bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil in Subjects With MCI
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      To purpose of this study is to estimate the effect of donepezil on Neuropsychological Testing
      (NPT) and brain Proton Magnetic Resonance Spectroscopy.
    


Intervention name(s): donezepil (Aricept)
Intervention type(s): Drug
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
#iBeatCRC: A Community-based Intervention to Increase Early-onset Colorectal Cancer Awareness
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Dr. Rogers' long-term goal is to better understand the etiology of an early-onset colorectal
      (CRC) diagnosis and to improve long-term survivorship and quality of life for early-onset CRC
      (EOCRC) survivors globally by studying the burdens accompanying this condition. The goal of
      this study is to better understand the reasons why people under age 50 in Utah and Wisconsin
      are being diagnosed with CRC. As a first step, the researchers identified the specific places
      in Utah and Wisconsin where diagnoses of CRC among younger people are increasing the most.
      Next, they conducted 1-hour recorded Zoom interviews over phone and/or video with 27 people
      across the United States diagnosed with CRC when they were under age 50. Thirdly, the
      researchers plan to create and test a program that will raise the awareness of residents in
      Utah and Wisconsin of the increasing risk of CRC among residents of the state who are aged
      under 50. This study is unique as CRC survivors are key to helping drive the study forward.
    

Detailed description: 
      Colorectal cancer (CRC) is preventable when detected early. Because of effective screening,
      fewer Americans aged 50 and older are now being diagnosed with CRC or dying from it. Over the
      past 20 years, however, the number of Americans under age 50 who are diagnosed with CRC has
      doubled. Health experts estimate that the numbers of younger Americans with CRC will continue
      to increase rapidly over the next 10 years. The reasons for this increase are poorly
      understood. In addition, younger people are less likely to be diagnosed with CRC when the
      disease is still at an early stage. Also, of concern is that among men and women of all ages
      and all races, African-American men are the most likely to die of CRC.

      Central hypotheses were: (1) Patients residing in hotspots-counties with high EOCRC
      incidence/mortality rates-will have significantly worse EOCRC survival juxtaposed to those in
      other Utah areas, specifically. (2) Rurality and county-level access to health care will
      contribute to an explanation of EOCRC incidence and survival.
    

Intervention name(s): Interviews; Pilot
Intervention type(s): Behavioral; Behavioral
Intervention description(s): We will understand the impact psychosocial, lifestyle, and familial aspects play on an EOCRC diagnosis through 20 one-hour interviews with EOCRC patients and survivors.; Utilizing the Behaviour Change Wheel in conjunction with results gathered from Aims 1 and 2 we will develop a theory-driven, multi-media campaign intervention to increase awareness of EOCRC, risk factors, and early detection benefit.
Intervention model: Sequential Assignment
Intervention model description: Explanatory Mixed Methods Approach
Masking: None (Open Label)
Primary purpose: Prevention
Lung Recruitment and Postoperative CPAP
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      General anesthesia lowers FRC thereby promoting airway closure and absorption atelectasis.
      Alveolar recruitment manoeuvers recruit collapsed alveoli, increase gas exchange, and improve
      arterial oxygenation.
    

Detailed description: 
      General anesthesia lowers FRC thereby promoting airway closure and absorption atelectasis.
      Alveolar recruitment manoeuvers recruit collapsed alveoli, increase gas exchange, and improve
      arterial oxygenation. However, the effect of recruitment manoeuvre is short lasting and does
      not extend to the post operative period. Postoperative CPAP keeps the lung open and can
      improve oxygenation in the early postoperative period.
    

Intervention name(s): Engström Datex-Ohmeda ICU Ventilator; Postoperative CPAP mask
Intervention type(s): Device; Device
Intervention description(s): patients will be mechanically ventilated and a vital capacity manoeuvre for lung inflation will be done by increasing the PIP to 35 cmH2o for 15 seconds followed by PEEP until extubation.; patients will be mechanically ventilated and a vital capacity manoeuvre for lung inflation will be done by increasing the PIP to 35 cmH2o for 15 seconds followed by PEEP until extubation and a CPAP mask will be applied immediately postoperative.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      To compare glycemic control and treatment satisfaction using a novel bolus insulin patch
      (Finesse) versus a pen for initiating and managing bolus insulin dosing in patients with T2DM
      not achieving glycemic targets on basal insulin with/without anti-hyperglycemic agents.
    

Detailed description: 
      Patients sub-optimally controlled on basal insulin (with/without other antihyperglycemic
      agents (AHAs)) will be randomized 1:1 to either Finesse or pen to initiate bolus insulin
      dosing and followed for a 44-week intervention period. Patients will have both basal and
      bolus doses of insulin adjusted throughout the trial, as is clinically indicated, based on an
      easy to follow insulin dosing algorithm. After the final endpoint evaluation at week 44,
      patients will crossover to the alternate bolus insulin delivery device for 4 weeks and
      complete a patient preference survey at week 48.
    

Intervention name(s): Bolus Insulin Patch (Calibra Finesse); Insulin Pen (Novo-Nordisk FlexPen®)
Intervention type(s): Device; Device
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate MEDI-534 in Healthy Adults
Condition: Respiratory Syncytial Virus Infections; Parainfluenza Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Syncytial Virus Infections; Paramyxoviridae Infections
Study type: Observational

Summary: 
      The primary objective of this study is to describe the safety and tolerability of a single
      dose of MEDI-534 when administered to healthy adult volunteers.
    


Intervention name(s): MEDI-534
Intervention type(s): Drug
Observational model: Defined Population
Time perspective: Prospective
Keywords: Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3)
Breakfast Consumption and Energy Balance in Active Adult Males
Condition: Energy Intake; Substrate Utilization; Hormones; Satiety
Study type: Interventional

Summary: 
      Exercising in the fasted state results in greater fat oxidation during exercise and results
      in decreased caloric intake in the meals after exercise. However, the studies that examine
      fasted vs. fed exercise utilize a carbohydrate-based breakfast, which can increase blood
      glucose and insulin concentrations, which is considered a negative consequence. A protein
      breakfast, which can increase satiety and rest of day energy intake could also increase
      resting energy expenditure as well as fat oxidation during exercise. However, comparisons
      between fasting exercise and pre-exercise breakfast macronutrient intake (i.e., carbohydrate
      vs. protein) have not been made. Therefore the purpose of this study is to investigate if
      eating breakfast and the composition of this breakfast before exercise has an effect on the
      food eaten throughout the rest of the day.
    


Intervention name(s): Maltodextrin supplement; Whey supplement; Water; Maltodextrin supplement
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): maltodextrin (25g in 12 oz water) 1 hour pre-exercise; whey (25g in 12 oz water) 1 hour pre-exercise; non-caloric control (12 oz flavored water) 1 hour pre-exercise; maltodextrin (25g in 12 oz water) with no exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
The Effect of 5 Times Dry Cupping in the Treatment of Chronic Neck Pain
Condition: Neck Pain; Neck Pain Musculoskeletal; Mechanical/Motor Problems With Neck and Trunk
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The study aims to investigate the influence of 5 dry cupping treatments on chronic non
      specific neck pain. 50 patients with neck pain are randomised into cupping treatment and
      waiting list control group at T0 (Day 0). At T1 (Day 7)the investigators evaluate the neck
      pain (VAS), the neck related disability (NDI), pain related to movement (PRTM) and the
      quality of life (SF36). To investigate neurophysiological effects of cupping we also measure
      mechanical detection threshold (MDT), vibration detection threshold (VDT) and pressure pain
      threshold (PPT) at pain related and control areas. The treatment group then receives 5
      cupping treatments over a period of two weeks. After the cupping series resp. a waiting
      period for the waiting list control group (T2, Day 25) all measurements from T1 are repeated
      (VAS, NDI, PRTM, SF36, MDT, PPT, VDT). At last, a pain and medication diary is filled in by
      the patients from T0(Day 0) until T2 (Day 25). The investigators hypothesize, that cupping
      treatment is effective against neck pain (diary, VAS, NDI, PRTM, SF36) and that it leads to
      changes on perceptual level (MDT, VDT, PPT), when compared to the waiting list control group.
    

Detailed description: 
      see above
    

Intervention name(s): Dry Cupping or fire cupping
Intervention type(s): Procedure
Intervention description(s): 5 dry cupping treatments, application twice a week, non standardised procedure
Other intervention name(s): Cupping is: heating glas cups to create a vacuum on the skin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Biomarkers of Exposure and Biomarkers of Potential Harm in Adult Smokers Who Completely Switch to E-vapor Products
Condition: Tobacco Use
Study type: Interventional

Summary: 
      The purpose of this study was to estimate changes in biomarkers of exposure (BoE) and
      biomarkers of potential harm (BoPH) in adult cigarette smokers (AS) who switched to using an
      e-vapor product (EVP) relative to adult smokers who continue smoking exclusively.
    

Detailed description: 
      This study was conducted as a randomized, parallel-group, open-label, 24-week, controlled
      clinical study split into an initial 12-week study (Study 1), with a follow-up at 24 weeks
      (Study 2) in a sub-population of switchers. For Study 1 a total of 450 subjects were
      enrolled. Of those subjects who successfully completed Study 1, 150 were then enrolled into
      Study 2 with no interruption in study participation. The study compared changes in BoE and
      BoPH in AS who switched to ad libitum use of one of two test EVPs with those in the Control
      group who continued to smoke conventional cigarettes. The study enrolled AS who were
      considered to be in overall good health.
    

Intervention name(s): Experimental: Test Product 1; Experimental: Test Product 2
Intervention type(s): Other; Other
Intervention description(s): Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC); Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This research study utilized a parallel-group, open-label, controlled design and was conducted at multiple study sites.
Masking: None (Open Label)
Primary purpose: Other
Impact on French Physician's Haemophilia Treatment Management Decision Based on Systematic Joint Examination
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional

Summary: 
      This low interventional study aims to describe if and how the haemophilia treatment
      management decisions are impacted by a systematic joint examination (ultrasound, functional,
      physical) in patients with haemophilia A in France.
    

Detailed description: 
      The study will assess the behavior of the physicians with regards to haemophilia management
      decisions, and if systematic joint examination have an impact on their decisions. The main
      objective is to evaluate if the use of HEAD-US and Haemophilia Joint Health Score (HJHS) have
      an impact on these decisions. The study is classified as a low-interventional study due to
      mandated systematically assessment (HEAD-US, HJHS) on patients which may not be part of
      routine clinical practice.
    

Intervention name(s): Ultrasound, Haemophilia Joint Health Score
Intervention type(s): Procedure
Intervention description(s): Systematic joint examinations of ankles, knees and elbows
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: joint health
Palmitic Acid in the Sn-2 Position of Triacylglycerols and Postprandial Lipemia
Condition: Healthy Men; Raised Fasting Plasma Triacylglycerol Concentrations
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether high-fat meals rich in palmitic acid in the
      sn-2 position decrease lipaemia in men aged 40-70 y with higher than optimal fasting
      triacylglycerol concentrations.
    


Intervention name(s): High-fat meal containing native palm olein; High-fat meal containing interesterified palm olein
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Lipemia; Vascular function; Blood pressure
Effect of Schistosomiasis Mansoni on HIV Susceptibility and Female Genital Immunology
Condition: Schistosomiasis Mansoni; HIV
MeSH terms: Schistosomiasis; Schistosomiasis mansoni; Disease Susceptibility
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess the impact of Schistosoma mansoni infection and its
      treatment on genital immunology and HIV susceptibility in Ugandan women.
    

Detailed description: 
      Schistosomiasis mansoni is a water-borne disease caused by helminth Schistosoma mansoni (S.
      mansoni), in which adult worms deposit eggs in mesenteric blood vessels. Schistomiasis
      prevalence in the fishing communities in East Africa, and particularly in the Lake Victoria
      region, exceeds 60% and there is overlap in this region with a high prevalence of HIV (29%).

      A recent epidemiological study found an association between S. mansoni and HIV infection in
      adult women residing near Lake Victoria in Tanzania. Furthermore, in primate studies S.
      mansoni infection was shown to increase susceptibility to SIV infection after rectal (but not
      intravenous) challenge, implying that S. mansoni might increase HIV susceptibility by
      altering local mucosal (gut) immunology.

      While S. mansoni does not directly infect the genital tract, we hypothesize that the
      inflammation it causes in the gut may be associated with mucosal inflammation at other sites
      through activation of common mucosal homing integrins such as a4b7. Therefore in this study
      we propose to explore whether S. mansoni increases inflammation and/or HIV susceptibility in
      the endocervix of adult women.

      HIV-uninfected adult women from Entebbe, Uganda will be screened for schistosomiasis using a
      commercial CCA rapid test kit, and infected women who fulfill the study eligibility criteria
      will be recruited into the study. Kato-Katz microscopy analysis will be performed to assess
      egg shedding at baseline. Additionally, urine microscopy will be done to screen for
      Schistosoma hematobium (which can directly involve the genital mucosa). Schistosomiasis
      treatment will be provided to all participants according to Ugandan clinical guidelines.

      Endocervical cytobrush, vaginal SoftCup and blood samples will be collected at three time
      points; at baseline and 4 and 8 weeks after schistosomiasis treatment, at the same stage of
      the menstrual cycle. Using an ex vivo HIV entry assay and mucosal cytokine and microbiome
      analyses we will quantify the effect of S. mansoni and its treatment on cervical HIV
      susceptibility and genital inflammation.
    

Intervention name(s): Praziquantel
Intervention type(s): Drug
Intervention description(s): 40 mg/kg, PO (orally administered tablets)
Other intervention name(s): Agopraz, bromoxel, biltricide
Intervention MeSH terms: Praziquantel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Schistosomiasis mansoni; HIV susceptibility; Genital immunology; Mucosal immunology; HIV entry assay; Adult women
Myofascial Pain:Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine
Condition: Myofascial Pain Syndromes
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia
Study type: Interventional

Summary: 
      CONTEXT AND OBJECTIVE: Myofascial syndrome is the most frequent condition of chronic pain.
      The objective of the present study was to compare the analgesic action of acupuncture and
      trigger point injection combined with cyclobenzaprine and dipyrone.

      DESIGN AND SETTING: A randomized study was performed at the Pain Clinic. METHODS: Thirty
      patients were divided into two groups: G1 received trigger point injection of 0.25%
      bupivacaine (1 ml/point) twice a week, 10 mg/day cyclobenzaprine and 500 mg dipyrone every 8
      h. G2 was submitted to classical and trigger point acupuncture twice a week. The patients
      were asked to continue physical exercise. The following parameters were evaluated: pain
      intensity rated on a numerical and verbal scale, quality of life before and four weeks after
      treatment, and quality of analgesia.
    

Detailed description: 
      Among the 39 patients selected, nine (3 in group 1 and 6 in group 2) were excluded from the
      study because they did not attend the visits scheduled for the procedures and assessment or
      because they did not respond to the questionnaires.
    

Intervention name(s): bupivacaine and acupuncture
Intervention type(s): Drug
Intervention description(s): trigger point injection of 0.25% bupivacaine (1 ml/point) twice a week, 10 mg/day cyclobenzaprine and 500 mg dipyrone every 8 h.
acupuncture twice a week
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myofascial pain syndrome; Acupuncture; Nonsteroidal anti-inflammatory agents; Muscle relaxants, central; Quality of life.; muscle relaxants, analgesia
An Evaluation Of Healthy Ankle Motion And Morphology
Condition: Healthy Ankle
Study type: Observational

Summary: 
      Determine motion and morphology of the healthy ankle during simulated gait.
    

Detailed description: 
      Healthy volunteers will undergo weight-bearing, cone beam CT scans of their foot/ankle during
      3 phases of simulated gait. Motion and morphology of the foot and ankle will be quantified
      and analyzed.
    

Intervention name(s): Cone Beam Computed Tomography; Radiographs
Intervention type(s): Radiation; Radiation
Intervention description(s): Computer tomography (CT) of the foot/ankle for determination of motion and morphology; Standard radiographs of the foot/ankle as part of the screening criteria
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Volunteers who have a healthy ankle
      
Keywords: ankle
Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults
Condition: COVID-19; SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different
      lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373).The study will enroll
      approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive.
    

Detailed description: 
      This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different
      lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373). The study will enroll
      approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive. Participants
      will be screened at baseline with the goal of enrolling approximately 900 previously
      vaccinated participants. Participants will be randomized 1:1:1 to receive 1 dose of the
      vaccine from 1 of 3 different lots, given on Day 1, at a dose level of 5 µg of antigen with
      50 µg of Matrix-M adjuvant. All participants will remain on study for immunogenicity and
      safety data collection through 28 days following the vaccination.
    

Intervention name(s): NVX-Cov2373
Intervention type(s): Drug
Intervention description(s): Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
Other intervention name(s): SARS-CoV-2 rS/Matrix-M Adjuvant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Coronavirus; COVID-19