bioihbjkbjnl/mcl2 huggingface dataset:
Use of Electromyography With Bio-Feedback for the Treatment of Craniomandibular Disorders
Condition: Craniomandibular Dysfunction; Orofacial Pain
MeSH terms: Facial Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The treatment of craniomandibular disorders is a challenging task. Many different treatments
      are yet available with occlusal splints being one of the most commonly used. A relative new
      diagnostic and treatment alternative is the Grindcare device. This enables the
      electromyographic (EMG) assessment of the activity of the temporal muscle and the contigent
      electrical stimulation of this muscle as bio-feedback whenever the EMG activity exceeds a
      certain limit. This stimulation results to a sudden break of the muscle activity.

      Aim of this study is to compare the therapeutic efficacy of the Grindcare device in pain
      reduction at female non-chronic CMD patients to that of a Michigan-type splint. Our
      null-hypothesis was that there is no difference between the device and the splint in the
      reduction of pain intensity.
    


Intervention name(s): Grindcare; Michigan-type occlusal splint
Intervention type(s): Device; Device
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Impact of Individualized Radiotherapy Plan Review in Patients Receiving Adjuvant Radiotherapy for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This study is being conducted to investigate the effect of a more in-depth education plan for
      patients with breast cancer. Patients will be randomized to receive either the standard
      education plan during their breast cancer treatment or they will receive in-depth education
      about their breast cancer treatment. In order to see what kind of effect the different
      education plans have, patients will fill out three identical questionnaires during the course
      of treatment.
    

Detailed description: 
      This study will be a prospective study of women receiving adjuvant radiation therapy for
      management of breast cancer at the University of California Davis. All patients will be
      staged according to the American Joint Committee on Cancer Seventh edition. Primary disease
      treatment information including surgical approach and utilization of adjuvant chemotherapy
      will be evaluated.

      All patients will have a validated quality of life assessment (FACIT-TS-PS) completed at
      three time points during their radiation therapy process. The patients will be randomized at
      the time of completion of radiation plan approval by the treating radiation oncologist in a
      one to one fashion to either proceed with standard education or more extensive plan review.
      The radiation oncology quality assurance (QA) process will be blinded to the randomization of
      the patient.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study is for women with breast cancer. All patients will be staged according to the
        American Joint Committee on Cancer Seventh edition. Primary disease treatment information
        including surgical approach and utilization of adjuvant chemotherapy will be evaluated.
      
Keywords: Breast Cancer; AJCC Stage 1, 2, 3; Educational Design; Radiation Therapy Treatment
Diabetes Prevention Program Pilot Study
Condition: Diabetes Prevention
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This pilot study is intended to demonstrate that we can actually deliver the Diabetes
      Prevention Program intervention well and to show that it is likely effective. We will use
      results from this pilot study to support our application to The National Institute of Health.
      NIH is asking for health care centers to show ways to provide this treatment at a reasonable
      cost. We propose to demonstrate successful and sustainable use DPP's lifestyle intervention
      in a primary care health care setting (University of Rochester Primary Care).
    


Intervention name(s): DPP; DPP
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The primary outcome measure is weight loss with a goal of 7% of initial weight.
Secondary outcomes are adherence to behavior changes:
Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week
Fat intake less than 25% and saturated fat less than 10%
Fiber intake of at least 25 grams per day
Fasting blood sugar < 100 mg/dL
Absence of tobacco use; The primary outcome measure is weight loss with a goal of 7% of initial weight.
Secondary outcomes are adherence to behavior changes:
Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week
Fat intake less than 25% and saturated fat less than 10%
Fiber intake of at least 25 grams per day
Fasting blood sugar < 100 mg/dL
Absence of tobacco use
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes Prevention; Pre-Diabetes; Exercise; Fat Intake; Fasting blood sugar; tobacco cessation
Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single
      dose, crossover, oral bioequivalence study.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, oral bioequivalence study of Montelukast Sodium Oral Granules 4mg of Dr. Reddy's
      Laboratories Limited, India comparing with that of SINGULAIR® (Montelukast sodium) 4mg oral
      granules of Merck Sharp & Dohme Ltd., USA in healthy, adult, human subjects under fed
      conditions.
    

Intervention name(s): Montelukast sodium
Intervention type(s): Drug
Intervention description(s): Montelukast Sodium Oral Granules 4mg
Other intervention name(s): SINGULAIR
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Montelukast Sodium; crossover
A Study to Investigate the Effects of Sisunatovir on QTc Interval in Healthy Adult Participants.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the effects of multiple oral doses of sisunatovir
      on QTc Interval.

      This study is seeking participants who:

        -  are male or female of 18 years of age or older

        -  are examined to be healthy All participants will receive Treatment A, B, and C in a
           randomized order based on 6 possible sequences. All treatments will be taken by mouth.
           Participants assigned to treatment A will receive 5 oral doses of sisunatovir
           administered Q12 hours over 3 days in a fed state. Participants assigned to treatment B
           will receive 5 oral doses of matching placebo administered Q12 hours over 3 days in a
           fed state. Participants assigned to treatment C will receive 4 oral doses of placebo
           administered Q12 hours for 2 days followed by a single dose of 400 mg moxifloxacin on
           the morning of Day 3.

      All participants will remain in the study clinic for 4 days for each treatment, for safety
      review, laboratory collections, and to assess how the study medicine affects QTc intervals.

      All participants selected in the study will be required to go through a screening period up
      to 28 days. A screening period is the time during which a few participants are examined to
      see whether they are fit for the study. During this period, the participant's medical history
      and past and current medications will be reviewed. A series of tests will also be performed
      to see if they are good to be selected for the study. If the participant meets all required
      criteria and are interested in continuing, the participant will be brought into the study
      clinic to stay overnight for 4 days for each treatment. On day 4, the participant will be
      discharged. About 28 to 35 days after discharge following the final treatment, the
      participant will be contacted for a follow up visit either in person or by telephone. This is
      to check up on how the participant is doing and to conclude the study.
    


Intervention name(s): sisunatovir; placebo; moxifloxacin; sisunatovir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 6 capsules administered Q12 hours for 5 doses; 6 capsules administered Q12 hours for 5 doses; 6 capsules of placebo administered Q12 hours for 4 doses, followed by a single tablet of moxifloxacin; 7 capsules administered Q12 hours for 5 doses
Other intervention name(s): PF-07923568; PF-07923568
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single Group, Crossover study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Healthy volunteers
Mediterranean Style Diet and Low Glycemic Responses
Condition: Insulin Sensitivity
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      the aim of this study is to evaluate whether a Mediterranean diet rich in pasta and other
      starchy foods with a (Low-GI), as compared with a similar Mediterranean diet containing very
      little pasta and based on starchy foods with a (Hi-GI) is able to reduce insulin and glucose
      concentrations during a prolonged test study meal.
    

Detailed description: 
      The overall aim of this study is to evaluate whether a Mediterranean diet rich in pasta and
      other starchy foods with a low glycemic response (Low-GI), as compared with a similar
      Mediterranean diet containing very little pasta and based on starchy foods with a high
      glycemic response (Hi-GI) is able to reduce insulin and glucose concentrations during a
      prolonged test study meal.
    

Intervention name(s): Hi GI
Intervention type(s): Other
Intervention description(s): subjects will consume the same quantities of metabolizable CHOs (270 g/d) with 135 g of CHOs assigned to the GI intervention foods. The 135 g of CHOs will be distributed as 35 g GI breakfast product, 40 g GI lunch product, and 60 g GI dinner product. Assuming an average 2400 kcal/d total energy requirement among subjects, the 270 g/d metabolizable CHO equates to 40% of total energy intake (1080 kcal/d). One-half of daily CHO intake (135 g/d) will be the same between the Hi-GI and Low-GI groups, including CHOs in fruits, vegetables, and other foods that all subjects will consume. The other one-half of daily CHO intake (135 g) will be different between the Low-GI and Hi-GI groups. Specifically, the GI values of these foods will either be <55 (Low-GI group) or >70 (Hi-GI group).
Other intervention name(s): Low GI
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: block randomized, parallel, controlled,
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Chewing Versus Traditional Oral Administration of Ticagrelor in STEMI Patients
Condition: Acute Coronary Syndromes; ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      To examine chewing versus traditional oral administration of ticagrelor in ST-elevation
      Myocardial Infarction (STEMI) patients on platelet reactivity.
    


Intervention name(s): Chewing Ticagrelor; Oral Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): 180 mg Chewing Ticagrelor; 180 mg oral Ticagrelor
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: STEMI
A Multicenter, Open Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Parietaria Judaica
Condition: Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was designed according to the draft of allergenic product regulation published by
      Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of
      subcutaneous immunotherapy with Parietaria judaica pollen extract in patients with
      rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy
      parameters will be evaluated: immunoglobulin level changes and skin reactivity.
    

Detailed description: 
      Parietaria judaica is a weed widespread throughout the Mediterranean área. Prevalence of
      sensitization to Parietaria judaica's pollen is very high in the Mediterranean areas,
      reaching 41.4% among allergic patients on the Spanish Mediterranean coast.

      The study has been designed as an open trial which will be conducted in 4 Spanish sites.
    

Intervention name(s): Allergovac depot with Parietaria judaica pollen extract
Intervention type(s): Biological
Intervention description(s): Subcutaneous immunotherapy in depot presentation in a rapid dose escalation scheme: 6 weekly dose increasing injections at the initiation phase plus 3 maintenance monthly injections
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: allergy; SCIT
Effects of Korean Red Ginseng on Male Infertility
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: Several in vitro studies report positive effects of ginseng on spermatogenesis.
      However, no controlled human clinical study of the effect of Korean red ginseng (KRG) on
      spermatogenesis has been performed. This study was performed to investigate the effects of
      KRG on semen parameters in male infertility patients in a randomized, double-blind,
      placebo-controlled study. Methods: A total of 80 male infertility patients with varicocele
      were recruited from April 2011 to February 2012. The subjects were then divided into the
      following four groups: non-V + P group, placebo; V + P group, placebo and varicocelectomy;
      non-V + KRG group, 1.5-g KRG daily; V + KGR group, 1.5-g KRG daily and varicocelectomy. Semen
      analysis was performed and hormonal levels were measured in each treatment arm after 12
      weeks.
    


Intervention name(s): Korean Red Ginseng, Varicocelectomy; Placebo; Varicocelectomy
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): Placebo were provided by Korean Ginseng Corporation (Daejeon, Korea). The placebo capsules were identical in shape, color, and taste.; Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Immune Response to Influenza Vaccinations in Elderly Individuals
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to characterize the immune profile of frail and healthy aged
      individuals and investigate their immune responsiveness including the response to influenza
      vaccine over an 18-month period. The project will include a longitudinal study to define
      immune signatures and multi-parameter profiles associated with frailty and may lead to the
      identification of predictive markers of evolution to frailty and Immunosenescence in the
      elderly.
    

Detailed description: 
      With better healthcare available and improved accessibility, people are living longer.
      However, a majority of older persons cannot be considered to be aging well. Approximately 70%
      of those aged 85 years or older require frequent long hospitalizations because of their
      increased susceptibility to infections, cancers, dementia, and other age-related health
      problems, along with overall loss of function and autonomy associated with old age. Previous
      studies have shown that vaccination against influenza, which significantly reduces all-cause
      mortality in the elderly (65 years and older), was less immunogenic and effective with age.
      Frailty, a geriatric syndrome associated with low functional activity, weight loss,
      exhaustion, disability, decreased resilience to stressors, has been shown to increase risk
      for adverse outcomes and death. Better understanding the relationship between aging and
      waning immune responsiveness will enable the development of strategies to improve response to
      vaccination in the elderly and reduce morbidity and eventually mortality associated with age
      related complications and outcomes such as infectious diseases or frailty. A comprehensive
      analysis of the immune phenotype and function after antigenic challenge in older individuals
      would be a unique approach to understand (i) the potential associations between aging,
      impaired immune function and transition to frailty, (ii) which components of the immune
      system are altered with aging (innate vs adaptive immunity) and (iii) if early and/or late
      immune responses are preferentially altered with aging and frailty.
    

Intervention name(s): Vaxigrip®
Intervention type(s): Drug
Intervention description(s): To describe the humoral immune response to Vaxigrip (IM) vaccination at Day 0 (baseline) and Day 28 according to the age and frailty status at baseline (i.e. in each study group) for each Influenza strain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Influenza Virus Vaccines; Vaxigrip; Respiratory Tract Infections; Orthomyxoviridae Infections; Frailty; Aging; Safety; Immunogenicity
Chocolate Consumption in Healthy Pregnant Women Trial
Condition: Hypertension Pregnancy-induced
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to to test the feasibility of design methods and procedures for
      later use on a larger scale and to examine the acute and chronic effect of consumption of
      flavanol-rich chocolate on endothelium function and blood pressure in healthy pregnant women.
    


Intervention name(s): Flavanol-rich dark chocolate; Placebo Chocolate
Intervention type(s): Other; Other
Intervention description(s): The primary objective of this pilot RCT is to test the feasibility of design methods and procedures for later use on a larger scale. The secondary objective is to examine the acute and chronic effect of dark chocolate on endothelial function and blood pressure, among healthy pregnant women.; Placebo intervention
Other intervention name(s): Chocolate rich in flavanols; Flavanol-free chocolate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Cacao; Chocolate; Theobromine; Flavonoids; Pregnant women; Hypertension pregnancy-induced; Pre-eclampsia; Epicatechin
Predictors of Asthma Exacerbations in Children
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of this study is to determine whether parameters of the pulmonary function tests
      and the bronchial hyperresponsiveness to methacholine are predictors of asthma exacerbations.
    

Detailed description: 
      Preliminary investigations from our own research group showed that lung function parameters
      (FEV1, the FEV1/FVC ratio and a moderate to severe hyperresponsiveness to methacholine
      challenge were risk factors of asthma exacerbations (OR 11.3). In the present study, these
      parameters will be evaluated in prospective design.

      One hundred children will be included in the study. Baseline parameters will be collected in
      a healthy interval (visit 1), then the children will be followed up for 1 year. If the
      patients fulfill the criteria for an exacerbation the children will present in our
      department. We expect that 44% of the children have an exacerbation. All children will
      present at a second visit after one year (visit 2).
    

Intervention name(s): Methacholine challenge testing
Intervention type(s): Other
Intervention description(s): Nebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mg
Other intervention name(s): Aerosol Provocation System (Cardinal Health GmbH)
Intervention MeSH terms: Methacholine Chloride
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Outpatients of departement of Pediatric Pulmonology and Allergology.
      
Keywords: Asthma; children; predictors of exacerbation; Methacholine challenge; Pulmonary function testing
The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is comparing the effectiveness of a mechanical manual therapy device to a specific
      exercise to no treatment in individuals experiencing neck pain. We are interested in the
      effects of the interventions on neck pain, disability related to neck pain, and pain
      sensitivity.
    


Intervention name(s): Pulstar Multiple Impulse Therapy; Exercise
Intervention type(s): Other; Other
Intervention description(s): Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.; Participants perform an exercise to strengthen the deep neck flexors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neck pain; manual therapy; exercise