bioihbjkbjnl/mcl2 huggingface dataset:
The Potentially Addictive Properties of Soda: A Feasibility Study
Condition: Withdrawal Symptoms
MeSH terms: Substance Withdrawal Syndrome
Study type: Interventional

Summary: 
      The purpose of this study to investigate the addictive properties of soda and other sugar
      sweetened beverages (SBBs) in teenagers aged 13-18 years. It is hypothesized that
      participants who were regularly consuming sweetened and caffeinated beverages will experience
      symptoms typical of caffeine withdrawal, such as headache and fatigue, during the SSB
      withdrawal period.
    


Intervention name(s): SSB withdrawal
Intervention type(s): Behavioral
Intervention description(s): During days 1-5, participants will drink the beverages they normally consume (no intervention). On days 6-8, participants will be instructed to drink only water and unflavored milk during the withdrawal period (days 6-8).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Caffeine; Addiction; Withdrawal symptoms; Pediatric; Adolescent; Overweight
Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception
Condition: Genital Tract Mucosal Immunity; Genital Tract Microflora
Study type: Interventional

Summary: 
      This pilot study is being performed to investigate the influence that starting contraception
      with an IUD has on the local immune cell populations and features, with a particular focus on
      the cells and cell-surface features that are important in HIV transmission (CD4 cells and
      CCR5 cell receptors).

      Based on results from large epidemiologic studies there seems to be a consistent finding of
      slightly increased HIV acquisition in women who use hormonal contraception. It is not clear
      if this is due to a biological phenomenon or if it relates to a difference in sexual
      behaviors/risks of women on hormonal contraceptives.

      The study hypothesis is that CD4 cells and CCR5 HIV-tropic receptor density increases within
      the upper and lower genital tract of women 2 months after placement of progestin-containing
      intrauterine devices for contraception as compared with women not using hormonal
      contraception.
    


Intervention name(s): IUD placement; Levonorgestrel IUD; Copper T380A IUD
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).
Other intervention name(s): Mirena IUD; ParaGard IUD
Intervention MeSH terms: Copper; Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: intrauterine device; IUD; levonorgestrel; copper; CD4; CCR5; microflora
Computer-Assisted Versus Manual Hair Harvest Comparative Study
Condition: Androgenetic Alopecia
MeSH terms: Alopecia
Study type: Interventional

Summary: 
      The objective of this clinical study is to investigate and compare the safety and efficacy of
      the Restoration Robotics Computer-Assisted Harvesting System to the manual hair follicle
      harvesting method following a nine-month period of post-procedural evaluation.
    

Detailed description: 
      A major technical step in hair transplantation is harvesting of the hair follicles. There are
      two accepted techniques for obtaining the hair grafts that are transplanted during the
      procedure. The first is donor strip harvest and stereomicroscopic dissection of the
      follicular unit grafts. The second is dissection and extraction of the follicular unit graft
      directly from the patient's scalp referred to as Follicular Unit Extraction or "FUE".
      Potential benefits of the FUE technique may be less scalp scarring in the Donor Area, less
      patient discomfort and faster wound healing. Although the FUE approach to harvest has highly
      desirable attributes, it is technically difficult to perform, labor intensive, tedious and
      requires an excessive amount of time to harvest follicular units. These procedural factors
      have prevented the FUE approach from gaining wider adoption.

      Restoration Robotics, Inc. has developed the Restoration Robotics ARTAS™ Computer-Assisted
      Harvesting System to assist physicians in the harvest of hair follicles during hair
      transplantation procedures. The System mimics the manual FUE approach to harvesting
      follicular units and has the potential to solve the technical challenges inherent in the
      manual FUE technique. The ARTAS™ System is capable of identifying and harvesting hair
      follicles directly from the patient's scalp through a semi-automated process. The goal of the
      ARTAS™ System is to harvest the hair follicles while maintaining their critical anatomic
      structures intact.
    

Intervention name(s): ARTAS™ System; Manual Hair Harvest
Intervention type(s): Device; Procedure
Intervention description(s): Hair harvest using a computer-assisted system; Hair harvesting via the manual technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of IGN-ES001 in Chronic Widespread Pain With or Without Fibromyalgia
Condition: Chronic Widespread Pain; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Chronic Pain
Study type: Interventional

Summary: 
      This is a randomized, double-blind, placebo-controlled exploratory trial to investigate
      efficacy and safety of food supplement IGN-ES001 in patients with chronic widespread pain
      (CWP) with or without fibromyalgia (FM).
    

Detailed description: 
      Patients will perform five scheduled on-site visits and five phone calls:

        -  Screening visit, V1 (Day -10 to -7), informed consent

        -  Baseline visit, V2 (Day 1), randomization, treatment start

        -  Phone call, V3 (Day 4 ± 1)

        -  Phone call, V4 (Day 8 ± 3)

        -  Phone call, V5 (Day 15 ± 3)

        -  On-site visit, V6 (Day 22 ± 3)

        -  Phone call, V7 (Day 29 ± 3)

        -  Phone call, V8 (Day 36 ± 3)

        -  On-site visit, V9 (Day 43 + 3), treatment end

        -  Follow-up on-site visit, V10 (Day 50 + 7, or 7 + 7 days after EDV).

      In addition, patients may be asked to return to the trial site between scheduled visits for
      assessment of safety data (unscheduled visits).

      The maximum duration of treatment for the individual patient will be 46 days (including
      allowed visit window deviation). The maximum duration of trial participation for the
      individual patient will be 67 days.
    

Intervention name(s): IGN-ES001; Parol 500 mg Tablets (acetaminophen)
Intervention type(s): Drug; Drug
Intervention description(s): Only active product will be compared with placebo as described in Arms and Interventions.; Analgesic Rescue Medication
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pain, Symptom Severity; Immunoglobulin IgY; Fibromyalgia; Widespread Pain Index; Eggyolk; FIQ-R; SF-36v2TM; MOS-SS; FSS; PGIC; Quality of life
Study Evaluating Streptococcus Pneumoniae Serotype Carriage Rate for Nasopharyngeal Carriage in Filipino Children
Condition: Pneumonia, Bacterial
MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Pneumonia, Bacterial
Study type: Observational

Summary: 
      Evaluation of the carriage rate of Streptococcus pneumoniae in the nasopharynx of healthy
      children and the carriage rate and distribution of Streptococcus pneumoniae serotypes
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care clinic
      
Keywords: Bacterial otitis media; pneumoniae; sepsis; bacteremia; meningitis; Streptococcus pneumoniae carriage rate
PERFECT Project - Part 1 - Study 2
Condition: Diabetes Prevention; Obesity Prevention
Study type: Interventional

Summary: 
      The objectives are to test the acute effects of different cereals containing pulse
      ingredients on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2)
      food intake two hours following consumption of pulse products.

      We hypothesize that cereals containing pulse ingredients will lead to lower blood glucose,
      insulin, appetite and food intake responses compared to non-pulse cereals.
    


Intervention name(s): Control; Pea protein; Pea starch; Pea fibre + pea starch; Pea protein + pea starch; Pea fibre + pea starch + pea protein
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Non pulse extruded cereal; Pulse extruded cereal; Pulse extruded cereal; Pulse extruded cereal; Pulse extruded cereal; Pulse extruded cereal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Randomized, Crossover, Multi-Dose Pharmacokinetics of EXCL-100 Pirfenidone-Sustained Release Tablet and Esbriet in Healthy Volunteers
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, 2-treatment, 2-period, crossover steady state study
      conducted to evaluate the comparative bioavailability/bioequivalence of pirfenidone after
      multi-dose administration of EXCL-100 at doses of 1200 mg (600 mg x 2) in the fed state, and
      Esbriet® 801 mg (267 mg capsule x 3) given in the fed state, to healthy volunteers.
    

Detailed description: 
      After signing the Institutional Review Board (IRB) approved Informed Consent Form (ICF),
      subjects will undergo a screening evaluation up to 28 days prior to dosing on Day 1 of Period
      1. Subjects who satisfy the screening evaluation and who meet the inclusion and exclusion
      criteria will be enrolled in the study. Subjects will receive multiple doses of study drug
      according to their assigned sequence of treatment in Period 1. After completion of study
      procedures, a washout period will be completed prior to crossover to Period 2 to receive the
      second treatment in their sequence. Subjects will receive Regimens A (Esbriet® 801 mg three
      times daily with meals for 3 days) and B (EXCL-100, 1200 mg twice daily with meals) according
      to the randomization schedule. Pharmacokinetic (PK) blood samples will be taken on multiple
      days during the study periods.
    

Intervention name(s): Esbriet 267 MG Oral Capsule; EXCL-100, 600 MG Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Reference Formulation; Test Formulation
Intervention MeSH terms: Pirfenidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Innate Immune Response in COPD
Condition: Pulmonary Disease, Chronic Obstructive; Immunity, Innate; Inflammation; Bronchitis, Chronic; Toll-Like Receptors
MeSH terms: Bronchitis; Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive; Inflammation
Study type: Observational

Summary: 
      The purpose of this study is to determine whether the response of the immune system to
      bacterial components differs between patients with severe COPD compared to those with less
      severe COPD.
    

Detailed description: 
      The airways of COPD patients are often colonized with bacteria leading to increased airway
      inflammation. This study sought to determine whether systemic cytokine responses to microbial
      pathogen-associated molecular patterns (PAMPs) are increased among subjects with severe COPD.

      In an observational cross-sectional study of COPD subjects, PAMP-induced cytokine responses
      were measured in whole blood ex vivo. We used PAMPs derived from microbial products
      recognized by TLR 1, 2, 4, 5, 6, 7, and 8. Patterns of cytokine response to PAMPs were
      assessed using hierarchical clustering. One-sided t-tests were used to compare PAMP-induced
      cytokine levels in blood from patients with and without severe COPD, and for subjects with
      and without chronic bronchitis.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with a clinical history of COPD recruited from a pulmonary subspecialty clinic at
        an academic medical center
Friendship Based HIV/STI (Sexually Transmitted Infections) Intervention for African American Females
Condition: Sexual Behavior; Sexually Transmitted Diseases; HIV Infections
MeSH terms: Infections; Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      The Project ÒRÉ intervention is a half-day community-based HIV/STI intervention program for
      friendship groups of adolescents that is tailored to African American culture. The four
      participating community sites will be assigned to either the Project ÒRÉ intervention or a
      standard health promotion program. Sexually experienced African American adolescent females
      will recruit members of their friendship group for the five-hour program. All participants
      will complete questionnaires before and immediately following the programs and another one 3
      months later. Immediately following the program some of the Project ÒRÉ groups will also
      participate in a focus group to provide feedback about the program.
    

Detailed description: 
      A group-randomized controlled design to test the efficacy of the Project ÒRÉ intervention, a
      community-based adolescent social network HIV/STI intervention tailored to African American
      culture. Four community based organization sites (CBOs) will be randomly assigned to an
      experimental or attention control condition. In both conditions, sexually experienced African
      American adolescent females will recruit members of their friendship group for the five-hour
      program. In the experimental condition, the intervention group will receive the half-day
      Project ÒRÉ intervention. The attention control group will receive a standard health
      promotion control program which has been used previously with similar populations. All
      participants will complete pre-, post- and 3-month follow-up self-administered
      questionnaires. In the experimental condition, a subset of groups will participate in a
      process evaluation focus group immediately following the program.
    

Intervention name(s): Project ÒRÉ
Intervention type(s): Behavioral
Intervention description(s): Community-based adolescent social network HIV/STI intervention tailored to African American culture
Other intervention name(s): ÒRÉ
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: adolescent; female; community-based; social network; HIV/STI intervention; High HIV-risk African American adolescent females
TECPR2 Observational Study
Condition: TECPR2
Study type: Observational

Summary: 
      The purpose of this study is to learn more about the disease progression in patients with a
      TECPR2 mutation.
    

Detailed description: 
      A mutation in the tectonin beta-propeller repeat containing 2 (TECPR2) gene can disrupt the
      cellular process of autophagy resulting in neuronal cell death. This disruption leads to a
      form of spastic paraplegia with the additional disruption to involuntary body processes, such
      as respiration and thermoregulation. This study will provide valuable information about the
      natural progression of children with a TECPR2 mutation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with TECPR2-Related disorder, confirmed by genetic mutation analysis and
        demonstrates clinical findings such as autophagy, developmental delay, hypotonia, or other
        positive findings.
      
Biospecimen description: 
      Blood and
Young Pectus Excavatum Patients and Genetic Defects
Condition: Genetic Disease; Pectus Excavatum; Children, Adult
MeSH terms: Funnel Chest; Genetic Diseases, Inborn
Study type: Observational

Summary: 
      In most pectus excavatum (PE) patients an underlying genetic defect is not found with
      molecular analysis, as a direct genetic link with PE has yet to be found and because
      potential underlying genetic disorders are quite rare. Only one-fifth of all PE cases are
      identified in the first decade of life and thus of congenital origin making younger PE
      patients a unique patient group. Therefore, the research question is; is early-onset pectus
      excavatum (PE) more likely to be part of a genetic defect than PE which became apparent
      during puberty or adolescence?
    

Detailed description: 
      Importance: In most pectus excavatum (PE) patients an underlying genetic defect is not found
      with molecular analysis, as a direct genetic link with PE has yet to be found and because
      potential underlying genetic disorders are quite rare. Only one-fifth of all PE cases are
      identified in the first decade of life and thus of congenital origin making younger PE
      patients a unique patient group.

      Objective: the investigators hypothesize that early-onset PE is more likely to be part of a
      genetic defect than PE which became apparent during puberty or adolescence.

      Design: Cohort study Setting: Single center Participants: All pediatric PE patients aged
      younger than 11 years upon first visit of the outpatient clinic of the department of
      pediatric surgery at the Sophia Children's Hospital - Erasmus Medical Center between 2014 and
      2020 were identified and informed consent was obtained for inclusion. Two clinical
      geneticists performed the anamnesis and physical examination. Molecular analysis was
      performed based on the differential diagnosis. All young PE patients which have been referred
      for genetic counseling already, were analyzed retrospectively.

      Main Outcome: incidence of genetic defects
    

Intervention name(s): Genetic analysis
Intervention type(s): Diagnostic Test
Intervention description(s): Genetic analysis by geneticists
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with pectus excavatum aged younger than 11 years
      
Biospecimen description: 
      Saliva
    
Keywords: Pectus excavatum; Children; Gene; Syndrome
Remote Access to Care, Everywhere, for Parkinson Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the feasibility, efficacy and the value of
      providing care to individuals with Parkinson disease directly into their homes. The specific
      aims are:

        1. To demonstrate the feasibility of conducting remote evaluations of patients with
           Parkinson disease nationally;

        2. To measure the impact of remote care on each patient's ability to improve his or her
           quality of life (QoL) and better manage his or her Parkinson disease; and

        3. To assess the long-term acceptability to patients in receiving ongoing care remotely via
           telemedicine.
    


Intervention name(s): Virtual care visit
Intervention type(s): Other
Intervention description(s): Video-conferencing visit with a Parkinson disease specialist
Other intervention name(s): Telemedicine visit; Virtual house call
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Telemedicine; Virtual care visit; Remote visit; Video-conferencing
Retrospective Study Collecting Neurological Follow-up of Hereditary Transthyretin Amyloidosis (ATTRv) Patients Included in B3461028 and B3461045.
Condition: Hereditary Transthyretin Amyloidosis (ATTRv); Polyneuropathy
MeSH terms: Polyneuropathies; Amyloid Neuropathies, Familial; Amyloidosis
Study type: Observational

Summary: 
      A study of patients with hereditary transthyretin amyloidosis (ATTRv) and wild-type
      transthyretin amyloidosis (ATTRwt) that have been enrolled in B3461028 and B3461045 studies
      in Spain - exposed to tafamidis 61mg for ≥12 months with polyneuropathy (PN) have kept going
      to their multisystemic follow-ups (neuro/ophtalmo/gastrointestinal) ≥12 months.
    


Intervention name(s): Tafamidis
Intervention type(s): Drug
Intervention description(s): 61 milligrams (mg) as received in studies B3461028 and B3461045
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Study population: retrospective cohort of patients with hereditary transthyretin
        amyloidosis (ATTRv) and wild-type transthyretin amyloidosis (ATTRwt) that have been
        enrolled in B3461028 and B3461045 studies in Spain - exposed to tafamidis 61mg for ≥12
        months with polyneuropathy have kept going to their multisystemic follow-ups
        (neuro/ophtalmo/gastrointestinal) ≥12 months
Dawn Simulation and Postural Hypotension
Condition: Orthostatic Hypotension
MeSH terms: Hypotension, Orthostatic; Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      One of the most physiologically demanding things that older people do every day is to get up
      in the morning. After spending a night laying flat, where the blood distributes evenly across
      the body, when they stand in the morning (and the blood rushes to their feet), their
      cardiovascular system may not be able to compensate and maintain blood flow to the brain.
      This phenomenon is known as orthostatic or postural hypotension. The investigators have found
      in a group of young individuals that use of a dawn-simulation light that gradually wakes the
      brain is able to increase cardiovascular tone prior to arising. The goal of this experiment
      is to determine whether this dawn simulation light is able to increase cardiovascular tone in
      older adults such that they would have reduced or absent postural hypotension when they
      awaken in the morning. This would greatly reduce the risks of falls and their associated
      morbidities in older adults.
    


Intervention name(s): Light
Intervention type(s): Device
Intervention description(s): 30 minutes of dawn simulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science