovery from feces and
      overall tolerance in healthy young adults.
    

Detailed description: 
      The study included seventy-one healthy young vounteers, and was designed as a double-blind
      placebo controlled dose-response trial based on a 2 wk run-in period, a 3 wk intervention and
      2 wk wash-out period. The subjects were randomly assigned into 5 groups of 15 subjects each,
      who were supplemented with 0, 10E8, 10E9, 10E10 or 10E10 CFU/d, respectively, og a mixture of
      BB-12 and CRL-431. Blood samples were collected 4 times and fecal samples 3 times. Diary
      reporting bowel habits and weel being was kept for all 7 weeks.

      There are very few articles concerning the issue dose-response effect of probiotics.The aim
      of the study was to investigate the dose-response effect of increasing concentrations of
      probiotics on the immune response, blood lipids, composition of the gut microflora, recovery
      from feces and the overall tolerance.

      The hypothesis was that the increasing dose would influence the immunresponse (eg incresae
      phagocytosis), improve blood lipid profile (eg.lower HDL-cholesterol), would be recovered in
      increasing concentrations in feces, would change the intestinal microfloraprofile and would
      be well tolerated even in high doses.
    

Intervention name(s): BB-12 and CRL 431
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Keywords: Probiotics; Immune response; Blood lipids; Intestinal microflora; Tolerance
Sleep Study Among Inpatients With TBI in an Acute Rehabilitation Hospital
Condition: Motor Learning in TBI
Study type: Interventional

Summary: 
      The purpose of this research study is to better understand how a daytime nap after training
      on a motor skill after brain injury improves performance compared with the same amount of
      time after training spent awake and resting.
    


Intervention name(s): Nap after rehearsal trials
Intervention type(s): Behavioral
Intervention description(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: motor learning TBI
Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with
      relapsing-remitting multiple sclerosis.
    


Intervention name(s): ACT-128800 Dose 1; Placebo; ACT-128800 Dose 2; ACT-128800 Dose 3
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ACT-128800 (Dose 1) administered orally once daily; Matching placebo administered orally once daily; ACT-128800 (Dose 2) administered orally once daily; ACT-128800 (Dose 3) administered orally once daily
Intervention MeSH terms: Ponesimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluating Cerebrospinal Fluid Biomarkers in Alzheimer's, Progressive Supranuclear Palsy Subjects, and Controls
Condition: Alzheimer Disease; Progressive Supranuclear Palsy
MeSH terms: Alzheimer Disease; Paralysis; Supranuclear Palsy, Progressive
Study type: Observational

Summary: 
      This is an experimental medicine study to evaluate the kinetics of cerebrospinal fluid (CSF)
      biomarkers in subjects with Alzheimer's disease (AD) or progressive supranuclear palsy (PSP)
      compared to healthy controls using a heavy water (2H2O) labeling method. This study is
      exploring the time profile of appearance and disappearance of pulse deuterium-labeled cargo
      proteins in CSF of subjects with AD and/or PSP, which is different from healthy controls, due
      to deficits in fast axonal transport.
    

Detailed description: 
      Primary Objective:

      To compare the time profile of appearance and disappearance in CSF of pulse deuterium-labeled
      chromogranin B, sAPPα and β-Trace in AD and PSP subjects compared to healthy controls.

      Secondary Objectives:

        -  To measure body water enrichment of deuterium in saliva and plasma (2H-enrichment (%))

        -  To explore the effect of age on the kinetics of deuterium labeling of CSF biomarkers

        -  To assess intra and inter subject variability of deuterium-labeling of chromogranin B,
           sAPPα and β-Trace

      Subjects will undergo screening evaluations to determine eligibility prior to heavy water
      (2H20) administration. Eligible subjects will be admitted to the clinical facility on Day -1.
      On Day 1, subjects will ingest small doses of 2H20 during their inpatient stay. They will
      also drink 2H20 for 7 more days. Subjects will undergo two lumbar punctures (LPs) for CSF
      samples. Subjects will return to the study site approximately 7 days after the last LP (or
      early termination) for a follow-up assessment and discharge.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        AD, PSP and EHV subjects will be recruited via Contract Research Organizations (CROs).
        Recruitment efforts will target the general population residing in communities in proximity
        to the CROs.
      
Biospecimen description: 
      Whole blood
    
Keywords: Alzheimers Disease; Progressive Supranuclear Palsy; CSF; Cerebrospinal Fluid; Biomarker; Heavy Water; Cargo proteins
Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Pneumonia; Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Multiple sclerosis (MS) is an inflammatory, demyelinating disease which affects the central
      nervous system (CNS). The etiology of MS is unknown, although the immune system appears to
      play a role. Many different infectious agents have been proposed as potential causes for MS,
      including Epstein-Barr virus, human herpesvirus 6, and coronaviruses. Recently Dr. Sriram at
      Vanderbilt University has found evidence for active Chlamydia pneumonia infection in the CNS
      of MS patients. These findings have been replicated in part by other laboratories.

      The purpose of the current study is to test whether antibiotic treatment aimed at eradicating
      Chlamydia infection will reduce the disease activity in MS. The primary outcome measure will
      be reduction in new enhancing MS lesions on brain MRI. Forty patients will be entered into
      the trial. To be eligible, patients must have evidence of chlamydia infection in their spinal
      fluid and enhancing lesions on their pre-randomization MRI scans. Patients who meet these
      criteria will be randomized to either placebo or antibiotic therapy, and followed for 6
      months on treatment.
    


Intervention name(s): Rifampin; Azithromycin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Azithromycin; Rifampin
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Use of Radiographic Contrast to Detect Dental Caries
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed test is intended to enable dentists to differentiate between cavitated and
      non-cavitated tooth decay in the areas where teeth are in contact (interproximal surfaces).
      In these areas, dentists cannot visually inspect for caries, and currently bitewing X-rays
      (BWs) only correctly detect the presence of enamel decay 15-25% of the time. This low
      sensitivity can lead to late treatment resulting in unnecessarily large fillings, crowns,
      pain, root canals, and possible later loss of teeth.

      Hypothesis: Use of radiographic contrast on teeth will increase the accuracy of detection of
      early cavitation from 58% to 90%.
    

Detailed description: 
      Tooth sites will be recorded by tooth number, type of surface (mesial, distal,occlusal),
      cavitated, non-cavitated, healthy. Radiographs will similarly be scored.Although contrast
      agents are classified as drugs this is not a study of drug properties or effect on cells
      since the properties of the agent are already well know and its safety record well
      established. This study will be recording the radiopacity of the contrast agent on healthy
      tooth surfaces, non-cavitated tooth surfaces and cavitated tooth surfaces. The outcome for
      each surface type will be presence or absence of a radiopacity on a radiograph which will be
      made at the one and only visit for each study subject. The radiograph contains the data from
      the intervention (placement of contrast agent) and the outcome will be assessed some weeks
      later after the completion of the data collection.
    

Intervention name(s): Radiographic contrast agent. Sodium Iodide.
Intervention type(s): Device
Intervention description(s): Application of Sodium Iodide contrast topically to tooth immediately followed by radiograph.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Dental Caries; Radiography, Dental; Contrast media; Tooth
A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and
      atorvastatin from prototype fixed dose combination formulations in healthy volunteers.
      Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four
      treatment periods.
    


Intervention name(s): atorvastatin; dalcetrapib
Intervention type(s): Drug; Drug
Intervention description(s): single dose of atorvastatin on day 1; single dose of dalcetrapib on day 1
Intervention MeSH terms: Atorvastatin; Dalcetrapib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Naps and Pulses of Bright Light in Shift Workers
Condition: Sleep
MeSH terms: Sleepiness
Study type: Interventional

Summary: 
      Design: paired trials without and with naps and bright light. Setting: Real driving on a
      private road circuit. Environmental controlled car. Participants: 9 shift workers on tree
      shifts (morning-afternoon-night) Measurements: Sleepiness at the wheel was measured by
      ambulatory polysomnography and assessed using 30 seconds segments of recordings when the
      percentage of theta EEG was at least 50% (15 seconds) of the period recorded. Subjects were
      also called to rate their sleepiness on the 7-point Stanford Sleepiness Scale (SSS).

      Intervention: Participants drove the same car on two similar 24 hours periods of work, with
      three pilots in each shift (morning, afternoon, night), separated by three weeks. During the
      baseline period, the subjects were told to manage their rest as they usually do in the real
      life. During the second experimental period, they had to rest lied in a dark room during two
      naps of 20 minutes and then exposed to bright light pulse (5000 lux) during 10 minutes.
    

Detailed description: 
      Results are submitted to publication
    

Intervention name(s): naps and pulses of bright light
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: accidents; shift work; sleepiness; naps; bright light pulses; sleep