bioihbjkbjnl/mcl2 huggingface dataset:
A 16-Week Study of Pirenzepine or Placebo to Treat HIV-Associated Distal Sensory Polyneuropathy in Patients With HIV
Condition: HIV Associated Polyneuropathy
MeSH terms: Polyneuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a two-part study of the safety, tolerability, and efficacy of topically administered
      WST-057 for 16 weeks in subjects with HIV with sensory polyneuropathy.
    

Detailed description: 
      Phase A: Is an open-labeled feasibility investigation of the safety, tolerability, and
      limited efficacy in 14 subjects with HIV-associated distal sensory polyneuropathy (HIV-DSP)
      after topical daily dosing of WST-057 (4% pirenzepine free base monohydrate). Subjects will
      be stratified based on their baseline scores for pain/discomfort using the Visual Analog
      Scale (VAS). Subjects will attend visits at screening; Day 0 (baseline); Weeks 4, 8, and 16;
      and follow-up (Week 18).

      Phase B: Is a randomized outpatient, double-blind, placebo-controlled, single-site study of
      the safety, tolerability, and exploratory efficacy of topically administered WST-057 for 16
      weeks in subjects with HIV-associated distal sensory polyneuropathy (HIV-DSP). Stratification
      of subjects based on baseline pain will be included based on the results of Part A.

      Subjects will attend visits at screening; Day 0 (baseline); Weeks 4, 8, and 16; and follow-up
      (Week 18). Approximately 60 subjects with HIV-DSP will be randomized to 1 of 2 treatment
      groups in a 3:2 ratio: WST-057 (4 mL) (n = 36 subjects) versus placebo control 4 mL (n = 24
      subjects); with the assumption that a total of 50 subjects will complete the study.

      This study is designed with 4 periods in both study phases: screening, baseline/day 0,
      outpatient treatment, and safety follow-up.
    

Intervention name(s): WST-057; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): WST-057 topical solution; WST-057 Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuropathy; HIV-DSP
The Effect of Head Position on the Intubating Condition Using Fiberoptic Bronchoscopy
Condition: Intubation; Posture
Study type: Interventional

Summary: 
      For better view of fiberoptic intubation, the posture of neck is compared between neck
      flexion and extension.
    


Intervention name(s): Intubation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: fiberoptic; intubation; posture
Cardiac Fibroblast Activation Detected by 68Ga-FAPI PET/MR
Condition: Myocardial Remodeling After AMI
Study type: Interventional

Summary: 
      Myocardial infarction is the most common cause of high mortality in the modern world. The
      short-term survival rate of ST-elevated myocardial infarction (STEMI) has been dramatically
      increased in the past decades thanks to primary coronary intervention and standardization of
      treatment. However, the long-term prognosis of patients with acute myocardial infarction
      (AMI) is still poor, especially in the aging population, due to heart failure related to
      inappropriate myocardial fibrosis and subsequent left ventricular (LV) remodeling. Despite
      the amelioration of STEMI management, LV remodeling still occurs in approximately 1/3 of all
      STEMI patients. Therefore, early identification of such patients may help the optimization of
      therapy and eventually the outcomes.

      One characteristic of activated cardiac fibroblasts is the expression of FAP (fibroblast
      activation protein). A tracer (FAP inhibitor) for positron emission tomography that targets
      FAP has been used to measure relative FAP density indicative of activated fibroblasts in
      different cancer entities. However, whether it can reliably assess myocardial fibrosis and
      predict the poor prognosis caused by LV remodeling is not yet known. Therefore, We aim to
      observe active myocardial fibrosis process in patients with AMI, and analyze its relationship
      with the patients'prognosis in a longitudinal study through 68Ga-FAPI PET/MRI.
    


Intervention name(s): 68Ga-FAPI PET/MRI
Intervention type(s): Diagnostic Test
Intervention description(s): PET and MRI in patients with acute myocardiac infarction are simultaneously analyzed using hybrid PET/MRI device for monitoring myocardial fibrosis and function.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Sun Protection Factor (SPF) Determination of Two Sunscreen-Containing Lip Balms
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      The aim of this study is to determine the SPF of two test materials ChapStick Moisturizer,
      Classic Flavor and ChapStick Moisturizer, Strawberry Flavor using the methodology described
      in the International Standard Test Method. This static methodology also meets the
      requirements of the Australia/New Zealand standard.
    

Detailed description: 
      A single-center, randomized, evaluator blind, intra-individual comparison, no treatment and
      positive controlled clinical study to determine the SPF of two ChapStick sunscreen-containing
      lip balms as per ISO 24444:2010. For each participant, 4 test sites will have a random
      assignment number for up to two test materials, control standard, and minimal erythemal dose
      of unprotected skin (MEDu), with at least 3 of the test sites being utilized for application.
      All three test sites will be exposed to UV radiation at the expected MED and subsequently
      evaluated for erythema 16-24 hours after UV exposure.
    

Intervention name(s): ChapStick Moisturizer, Strawberry Flavor; ChapStick Moisturizer, Classic Flavor; ISO 24444:2010 P2 Standard Reference Sunscreen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single topical application of ChapStick Moisturizer, Strawberry Flavor will be applied to the appropriate 40 square centimeter (cm^2) test site (on the back of each participants). This application shall provide a test material film of approximately 2.00 +/- 0.05 milligram per centimeter square (mg/cm^2), using 80 +/-2 milligrams (mg) of material.; A single topical application of ChapStick Moisturizer, Classic Flavor will be applied to the appropriate 40 cm^2 test site (on the back of each participants). This application shall provide a test material film of approximately 2.00 +/- 0.05 mg/cm^2, using 80 +/-2 mg of material.; A single topical application of ISO 24444:2010 P2 Standard Sunscreen will be applied to the appropriate 40 cm^2 test site (on the back of each participants). This application shall provide a test material film of approximately 2.00 +/- 0.05 mg/cm^2, using 80 +/-2 mg of material.
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Sleep Inertia and Functional Connectivity
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the study is to investigate the functional connectivity between the brain regions
      of the default mode network before and after a 40 min nap slot in the afternoon. The
      hypothesis is that connectivity between brain regions will be decreased after the nap as
      compared to before the nap.
    


Intervention name(s): fMRI
Intervention type(s): Other
Intervention description(s): fMRI scans will be acquired before and after a 40 min nap slot in the afternoon. Functional connectivity between brain region will be assessed analyzing the scans with the CONN toolbox of the Statistical Parametric Mapping (SPM) software.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of Lycium Barbarum Supplements on the Progression of Senile Cataract in Hong Kong Chinese Population
Condition: Lens Opacity
MeSH terms: Cataract
Study type: Interventional

Summary: 
      With the rapid growing aging population, age-related eye diseases including cataract are
      becoming more prevalent. The demand for cataract surgery and post-surgical care posed
      enormous financial burdens to the government.

      Lycium barbarum contains lutein and zeaxanthin which can filter the phototoxic blue light and
      neutralize the reactive oxygen species, thus provide a protective effect against cataract
      formation.

      This study aims to determine the effects of Lycium barbarum Supplements on the progression of
      senile cataract in Hong Kong Chinese elderly.
    

Detailed description: 
      Please note that a manuscript for this study is being prepared. Detailed description will be
      provided after we come up with the final draft.
    

Intervention name(s): Starch; Lycium Barbarum
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1350mg/day; 1350mg/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Iron Bioavailability From Encapsulated Ferrous Sulphate
Condition: Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Salt is one of the very few regularly purchased food item in all socioeconomic classes
      including poor remote areas with subsistence farming. Therefore, it is a promising vehicle
      for fortification with micronutrients, such as iodine, iron, vitamin A, to alleviate the
      burden of micronutrient deficiencies. However, ensuring the bioavailability of iron and the
      sensory quality in fortified salt is difficult. Water-soluble iron compounds, such as ferrous
      sulphate FeSO4, are the most bioavailable, but they react with moisture and impurities in
      salt, and cause unacceptable changes in colour. Encapsulation can reduce iron-mediated colour
      change in fortified salt without significantly compromise bioavailability. In the present
      project we aim to investigate the iron bioavailability from salt fortified with FeSO4 using a
      new encapsulation type based on hyaluronic acid (HA) and a polymer from the eudragit family
      (EPO).
    


Intervention name(s): non-encapsulated FeSO4; encapsulated FeSO4, before cooking; encapsulated FeSO4, after cooking; non-encapsulated FeSO4 + ascorbic acid; encapsulated FeSO4 + ascorbic acid, before cooking; encapsulated FeSO4 + ascorbic acid, after cooking
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Ascorbic Acid; Fesoterodine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Iron deficiency; Iron fortification; Iron encapsulation
Alcohol and Implicit Process in Sexual Risk Behavior in MSM
Condition: Alcohol Drinking; Sex Behavior; Men
MeSH terms: Alcohol Drinking
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is the first empirical investigation that directly addresses the
      correspondence between responses regarding indicators of risky sexual behavior while under
      the influence of alcohol in the laboratory and the occurrence of sexually risky behavior
      while under the influence of alcohol in the natural environment, by use of Ecological
      Sampling Methodology (ESM). The study will allow us to compare and contrast implicit and
      explicit assessments of sexual risk in respect to future behavior in the natural environment.
      The data obtained will thus provide new information regarding the external validity of
      alcohol administration studies of sexual risk behavior and will provide information to
      optimize the selection of dependent measures. The current study also represents the first
      attempt to test a causal model linking alcohol intoxication and risky sexual behavior as a
      function of both automatic, reflexive, approach tendencies and effortful, deliberative,
      self-control (operationalized by executive working memory in this application). The ESM study
      will augment the findings of the experiment by providing a detailed assessment of contextual
      factors that affect sexual risk behavior as well as replicating and extending the findings of
      the experiment to sexual risk situations in the natural environment. Finally, to our
      knowledge there has been only one experimental study of alcohol and sexual risk in MSM
      (Maisto, Palfai, Vanable, Heath, & Woolf-King, 2012), which is remarkable given that MSM have
      been identified as the population at highest risk to contract the HIV in the U.S. since the
      virus was identified in the early 1980s. Thus the proposed research is only the second
      attempt to add to an understanding of the connections among alcohol, cognitive processes, and
      sexual risk behaviors in MSM.
    


Intervention name(s): Alcohol; Placebo (non-alcoholic beverage)
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomly assigned to a beverage condition: alcohol, placebo, or control (water).
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: men who have sex with men
Urine Drug Levels Related to Source of Water for Irrigation for Vegetable Crops Among Healthy Israeli Volunteers
Condition: Healthy Individuals
Study type: Interventional

Summary: 
      Over 60% of crops in Israel are grown in recycled treated waste water. This study aims to
      determine whether minute quantities of drugs such as Carbamazepine can be found in
      individuals who ingest vegetables grown in waste water.
    

Detailed description: 
      40 healthy volunteers will undergo a food frequency questionnaire and ask to undergo a daily
      food diary.They will also be asked about drug exposure.

      At baseline they will provide a urine and hair sample to determine presence of
      pharmaceuticals.

      They will then undergo a crossover trial wih one week exposure to vegetables grown in
      recycled waste water or fresh water, with a three day wash out period. Participants will be
      asked to ingest a minimal amount of lettuce, carrots, peppers, tomatoes and lettuce during
      the study period.

      During this period questionnaires will continue and urine samples will be collected every
      three days. The first compound to be tested will be carbamazepine, as it is stable in water.

      It is important to note that vegetables provided to the participants are available in regular
      grocery stores.

      Participants will be asked to drink bottled water throughout the study period . A sample of
      their home drinking water will also be tested for Carbamazepine as will a sample of the
      vegetables they consume.
    

Intervention name(s): vegetables from fresh or recycled water; receives vegetables from fresh water or recycled waste water farms
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: environment, recycled wastewater, carbamazepine
Seasickness Susceptability and Vestibular Time Constant
Condition: Seasickness
MeSH terms: Motion Sickness
Study type: Interventional

Summary: 
      Participants were selected from the military navy crewmembers prior to commencing of active
      sailing.

      A vestibular time constant was calculated based on velocity step testing on a rotatory chair
      at baseline, 3 months and 6 month following active sailing duty.

      A seasickness questionnaire (WIKER) was completed during follow-up visits. study participants
      were divided to three groups based on WIKER score - susceptible , non-susceptible and
      habituating. Vestibular time constant was compared between study groups.
    


Intervention name(s): rotatory chair testing in a velocity step protocol.
Intervention type(s): Diagnostic Test
Intervention description(s): Tc was evaluated by the rotational velocity step test using the OtoaccessTM interface (Interacoustics Nydiag 200, Middlefart, Denmark). Subjects were seated on the rotatory chair wearing videonystagmography goggles with their heads supported and tilted 30° forward, thus bringing the horizontal semicircular canals plane perpendicular to the axis of rotation. Standard videonystagmography techniques were employed to record eye-movements. Subsequent to eye movements' calibration, the chair was accelerated about the yaw axis at 30°/sec2 to a maximal velocity of 90°/sec, followed by rotation at a constant velocity. After 57 seconds of constant velocity rotation, the chair was decelerated to zero velocity at 30°/sec2. The described velocity step was conducted both clockwise and counter-clockwise, giving a total run time of 4 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Single and Multiple Ascending Dose, First-in- Human Study in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists
      of 2 parts: Part A is a single ascending dose (SAD) study in healthy subjects and Part B is a
      multiple ascending dose (MAD) study in healthy subjects.
    


Intervention name(s): TD-5202; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study Drug to be administered orally; Placebo to be administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: TD-5202; 0177; single ascending dose; SAD; multiple ascending dose; MAD; first-in-human; Phase 1
ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty
Condition: Osteoarthritis; Post-traumatic Arthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This post-marketing investigation will evaluate the mechanical axis alignment achieved with
      the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment
      achieved with the ATTUNE Reusable Instrumentation (RUI) in primary cemented Total Knee
      Arthroplasty.
    

Detailed description: 
      This study is designed as comparative, sequential, non-randomized, multi-center
      investigation.

      Up to four sites will recruit approximately 88 subjects. Each site is expected to implant the
      ATTUNE primary cemented total knee in approximately 22 subjects. The sequential design
      requires all ATTUNE TKA with reusable instruments be completed before doing any ATTUNE TKA
      with single use instruments.

      The mechanical axis alignment will be assessed at the 3 month follow-up by independent
      radiographic review.
    

Intervention name(s): ATTUNE TKA with ATTUNE RUI; ATTUNE TKA with ATTUNE SUI
Intervention type(s): Device; Device
Intervention description(s): ATTUNE TKA with ATTUNE RUI; ATTUNE TKA with ATTUNE SUI
Other intervention name(s): ATTUNE Intuition; ATTUNE SOLO
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mechanical Axis Alignment; Knee Arthroplasty, Total
Pilot Study to Evaluate the Safety and Efficacy of Ariva® Silver Wintergreen in Reducing Cigarette Craving in Smokers
Condition: Tobacco Use Disorder; Smoking
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the safety and effectiveness of Ariva® Silver Wintergreen lozenge on
      reducing craving for a cigarette in daily smokers.
    

Detailed description: 
      Each subject will be given an Ariva® Silver Wintergreen lozenge or a Silver Wintergreen
      lozenge, which contains only silver salt, on a random basis.

      Once the lozenge has dissolved in the mouth, subjects will smoke one of their own cigarettes,
      and will answer questions about the experience and their craving for a cigarette.

      After a washout period, each subject will repeat the steps with the second type of lozenge.
    

Intervention name(s): Ariva® Silver Wintergreen; Silver Wintergreen
Intervention type(s): Other; Other
Intervention description(s): Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.; Comparator product containing 6 mg silver salt and no tobacco (i.e., no nicotine), administered orally as a single dose.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: smoking; smokeless; aversion; nicotine; nicotine replacement
Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of sublingual zolpidem
      presentation 5 mg in the induction of sleep in patients with primary insomnia.
    

Detailed description: 
      -  National study, phase IV, single-center, double-blind, randomized, parallel, controlled
           by zolpidem 10mg oral.

        -  Experiment duration: 93 days.

        -  05 visits (days -3, 0, 15, 45 and 90).

        -  Efficacy will be evaluated for: Sleep induction and the maintenance of sleep.

        -  Adverse events evaluation.
    

Intervention name(s): Zolpidem Hemitartrate
Intervention type(s): Drug
Intervention description(s): Patz - 5mg sublingual zolpidem hemitartrate
1 QD
Stilnox - 10mg oral zolpidem hemitartrate
1 QD
Other intervention name(s): Patz - 5mg sublingual zolpidem hemitartrate; Stilnox - 10mg oral zolpidem hemitartrate
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment