bioihbjkbjnl/mcl2 huggingface dataset:
Colonic Duplication; Two Cases Report and Review of Literature
Condition: Colonic Diseases
MeSH terms: Colonic Diseases
Study type: Observational [Patient Registry]

Summary: 
      Duplicated colon appendix are infrequent detected during surgical exploration. For Diagnosed
      cases, excision of the duplicated part is indispensable, due to risk of malignancy.
    

Detailed description: 
      Alimentary tract duplication represents(ATD) 0.2% of all pediatric congenital malformations
      Which affect all gastrointestinal tracts (GIT) from the mouth to the anus.

      ATD more common in with no familial or racial predilection. The ileum is the most common site
      (30%-35%) and the colon is the least common site (7%-20%).

      The transverse colon is the most common site for colonic duplication. The duplicated part of
      GIT maybe in the mesenteric or anti-mesenteric side. It may has same vascular supply and
      mesentry or not(reported only in small bowel)..

      Communication between the anomalous and actual enteric lumens may or may not be present.

      Here in, two cases of colonic and anal duplication add to the knowledge with review of
      literature of duplicated colon in children.
    

Intervention name(s): colonic surgery
Intervention type(s): Other
Intervention description(s): resection of duplicated colon
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients age group from 1 day till 18 years
Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function
Condition: Liver Disease; Hyponatremia
MeSH terms: Liver Diseases; Hyponatremia
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and
      moderate liver impairment versus subjects with normal liver function
    


Intervention name(s): conivaptan hydrochloride
Intervention type(s): Drug
Intervention description(s): intravenous
Other intervention name(s): Vaprisol; YM087
Intervention MeSH terms: Conivaptan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics; Protein Binding; Conivaptan; Vaprisol; Liver Disease
Assessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease Patients
Condition: Polycystic Kidney Diseases
MeSH terms: Kidney Diseases; Polycystic Kidney Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to find a protein (ex. Polycystin 1 or mucin and cadherin like
      protein) in the urine that is changed after treatment of hydralazine.
    


Intervention name(s): Hydralazine
Intervention type(s): Drug
Intervention description(s): Participants will be asked to take pills two times per day for 6 weeks. This is a dose increasing study with potential doses ranging from 5 mg two times per day to 50 mg two times per day.
Intervention MeSH terms: Hydralazine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Compare 3 Doses of a Hormonal Intra-uterine Device Containing Levonorgestrel and Indomethacin With a Hormonal Intra-uterine Device Containing Only Levonorgestrel to Assess the Effect and Safety of the Combined Components
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is the first study investigating the combined intrauterine administration of LNG
      (levonorgestrel) and IND (indomethacin). It is a combined proof-of-concept (PoC) and dose
      finding (DF) study in pre-menopausal women. It is designed to investigate the
      pharmacodynamics (PD) of BAY 987443 (i.e. IUS (intrauterine system) releasing LNG and IND),
      as well as pharmacokinetics (PK) of both active substances, safety and tolerability. In this
      study, Jaydess, as an LNG-only IUS, will be used as a comparator.
    


Intervention name(s): BAY98-7443; Levonogestrel (Skyla, BAY86-5028)
Intervention type(s): Drug; Drug
Intervention description(s): Active ingredient content (in mg IND/LNG):
low dose 6.5 / 13.5; middle dose 12.5 / 13.5; high dose 15.4 / 13.5; Comparative LNG dose
Other intervention name(s): Jaydess
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Single Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of RBD1016
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single dose-escalation phase Ⅰa clinical study to observe the safety and
      pharmacokinetic profiles of RBD1016 in healthy subjects.

      The study consists of screening period (Day -28 to Day -1), treatment period (Day 1 to Day
      2), safety assessment period (to Day 29) and safety follow-up period (up to Day 85).
    

Detailed description: 
      It is a randomized, double-blind, placebo-controlled, single dose-escalation, phase Ia study.
      The study will enroll 40 healthy subjects, including 5 dose escalation cohorts for dose
      escalation with 0.3 mg/kg body weight as the starting dose.

      After a single-dose injection, there will be a 4-week safety assessment and monitoring phase
      (Days 1-29). Blood samples for PK analysis will be collected within 60 minutes before dosing,
      and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after dosing, respectively.
      According to the previous PK results, the subsequent PK blood collection points can be
      adjusted. Total urine samples will be collected once before dosing and in each of 2 time
      periods after dosing: 0~8 h and 8~24 h. The total urine output will be recorded, and some
      urine samples will be collected in each time period to analyze and detect the urine drug
      concentration.

      Subjects will undergo safety follow-up from Day 29 to Day 85.
    

Intervention name(s): RBD1016; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): "Sentinel cohort" design is used in each cohort: each cohort will be administered in two batches, the first 2 subjects will receive RBD1016 or placebo respectively, and safety assessment will be done on D8±1. After safety is confirmed through SRC assessment, the remaining 6 subjects will be randomly assigned to receive RBD1016 or placebo in a ratio of 5:1. SRC will assess the safety after all the subjects in each cohort complete the 28-day safety observation and the subjects may proceed to the next dose cohort with permission.
Only after all the subjects in the previous dose cohort have completed the safety assessment by SRC (observed for 28 days) may the next dose cohort be initiated with permission.; the same as RBD1016
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Rabies Virus Neutralizing Activity and Safety of CL184, a Monoclonal Antibody Cocktail, in Simulated Rabies Post-Exposure Prophylaxis in Healthy Adults
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 2

Summary: 
      Study design:

      Single-blind (subject and observer-blinded), active-controlled, randomized [6:2:1:2:1; CL184
      + purified vero cell rabies vaccine (PVRV) vs. human rabies immune globulin (HRIG) + PVRV vs.
      placebo + PVRV vs. CL184 + human diploid cell vaccine (HDCV) vs. placebo + HDCV], mono-center
      study

      Study objectives:

      Primary: To evaluate the safety of CL184 in combination with PVRV in healthy adult subjects.

      Secondary: To evaluate the safety of HRIG or placebo in combination with PVRV and to evaluate
      the safety of CL184 or placebo in combination with HDCV in healthy adult subjects. To
      evaluate the rabies virus neutralizing activity (RVNA) after administration of CL184 or
      placebo in combination with PVRV, of HRIG in combination with PVRV, and of CL184 or placebo
      in combination with HDCV in healthy adult subjects. To evaluate the pharmacokinetics of the
      monoclonal antibodies (mAbs).
    

Detailed description: 
      This study was designed to explore and obtain further safety and RVNA data on CL184 in
      comparison to HRIG and placebo as part of a classical post-exposure prophylaxis (PEP)
      regimen. This regimen will be applied as simulated PEP regimen to healthy subjects (i.e. in a
      pre-exposure setting) in this study. A comparison with placebo combined with each rabies
      vaccine was included to differentiate between the contribution of immune globulin and vaccine
      and to investigate potential interactions between immune globulin and vaccine. RVNA provided
      by CL184 or HRIG, as well as vaccination response will be checked regularly during the study
      and booster doses can be applied after the study, if necessary. In addition pharmacokinetic
      data will be collected.
    

Intervention name(s): Rabies virus-specific monoclonal antibodies; human polyclonal rabies immune globulin (HRIG); Placebo; Human diploid cell vaccine (HDCV); Purified verocell rabies vaccine (PVRV)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): CL184 20 IU/kg intramuscularly on Day 0.; HRIG 20 IU/kg intramuscularly on Day 0.; Placebo intramuscularly on Day 0.; Rabies vaccine (HDCV) given on Days 0, 3, 7, 14, and 28.; Rabies vaccine (PVRV) given on Days 0, 3, 7, 14, and 28.
Other intervention name(s): CL184; Imogam® Rabies-HT; Imovax®; Verorab™
Intervention MeSH terms: Vaccines; Antibodies; Antibodies, Monoclonal; Immunoglobulins; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Monoclonal antibody; Rabies; Post-exposure prophylaxis
AZD8566 Food Effect/Microtracer Study
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      A study designed to look at how the drug AZD8566 is taken up by the body when given with or
      without food. In some subjects a comparison will be made with a very small labelled microdose
      given into a vein.
    


Intervention name(s): AZD8566; AZD8566 IV carbon labelled
Intervention type(s): Drug; Drug
Intervention description(s): Single 6 mg oral solution dose; Single 10 mcg intravenous carbon-14 microtracer dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteer; AZD8566; Food Effect; Microtracer
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
Condition: Hepatitis A
MeSH terms: Hepatitis A
Study type: Interventional
Phase: Phase 2

Summary: 
      Three dose primary vaccination study of reactogenicity and immunogenicity in healthy infants
      between 6-12 weeks of age at the time of the first vaccination against Streptococcus
      pneumoniae.
    

Detailed description: 
      Test groups: 2 (120 subjects/group). 1 group receiving GSK Biologicals' 10-valent
      pneumococcal conjugate vaccine + DTPa combined vaccine; Control group receiving GSK
      Biologicals' Havrix + DTPa combined vaccine
    

Intervention name(s): Pneumococcal (vaccine)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Efficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss
Condition: Female Pattern Hair Loss
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared
      to topical minoxidil in female pattern hair loss.
    


Intervention name(s): Spironolactone; Minoxidil
Intervention type(s): Drug; Drug
Intervention description(s): This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.; This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.
Intervention MeSH terms: Minoxidil; Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population; Part 2
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a 6-visit, subject-masked, multi-site, 2×3 crossover dispensing trial that will last
      approximately 2 - 4 months.
    


Intervention name(s): JJVC Investigational Multifocal Contact Lens; Dailies Total 1® Multifocal Contact Lens
Intervention type(s): Device; Device
Intervention description(s): TEST Lens; CONTROL Lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Project Attention Deficit Hyperactivity Disorder (ADHD) and Electroencephalography (EEG)-Neurofeedback THERapy
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Background:

      Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to
      patients with ADHD in several mostly uncontrolled studies with relatively small sample sizes.
      It is unknown how EEG-neurofeedback affects brain functioning and exerts therapeutic effects
      in ADHD. This study is designed to examine the efficacy and safety of EEG-neurofeedback in a
      scientific rigorously way and to study the underlying neurobiological mechanisms of
      EEG-neurofeedback.

      Objectives:

        1. To investigate the efficacy of EEG-neurofeedback in reducing behavioral symptoms of
           ADHD.

        2. To investigate whether EEG-neurofeedback is able to improve neurocognitive functioning.

        3. To investigate whether EEG-neurofeedback is able to improve neural functioning.

      Study design:

      Double-blind randomized placebo-controlled treatment study.Study population: 120 subjects
      with ADHD (age 8-15, IQ of 80 or more). Intervention: 60 subjects with ADHD receive 30
      sessions EEG-neurofeedback, and 60 subjects with ADHD receive placebo EEG-neurofeedback.

      Main study parameter: ADHD-DSM-IV rating scale, rated by the investigator.

      Hypothesis:

      The hypothesis is EEG-Neurofeedback can reduce symptoms of ADHD.
    


Intervention name(s): Placebo EEG Neurofeedback; EEG-Neurofeedback
Intervention type(s): Other; Other
Intervention description(s): The placebo EEG-neurofeedback group will get an identical procedure as the real EEG-Neurofeedback, but with feedback on a EEG signal simulation. The placebo group will not be rewarded on their real-time EEG but on a random, simulated EEG; known to be effective for this purpose (Utrecht University, study in progress).
In the protocol selection the electrode position and rewarding versus inhibition of the treatment frequency band or bands will be individually created. The first 30 seconds of the treatment will start on a predetermined fixed threshold value for all treatment subjects.; The EEG-neurofeedback group will receive feedback on their real-time EEG-signal (brain activity). The treatment group will be rewarded, by brightening (i.e. not being blackened of) the feedback screen. Rewards will be given to the subjects when their digitally filtered frequency EEG activity meets the criteria in the 'percentage time over threshold' parameter. The 'percentage time over threshold' parameter will be auto-adjusted on the digitally filtered real-time EEG every 30 seconds, and the percentage parameter will be kept as a constant over all participants during the entire study (i.e. not adjusted during treatment based on individual capabilities).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Children; EEG-Neurofeedback
Does Menopause Matter?
Condition: Menopause
Study type: Observational

Summary: 
      The purpose of this study is to follow a woman's progression through menopause in order to
      examine the effects on health related quality of life and use of health care resources, and
      to understand how women are using alternative therapies.
    

Detailed description: 
      Menopause affects every woman as she ages, yet every woman's experience is different. We are
      seeking to enroll 720 women from the University of Pittsburgh's Division of General Internal
      Medicine Outpatient practice (GIMO) at all stages of menopause (pre-, peri-, and
      post-menopausal), between 40 and 65 years old. They will be followed for 5 years as they
      progress through menopause.

      Women will complete yearly questionnaires during their usual doctor's visit (or by phone or
      online if necessary) regarding general health, menopause and menopausal symptoms, health
      related quality of life, traditional and alternative therapy use, social support, and
      attitudes towards menopause and aging.

      We will combine this information with information from women's medical charts to look at how
      menopause and health related quality of life impact the use of health care resources.
      Additionally, some women may be asked about the use of health care resources, such as
      doctor's visits, hospitalizations and lab tests.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women from the University of Pittsburgh's Division of General Internal Medicine Outpatient
        practice (GIMO)
      
Keywords: Menopause; Quality of Life; Health Services; Complementary Therapies
Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD
Condition: ADHD; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety, effectiveness, and tolerability of
      atomoxetine and OROS methylphenidate, taken together, in the treatment of ADHD in children
      and adolescents ages 6-17.
    


Intervention name(s): Atomoxetine and OROS Methylphenidate
Intervention type(s): Drug
Intervention description(s): Subjects must have at least attempted to tolerate a dose of 1.2 mg/kg of atomoxetine. If tolerated, they must remain on this dose for at least two weeks. OROS methylphenidate will be target dosed and titrated to a maximum dose of 54 mg.
Other intervention name(s): Strattera, Concerta
Intervention MeSH terms: Methylphenidate; Atomoxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Attention Deficit Hyperactivity Disorder; Strattera; Concerta; Atomoxetine; OROS Methylphenidate
Diet and Disease Activity in Patients With Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational [Patient Registry]

Summary: 
      In addition to a genetic susceptibility, the immune system and the intestinal microbiota,
      diet is hypothesized to be an important factor in the onset and progression of Inflammatory
      Bowel Diseases (IBD). Further insight in factors affecting disease activity may contribute to
      targeted interventions improving disease burden and healthcare costs for these patients.
      However, well-designed studies exploring the role of diet in the development of exacerbations
      are hardly available.

      The investigators hypothesize that differences in dietary patterns affects the intestinal
      microbiota composition and thereby contributes to the development of exacerbations in IBD.

      Furthermore, a subgroup of patients suffers from malnutrition, although the exact prevalence
      is unknown since simple noninvasive screening tools have not been validated for IBD. The
      investigators hypothesize that malnutrition is frequently present in IBD patients and
      associated with dietary intake and disease characteristics.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive IBD patients, visiting the gastroenterology outpatient clinic, participating
        the IBD-SL cohort
Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold Adapted (CAIV-T) in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      To perform a variety of assays on blood, serum, nasal wash samples and cells obtained from
      healthy adult subjects for the purposes of developing assays for application in the further
      investigation of immune responses generated by influenza virus vaccine, trivalent, types A
      and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle Vaccines, Marietta, PA).
    


Intervention name(s): CAIV-T
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
A Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)
Condition: Alzheimer's Disease; Huntington Disease
MeSH terms: Alzheimer Disease; Huntington Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate four different modified release formulation to estimate the amount
      of dimebon available to the body relative to the current dimebon formulation that is given
      three times a day. The results of this study will help inform and guide further formulation
      development efforts with the ultimate goal of reducing dose frequency to once-a-day or
      twice-a-day.
    


Intervention name(s): Dimebon IR Tablet; Dimebon MR1; Dimebon MR2; Dimebon MR3; Dimebon MR4
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pharmacokinetics of a single oral dose of 10 mg dimebon immediate release tablet will be assessed on Day 1 - 3.; Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR1, will be assessed on Day 1 - 3.; Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR2, will be assessed on Day 1 - 3.; Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR3, will be assessed on Day 1 - 3.; Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR4, will be assessed on Day 1 - 3.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioavailability pharmacokinetics Alzheimer's Disease Huntington Disease